[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2012 Edition]
[From the U.S. Government Printing Office]
[[Page i]]
Title 21
Food and Drugs
________________________
Parts 100 to 169
Revised as of April 1, 2012
Containing a codification of documents of general
applicability and future effect
As of April 1, 2012
Published by the Office of the Federal Register
National Archives and Records Administration as a
Special Edition of the Federal Register
[[Page ii]]
U.S. GOVERNMENT OFFICIAL EDITION NOTICE
Legal Status and Use of Seals and Logos
The seal of the National Archives and Records Administration
(NARA) authenticates the Code of Federal Regulations (CFR) as
the official codification of Federal regulations established
under the Federal Register Act. Under the provisions of 44
U.S.C. 1507, the contents of the CFR, a special edition of the
Federal Register, shall be judicially noticed. The CFR is
prima facie evidence of the original documents published in
the Federal Register (44 U.S.C. 1510).
It is prohibited to use NARA's official seal and the stylized Code
of Federal Regulations logo on any republication of this
material without the express, written permission of the
Archivist of the United States or the Archivist's designee.
Any person using NARA's official seals and logos in a manner
inconsistent with the provisions of 36 CFR part 1200 is
subject to the penalties specified in 18 U.S.C. 506, 701, and
1017.
Use of ISBN Prefix
This is the Official U.S. Government edition of this publication
and is herein identified to certify its authenticity. Use of
the 0-16 ISBN prefix is for U.S. Government Printing Office
Official Editions only. The Superintendent of Documents of the
U.S. Government Printing Office requests that any reprinted
edition clearly be labeled as a copy of the authentic work
with a new ISBN.
U . S . G O V E R N M E N T P R I N T I N G O F F I C E
------------------------------------------------------------------
U.S. Superintendent of Documents Washington, DC
20402-0001
http://bookstore.gpo.gov
Phone: toll-free (866) 512-1800; DC area (202) 512-1800
[[Page iii]]
Table of Contents
Page
Explanation................................................. v
Title 21:
Chapter I--Food and Drug Administration, Department
of Health and Human Services (Continued) 3
Finding Aids:
Table of CFR Titles and Chapters........................ 609
Alphabetical List of Agencies Appearing in the CFR...... 629
List of CFR Sections Affected........................... 639
[[Page iv]]
----------------------------
Cite this Code: CFR
To cite the regulations in
this volume use title,
part and section number.
Thus, 21 CFR 100.1 refers
to title 21, part 100,
section 1.
----------------------------
[[Page v]]
EXPLANATION
The Code of Federal Regulations is a codification of the general and
permanent rules published in the Federal Register by the Executive
departments and agencies of the Federal Government. The Code is divided
into 50 titles which represent broad areas subject to Federal
regulation. Each title is divided into chapters which usually bear the
name of the issuing agency. Each chapter is further subdivided into
parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year
and issued on a quarterly basis approximately as follows:
Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1
The appropriate revision date is printed on the cover of each
volume.
LEGAL STATUS
The contents of the Federal Register are required to be judicially
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie
evidence of the text of the original documents (44 U.S.C. 1510).
HOW TO USE THE CODE OF FEDERAL REGULATIONS
The Code of Federal Regulations is kept up to date by the individual
issues of the Federal Register. These two publications must be used
together to determine the latest version of any given rule.
To determine whether a Code volume has been amended since its
revision date (in this case, April 1, 2012), consult the ``List of CFR
Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative
List of Parts Affected,'' which appears in the Reader Aids section of
the daily Federal Register. These two lists will identify the Federal
Register page number of the latest amendment of any given rule.
EFFECTIVE AND EXPIRATION DATES
Each volume of the Code contains amendments published in the Federal
Register since the last revision of that volume of the Code. Source
citations for the regulations are referred to by volume number and page
number of the Federal Register and date of publication. Publication
dates and effective dates are usually not the same and care must be
exercised by the user in determining the actual effective date. In
instances where the effective date is beyond the cut-off date for the
Code a note has been inserted to reflect the future effective date. In
those instances where a regulation published in the Federal Register
states a date certain for expiration, an appropriate note will be
inserted following the text.
OMB CONTROL NUMBERS
The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires
Federal agencies to display an OMB control number with their information
collection request.
[[Page vi]]
Many agencies have begun publishing numerous OMB control numbers as
amendments to existing regulations in the CFR. These OMB numbers are
placed as close as possible to the applicable recordkeeping or reporting
requirements.
OBSOLETE PROVISIONS
Provisions that become obsolete before the revision date stated on
the cover of each volume are not carried. Code users may find the text
of provisions in effect on a given date in the past by using the
appropriate numerical list of sections affected. For the period before
January 1, 2001, consult either the List of CFR Sections Affected, 1949-
1963, 1964-1972, 1973-1985, or 1986-2000, published in eleven separate
volumes. For the period beginning January 1, 2001, a ``List of CFR
Sections Affected'' is published at the end of each CFR volume.
``[RESERVED]'' TERMINOLOGY
The term ``[Reserved]'' is used as a place holder within the Code of
Federal Regulations. An agency may add regulatory information at a
``[Reserved]'' location at any time. Occasionally ``[Reserved]'' is used
editorially to indicate that a portion of the CFR was left vacant and
not accidentally dropped due to a printing or computer error.
INCORPORATION BY REFERENCE
What is incorporation by reference? Incorporation by reference was
established by statute and allows Federal agencies to meet the
requirement to publish regulations in the Federal Register by referring
to materials already published elsewhere. For an incorporation to be
valid, the Director of the Federal Register must approve it. The legal
effect of incorporation by reference is that the material is treated as
if it were published in full in the Federal Register (5 U.S.C. 552(a)).
This material, like any other properly issued regulation, has the force
of law.
What is a proper incorporation by reference? The Director of the
Federal Register will approve an incorporation by reference only when
the requirements of 1 CFR part 51 are met. Some of the elements on which
approval is based are:
(a) The incorporation will substantially reduce the volume of
material published in the Federal Register.
(b) The matter incorporated is in fact available to the extent
necessary to afford fairness and uniformity in the administrative
process.
(c) The incorporating document is drafted and submitted for
publication in accordance with 1 CFR part 51.
What if the material incorporated by reference cannot be found? If
you have any problem locating or obtaining a copy of material listed as
an approved incorporation by reference, please contact the agency that
issued the regulation containing that incorporation. If, after
contacting the agency, you find the material is not available, please
notify the Director of the Federal Register, National Archives and
Records Administration, 8601 Adelphi Road, College Park, MD 20740-6001,
or call 202-741-6010.
CFR INDEXES AND TABULAR GUIDES
A subject index to the Code of Federal Regulations is contained in a
separate volume, revised annually as of January 1, entitled CFR Index
and Finding Aids. This volume contains the Parallel Table of Authorities
and Rules. A list of CFR titles, chapters, subchapters, and parts and an
alphabetical list of agencies publishing in the CFR are also included in
this volume.
An index to the text of ``Title 3--The President'' is carried within
that volume.
[[Page vii]]
The Federal Register Index is issued monthly in cumulative form.
This index is based on a consolidation of the ``Contents'' entries in
the daily Federal Register.
A List of CFR Sections Affected (LSA) is published monthly, keyed to
the revision dates of the 50 CFR titles.
REPUBLICATION OF MATERIAL
There are no restrictions on the republication of material appearing
in the Code of Federal Regulations.
INQUIRIES
For a legal interpretation or explanation of any regulation in this
volume, contact the issuing agency. The issuing agency's name appears at
the top of odd-numbered pages.
For inquiries concerning CFR reference assistance, call 202-741-6000
or write to the Director, Office of the Federal Register, National
Archives and Records Administration, 8601 Adelphi Road, College Park, MD
20740-6001 or e-mail [email protected].
SALES
The Government Printing Office (GPO) processes all sales and
distribution of the CFR. For payment by credit card, call toll-free,
866-512-1800, or DC area, 202-512-1800, M-F 8 a.m. to 4 p.m. e.s.t. or
fax your order to 202-512-2104, 24 hours a day. For payment by check,
write to: US Government Printing Office - New Orders, P.O. Box 979050,
St. Louis, MO 63197-9000.
ELECTRONIC SERVICES
The full text of the Code of Federal Regulations, the LSA (List of
CFR Sections Affected), The United States Government Manual, the Federal
Register, Public Laws, Public Papers of the Presidents of the United
States, Compilation of Presidential Documents and the Privacy Act
Compilation are available in electronic format via www.ofr.gov. For more
information, contact the GPO Customer Contact Center, U.S. Government
Printing Office. Phone 202-512-1800, or 866-512-1800 (toll-free). E-
mail, [email protected].
The Office of the Federal Register also offers a free service on the
National Archives and Records Administration's (NARA) World Wide Web
site for public law numbers, Federal Register finding aids, and related
information. Connect to NARA's web site at www.archives.gov/federal-
register.
Michael L. White,
Acting Director,
Office of the Federal Register.
April 1, 2012.
[[Page ix]]
THIS TITLE
Title 21--Food and Drugs is composed of nine volumes. The parts in
these volumes are arranged in the following order: Parts 1-99, 100-169,
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300 to end.
The first eight volumes, containing parts 1-1299, comprise Chapter I--
Food and Drug Administration, Department of Health and Human Services.
The ninth volume, containing part 1300 to end, includes Chapter II--Drug
Enforcement Administration, Department of Justice, and Chapter III--
Office of National Drug Control Policy. The contents of these volumes
represent all current regulations codified under this title of the CFR
as of April 1, 2012.
For this volume, Robert J. Sheehan, III was Chief Editor. The Code
of Federal Regulations publication program is under the direction of
Michael L. White, assisted by Ann Worley.
[[Page 1]]
TITLE 21--FOOD AND DRUGS
(This book contains parts 100 to 169)
--------------------------------------------------------------------
Part
chapter i--Food and Drug Administration, Department of
Health and Human Services (Continued)..................... 100
[[Page 3]]
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
(Parts 100 to 169)
--------------------------------------------------------------------
Editorial Notes: 1. Nomenclature changes to chapter I appear at 59 FR
14366, Mar. 28, 1994, 59 FR 24879, May 9, 1994, 68 FR 13717, Mar. 24,
2004, 69 FR 18803, Apr. 9, 2004, 70 FR 40880, July 15, 2005, and 70 FR
67650, Nov. 8, 2005.
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION
Part Page
100 General..................................... 5
101 Food labeling............................... 10
102 Common or usual name for nonstandardized
foods................................... 173
104 Nutritional quality guidelines for foods.... 180
105 Foods for special dietary use............... 184
106 Infant formula quality control procedures... 186
107 Infant formula.............................. 192
108 Emergency permit control.................... 201
109 Unavoidable contaminants in food for human
consumption and food-packaging material. 211
110 Current good manufacturing practice in
manufacturing, packing, or holding human
food.................................... 217
111 Current good manufacturing practice in
manufacturing, packaging, labeling, or
holding operations for dietary
supplements............................. 227
113 Thermally processed low-acid foods packaged
in hermetically sealed containers....... 256
114 Acidified foods............................. 291
115 Shell eggs.................................. 297
118 Production, storage, and transportation of
shell eggs.............................. 300
119 Dietary supplements that present a
significant or unreasonable risk........ 310
120 Hazard Analysis and Critical Control Point
(HACCP) systems......................... 311
123 Fish and fishery products................... 320
[[Page 4]]
129 Processing and bottling of bottled drinking
water................................... 328
130 Food standards: General..................... 333
131 Milk and cream.............................. 341
133 Cheeses and related cheese products......... 359
135 Frozen desserts............................. 411
136 Bakery products............................. 418
137 Cereal flours and related products.......... 422
139 Macaroni and noodle products................ 437
145 Canned fruits............................... 448
146 Canned fruit juices......................... 488
150 Fruit butters, jellies, preserves, and
related products........................ 502
152 Fruit pies.................................. 510
155 Canned vegetables........................... 512
156 Vegetable juices............................ 534
158 Frozen vegetables........................... 537
160 Eggs and egg products....................... 540
161 Fish and shellfish.......................... 545
163 Cacao products.............................. 562
164 Tree nut and peanut products................ 570
165 Beverages................................... 574
166 Margarine................................... 593
168 Sweeteners and table sirups................. 596
169 Food dressings and flavorings............... 601
[[Page 5]]
SUBCHAPTER B_FOOD FOR HUMAN CONSUMPTION
PART 100_GENERAL--Table of Contents
Subpart A_State and Local Requirements
Sec.
100.1 Petitions requesting exemption from preemption for State or local
requirements.
100.2 State enforcement of Federal regulations.
Subparts B-E [Reserved]
Subpart F_Misbranding for Reasons Other Than Labeling
100.100 Misleading containers.
Subpart G_Specific Administrative Rulings and Decisions
100.155 Salt and iodized salt.
Authority: 21 U.S.C. 321, 331, 337, 342, 343, 348, 371.
Source: 42 FR 14306, Mar. 15, 1977, unless otherwise noted.
Subpart A_State and Local Requirements
Sec. 100.1 Petitions requesting exemption from preemption for State or local
requirements.
(a) Scope and purpose. (1) This subpart applies to the submission
and consideration of petitions under section 403A(b) of the Federal
Food, Drug, and Cosmetic Act (the act), by a State or a political
subdivision of a State, requesting exemption of a State requirement from
preemption under section 403A(a) of the act.
(2) Section 403A(b) of the act provides that where a State
requirement has been preempted under section 403A(a) of the act, the
State may petition the agency for an exemption. The agency may grant the
exemption, under such conditions as it may prescribe by regulation, if
the agency finds that the State requirement will not cause any food to
be in violation of any applicable requirement under Federal law, will
not unduly burden interstate commerce, and is designed to address a
particular need for information that is not met by the preemptive
Federal requirement.
(b) Definitions. (1) Act means the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321 et seq.).
(2) Agency means the Food and Drug Administration.
(3) Commissioner means the Commissioner of Food and Drugs.
(4) State means a State as defined in section 201(a)(1) of the act
(which includes a territory of the United States, the District of
Columbia, and Puerto Rico) or any political subdivision of a State
having authority to issue food standards and food labeling regulations
having force of law.
(5) State requirement means any statute, standard, regulation, or
other requirement that is issued by a State.
(c) Prerequisites for petitions for exemption from preemption. The
Food and Drug Administration will consider a petition for exemption from
preemption on its merits only if the petition demonstrates that:
(1) The State requirement was enacted or was issued as a final rule
by an authorized official of the State and is in effect or would be in
effect but for the provisions of section 403A of the act.
(2) The State requirement is subject to preemption under section
403A(a) of the act because of a statutory provision listed in that
section or because of a Federal standard or other Federal regulation
that is in effect, or that has been published as a final rule with a
designated effective date, and that was issued under the authority of a
statutory provision listed in that section. For the purposes of this
subpart, all petitions seeking exemption from preemption under section
403A(a)(3) through (a)(5) of the act submitted before May 8, 1992, will
be considered timely even though the applicable statutory provisions or
regulations are not yet in effect.
(3) The petitioner is an official of a State having authority to act
for, or on behalf of, the Government in applying for an exemption of
State requirements from preemption.
(4) The State requirement is subject to preemption under section
403A(a) of the act because it is not identical to
[[Page 6]]
the requirement of the preemptive Federal statutory provision or
regulation including a standard of identity, quality, and fill. ``Not
identical to'' does not refer to the specific words in the requirement
but instead means that the State requirement directly or indirectly
imposes obligations or contains provisions concerning the composition or
labeling of food, or concerning a food container, that:
(i) Are not imposed by or contained in the applicable provision
(including any implementing regulation) of section 401 or 403 of the
act; or
(ii) Differ from those specifically imposed by or contained in the
applicable provision (including any implementing regulation) of section
401 or 403 of the act.
(d) Form of petition. (1) All information included in the petition
should meet the general requirements of Sec. 10.20(c) of this chapter.
(2) An original and one copy of the petition shall be submitted, or
the petitioner may submit an original and a computer readable disk
containing the petition. Contents of the disk should be in a standard
format, such as ASCII format. (Petitioners interested in submitting a
disk should contact the Center for Food Safety and Applied Nutrition for
details.)
(3) Petitions for exemption from preemption for a State requirement
shall be submitted to the Division of Dockets Management in the
following form:
(Date) ----------------
Division of Dockets Management,
Food and Drug Administration,
Department of Health and Human Services,
5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
Petition Requesting Exemption from Preemption for State Requirement
The undersigned submits this petition under section 403A(b)of the
Federal Food, Drug, and Cosmetic Act to request that the Food and Drug
Administration exempt a State requirement from preemption.
The undersigned has authority to act for, or on behalf of, the
(identify State or political subdivision of the State) because (document
petitioner's authority to submit petition on behalf of the State).
A. Action Requested
1. Identify and give the exact wording of the State requirement and
give date it was enacted or issued in final form.
2. Identify the specific standard or regulation that is believed to
preempt the State requirement and the section and paragraph of the act
that the standard or regulation implements.
B. Documentation of State Requirement
Provide a copy of the State requirement that is the subject of the
application. Where available, the application should also include copies
of any legislative history or background materials used in issuing the
requirement, including hearing reports or studies concerning the
development or consideration of the requirement.
C. Statement of Grounds
A petition for an exemption from preemption should contain the
following:
1. An explanation of the State requirement and its rationale, and a
comparison of State and Federal requirements to show differences.
2. An explanation of why compliance with the State requirement would
not cause a food to be in violation of any applicable requirement under
Federal law.
3. Information on the effect that granting the State petition will
have on interstate commerce. The petition should contain information on
economic feasibility, i.e., whether the State and Federal requirements
have significantly different effects on the production and distribution
of the food product; comparison of the costs of compliance as shown by
data or information on the actual or anticipated effect of the State and
Federal requirements on the sale and price of the food product in
interstate commerce; and the effect of the State requirement on the
availability of the food product to consumers. To the extent possible,
the petition should include information showing that it is practical and
feasible for producers of food products to comply with the State
requirement. Such information may be submitted in the form of statements
from affected persons indicating their ability to comply.
4. Identification of a particular need for information that the
State requirement is designed to meet, which need is not met by Federal
law. The petition should describe the conditions that require the State
to petition for an exemption, the information need that the State
requirement fulfills, the inadequacy of the Federal requirement in
addressing this need, and the geographical area or political subdivision
in which such need exists.
[[Page 7]]
D. Environmental Impact
The petition shall contain a claim for categorical exclusion under
21 CFR 25.24 or an environmental assessment under 21 CFR 25.31.
E. Notification
Provide name and address of person, branch, department, or other
instrumentality of the State government that should be notified of the
Commissioner's action concerning the petition.
F. Certification
The undersigned certifies, that, to the best knowledge and belief of
the undersigned, this petition includes all information and views on
which the petition relies.
(Signature) ------------------------
(Name of petitioner) ----------------
(Mailing address) ------------------
(Telephone number) ----------------
(Information collection requirements in this section were approved
by the Office of Management and Budget (OMB) and assigned OMB number
0910-0277)
(e) Submission of petition for exemption; public disclosure. The
availability for public disclosure of a petition for exemption will be
governed by the rules specified in Sec. 10.20(j) of this chapter.
(f) Agency consideration of petitions. (1) Unless otherwise
specified in this section, all relevant provisions and requirements of
subpart B of part 10 of this chapter, are applicable to State petitions
requesting exemption from Federal preemption under section 403A(b) of
the act.
(2) If a petition does not meet the prerequisite requirements of
paragraph (c) of this section, the agency will issue a letter to the
petitioner denying the petition and stating in what respect the petition
does not meet these requirements.
(3) If a petition appears to meet the prerequisite requirements in
paragraph (c) of this section, it will be filed by the Division of
Dockets Management, stamped with the date of filing, and assigned a
docket number. The docket number identifies the file established by the
Division of Dockets Management for all submissions relating to the
petition, as provided in this part. Subsequent submissions relating to
the matter must refer to the docket number and will be filed in the
docket file. The Division of Dockets Management will promptly notify the
petitioner in writing of the filing and docket number of a petition.
(4) Any interested person may submit written comments to the
Division of Dockets Management on a filed petition as provided in Sec.
10.30(d) of this chapter.
(5) Within 90 days of the date of filing the agency will furnish a
response to the petitioner. The response will either:
(i) State that the agency has tentatively determined that the
petition merits the granting of an exemption, and that it intends to
publish in the Federal Register a proposal to grant the exemption
through rulemaking;
(ii) Deny the petition and state the reasons for such denial; or
(iii) Provide a tentative response indicating why the agency has
been unable to reach a decision on the petition, e.g., because of other
agency priorities or a need for additional information.
(g) If a State submitted a petition for exemption of a State
requirement from preemption under section 403A(a)(3) through (a)(5) of
the act before May 8, 1992, that State requirement will not be subject
to preemption until:
(1) November 8, 1992; or
(2) Action on the petition, whichever occurs later.
[58 FR 2468, Jan. 6, 1993]
Sec. 100.2 State enforcement of Federal regulations.
(a) Under section 307 of the Federal Food, Drug, and Cosmetic Act
(the act), a State may bring, in its own name and within its own
jurisdiction, proceedings for the civil enforcement, or to restrain
violations, of sections 401, 403(b), 403(c), 403(d), 403(e), 403(f),
403(g), 403(h), 403(i), 403(k), 403(q), or 403(r) of the act if the food
that is the subject of the proceedings is located in the State.
(b) No proceeding may be commenced by a State under paragraph (a) of
this section:
(1) Before 30 days after the State has given notice to the Food and
Drug Administration (FDA) that the State intends to bring such
proceeding.
(2) Before 90 days after the State has given notice to FDA of such
intent if
[[Page 8]]
FDA has, within such 30 days, commenced an informal or formal
enforcement action pertaining to the food which would be the subject of
such proceeding.
(3) If FDA is diligently prosecuting a proceeding in court
pertaining to such food, has settled such proceeding, or has settled the
informal or formal enforcement action pertaining to such food.
(c) A State may intervene as a matter of right, in any court
proceeding described in paragraph (b)(3) of this section.
(d) The notification that a State submits in accordance with
paragraph (b) of this section should include the following information
and be submitted in the following recommended format:
(Date) ----------------
Name of State agency ------------
Post office address ------------
Street address ------------
City, State, and ZIP code ------------
Name of product(s) covered by the notification ------------
Reporting official, title, and telephone no. ------------
FAX No. ------------
Agency contact (if different from reporting official), title, and
telephone no. ------------
Director,
Division of Enforcement (HFS-605),
Center for Food Safety and Applied Nutrition,
Food and Drug Administration,
5100 Paint Branch Pkwy.,
College Park, MD 20740.
To Whom It May Concern:
The undersigned, ------, submits this letter of notification
pursuant to section 307(b)(1) of the Federal Food, Drug, and Cosmetic
Act
(21 U.S.C. 337(b)(1)) with respect to --------. (name of products
covered by the notification and the enforcement action that is to be
initiated)
Attached hereto, and constituting a part of this letter of notification
are the following:
A. The name of the product.
B. The type and size of each product container.
C. Copy of the label and labeling of the product.
D. Manufacturing code (if applicable).
E. Name and address of firm believed to be responsible for
violations.
F. Name and address of parent firm (if known).
G. Reason for the anticipated State enforcement action (list
specific violations, including sections of the law violated).
H. Name of firm against which action is anticipated (if applicable).
I. Type of enforcement action.
Yours very truly,
Reporting Agency
By ------------
(Indicate authority)
(e) The letter of notification should be signed by a State official
authorized by the State to institute the contemplated enforcement
actions.
(f) The letter of notification should be sent to the Division of
Enforcement (HFS-605), Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740, FAX number 202-205-4642.
(g) FDA will notify the State of the date in which its letter of
notification was received by FDA, Center for Food Safety and Applied
Nutrition, Division of Enforcement (HFS-605) (within 2 working days
after date of receipt). This date will be the date of notification for
the purposes of paragraph (b) of this section.
(h) The Director, Division of Enforcement, Office of Field Programs,
Center for Food Safety and Applied Nutrition, FDA, will respond to the
State's notification within 30 days of the date of notification by
advising:
(1) Whether FDA has commenced an informal or formal enforcement
action pertaining to the food that is the subject of the notification;
or
(2) Whether FDA is prosecuting a proceeding in court pertaining to
such food, has settled such proceeding, or has settled informal or
formal enforcement action pertaining to such food.
(i) Information contained in State notification letters shall be
exempt from public disclosure to the same extent to which such
information would be so exempt pursuant to Sec. Sec. 20.61, 20.64, and
20.88 of this chapter.
(j) Definitions. (1) Informal enforcement actions include warning
letters, recalls, detentions, or other administrative enforcement
actions that pertain to the food in question.
(2) Formal enforcement actions include seizures, injunctions, or
other civil judicial enforcement actions that pertain to the food in
question. (Information collection requirements in this section
[[Page 9]]
were approved by the Office of Management and Budget (OMB) and assigned
OMB control number 0910-0275.)
[58 FR 2460, Jan. 6, 1993; 58 FR 17097, Apr. 1, 1993, as amended at 66
FR 56035, Nov. 6, 2001]
Subparts B-E [Reserved]
Subpart F_Misbranding for Reasons Other Than Labeling
Sec. 100.100 Misleading containers.
In accordance with section 403(d) of the act, a food shall be deemed
to be misbranded if its container is so made, formed, or filled as to be
misleading.
(a) A container that does not allow the consumer to fully view its
contents shall be considered to be filled as to be misleading if it
contains nonfunctional slack-fill. Slack-fill is the difference between
the actual capacity of a container and the volume of product contained
therein. Nonfunctional slack-fill is the empty space in a package that
is filled to less than its capacity for reasons other than:
(1) Protection of the contents of the package;
(2) The requirements of the machines used for enclosing the contents
in such package;
(3) Unavoidable product settling during shipping and handling;
(4) The need for the package to perform a specific function (e.g.,
where packaging plays a role in the preparation or consumption of a
food), where such function is inherent to the nature of the food and is
clearly communicated to consumers;
(5) The fact that the product consists of a food packaged in a
reusable container where the container is part of the presentation of
the food and has value which is both significant in proportion to the
value of the product and independent of its function to hold the food,
e.g., a gift product consisting of a food or foods combined with a
container that is intended for further use after the food is consumed;
or durable commemorative or promotional packages; or
(6) Inability to increase level of fill or to further reduce the
size of the package (e.g., where some minimum package size is necessary
to accommodate required food labeling (excluding any vignettes or other
nonmandatory designs or label information), discourage pilfering,
facilitate handling, or accommodate tamper-resistant devices).
(b) [Reserved]
[59 FR 537, Jan. 5, 1994]
Subpart G_Specific Administrative Rulings and Decisions
Sec. 100.155 Salt and iodized salt.
(a) For the purposes of this section, the term iodized salt or
iodized table salt is designated as the name of salt for human food use
to which iodide has been added in the form of cuprous iodide or
potassium iodide permitted by Sec. Sec. 184.1265 and 184.1634 of this
chapter. In the labeling of such products, all words in the name shall
be equal in prominence and type size. The statement ``This salt supplies
iodide, a necessary nutrient'' shall appear on the label immediately
following the name and shall be in letters which are not less in height
than those required for the declaration of the net quantity of contents
as specified in Sec. 101.105 of this chapter.
(b) Salt or table salt for human food use to which iodide has not
been added shall bear the statement, ``This salt does not supply iodide,
a necessary nutrient.'' This statement shall appear immediately
following the name of the food and shall be in letters which are not
less in height than those required for the declaration of the net
quantity of contents as specified in Sec. 101.105 of this chapter.
(c) Salt, table salt, iodized salt, or iodized table salt to which
anticaking agents have been added may bear in addition to the ingredient
statement designating the anticaking agent(s), a label statement
describing the characteristics imparted by such agent(s) (for example,
``free flowing''), providing such statement does not appear with greater
prominence or in type size larger than the statements which immediately
follow the name of the food as required by paragraphs (a) and (b) of
this section.
(d) Individual serving-sized packages containing less than \1/2\
ounce and packages containing more than 2\1/2\ pounds
[[Page 10]]
of a food described in this section shall be exempt from declaration of
the statements which paragraphs (a) and (b) of this section require
immediately following the name of the food. Such exemption shall not
apply to the outer container or wrapper of a multiunit retail package.
(e) All salt, table salt, iodized salt, or iodized table salt in
packages intended for retail sale shipped in interstate commerce 18
months after the date of publication of this statement of policy in the
Federal Register, shall be labeled as prescribed by this section; and if
not so labeled, the Food and Drug Administration will regard them as
misbranded within the meaning of sections 403 (a) and (f) of the Federal
Food, Drug, and Cosmetic Act.
[42 FR 14306, Mar. 15, 1977, as amended at 48 FR 10811, Mar. 15, 1983;
49 FR 24119, June 12, 1984]
PART 101_FOOD LABELING--Table of Contents
Subpart A_General Provisions
Sec.
101.1 Principal display panel of package form food.
101.2 Information panel of package form food.
101.3 Identity labeling of food in packaged form.
101.4 Food; designation of ingredients.
101.5 Food; name and place of business of manufacturer, packer, or
distributor.
101.9 Nutrition labeling of food.
101.10 Nutrition labeling of restaurant foods.
101.12 Reference amounts customarily consumed per eating occasion.
101.13 Nutrient content claims--general principles.
101.14 Health claims: general requirements.
101.15 Food; prominence of required statements.
101.17 Food labeling warning, notice, and safe handling statements.
101.18 Misbranding of food.
Subpart B_Specific Food Labeling Requirements
101.22 Foods; labeling of spices, flavorings, colorings and chemical
preservatives.
101.30 Percentage juice declaration for foods purporting to be beverages
that contain fruit or vegetable juice.
Subpart C_Specific Nutrition Labeling Requirements and Guidelines
101.36 Nutrition labeling of dietary supplements.
101.42 Nutrition labeling of raw fruit, vegetables, and fish.
101.43 Substantial compliance of food retailers with the guidelines for
the voluntary nutrition labeling of raw fruit, vegetables, and
fish.
101.44 Identification of the 20 most frequently consumed raw fruit,
vegetables, and fish in the United States.
101.45 Guidelines for the voluntary nutrition labeling of raw fruit,
vegetables, and fish.
Subpart D_Specific Requirements for Nutrient Content Claims
101.54 Nutrient content claims for ``good source,'' ``high,'' ``more,''
and ``high potency.''
101.56 Nutrient content claims for ``light'' or ``lite.''
101.60 Nutrient content claims for the calorie content of foods.
101.61 Nutrient content claims for the sodium content of foods.
101.62 Nutrient content claims for fat, fatty acid, and cholesterol
content of foods.
101.65 Implied nutrient content claims and related label statements.
101.67 Use of nutrient content claims for butter.
101.69 Petitions for nutrient content claims.
Subpart E_Specific Requirements for Health Claims
101.70 Petitions for health claims.
101.71 Health claims: claims not authorized.
101.72 Health claims: calcium, vitamin D, and osteoporosis.
101.73 Health claims: dietary lipids and cancer.
101.74 Health claims: sodium and hypertension.
101.75 Health claims: dietary saturated fat and cholesterol and risk of
coronary heart disease.
101.76 Health claims: fiber-containing grain products, fruits, and
vegetables and cancer.
101.77 Health claims: fruits, vegetables, and grain products that
contain fiber, particularly soluble fiber, and risk of
coronary heart disease.
101.78 Health claims: fruits and vegetables and cancer.
101.79 Health claims: Folate and neural tube defects.
101.80 Health claims: dietary noncariogenic carbohydrate sweeteners and
dental caries.
[[Page 11]]
101.81 Health claims: Soluble fiber from certain foods and risk of
coronary heart disease (CHD).
101.82 Health claims: Soy protein and risk of coronary heart disease
(CHD).
101.83 Health claims: plant sterol/stanol esters and risk of coronary
heart disease (CHD).
Subpart F_Specific Requirements for Descriptive Claims That Are Neither
Nutrient Content Claims nor Health Claims
101.93 Certain types of statements for dietary supplements.
101.95 ``Fresh,'' ``freshly frozen,'' ``fresh frozen,'' ``frozen
fresh.''
Subpart G_Exemptions From Food Labeling Requirements
101.100 Food; exemptions from labeling.
101.105 Declaration of net quantity of contents when exempt.
101.108 Temporary exemptions for purposes of conducting authorized food
labeling experiments.
Appendix A to Part 101--Monier-Williams Procedure (With Modifications)
for Sulfites in Food, Center for Food Safety and Applied
Nutrition, Food and Drug Administration (November 1985)
Appendix B to Part 101--Graphic Enhancements Used by the FDA
Appendix C to Part 101--Nutrition Facts for Raw Fruits and Vegetables
Appendix D to Part 101--Nutrition Facts for Cooked Fish
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343,
348, 371; 42 U.S.C. 243, 264, 271.
Source: 42 FR 14308, Mar. 15, 1977, unless otherwise noted.
Editorial Note: Nomenclature changes to part 101 appear at 63 FR
14035, Mar. 24, 1998, 66 FR 17358, Mar. 30, 2001, and 66 FR 56035, Nov.
6, 2001.
Subpart A_General Provisions
Sec. 101.1 Principal display panel of package form food.
The term principal display panel as it applies to food in package
form and as used in this part, means the part of a label that is most
likely to be displayed, presented, shown, or examined under customary
conditions of display for retail sale. The principal display panel shall
be large enough to accommodate all the mandatory label information
required to be placed thereon by this part with clarity and
conspicuousness and without obscuring design, vignettes, or crowding.
Where packages bear alternate principal display panels, information
required to be placed on the principal display panel shall be duplicated
on each principal display panel. For the purpose of obtaining uniform
type size in declaring the quantity of contents for all packages of
substantially the same size, the term area of the principal display
panel means the area of the side or surface that bears the principal
display panel, which area shall be:
(a) In the case of a rectangular package where one entire side
properly can be considered to be the principal display panel side, the
product of the height times the width of that side;
(b) In the case of a cylindrical or nearly cylindrical container, 40
percent of the product of the height of the container times the
circumference;
(c) In the case of any otherwise shaped container, 40 percent of the
total surface of the container: Provided, however, That where such
container presents an obvious ``principal display panel'' such as the
top of a triangular or circular package of cheese, the area shall
consist of the entire top surface. In determining the area of the
principal display panel, exclude tops, bottoms, flanges at tops and
bottoms of cans, and shoulders and necks of bottles or jars. In the case
of cylindrical or nearly cylindrical containers, information required by
this part to appear on the principal display panel shall appear within
that 40 percent of the circumference which is most likely to be
displayed, presented, shown, or examined under customary conditions of
display for retail sale.
Sec. 101.2 Information panel of package form food.
(a) The term information panel as it applies to packaged food means
that part of the label immediately contiguous and to the right of the
principal display panel as observed by an individual facing the
principal display panel with the following exceptions:
(1) If the part of the label immediately contiguous and to the right
of the principal display panel is too small
[[Page 12]]
to accommodate the necessary information or is otherwise unusable label
space, e.g., folded flaps or can ends, the panel immediately contiguous
and to the right of this part of the label may be used.
(2) If the package has one or more alternate principal display
panels, the information panel is immediately contiguous and to the right
of any principal display panel.
(3) If the top of the container is the principal display panel and
the package has no alternate principal display panel, the information
panel is any panel adjacent to the principal display panel.
(b) All information required to appear on the label of any package
of food under Sec. Sec. 101.4, 101.5, 101.8, 101.9, 101.13, 101.17,
101.36, subpart D of part 101, and part 105 of this chapter shall appear
either on the principal display panel or on the information panel,
unless otherwise specified by regulations in this chapter.
(c) All information appearing on the principal display panel or the
information panel pursuant to this section shall appear prominently and
conspicuously, but in no case may the letters and/or numbers be less
than one-sixteenth inch in height unless an exemption pursuant to
paragraph (f) of this section is established. The requirements for
conspicuousness and legibility shall include the specifications of
Sec. Sec. 101.105(h) (1) and (2) and 101.15.
(1)(i) Soft drinks packaged in bottles manufactured before October
31, 1975 shall be exempt from the requirements prescribed by this
section to the extent that information which is blown, lithographed, or
formed onto the surface of the bottle is exempt from the size and
placement requirements of this section.
(ii) Soft drinks packaged in bottles shall be exempt from the size
and placement requirements prescribed by this section if all of the
following conditions are met:
(A) If the soft drink is packaged in a bottle bearing a paper,
plastic foam jacket, or foil label, or is packaged in a nonreusable
bottle bearing a label lithographed onto the surface of the bottle or is
packaged in metal cans, the product shall not be exempt from any
requirement of this section other than the exemptions created by Sec.
1.24(a)(5) (ii) and (v) of this chapter and the label shall bear all
required information in the specified minimum type size, except the
label will not be required to bear the information required by Sec.
101.5 if this information appears on the bottle closure or on the lid of
the can in a type size not less than one-sixteenth inch in height, or if
embossed on the lid of the can in a type size not less than one-eighth
inch in height.
(B) If the soft drink is packaged in a bottle which does not bear a
paper, plastic foam jacket or foil label, or is packaged in a reusable
bottle bearing a label lithographed onto the surface of the bottle:
(1) Neither the bottle nor the closure is required to bear nutrition
labeling in compliance with Sec. 101.9, except that any multiunit
retail package in which it is contained shall bear nutrition labeling if
required by Sec. 101.9; and any vending machine in which it is
contained shall bear nutrition labeling if nutrition labeling is not
present on the bottle or closure, if required by Sec. 101.9.
(2) All other information pursuant to this section shall appear on
the top of the bottle closure prominently and conspicuously in letters
and/or numbers no less than one thirty-second inch in height, except
that if the information required by Sec. 101.5 is placed on the side of
the closure in accordance with Sec. 1.24(a)(5)(ii) of this chapter,
such information shall appear in letters and/or numbers no less than
one-sixteenth inch in height.
(3) Upon the petition of any interested person demonstrating that
the bottle closure is too small to accommodate this information, the
Commissioner may by regulation establish an alternative method of
disseminating such information. Information appearing on the closure
shall appear in the following priority:
(i) The statement of ingredients.
(ii) The name and address of the manufacturer, packer, or
distributor.
(iii) The statement of identity.
(2) Individual serving-size packages of food served with meals in
restaurants, institutions, and on board passenger carriers, and not
intended for sale at retail, are exempt from
[[Page 13]]
type-size requirements of this paragraph, provided:
(i) The package has a total area of 3 square inches or less
available to bear labeling;
(ii) There is insufficient area on the package available to print
all required information in a type size of \1/16\ inch in height;
(iii) The information required by paragraph (b) of this section
appears on the label in accordance with the provisions of this
paragraph, except that the type size is not less than \1/32\ inch in
height.
(d)(1) Except as provided by Sec. Sec. 101.9(j)(13) and (j)(17) and
101.36(i)(2) and (i)(5), all information required to appear on the
principal display panel or on the information panel under this section
shall appear on the same panel unless there is insufficient space. In
determining the sufficiency of the available space, except as provided
by Sec. Sec. 101.9(j)(17) and 101.36(i)(5), any vignettes, designs, and
other nonmandatory label information shall not be considered. If there
is insufficient space for all of this information to appear on a single
panel, it may be divided between these two panels, except that the
information required under any given section or part shall all appear on
the same panel. A food whose label is required to bear the ingredient
statement on the principal display panel may bear all other information
specified in paragraph (b) of this section on the information panel.
(2) Any food, not otherwise exempted in this section, if packaged in
a container consisting of a separate lid and body, and bearing nutrition
labeling pursuant to Sec. 101.9, and if the lid qualifies for and is
designed to serve as a principal display panel, shall be exempt from the
placement requirements of this section in the following respects:
(i) The name and place of business information required by Sec.
101.5 shall not be required on the body of the container if this
information appears on the lid in accordance with this section.
(ii) The nutrition information required by Sec. 101.9 shall not be
required on the lid if this information appears on the container body in
accordance with this section.
(iii) The statement of ingredients required by Sec. 101.4 shall not
be required on the lid if this information appears on the container body
in accordance with this section. Further, the statement of ingredients
is not required on the container body if this information appears on the
lid in accordance with this section.
(e) All information appearing on the information panel pursuant to
this section shall appear in one place without other intervening
material.
(f) If the label of any package of food is too small to accommodate
all of the information required by Sec. Sec. 101.4, 101.5, 101.8,
101.9, 101.13, 101.17, 101.36, subpart D of part 101, and part 105 of
this chapter, the Commissioner may establish by regulation an acceptable
alternative method of disseminating such information to the public,
e.g., a type size smaller than one-sixteenth inch in height, or labeling
attached to or inserted in the package or available at the point of
purchase. A petition requesting such a regulation, as an amendment to
this paragraph, shall be submitted under part 10 of this chapter.
[42 FR 14308, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977;
42 FR 45905, Sept. 13, 1977; 42 FR 47191, Sept. 20, 1977; 44 FR 16006,
Mar. 16, 1979; 49 FR 13339, Apr. 4, 1984; 53 FR 16068, May 5, 1988; 58
FR 44030, Aug. 18, 1993; 60 FR 17205, Apr. 5, 1995; 62 FR 43074, Aug.
12, 1997; 62 FR 49847, Sept. 23, 1997; 63 FR 14817, Mar. 27, 1998]
Sec. 101.3 Identity labeling of food in packaged form.
(a) The principal display panel of a food in package form shall bear
as one of its principal features a statement of the identity of the
commodity.
(b) Such statement of identity shall be in terms of:
(1) The name now or hereafter specified in or required by any
applicable Federal law or regulation; or, in the absence thereof,
(2) The common or usual name of the food; or, in the absence
thereof,
(3) An appropriately descriptive term, or when the nature of the
food is obvious, a fanciful name commonly used by the public for such
food.
(c) Where a food is marketed in various optional forms (whole,
slices, diced, etc.), the particular form shall
[[Page 14]]
be considered to be a necessary part of the statement of identity and
shall be declared in letters of a type size bearing a reasonable
relation to the size of the letters forming the other components of the
statement of identity; except that if the optional form is visible
through the container or is depicted by an appropriate vignette, the
particular form need not be included in the statement. This
specification does not affect the required declarations of identity
under definitions and standards for foods promulgated pursuant to
section 401 of the act.
(d) This statement of identity shall be presented in bold type on
the principal display panel, shall be in a size reasonably related to
the most prominent printed matter on such panel, and shall be in lines
generally parallel to the base on which the package rests as it is
designed to be displayed.
(e) Under the provisions of section 403(c) of the Federal Food,
Drug, and Cosmetic Act, a food shall be deemed to be misbranded if it is
an imitation of another food unless its label bears, in type of uniform
size and prominence, the word ``imitation'' and, immediately thereafter,
the name of the food imitated.
(1) A food shall be deemed to be an imitation and thus subject to
the requirements of section 403(c) of the act if it is a substitute for
and resembles another food but is nutritionally inferior to that food.
(2) A food that is a substitute for and resembles another food shall
not be deemed to be an imitation provided it meets each of the following
requirements:
(i) It is not nutritionally inferior to the food for which it
substitutes and which it resembles.
(ii) Its label bears a common or usual name that complies with the
provisions of Sec. 102.5 of this chapter and that is not false or
misleading, or in the absence of an existing common or usual name, an
appropriately descriptive term that is not false or misleading. The
label may, in addition, bear a fanciful name which is not false or
misleading.
(3) A food for which a common or usual name is established by
regulation (e.g., in a standard of identity pursuant to section 401 of
the act, in a common or usual name regulation pursuant to part 102 of
this chapter, or in a regulation establishing a nutritional quality
guideline pursuant to part 104 of this chapter), and which complies with
all of the applicable requirements of such regulation(s), shall not be
deemed to be an imitation.
(4) Nutritional inferiority includes:
(i) Any reduction in the content of an essential nutrient that is
present in a measurable amount, but does not include a reduction in the
caloric or fat content provided the food is labeled pursuant to the
provisions of Sec. 101.9, and provided the labeling with respect to any
reduction in caloric content complies with the provisions applicable to
caloric content in part 105 of this chapter.
(ii) For the purpose of this section, a measurable amount of an
essential nutrient in a food shall be considered to be 2 percent or more
of the Daily Reference Value (DRV) of protein listed under Sec.
101.9(c)(7)(iii) and of potassium listed under Sec. 101.9(c)(9) per
reference amount customarily consumed and 2 percent or more of the
Reference Daily Intake (RDI) of any vitamin or mineral listed under
Sec. 101.9(c)(8)(iv) per reference amount customarily consumed, except
that selenium, molybdenum, chromium, and chloride need not be
considered.
(iii) If the Commissioner concludes that a food is a substitute for
and resembles another food but is inferior to the food imitated for
reasons other than those set forth in this paragraph, he may propose
appropriate revisions to this regulation or he may propose a separate
regulation governing the particular food.
(f) A label may be required to bear the percentage(s) of a
characterizing ingredient(s) or information concerning the presence or
absence of an ingredient(s) or the need to add an ingredient(s) as part
of the common or usual name of the food pursuant to subpart B of part
102 of this chapter.
(g) Dietary supplements shall be identified by the term ``dietary
supplement'' as a part of the statement of identity, except that the
word ``dietary'' may be deleted and replaced by the name of the dietary
ingredients in the product (e.g., calcium supplement)
[[Page 15]]
or an appropriately descriptive term indicating the type of dietary
ingredients that are in the product (e.g., herbal supplement with
vitamins).
[42 FR 14308, Mar. 15, 1977, as amended at 48 FR 10811, Mar. 15, 1983;
58 FR 2227, Jan. 6, 1993; 60 FR 67174, Dec. 28, 1995; 62 FR 49847, Sept.
23, 1997]
Sec. 101.4 Food; designation of ingredients.
(a)(1) Ingredients required to be declared on the label or labeling
of a food, including foods that comply with standards of identity,
except those ingredients exempted by Sec. 101.100, shall be listed by
common or usual name in descending order of predominance by weight on
either the principal display panel or the information panel in
accordance with the provisions of Sec. 101.2, except that ingredients
in dietary supplements that are listed in the nutrition label in
accordance with Sec. 101.36 need not be repeated in the ingredient
list. Paragraph (g) of this section describes the ingredient list on
dietary supplement products.
(2) The descending order of predominance requirements of paragraph
(a)(1) of this section do not apply to ingredients present in amounts of
2 percent or less by weight when a listing of these ingredients is
placed at the end of the ingredient statement following an appropriate
quantifying statement, e.g., ``Contains -- percent or less of ------''
or ``Less than -- percent of ------.'' The blank percentage within the
quantifying statement shall be filled in with a threshold level of 2
percent, or, if desired, 1.5 percent, 1.0 percent, or 0.5 percent, as
appropriate. No ingredient to which the quantifying phrase applies may
be present in an amount greater than the stated threshold.
(b) The name of an ingredient shall be a specific name and not a
collective (generic) name, except that:
(1) Spices, flavorings, colorings and chemical preservatives shall
be declared according to the provisions of Sec. 101.22.
(2) An ingredient which itself contains two or more ingredients and
which has an established common or usual name, conforms to a standard
established pursuant to the Meat Inspection or Poultry Products
Inspection Acts by the U.S. Department of Agriculture, or conforms to a
definition and standard of identity established pursuant to section 401
of the Federal Food, Drug, and Cosmetic Act, shall be designated in the
statement of ingredients on the label of such food by either of the
following alternatives:
(i) By declaring the established common or usual name of the
ingredient followed by a parenthetical listing of all ingredients
contained therein in descending order of predominance except that, if
the ingredient is a food subject to a definition and standard of
identity established in subchapter B of this chapter that has specific
labeling provisions for optional ingredients, optional ingredients may
be declared within the parenthetical listing in accordance with those
provisions.
(ii) By incorporating into the statement of ingredients in
descending order of predominance in the finished food, the common or
usual name of every component of the ingredient without listing the
ingredient itself.
(3) Skim milk, concentrated skim milk, reconstituted skim milk, and
nonfat dry milk may be declared as ``skim milk'' or ``nonfat milk''.
(4) Milk, concentrated milk, reconstituted milk, and dry whole milk
may be declared as ``milk''.
(5) Bacterial cultures may be declared by the word ``cultured''
followed by the name of the substrate, e.g., ``made from cultured skim
milk or cultured buttermilk''.
(6) Sweetcream buttermilk, concentrated sweetcream buttermilk,
reconstituted sweetcream buttermilk, and dried sweetcream buttermilk may
be declared as ``buttermilk''.
(7) Whey, concentrated whey, reconstituted whey, and dried whey may
be declared as ``whey''.
(8) Cream, reconstituted cream, dried cream, and plastic cream
(sometimes known as concentrated milk fat) may be declared as ``cream''.
(9) Butteroil and anhydrous butterfat may be declared as
``butterfat''.
(10) Dried whole eggs, frozen whole eggs, and liquid whole eggs may
be declared as ``eggs''.
(11) Dried egg whites, frozen egg whites, and liquid egg whites may
be declared as ``egg whites''.
[[Page 16]]
(12) Dried egg yolks, frozen egg yolks, and liquid egg yolks may be
declared as ``egg yolks''.
(13) [Reserved]
(14) Each individual fat and/or oil ingredient of a food intended
for human consumption shall be declared by its specific common or usual
name (e.g., ``beef fat'', ``cottonseed oil'') in its order of
predominance in the food except that blends of fats and/or oils may be
designated in their order of predominance in the foods as ``------
shortening'' or ``blend of ------ oils'', the blank to be filled in with
the word ``vegetable'', ``animal'', ``marine'', with or without the
terms ``fat'' or ``oils'', or combination of these, whichever is
applicable if, immediately following the term, the common or usual name
of each individual vegetable, animal, or marine fat or oil is given in
parentheses, e.g., ``vegetable oil shortening (soybean and cottonseed
oil)''. For products that are blends of fats and/or oils and for foods
in which fats and/or oils constitute the predominant ingredient, i.e.,
in which the combined weight of all fat and/or oil ingredients equals or
exceeds the weight of the most predominant ingredient that is not a fat
or oil, the listing of the common or usual names of such fats and/or
oils in parentheses shall be in descending order of predominance. In all
other foods in which a blend of fats and/or oils is used as an
ingredient, the listing of the common or usual names in parentheses need
not be in descending order of predominance if the manufacturer, because
of the use of varying mixtures, is unable to adhere to a constant
pattern of fats and/or oils in the product. If the fat or oil is
completely hydrogenated, the name shall include the term hydrogenated,
or if partially hydrogenated, the name shall include the term partially
hydrogenated. If each fat and/or oil in a blend or the blend is
completely hydrogenated, the term ``hydrogenated'' may precede the
term(s) describing the blend, e.g., ``hydrogenated vegetable oil
(soybean, cottonseed, and palm oils)'', rather than preceding the name
of each individual fat and/or oil; if the blend of fats and/or oils is
partially hydrogenated, the term ``partially hydrogenated'' may be used
in the same manner. Fat and/or oil ingredients not present in the
product may be listed if they may sometimes be used in the product. Such
ingredients shall be identified by words indicating that they may not be
present, such as ``or'', ``and/or'', ``contains one or more of the
following:'', e.g., ``vegetable oil shortening (contains one or more of
the following: cottonseed oil, palm oil, soybean oil)''. No fat or oil
Fingredient shall be listed unless actually present if the fats and/or
oils constitute the predominant ingredient of the product, as defined in
this paragraph (b)(14).
(15) When all the ingredients of a wheat flour are declared in an
ingredient statement, the principal ingredient of the flour shall be
declared by the name(s) specified in Sec. Sec. 137.105, 137.200,
137.220 and 137.225 of this chapter, i.e., the first ingredient
designated in the ingredient list of flour, or bromated flour, or
enriched flour, or self-rising flour is ``flour'', ``white flour'',
``wheat flour'', or ``plain flour''; the first ingredient designated in
the ingredient list of durum flour is ``durum flour''; the first
ingredient designated in the ingredient list of whole wheat flour, or
bromated whole wheat flour is ``whole wheat flour'', ``graham flour'',
or ``entire wheat flour''; and the first ingredient designated in the
ingredient list of whole durum wheat flour is ``whole durum wheat
flour''.
(16) Ingredients that act as leavening agents in food may be
declared in the ingredient statement by stating the specific common or
usual name of each individual leavening agent in parentheses following
the collective name ``leavening'', e.g., ``leavening (baking soda,
monocalcium phosphate, and calcium carbonate)''. The listing of the
common or usual name of each individual leavening agent in parentheses
shall be in descending order of predominance: Except, That if the
manufacturer is unable to adhere to a constant pattern of leavening
agents in the product, the listing of individual leavening agents need
not be in descending order of predominance. Leavening agents not present
in the product may be listed if they are sometimes used in the product.
Such ingredients shall be identified by words indicating that they may
not be present, such as
[[Page 17]]
``or'', ``and/or'', ``contains one or more of the following:''.
(17) Ingredients that act as yeast nutrients in foods may be
declared in the ingredient statement by stating the specific common or
usual name of each individual yeast nutrient in parentheses following
the collective name ``yeast nutrients'', e.g., ``yeast nutrients
(calcium sulfate and ammonium phosphate)''. The listing of the common or
usual name of each individual yeast nutrient in parentheses shall be in
descending order of predominance: Except, That if the manufacturer is
unable to adhere to a constant pattern of yeast nutrients in the
product, the listing of the common or usual names of individual yeast
nutrients need not be in descending order of predominance. Yeast
nutrients not present in the product may be listed if they are sometimes
used in the product. Such ingredients shall be identified by words
indicating that they may not be present, such as ``or'', ``and/or'', or
``contains one or more of the following:''.
(18) Ingredients that act as dough conditioners may be declared in
the ingredient statement by stating the specific common or usual name of
each individual dough conditioner in parentheses following the
collective name ``dough conditioner'', e.g., ``dough conditioners (L-
cysteine, ammonium sulfate)''. The listing of the common or usual name
of each dough conditioner in parentheses shall be in descending order of
predominance: Except, That if the manufacturer is unable to adhere to a
constant pattern of dough conditioners in the product, the listing of
the common or usual names of individual dough conditioners need not be
in descending order of predominance. Dough conditioners not present in
the product may be listed if they are sometimes used in the product.
Such ingredients shall be identified by words indicating that they may
not be present, such as ``or'', ``and/or'', or ``contains one or more of
the following:''.
(19) Ingredients that act as firming agents in food (e.g., salts of
calcium and other safe and suitable salts in canned vegetables) may be
declared in the ingredient statement, in order of predominance
appropriate for the total of all firming agents in the food, by stating
the specific common or usual name of each individual firming agent in
descending order of predominance in parentheses following the collective
name ``firming agents''. If the manufacturer is unable to adhere to a
constant pattern of firming agents in the food, the listing of the
individual firming agents need not be in descending order of
predominance. Firming agents not present in the product may be listed if
they are sometimes used in the product. Such ingredients shall be
identified by words indicating that they may not be present, such as
``or'', ``and/or'', ``contains one or more of the following:''.
(20) For purposes of ingredient labeling, the term sugar shall refer
to sucrose, which is obtained from sugar cane or sugar beets in
accordance with the provisions of Sec. 184.1854 of this chapter.
(21) [Reserved]
(22) Wax and resin ingredients on fresh produce when such produce is
held for retail sale, or when held for other than retail sale by packers
or repackers shall be declared collectively by the phrase ``coated with
food-grade animal-based wax, to maintain freshness'' or the phrase
``coated with food-grade vegetable-, petroleum-, beeswax-, and/or
shellac-based wax or resin, to maintain freshness'' as appropriate. The
terms ``food-grade'' and ``to maintain freshness'' are optional. The
term lac-resin may be substituted for the term shellac.
(23) When processed seafood products contain fish protein
ingredients consisting primarily of the myofibrillar protein fraction
from one or more fish species and the manufacturer is unable to adhere
to a constant pattern of fish species in the fish protein ingredient,
because of seasonal or other limitations of species availability, the
common or usual name of each individual fish species need not be listed
in descending order of predominance. Fish species not present in the
fish protein ingredient may be listed if they are sometimes used in the
product. Such ingredients must be identified by words indicating that
they may not be present, such as ``or'', ``and/or'', or ``contains one
or more of the following:'' Fish protein ingredients may
[[Page 18]]
be declared in the ingredient statement by stating the specific common
or usual name of each fish species that may be present in parentheses
following the collective name ``fish protein'', e.g., ``fish protein
(contains one or more of the following: Pollock, cod, and/or pacific
whiting)''.
(c) When water is added to reconstitute, completely or partially, an
ingredient permitted by paragraph (b) of this section to be declared by
a class name, the position of the ingredient class name in the
ingredient statement shall be determined by the weight of the
unreconstituted ingredient plus the weight of the quantity of water
added to reconstitute that ingredient, up to the amount of water needed
to reconstitute the ingredient to single strength. Any water added in
excess of the amount of water needed to reconstitute the ingredient to
single strength shall be declared as ``water'' in the ingredient
statement.
(d) When foods characterized on the label as ``nondairy'' contain a
caseinate ingredient, the caseinate ingredient shall be followed by a
parenthetical statement identifying its source. For example, if the
manufacturer uses the term ``nondairy'' on a creamer that contains
sodium caseinate, it shall include a parenthetical term such as ``a milk
derivative'' after the listing of sodium caseinate in the ingredient
list.
(e) If the percentage of an ingredient is included in the statement
of ingredients, it shall be shown in parentheses following the name of
the ingredient and expressed in terms of percent by weight. Percentage
declarations shall be expressed to the nearest 1 percent, except that
where ingredients are present at levels of 2 percent or less, they may
be grouped together and expressed in accordance with the quantifying
guidance set forth in paragraph (a)(2) of this section.
(f) Except as provided in Sec. 101.100, ingredients that must be
declared on labeling because there is no label for the food, including
foods that comply with standards of identity, shall be listed
prominently and conspicuously by common or usual name in the manner
prescribed by paragraph (b) of this section.
(g) When present, the ingredient list on dietary supplement products
shall be located immediately below the nutrition label, or, if there is
insufficient space below the nutrition label, immediately contiguous and
to the right of the nutrition label and shall be preceded by the word
``Ingredients,'' unless some ingredients (i.e., sources) are identified
within the nutrition label in accordance with Sec. 101.36(d), in which
case the ingredients listed outside the nutrition label shall be in a
list preceded by the words ``Other ingredients.'' Ingredients in dietary
supplements that are not dietary ingredients or that do not contain
dietary ingredients, such as excipients, fillers, artificial colors,
artificial sweeteners, flavors, or binders, shall be included in the
ingredient list.
(h) The common or usual name of ingredients of dietary supplements
that are botanicals (including fungi and algae) shall be consistent with
the names standardized in Herbs of Commerce, 1992 edition, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies may be obtained from the American Herbal Products
Association, 8484 Georgia Ave., suite 370, Silver Spring, MD 20910, 301-
588-1171, FAX 301-588-1174, e-mail: [email protected], or may be examined at
the Center for Food Safety and Applied Nutrition's Library, 5100 Paint
Branch Pkwy., College Park, MD 20740, or at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, call 202-741-6030, or go to:http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html. The listing of these names on the label shall be
followed by statements of:
(1) The part of the plant (e.g., root, leaves) from which the
dietary ingredient is derived (e.g., ``Garlic bulb'' or ``Garlic
(bulb)''), except that this designation is not required for algae. The
name of the part of the plant shall be expressed in English (e.g.,
``flower'' rather than ``flos'');
(2) The Latin binomial name of the plant, in parentheses, except
that this name is not required when it is available in the reference
entitled: Herbs of
[[Page 19]]
Commerce for the common or usual name listed on the label, and, when
required, the Latin binomial name may be listed before the part of the
plant. Any name in Latin form shall be in accordance with
internationally accepted rules on nomenclature, such as those found in
the International Code of Botanical Nomenclature and shall include the
designation of the author or authors who published the Latin name, when
a positive identification cannot be made in its absence. The
International Code of Botanical Nomenclature (Tokyo Code), 1994 edition,
a publication of the International Association for Plant Taxonomy, is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies of the International Code of Botanical Nomenclature may
be obtained from Koeltz Scientific Books, D-61453 Konigstein, Germany,
and University Bookstore, Southern Illinois University, Carbondale, IL
62901-4422, 618-536-3321, FAX 618-453-5207, or may be examined at the
Center for Food Safety and Applied Nutrition's Library, 5100 Paint
Branch Pkwy., College Park, MD 20740, or at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html.
(3) On labels of single-ingredient dietary supplements that do not
include an ingredient list, the identification of the Latin binomial
name, when needed, and the part of the plant may be prominently placed
on the principal display panel or information panel, or included in the
nutrition label.
[42 FR 14308, Mar. 15, 1977, as amended at 43 FR 12858, Mar. 28, 1978;
43 FR 24519, June 6, 1978; 48 FR 8054, Feb. 25, 1983; 55 FR 17433, Apr.
25, 1990; 58 FR 2875, Jan. 6, 1993; 62 FR 49847, Sept. 23, 1997; 62 FR
64634, Dec. 8, 1997; 64 FR 50448, Sept. 17, 1999; 66 FR 17358, Mar. 30,
2001; 66 FR 66742, Dec. 27, 2001; 68 FR 15355, Mar. 31, 2003]
Sec. 101.5 Food; name and place of business of manufacturer, packer, or
distributor.
(a) The label of a food in packaged form shall specify conspicuously
the name and place of business of the manufacturer, packer, or
distributor.
(b) The requirement for declaration of the name of the manufacturer,
packer, or distributor shall be deemed to be satisfied, in the case of a
corporation, only by the actual corporate name, which may be preceded or
followed by the name of the particular division of the corporation. In
the case of an individual, partnership, or association, the name under
which the business is conducted shall be used.
(c) Where the food is not manufactured by the person whose name
appears on the label, the name shall be qualified by a phrase that
reveals the connection such person has with such food; such as
``Manufactured for ------'', ``Distributed by ------'', or any other
wording that expresses the facts.
(d) The statement of the place of business shall include the street
address, city, State, and ZIP code; however, the street address may be
omitted if it is shown in a current city directory or telephone
directory. The requirement for inclusion of the ZIP code shall apply
only to consumer commodity labels developed or revised after the
effective date of this section. In the case of nonconsumer packages, the
ZIP code shall appear either on the label or the labeling (including
invoice).
(e) If a person manufactures, packs, or distributes a food at a
place other than his principal place of business, the label may state
the principal place of business in lieu of the actual place where such
food was manufactured or packed or is to be distributed, unless such
statement would be misleading.
Sec. 101.9 Nutrition labeling of food.
(a) Nutrition information relating to food shall be provided for all
products intended for human consumption and offered for sale unless an
exemption is provided for the product in paragraph (j) of this section.
(1) When food is in package form, the required nutrition labeling
information shall appear on the label in the format specified in this
section.
(2) When food is not in package form, the required nutrition
labeling information shall be displayed clearly at the point of purchase
(e.g., on a
[[Page 20]]
counter card, sign, tag affixed to the product, or some other
appropriate device). Alternatively, the required information may be
placed in a booklet, looseleaf binder, or other appropriate format that
is available at the point of purchase.
(3) Solicitation of requests for nutrition information by a
statement ``For nutrition information write to ---------------------- ''
on the label or in the labeling or advertising for a food, or providing
such information in a direct written reply to a solicited or unsolicited
request, does not subject the label or the labeling of a food exempted
under paragraph (j) of this section to the requirements of this section
if the reply to the request conforms to the requirements of this
section.
(4) If any vitamin or mineral is added to a food so that a single
serving provides 50 percent or more of the Reference Daily Intake (RDI)
for the age group for which the product is intended, as specified in
paragraph (c)(8)(iv) of this section, of any one of the added vitamins
or minerals, unless such addition is permitted or required in other
regulations, e.g., a standard of identity or nutritional quality
guideline, or is otherwise exempted by the Commissioner, the food shall
be considered a food for special dietary use within the meaning of Sec.
105.3(a)(1)(iii) of this chapter.
(b) Except as provided in Sec. 101.9(h)(3), all nutrient and food
component quantities shall be declared in relation to a serving as
defined in this section.
(1) The term serving or serving size means an amount of food
customarily consumed per eating occasion by persons 4 years of age or
older which is expressed in a common household measure that is
appropriate to the food. When the food is specially formulated or
processed for use by infants or by toddlers, a serving or serving size
means an amount of food customarily consumed per eating occasion by
infants up to 12 months of age or by children 1 through 3 years of age,
respectively.
(2) Except as provided in paragraphs (b)(3), (b)(4), and (b)(6) of
this section and for products that are intended for weight control and
are available only through a weight-control or weight-maintenance
program, serving size declared on a product label shall be determined
from the ``Reference Amounts Customarily Consumed Per Eating Occasion *
* * *'' (reference amounts) that appear in Sec. 101.12(b) using the
procedures described below. For products that are both intended for
weight control and available only through a weight-control program, a
manufacturer may determine the serving size that is consistent with the
meal plan of the program. Such products must bear a statement, ``for
sale only through the ------ program'' (fill in the blank with the name
of the appropriate weight-control program, e.g., Smith's Weight
Control), on the principal display panel. However, the reference amounts
in Sec. 101.12(b) shall be used for purposes of evaluating whether
weight-control products that are available only through a weight-control
program qualify for nutrient content claims or health claims.
(i) For products in discrete units (e.g., muffins, sliced products,
such as sliced bread, or individually packaged products within a
multiserving package) and for products which consist of two or more
foods packaged and presented to be consumed together where the
ingredient represented as the main ingredient is in discrete units
(e.g., pancakes and syrup), the serving size shall be declared as
follows:
(A) If a unit weighs 50 percent or less of the reference amount, the
serving size shall be the number of whole units that most closely
approximates the reference amount for the product category;
(B) If a unit weighs more than 50 percent, but less than 67 percent
of the reference amount, the manufacturer may declare one unit or two
units as the serving size;
(C) If a unit weighs 67 percent or more, but less than 200 percent
of the reference amount, the serving size shall be one unit;
(D) If a unit weighs 200 percent or more of the reference amount,
the manufacturer may declare one unit as the serving size if the whole
unit can reasonably be consumed at a single-eating occasion.
(E) For products that have reference amounts of 100 grams (g) (or
milliliter
[[Page 21]]
(mL)) or larger and are individual units within a multiserving package,
if a unit contains more than 150 percent but less than 200 percent of
the reference amount, the manufacturer may decide whether to declare the
individual unit as 1 or 2 servings.
(F) The serving size for maraschino cherries shall be expressed as 1
cherry with the parenthetical metric measure equal to the average weight
of a medium size cherry.
(G) The serving size for products that naturally vary in size (e.g.,
pickles, shellfish, whole fish, and fillet of fish) may be the amount in
ounces that most closely approximates the reference amount for the
product category. Manufacturers shall adhere to the requirements in
paragraph (b)(5)(vi) of this section for expressing the serving size in
ounces.
(H) For products which consist of two or more foods packaged and
presented to be consumed together where the ingredient represented as
the main ingredient is in discrete units (e.g., pancakes and syrup), the
serving size may be the number of discrete units represented as the main
ingredient plus proportioned minor ingredients used to make the
reference amount for the combined product determined in Sec. 101.12(f).
(I) For packages containing several individual single-serving
containers, each of which is labeled with all required information
including nutrition labeling as specified in Sec. 101.9 (that is, are
labeled appropriately for individual sale as single-serving containers),
the serving size shall be 1 unit.
(ii) For products in large discrete units that are usually divided
for consumption (e.g., cake, pie, pizza, melon, cabbage), for unprepared
products where the entire contents of the package is used to prepare
large discrete units that are usually divided for consumption (e.g.,
cake mix, pizza kit), and for products which consist of two or more
foods packaged and presented to be consumed together where the
ingredient represented as the main ingredient is a large discrete unit
usually divided for consumption (e.g., prepared cake packaged with a can
of frosting), the serving size shall be the fractional slice of the
ready-to-eat product (e.g., 1/12 cake, 1/8 pie, 1/4 pizza, 1/4 melon, 1/
6 cabbage) that most closely approximates the reference amount for the
product category, and may be the fraction of the package used to make
the reference amount for the unprepared product determined in Sec.
101.12(c) or the fraction of the large discrete unit represented as the
main ingredient plus proportioned minor ingredients used to make the
reference amount for the combined product determined in Sec. 101.12(f).
In expressing the fractional slice, manufacturers shall use 1/2, 1/3, 1/
4, 1/5, 1/6, or smaller fractions that can be generated by further
division by 2 or 3.
(iii) For nondiscrete bulk products (e.g., breakfast cereal, flour,
sugar, dry mixes, concentrates, pancake mixes, macaroni and cheese
kits), and for products which consist of two or more foods packaged and
presented to be consumed together where the ingredient represented as
the main ingredient is a bulk product (e.g., peanut butter and jelly),
the serving size shall be the amount in household measure that most
closely approximates the reference amount for the product category and
may be the amount of the bulk product represented as the main ingredient
plus proportioned minor ingredients used to make the reference amount
for the combined product determined in Sec. 101.12(f).
(3) The serving size for meal products and main dish products as
defined in Sec. 101.13 (l) and (m) that comes in single-serving
containers as defined in paragraph (b)(6) of this section shall be the
entire content (edible portion only) of the package. Serving size for
meal products and main dish products in multiserving containers shall be
based on the reference amount applicable to the product in Sec.
101.12(b) if the product is listed in Sec. 101.12(b). Serving size for
meal products and main dish products in multiserving containers that are
not listed in Sec. 101.12(b) shall be based on the reference amount
according to Sec. 101.12(f).
(4) A variety pack, such as a package containing several varieties
of single-serving units as defined in paragraph (b)(2)(i) of this
section, and a product having two or more compartments with each
compartment containing a
[[Page 22]]
different food, shall provide nutrition information for each variety or
food per serving size that is derived from the reference amount in Sec.
101.12(b) applicable for each variety or food and the procedures to
convert the reference amount to serving size in paragraph (b)(2) of this
section.
(5) For labeling purposes, the term common household measure or
common household unit means cup, tablespoon, teaspoon, piece, slice,
fraction (e.g., 1/4 pizza), ounce (oz), fluid ounce (fl oz), or other
common household equipment used to package food products (e.g., jar,
tray). In expressing serving size in household measures, except as
specified in paragraphs (b)(5)(iv), (b)(5)(v), (b)(5)(vi), and
(b)(5)(vii) of this section, the following rules shall be used:
(i) Cups, tablespoons, or teaspoons shall be used wherever possible
and appropriate except for beverages. For beverages, a manufacturer may
use fluid ounces. Cups shall be expressed in 1/4- or 1/3-cup increments.
Tablespoons shall be expressed as 1, 1 1/3, 1 1/2, 1 2/3, 2, or 3
tablespoons. Teaspoons shall be expressed as 1/8, 1/4, 1/2, 3/4, 1, or 2
teaspoons.
(ii) If cups, tablespoons or teaspoons are not applicable, units
such as piece, slice, tray, jar, and fraction shall be used.
(iii) If paragraphs (b)(5)(i) and (b)(5)(ii) of this section are not
applicable, ounces may be used with an appropriate visual unit of
measure such as a dimension of a piece, e.g., 1 oz (28 g/about 1/2
pickle). Ounce measurements shall be expressed in 0.5 oz increments most
closely approximating the reference amount.
(iv) A description of the individual container or package shall be
used for single serving containers and for individually packaged
products within multiserving containers (e.g., can, box, package). A
description of the individual unit shall be used for other products in
discrete units (e.g., piece, slice, cracker, bar).
(v) For unprepared products where the entire contents of the package
is used to prepare large discrete units that are usually divided for
consumption (e.g., cake mix, pizza kit), the fraction or portion of the
package may be used.
(vi) Ounces with an appropriate visual unit of measure, as described
in paragraph (b)(5)(iii) of this section, may be used for products that
naturally vary in size as provided for in paragraph (b)(2)(i)(G) of this
section.
(vii) As provided for in Sec. 101.9(h)(1), for products that
consist of two or more distinct ingredients or components packaged and
presented to be consumed together (e.g. dry macaroni and cheese mix,
cake and muffin mixes with separate ingredient packages, pancakes and
syrup), nutrition information may be declared for each component or as a
composite. The serving size may be provided in accordance with the
provisions of paragraphs (b)(2)(i), (b)(2)(ii), and (b)(2)(iii) of this
section, or alternatively in ounces with an appropriate visual unit of
measure, as described in paragraph (b)(5)(iii) of this section (e.g.,
declared as separate components: ``3 oz dry macaroni (84 g/about 2/3
cup)'' and ``1 oz dry cheese mix (28 g/about 2 tbsp);'' declared as a
composite value: ``4 oz (112 g/about 2/3 cup macaroni and 2 tbsp dry
cheese mix)'').
(viii) For nutrition labeling purposes, a teaspoon means 5
milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, 1 fl oz
means 30 mL, and 1 oz in weight means 28 g.
(ix) When a serving size, determined from the reference amount in
Sec. 101.12(b) and the procedures described in this section, falls
exactly half way between two serving sizes, e.g., 2.5 tbsp,
manufacturers shall round the serving size up to the next incremental
size.
(6) A product that is packaged and sold individually and that
contains less than 200 percent of the applicable reference amount shall
be considered to be a single-serving container, and the entire content
of the product shall be labeled as one serving except for products that
have reference amounts of 100 g (or mL) or larger, manufacturers may
decide whether a package that contains more than 150 percent but less
than 200 percent of the reference amount is 1 or 2 servings. Packages
sold individually that contain 200 percent or more of the applicable
reference amount may be labeled as a single-serving if the entire
content of the package can reasonably
[[Page 23]]
be consumed at a single-eating occasion.
(7) A label statement regarding a serving shall be the serving size
expressed in common household measures as set forth in paragraphs (b)(2)
through (b)(6) of this section and shall be followed by the equivalent
metric quantity in parenthesis (fluids in milliliters and all other
foods in grams) except for single-serving containers.
(i) For a single-serving container, the parenthetical metric
quantity, which will be presented as part of the net weight statement on
the principal display panel, is not required except where nutrition
information is required on a drained weight basis according to Sec.
101.9(b)(9). However, if a manufacturer voluntarily provides the metric
quantity on products that can be sold as single servings, then the
numerical value provided as part of the serving size declaration must be
identical to the metric quantity declaration provided as part of the net
quantity of contents statement.
(ii) The gram or milliliter quantity equivalent to the household
measure should be rounded to the nearest whole number except for
quantities that are less than 5 g (mL). The gram (mL) quantity between 2
and 5 g (mL) should be rounded to the nearest 0.5 g (mL) and the g (mL)
quantity less than 2 g (mL) should be expressed in 0.1-g (mL)
increments.
(iii) In addition, serving size may be declared in ounce and fluid
ounce, in parenthesis, following the metric measure separated by a slash
where other common household measures are used as the primary unit for
serving size, e.g., 1 slice (28 g/1 oz) for sliced bread. The ounce
quantity equivalent to the metric quantity should be expressed in 0.1 oz
increments.
(iv) If a manufacturer elects to use abbreviations for units, the
following abbreviations shall be used: tbsp for tablespoon, tsp for
teaspoon, g for gram, mL for milliliter, oz for ounce, and fl oz for
fluid ounce.
(v) For products that only require the addition of water or another
ingredient that contains insignificant amounts of nutrients in the
amount added and that are prepared in such a way that there are no
significant changes to the nutrient profile, the amount of the finished
product may be declared in parentheses at the end of the serving size
declaration (e.g., 1/2 cup (120 mL) concentrated soup (makes 1 cup
prepared)).
(vi) To promote uniformity in label serving sizes in household
measures declared by different manufacturers, FDA has provided a
guidance document entitled, ``Guidelines for Determining the Gram Weight
of the Household Measure.'' The guidance document can be obtained from
the Office of Nutritional Products, Labeling and Dietary Supplements
(HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740.
(8) Determination of the number of servings per container shall be
based on the serving size of the product determined by following the
procedures described in this section.
(i) The number of servings shall be rounded to the nearest whole
number except for the number of servings between 2 and 5 servings and
random weight products. The number of servings between 2 and 5 servings
shall be rounded to the nearest 0.5 serving. Rounding should be
indicated by the use of the term about (e.g., about 2 servings, about
3.5 servings).
(ii) When the serving size is required to be expressed on a drained
solids basis and the number of servings varies because of a natural
variation in unit size (e.g., maraschino cherries, pickles), the
manufacturer may state the typical number of servings per container
(e.g., usually 5 servings).
(iii) For random weight products, a manufacturer may declare
``varied'' for the number of servings per container provided the
nutrition information is based on the reference amount expressed in
ounces. The manufacturer may provide the typical number of servings in
parenthesis following the ``varied'' statement.
(iv) For packages containing several individual single-serving
containers, each of which is labeled with all required information
including nutrition labeling as specified in Sec. 101.9 (that is, are
labeled appropriately for individual sale as single-serving containers),
the number of servings shall be the number
[[Page 24]]
of individual packages within the total package.
(v) For packages containing several individually packaged
multiserving units, the number of servings shall be determined by
multiplying the number of individual multiserving units in the total
package by the number of servings in each individual unit.
(9) The declaration of nutrient and food component content shall be
on the basis of food as packaged or purchased with the exception of raw
fish covered under Sec. 101.42 (see 101.44), packaged single-ingredient
products that consist of fish or game meat as provided for in paragraph
(j)(11) of this section, and of foods that are packed or canned in
water, brine, or oil but whose liquid packing medium is not customarily
consumed (e.g., canned fish, maraschino cherries, pickled fruits, and
pickled vegetables). Declaration of nutrient and food component content
of raw fish shall follow the provisions in Sec. 101.45. Declaration of
the nutrient and food component content of foods that are packed in
liquid which is not customarily consumed shall be based on the drained
solids.
(10) Another column of figures may be used to declare the nutrient
and food component information:
(i) Per 100 g or 100 mL, or per 1 oz or 1 fl oz of the food as
packaged or purchased;
(ii) Per one unit if the serving size of a product in discrete units
in a multiserving container is more than 1 unit;
(iii) Per cup popped for popcorn in a multiserving container.
(11) If a product is promoted on the label, labeling, or advertising
for a use that differs in quantity by twofold or greater from the use
upon which the reference amount in Sec. 101.12(b) was based (e.g.,
liquid cream substitutes promoted for use with breakfast cereals), the
manufacturer shall provide a second column of nutrition information
based on the amount customarily consumed in the promoted use, in
addition to the nutrition information per serving derived from the
reference amount in Sec. 101.12(b), except that nondiscrete bulk
products that are used primarily as ingredients (e.g., flour,
sweeteners, shortenings, oils), or traditionally used for multipurposes
(e.g., eggs, butter, margarine), and multipurpose baking mixes are
exempt from this requirement.
(c) The declaration of nutrition information on the label and in
labeling of a food shall contain information about the level of the
following nutrients, except for those nutrients whose inclusion, and the
declaration of amounts, is voluntary as set forth in this paragraph. No
nutrients or food components other than those listed in this paragraph
as either mandatory or voluntary may be included within the nutrition
label. Except as provided for in paragraphs (f) or (j) of this section,
nutrient information shall be presented using the nutrient names
specified and in the following order in the formats specified in
paragraphs (d) or (e) of this section.
(1) ``Calories, total,'' ``Total calories,'' or ``Calories'': A
statement of the caloric content per serving, expressed to the nearest
5-calorie increment up to and including 50 calories, and 10-calorie
increment above 50 calories, except that amounts less than 5 calories
may be expressed as zero. Energy content per serving may also be
expressed in kilojoule units, added in parentheses immediately following
the statement of the caloric content.
(i) Caloric content may be calculated by the following methods.
Where either specific or general food factors are used, the factors
shall be applied to the actual amount (i.e., before rounding) of food
components (e.g., fat, carbohydrate, protein, or ingredients with
specific food factors) present per serving.
(A) Using specific Atwater factors (i. e., the Atwater method) given
in Table 13, ``Energy Value of Foods--Basis and Derivation,'' by A. L.
Merrill and B. K. Watt, United States Department of Agriculture (USDA)
Handbook No. 74 (slightly revised, 1973), which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 and is
available from the Office of Nutritional Products, Labeling and Dietary
Supplements (HFS-800), Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
[[Page 25]]
20740, or may be inspected at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.;
(B) Using the general factors of 4, 4, and 9 calories per gram for
protein, total carbohydrate, and total fat, respectively, as described
in USDA Handbook No. 74 (slightly revised 1973) pp. 9-11, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51 (the availability of this incorporation by reference is given in
paragraph (c)(1)(i)(A) of this section);
(C) Using the general factors of 4, 4, and 9 calories per gram for
protein, total carbohydrate less the amount of insoluble dietary fiber,
and total fat, respectively, as described in USDA Handbook No. 74
(slightly revised 1973) pp. 9-11, which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the availability of
this incorporation by reference is given in paragraph (c)(1)(i)(A) of
this section;
(D) Using data for specific food factors for particular foods or
ingredients approved by the Food and Drug Administration (FDA) and
provided in parts 172 or 184 of this chapter, or by other means, as
appropriate; or
(E) Using bomb calorimetry data subtracting 1.25 calories per gram
protein to correct for incomplete digestibility, as described in USDA
Handbook No. 74 (slightly revised 1973) p. 10, which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the
availability of this incorporation by reference is given in paragraph
(c)(1)(i)(A) of this section).
(ii) ``Calories from fat'': A statement of the caloric content
derived from total fat as defined in paragraph (c)(2) of this section in
a serving, expressed to the nearest 5-calorie increment, up to and
including 50 calories, and the nearest 10-calorie increment above 50
calories, except that label declaration of ``calories from fat'' is not
required on products that contain less than 0.5 gram of fat in a serving
and amounts less than 5 calories may be expressed as zero. This
statement shall be declared as provided in paragraph (d)(5) of this
section. Except as provided for in paragraph (f) of this section, if
``Calories from fat'' is not required and, as a result, not declared,
the statement ``Not a significant source of calories from fat'' shall be
placed at the bottom of the table of nutrient values in the same type
size.
(iii) ``Calories from saturated fat'' or ``Calories from saturated''
(VOLUNTARY): A statement of the caloric content derived from saturated
fat as defined in paragraph (c)(2)(i) of this section in a serving may
be declared voluntarily, expressed to the nearest 5-calorie increment,
up to and including 50 calories, and the nearest 10-calorie increment
above 50 calories, except that amounts less than 5 calories may be
expressed as zero. This statement shall be indented under the statement
of calories from fat as provided in paragraph (d)(5) of this section.
(2) ``Fat, total'' or ``Total fat'': A statement of the number of
grams of total fat in a serving defined as total lipid fatty acids and
expressed as triglycerides. Amounts shall be expressed to the nearest
0.5 (1/2) gram increment below 5 grams and to the nearest gram increment
above 5 grams. If the serving contains less than 0.5 gram, the content
shall be expressed as zero.
(i) ``Saturated fat,'' or ``Saturated'': A statement of the number
of grams of saturated fat in a serving defined as the sum of all fatty
acids containing no double bonds, except that label declaration of
saturated fat content information is not required for products that
contain less than 0.5 gram of total fat in a serving if no claims are
made about fat, fatty acid, or cholesterol content, and if ``calories
from saturated fat'' is not declared. Except as provided for in
paragraph (f) of this section, if a statement of the saturated fat
content is not required and, as a result, not declared, the statement
``Not a significant source of saturated fat'' shall be placed at the
bottom of the table of nutrient values. Saturated fat content shall be
indented and expressed as grams per serving to the nearest 0.5 gram (1/
2) gram increment below 5
[[Page 26]]
grams and to the nearest gram increment above 5 grams. If the serving
contains less than 0.5 gram, the content shall be expressed as zero.
(ii) ``Trans fat'' or ``Trans'': A statement of the number of grams
of trans fat in a serving, defined as the sum of all unsaturated fatty
acids that contain one or more isolated (i.e., nonconjugated) double
bonds in a trans configuration, except that label declaration of trans
fat content information is not required for products that contain less
than 0.5 gram of total fat in a serving if no claims are made about fat,
fatty acid or cholesterol content. The word ``trans'' may be italicized
to indicate its Latin origin. Trans fat content shall be indented and
expressed as grams per serving to the nearest 0.5 (1/2)-gram increment
below 5 grams and to the nearest gram increment above 5 grams. If the
serving contains less than 0.5 gram, the content, when declared, shall
be expressed as zero. Except as provided for in paragraph (f) of this
section, if a statement of the trans fat content is not required and, as
a result, not declared, the statement ``Not a significant source of
trans fat'' shall be placed at the bottom of the table of nutrient
values.
(iii) ``Polyunsaturated fat'' or ``Polyunsaturated'' (VOLUNTARY): A
statement of the number of grams of polyunsaturated fat in a serving
defined as cis,cis-methylene-interrupted polyunsaturated fatty acids may
be declared voluntarily, except that when monounsaturated fat is
declared, or when a claim about fatty acids or cholesterol is made on
the label or in labeling of a food other than one that meets the
criteria in Sec. 101.62(b)(1) for a claim for ``fat free,'' label
declaration of polyunsaturated fat is required. Polyunsaturated fat
content shall be indented and expressed as grams per serving to the
nearest 0.5 (1/2) gram increment below 5 grams and to the nearest gram
increment above 5 grams. If the serving contains less than 0.5 gram, the
content shall be expressed as zero.
(iv) ``Monounsaturated fat'' or ``Monounsaturated'' (VOLUNTARY): A
statement of the number of grams of monounsaturated fat in a serving
defined as cis-monounsaturated fatty acids may be declared voluntarily
except that when polyunsaturated fat is declared, or when a claim about
fatty acids or cholesterol is made on the label or in labeling of a food
other than one that meets the criteria in Sec. 101.62(b)(1) for a claim
for ``fat free,'' label declaration of monounsaturated fat is required.
Monounsaturated fat content shall be indented and expressed as grams per
serving to the nearest 0.5 (1/2) gram increment below 5 grams and to the
nearest gram increment above 5 grams. If the serving contains less than
0.5 gram, the content shall be expressed as zero.
(3) ``Cholesterol'': A statement of the cholesterol content in a
serving expressed in milligrams to the nearest 5-milligram increment,
except that label declaration of cholesterol information is not required
for products that contain less than 2 milligrams cholesterol in a
serving and make no claim about fat, fatty acids, or cholesterol
content, or such products may state the cholesterol content as zero.
Except as provided for in paragraph (f) of this section, if cholesterol
content is not required and, as a result, not declared, the statement
``Not a significant source of cholesterol'' shall be placed at the
bottom of the table of nutrient values in the same type size. If the
food contains 2 to 5 milligrams of cholesterol per serving, the content
may be stated as ``less than 5 milligrams.''
(4) ``Sodium'': A statement of the number of milligrams of sodium in
a specified serving of food expressed as zero when the serving contains
less than 5 milligrams of sodium, to the nearest 5-milligram increment
when the serving contains 5 to 140 milligrams of sodium, and to the
nearest 10-milligram increment when the serving contains greater than
140 milligrams.
(5) ``Potassium'' (VOLUNTARY): A statement of the number of
milligrams of potassium in a specified serving of food may be declared
voluntarily, except that when a claim is made about potassium content,
label declaration shall be required. Potassium content shall be
expressed as zero when the serving contains less than 5 milligrams of
potassium, to the nearest 5-milligram increment when the serving
contains less than or equal to 140 milligrams of potassium, and to the
nearest
[[Page 27]]
10-milligram increment when the serving contains more than 140
milligrams.
(6) ``Carbohydrate, total'' or ``Total carbohydrate'': A statement
of the number of grams of total carbohydrate in a serving expressed to
the nearest gram, except that if a serving contains less than 1 gram,
the statement ``Contains less than 1 gram'' or ``less than 1 gram'' may
be used as an alternative, or if the serving contains less than 0.5
gram, the content may be expressed as zero. Total carbohydrate content
shall be calculated by subtraction of the sum of the crude protein,
total fat, moisture, and ash from the total weight of the food. This
calculation method is described in A. L. Merrill and B. K. Watt,
``Energy Value of Foods--Basis and Derivation,'' USDA Handbook 74
(slightly revised 1973) pp. 2 and 3, which is incorporated by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the availability
of this incorporation by reference is given in paragraph (c)(1)(i)(A) of
this section).
(i) ``Dietary fiber'': A statement of the number of grams of total
dietary fiber in a serving, indented and expressed to the nearest gram,
except that if a serving contains less than 1 gram, declaration of
dietary fiber is not required or, alternatively, the statement
``Contains less than 1 gram'' or ``less than 1 gram'' may be used, and
if the serving contains less than 0.5 gram, the content may be expressed
as zero. Except as provided for in paragraph (f) of this section, if
dietary fiber content is not required and as a result, not declared, the
statement ``Not a significant source of dietary fiber'' shall be placed
at the bottom of the table of nutrient values in the same type size.
(A) ``Soluble fiber'' (VOLUNTARY): A statement of the number of
grams of soluble dietary fiber in a serving may be declared voluntarily
except when a claim is made on the label or in labeling about soluble
fiber, label declaration shall be required. Soluble fiber content shall
be indented under dietary fiber and expressed to the nearest gram,
except that if a serving contains less than 1 gram, the statement
``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an
alternative, and if the serving contains less than 0.5 gram, the content
may be expressed as zero.
(B) ``Insoluble fiber'' (VOLUNTARY): A statement of the number of
grams of insoluble dietary fiber in a serving may be declared
voluntarily except that when a claim is made on the label or in labeling
about insoluble fiber, label declaration shall be required. Insoluble
fiber content shall be indented under dietary fiber and expressed to the
nearest gram except that if a serving contains less than 1 gram, the
statement ``Contains less than 1 gram'' or ``less than 1 gram'' may be
used as an alternative, and if the serving contains less than 0.5 gram,
the content may be expressed as zero.
(ii) ``Sugars'': A statement of the number of grams of sugars in a
serving, except that label declaration of sugars content is not required
for products that contain less than 1 gram of sugars in a serving if no
claims are made about sweeteners, sugars, or sugar alcohol content.
Except as provided for in paragraph (f) of this section, if a statement
of the sugars content is not required and, as a result, not declared,
the statement ``Not a significant source of sugars'' shall be placed at
the bottom of the table of nutrient values in the same type size. Sugars
shall be defined as the sum of all free mono- and disaccharides (such as
glucose, fructose, lactose, and sucrose). Sugars content shall be
indented and expressed to the nearest gram, except that if a serving
contains less than 1 gram, the statement ``Contains less then 1 gram''
or ``less than 1 gram'' may be used as an alternative, and if the
serving contains less than 0.5 gram, the content may be expressed as
zero.
(iii) ``Sugar alcohol'' (VOLUNTARY): A statement of the number of
grams of sugar alcohols in a serving may be declared voluntarily on the
label, except that when a claim is made on the label or in labeling
about sugar alcohol or sugars when sugar alcohols are present in the
food, sugar alcohol content shall be declared. For nutrition labeling
purposes, sugar alcohols are defined as the sum of saccharide
derivatives in which a hydroxyl group replaces a ketone or aldehyde
group and whose use in the food is listed by FDA (e.g., mannitol or
xylitol) or is generally recognized as
[[Page 28]]
safe (e.g., sorbitol). In lieu of the term ``sugar alcohol,'' the name
of the specific sugar alcohol (e.g., ``xylitol'') present in the food
may be used in the nutrition label provided that only one sugar alcohol
is present in the food. Sugar alcohol content shall be indented and
expressed to the nearest gram, except that if a serving contains less
than 1 gram, the statement ``Contains less then 1 gram'' or ``less than
1 gram'' may be used as an alternative, and if the serving contains less
than 0.5 gram, the content may be expressed as zero.
(iv) ``Other carbohydrate'' (VOLUNTARY): A statement of the number
of grams of other carbohydrates may be declared voluntarily. Other
carbohydrates shall be defined as the difference between total
carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol,
except that if sugar alcohol is not declared (even if present), it shall
be defined as the difference between total carbohydrate and the sum of
dietary fiber and sugars. Other carbohydrate content shall be indented
and expressed to the nearest gram, except that if a serving contains
less than 1 gram, the statement ``Contains less than 1 gram'' or ``less
than 1 gram'' may be used as an alternative, and if the serving contains
less than 0.5 gram, the content may be expressed as zero.
(7) ``Protein'': A statement of the number of grams of protein in a
serving, expressed to the nearest gram, except that if a serving
contains less than 1 gram, the statement ``Contains less than 1 gram''
or ``less than 1 gram'' may be used as an alternative, and if the
serving contains less than 0.5 gram, the content may be expressed as
zero. When the protein in foods represented or purported to be for
adults and children 4 or more years of age has a protein quality value
that is a protein digestibility-corrected amino acid score of less than
20 expressed as a percent, or when the protein in a food represented or
purported to be for children greater than 1 but less than 4 years of age
has a protein quality value that is a protein digestibility-corrected
amino acid score of less than 40 expressed as a percent, either of the
following shall be placed adjacent to the declaration of protein content
by weight: The statement ``not a significant source of protein,'' or a
listing aligned under the column headed ``Percent Daily Value'' of the
corrected amount of protein per serving, as determined in paragraph
(c)(7)(ii) of this section, calculated as a percentage of the Daily
Reference Value (DRV) or Reference Daily Intake (RDI), as appropriate,
for protein and expressed as Percent of Daily Value. When the protein
quality in a food as measured by the Protein Efficiency Ratio (PER) is
less than 40 percent of the reference standard (casein) for a food
represented or purported to be for infants, the statement ``not a
significant source of protein'' shall be placed adjacent to the
declaration of protein content. Protein content may be calculated on the
basis of the factor of 6.25 times the nitrogen content of the food as
determined by the appropriate method of analysis as given in the
``Official Methods of Analysis of the AOAC International'' (formerly the
Association of Official Analytical Chemists), 15th Ed. (1990), which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51, except when the official procedure for a specific food requires
another factor. Copies may be obtained from AOAC INTERNATIONAL, 481
North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be
inspected at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal--register/code--of--
federal--regulations/ibr--locations.html.
(i) A statement of the corrected amount of protein per serving, as
determined in paragraph (c)(7)(ii) of this section, calculated as a
percentage of the RDI or DRV for protein, as appropriate, and expressed
as Percent of Daily Value, may be placed on the label, except that such
a statement shall be given if a protein claim is made for the product,
or if the product is represented or purported to be for use by infants
or children under 4 years of age. When such a declaration is provided,
it shall be placed on the label adjacent to the statement of grams of
protein and aligned under the column
[[Page 29]]
headed ``Percent Daily Value,'' and expressed to the nearest whole
percent. However, the percentage of the RDI for protein shall not be
declared if the food is represented or purported to be for use by
infants and the protein quality value is less than 40 percent of the
reference standard.
(ii) The ``corrected amount of protein (gram) per serving'' for
foods represented or purported for adults and children 1 or more years
of age is equal to the actual amount of protein (gram) per serving
multiplied by the amino acid score corrected for protein digestibility.
If the corrected score is above 1.00, then it shall be set at 1.00. The
protein digestibility-corrected amino acid score shall be determined by
methods given in sections 5.4.1, 7.2.1, and 8.00 in ``Protein Quality
Evaluation, Report of the Joint FAO/WHO Expert Consultation on Protein
Quality Evaluation,'' Rome, 1990, except that when official AOAC
procedures described in section (c)(7) of this paragraph require a
specific food factor other than 6.25, that specific factor shall be
used. The ``Report of the Joint FAO/WHO Expert Consultation on Protein
Quality Evaluation'' as published by the Food and Agriculture
Organization of the United Nations/World Health Organization is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies are available from the Center for Food Safety and
Applied Nutrition (HFS-800), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, or may be inspected at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html. For foods represented or purported for
infants, the corrected amount of protein (grams) per serving is equal to
the actual amount of protein (grams) per serving multiplied by the
relative protein quality value. The relative protein quality value shall
be determined by dividing the subject food protein PER value by the PER
value for casein. If the relative protein value is above 1.00, it shall
be set at 1.00.
(iii) For the purpose of labeling with a percent of the Daily
Reference Value (DRV) or RDI, a value of 50 grams of protein shall be
the DRV for adults and children 4 or more years of age, and the RDI for
protein for children less than 4 years of age, infants, pregnant women,
and lactating women shall be 16 grams, 14 grams, 60 grams, and 65 grams,
respectively.
(8) Vitamins and minerals: A statement of the amount per serving of
the vitamins and minerals as described in this paragraph, calculated as
a percent of the RDI and expressed as percent of Daily Value.
(i) For purposes of declaration of percent of Daily Value as
provided for in paragraphs (d), (e), and (f) of this section, foods
represented or purported to be for use by infants, children less than 4
years of age, pregnant women, or lactating women shall use the RDI's
that are specified for the intended group. For foods represented or
purported to be for use by both infants and children under 4 years of
age, the percent of Daily Value shall be presented by separate
declarations according to paragraph (e) of this section based on the RDI
values for infants from birth to 12 months of age and for children under
4 years of age. Similarly, the percent of Daily Value based on both the
RDI values for pregnant women and for lactating women shall be declared
separately on foods represented or purported to be for use by both
pregnant and lactating women. When such dual declaration is used on any
label, it shall be included in all labeling, and equal prominence shall
be given to both values in all such labeling. All other foods shall use
the RDI for adults and children 4 or more years of age.
(ii) The declaration of vitamins and minerals as a percent of the
RDI shall include vitamin A, vitamin C, calcium, and iron, in that
order, and shall include any of the other vitamins and minerals listed
in paragraph (c)(8)(iv) of this section when they are added as a
nutrient supplement, or when a claim is made about them. Other vitamins
and minerals need not be declared if neither the nutrient nor the
component is otherwise referred to on the label or in labeling or
advertising and the vitamins and minerals are:
[[Page 30]]
(A) Required or permitted in a standardized food (e.g., thiamin,
riboflavin, and niacin in enriched flour) and that standardized food is
included as an ingredient (i.e., component) in another food; or
(B) Included in a food solely for technological purposes and
declared only in the ingredient statement. The declaration may also
include any of the other vitamins and minerals listed in paragraph
(c)(8)(iv) of this section when they are naturally occurring in the
food. The additional vitamins and minerals shall be listed in the order
established in paragraph (c)(8)(iv) of this section.
(iii) The percentages for vitamins and minerals shall be expressed
to the nearest 2-percent increment up to and including the 10-percent
level, the nearest 5-percent increment above 10 percent and up to and
including the 50-percent level, and the nearest 10-percent increment
above the 50-percent level. Amounts of vitamins and minerals present at
less than 2 percent of the RDI are not required to be declared in
nutrition labeling but may be declared by a zero or by the use of an
asterisk (or other symbol) that refers to another asterisk (or symbol)
that is placed at the bottom of the table and that is followed by the
statement ``Contains less than 2 percent of the Daily Value of this
(these) nutrient (nutrients)'' or ``Contains < 2 percent of the Daily
Value of this (these) nutrient (nutrients).'' Alternatively, except as
provided for in paragraph (f) of this section, if vitamin A, vitamin C,
calcium, or iron is present in amounts less than 2 percent of the RDI,
label declaration of the nutrient(s) is not required if the statement
``Not a significant source of -- (listing the vitamins or minerals
omitted)'' is placed at the bottom of the table of nutrient values.
Either statement shall be in the same type size as nutrients that are
indented.
(iv) The following RDI's and nomenclature are established for the
following vitamins and minerals which are essential in human nutrition:
Vitamin A, 5,000 International Units
Vitamin C, 60 milligrams
Calcium, 1,000 milligrams
Iron, 18 milligrams
Vitamin D, 400 International Units
Vitamin E, 30 International Units
Vitamin K, 80 micrograms
Thiamin, 1.5 milligrams
Riboflavin, 1.7 milligrams
Niacin, 20 milligrams
Vitamin B6, 2.0 milligrams
Folate, 400 micrograms
Vitamin B12, 6 micrograms
Biotin, 300 micrograms
Pantothenic acid, 10 milligrams
Phosphorus, 1,000 milligrams
Iodine, 150 micrograms
Magnesium, 400 milligrams
Zinc, 15 milligrams
Selenium, 70 micrograms
Copper, 2.0 milligrams
Manganese, 2.0 milligrams
Chromium, 120 micrograms
Molybdenum, 75 micrograms
Chloride, 3,400 milligrams
(v) The following synonyms may be added in parentheses immediately
following the name of the nutrient or dietary component:
Calories--Energy
Vitamin C--Ascorbic acid
Thiamin--Vitamin B1
Riboflavin--Vitamin B2
Folate--Folic acid or Folacin.
Alternatively, folic acid or folacin may be listed without parentheses
in place of folate.
(vi) A statement of the percent of vitamin A that is present as
beta-carotene may be declared voluntarily. When the vitamins and
minerals are listed in a single column, the statement shall be indented
under the information on vitamin A. When vitamins and minerals are
arrayed horizontally, the statement of percent shall be presented in
parenthesis following the declaration of vitamin A and the percent DV of
vitamin A in the food (e.g., ``Percent Daily Value: Vitamin A 50 (90
percent as beta-carotene)''). When declared, the percentages shall be
expressed in the same increments as are provided for vitamins and
minerals in paragraph (c)(8)(iii) of this section.
(9) For the purpose of labeling with a percent of the DRV, the
following DRV's are established for the following food components based
on the reference caloric intake of 2,000 calories:
------------------------------------------------------------------------
Unit of
Food component measurement DRV
------------------------------------------------------------------------
Fat............................. gram (g).......... 65
Saturated fatty acids........... do................ 20
Cholesterol..................... milligrams (mg)... 300
[[Page 31]]
Total carbohydrate.............. grams (g)......... 300
Fiber........................... do................ 25
Sodium.......................... milligrams (mg)... 2,400
Potassium....................... do................ 3,500
Protein......................... grams (g)......... 50
------------------------------------------------------------------------
(d)(1) Nutrient information specified in paragraph (c) of this
section shall be presented on foods in the following format, as shown in
paragraph (d)(12) of this section, except on foods on which dual columns
of nutrition information are declared as provided for in paragraph (e)
of this section, on those food products on which the simplified format
is required to be used as provided for in paragraph (f) of this section,
on foods for infants and children less than 4 years of age as provided
for in paragraph (j)(5) of this section, and on foods in small or
intermediate-sized packages as provided for in paragraph (j)(13) of this
section. In the interest of uniformity of presentation, FDA urges that
the nutrition information be presented using the graphic specifications
set forth in appendix B to part 101.
(i) The nutrition information shall be set off in a box by use of
hairlines and shall be all black or one color type, printed on a white
or other neutral contrasting background whenever practical.
(ii) All information within the nutrition label shall utilize:
(A) Except as provided for in paragraph (c)(2)(ii) of this section,
a single easy-to-read type style,
(B) Upper and lower case letters,
(C) At least one point leading (i.e., space between two lines of
text) except that at least four points leading shall be utilized for the
information required by paragraphs (d)(7) and (d)(8) of this section as
shown in paragraph (d)(12), and
(D) Letters should never touch.
(iii) Information required in paragraphs (d)(3), (d)(5), (d)(7), and
(d)(8) of this section shall be in type size no smaller than 8 point.
Except for the heading ``Nutrition Facts,'' the information required in
paragraphs (d)(4), (d)(6), and (d)(9) of this section and all other
information contained within the nutrition label shall be in type size
no smaller than 6 point. When provided, the information described in
paragraph (d)(10) of this section shall also be in type no smaller than
6 point.
(iv) The headings required by paragraphs (d)(2), (d)(4), and (d)(6)
of this section (i.e., ``Nutrition Facts,'' ``Amount per Serving,'' and
``% Daily Value*''), the names of all nutrients that are not indented
according to requirements of paragraph (c) of this section (i.e.,
``Calories,'' ``Total Fat,'' ``Cholesterol,'' ``Sodium,'' ``Total
Carbohydrate,'' and ``Protein''), and the percentage amounts required by
paragraph (d)(7)(ii) of this section shall be highlighted by bold or
extra bold type or other highlighting (reverse printing is not permitted
as a form of highlighting) that prominently distinguishes it from other
information. No other information shall be highlighted.
(v) A hairline rule that is centered between the lines of text shall
separate ``Amount Per Serving'' from the calorie statements required in
paragraph (d)(5) of this section and shall separate each nutrient and
its corresponding percent Daily Value required in paragraphs (d)(7)(i)
and (d)(7)(ii) of this section from the nutrient and percent Daily Value
above and below it, as shown in paragraph (d)(12) of this section.
(2) The information shall be presented under the identifying heading
of ``Nutrition Facts'' which shall be set in a type size larger than all
other print size in the nutrition label and, except for labels presented
according to the format provided for in paragraph (d)(11) of this
section, unless impractical, shall be set the full width of the
information provided under paragraph (d)(7) of this section, as shown in
paragraph (d)(12) of this section.
(3) Information on serving size shall immediately follow the heading
as shown in paragraph (d)(12) of this section. Such information shall
include:
(i) ``Serving Size'': A statement of the serving size as specified
in paragraph (b)(7) of this section.
(ii) ``Servings Per Container'': The number of servings per
container, except that this statement is not required on single serving
containers as defined in paragraph (b)(6) of this section or on other
food containers when this information is stated in the net quantity of
contents declaration.
[[Page 32]]
(4) A subheading ``Amount Per Serving'' shall be separated from
serving size information by a bar as shown in paragraph (d)(12) of this
section.
(5) Information on calories shall immediately follow the heading
``Amount Per Serving'' and shall be declared in one line, leaving
sufficient space between the declaration of ``Calories'' and ``Calories
from fat'' to allow clear differentiation, or, if ``Calories from
saturated fat'' is declared, in a column with total ``Calories'' at the
top, followed by ``Calories from fat'' (indented), and ``Calories from
saturated fat'' (indented).
(6) The column heading ``% Daily Value,'' followed by an asterisk
(e.g., ``% Daily Value*''), shall be separated from information on
calories by a bar as shown in paragraph (d)(12) of this section. The
position of this column heading shall allow for a list of nutrient names
and amounts as described in paragraph (d)(7) of this section to be to
the left of, and below, this column heading. The column headings
``Percent Daily Value,'' ``Percent DV,'' or ``% DV'' may be substituted
for ``% Daily Value.''
(7) Except as provided for in paragraph (j)(13) of this section,
nutrient information for both mandatory and any voluntary nutrients
listed in paragraph (c) of this section that are to be declared in the
nutrition label, except vitamins and minerals, shall be declared as
follows:
(i) The name of each nutrient, as specified in paragraph (c) of this
section, shall be given in a column and followed immediately by the
quantitative amount by weight for that nutrient appended with a ``g''
for grams or a ``mg'' for milligrams as shown in paragraph (d)(12) of
this section. The symbol ``<'' may be used in place of ``less than.''
(ii) A listing of the percent of the DRV as established in
paragraphs (c)(7)(iii) and (c)(9) of this section shall be given in a
column aligned under the heading ``% Daily Value'' established in
paragraph (d)(6) of this section with the percent expressed to the
nearest whole percent for each nutrient declared in the column described
in paragraph (d)(7)(i) of this section for which a DRV has been
established, except that the percent for protein may be omitted as
provided in paragraph (c)(7) of this section. The percent shall be
calculated by dividing either the amount declared on the label for each
nutrient or the actual amount of each nutrient (i.e., before rounding)
by the DRV for the nutrient, except that the percent for protein shall
be calculated as specified in paragraph (c)(7)(ii) of this section. The
numerical value shall be followed by the symbol for percent (i.e., %).
(8) Nutrient information for vitamins and minerals shall be
separated from information on other nutrients by a bar and shall be
arrayed horizontally (e.g., Vitamin A 4%, Vitamin C 2%, Calcium 15%,
Iron 4%) or may be listed in two columns as shown in paragraph (d)(12)
of this section, except that when more than four vitamins and minerals
are declared, they may be declared vertically with percentages listed
under the column headed ``% Daily Value.''
(9) A footnote, preceded by an asterisk, shall be placed beneath the
list of vitamins and minerals and shall be separated from that list by a
hairline.
(i) The footnote shall state:
Percent Daily Values are based on a 2,000 calorie diet.
Your daily values may be higher or lower depending on your calorie
needs.
------------------------------------------------------------------------
Calories: 2,000 2,500
------------------------------------------------------------------------
Total fat........................ Less than 65 g 80 g
Saturated fat.................... Less than 20 g 25 g
Cholesterol...................... Less than 300 mg 300 mg
Sodium........................... Less than 2,400 mg 2,400 mg
Total carbohydrate............... ............... 300 g 375 g
Dietary fiber.................... ............... 25 g 30 g
------------------------------------------------------------------------
(ii) If the percent of Daily Value is given for protein in the
Percent of Daily Value column as provided in paragraph (d)(7)(ii) of
this section, protein shall be listed under dietary fiber, and a value
of 50 g shall be inserted on the same line in the column headed
``2,000'' and a value of 65 g in the column headed ``2,500''.
(iii) If potassium is declared in the column described in paragraph
(d)(7)(i) of this section, potassium shall be listed under sodium and
the DRV established in paragraph (c)(9) of this section shall be
inserted on the same line in the numeric columns.
[[Page 33]]
(iv) The abbreviations established in paragraph (j)(13)(ii)(B) of
this section may be used within the footnote.
(10) Caloric conversion information on a per gram basis for fat,
carbohydrate, and protein may be presented beneath the information
required in paragraph (d)(9) of this section, separated from that
information by a hairline. This information may be presented
horizontally as shown in paragraph (d)(12) of this section (i.e.,
``Calories per gram: fat 9, carbohydrate 4, protein 4'') or vertically
in columns.
(11)(i) If the space beneath the information on vitamins and
minerals is not adequate to accommodate the information required in
paragraph (d)(9) of this section, the information required in paragraph
(d)(9) may be moved to the right of the column required in paragraph
(d)(7)(ii) of this section and set off by a line that distinguishes it
and sets it apart from the percent Daily Value information. The caloric
conversion information provided for in paragraph (d)(10) of this section
may be presented beneath either side or along the full length of the
nutrition label.
(ii) If the space beneath the mandatory declaration of iron is not
adequate to accommodate any remaining vitamins and minerals to be
declared or the information required in paragraph (d)(9) of this
section, the remaining information may be moved to the right and set off
by a line that distinguishes it and sets it apart from the nutrients and
the percent DV information given to the left. The caloric conversion
information provided for in paragraph (d)(10) of this section may be
presented beneath either side or along the full length of the nutrition
label.
(iii) If there is not sufficient continuous vertical space (i.e.,
approximately 3 in) to accommodate the required components of the
nutrition label up to and including the mandatory declaration of iron,
the nutrition label may be presented in a tabular display as shown
below.
[GRAPHIC] [TIFF OMITTED] TR11JY03.000
[[Page 34]]
(12) The following sample label illustrates the provisions of
paragraph (d) of this section.
[GRAPHIC] [TIFF OMITTED] TR11JY03.001
(13)(i) Nutrition labels on the outer label of packages of products
that contain two or more separately packaged foods that are intended to
be eaten individually (e.g., variety packs of cereals or snack foods) or
of packages that are used interchangeably for the same type of food
(e.g., round ice cream containers) may use an aggregate display.
(ii) Aggregate displays shall comply with the format requirements of
paragraph (d) of this section to the maximum extent possible, except
that the identity of each food shall be specified immediately under the
``Nutrition Facts'' title, and both the quantitative amount by weight
(i.e., g/mg amounts) and the percent Daily Value for each nutrient shall
be listed in separate columns under the name of each food. The following
sample label illustrates an aggregate display.
[[Page 35]]
[GRAPHIC] [TIFF OMITTED] TR11JY03.002
(14) In accordance with Sec. 101.15(c)(2), when nutrition labeling
must appear in a second language, the nutrition information may be
presented in a separate nutrition label for each language or in one
nutrition label with the information in the second language following
that in English. Numeric characters that are identical in both languages
need not be repeated (e.g., ``Protein/Proteinas 2 g''). All required
information must be included in both languages.
(e) Nutrition information may be presented for two or more forms of
the same food (e.g., both ``as purchased'' and ``as prepared'') or for
common combinations of food as provided for in paragraph (h)(4) of this
section, for different units (e.g., slices of bread or per 100 grams) as
provided for in paragraph (b) of this section, or for two or more groups
for which RDI's are established (e.g., both infants and children less
than 4 years of age) as shown in paragraph (e)(5) of this section. When
such dual labeling is provided, equal prominence shall be given to both
sets of values. Information shall be presented in a format consistent
with paragraph (d) of this section, except that:
(1) Following the subheading of ``Amount Per Serving,'' there shall
be two or more column headings accurately describing the forms of the
same food (e.g., ``Mix'' and ``Baked''), the combinations of food, the
units, or the RDI groups that are being declared. The column
representing the product as packaged and according to the label serving
size based on the reference
[[Page 36]]
amount in Sec. 101.12(b) shall be to the left of the numeric columns.
(2) When the dual labeling is presented for two or more forms of the
same food, for combinations of food, or for different units, total
calories and calories from fat (and calories from saturated fat, when
declared) shall be listed in a column and indented as specified in
paragraph (d)(5) of this section with quantitative amounts declared in
columns aligned under the column headings set forth in paragraph (e)(1)
of this section.
(3) Quantitative information by weight required in paragraph
(d)(7)(i) of this section shall be specified for the form of the product
as packaged and according to the label serving size based on the
reference amount in Sec. 101.12(b).
(i) Quantitative information by weight may be included for other
forms of the product represented by the additional column(s) either
immediately adjacent to the required quantitative information by weight
for the product as packaged and according to the label serving size
based on the reference amount in Sec. 101.12(b) or as a footnote.
(A) If such additional quantitative information is given immediately
adjacent to the required quantitative information, it shall be declared
for all nutrients listed and placed immediately following and
differentiated from the required quantitative information (e.g.,
separated by a comma). Such information shall not be put in a separate
column.
(B) If such additional quantitative information is given in a
footnote, it shall be declared in the same order as the nutrients are
listed in the nutrition label. The additional quantitative information
may state the total nutrient content of the product identified in the
second column or the nutrient amounts added to the product as packaged
for only those nutrients that are present in different amounts than the
amounts declared in the required quantitative information. The footnote
shall clearly identify which amounts are declared. Any subcomponents
declared shall be listed parenthetically after principal components
(e.g., 1/2 cup skim milk contributes an additional 40 calories, 65 mg
sodium, 6 g total carbohydrate (6 g sugars), and 4 g protein).
(ii) Total fat and its quantitative amount by weight shall be
followed by an asterisk (or other symbol) (e.g., ``Total fat (2 g)*'')
referring to another asterisk (or symbol) at the bottom of the nutrition
label identifying the form(s) of the product for which quantitative
information is presented.
(4) Information required in paragraphs (d)(7)(ii) and (d)(8) of this
section shall be presented under the subheading ``% DAILY VALUE'' and in
columns directly under the column headings set forth in paragraph (e)(1)
of this section.
(5) The following sample label illustrates the provisions of
paragraph (e) of this section:
[[Page 37]]
[GRAPHIC] [TIFF OMITTED] TR11JY03.003
(f) The declaration of nutrition information may be presented in the
simplified format set forth herein when a food product contains
insignificant amounts of eight or more of the following: Calories, total
fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate,
dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, and iron;
except that for foods intended for children less than 2 years of age to
which Sec. 101.9(j)(5)(i) applies, nutrition information may be
presented in the simplified format when a food product contains
insignificant amounts of six or more of the following: Calories, total
fat, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin
A, vitamin C, calcium, and iron.
(1) An ``insignificant amount'' shall be defined as that amount that
allows a declaration of zero in nutrition labeling, except that for
total carbohydrate, dietary fiber, and protein, it shall be an amount
that allows a declaration of ``less than 1 gram.''
(2) The simplified format shall include information on the following
nutrients:
(i) Total calories, total fat, total carbohydrate, protein, and
sodium;
(ii) Calories from fat and any other nutrients identified in
paragraph (f) of this section that are present in the
[[Page 38]]
food in more than insignificant amounts; and
(iii) Any vitamins and minerals listed in paragraph (c)(8)(iv) of
this section when they are required to be added as a nutrient supplement
to foods for which a standard of identity exists.
(iv) Any vitamins or minerals listed in paragraph (c)(8)(iv) of this
section voluntarily added to the food as nutrient supplements.
(3) Other nutrients that are naturally present in the food in more
than insignificant amounts may be voluntarily declared as part of the
simplified format.
(4) If any nutrients are declared as provided in paragraphs
(f)(2)(iii), (f)(2)(iv), or (f)(3) of this section as part of the
simplified format or if any nutrition claims are made on the label or in
labeling, the statement ``Not a significant source of ------'' (with the
blank filled in with the name(s) of any nutrient(s) identified in Sec.
101.9(f) and calories from fat that are present in insignificant
amounts) shall be included at the bottom of the nutrition label.
(5) Except as provided for in paragraphs (j)(5) and (j)(13) of this
section, nutrient information declared in the simplified format shall be
presented in the same manner as specified in paragraphs (d) or (e) of
this section, except that the footnote required in paragraph (d)(9) of
this section is not required. When the footnote is omitted, an asterisk
shall be placed at the bottom of the label followed by the statement
``Percent Daily Values are based on a 2,000 calorie diet'' and, if the
term ``Daily Value'' is not spelled out in the heading, a statement that
``DV'' represents ``Daily Value.''
(g) Compliance with this section shall be determined as follows:
(1) A collection of primary containers or units of the same size,
type, and style produced under conditions as nearly uniform as possible,
designated by a common container code or marking, or in the absence of
any common container code or marking, a day's production, constitutes a
``lot.''
(2) The sample for nutrient analysis shall consist of a composite of
12 subsamples (consumer units), taken 1 from each of 12 different
randomly chosen shipping cases, to be representative of a lot. Unless a
particular method of analysis is specified in paragraph (c) of this
section, composites shall be analyzed by appropriate methods as given in
the ``Official Methods of Analysis of the AOAC International,'' 15th Ed.
(1990), which is incorporated by reference in accordance with 5 U.S.C.
552(a) or 1 CFR part 51 or, if no AOAC method is available or
appropriate, by other reliable and appropriate analytical procedures.
The availability of this incorporation by reference is given in
paragraph (c)(7) of this section.
(3) Two classes of nutrients are defined for purposes of compliance:
(i) Class I. Added nutrients in fortified or fabricated foods; and
(ii) Class II. Naturally occurring (indigenous) nutrients. If any
ingredient which contains a naturally occurring (indigenous) nutrient is
added to a food, the total amount of such nutrient in the final food
product is subject to class II requirements unless the same nutrient is
also added.
(4) A food with a label declaration of a vitamin, mineral, protein,
total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated
or monounsaturated fat, or potassium shall be deemed to be misbranded
under section 403(a) of the Federal Food, Drug, and Cosmetic Act (the
act) unless it meets the following requirements:
(i) Class I vitamin, mineral, protein, dietary fiber, or potassium.
The nutrient content of the composite is at least equal to the value for
that nutrient declared on the label.
(ii) Class II vitamin, mineral, protein, total carbohydrate, dietary
fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or
potassium. The nutrient content of the composite is at least equal to 80
percent of the value for that nutrient declared on the label. Provided,
That no regulatory action will be based on a determination of a nutrient
value that falls below this level by a factor less than the variability
generally recognized for the analytical method used in that food at the
level involved.
(5) A food with a label declaration of calories, sugars, total fat,
saturated fat, trans fat, cholesterol, or sodium shall be deemed to be
misbranded
[[Page 39]]
under section 403(a) of the act if the nutrient content of the composite
is greater than 20 percent in excess of the value for that nutrient
declared on the label. Provided, That no regulatory action will be based
on a determination of a nutrient value that falls above this level by a
factor less than the variability generally recognized for the analytical
method used in that food at the level involved.
(6) Reasonable excesses of a vitamin, mineral, protein, total
carbohydrate, dietary fiber, other carbohydrate, polyunsaturated or
monounsaturated fat, or potassium over labeled amounts are acceptable
within current good manufacturing practice. Reasonable deficiencies of
calories, sugars, total fat, saturated fat, trans fat, cholesterol, or
sodium under labeled amounts are acceptable within current good
manufacturing practice.
(7) Compliance will be based on the metric measure specified in the
label statement of serving size.
(8) Compliance with the provisions set forth in paragraphs (g)(1)
through (g)(6) of this section may be provided by use of an FDA approved
data base that has been computed following FDA guideline procedures and
where food samples have been handled in accordance with current good
manufacturing practice to prevent nutrition loss. FDA approval of a data
base shall not be considered granted until the Center for Food Safety
and Applied Nutrition has agreed to all aspects of the data base in
writing. The approval will be granted where a clear need is presented
(e.g., raw produce and seafood). Approvals will be in effect for a
limited time, e.g., 10 years, and will be eligible for renewal in the
absence of significant changes in agricultural or industry practices.
Approval requests shall be submitted in accordance with the provisions
of Sec. 10.30 of this chapter. Guidance in the use of data bases may be
found in the ``FDA Nutrition Labeling Manual--A Guide for Developing and
Using Data Bases,'' available from the Office of Nutritional Products,
Labeling and Dietary Supplements (HFS-800), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740.
(9) When it is not technologically feasible, or some other
circumstance makes it impracticable, for firms to comply with the
requirements of this section (e.g., to develop adequate nutrient
profiles to comply with the requirements of paragraph (c) of this
section), FDA may permit alternative means of compliance or additional
exemptions to deal with the situation. Firms in need of such special
allowances shall make their request in writing to the Center for Food
Safety and Applied Nutrition (HFS-800), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740.
(h) Products with separately packaged ingredients or foods, with
assortments of food, or to which other ingredients are added by the user
may be labeled as follows:
(1) If a product consists of two or more separately packaged
ingredients enclosed in an outer container or of assortments of the same
type of food (e.g., assorted nuts or candy mixtures) in the same retail
package, nutrition labeling shall be located on the outer container or
retail package (as the case may be) to provide information for the
consumer at the point of purchase. However, when two or more food
products are simply combined together in such a manner that no outer
container is used, or no outer label is available, each product shall
have its own nutrition information, e.g., two boxes taped together or
two cans combined in a clear plastic overwrap. When separately packaged
ingredients or assortments of the same type of food are intended to be
eaten at the same time, the nutrition information may be specified per
serving for each component or as a composite value.
(2) If a product consists of two or more separately packaged foods
that are intended to be eaten individually and that are enclosed in an
outer container (e.g., variety packs of cereals or snack foods), the
nutrition information shall:
(i) Be specified per serving for each food in a location that is
clearly visible to the consumer at the point of purchase; and
(ii) Be presented in separate nutrition labels or in one aggregate
nutrition label with separate columns for
[[Page 40]]
the quantitative amount by weight and the percent Daily Value for each
food.
(3) If a package contains a variety of foods, or an assortment of
foods, and is in a form intended to be used as a gift, the nutrition
labeling shall be in the form required by paragraphs (a) through (f) of
this section, but it may be modified as follows:
(i) Nutrition information may be presented on the label of the outer
package or in labeling within or attached to the outer package.
(ii) In the absence of a reference amount customarily consumed in
Sec. 101.12(b) that is appropriate for the variety or assortment of
foods in a gift package, 1 ounce for solid foods, 2 fluid ounces for
nonbeverage liquids (e.g., syrups), and 8 fluid ounces for beverages may
be used as the standard serving size for purposes of nutrition labeling
of foods subject to this paragraph. However, the reference amounts
customarily consumed in Sec. 101.12(b) shall be used for purposes of
evaluating whether individual foods in a gift package qualify for
nutrient content claims or health claims.
(iii) The number of servings per container may be stated as
``varied.''
(iv) Nutrition information may be provided per serving for
individual foods in the package, or, alternatively, as a composite per
serving for reasonable categories of foods in the package having similar
dietary uses and similar significant nutritional characteristics.
Reasonable categories of foods may be used only if accepted by FDA. In
determining whether a proposed category is reasonable, FDA will consider
whether the values of the characterizing nutrients in the foods proposed
to be in the category meet the compliance criteria set forth in
paragraphs (g)(3) through (g)(6) of this section. Proposals for such
categories may be submitted in writing to the Office of Nutritional
Products, Labeling and Dietary Supplements (HFS-800), Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740.
(v) If a food subject to paragraph (j)(13) of this section because
of its small size is contained in a gift package, the food need not be
included in the determination of nutrition information under paragraph
(h) of this section if it is not specifically listed in a promotional
catalogue as being present in the gift package, and:
(A) It is used in small quantities primarily to enhance the
appearance of the gift package; or
(B) It is included in the gift package as a free gift or promotional
item.
(4) If a food is commonly combined with other ingredients or is
cooked or otherwise prepared before eating, and directions for such
combination or preparations are provided, another column of figures may
be used to declare nutrition information on the basis of the food as
consumed in the format required in paragraph (e) of this section (e.g.,
a dry ready-to-eat cereal may be described with one set of Percent Daily
Values for the cereal as sold (e.g., per ounce), and another set for the
cereal and milk as suggested in the label (e.g., per ounce of cereal and
1/2 cup of vitamin D fortified skim milk); and a cake mix may be labeled
with one set of Percent Daily Values for the dry mix (per serving) and
another set for the serving of the final cake when prepared): Provided,
That, the type and quantity of the other ingredients to be added to the
product by the user and the specific method of cooking and other
preparation shall be specified prominently on the label.
(i) Except as provided in paragraphs (j)(13) and (j)(17) of this
section, the location of nutrition information on a label shall be in
compliance with Sec. 101.2.
(j) The following foods are exempt from this section or are subject
to special labeling requirements:
(1)(i) Food offered for sale by a person who makes direct sales to
consumers (e.g., a retailer) who has annual gross sales made or business
done in sales to consumers that is not more than $500,000 or has annual
gross sales made or business done in sales of food to consumers of not
more than $50,000, Provided, That the food bears no nutrition claims or
other nutrition information in any context on the label or in labeling
or advertising. Claims or other nutrition information subject the food
to the provisions of this section.
(ii) For purposes of this paragraph, calculation of the amount of
sales shall
[[Page 41]]
be based on the most recent 2-year average of business activity. Where
firms have been in business less than 2 years, reasonable estimates must
indicate that annual sales will not exceed the amounts specified. For
foreign firms that ship foods into the United States, the business
activities to be included shall be the total amount of food sales, as
well as other sales to consumers, by the firm in the United States.
(2) Food products which are:
(i) Served in restaurants, Provided, That the food bears no
nutrition claims or other nutrition information in any context on the
label or in labeling or advertising. Claims or other nutrition
information subject the food to the provisions of this section;
(ii) Served in other establishments in which food is served for
immediate human consumption (e.g., institutional food service
establishments, such as schools, hospitals, and cafeterias;
transportation carriers, such as trains and airplanes; bakeries,
delicatessens, and retail confectionery stores where there are
facilities for immediate consumption on the premises; food service
vendors, such as lunch wagons, ice cream shops, mall cookie counters,
vending machines, and sidewalk carts where foods are generally consumed
immediately where purchased or while the consumer is walking away,
including similar foods sold from convenience stores; and food delivery
systems or establishments where ready-to-eat foods are delivered to
homes or offices), Provided, That the food bears no nutrition claims or
other nutrition information in any context on the label or in labeling
or advertising. Claims or other nutrition information subject the food
to the provisions of this section;
(iii) Sold only in such facilities, Provided, That the food bears no
nutrition claims or other nutrition information in any context on the
label or in labeling or advertising. Claims or other nutrition
information subject the food to the provisions of this section;
(iv) Used only in such facilities and not served to the consumer in
the package in which they are received (e.g., foods that are not
packaged in individual serving containers); or
(v) Sold by a distributor who principally sells food to such
facilities: Provided, That:
(A) This exemption shall not be available for those foods that are
manufactured, processed, or repackaged by that distributor for sale to
any persons other than restaurants or other establishments that serve
food for immediate human consumption, and
(B) The manufacturer of such products is responsible for providing
the nutrition information on the products if there is a reasonable
possibility that the product will be purchased directly by consumers.
(3) Food products that are:
(i) Of the type of food described in paragraphs (j)(2)(i) and
(j)(2)(ii) of this section,
(ii) Ready for human consumption,
(iii) Offered for sale to consumers but not for immediate human
consumption,
(iv) Processed and prepared primarily in a retail establishment, and
(v) Not offered for sale outside of that establishment (e.g., ready-
to-eat foods that are processed and prepared on-site and sold by
independent delicatessens, bakeries, or retail confectionery stores
where there are no facilities for immediate human consumption; by in-
store delicatessen, bakery, or candy departments; or at self-service
food bars such as salad bars), Provided, That the food bears no
nutrition claims or other nutrition information in any context on the
label or in labeling or advertising. Claims or other nutrition
information subject the food to the provisions of this section.
(4) Foods that contain insignificant amounts of all of the nutrients
and food components required to be included in the declaration of
nutrition information under paragraph (c) of this section, Provided,
That the food bears no nutrition claims or other nutrition information
in any context on the label or in labeling or advertising. Claims or
other nutrition information subject the food to the provisions of this
section. An insignificant amount of a nutrient or food component shall
be that amount that allows a declaration of zero in nutrition labeling,
except that for total carbohydrate, dietary fiber, and protein, it shall
be an amount that
[[Page 42]]
allows a declaration of ``less than 1 gram.'' Examples of foods that are
exempt under this paragraph include coffee beans (whole or ground), tea
leaves, plain unsweetened instant coffee and tea, condiment-type
dehydrated vegetables, flavor extracts, and food colors.
(5)(i) Foods, other than infant formula, represented or purported to
be specifically for infants and children less than 2 years of age shall
bear nutrition labeling, except as provided in paragraph (j)(5)(ii) and
except that such labeling shall not include calories from fat (paragraph
(c)(1)(ii) of this section), calories from saturated fat ((c)(1)(iii)),
saturated fat ((c)(2)(i)), polyunsaturated fat ((c)(2)(ii)),
monounsaturated fat ((c)(2)(iii)), and cholesterol ((c)(3)).
(ii) Foods, other than infant formula, represented or purported to
be specifically for infants and children less than 4 years of age shall
bear nutrition labeling, except that:
(A) Such labeling shall not include declarations of percent of Daily
Value for total fat, saturated fat, cholesterol, sodium, potassium,
total carbohydrate, and dietary fiber;
(B) Nutrient names and quantitative amounts by weight shall be
presented in two separate columns.
(C) The heading ``Percent Daily Value'' required in paragraph (d)(6)
of this section shall be placed immediately below the quantitative
information by weight for protein;
(D) Percent of Daily Value for protein, vitamins, and minerals shall
be listed immediately below the heading ``Percent Daily Value''; and
(E) Such labeling shall not include the footnote specified in
paragraph (d)(9) of this section.
(6) Dietary supplements, except that such foods shall be labeled in
compliance with Sec. 101.36.
(7) Infant formula subject to section 412 of the act, as amended,
except that such foods shall be labeled in compliance with part 107 of
this chapter.
(8) Medical foods as defined in section 5(b) of the Orphan Drug Act
(21 U.S.C. 360ee(b)(3)). A medical food is a food which is formulated to
be consumed or administered enterally under the supervision of a
physician and which is intended for the specific dietary management of a
disease or condition for which distinctive nutritional requirements,
based on recognized scientific principles, are established by medical
evaluation. A food is subject to this exemption only if:
(i) It is a specially formulated and processed product (as opposed
to a naturally occurring foodstuff used in its natural state) for the
partial or exclusive feeding of a patient by means of oral intake or
enteral feeding by tube;
(ii) It is intended for the dietary management of a patient who,
because of therapeutic or chronic medical needs, has limited or impaired
capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or
certain nutrients, or who has other special medically determined
nutrient requirements, the dietary management of which cannot be
achieved by the modification of the normal diet alone;
(iii) It provides nutritional support specifically modified for the
management of the unique nutrient needs that result from the specific
disease or condition, as determined by medical evaluation;
(iv) It is intended to be used under medical supervision; and
(v) It is intended only for a patient receiving active and ongoing
medical supervision wherein the patient requires medical care on a
recurring basis for, among other things, instructions on the use of the
medical food.
(9) Food products shipped in bulk form that are not for distribution
to consumers in such form and that are for use solely in the manufacture
of other foods or that are to be processed, labeled, or repacked at a
site other than where originally processed or packed.
(10) Raw fruits, vegetables, and fish subject to section 403(q)(4)
of the act, except that the labeling of such foods should adhere to
guidelines in Sec. 101.45. This exemption is contingent on the food
bearing no nutrition claims or other nutrition information in any
context on the label or in labeling or advertising. Claims or other
nutrition information subject the food to nutrition labeling in
accordance with Sec. 101.45. The term fish includes freshwater or
marine fin fish, crustaceans,
[[Page 43]]
and mollusks, including shellfish, amphibians, and other forms of
aquatic animal life.
(11) Packaged single-ingredient products that consist of fish or
game meat (i.e., animal products not covered under the Federal Meat
Inspection Act or the Poultry Products Inspection Act, such as flesh
products from deer, bison, rabbit, quail, wild turkey, or ostrich)
subject to this section may provide required nutrition information for a
3-ounce cooked edible portion (i.e., on an ``as prepared'' basis),
except that:
(i) Such products that make claims that are based on values as
packaged must provide nutrition information on an as packaged basis, and
(ii) Nutrition information is not required for custom processed fish
or game meats.
(12) Game meats (i.e., animal products not covered under the Federal
Meat Inspection Act or the Poultry Products Inspection Act, such as
flesh products from deer, bison, rabbit, quail, wild turkey, or ostrich)
may provide required nutrition information on labeling in accordance
with the provisions of paragraph (a)(2) of this section.
(13)(i) Foods in small packages that have a total surface area
available to bear labeling of less than 12 square inches, Provided, That
the labels for these foods bear no nutrition claims or other nutrition
information in any context on the label or in labeling or advertising.
Claims or other nutrition information subject the food to the provisions
of this section.
(A) The manufacturer, packer, or distributor shall provide on the
label of packages that qualify for and use this exemption an address or
telephone number that a consumer can use to obtain the required
nutrition information (e.g., ``For nutrition information, call 1-800-
123-4567'').
(B) When such products bear nutrition labeling, either voluntarily
or because nutrition claims or other nutrition information is provided,
all required information shall be in type size no smaller than 6 point
or all uppercase type of 1/16 inches minimum height, except that
individual serving-size packages of food served with meals in
restaurants, institutions, and on board passenger carriers, and not
intended for sale at retail, may comply with Sec. 101.2(c)(5).
(ii) Foods in packages that have a total surface area available to
bear labeling of 40 or less square inches may modify the requirements of
paragraphs (c) through (f) and (i) of this section by one or more of the
following means:
(A) Presenting the required nutrition information in a tabular or,
as provided below, linear (i.e., string) fashion rather than in vertical
columns if the product has a total surface area available to bear
labeling of less than 12 square inches, or if the product has a total
surface area available to bear labeling of 40 or less square inches and
the package shape or size cannot accommodate a standard vertical column
or tabular display on any label panel. Nutrition information may be
given in a linear fashion only if the label will not accommodate a
tabular display.
(1) The following sample label illustrates the tabular display.
[GRAPHIC] [TIFF OMITTED] TR11JY03.004
[[Page 44]]
(2) The following sample label illustrates the linear display. When
nutrition information is given in a linear fashion, bolding is required
only on the title ``Nutrition Facts`` and is allowed voluntarily for the
nutrient names for ``Calories,'' ``Total fat,'' ``Cholesterol,''
``Sodium,'' ``Total carbohydrate,'' and ``Protein.''
[GRAPHIC] [TIFF OMITTED] TR11JY03.005
(B) Using any of the following abbreviations:
Serving size--Serv size
Servings per container--Servings
Calories from fat--Fat cal
Calories from saturated fat--Sat fat cal
Saturated fat--Sat fat
Monounsaturated fat--Monounsat fat
Polyunsaturated fat--Polyunsat fat
Cholesterol--Cholest
Total carbohydrate--Total carb
Dietary fiber--Fiber
Soluble fiber--Sol fiber
Insoluble fiber--Insol fiber
Sugar alcohol--Sugar alc
Other carbohydrate--Other carb
(C) Omitting the footnote required in paragraph (d)(9) of this
section and placing another asterisk at the bottom of the label followed
by the statement ``Percent Daily Values are based on a 2,000 calorie
diet`` and, if the term ``Daily Value'' is not spelled out in the
heading, a statement that ``DV'' represents ``Daily Value.''
(D) Presenting the required nutrition information on any label
panel.
(14) Shell eggs packaged in a carton that has a top lid designed to
conform to the shape of the eggs are exempt from outer carton label
requirements where the required nutrition information is clearly
presented immediately beneath the carton lid or in an insert that can be
clearly seen when the carton is opened.
(15) The unit containers in a multiunit retail food package where:
(i) The multiunit retail food package labeling contains all
nutrition information in accordance with the requirements of this
section;
(ii) The unit containers are securely enclosed within and not
intended to be separated from the retail package under conditions of
retail sale; and
(iii) Each unit container is labeled with the statement ``This Unit
Not Labeled For Retail Sale'' in type size not less than 1/16-inch in
height, except that this statement shall not be required when the inner
unit containers bear no labeling at all. The word ``individual'' may be
used in lieu of or immediately preceding the word ``Retail'' in the
statement.
(16) Food products sold from bulk containers: Provided, That
nutrition information required by this section be displayed to consumers
either on the labeling of the bulk container plainly in view or in
accordance with the provisions of paragraph (a)(2) of this section.
(17) Foods in packages that have a total surface area available to
bear labeling greater than 40 square inches but whose principal display
panel and information panel do not provide sufficient space to
accommodate all required information may use any alternate panel that
can be readily seen by consumers for the nutrition label. The space
needed for vignettes, designs, and other nonmandatory label information
on the principal display panel may be considered in determining the
sufficiency of available space on the principal display panel for the
placement of the nutrition label. Nonmandatory label information on the
information panel shall not be considered in determining the sufficiency
of available
[[Page 45]]
space for the placement of the nutrition label.
(18) Food products that are low-volume (that is, they meet the
requirements for units sold in paragraphs (j)(18)(i) or (j)(18)(ii) of
this section); that, except as provided in paragraph (j)(18)(iv) of this
section, are the subject of a claim for an exemption that provides the
information required under paragraph (j)(18)(iv) of this section, that
is filed before the beginning of the time period for which the exemption
is claimed, and that is filed by a person, whether it is the
manufacturer, packer, or distributor, that qualifies to claim the
exemption under the requirements for average full-time equivalent
employees in paragraphs (j)(18)(i) or (j)(18)(ii) of this section; and
whose labels, labeling, and advertising do not provide nutrition
information or make a nutrient content or health claim.
(i) For food products first introduced into interstate commerce
before May 8, 1994, the product shall be exempt for the period:
(A) Between May 8, 1995, and May 7, 1996, if, for the period between
May 8, 1994, and May 7, 1995, the person claiming the exemption employed
fewer than an average of 300 full-time equivalent employees and fewer
than 400,000 units of that product were sold in the United States; and
(B) Between May 8, 1996, and May 7, 1997, if for the period between
May 8, 1995, and May 7, 1996, the person claiming the exemption employed
fewer than an average of 200 full-time equivalent employees and fewer
than 200,000 units of that product were sold in the United States.
(ii) For all other food products, the product shall be eligible for
an exemption for any 12-month period if, for the preceding 12 months,
the person claiming the exemption employed fewer than an average of 100
full-time equivalent employees and fewer than 100,000 units of that
product were sold in the United States, or in the case of a food product
that was not sold in the 12-month period preceding the period for which
exemption is claimed, fewer than 100,000 units of such product are
reasonably anticipated to be sold in the United States during the period
for which exemption is claimed.
(iii) If a person claims an exemption under paragraphs (j)(18)(i) or
(j)(18)(ii) of this section for a food product and then, during the
period of such exemption, the number of full-time equivalent employees
of such person exceeds the appropriate number, or the number of food
products sold in the United States exceeds the appropriate number, or,
if at the end of the period of such exemption, the food product no
longer qualifies for an exemption under the provisions of paragraphs
(j)(18)(i) or (j)(18)(ii) of this section, such person shall have 18
months from the date that the product was no longer qualified as a low-
volume product of a small business to comply with this section.
(iv) A notice shall be filed with the Office of Nutritional
Products, Labeling and Dietary Supplements (HFS-800), Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740 and contain the following
information, except that if the person is not an importer and has fewer
than 10 full-time equivalent employees, that person does not have to
file a notice for any food product with annual sales of fewer than
10,000 total units:
(A) Name and address of person requesting exemption. This should
include a telephone number or FAX number that can be used to contact the
person along with the name of a specific contact;
(B) Names of the food products (including the various brand names)
for which exemption is claimed;
(C) Name and address of the manufacturer, distributor, or importer
of the food product for which an exemption is claimed, if different than
the person that is claiming the exemption;
(D) The number of full-time equivalent employees. Provide the
average number of full-time equivalent individuals employed by the
person and its affiliates for the 12 months preceding the period for
which a small business exemption is claimed for a product. The average
number of full-time equivalent employees is to be determined by dividing
the total number of hours of salary or wages paid to employees of the
person and its affiliates by the number of
[[Page 46]]
hours of work in a year, 2,080 hours (i.e., 40 hours x 52 weeks);
(E) Approximate total number of units of the food product sold by
the person in the United States in the 12-month period preceding that
for which a small business exemption is claimed. Provide the approximate
total number of units sold, or expected to be sold, in a 12-month period
for each product for which an exemption is claimed. For products that
have been in production for 1 year or more prior to the period for which
exemption is claimed, the 12-month period is the period immediately
preceding the period for which an exemption is claimed. For other
products, the 12-month period is the period for which an exemption is
claimed; and
(F) The notice shall be signed by a responsible individual for the
person who can certify the accuracy of the information presented in the
notice. The individual shall certify that the information contained in
the notice is a complete and accurate statement of the average number of
full-time equivalent employees of this person and its affiliates and of
the number of units of the product for which an exemption is claimed
sold by the person. The individual shall also state that should the
average number of full-time equivalent employees or the number of units
of food products sold in the United States by the person exceed the
applicable numbers for the time period for which exemption is claimed,
the person will notify FDA of that fact and the date on which the number
of employees or the number of products sold exceeded the standard.
(v) FDA may by regulation lower the employee or units of food
products requirements of paragraph (j)(18)(ii) of this section for any
food product first introduced into interstate commerce after May 8,
2002, if the agency determines that the cost of compliance with such
lower requirement will not place an undue burden on persons subject to
it.
(vi) For the purposes of this paragraph, the following definitions
apply:
(A) Unit means the packaging or, if there is no packaging, the form
in which a food product is offered for sale to consumers.
(B) Food product means food in any sized package which is
manufactured by a single manufacturer or which bears the same brand
name, which bears the same statement of identity, and which has similar
preparation methods.
(C) Person means all domestic and foreign affiliates, as defined in
13 CFR 121.401, of the corporation, in the case of a corporation, and
all affiliates, as defined in 13 CFR 121.401, of a firm or other entity,
when referring to a firm or other entity that is not a corporation.
(D) Full-time equivalent employee means all individuals employed by
the person claiming the exemption. This number shall be determined by
dividing the total number of hours of salary or wages paid directly to
employees of the person and of all of its affiliates by the number of
hours of work in a year, 2,080 hours (i.e., 40 hoursx52 weeks).
(k) A food labeled under the provisions of this section shall be
deemed to be misbranded under sections 201(n) and 403(a) of the act if
its label or labeling represents, suggests, or implies:
(1) That the food, because of the presence or absence of certain
dietary properties, is adequate or effective in the prevention, cure,
mitigation, or treatment of any disease or symptom. Information about
the relationship of a dietary property to a disease or health-related
condition may only be provided in conformance with the requirements of
Sec. 101.14 and part 101, subpart E.
(2) That the lack of optimum nutritive quality of a food, by reason
of the soil on which that food was grown, is or may be responsible for
an inadequacy or deficiency in the quality of the daily diet.
(3) That the storage, transportation, processing, or cooking of a
food is or may be responsible for an inadequacy or deficiency in the
quality of the daily diet.
(4) That a natural vitamin in a food is superior to an added or
synthetic vitamin.
[58 FR 2175, Jan. 6, 1993]
Editorial Note: For Federal Register citations affecting Sec.
101.9, see the List of CFR Sections Affected, which appears in the
Finding Aids section of the printed volume and at www.fdsys.gov.
[[Page 47]]
Sec. 101.10 Nutrition labeling of restaurant foods.
Nutrition labeling in accordance with Sec. 101.9 shall be provided
upon request for any restaurant food or meal for which a nutrient
content claim (as defined in Sec. 101.13 or in subpart D of this part)
or a health claim (as defined in Sec. 101.14 and permitted by a
regulation in subpart E of this part) is made, except that information
on the nutrient amounts that are the basis for the claim (e.g., ``low
fat, this meal provides less than 10 grams of fat'') may serve as the
functional equivalent of complete nutrition information as described in
Sec. 101.9. Nutrient levels may be determined by nutrient data bases,
cookbooks, or analyses or by other reasonable bases that provide
assurance that the food or meal meets the nutrient requirements for the
claim. Presentation of nutrition labeling may be in various forms,
including those provided in Sec. 101.45 and other reasonable means.
[61 FR 40332, Aug. 2, 1996]
Sec. 101.12 Reference amounts customarily consumed per eating occasion.
(a) The general principles and factors that the Food and Drug
Administration (FDA) considered in arriving at the reference amounts
customarily consumed per eating occasion (reference amounts) which are
set forth in paragraph (b) of this section, are that:
(1) FDA calculated the reference amounts for persons 4 years of age
or older to reflect the amount of food customarily consumed per eating
occasion by persons in this population group. These reference amounts
are based on data set forth in appropriate national food consumption
surveys.
(2) FDA calculated the reference amounts for an infant or child
under 4 years of age to reflect the amount of food customarily consumed
per eating occasion by infants up to 12 months of age or by children 1
through 3 years of age, respectively. These reference amounts are based
on data set forth in appropriate national food consumption surveys. Such
reference amounts are to be used only when the food is specially
formulated or processed for use by an infant or by a child under 4 years
of age.
(3) An appropriate national food consumption survey includes a large
sample size representative of the demographic and socioeconomic
characteristics of the relevant population group and must be based on
consumption data under actual conditions of use.
(4) To determine the amount of food customarily consumed per eating
occasion, FDA considered the mean, median, and mode of the consumed
amount per eating occasion.
(5) When survey data were insufficient, FDA took various other
sources of information on serving sizes of food into consideration.
These other sources of information included:
(i) Serving sizes used in dietary guidance recommendations or
recommended by other authoritative systems or organizations;
(ii) Serving sizes recommended in comments;
(iii) Serving sizes used by manufacturers and grocers; and
(iv) Serving sizes used by other countries.
(6) Because they reflect the amount customarily consumed, the
reference amount and, in turn, the serving size declared on the product
label are based on only the edible portion of food, and not bone, seed,
shell, or other inedible components.
(7) The reference amount is based on the major intended use of the
food (e.g., milk as a beverage and not as an addition to cereal).
(8) The reference amounts for products that are consumed as an
ingredient of other foods, but that may also be consumed in the form in
which they are purchased (e.g., butter), are based on use in the form
purchased.
(9) FDA sought to ensure that foods that have similar dietary usage,
product characteristics, and customarily consumed amounts have a uniform
reference amount.
(b) The following reference amounts shall be used as the basis for
determining serving sizes for specific products:
[[Page 48]]
Table 1--Reference Amounts Customarily Consumed Per Eating Occasion:
Infant and Toddler Foods \1,2,3,4\
------------------------------------------------------------------------
Product category Reference amount Label statement \5\
------------------------------------------------------------------------
Cereals, dry instant........... 15 g............ -- cup (-- g)
Cereals, prepared, ready-to- 110 g........... -- cup(s) (-- g)
serve.
Other cereal and grain 7 g for infants -- cup(s) (-- g) for
products, dry ready-to-eat, and 20 g for ready-to-eat
e.g., ready-to-eat cereals, toddlers for cereals; -- piece(s)
cookies, teething biscuits, ready-to-eat (-- g) for others
and toasts. cereals; 7 g
for all others.
Dinners, desserts, fruits, 15 g............ -- tbsp(s) (-- g); --
vegetables or soups, dry mix. cup(s) (-- g)
Dinners, desserts, fruits, 110 g........... -- cup(s) (-- g); --
vegetables or soups, ready-to- cup(s) (-- mL)
serve, junior type.
Dinners, desserts, fruits, 60 g............ -- cup(s) (-- g); --
vegetables or soups, ready-to- cup(s) (-- mL)
serve, strained type.
Dinners, stews or soups for 170 g........... -- cup(s) (-- g); --
toddlers, ready-to-serve. cup(s) (-- mL)
Fruits for toddlers, ready-to- 125 g........... -- cup(s) (-- g)
serve.
Vegetables for toddlers, ready- 70 g............ -- cup(s) (-- g)
to- serve.
Eggs/egg yolks, ready-to-serve. 55 g............ -- cup(s) (-- g)
Juices, all varieties.......... 120 mL.......... 4 fl oz (120 mL)
------------------------------------------------------------------------
\1\ These values represent the amount of food customarily consumed per
eating occasion and were primarily derived from the 1977-1978 and the
1987-1988 Nationwide Food Consumption Surveys conducted by the U.S.
Department of Agriculture.
\2\ Unless otherwise noted in the Reference amount column, the reference
amounts are for the ready-to-serve or almost ready-to-serve form of
the product (i.e., heat and serve, brown and serve). If not listed
separately, the reference amount for the unprepared form (e.g., dry
cereal) is the amount required to make the reference amount of the
prepared form. Prepared means prepared for consumption (e.g., cooked).
\3\ Manufacturers are required to convert the reference amount to the
label serving size in a household measure most appropriate to their
specific product using the procedures in 21 CFR 101.9(b).
\4\Copies of the list of products for each product category are
available from the Office of Nutritional Products, Labeling and
Dietary Supplements (HFS-800), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740.
\5\ The label statements are meant to provide guidance to manufacturers
on the presentation of serving size information on the label, but they
are not required. The term ``piece'' is used as a generic description
of a discrete unit. Manufacturers should use the description of a unit
that is most appropriate for the specific product (e.g., sandwich for
sandwiches, cookie for cookies, and bar for frozen novelties).
Table 2--Reference Amounts Customarily Consumed Per Eating Occasion:
General Food Supply \1,2,3,4\
------------------------------------------------------------------------
Product category Reference amount Label statement\5\
------------------------------------------------------------------------
Bakery products:
Biscuits, croissants, 55 g............ -- piece(s) (-- g)
bagels, tortillas, soft
bread sticks, soft
pretzels, corn bread, hush
puppies.
Breads (excluding sweet 50 g............ -- piece(s) (-- g)
quick type), rolls. for sliced bread and
distinct pieces
(e.g., rolls); 2 oz
(56 g/-- inch slice)
for unsliced bread
Bread sticks--see crackers. ................ .....................
Toaster pastries--see ................ .....................
coffee cakes.
Brownies................... 40 g............ -- piece(s) (-- g)
for distinct pieces;
fractional slice (--
g) for bulk
Cakes, heavy weight (cheese 125 g........... -- piece(s) (-- g)
cake; pineapple upside- for distinct pieces
down cake; fruit, nut, and (e.g., sliced or
vegetable cakes with more individually
than or equal to 35 packaged products);
percent of the finished -- fractional slice
weight as fruit, nuts, or (-- g) for large
vegetables or any of these discrete units
combined) \6\.
Cakes, medium weight 80 g............ -- piece(s) (-- g)
(chemically leavened cake for distinct pieces
with or without icing or (e.g., cupcake); --
filling except those fractional slice (--
classified as light weight g) for large
cake; fruit, nut, and discrete units
vegetable cake with less
than 35 percent of the
finished weight as fruit,
nuts, or vegetables or any
of these combined; light
weight cake with icing;
Boston cream pie; cupcake;
eclair; cream puff) \7\.
Cakes, light weight (angel 55 g............ -- piece(s) (-- g)
food, chiffon, or sponge for distinct pieces
cake without icing or (e.g., sliced or
filling) \8\. individually
packaged products);
-- fractional slice
(-- g) for large
discrete units
Coffee cakes, crumb cakes, 55 g............ -- piece(s) (-- g)
doughnuts, Danish, sweet for sliced bread and
rolls, sweet quick type distinct pieces
breads, muffins, toaster (e.g., doughnut); 2
pastries. oz (56 g/visual unit
of measure) for bulk
products (e.g.,
unsliced bread)
Cookies.................... 30 g............ -- piece(s) (-- g)
Crackers that are usually 15 g............ -- piece(s) (-- g)
not used as snack, melba
toast, hard bread sticks,
ice cream cones \9\.
Crackers that are usually 30 g............ -- piece(s) (-- g)
used as snacks.
[[Page 49]]
Croutons................... 7 g............. -- tbsp(s) (-- g); --
cup(s) (-- g); --
piece(s) (-- g) for
large pieces
French toast, pancakes, 110 g prepared -- piece(s) (-- g); --
variety mixes. for french cup(s) (-- g) for
toast and dry mix
pancakes; 40 g
dry mix for
variety mixes.
Grain-based bars with or 40 g............ -- piece(s) (-- g)
without filling or
coating, e.g., breakfast
bars, granola bars, rice
cereal bars.
Ice cream cones--see ................ .....................
crackers.
Pies, cobblers, fruit 125 g........... -- piece(s) (--g) for
crisps, turnovers, other distinct pieces; --
pastries. fractional slice (--
g) for large
discrete units
Pie crust.................. 1/6 of 8 inch 1/6 of 8 inch crust
crust; 1/8 of 9 (-- g); 1/8 of 9
inch crust. inch crust (-- g)
Pizza crust................ 55 g............ -- fractional slice
(-- g)
Taco shells, hard.......... 30 g............ -- shell(s) (-- g)
Waffles.................... 85 g............ -- piece(s) (-- g)
Beverages:
Carbonated and 240 mL.......... 8 fl oz (240 mL)
noncarbonated beverages,
wine coolers, water.
Coffee or tea, flavored and 240 mL prepared. 8 fl oz (240 mL)
sweetened.
Cereal and Other Grain
Products:
Breakfast cereals (hot 1 cup prepared; -- cup(s) (-- g)
cereal type), hominy grits. 40 g plain dry
cereal; 55 g
flavored,
sweetened dry
cereal.
Breakfast cereals, ready-to- 15 g............ -- cup(s) (-- g)
eat, weighing less than 20
g per cup, e.g., plain
puffed cereal grains.
Breakfast cereals, ready-to- 30 g............ -- cup(s) (-- g)
eat weighing 20 g or more
but less than 43 g per
cup; high fiber cereals
containing 28 g or more of
fiber per 100 g.
Breakfast cereals, ready-to- 55 g............ -- piece(s) (-- g)
eat, weighing 43 g or more for large distinct
per cup; biscuit types. pieces (e.g.,
biscuit type);--
cup(s) (-- g) for
all others
Bran or wheat germ......... 15 g............ -- tbsp(s) (-- g); --
cup(s) (-- g)
Flours or cornmeal......... 30 g............ -- tbsp(s) (-- g); --
cup(s) (-- g)
Grains, e.g., rice, barley, 140 g prepared; -- cup(s) (-- g)
plain. 45 g dry.
Pastas, plain.............. 140 g prepared; -- cup(s) (-- g); --
55 g dry. piece(s) (-- g) for
large pieces (e.g.,
large shells or
lasagna noodles) or
2 oz (56 g/visual
unit of measure) for
dry bulk products
(e.g., spaghetti)
Pastas, dry, ready-to-eat, 25 g............ -- cup(s) (-- g)
e.g., fried canned chow
mein noodles.
Starches, e.g., cornstarch, 10 g............ -- tbsp (-- g)
potato starch, tapioca,
etc..
Stuffing................... 100 g........... -- cup(s) (-- g)
Dairy Products and Substitutes:
Cheese, cottage............ 110 g........... -- cup (-- g)
Cheese used primarily as 55 g............ -- cup (-- g)
ingredients, e.g., dry
cottage cheese, ricotta
cheese.
Cheese, grated hard, e.g., 5 g............. -- tbsp (-- g)
Parmesan, Romano.
Cheese, all others except 30 g............ -- piece(s) (-- g)
those listed as separate for distinct
categories--includes cream pieces;-- tbsp(s) (--
cheese and cheese spread. g) for cream cheese
and cheese spread; 1
oz (28 g/visual unit
of measure) for bulk
Cheese sauce--see sauce
category.
Cream or cream substitutes, 15 mL........... 1 tbsp (15 mL)
fluid.
Cream or cream substitutes, 2 g............. -- tsp (-- g)
powder.
Cream, half & half......... 30 mL........... 2 tbsp (30 mL)
Eggnog..................... 120 mL.......... 1/2 cup (120 mL); 4
fl oz (120 mL)
Milk, condensed, undiluted. 30 mL........... 2 tbsp (30 mL)
Milk, evaporated, undiluted 30 mL........... 2 tbsp (30 mL)
Milk, milk-based drinks, 240 mL.......... 1 cup (240 mL); 8 fl
e.g., instant breakfast, oz (240 mL)
meal replacement, cocoa.
Shakes or shake 240 mL.......... 1 cup (240 mL); 8 fl
substitutes, e.g., dairy oz (240 mL)
shake mixes, fruit frost
mixes.
Sour cream................. 30 g............ -- tbsp (-- g)
Yogurt..................... 225 g........... -- cup (-- g)
[[Page 50]]
Desserts:
Ice cream, ice milk, frozen 1/2 cup-includes -- piece(s) (-- g)
yogurt, sherbet: all the volume for for individually
types, bulk and novelties coatings and wrapped or packaged
(e.g., bars, sandwiches, wafers for the products; 1/2 cup (--
cones). novelty type g) for others
varieties.
Frozen flavored and 85 g............ -- piece(s) (-- g)
sweetened ice and pops, for individually
frozen fruit juices: all wrapped or packaged
types, bulk and novelties products; -- cup(s)
(e.g., bars, cups). (-- g) for others
Sundae..................... 1 cup........... 1 cup (-- g)
Custards, gelatin or 1/2 cup......... -- piece(s) (-- g)
pudding. for distinct unit
(e.g., individually
packaged products);
1/2 cup (-- g) for
bulk
Dessert Toppings and Fillings:
Cake frostings or icings... 35 g............ -- tbsp(s) (-- g)
Other dessert toppings, 2 tbsp.......... 2 tbsp (-- g); 2 tbsp
e.g., fruits, syrups, (30 mL)
spreads, marshmallow
cream, nuts, dairy and
nondairy whipped toppings.
Pie fillings............... 85 g............ -- cup(s) (-- g)
Egg and Egg Sustitutes:
Egg mixtures, e.g., egg foo 110 g........... -- piece(s) (-- g)
young, scrambled eggs, for discrete pieces;
omelets. -- cup(s) (-- g)
Eggs (all sizes) \9\....... 50 g............ 1 large, medium, etc.
(-- g)
Egg substitutes............ An amount to -- cup(s) (-- g); --
make 1 large cup(s) (-- mL)
(50 g) egg.
Fats and Oils:
Butter, margarine, oil, 1 tbsp.......... 1 tbsp (-- g); 1 tbsp
shortening. (15 mL)
Butter replacement, powder. 2 g............. -- tsp(s) (-- g)
Dressings for salads....... 30 g............ -- tbsp (-- g); --
tbsp (-- mL)
Mayonnaise, sandwich 15 g............ -- tbsp (-- g)
spreads, mayonnaise-type
dressings.
Spray types................ 0.25 g.......... About -- seconds
spray (-- g)
Fish, Shellfish, Game Meats
\10\, and Meat or Poultry
Substitutes:
Bacon substitutes, canned 15 g............ -- piece(s) (-- g)
anchovies, \11\ anchovy for discrete pieces;
pastes, caviar. -- tbsp(s) (-- g)
for others
Dried, e.g., jerky......... 30 g............ -- piece(s) (-- g)
Entrees with sauce, e.g., 140 g cooked.... -- cup(s) (-- g); 5
fish with cream sauce, oz (140 g/visual
shrimp with lobster sauce. unit of measure) if
not measurable by
cup
Entrees without sauce, 85 g cooked; 110 -- piece(s) (-- g)
e.g., plain or fried fish g uncooked \12\. for discrete pieces;
and shellfish, fish and -- cup(s) (-- g); --
shellfish cake. oz (-- g/visual unit
of measure) if not
measurable by cup
\13\
Fish, shellfish or game 55 g............ -- piece(s) (-- g)
meat \10\, canned \11\. for discrete pieces;
-- cup(s) (-- g); 2
oz (56 g/-- cup) for
products that are
difficult to measure
the g weight of cup
measure (e.g.,
tuna); 2 oz (56 g/--
pieces) for products
that naturally vary
in size (e.g.,
sardines)
Substitute for luncheon 55 g............ -- piece(s) (-- g)
meat, meat spreads, for distinct pieces
Canadian bacon, sausages (e.g., slices,
and frankfurters. links); -- cup(s) (--
g); 2 oz (56 g/
visual unit of
measure) for
nondiscrete bulk
product
Smoked or pickled \11\ 55 g............ -- piece(s) (-- g)
fish, shellfish, or game for distinct pieces
meat \10\; fish or (e.g., slices,
shellfish spread. links) or -- cup(s)
(-- g); 2 oz (56 g/
visual unit of
measure) for
nondiscrete bulk
product
Substitutes for bacon bits--
see miscellaneous category.
Fruits and Fruit Juices:
Candied or pickled \11\.... 30 g............ -- piece(s) (-- g)
Dehydrated fruits--see ................ .....................
snacks category.
Dried...................... 40 g............ -- piece(s) (-- g)
for large pieces
(e.g., dates, figs,
prunes); -- cup(s)
(-- g) for small
pieces (e.g.,
raisins)
Fruits for garnish or 4 g............. 1 cherry (-- g)
flavor, e.g., maraschino
cherries \11\.
Fruit relishes, e.g., 70 g............ -- cup(s) (-- g)
cranberry sauce, cranberry
relish.
Fruits used primarily as 30 g............ See footnote 13
ingredients, avocado.
[[Page 51]]
Fruits used primarily as 55 g............ -- piece(s) (-- g)
ingredients, others for large fruits; --
(cranberries, lemon, lime). cup(s) (-- g) for
small fruits
measurable by cup
\13\
Watermelon................. 280 g........... See footnote 13
All other fruits (except 140 g........... -- piece(s) (-- g)
those listed as separate for large pieces
categories), fresh, (e.g., strawberries,
canned, or frozen. prunes, apricots,
etc.); -- cup(s) (--
g) for small pieces
(e.g., blueberries,
raspberries, etc.)
\13\
Juices, nectars, fruit 240 mL.......... 8 fl oz (240 mL)
drinks.
Juices used as ingredients, 5 mL............ 1 tsp (5 mL)
e.g., lemon juice, lime
juice.
Legumes:
Bean cake (tofu) \11\, 85 g............ -- piece(s) (-- g)
tempeh. for discrete pieces;
3 oz (84 g/visual
unit of measure) for
bulk products
Beans, plain or in sauce... 130 g for beans -- cup (-- g)
in sauce or
canned in
liquid and
refried beans
prepared; 90 g
for others
prepared; 35 g
dry.
Miscellaneous Category:
Baking powder, baking soda, 0.6 g........... -- tsp (-- g)
pectin.
Baking decorations, e.g., 1 tsp or 4 g if -- piece(s) (-- g)
colored sugars and not measurable for discrete pieces;
sprinkles for cookies, by teaspoon. 1 tsp (-- g)
cake decorations.
Batter mixes, bread crumbs. 30 g............ -- tbsp(s) (-- g);--
cup(s) (-- g)
Cooking wine............... 30 mL........... 2 tbsp (30 mL)
Dietary supplements........ The maximum -- tablet(s), --
amount capsule(s), --
recommended, as packet(s), -- tsp(s)
appropriate, on (-- g), etc.
the label for
consumption per
eating
occasion, or,
in the absence
of
recommendations
, 1 unit, e.g.,
tablet,
capsule,
packet,
teaspoonsful,
etc..
Drink mixers (without Amount to make -- fl oz (-- mL)
alcohol). 240 mL drink
(without ice).
Chewing gum \9\............ 3 g............. -- piece(s) (-- g)
Meat, poultry and fish Amount to make -- tsp(s) (-- g); --
coating mixes, dry; one reference tbsp(s) (-- g)
seasoning mixes, dry, amount of final
e.g., chili seasoning dish.
mixes, pasta salad
seasoning mixes.
Salad and potato toppers, 7 g............. -- tbsp(s) (-- g)
e.g., salad crunchies,
salad crispins,
substitutes for bacon bits.
Salt, salt substitutes, 1/4 tsp......... 1/4 tsp (--g); --
seasoning salts (e.g., piece(s) (--g) for
garlic salt). discrete pieces
(e.g., individually
packaged products)
Spices, herbs (other than 1/4 tsp or 0.5 g 1/4 tsp (-- g); --
dietary supplements). if not piece(s) (-- g) if
measurable by not measurable by
teaspoon. teaspoons (e.g., bay
leaf)
Mixed Dishes:
Measurable with cup, e.g., 1 cup........... 1 cup (-- g)
casseroles, hash, macaroni
and cheese, pot pies,
spaghetti with sauce,
stews, etc..
Not measurable with cup, 140 g, add 55 g -- piece(s) (-- g)
e.g., burritos, egg rolls, for products for discrete pieces;
enchiladas, pizza, pizza with gravy or -- fractional slice
rolls, quiche, all types sauce topping, (-- g) for large
of sandwiches. e.g., enchilada discrete units
with cheese
sauce, crepe
with white
sauce \14\.
[[Page 52]]
Nuts and Seeds:
Nuts, seeds, and mixtures, 30 g............ -- piece(s) (-- g)
all types: sliced, for large pieces
chopped, slivered, and (e.g., unshelled
whole. nuts);-- tbsp(s) (--
g) ;-- cup(s) (-- g)
for small pieces
(e.g., peanuts,
sunflower seeds)
Nut and seed butters, 2 tbsp.......... 2 tbsp (-- g)
pastes, or creams.
Coconut, nut and seed 15 g............ -- tbsp(s) (-- g); --
flours. cup (-- g)
Potatoes and Sweet Potatoes/
Yams:
French fries, hash browns, 70 g prepared; -- piece(s) (-- g)
skins, or pancakes. 85 g for frozen for large distinct
unprepared pieces (e.g.,
french fries. patties, skins); 2.5
oz (70 g/-- pieces)
for prepared fries;
3 oz (84 g/--
pieces) for
unprepared fries
Mashed, candied, stuffed, 140 g........... -- piece(s) (-- g)
or with sauce. for discrete pieces
(e.g., stuffed
potato); -- cup(s)
(-- g)
Plain, fresh, canned, or 110 g for fresh -- piece(s) (-- g)
frozen. or frozen; 125 for discrete
g for vacuum pieces;-- cup(s) (--
packed; 160 g g) for sliced or
for canned in chopped products
liquid.
Salads:
Gelatin salad.............. 120 g........... -- cup (-- g)
Pasta or potato salad...... 140 g........... -- cup(s) (-- g)
All other salads, e.g., 100 g........... -- cup(s) (-- g)
egg, fish, shellfish,
bean, fruit, or vegetable
salads.
Sauces, Dips, Gravies and
Condiments:
Barbecue sauce, hollandaise 2 tbsp.......... 2 tbsp (-- g); 2 tbsp
sauce, tartar sauce, other (30 mL)
sauces for dipping (e.g.,
mustard sauce, sweet and
sour sauce), all dips
(e.g., bean dips, dairy-
based dips, salsa).
Major main entree sauces, 125 g........... -- cup (-- g); -- cup
e.g., spaghetti sauce. (-- mL)
Minor main entree sauces 1/4 cup......... 1/4 cup (-- g); 1/4
(e.g., pizza sauce, pesto cup (60 mL)
sauce), other sauces used
as toppings (e.g., gravy,
white sauce, cheese
sauce), cocktail sauce.
Major condiments, e.g., 1 tbsp.......... 1 tbsp (-- g); 1 tbsp
catsup, steak sauce, soy (15 mL)
sauce, vinegar, teriyaki
sauce, marinades.
Minor condiments, e.g., 1 tsp........... 1 tsp (-- g); 1 tsp
horseradish, hot sauces, (5 mL)
mustards, worcestershire
sauce.
Snacks:
All varieties, chips, 30 g............ -- cup(s) (-- g) for
pretzels, popcorns, small pieces (e.g.,
extruded snacks, fruit- popcorn) -- piece(s)
based snacks (e.g., fruit (-- g) for large
chips,) grain-based snack pieces (e.g., large
mixes. pretzels; pressed
dried fruit sheet);
1 oz (28 g/visual
unit of measure) for
bulk products (e.g.,
potato chips)
Soups:
All varieties.............. 245 g........... -- cup (-- g); -- cup
(-- mL)
Sugars and Sweets:
Baking candies (e.g., 15 g............ -- piece(s) (-- g)
chips). for large pieces; --
tbsp(s) (-- g) for
small pieces; 1/2 oz
(14 g/visual unit of
measure) for bulk
products
Hard candies, breath mints. 2 g............. -- piece(s) (-- g)
Hard candies, roll-type, 5 g............. -- piece(s) (-- g)
mini-size in dispenser
packages.
Hard candies, others....... 15 g............ -- piece(s) (-- g)
for large pieces;--
tbsp(s) (-- g) for
``mini-size''
candies measurable
by tablespoon; 1/2
oz (14 g/visual unit
of measure) for bulk
products
All other candies.......... 40 g............ -- piece(s) (-- g); 1
1/2 oz (42 g/visual
unit of measure) for
bulk products
Confectioner's sugar....... 30 g............ -- cup (-- g)
Honey, jams, jellies, fruit 1 tbsp.......... 1 tbsp (-- g); 1 tbsp
butter, molasses. (15 mL)
Marshmallows............... 30 g............ -- cup(s) (-- g) for
small pieces; --
piece(s) (-- g) for
large pieces
Sugar...................... 4 g............. -- tsp (-- g) ; --
piece(s) (-- g) for
discrete pieces
(e.g., sugar cubes,
individually
packaged products)
[[Page 53]]
Sugar substitutes.......... An amount -- tsp(s) (-- g) for
equivalent to solids; -- drop(s)
one reference (-- g) for liquid; --
amount for piece(s) (-- g)
sugar in (e.g., individually
sweetness. packaged products)
Syrups..................... 30 mL for syrups 2 tbsp (30 mL) for
used primarily syrups used
as an primarily as an
ingredient ingredient; 1/4 cup
(e.g., light or (60 mL) for all
dark corn others
syrup); 60 mL
for all others.
Vegetables:
Vegetables primarily used 4 g............. -- piece(s) (-- g); --
for garnish or flavor, tbsp(s) (-- g) for
e.g., pimento, parsley. chopped products
Chili pepper, green onion.. 30 g............ -- piece(s) (-- g)
\13\; -- tbsp(s) (--
g); -- cup(s) (-- g)
for sliced or
chopped products
All other vegetables 85 g for fresh -- piece(s) (-- g)
without sauce: fresh, or frozen; 95 g for large pieces
canned, or frozen. for vacuum (e.g., brussel
packed; 130 g sprouts); -- cup(s)
for canned in (-- g) for small
liquid, cream- pieces (e.g., cut
style corn, corn, green peas); 3
canned or oz (84 g/visual unit
stewed of measure) if not
tomatoes, measurable by cup
pumpkin, or \13\
winter squash.
All other vegetables with 110 g........... -- piece(s) (-- g)
sauce: fresh, canned, or for large pieces
frozen. (e.g., brussel
sprouts); -- cup(s)
(-- g) for small
pieces (e.g., cut
corn, green peas); 4
oz (112 g/visual
unit of measure) if
not measurable by
cup
Vegetable juice............ 240 mL.......... 8 fl oz (240 mL)
Olives \11\................ 15 g............ -- piece(s) (-- g); --
tbsp(s) (-- g) for
sliced products
Pickles, all types \11\.... 30 g............ 1 oz (28 g/visual
unit of measure)
Pickle relishes............ 15 g............ -- tbsp (-- g)
Vegetable pastes, e.g., 30 g............ -- tbsp (-- g)
tomato paste.
Vegetable sauces or purees, 60 g............ -- cup (-- g); -- cup
e.g, tomato sauce, tomato (-- mL)
puree.
------------------------------------------------------------------------
\1\ These values represent the amount (edible portion) of food
customarily consumed per eating occasion and were primarily derived
from the 1977-1978 and the 1987-1988 Nationwide Food Consumption
Surveys conducted by the U.S. Department of Argiculture.
\2\ Unless otherwise noted in the Reference Amount column, the reference
amounts are for the ready-to-serve or almost ready-to-serve form of
the product (i.e., heat and serve, brown and serve). If not listed
separately, the reference amount for the unprepared form (e.g., dry
mixes; concentrates; dough; batter; fresh and frozen pasta) is the
amount required to make the reference amount of the prepared form.
Prepared means prepared for consumption (e.g., cooked).
\3\ Manufacturers are required to convert the reference amount to the
label serving size in a household measure most appropriate to their
specific product using the procedures in 21 CFR 101.9(b).
\4\ Copies of the list of products for each product category are
available from the Office of Nutritional Products, Labeling and
Dietary Supplements (HFS-800), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740.
\5\ The label statements are meant to provide guidance to manufacturers
on the presentation of serving size information on the label, but they
are not required. The term ``piece'' is used as a generic description
of a discrete unit. Manufacturers should use the description of a unit
that is most appropriate for the specific product (e.g., sandwich for
sandwiches, cookie for cookies, and bar for ice cream bars). The
guidance provided is for the label statement of products in ready-to-
serve or almost ready-to-serve form. The guidance does not apply to
the products which require further preparation for consumption (e.g.,
dry mixes, concentrates) unless specifically stated in the product
category, reference amount, or label statement column that it is for
these forms of the product. For products that require further
preparation, manufacturers must determine the label statement
following the rules in Sec. 101.9(b) using the reference amount
determined according to Sec. 101.12(c).
\6\ Includes cakes that weigh 10 g or more per cubic inch.
\7\ Includes cakes that weigh 4 g or more per cubic inch but less than
10 g per cubic inch.
\8\ Includes cakes that weigh less than 4 g per cubic inch.
\9\ Label serving size for ice cream cones and eggs of all sizes will be
1 unit. Label serving size of all chewing gums that weigh more than
the reference amount that can reasonably be consumed at a single-
eating occasion will be 1 unit.
\10\ Animal products not covered under the Federal Meat Inspection Act
or the Poultry Products Inspection Act, such as flesh products from
deer, bison, rabbit, quail, wild turkey, geese, ostrich, etc.
\11\ If packed or canned in liquid, the reference amount is for the
drained solids, except for products in which both the solids and
liquids are customarily consumed (e.g., canned chopped clam in juice).
\12\ The reference amount for the uncooked form does not apply to raw
fish in Sec. 101.45 or to single-ingredient products that consist of
fish or game meat as provided for in Sec. 101.9(b)(j)(11).
\13\ For raw fruit, vegetables, and fish, manufacturers should follow
the label statement for the serving size specified in Appendices A and
B to the regulation entitled ``Food Labeling; Guidelines for Voluntary
Nutrition Labeling; and Identification of the 20 Most Frequently
Consumed Raw Fruits, Vegetables, and Fish; Definition of Substantial
Compliance; Correction'' (56 FR 60880 as amended 57 FR 8174, March 6,
1992).
\14\ Pizza sauce is part of the pizza and is not considered to be sauce
topping.
[[Page 54]]
(c) If a product requires further preparation, e.g., cooking or the
addition of water or other ingredients, and if paragraph (b) of this
section provides a reference amount for the product in the prepared but
not the unprepared form, then the reference amount for the unprepared
product shall be determined using the following rules:
(1) Except as provided for in paragraph (c)(2) of this section, the
reference amount for the unprepared product shall be the amount of the
unprepared product required to make the reference amount for the
prepared product as established in paragraph (b) of this section.
(2) For products where the entire contents of the package is used to
prepare one large discrete unit usually divided for consumption, the
reference amount for the unprepared product shall be the amount of the
unprepared product required to make the fraction of the large discrete
unit closest to the reference amount for the prepared product as
established in paragraph (b) of this section.
(d) The reference amount for an imitation or substitute food or
altered food, such as a ``low calorie'' version, shall be the same as
for the food for which it is offered as a substitute.
(e) If a food is modified by incorporating air (aerated), and
thereby the density of the food is lowered by 25 percent or more in
weight than that of an appropriate reference regular food as described
in Sec. 101.13(j)(1)(ii)(A), and the reference amount of the regular
food is in grams, the manufacturer may determine the reference amount of
the aerated food by adjusting for the difference in density of the
aerated food relative to the density of the appropriate reference food
provided that the manufacturer will show FDA detailed protocol and
records of all data that were used to determine the density-adjusted
reference amount for the aerated food. The reference amount for the
aerated food shall be rounded to the nearest 5-g increment. Such
products shall bear a descriptive term indicating that extra air has
been incorporated (e.g., whipped, aerated). The density-adjusted
reference amounts described in paragraph (b) of this section may not be
used for cakes except for cheese cake. The differences in the densities
of different types of cakes having different degrees of air
incorporation have already been taken into consideration in determining
the reference amounts for cakes in Sec. 101.12(b). In determining the
difference in density of the aerated and the regular food, the
manufacturer shall adhere to the following:
(1) The regular and the aerated product must be the same in size,
shape, and volume. To compare the densities of products having nonsmooth
surfaces (e.g., waffles), manufacturers shall use a device or method
that ensures that the volumes of the regular and the aerated products
are the same.
(2) Sample selections for the density measurements shall be done in
accordance with the provisions in Sec. 101.9(g).
(3) Density measurements of the regular and the aerated products
shall be conducted by the same trained operator using the same
methodology (e.g., the same equipment, procedures, and techniques) under
the same conditions.
(4) Density measurements shall be replicated a sufficient number of
times to ensure that the average of the measurements is representative
of the true differences in the densities of the regular and the
``aerated'' products.
(f) For products that have no reference amount listed in paragraph
(b) of this section for the unprepared or the prepared form of the
product and that consist of two or more foods packaged and presented to
be consumed together (e.g., peanut putter and jelly, cracker and cheese
pack, pancakes and syrup, cake and frosting), the reference amount for
the combined product shall be determined using the following rules:
(1) For bulk products (e.g., peanut butter and jelly), the reference
amount for the combined product shall be the reference amount, as
established in paragraph (b) of this section, for the ingredient that is
represented as the main ingredient plus proportioned amounts of all
minor ingredients.
(2) For products where the ingredient represented as the main
ingredient is one or more discrete units (e.g., cracker and cheese pack,
pancakes and syrup, cake and frosting), the reference amount for the
combined product shall
[[Page 55]]
be either the number of small discrete units or the fraction of the
large discrete unit that is represented as the main ingredient that is
closest to the reference amount for that ingredient as established in
paragraph (b) of this section plus proportioned amounts of all minor
ingredients.
(3) If the reference amounts are in compatible units, they shall be
summed (e.g., the reference amount for equal volumes of peanut butter
and jelly for which peanut butter is represented as the main ingredient
would be 4 tablespoons (tbsp) (2 tbsp peanut butter plus 2 tbsp jelly).
If the reference amounts are in incompatible units, the weights of the
appropriate volumes should be used (e.g., 110 grams (g) pancakes plus
the gram weight of the proportioned amount of syrup).
(g) The reference amounts set forth in paragraphs (b) through (f) of
this section shall be used in determining whether a product meets the
criteria for nutrient content claims, such as ``low calorie,'' and for
health claims. If the serving size declared on the product label differs
from the reference amount, and the product meets the criteria for the
claim only on the basis of the reference amount, the claim shall be
followed by a statement that sets forth the basis on which the claim is
made. That statement shall include the reference amount as it appears in
paragraph (b) of this section followed, in parenthesis, by the amount in
common household measure if the reference amount is expressed in
measures other than common household measures (e.g., for a beverage,
``Very low sodium, 35 mg or less per 240 mL (8 fl oz)'').
(h) The Commissioner of Food and Drugs, either on his or her own
initiative or in response to a petition submitted pursuant to part 10 of
this chapter, may issue a proposal to establish or amend a reference
amount in paragraph (b) of this section. A petition to establish or
amend a reference amount shall include:
(1) Objective of the petition;
(2) A description of the product;
(3) A complete sample product label including nutrition label, using
the format established by regulation;
(4) A description of the form (e.g., dry mix, frozen dough) in which
the product will be marketed;
(5) The intended dietary uses of the product with the major use
identified (e.g., milk as a beverage and chips as a snack);
(6) If the intended use is primarily as an ingredient in other
foods, list of foods or food categories in which the product will be
used as an ingredient with information on the prioritization of the use;
(7) The population group for which the product will be offered for
use (e.g., infants, children under 4 years of age);
(8) The names of the most closely related products (or in the case
of foods for special dietary use and imitation or substitute foods, the
names of the products for which they are offered as substitutes);
(9) The suggested reference amount (the amount of edible portion of
food as consumed, excluding bone, seed, shell, or other inedible
components) for the population group for which the product is intended
with full description of the methodology and procedures that were used
to determine the suggested reference amount. In determining the
reference amount, general principles and factors in paragraph (a) of
this section should be followed.
(10) The suggested reference amount shall be expressed in metric
units. Reference amounts for fluids shall be expressed in milliliters.
Reference amounts for other foods shall be expressed in grams except
when common household units such as cups, tablespoons, and teaspoons,
are more appropriate or are more likely to promote uniformity in serving
sizes declared on product labels. For example, common household measures
would be more appropriate if products within the same category differ
substantially in density, such as frozen desserts.
(i) In expressing the reference amounts in milliliters, the
following rules shall be followed:
(A) For volumes greater than 30 milliliters (mL), the volume shall
be expressed in multiples of 30 mL.
(B) For volumes less than 30 mL, the volume shall be expressed in
milliliters equivalent to a whole number of teaspoons or 1 tbsp, i.e.,
5, 10, or 15 mL.
[[Page 56]]
(ii) In expressing the reference amounts in grams, the following
general rules shall be followed:
(A) For quantities greater than 10 g, the quantity shall be
expressed in the nearest 5-g increment.
(B) For quantities less than 10 g, exact gram weights shall be used.
(11) A petition to create a new subcategory of food with its own
reference amount shall include the following additional information:
(i) Data that demonstrate that the new subcategory of food will be
consumed in amounts that differ enough from the reference amount for the
parent category to warrant a separate reference amount. Data must
include sample size; and the mean, standard deviation, median, and modal
consumed amount per eating occasion for the petitioned product and for
other products in the category, excluding the petitioned product. All
data must be derived from the same survey data.
(ii) Documentation supporting the difference in dietary usage and
product characteristics that affect the consumption size that
distinguishes the petitioned product from the rest of the products in
the category.
(12) A claim for categorical exclusion under Sec. 25.30 or Sec.
25.32 of this chapter or an environmental assessment under Sec. 25.40
of this chapter, and
(13) In conducting research to collect or process food consumption
data in support of the petition, the following general guidelines should
be followed.
(i) Sampled population selected should be representative of the
demographic and socioeconomic characteristics of the target population
group for which the food is intended.
(ii) Sample size (i.e., number of eaters) should be large enough to
give reliable estimates for customarily consumed amounts.
(iii) The study protocol should identify potential biases and
describe how potential biases are controlled for or, if not possible to
control, how they affect interpretation of results.
(iv) The methodology used to collect or process data should be fully
documented and should include: study design, sampling procedures,
materials used (e.g., questionnaire, and interviewer's manual),
procedures used to collect or process data, methods or procedures used
to control for unbiased estimates, and procedures used to correct for
nonresponse.
(14) A statement concerning the feasibility of convening
associations, corporations, consumers, and other interested parties to
engage in negotiated rulemaking to develop a proposed rule consistent
with the Negotiated Rulemaking Act (5 U.S.C. 561).
[58 FR 44051, Aug. 18, 1993; 58 FR 60109, Nov. 15, 1993, as amended at
59 FR 371, Jan. 4, 1994; 59 FR 24039, May 10, 1994; 62 FR 40598, July
29, 1997; 62 FR 49848, Sept. 23, 1997; 63 FR 14818, Mar. 27, 1998; 64 FR
12890, Mar. 16, 1999; 66 FR 56035, Nov. 6, 2001]
Sec. 101.13 Nutrient content claims--general principles.
(a) This section and the regulations in subpart D of this part apply
to foods that are intended for human consumption and that are offered
for sale, including conventional foods and dietary supplements.
(b) A claim that expressly or implicitly characterizes the level of
a nutrient of the type required to be in nutrition labeling under Sec.
101.9 or under Sec. 101.36 (that is, a nutrient content claim) may not
be made on the label or in labeling of foods unless the claim is made in
accordance with this regulation and with the applicable regulations in
subpart D of this part or in part 105 or part 107 of this chapter.
(1) An expressed nutrient content claim is any direct statement
about the level (or range) of a nutrient in the food, e.g., ``low
sodium'' or ``contains 100 calories.''
(2) An implied nutrient content claim is any claim that:
(i) Describes the food or an ingredient therein in a manner that
suggests that a nutrient is absent or present in a certain amount (e.g.,
``high in oat bran''); or
(ii) Suggests that the food, because of its nutrient content, may be
useful in maintaining healthy dietary practices and is made in
association with an explicit claim or statement about a nutrient (e.g.,
``healthy, contains 3 grams (g) of fat'').
(3) Except for claims regarding vitamins and minerals described in
paragraph (q)(3) of this section, no nutrient
[[Page 57]]
content claims may be made on food intended specifically for use by
infants and children less than 2 years of age unless the claim is
specifically provided for in parts 101, 105, or 107 of this chapter.
(4) Reasonable variations in the spelling of the terms defined in
part 101 and their synonyms are permitted provided these variations are
not misleading (e.g., ``hi'' or ``lo'').
(5) For dietary supplements, claims for calories, fat, saturated
fat, and cholesterol may not be made on products that meet the criteria
in Sec. 101.60(b)(1) or (b)(2) for ``calorie free'' or ``low calorie''
claims, except, in the case of calorie claims, when an equivalent amount
of a similar dietary supplement (e.g., another protein supplement) that
the labeled food resembles and for which it substitutes, normally
exceeds the definition for ``low calorie'' in Sec. 101.60(b)(2).
(c) Information that is required or permitted by Sec. 101.9 or
Sec. 101.36, as applicable, to be declared in nutrition labeling, and
that appears as part of the nutrition label, is not a nutrient content
claim and is not subject to the requirements of this section. If such
information is declared elsewhere on the label or in labeling, it is a
nutrient content claim and is subject to the requirements for nutrient
content claims.
(d) A ``substitute'' food is one that may be used interchangeably
with another food that it resembles, i.e., that it is organoleptically,
physically, and functionally (including shelf life) similar to, and that
it is not nutritionally inferior to unless it is labeled as an
``imitation.''
(1) If there is a difference in performance characteristics that
materially limits the use of the food, the food may still be considered
a substitute if the label includes a disclaimer adjacent to the most
prominent claim as defined in paragraph (j)(2)(iii) of this section,
informing the consumer of such difference (e.g., ``not recommended for
frying'').
(2) This disclaimer shall be in easily legible print or type and in
a size no less than that required by Sec. 101.105(i) for the net
quantity of contents statement, except where the size of the claim is
less than two times the required size of the net quantity of contents
statement, in which case the disclaimer shall be no less than one-half
the size of the claim but no smaller than one-sixteenth of an inch,
unless the package complies with Sec. 101.2(c)(5), in which case the
disclaimer may be in type of not less than one thirty-second of an inch.
(e)(1) Because the use of a ``free'' or ``low'' claim before the
name of a food implies that the food differs from other foods of the
same type by virtue of its having a lower amount of the nutrient, only
foods that have been specially processed, altered, formulated, or
reformulated so as to lower the amount of the nutrient in the food,
remove the nutrient from the food, or not include the nutrient in the
food, may bear such a claim (e.g., ``low sodium potato chips'').
(2) Any claim for the absence of a nutrient in a food, or that a
food is low in a nutrient when the food has not been specially
processed, altered, formulated, or reformulated to qualify for that
claim shall indicate that the food inherently meets the criteria and
shall clearly refer to all foods of that type and not merely to the
particular brand to which the labeling attaches (e.g., ``corn oil, a
sodium-free food'').
(f) A nutrient content claim shall be in type size no larger than
two times the statement of identity and shall not be unduly prominent in
type style compared to the statement of identity.
(g) [Reserved]
(h)(1) If a food, except a meal product as defined in Sec.
101.13(l), a main dish product as defined in Sec. 101.13(m), or food
intended specifically for use by infants and children less than 2 years
of age, contains more than 13.0 g of fat, 4.0 g of saturated fat, 60
milligrams (mg) of cholesterol, or 480 mg of sodium per reference amount
customarily consumed, per labeled serving, or, for a food with a
reference amount customarily consumed of 30 g or less or 2 tablespoons
or less, per 50 g (for dehydrated foods that must be reconstituted
before typical consumption with water or a diluent containing an
insignificant amount, as defined in Sec. 101.9(f)(1), of all nutrients
per reference amount customarily consumed, the per 50 g criterion refers
to the ``as
[[Page 58]]
prepared'' form), then that food must bear a statement disclosing that
the nutrient exceeding the specified level is present in the food as
follows: ``See nutrition information for ---- content'' with the blank
filled in with the identity of the nutrient exceeding the specified
level, e.g., ``See nutrition information for fat content.''
(2) If a food is a meal product as defined in Sec. 101.13(l), and
contains more than 26 g of fat, 8.0 g of saturated fat, 120 mg of
cholesterol, or 960 mg of sodium per labeled serving, then that food
must disclose, in accordance with the requirements as provided in
paragraph (h)(1) of this section, that the nutrient exceeding the
specified level is present in the food.
(3) If a food is a main dish product as defined in Sec. 101.13(m),
and contains more than 19.5 g of fat, 6.0 g of saturated fat, 90 mg of
cholesterol, or 720 mg of sodium per labeled serving, then that food
must disclose, in accordance with the requirements as provided in
paragraph (h)(1) of this section, that the nutrient exceeding the
specified level is present in the food.
(4)(i) The disclosure statement ``See nutrition information for ----
content'' shall be in easily legible boldface print or type, in distinct
contrast to other printed or graphic matter, and in a size no less than
that required by Sec. 101.105(i) for the net quantity of contents
statement, except where the size of the claim is less than two times the
required size of the net quantity of contents statement, in which case
the disclosure statement shall be no less than one-half the size of the
claim but no smaller than one-sixteenth of an inch, unless the package
complies with Sec. 101.2(c)(2), in which case the disclosure statement
may be in type of not less than one thirty-second of an inch.
(ii) The disclosure statement shall be immediately adjacent to the
nutrient content claim and may have no intervening material other than,
if applicable, other information in the statement of identity or any
other information that is required to be presented with the claim under
this section (e.g., see paragraph (j)(2) of this section) or under a
regulation in subpart D of this part (e.g., see Sec. Sec. 101.54 and
101.62). If the nutrient content claim appears on more than one panel of
the label, the disclosure statement shall be adjacent to the claim on
each panel except for the panel that bears the nutrition information
where it may be omitted.
(iii) If a single panel of a food label or labeling contains
multiple nutrient content claims or a single claim repeated several
times, a single disclosure statement may be made. The statement shall be
adjacent to the claim that is printed in the largest type on that panel.
(i) Except as provided in Sec. 101.9 or Sec. 101.36, as
applicable, or in paragraph (q)(3) of this section, the label or
labeling of a product may contain a statement about the amount or
percentage of a nutrient if:
(1) The use of the statement on the food implicitly characterizes
the level of the nutrient in the food and is consistent with a
definition for a claim, as provided in subpart D of this part, for the
nutrient that the label addresses. Such a claim might be, ``less than 3
g of fat per serving;''
(2) The use of the statement on the food implicitly characterizes
the level of the nutrient in the food and is not consistent with such a
definition, but the label carries a disclaimer adjacent to the statement
that the food is not ``low'' in or a ``good source'' of the nutrient,
such as ``only 200 mg sodium per serving, not a low sodium food.'' The
disclaimer must be in easily legible print or type and in a size no less
than that required by Sec. 101.105(i) for the net quantity of contents
statement except where the size of the claim is less than two times the
required size of the net quantity of contents statement, in which case
the disclaimer shall be no less than one-half the size of the claim but
no smaller than one-sixteenth of an inch unless the package complies
with Sec. 101.2(c)(5), in which case the disclaimer may be in type of
not less less than one thirty-second of an inch, or
(3) The statement does not in any way implicitly characterize the
level of the nutrient in the food and it is not false or misleading in
any respect (e.g., ``100 calories'' or ``5 grams of fat''), in which
case no disclaimer is required.
(4) ``Percent fat free'' claims are not authorized by this
paragraph. Such claims shall comply with Sec. 101.62(b)(6).
[[Page 59]]
(j) A food may bear a statement that compares the level of a
nutrient in the food with the level of a nutrient in a reference food.
These statements shall be known as ``relative claims'' and include
``light,'' ``reduced,'' ``less'' (or ``fewer''), and ``more'' claims.
(1) To bear a relative claim about the level of a nutrient, the
amount of that nutrient in the food must be compared to an amount of
nutrient in an appropriate reference food as specified below.
(i)(A) For ``less'' (or ``fewer'') and ``more'' claims, the
reference food may be a dissimilar food within a product category that
can generally be substituted for one another in the diet (e.g., potato
chips as reference for pretzels, orange juice as a reference for vitamin
C tablets) or a similar food (e.g., potato chips as reference for potato
chips, one brand of multivitamin as reference for another brand of
multivitamin).
(B) For ``light,'' ``reduced,'' ``added,'' ``extra,'' ``plus,''
``fortified,'' and ``enriched'' claims, the reference food shall be a
similar food (e.g., potato chips as a reference for potato chips, one
brand of multivitamin for another brand of multivitamin), and
(ii)(A) For ``light'' claims, the reference food shall be
representative of the type of food that includes the product that bears
the claim. The nutrient value for the reference food shall be
representative of a broad base of foods of that type; e.g., a value in a
representative, valid data base; an average value determined from the
top three national (or regional) brands, a market basket norm; or, where
its nutrient value is representative of the food type, a market leader.
Firms using such a reference nutrient value as a basis for a claim, are
required to provide specific information upon which the nutrient value
was derived, on request, to consumers and appropriate regulatory
officials.
(B) For relative claims other than ``light,'' including ``less'' and
``more'' claims, the reference food may be the same as that provided for
``light'' in paragraph (j)(1)(ii)(A) of this section, or it may be the
manufacturer's regular product, or that of another manufacturer, that
has been offered for sale to the public on a regular basis for a
substantial period of time in the same geographic area by the same
business entity or by one entitled to use its trade name. The nutrient
values used to determine the claim when comparing a single
manufacturer's product to the labeled product shall be either the values
declared in nutrition labeling or the actual nutrient values, provided
that the resulting label is internally consistent to (i.e., that the
values stated in the nutrition information, the nutrient values in the
accompanying information and the declaration of the percentage of
nutrient by which the food has been modified are consistent and will not
cause consumer confusion when compared), and that the actual
modification is at least equal to the percentage specified in the
definition of the claim.
(2) For foods bearing relative claims:
(i) The label or labeling must state the identity of the reference
food and the percentage (or fraction) of the amount of the nutrient in
the reference food by which the nutrient in the labeled food differs
(e.g., ``50 percent less fat than (reference food)'' or ``1/3 fewer
calories than (reference food)''),
(ii) This information shall be immediately adjacent to the most
prominent claim. The type size shall be in accordance with paragraph
(h)(4)(i) of this section.
(iii) The determination of which use of the claim is in the most
prominent location on the label or labeling will be made based on the
following factors, considered in order:
(A) A claim on the principal display panel adjacent to the statement
of identity;
(B) A claim elsewhere on the principal display panel;
(C) A claim on the information panel; or
(D) A claim elsewhere on the label or labeling.
(iv) The label or labeling must also bear:
(A) Clear and concise quantitative information comparing the amount
of the subject nutrient in the product per labeled serving with that in
the reference food; and
(B) This statement shall appear adjacent to the most prominent claim
or to
[[Page 60]]
the nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located elsewhere
on the information panel in accordance with Sec. 101.2.
(3) A relative claim for decreased levels of a nutrient may not be
made on the label or in labeling of a food if the nutrient content of
the reference food meets the requirement for a ``low'' claim for that
nutrient (e.g., 3 g fat or less).
(k) The term ``modified'' may be used in the statement of identity
of a food that bears a relative claim that complies with the
requirements of this part, followed immediately by the name of the
nutrient whose content has been altered (e.g., ``Modified fat
cheesecake''). This statement of identity must be immediately followed
by the comparative statement such as ``Contains 35 percent less fat than
------.'' The label or labeling must also bear the information required
by paragraph (j)(2) of this section in the manner prescribed.
(l) For purposes of making a claim, a ``meal product shall be
defined as a food that:
(1) Makes a major contribution to the total diet by:
(i) Weighing at least 10 ounces (oz) per labeled serving; and
(ii) Containing not less than three 40-g portions of food, or
combinations of foods, from two or more of the following four food
groups, except as noted in paragraph (l)(1)(ii)(E) of this section.
(A) Bread, cereal, rice, and pasta group;
(B) Fruits and vegetables group;
(C) Milk, yogurt, and cheese group;
(D) Meat, poultry, fish, dry beans, eggs, and nuts group; except
that;
(E) These foods shall not be sauces (except for foods in the above
four food groups that are in the sauces), gravies, condiments, relishes,
pickles, olives, jams, jellies, syrups, breadings or garnishes; and
(2) Is represented as, or is in a form commonly understood to be, a
breakfast, lunch, dinner, or meal. Such representations may be made
either by statements, photographs, or vignettes.
(m) For purposes of making a claim, a ``main dish product'' shall be
defined as a food that:
(1) Makes a major contribution to a meal by
(i) Weighing at least 6 oz per labeled serving; and
(ii) Containing not less than 40 g of food, or combinations of
foods, from each of at least two of the following four food groups,
except as noted in paragraph (m)(1)(ii)(E) of this section.
(A) Bread, cereal, rice, and pasta group;
(B) Fruits and vegetables group;
(C) Milk, yogurt, and cheese group;
(D) Meat, poultry, fish, dry beans, eggs, and nuts groups; except
that:
(E) These foods shall not be sauces (except for foods in the above
four food groups that are in the sauces) gravies, condiments, relishes,
pickles, olives, jams, jellies, syrups, breadings, or garnishes; and
(2) Is represented as, or is in a form commonly understood to be, a
main dish (e.g, not a beverage or a dessert). Such representations may
be made either by statements, photographs, or vignettes.
(n) Nutrition labeling in accordance with Sec. 101.9, Sec. 101.10,
or Sec. 101.36, as applicable, shall be provided for any food for which
a nutrient content claim is made.
(o) Except as provided in Sec. 101.10, compliance with requirements
for nutrient content claims in this section and in the regulations in
subpart D of this part, will be determined using the analytical
methodology prescribed for determining compliance with nutrition
labeling in Sec. 101.9.
(p)(1) Unless otherwise specified, the reference amount customarily
consumed set forth in Sec. 101.12(b) through (f) shall be used in
determining whether a product meets the criteria for a nutrient content
claim. If the serving size declared on the product label differs from
the reference amount customarily consumed, and the amount of the
nutrient contained in the labeled serving does not meet the maximum or
minimum amount criterion in the definition for the descriptor for that
nutrient, the claim shall be followed by the criteria for the claim as
required by
[[Page 61]]
Sec. 101.12(g) (e.g., ``very low sodium, 35 mg or less per 240
milliliters (8 fl oz.)'').
(2) The criteria for the claim shall be immediately adjacent to the
most prominent claim in easily legible print or type and in a size in
accordance with paragraph (h)(4)(i) of this section.
(q) The following exemptions apply:
(1) Nutrient content claims that have not been defined by regulation
and that are contained in the brand name of a specific food product that
was the brand name in use on such food before October 25, 1989, may
continue to be used as part of that brand name for such product,
provided that they are not false or misleading under section 403(a) of
the Federal Food, Drug, and Cosmetic Act (the act). However, foods
bearing such claims must comply with section 403(f), (g), and (h) of the
act;
(2) A soft drink that used the term diet as part of its brand name
before October 25, 1989, and whose use of that term was in compliance
with Sec. 105.66 of this chapter as that regulation appeared in the
Code of Federal Regulations on that date, may continue to use that term
as part of its brand name, provided that its use of the term is not
false or misleading under section 403(a) of the act. Such claims are
exempt from the requirements of section 403(r)(2) of the act (e.g., the
disclosure statement also required by Sec. 101.13(h)). Soft drinks
marketed after October 25, 1989, may use the term ``diet'' provided they
are in compliance with the current Sec. 105.66 of this chapter and the
requirements of Sec. 101.13.
(3)(i) A statement that describes the percentage of a vitamin or
mineral in the food, including foods intended specifically for use by
infants and children less than 2 years of age, in relation to a
Reference Daily Intake (RDI) as defined in Sec. 101.9 may be made on
the label or in labeling of a food without a regulation authorizing such
a claim for a specific vitamin or mineral unless such claim is expressly
prohibited by regulation under section 403(r)(2)(A)(vi) of the act.
(ii) Percentage claims for dietary supplements. Under section
403(r)(2)(F) of the act, a statement that characterizes the percentage
level of a dietary ingredient for which a reference daily intake (RDI)
or daily reference value (DRV) has not been established may be made on
the label or in labeling of dietary supplements without a regulation
that specifically defines such a statement. All such claims shall be
accompanied by any disclosure statement required under paragraph (h) of
this section.
(A) Simple percentage claims. Whenever a statement is made that
characterizes the percentage level of a dietary ingredient for which
there is no RDI or DRV, the statement of the actual amount of the
dietary ingredient per serving shall be declared next to the percentage
statement (e.g., ``40 percent omega-3 fatty acids, 10 mg per capsule'').
(B) Comparative percentage claims. Whenever a statement is made that
characterizes the percentage level of a dietary ingredient for which
there is no RDI or DRV and the statement draws a comparison to the
amount of the dietary ingredient in a reference food, the reference food
shall be clearly identified, the amount of that food shall be
identified, and the information on the actual amount of the dietary
ingredient in both foods shall be declared in accordance with paragraph
(j)(2)(iv) of this section (e.g., ``twice the omega-3 fatty acids per
capsule (80 mg) as in 100 mg of menhaden oil (40 mg)'').
(4) The requirements of this section do not apply to:
(i) Infant formulas subject to section 412(h) of the act; and
(ii) Medical foods defined by section 5(b) of the Orphan Drug Act.
(5) A nutrient content claim used on food that is served in
restaurants or other establishments in which food is served for
immediate human consumption or which is sold for sale or use in such
establishments shall comply with the requirements of this section and
the appropriate definition in subpart D of this part, except that:
(i) Such claim is exempt from the requirements for disclosure
statements in paragraph (h) of this section and Sec. Sec. 101.54(d),
101.62(c), (d)(1)(ii)(D), (d)(2)(iii)(C), (d)(3), (d)(4)(ii)(C), and
(d)(5)(ii)(C); and
(ii) In lieu of analytical testing, compliance may be determined
using a reasonable basis for concluding that the food that bears the
claim meets the
[[Page 62]]
definition for the claim. This reasonable basis may derive from
recognized data bases for raw and processed foods, recipes, and other
means to compute nutrient levels in the foods or meals and may be used
provided reasonable steps are taken to ensure that the method of
preparation adheres to the factors on which the reasonable basis was
determined (e.g., types and amounts of ingredients, cooking
temperatures, etc.). Firms making claims on foods based on this
reasonable basis criterion are required to provide to appropriate
regulatory officials on request the specific information on which their
determination is based and reasonable assurance of operational adherence
to the preparation methods or other basis for the claim; and
(iii) A term or symbol that may in some contexts constitute a claim
under this section may be used, provided that the use of the term or
symbol does not characterize the level of a nutrient, and a statement
that clearly explains the basis for the use of the term or symbol is
prominently displayed and does not characterize the level of a nutrient.
For example, a term such as ``lite fare'' followed by an asterisk
referring to a note that makes clear that in this restaurant ``lite
fare'' means smaller portion sizes than normal; or an item bearing a
symbol referring to a note that makes clear that this item meets the
criteria for the dietary guidance established by a recognized dietary
authority would not be considered a nutrient content claim under Sec.
101.13.
(6) Nutrient content claims that were part of the common or usual
names of foods that were subject to a standard of identity on November
8, 1990, are not subject to the requirements of paragraphs (b) and (h)
of this section or to definitions in subpart D of this part.
(7) Implied nutrient content claims may be used as part of a brand
name, provided that the use of the claim has been authorized by the Food
and Drug Administration. Petitions requesting approval of such a claim
may be submitted under Sec. 101.69(o).
(8) The term fluoridated, fluoride added or with added fluoride may
be used on the label or in labeling of bottled water that contains added
fluoride.
[58 FR 2410, Jan. 6, 1993; 58 FR 17341, 17342, Apr. 2, 1993, as amended
at 58 FR 44030, Aug. 18, 1993; 59 FR 393, Jan. 4, 1994; 59 FR 15051,
Mar. 31, 1994; 60 FR 17205, Apr. 5, 1995; 61 FR 11731, Mar. 22, 1996; 61
FR 40332, Aug. 2, 1996; 61 FR 67452, Dec. 23, 1996; 62 FR 31339, June 9,
1997; 62 FR 49867, Sept. 23, 1997; 63 FR 14818, Mar. 27, 1998; 63 FR
26980, May 15, 1998]
Sec. 101.14 Health claims: general requirements.
(a) Definitions. For purposes of this section, the following
definitions apply:
(1) Health claim means any claim made on the label or in labeling of
a food, including a dietary supplement, that expressly or by
implication, including ``third party'' references, written statements
(e.g., a brand name including a term such as ``heart''), symbols (e.g.,
a heart symbol), or vignettes, characterizes the relationship of any
substance to a disease or health-related condition. Implied health
claims include those statements, symbols, vignettes, or other forms of
communication that suggest, within the context in which they are
presented, that a relationship exists between the presence or level of a
substance in the food and a disease or health-related condition.
(2) Substance means a specific food or component of food, regardless
of whether the food is in conventional food form or a dietary supplement
that includes vitamins, minerals, herbs, or other similar nutritional
substances.
(3) Nutritive value means a value in sustaining human existence by
such processes as promoting growth, replacing loss of essential
nutrients, or providing energy.
(4) Disqualifying nutrient levels means the levels of total fat,
saturated fat, cholesterol, or sodium in a food above which the food
will be disqualified from making a health claim. These levels are 13.0
grams (g) of fat, 4.0 g of saturated fat, 60 milligrams (mg) of
cholesterol, or 480 mg of sodium, per reference amount customarily
consumed, per label serving size, and, only for foods with reference
amounts customarily consumed of 30 g or less or 2 tablespoons or less,
per 50 g. For dehydrated foods that must have water
[[Page 63]]
added to them prior to typical consumption, the per 50-g criterion
refers to the as prepared form. Any one of the levels, on a per
reference amount customarily consumed, a per label serving size or, when
applicable, a per 50 g basis, will disqualify a food from making a
health claim unless an exception is provided in subpart E of this part,
except that:
(i) The levels for a meal product as defined in Sec. 101.13(l) are
26.0 g of fat, 8.0 g of saturated fat, 120 mg of cholesterol, or 960 mg
of sodium per label serving size, and
(ii) The levels for a main dish product as defined in Sec.
101.13(m) are 19.5 g of fat, 6.0 g of saturated fat, 90 mg of
cholesterol, or 720 mg of sodium per label serving size.
(5) Disease or health-related condition means damage to an organ,
part, structure, or system of the body such that it does not function
properly (e.g., cardiovascular disease), or a state of health leading to
such dysfunctioning (e.g., hypertension); except that diseases resulting
from essential nutrient deficiencies (e.g., scurvy, pellagra) are not
included in this definition (claims pertaining to such diseases are
thereby not subject to Sec. 101.14 or Sec. 101.70).
(b) Eligibility. For a substance to be eligible for a health claim:
(1) The substance must be associated with a disease or health-
related condition for which the general U.S. population, or an
identified U.S. population subgroup (e.g., the elderly) is at risk, or,
alternatively, the petition submitted by the proponent of the claim
otherwise explains the prevalence of the disease or health-related
condition in the U.S. population and the relevance of the claim in the
context of the total daily diet and satisfies the other requirements of
this section.
(2) If the substance is to be consumed as a component of a
conventional food at decreased dietary levels, the substance must be a
nutrient listed in 21 U.S.C. 343(q)(1)(C) or (q)(1)(D), or one that the
Food and Drug Administration (FDA) has required to be included in the
label or labeling under 21 U.S.C. 343(q)(2)(A); or
(3) If the substance is to be consumed at other than decreased
dietary levels:
(i) The substance must, regardless of whether the food is a
conventional food or a dietary supplement, contribute taste, aroma, or
nutritive value, or any other technical effect listed in Sec. 170.3(o)
of this chapter, to the food and must retain that attribute when
consumed at levels that are necessary to justify a claim; and
(ii) The substance must be a food or a food ingredient or a
component of a food ingredient whose use at the levels necessary to
justify a claim has been demonstrated by the proponent of the claim, to
FDA's satisfaction, to be safe and lawful under the applicable food
safety provisions of the Federal Food, Drug, and Cosmetic Act.
(c) Validity requirement. FDA will promulgate regulations
authorizing a health claim only when it determines, based on the
totality of publicly available scientific evidence (including evidence
from well-designed studies conducted in a manner which is consistent
with generally recognized scientific procedures and principles), that
there is significant scientific agreement, among experts qualified by
scientific training and experience to evaluate such claims, that the
claim is supported by such evidence.
(d) General health claim labeling requirements. (1) When FDA
determines that a health claim meets the validity requirements of
paragraph (c) of this section, FDA will propose a regulation in subpart
E of this part to authorize the use of that claim. If the claim pertains
to a substance not provided for in Sec. 101.9 or Sec. 101.36, FDA will
propose amending that regulation to include declaration of the
substance.
(2) When FDA has adopted a regulation in subpart E of this part
providing for a health claim, firms may make claims based on the
regulation in subpart E of this part, provided that:
(i) All label or labeling statements about the substance-disease
relationship that is the subject of the claim are based on, and
consistent with, the conclusions set forth in the regulations in subpart
E of this part;
(ii) The claim is limited to describing the value that ingestion (or
reduced ingestion) of the substance, as part of a total dietary pattern,
may have on a
[[Page 64]]
particular disease or health-related condition;
(iii) The claim is complete, truthful, and not misleading. Where
factors other than dietary intake of the substance affect the
relationship between the substance and the disease or health-related
condition, such factors may be required to be addressed in the claim by
a specific regulation in subpart E of this part;
(iv) All information required to be included in the claim appears in
one place without other intervening material, except that the principal
display panel of the label or labeling may bear the reference statement,
``See ------ for information about the relationship between ------ and
------,'' with the blanks filled in with the location of the labeling
containing the health claim, the name of the substance, and the disease
or health-related condition (e.g., ``See attached pamphlet for
information about calcium and osteoporosis''), with the entire claim
appearing elsewhere on the other labeling, Provided that, where any
graphic material (e.g., a heart symbol) constituting an explicit or
implied health claim appears on the label or labeling, the reference
statement or the complete claim shall appear in immediate proximity to
such graphic material;
(v) The claim enables the public to comprehend the information
provided and to understand the relative significance of such information
in the context of a total daily diet; and
(vi) If the claim is about the effects of consuming the substance at
decreased dietary levels, the level of the substance in the food is
sufficiently low to justify the claim. To meet this requirement, if a
definition for use of the term low has been established for that
substance under this part, the substance must be present at a level that
meets the requirements for use of that term, unless a specific
alternative level has been established for the substance in subpart E of
this part. If no definition for ``low'' has been established, the level
of the substance must meet the level established in the regulation
authorizing the claim; or
(vii) If the claim is about the effects of consuming the substance
at other than decreased dietary levels, the level of the substance is
sufficiently high and in an appropriate form to justify the claim. To
meet this requirement, if a definition for use of the term high for that
substance has been established under this part, the substance must be
present at a level that meets the requirements for use of that term,
unless a specific alternative level has been established for the
substance in subpart E of this part. If no definition for ``high'' has
been established (e.g., where the claim pertains to a food either as a
whole food or as an ingredient in another food), the claim must specify
the daily dietary intake necessary to achieve the claimed effect, as
established in the regulation authorizing the claim; Provided That:
(A) Where the food that bears the claim meets the requirements of
paragraphs (d)(2)(vi) or (d)(2)(vii) of this section based on its
reference amount customarily consumed, and the labeled serving size
differs from that amount, the claim shall be followed by a statement
explaining that the claim is based on the reference amount rather than
the labeled serving size (e.g., ``Diets low in sodium may reduce the
risk of high blood pressure, a disease associated with many factors. A
serving of -- ounces of this product conforms to such a diet.'').
(B) Where the food that bears the claim is sold in a restaurant or
in other establishments in which food that is ready for immediate human
consumption is sold, the food can meet the requirements of paragraphs
(d)(2)(vi) or (d)(2)(vii) of this section if the firm that sells the
food has a reasonable basis on which to believe that the food that bears
the claim meets the requirements of paragraphs (d)(2)(vi) or (d)(2)(vii)
of this section and provides that basis upon request.
(3) Nutrition labeling shall be provided in the label or labeling of
any food for which a health claim is made in accordance with Sec.
101.9; for restaurant foods, in accordance with Sec. 101.10; or for
dietary supplements, in accordance with Sec. 101.36.
(e) Prohibited health claims. No expressed or implied health claim
may be made on the label or in labeling for a food, regardless of
whether the food is
[[Page 65]]
in conventional food form or dietary supplement form, unless:
(1) The claim is specifically provided for in subpart E of this
part; and
(2) The claim conforms to all general provisions of this section as
well as to all specific provisions in the appropriate section of subpart
E of this part;
(3) None of the disqualifying levels identified in paragraph (a)(4)
of this section is exceeded in the food, unless specific alternative
levels have been established for the substance in subpart E of this
part; or unless FDA has permitted a claim despite the fact that a
disqualifying level of a nutrient is present in the food based on a
finding that such a claim will assist consumers in maintaining healthy
dietary practices, and, in accordance with the regulation in subpart E
of this part that makes such a finding, the label bears a disclosure
statement that complies with Sec. 101.13(h), highlighting the nutrient
that exceeds the disqualifying level;
(4) Except as provided in paragraph (e)(3) of this section, no
substance is present at an inappropriate level as determined in the
specific provision authorizing the claim in subpart E of this part;
(5) The label does not represent or purport that the food is for
infants and toddlers less than 2 years of age except if the claim is
specifically provided for in subpart E of this part; and
(6) Except for dietary supplements or where provided for in other
regulations in part 101, subpart E, the food contains 10 percent or more
of the Reference Daily Intake or the Daily Reference Value for vitamin
A, vitamin C, iron, calcium, protein, or fiber per reference amount
customarily consumed prior to any nutrient addition.
(f) The requirements of this section do not apply to:
(1) Infant formulas subject to section 412(h) of the Federal Food,
Drug, and Cosmetic Act, and
(2) Medical foods defined by section 5(b) of the Orphan Drug Act.
(g) Applicability. The requirements of this section apply to foods
intended for human consumption that are offered for sale, regardless of
whether the foods are in conventional food form or dietary supplement
form.
[58 FR 2533, Jan. 6, 1993; 58 FR 17097, Apr. 1, 1993, as amended at 58
FR 44038, Aug. 18, 1993; 59 FR 425, Jan. 4, 1994; 59 FR 15050, Mar. 31,
1994; 61 FR 40332, Aug. 2, 1996; 62 FR 49867, Sept. 23, 1997; 63 FR
26980, May 15, 1998; 66 FR 17358, Mar. 30, 2001]
Sec. 101.15 Food; prominence of required statements.
(a) A word, statement, or other information required by or under
authority of the act to appear on the label may lack that prominence and
conspicuousness required by section 403(f) of the act by reason (among
other reasons) of:
(1) The failure of such word, statement, or information to appear on
the part or panel of the label which is presented or displayed under
customary conditions of purchase;
(2) The failure of such word, statement, or information to appear on
two or more parts or panels of the label, each of which has sufficient
space therefor, and each of which is so designed as to render it likely
to be, under customary conditions of purchase, the part or panel
displayed;
(3) The failure of the label to extend over the area of the
container or package available for such extension, so as to provide
sufficient label space for the prominent placing of such word,
statement, or information;
(4) Insufficiency of label space (for the prominent placing of such
word, statement, or information) resulting from the use of label space
for any word, statement, design, or device which is not required by or
under authority of the act to appear on the label;
(5) Insufficiency of label space (for the prominent placing of such
word, statement, or information) resulting from the use of label space
to give materially greater conspicuousness to any other word, statement,
or information, or to any design or device; or
(6) Smallness or style of type in which such word, statement, or
information appears, insufficient background contrast, obscuring designs
or vignettes, or crowding with other written, printed, or graphic
matter.
(b) No exemption depending on insufficiency of label space, as
prescribed in
[[Page 66]]
regulations promulgated under section 403 (e) or (i) of the act, shall
apply if such insufficiency is caused by:
(1) The use of label space for any word, statement, design, or
device which is not required by or under authority of the act to appear
on the label;
(2) The use of label space to give greater conspicuousness to any
word, statement, or other information than is required by section 403(f)
of the act; or
(3) The use of label space for any representation in a foreign
language.
(c)(1) All words, statements, and other information required by or
under authority of the act to appear on the label or labeling shall
appear thereon in the English language: Provided, however, That in the
case of articles distributed solely in the Commonwealth of Puerto Rico
or in a Territory where the predominant language is one other than
English, the predominant language may be substituted for English.
(2) If the label contains any representation in a foreign language,
all words, statements, and other information required by or under
authority of the act to appear on the label shall appear thereon in the
foreign language: Provided, however, That individual serving-size
packages of foods containing no more than 1\1/2\ avoirdupois ounces or
no more than 1\1/2\ fluid ounces served with meals in restaurants,
institutions, and passenger carriers and not intended for sale at retail
are exempt from the requirements of this paragraph (c)(2), if the only
representation in the foreign language(s) is the name of the food.
(3) If any article of labeling (other than a label) contains any
representation in a foreign language, all words, statements, and other
information required by or under authority of the act to appear on the
label or labeling shall appear on such article of labeling.
Sec. 101.17 Food labeling warning, notice, and safe handling statements.
(a) Self-pressurized containers. (1) The label of a food packaged in
a self-pressurized container and intended to be expelled from the
package under pressure shall bear the following warning:
WARNING--Avoid spraying in eyes. Contents under pressure. Do not
puncture or incinerate. Do not store at temperature above 120 [deg]F.
Keep out of reach of children.
(2) In the case of products intended for use by children, the phrase
``except under adult supervision'' may be added at the end of the last
sentence in the warning required by paragraph (a)(1) of this section.
(3) In the case of products packaged in glass containers, the word
``break'' may be substituted for the word ``puncture'' in the warning
required by paragraph (a)(1) of this section.
(4) The words ``Avoid spraying in eyes'' may be deleted from the
warning required by paragraph (a)(1) of this section in the case of a
product not expelled as a spray.
(b) Self-pressurized containers with halocarbon or hydrocarbon
propellants. (1) In addition to the warning required by paragraph (a) of
this section, the label of a food packaged in a self-pressurized
container in which the propellant consists in whole or in part of a
halocarbon or a hydrocarbon shall bear the following warning:
WARNING--Use only as directed. Intentional misuse by deliberately
concentrating and inhaling the contents can be harmful or fatal.
(2) The warning required by paragraph (b)(1) of this section is not
required for the following products:
(i) Products expelled in the form of a foam or cream, which contain
less than 10 percent propellant in the container.
(ii) Products in a container with a physical barrier that prevents
escape of the propellant at the time of use.
(iii) Products of a net quantity of contents of less than 2 ounces
that are designed to release a measured amount of product with each
valve actuation.
(iv) Products of a net quantity of contents of less than one-half
ounce.
(c) Food containing or manufactured with a chloro fluoro carbon or
other ozone-depleting substance. Labeling requirements for foods that
contain or are manufactured with a chlorofluorocarbon or other ozone-
depleting substance designated by the Environmental Protection Agency
(EPA) are set forth in 40 CFR part 82.
(d) Protein products. (1) The label and labeling of any food product
in liquid, powdered, tablet, capsule, or similar
[[Page 67]]
forms that derives more than 50 percent of its total caloric value from
either whole protein, protein hydrolysates, amino acid mixtures, or a
combination of these, and that is represented for use in reducing weight
shall bear the following warning:
WARNING: Very low calorie protein diets (below 400 Calories per day)
may cause serious illness or death. Do Not Use for Weight Reduction in
Such Diets Without Medical Supervision. Not for use by infants,
children, or pregnant or nursing women.
(2) Products described in paragraph (d)(1) of this section are
exempt from the labeling requirements of that paragraph if the protein
products are represented as part of a nutritionally balanced diet plan
providing 400 or more Calories (kilocalories) per day and the label or
labeling of the product specifies the diet plan in detail or provides a
brief description of that diet plan and adequate information describing
where the detailed diet plan may be obtained and the label and labeling
bear the following statement:
Notice: For weight reduction, use only as directed in the
accompanying diet plan (the name and specific location in labeling of
the diet plan may be included in this statement in place of
``accompanying diet plan''). Do not use in diets supplying less than 400
Calories per day without medical supervision.
(3) The label and labeling of food products represented or intended
for dietery (food) supplementation that derive more than 50 percent of
their total caloric value from either whole protein, protein
hydrolysates, amino acid mixtures, or a combination of these, that are
represented specifically for purposes other than weight reduction; and
that are not covered by the requirements of paragraph (d) (1) and (2) of
this section; shall bear the following statement:
Notice: Use this product as a food supplement only. Do not use for
weight reduction.
(4) The provisions of this paragraph are separate from and in
addition to any labeling requirements promulgated by the Federal Trade
Commission for protein supplements.
(5) Protein products shipped in bulk form for use solely in the
manufacture of other foods and not for distribution to consumers in such
container are exempt from the labeling requirements of this paragraph.
(6) The warning and notice statements required by paragraphs (d)
(1), (2), and (3) of this section shall appear prominently and
conspicuously on the principal display panel of the package label and
any other labeling.
(e) Dietary supplements containing iron or iron salts. (1) The
labeling of any dietary supplement in solid oral dosage form (e.g.,
tablets or capsules) that contains iron or iron salts for use as an iron
source shall bear the following statement:
WARNING: Accidental overdose of iron-containing products is a
leading cause of fatal poisoning in children under 6. Keep this product
out of reach of children. In case of accidental overdose, call a doctor
or poison control center immediately.
(2)(i) The warning statement required by paragraph (e)(1) of this
section shall appear prominently and conspicuously on the information
panel of the immediate container label.
(ii) If a product is packaged in unit-dose packaging, and if the
immediate container bears labeling but not a label, the warning
statement required by paragraph (e)(1) of this section shall appear
prominently and conspicuously on the immediate container labeling in a
way that maximizes the likelihood that the warning is intact until all
of the dosage units to which it applies are used.
(3) Where the immediate container is not the retail package, the
warning statement required by paragraph (e)(1) of this section shall
also appear prominently and conspicuously on the information panel of
the retail package label.
(4) The warning statement shall appear on any labeling that contains
warnings.
(5) The warning statement required by paragraph (e)(1) of this
section shall be set off in a box by use of hairlines.
(f) Foods containing psyllium husk. (1) Foods containing dry or
incompletely hydrated psyllium husk, also known as psyllium seed husk,
and bearing a health claim on the association between soluble fiber from
psyllium husk
[[Page 68]]
and reduced risk of coronary heart disease, shall bear a label statement
informing consumers that the appropriate use of such foods requires
consumption with adequate amounts of fluids, alerting them of potential
consequences of failing to follow usage recommendations, and informing
persons with swallowing difficulties to avoid consumption of the product
(e.g., ``NOTICE: This food should be eaten with at least a full glass of
liquid. Eating this product without enough liquid may cause choking. Do
not eat this product if you have difficulty in swallowing.''). However,
a product in conventional food form may be exempt from this requirement
if a viscous adhesive mass is not formed when the food is exposed to
fluids.
(2) The statement shall appear prominently and conspicuously on the
information panel or principal display panel of the package label and
any other labeling to render it likely to be read and understood by the
ordinary individual under customary conditions of purchase and use. The
statement shall be preceded by the word ``NOTICE'' in capital letters.
(g) Juices that have not been specifically processed to prevent,
reduce, or eliminate the presence of pathogens. (1) For purposes of this
paragraph (g), ``juice'' means the aqueous liquid expressed or extracted
from one or more fruits or vegetables, purees of the edible portions of
one or more fruits or vegetables, or any concentrate of such liquid or
puree.
(2) The label of:
(i) Any juice that has not been processed in the manner described in
paragraph (g)(7) of this section; or
(ii) Any beverage containing juice where neither the juice
ingredient nor the beverage has been processed in the manner described
in paragraph (g)(7) of this section, shall bear the following warning
statement:
WARNING: This product has not been pasteurized and, therefore, may
contain harmful bacteria that can cause serious illness in children, the
elderly, and persons with weakened immune systems.
(3) The warning statement required by this paragraph (g) shall not
apply to juice that is not for distribution to retail consumers in the
form shipped and that is for use solely in the manufacture of other
foods or that is to be processed, labeled, or repacked at a site other
than originally processed, provided that for juice that has not been
processed in the manner described in paragraph (g)(7) of this section,
the lack of such processing is disclosed in documents accompanying the
juice, in accordance with the practice of the trade.
(4) The warning statement required by paragraph (g)(2) of this
section shall appear prominently and conspicuously on the information
panel or on the principal display panel of the label of the container.
(5) The word ``WARNING'' shall be capitalized and shall appear in
bold type.
(6) The warning statement required by paragraph (g)(2) of this
section, when on a label, shall be set off in a box by use of hairlines.
(7)(i) The requirements in this paragraph (g) shall not apply to a
juice that has been processed in a manner that will produce, at a
minimum, a reduction in the pertinent microorganism for a period at
least as long as the shelf life of the product when stored under normal
and moderate abuse conditions, of the following magnitude:
(A) A 5-log (i.e., 100,000-fold) reduction; or
(B) A reduction that is equal to, or greater than, the criterion
established for process controls by any final regulation requiring the
application of Hazard Analysis and Critical Control Point (HACCP)
principles to the processing of juice.
(ii) For the purposes of this paragraph (g), the ``pertinent
microorganism'' is the most resistant microorganism of public health
significance that is likely to occur in the juice.
(h) Shell eggs. (1) The label of all shell eggs, whether in
intrastate or interstate commerce, shall bear the following statement:
SAFE HANDLING INSTRUCTIONS: To prevent illness from bacteria: keep
eggs refrigerated, cook eggs until yolks are firm, and cook foods
containing eggs thoroughly.
(2) The label statement required by paragraph (h)(1) of this section
shall appear prominently and conspicuously,
[[Page 69]]
with the words ``SAFE HANDLING INSTRUCTIONS'' in bold type, on the
principal display panel, the information panel, or on the inside of the
lid of egg cartons. If this statement appears on the inside of the lid,
the words ``Keep Refrigerated'' must appear on the principal display
panel or information panel.
(3) The label statement required by paragraph (h)(1) of this section
shall be set off in a box by use of hairlines.
(4) Shell eggs that have been, before distribution to consumers,
specifically processed to destroy all viable Salmonella shall be exempt
from the requirements of paragraph (h) of this section.
(5) The safe handling statement for shell eggs that are not for
direct sale to consumers, e.g., those that are to be repacked or labeled
at a site other than where originally processed, or are sold for use in
food service establishments, may be provided on cartons or in labeling,
e.g., invoices or bills of lading in accordance with the practice of the
trade.
(6) Under sections 311 and 361 of the Public Health Service Act (PHS
Act), any State or locality that is willing and able to assist the
agency in the enforcement of paragraphs (h)(1) through (h)(5) of this
section, and is authorized to inspect or regulate establishments
handling packed shell eggs, may in its own jurisdiction, enforce
paragraphs (h)(1) through (h)(5) of this section through inspections
under paragraph (h)(8) of this section and through administrative
enforcement remedies identified in paragraph (h)(7) of this section
until FDA notifies the State or locality in writing that such assistance
is no longer needed. When providing such assistance, a State or locality
may follow the hearing procedures set out in paragraphs (h)(7)(ii)(C)
through (h)(7)(ii)(D) of this section, substituting, where necessary,
appropriate State or local officials for designated FDA officials or may
utilize State or local hearing procedures if such procedures satisfy due
process.
(7) This paragraph (h) is established under authority of both the
Federal Food, Drug, and Cosmetic Act (the act) and the PHS Act. Under
the act, the agency can enforce the food misbranding provisions under 21
U.S.C. 331, 332, 333, and 334. However, 42 U.S.C. 264 provides for the
issuance of implementing enforcement regulations; therefore, FDA has
established the following administrative enforcement procedures for the
relabeling, diversion, or destruction of shell eggs and informal
hearings under the PHS Act:
(i) Upon finding that any shell eggs are in violation of this
section an authorized FDA representative or State or local
representative in accordance with paragraph (h)(6) of this section may
order such eggs to be relabeled under the supervision of said
representative, diverted, under the supervision of said representative
for processing in accordance with the Egg Products Inspection Act (EPIA)
(21 U.S.C. 1031 et seq.), or destroyed by or under the supervision of an
officer or employee of the FDA, or, if applicable, of the State or
locality, in accordance with the following procedures:
(A) Order for relabeling, diversion, or destruction under the PHS
Act. Any district office of the FDA or any State or locality acting
under paragraph (h)(6) of this section, upon finding shell eggs held in
violation of this regulation, may serve upon the person in whose
possession such eggs are found a written order that such eggs be
relabeled with the required statement in paragraph (h)(1) of this
section before further distribution. If the person chooses not to
relabel, the district office of the FDA or, if applicable, the
appropriate State or local agency may serve upon the person a written
order that such eggs be diverted (from direct consumer sale, e.g., to
food service) under the supervision of an officer or employee of the
issuing entity, for processing in accordance with the EPIA (21 U.S.C.
1031 et seq.) or destroyed by or under the supervision of the issuing
entity, within 10-working days from the date of receipt of the order.
(B) Issuance of order. The order shall include the following
information:
(1) A statement that the shell eggs identified in the order are
subject to relabeling, diversion for processing in accordance with the
EPIA, or destruction;
(2) A detailed description of the facts that justify the issuance of
the order;
[[Page 70]]
(3) The location of the eggs;
(4) A statement that these eggs shall not be sold, distributed, or
otherwise disposed of or moved except as provided in paragraph
(h)(7)(i)(E) of this section;
(5) Identification or description of the eggs;
(6) The order number;
(7) The date of the order;
(8) The text of this entire section;
(9) A statement that the order may be appealed by written appeal or
by requesting an informal hearing;
(10) The name and phone number of the person issuing the order; and
(11) The location and telephone number of the responsible office or
agency and the name of its director.
(C) Approval of director. An order, before issuance, shall be
approved by the director of the office or agency issuing the order. If
prior written approval is not feasible, prior oral approval shall be
obtained and confirmed by written memorandum as soon as possible.
(D) Labeling or marking of shell eggs under order. An FDA, State, or
local representative issuing an order under paragraph (h)(7)(i)(A) of
this section shall label or mark the shell eggs with official tags that
include the following information:
(1) A statement that the shell eggs are detained in accordance with
regulations issued under section 361(a) of the PHS Act (42 U.S.C.
264(a)).
(2) A statement that the shell eggs shall not be sold, distributed
or otherwise disposed of or moved except, after notifying the issuing
entity in writing, to:
(i) Relabel, divert them for processing in accordance with the EPIA,
or destroy them, or
(ii) Move them to another location for holding pending appeal.
(3) A statement that the violation of the order or the removal or
alteration of the tag is punishable by fine or imprisonment or both
(section 368 of the PHS Act, 42 U.S.C. 271).
(4) The order number and the date of the order, and the name of the
government representative who issued the order.
(E) Sale or other disposition of shell eggs under order. After
service of the order, the person in possession of the shell eggs that
are the subject of the order shall not sell, distribute, or otherwise
dispose of or move any eggs subject to the order unless and until the
notice is withdrawn after an appeal except, after notifying FDA's
district office or, if applicable, the State or local agency in writing,
to:
(1) Relabel, divert, or destroy them as specified in paragraph
(h)(7)(i) of this section, or
(2) Move them to another location for holding pending appeal.
(ii) The person on whom the order for relabeling, diversion, or
destruction is served may either comply with the order or appeal the
order to the FDA Regional Food and Drug Director.
(A) Appeal of a detention order. Any appeal shall be submitted in
writing to the FDA District Director in whose district the shell eggs
are located within 5-working days of the issuance of the order. If the
appeal includes a request for an informal hearing, the hearing shall be
held within 5-working days after the appeal is filed or, if requested by
the appellant, at a later date, which shall not be later than 20-
calendar days after the issuance of the order. The order may also be
appealed within the same period of 5-working days by any other person
having an ownership or proprietary interest in such shell eggs. The
appellant of an order shall state the ownership or proprietary interest
the appellant has in the shell eggs.
(B) Summary decision. A request for a hearing may be denied, in
whole or in part and at any time after a request for a hearing has been
submitted, if the FDA Regional Food and Drug Director or his or her
designee determines that no genuine and substantial issue of fact has
been raised by the material submitted in connection with the hearing or
from matters officially noticed. If the FDA Regional Food and Drug
Director determines that a hearing is not justified, written notice of
the determination will be given to the parties explaining the reason for
denial.
(C) Informal hearing. Appearance by any appellant at the hearing may
be by mail or in person, with or without counsel. The informal hearing
shall be conducted by the FDA Regional Food and Drug Director or his
designee, and a written summary of the proceedings
[[Page 71]]
shall be prepared by the FDA Regional Food and Drug Director.
(1) The FDA Regional Food and Drug Director may direct that the
hearing be conducted in any suitable manner permitted by law and this
section. The FDA Regional Food and Drug Director has the power to take
such actions and make such rulings as are necessary or appropriate to
maintain order and to conduct an informal fair, expeditious, and
impartial hearing, and to enforce the requirements concerning the
conduct of hearings.
(2) Employees of FDA will first give a full and complete statement
of the action which is the subject of the hearing, together with the
information and reasons supporting it, and may present oral or written
information relevant to the hearing. The party requesting the hearing
may then present oral or written information relevant to the hearing.
All parties may conduct reasonable examination of any person (except for
the presiding officer and counsel for the parties) who makes any
statement on the matter at the hearing.
(3) The hearing shall be informal in nature, and the rules of
evidence do not apply. No motions or objections relating to the
admissibility of information and views will be made or considered, but
any party may comment upon or rebut any information and views presented
by another party.
(4) The party requesting the hearing may have the hearing
transcribed, at the party's expense, in which case a copy of the
transcript is to be furnished to FDA. Any transcript of the hearing will
be included with the FDA Regional Food and Drug Director's report of the
hearing.
(5) The FDA Regional Food and Drug Director shall prepare a written
report of the hearing. All written material presented at the hearing
will be attached to the report. Whenever time permits, the FDA Regional
Food and Drug Director may give the parties the opportunity to review
and comment on the report of the hearing.
(6) The FDA Regional Food and Drug Director shall include as part of
the report of the hearing a finding on the credibility of witnesses
(other than expert witnesses) whenever credibility is a material issue,
and shall include a recommended decision, with a statement of reasons.
(D) Written appeal. If the appellant appeals the detention order but
does not request a hearing, the FDA Regional Food and Drug Director
shall render a decision on the appeal affirming or revoking the
detention within 5-working days after the receipt of the appeal.
(E) Regional Food and Drug Director decision. If, based on the
evidence presented at the hearing or by the appellant in a written
appeal, the FDA Regional Food and Drug Director finds that the shell
eggs were held in violation of this section, he shall affirm the order
that they be relabeled, diverted under the supervision of an officer or
employee of the FDA for processing under the EPIA, or destroyed by or
under the supervision of an officer or employee of the FDA; otherwise,
the FDA Regional Food and Drug Director shall issue a written notice
that the prior order is withdrawn. If the FDA Regional Food and Drug
Director affirms the order he shall order that the relabeling,
diversion, or destruction be accomplished within 10-working days from
the date of the issuance of his decision. The FDA Regional Food and Drug
Director's decision shall be accompanied by a statement of the reasons
for the decision. The decision of the FDA Regional Food and Drug
Director shall constitute final agency action, reviewable in the courts.
(F) No appeal. If there is no appeal of the order and the person in
possession of the shell eggs that are subject to the order fails to
relabel, divert, or destroy them within 10-working days, or if the
demand is affirmed by the FDA Regional Food and Drug Director after an
appeal and the person in possession of such eggs fails to relabel,
divert, or destroy them within 10-working days, the FDA district office,
or, if applicable, the State or local agency may designate an officer or
employee to divert or destroy such eggs. It shall be unlawful to prevent
or to attempt to prevent such diversion or destruction of the shell eggs
by the designated officer or employee.
[[Page 72]]
(8) Persons engaged in handling or storing packed shell eggs for
retail distribution shall permit authorized representatives of FDA to
make at any reasonable time such inspection of the establishment in
which shell eggs are being held, including inspection and sampling of
the labeling of such eggs as may be necessary in the judgment of such
representatives to determine compliance with the provisions of this
section. Inspections may be made with or without notice and will
ordinarily be made during regular business hours.
(9) No State or local governing entity shall establish or continue
in effect any law, rule, regulation, or other requirement requiring safe
handling instructions on unpasteurized shell eggs that are less
stringent than those required in paragraphs (h)(1) through (h)(5) of
this section.
[42 FR 14308, Mar. 15, 1977, as amended at 42 FR 22033, Apr. 29, 1977;
49 FR 13690, Apr. 6, 1984; 49 FR 28548, July 13, 1984; 61 FR 20100, May
3, 1996; 62 FR 2249, Jan. 15, 1997; 63 FR 8118, Feb. 18, 1998; 63 FR
37055, July 8, 1998; 63 FR 63982, Nov. 18, 1998; 66 FR 17358, Mar. 30,
2001; 65 FR 76111, Dec. 5, 2000; 72 FR 46378, Aug. 20, 2007]
Sec. 101.18 Misbranding of food.
(a) Among representations in the labeling of a food which render
such food misbranded is a false or misleading representation with
respect to another food or a drug, device, or cosmetic.
(b) The labeling of a food which contains two or more ingredients
may be misleading by reason (among other reasons) of the designation of
such food in such labeling by a name which includes or suggests the name
of one or more but not all such ingredients, even though the names of
all such ingredients are stated elsewhere in the labeling.
(c) Among representations in the labeling of a food which render
such food misbranded is any representation that expresses or implies a
geographical origin of the food or any ingredient of the food except
when such representation is either:
(1) A truthful representation of geographical origin.
(2) A trademark or trade name provided that as applied to the
article in question its use is not deceptively misdescriptive. A
trademark or trade name composed in whole or in part of geographical
words shall not be considered deceptively misdescriptive if it:
(i) Has been so long and exclusively used by a manufacturer or
distributor that it is generally understood by the consumer to mean the
product of a particular manufacturer or distributor; or
(ii) Is so arbitrary or fanciful that it is not generally understood
by the consumer to suggest geographic origin.
(3) A part of the name required by applicable Federal law or
regulation.
(4) A name whose market significance is generally understood by the
consumer to connote a particular class, kind, type, or style of food
rather than to indicate geographical origin.
Subpart B_Specific Food Labeling Requirements
Sec. 101.22 Foods; labeling of spices, flavorings, colorings and chemical
preservatives.
(a)(1) The term artificial flavor or artificial flavoring means any
substance, the function of which is to impart flavor, which is not
derived from a spice, fruit or fruit juice, vegetable or vegetable
juice, edible yeast, herb, bark, bud, root, leaf or similar plant
material, meat, fish, poultry, eggs, dairy products, or fermentation
products thereof. Artificial flavor includes the substances listed in
Sec. Sec. 172.515(b) and 182.60 of this chapter except where these are
derived from natural sources.
(2) The term spice means any aromatic vegetable substance in the
whole, broken, or ground form, except for those substances which have
been traditionally regarded as foods, such as onions, garlic and celery;
whose significant function in food is seasoning rather than nutritional;
that is true to name; and from which no portion of any volatile oil or
other flavoring principle has been removed. Spices include the spices
listed in Sec. 182.10 and part 184 of this chapter, such as the
following:
Allspice, Anise, Basil, Bay leaves, Caraway seed, Cardamon, Celery seed,
Chervil, Cinnamon, Cloves, Coriander, Cumin seed, Dill seed, Fennel
seed, Fenugreek, Ginger, Horseradish, Mace, Marjoram, Mustard flour,
Nutmeg, Oregano, Paprika, Parsley, Pepper, black; Pepper, white; Pepper,
red;
[[Page 73]]
Rosemary, Saffron, Sage, Savory, Star aniseed, Tarragon, Thyme,
Turmeric.
Paprika, turmeric, and saffron or other spices which are also colors,
shall be declared as ``spice and coloring'' unless declared by their
common or usual name.
(3) The term natural flavor or natural flavoring means the essential
oil, oleoresin, essence or extractive, protein hydrolysate, distillate,
or any product of roasting, heating or enzymolysis, which contains the
flavoring constituents derived from a spice, fruit or fruit juice,
vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf
or similar plant material, meat, seafood, poultry, eggs, dairy products,
or fermentation products thereof, whose significant function in food is
flavoring rather than nutritional. Natural flavors include the natural
essence or extractives obtained from plants listed in Sec. Sec. 182.10,
182.20, 182.40, and 182.50 and part 184 of this chapter, and the
substances listed in Sec. 172.510 of this chapter.
(4) The term artificial color or artificial coloring means any
``color additive'' as defined in Sec. 70.3(f) of this chapter.
(5) The term chemical preservative means any chemical that, when
added to food, tends to prevent or retard deterioration thereof, but
does not include common salt, sugars, vinegars, spices, or oils
extracted from spices, substances added to food by direct exposure
thereof to wood smoke, or chemicals applied for their insecticidal or
herbicidal properties.
(b) A food which is subject to the requirements of section 403(k) of
the act shall bear labeling, even though such food is not in package
form.
(c) A statement of artificial flavoring, artificial coloring, or
chemical preservative shall be placed on the food or on its container or
wrapper, or on any two or all three of these, as may be necessary to
render such statement likely to be read by the ordinary person under
customary conditions of purchase and use of such food. The specific
artificial color used in a food shall be identified on the labeling when
so required by regulation in part 74 of this chapter to assure safe
conditions of use for the color additive.
(d) A food shall be exempt from compliance with the requirements of
section 403(k) of the act if it is not in package form and the units
thereof are so small that a statement of artificial flavoring,
artificial coloring, or chemical preservative, as the case may be,
cannot be placed on such units with such conspicuousness as to render it
likely to be read by the ordinary individual under customary conditions
of purchase and use.
(e) A food shall be exempt while held for sale from the requirements
of section 403(k) of the act (requiring label statement of any
artificial flavoring, artificial coloring, or chemical preservatives) if
said food, having been received in bulk containers at a retail
establishment, is displayed to the purchaser with either (1) the
labeling of the bulk container plainly in view or (2) a counter card,
sign, or other appropriate device bearing prominently and conspicuously
the information required to be stated on the label pursuant to section
403(k).
(f) A fruit or vegetable shall be exempt from compliance with the
requirements of section 403(k) of the act with respect to a chemical
preservative applied to the fruit or vegetable as a pesticide chemical
prior to harvest.
(g) A flavor shall be labeled in the following way when shipped to a
food manufacturer or processor (but not a consumer) for use in the
manufacture of a fabricated food, unless it is a flavor for which a
standard of identity has been promulgated, in which case it shall be
labeled as provided in the standard:
(1) If the flavor consists of one ingredient, it shall be declared
by its common or usual name.
(2) If the flavor consists of two or more ingredients, the label
either may declare each ingredient by its common or usual name or may
state ``All flavor ingredients contained in this product are approved
for use in a regulation of the Food and Drug Administration.'' Any
flavor ingredient not contained in one of these regulations, and any
nonflavor ingredient, shall be separately listed on the label.
(3) In cases where the flavor contains a solely natural flavor(s),
the flavor shall be so labeled, e.g., ``strawberry
[[Page 74]]
flavor'', ``banana flavor'', or ``natural strawberry flavor''. In cases
where the flavor contains both a natural flavor and an artificial
flavor, the flavor shall be so labeled, e.g., ``natural and artificial
strawberry flavor''. In cases where the flavor contains a solely
artificial flavor(s), the flavor shall be so labeled, e.g., ``artificial
strawberry flavor''.
(h) The label of a food to which flavor is added shall declare the
flavor in the statement of ingredients in the following way:
(1) Spice, natural flavor, and artificial flavor may be declared as
``spice'', ``natural flavor'', or ``artificial flavor'', or any
combination thereof, as the case may be.
(2) An incidental additive in a food, originating in a spice or
flavor used in the manufacture of the food, need not be declared in the
statement of ingredients if it meets the requirements of Sec.
101.100(a)(3).
(3) Substances obtained by cutting, grinding, drying, pulping, or
similar processing of tissues derived from fruit, vegetable, meat, fish,
or poultry, e.g., powdered or granulated onions, garlic powder, and
celery powder, are commonly understood by consumers to be food rather
than flavor and shall be declared by their common or usual name.
(4) Any salt (sodium chloride) used as an ingredient in food shall
be declared by its common or usual name ``salt.''
(5) Any monosodium glutamate used as an ingredient in food shall be
declared by its common or usual name ``monosodium glutamate.''
(6) Any pyroligneous acid or other artificial smoke flavors used as
an ingredient in a food may be declared as artificial flavor or
artificial smoke flavor. No representation may be made, either directly
or implied, that a food flavored with pyroligneous acid or other
artificial smoke flavor has been smoked or has a true smoked flavor, or
that a seasoning sauce or similar product containing pyroligneous acid
or other artificial smoke flavor and used to season or flavor other
foods will result in a smoked product or one having a true smoked
flavor.
(7) Because protein hydrolysates function in foods as both
flavorings and flavor enhancers, no protein hydrolysate used in food for
its effects on flavor may be declared simply as ``flavor,'' ``natural
flavor,'' or ``flavoring.'' The ingredient shall be declared by its
specific common or usual name as provided in Sec. 102.22 of this
chapter.
(i) If the label, labeling, or advertising of a food makes any
direct or indirect representations with respect to the primary
recognizable flavor(s), by word, vignette, e.g., depiction of a fruit,
or other means, or if for any other reason the manufacturer or
distributor of a food wishes to designate the type of flavor in the food
other than through the statement of ingredients, such flavor shall be
considered the characterizing flavor and shall be declared in the
following way:
(1) If the food contains no artificial flavor which simulates,
resembles or reinforces the characterizing flavor, the name of the food
on the principal display panel or panels of the label shall be
accompanied by the common or usual name of the characterizing flavor,
e.g., ``vanilla'', in letters not less than one-half the height of the
letters used in the name of the food, except that:
(i) If the food is one that is commonly expected to contain a
characterizing food ingredient, e.g., strawberries in ``strawberry
shortcake'', and the food contains natural flavor derived from such
ingredient and an amount of characterizing ingredient insufficient to
independently characterize the food, or the food contains no such
ingredient, the name of the characterizing flavor may be immediately
preceded by the word ``natural'' and shall be immediately followed by
the word ``flavored'' in letters not less than one-half the height of
the letters in the name of the characterizing flavor, e.g., ``natural
strawberry flavored shortcake,'' or ``strawberry flavored shortcake''.
(ii) If none of the natural flavor used in the food is derived from
the product whose flavor is simulated, the food in which the flavor is
used shall be labeled either with the flavor of the product from which
the flavor is derived or as ``artificially flavored.''
(iii) If the food contains both a characterizing flavor from the
product whose flavor is simulated and other natural flavor which
simulates, resembles or reinforces the characterizing
[[Page 75]]
flavor, the food shall be labeled in accordance with the introductory
text and paragraph (i)(1)(i) of this section and the name of the food
shall be immediately followed by the words ``with other natural flavor''
in letters not less than one-half the height of the letters used in the
name of the characterizing flavor.
(2) If the food contains any artificial flavor which simulates,
resembles or reinforces the characterizing flavor, the name of the food
on the principal display panel or panels of the label shall be
accompanied by the common or usual name(s) of the characterizing flavor,
in letters not less than one-half the height of the letters used in the
name of the food and the name of the characterizing flavor shall be
accompanied by the word(s) ``artificial'' or ``artificially flavored'',
in letters not less than one-half the height of the letters in the name
of the characterizing flavor, e.g., ``artificial vanilla'',
``artificially flavored strawberry'', or ``grape artificially
flavored''.
(3) Wherever the name of the characterizing flavor appears on the
label (other than in the statement of ingredients) so conspicuously as
to be easily seen under customary conditions of purchase, the words
prescribed by this paragraph shall immediately and conspicuously precede
or follow such name, without any intervening written, printed, or
graphic matter, except:
(i) Where the characterizing flavor and a trademark or brand are
presented together, other written, printed, or graphic matter that is a
part of or is associated with the trademark or brand may intervene if
the required words are in such relationship with the trademark or brand
as to be clearly related to the characterizing flavor; and
(ii) If the finished product contains more than one flavor subject
to the requirements of this paragraph, the statements required by this
paragraph need appear only once in each statement of characterizing
flavors present in such food, e.g., ``artificially flavored vanilla and
strawberry''.
(iii) If the finished product contains three or more distinguishable
characterizing flavors, or a blend of flavors with no primary
recognizable flavor, the flavor may be declared by an appropriately
descriptive generic term in lieu of naming each flavor, e.g.,
``artificially flavored fruit punch''.
(4) A flavor supplier shall certify, in writing, that any flavor he
supplies which is designated as containing no artificial flavor does
not, to the best of his knowledge and belief, contain any artificial
flavor, and that he has added no artificial flavor to it. The
requirement for such certification may be satisfied by a guarantee under
section 303(c)(2) of the act which contains such a specific statement. A
flavor user shall be required to make such a written certification only
where he adds to or combines another flavor with a flavor which has been
certified by a flavor supplier as containing no artificial flavor, but
otherwise such user may rely upon the supplier's certification and need
make no separate certification. All such certifications shall be
retained by the certifying party throughout the period in which the
flavor is supplied and for a minimum of three years thereafter, and
shall be subject to the following conditions:
(i) The certifying party shall make such certifications available
upon request at all reasonable hours to any duly authorized office or
employee of the Food and Drug Administration or any other employee
acting on behalf of the Secretary of Health and Human Services. Such
certifications are regarded by the Food and Drug Administration as
reports to the government and as guarantees or other undertakings within
the meaning of section 301(h) of the act and subject the certifying
party to the penalties for making any false report to the government
under 18 U.S.C. 1001 and any false guarantee or undertaking under
section 303(a) of the act. The defenses provided under section 303(c)(2)
of the act shall be applicable to the certifications provided for in
this section.
(ii) Wherever possible, the Food and Drug Administration shall
verify the accuracy of a reasonable number of certifications made
pursuant to this section, constituting a representative sample of such
certifications, and shall not request all such certifications.
(iii) Where no person authorized to provide such information is
reasonably available at the time of inspection, the
[[Page 76]]
certifying party shall arrange to have such person and the relevant
materials and records ready for verification as soon as practicable:
Provided, That, whenever the Food and Drug Administration has reason to
believe that the supplier or user may utilize this period to alter
inventories or records, such additional time shall not be permitted.
Where such additional time is provided, the Food and Drug Administration
may require the certifying party to certify that relevant inventories
have not been materially disturbed and relevant records have not been
altered or concealed during such period.
(iv) The certifying party shall provide, to an officer or
representative duly designated by the Secretary, such qualitative
statement of the composition of the flavor or product covered by the
certification as may be reasonably expected to enable the Secretary's
representatives to determine which relevant raw and finished materials
and flavor ingredient records are reasonably necessary to verify the
certifications. The examination conducted by the Secretary's
representative shall be limited to inspection and review of inventories
and ingredient records for those certifications which are to be
verified.
(v) Review of flavor ingredient records shall be limited to the
qualitative formula and shall not include the quantitative formula. The
person verifying the certifications may make only such notes as are
necessary to enable him to verify such certification. Only such notes or
such flavor ingredient records as are necessary to verify such
certification or to show a potential or actual violation may be removed
or transmitted from the certifying party's place of business: Provided,
That, where such removal or transmittal is necessary for such purposes
the relevant records and notes shall be retained as separate documents
in Food and Drug Administration files, shall not be copied in other
reports, and shall not be disclosed publicly other than in a judicial
proceeding brought pursuant to the act or 18 U.S.C. 1001.
(j) A food to which a chemical preservative(s) is added shall,
except when exempt pursuant to Sec. 101.100 bear a label declaration
stating both the common or usual name of the ingredient(s) and a
separate description of its function, e.g., ``preservative'', ``to
retard spoilage'', ``a mold inhibitor'', ``to help protect flavor'' or
``to promote color retention''.
(k) The label of a food to which any coloring has been added shall
declare the coloring in the statement of ingredients in the manner
specified in paragraphs (k)(1) and (k)(2) of this section, except that
colorings added to butter, cheese, and ice cream, if declared, may be
declared in the manner specified in paragraph (k)(3) of this section,
and colorings added to foods subject to Sec. Sec. 105.62 and 105.65 of
this chapter shall be declared in accordance with the requirements of
those sections.
(1) A color additive or the lake of a color additive subject to
certification under 721(c) of the act shall be declared by the name of
the color additive listed in the applicable regulation in part 74 or
part 82 of this chapter, except that it is not necessary to include the
``FD&C'' prefix or the term ``No.'' in the declaration, but the term
``Lake'' shall be included in the declaration of the lake of the
certified color additive (e.g., Blue 1 Lake). Manufacturers may
parenthetically declare an appropriate alternative name of the certified
color additive following its common or usual name as specified in part
74 or part 82 of this chapter.
(2) Color additives not subject to certification and not otherwise
required by applicable regulations in part 73 of this chapter to be
declared by their respective common or usual names may be declared as
``Artificial Color,'' ``Artificial Color Added,'' or ``Color Added'' (or
by an equally informative term that makes clear that a color additive
has been used in the food). Alternatively, such color additives may be
declared as ``Colored with ----------------'' or ``----------------
color,'' the blank to be filled in with the name of the color additive
listed in the applicable regulation in part 73 of this chapter.
(3) When a coloring has been added to butter, cheese, or ice cream,
it need not be declared in the ingredient list unless such declaration
is required by a regulation in part 73 or part 74 of this
[[Page 77]]
chapter to ensure safe conditions of use for the color additive.
Voluntary declaration of all colorings added to butter, cheese, and ice
cream, however, is recommended.
[42 FR 14308, Mar. 15, 1977, as amended at 44 FR 3963, Jan. 19, 1979; 44
FR 37220, June 26, 1979; 54 FR 24891, June 12, 1989; 58 FR 2875, Jan. 6,
1993; 63 FR 14818, Mar. 27, 1998; 74 FR 216, Jan. 5, 2009]
Sec. 101.30 Percentage juice declaration for foods purporting to be beverages
that contain fruit or vegetable juice.
(a) This section applies to any food that purports to be a beverage
that contains any fruit or vegetable juice (i.e., the product's
advertising, label, or labeling bears the name of, or variation on the
name of, or makes any other direct or indirect representation with
respect to, any fruit or vegetable juice), or the label or labeling
bears any vignette (i.e., depiction of a fruit or vegetable) or other
pictorial representation of any fruit or vegetable, or the product
contains color and flavor that gives the beverage the appearance and
taste of containing a fruit or vegetable juice. The beverage may be
carbonated or noncarbonated, concentrated, full-strength, diluted, or
contain no juice. For example, a soft drink (soda) that does not
represent or suggest by its physical characteristics, name, labeling,
ingredient statement, or advertising that it contains fruit or vegetable
juice does not purport to contain juice and therefore does not require a
percent juice declaration.
(b)(1) If the beverage contains fruit or vegetable juice, the
percentage shall be declared by the words ``Contains -- percent (or %)
------ juice'' or ``-- percent (or %) juice,'' or a similar phrase, with
the first blank filled in with the percentage expressed as a whole
number not greater than the actual percentage of the juice and the
second blank (if used) filled in with the name of the particular fruit
or vegetable (e.g., ``Contains 50 percent apple juice'' or ``50 percent
juice'').
(2) If the beverage contains less than 1 percent juice, the total
percentage juice shall be declared as ``less than 1 percent juice'' or
``less than 1 percent ------ juice'' with the blank filled in with the
name of the particular fruit or vegetable.
(3) If the beverage contains 100 percent juice and also contains
non-juice ingredients that do not result in a diminution of the juice
soluble solids or, in the case of expressed juice, in a change in the
volume, when the 100 percent juice declaration appears on a panel of the
label that does not also bear the ingredient statement, it must be
accompanied by the phrase ``with added ------,'' the blank filled in
with a term such as ``ingredient(s),'' ``preservative,'' or
``sweetener,'' as appropriate (e.g., ``100% juice with added
sweetener''), except that when the presence of the non-juice
ingredient(s) is declared as a part of the statement of identity of the
product, this phrase need not accompany the 100 percent juice
declaration.
(c) If a beverage contains minor amounts of juice for flavoring and
is labeled with a flavor description using terms such as ``flavor'',
``flavored'', or ``flavoring'' with a fruit or vegetable name and does
not bear:
(1) The term ``juice'' on the label other than in the ingredient
statement; or
(2) An explicit vignette depicting the fruit or vegetable from which
the flavor derives, such as juice exuding from a fruit or vegetable; or
(3) Specific physical resemblance to a juice or distinctive juice
characteristic such as pulp then total percentage juice declaration is
not required.
(d) If the beverage does not meet the criteria for exemption from
total juice percentage declaration as described in paragraph (c) of this
section and contains no fruit or vegetable juice, but the labeling or
color and flavor of the beverage represents, suggests, or implies that
fruit or vegetable juice may be present (e.g., the product advertising
or labeling bears the name, a variation of the name, or a pictorial
representation of any fruit or vegetable, or the product contains color
and flavor that give the beverage the appearance and taste of containing
a fruit or vegetable juice), then the label shall declare ``contains
zero (0) percent (or %) juice''. Alternatively, the label may declare
``Containing (or contains) no ------ juice'', or ``no ------ juice'', or
[[Page 78]]
``does not contain ------ juice'', the blank to be filled in with the
name of the fruits or vegetables represented, suggested, or implied, but
if there is a general suggestion that the product contains fruit or
vegetable juice, such as the presence of fruit pulp, the blank shall be
filled in with the word ``fruit'' or ``vegetable'' as applicable (e.g.,
``contains no fruit juice'', or ``does not contain fruit juice'').
(e) If the beverage is sold in a package with an information panel
as defined in Sec. 101.2, the declaration of amount of juice shall be
prominently placed on the information panel in lines generally parallel
to other required information, appearing:
(1) Near the top of the information panel, with no other printed
label information appearing above the statement except the brand name,
product name, logo, or universal product code; and
(2) In easily legible boldface print or type in distinct contrast to
other printed or graphic matter, in a height not less than the largest
type found on the information panel except that used for the brand name,
product name, logo, universal product code, or the title phrase
``Nutrition Facts'' appearing in the nutrition information as required
by Sec. 101.9.
(f) The percentage juice declaration may also be placed on the
principal display panel, provided that the declaration is consistent
with that presented on the information panel.
(g) If the beverage is sold in a package that does not bear an
information panel as defined in Sec. 101.2, the percentage juice
declaration shall be placed on the principal display panel, in type size
not less than that required for the declaration of net quantity of
contents statement in Sec. 101.105(i), and be placed near the name of
the food.
(h)(1) In enforcing these regulations, the Food and Drug
Administration will calculate the labeled percentage of juice from
concentrate found in a juice or juice beverage using the minimum Brix
levels listed below where single-strength (100 percent) juice has at
least the specified minimum Brix listed below:
------------------------------------------------------------------------
100
percent
Juice juice
\1\
------------------------------------------------------------------------
Acerola........................................................ 6.0
Apple.......................................................... 11.5
Apricot........................................................ 11.7
Banana......................................................... 22.0
Blackberry..................................................... 10.0
Blueberry...................................................... 10.0
Boysenberry.................................................... 10.0
Cantaloupe Melon............................................... 9.6
Carambola...................................................... 7.8
Carrot......................................................... 8.0
Casaba Melon................................................... 7.5
Cashew (Caju).................................................. 12.0
Celery......................................................... 3.1
Cherry, dark, sweet............................................ 20.0
Cherry, red, sour.............................................. 14.0
Crabapple...................................................... 15.4
Cranberry...................................................... 7.5
Currant (Black)................................................ 11.0
Currant (Red).................................................. 10.5
Date........................................................... 18.5
Dewberry....................................................... 10.0
Elderberry..................................................... 11.0
Fig............................................................ 18.2
Gooseberry..................................................... 8.3
Grape.......................................................... 16.0
Grapefruit..................................................... \3\10.0
Guanabana (soursop)............................................ 16.0
Guava.......................................................... 7.7
Honeydew melon................................................. 9.6
Kiwi........................................................... 15.4
Lemon.......................................................... \2\ 4.5
Lime........................................................... 2 4.5
Loganberry..................................................... 10.5
Mango.......................................................... 13.0
Nectarine...................................................... 11.8
Orange......................................................... \3\11.8
Papaya......................................................... 11.5
Passion Fruit.................................................. 14.0
Peach.......................................................... 10.5
Pear........................................................... 12.0
Pineapple...................................................... 12.8
Plum........................................................... 14.3
Pomegranate.................................................... 16.0
Prune.......................................................... 18.5
Quince......................................................... 13.3
Raspberry (Black).............................................. 11.1
Raspberry (Red)................................................ 9.2
Rhubarb........................................................ 5.7
Strawberry..................................................... 8.0
Tangerine...................................................... \3\11.8
Tomato......................................................... 5.0
Watermelon..................................................... 7.8
Youngberry..................................................... 10.0
------------------------------------------------------------------------
\1\ Indicates Brix value unless other value specified.
\2\ Indicates anhydrous citrus acid percent by weight.
\3\ Brix values determined by refractometer for citrus juices may be
corrected for citric acid.
(2) If there is no Brix level specified in paragraph (h)(1) of this
section, the labeled percentage of that juice from concentrate in a
juice or juice beverage will be calculated on the basis of the soluble
solids content of the single-strength (unconcentrated) juice used to
produce such concentrated juice.
(i) Juices directly expressed from a fruit or vegetable (i.e., not
concentrated and reconstituted) shall be
[[Page 79]]
considered to be 100 percent juice and shall be declared as ``100
percent juice.''
(j) Calculations of the percentage of juice in a juice blend or a
diluted juice product made directly from expressed juice (i.e., not from
concentrate) shall be based on the percentage of the expressed juice in
the product computed on a volume/volume basis.
(k) If the product is a beverage that contains a juice whose color,
taste, or other organoleptic properties have been modified to the extent
that the original juice is no longer recognizable at the time processing
is complete, or if its nutrient profile has been diminished to a level
below the normal nutrient range for the juice, then that juice to which
such a major modification has been made shall not be included in the
total percentage juice declaration.
(l) A beverage required to bear a percentage juice declaration on
its label, that contains less than 100 percent juice, shall not bear any
other percentage declaration that describes the juice content of the
beverage in its label or in its labeling (e.g., ``100 percent natural''
or ``100 percent pure''). However, the label or labeling may bear
percentage statements clearly unrelated to juice content (e.g.,
``provides 100 percent of U.S. RDA of vitamin C'').
(m) Products purporting to be beverages that contain fruit or
vegetable juices are exempted from the provisions of this section until
May 8, 1994. All products that are labeled on or after that date shall
comply with this section.
[58 FR 2925, Jan. 6, 1993, as amended at 58 FR 44063, Aug. 18, 1993; 58
FR 49192, Sept. 22, 1993]
Subpart C_Specific Nutrition Labeling Requirements and Guidelines
Source: 55 FR 60890, Nov. 27, 1991, unless otherwise noted.
Sec. 101.36 Nutrition labeling of dietary supplements.
(a) The label of a dietary supplement that is offered for sale shall
bear nutrition labeling in accordance with this regulation unless an
exemption is provided for the product in paragraph (h) of this section.
(b) The declaration of nutrition information on the label and in
labeling shall contain the following information, using the subheadings
and the format specified in paragraph (e) of this section.
(1) Serving size. (i) The subheading ``Serving Size'' shall be
placed under the heading ``Supplement Facts'' and aligned on the left
side of the nutrition label. The serving size shall be determined in
accordance with Sec. Sec. 101.9(b) and 101.12(b), Table 2. Serving size
for dietary supplements shall be expressed using a term that is
appropriate for the form of the supplement, such as ``tablets,''
``capsules,'' ``packets,'' or ``teaspoonfuls.''
(ii) The subheading ``Servings Per Container'' shall be placed under
the subheading ``Serving Size'' and aligned on the left side of the
nutrition label, except that this information need not be provided when
it is stated in the net quantity of contents declaration.
(2) Information on dietary ingredients that have a Reference Daily
Intake (RDI) or a Daily Reference Value (DRV) as established in Sec.
101.9(c) and their subcomponents (hereinafter referred to as ``(b)(2)-
dietary ingredients''). (i) The (b)(2)-dietary ingredients to be
declared, that is, total calories, calories from fat, total fat,
saturated fat, trans fat, cholesterol, sodium, total carbohydrate,
dietary fiber, sugars, protein, vitamin A, vitamin C, calcium and iron,
shall be declared when they are present in a dietary supplement in
quantitative amounts by weight that exceed the amount that can be
declared as zero in nutrition labeling of foods in accordance with Sec.
101.9(c). Calories from saturated fat and polyunsaturated fat,
monounsaturated fat, soluble fiber, insoluble fiber, sugar alcohol, and
other carbohydrate may be declared, but they shall be declared when a
claim is made about them. Any other vitamins or minerals listed in Sec.
101.9(c)(8)(iv) or (c)(9) may be declared, but they shall be declared
when they are added to the product for purposes of supplementation, or
when a claim is made about them. Any (b)(2)-dietary ingredients that are
not present, or that are present in amounts that can be declared as zero
in Sec. 101.9(c), shall not be declared (e.g., amounts corresponding
[[Page 80]]
to less than 2 percent of the RDI for vitamins and minerals). Protein
shall not be declared on labels of products that, other than ingredients
added solely for technological reasons, contain only individual amino
acids.
(A) The names and the quantitative amounts by weight of each (b)(2)-
dietary ingredient shall be presented under the heading ``Amount Per
Serving.'' When the quantitative amounts by weight are presented in a
separate column, the heading may be centered over a column of
quantitative amounts, described by paragraph (b)(2)(ii) of this section,
if space permits. A heading consistent with the declaration of the
serving size, such as ``Each Tablet Contains,'' or ``Amount Per 2
Tablets'' may be used in place of the heading ``Amount Per Serving.''
Other appropriate terms, such as capsule, packet, or teaspoonful, also
may be used in place of the term ``Serving.''
(B) The names of dietary ingredients that are declared under
paragraph (b)(2)(i) of this section shall be presented in a column
aligned on the left side of the nutrition label in the order and manner
of indentation specified in Sec. 101.9(c), except that calcium and iron
shall follow pantothenic acid, and sodium and potassium shall follow
chloride. This results in the following order for vitamins and minerals:
Vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, thiamin,
riboflavin, niacin, vitamin B6, folate, vitamin
B12, biotin, pantothenic acid, calcium, iron, phosphorus,
iodine, magnesium, zinc, selenium, copper, manganese, chromium,
molybdenum, chloride, sodium, and potassium. The (b)(2)-dietary
ingredients shall be listed according to the nomenclature specified in
Sec. 101.9 or in paragraph (b)(2)(i)(B)(2) of this section.
(1) When ``Calories'' are declared, they shall be listed first in
the column of names, beneath a light bar separating the heading ``Amount
Per Serving'' from the list of names. When ``Calories from fat'' or
``Calories from saturated fat'' are declared, they shall be indented
beneath ``Calories.''
(2) The following synonyms may be added in parentheses immediately
following the name of these (b)(2)-dietary ingredients: Vitamin C
(ascorbic acid), thiamin (vitamin B1), riboflavin (vitamin
B2), folate (folacin or folic acid), and calories (energy).
Alternatively, the term ``folic acid'' or ``folacin'' may be listed
without parentheses in place of ``folate.'' Energy content per serving
may be expressed in kilojoule units, added in parentheses immediately
following the statement of caloric content.
(3) Beta-carotene may be declared as the percent of vitamin A that
is present as beta-carotene, except that the declaration is required
when a claim is made about beta-carotene. When declared, the percent
shall be declared to the nearest whole percent, immediately adjacent to
or beneath the name vitamin A (e.g., ``Vitamin A (90% as beta-
carotene)''). The amount of beta-carotene in terms of international
units (IU) may be included in parentheses following the percent
statement (e.g., ``Vitamin A (90% (4500 IU) as beta-carotene)'').
(ii) The number of calories, if declared, and the quantitative
amount by weight per serving of each dietary ingredient required to be
listed under paragraph (b)(2)(i) of this section shall be presented
either in a separate column aligned to the right of the column of names
or immediately following the listing of names within the same column.
The quantitative amounts by weight shall represent the weight of the
dietary ingredient rather than the weight of the source of the dietary
ingredient (e.g., the weight of calcium rather than that of calcium
carbonate).
(A) These amounts shall be expressed in the increments specified in
Sec. 101.9(c)(1) through (c)(7), which includes increments for sodium
and potassium.
(B) The amounts of vitamins and minerals, excluding sodium and
potassium, shall be the amount of the vitamin or mineral included in one
serving of the product, using the units of measurement and the levels of
significance given in Sec. 101.9(c)(8)(iv), except that zeros following
decimal points may be dropped, and additional levels of significance may
be used when the number of decimal places indicated is not sufficient to
express lower amounts (e.g., the RDI for zinc is given in whole
milligrams (mg), but the quantitative
[[Page 81]]
amount may be declared in tenths of a mg).
(iii) The percent of the Daily Value of all dietary ingredients
declared under paragraph (b)(2)(i) of this section shall be listed,
except that the percent for protein may be omitted as provided in Sec.
101.9(c)(7); no percent shall be given for subcomponents for which DRV's
have not been established (e.g., sugars); and, for labels of dietary
supplements of vitamins and minerals that are represented or purported
to be for use by infants, children less than 4 years of age, or pregnant
or lactating women, no percent shall be given for total fat, saturated
fat, cholesterol, total carbohydrate, dietary fiber, vitamin K,
selenium, manganese, chromium, molybdenum, chloride, sodium, or
potassium.
(A) When information on the percent of Daily Values is listed, this
information shall be presented in one column aligned under the heading
of ``% Daily Value'' and to the right of the column of amounts. The
headings ``% Daily Value (DV),'' ``% DV,'' ``Percent Daily Value,'' or
``Percent DV'' may be substituted for ``% Daily Value.'' The heading ``%
Daily Value'' shall be placed on the same line as the heading ``Amount
Per Serving.'' When the acronym ``DV'' is unexplained in the heading and
a footnote is required under (b)(2)(iii)(D), (b)(2)(iii)(F), or
(b)(3)(iv) of this section, the footnote shall explain the acronym (e.g.
``Daily Value (DV) not established'').
(B) The percent of Daily Value shall be calculated by dividing the
quantitative amount by weight of each (b)(2)-dietary ingredient by the
RDI as established in Sec. 101.9(c)(8)(iv) or the DRV as established in
Sec. 101.9(c)(9) for the specified dietary ingredient and multiplying
by 100, except that the percent of Daily Value for protein, when
present, shall be calculated as specified in Sec. 101.9(c)(7)(ii). The
quantitative amount by weight of each dietary ingredient in this
calculation shall be the unrounded amount, except that for total fat,
saturated fat, cholesterol, sodium, potassium, total carbohydrate, and
dietary fiber, the quantitative amount by weight declared on the label
(i.e, rounded amount) may be used. The numerical value shall be followed
by the symbol for percent (i.e., %).
(C) The percentages based on RDI's and on DRV's shall be expressed
to the nearest whole percent, except that for dietary ingredients for
which DRV's have been established, ``Less than 1%'' or ``<1%'' shall be
used to declare the ``% Daily Value'' when the quantitative amount of
the dietary ingredient by weight is great enough to require that the
dietary ingredient be listed, but the amount is so small that the ``%
Daily Value'' when rounded to the nearest percent is zero (e.g., a
product that contains 1 gram of total carbohydrate would list the
percent Daily Value as ``Less than 1%'' or ``<1%'').
(D) If the percent of Daily Value is declared for total fat,
saturated fat, total carbohydrate, dietary fiber, or protein, a symbol
shall follow the value listed for those nutrients that refers to the
same symbol that is placed at the bottom of the nutrition label, below
the bar required under paragraph (e)(6) of this section and inside the
box, that is followed by the statement ``Percent Daily Values are based
on a 2,000 calorie diet.''
(E) The percent of Daily Value shall be based on RDI and DRV values
for adults and children 4 or more years of age, unless the product is
represented or purported to be for use by infants, children less than 4
years of age, pregnant women, or lactating women, in which case the
column heading shall clearly state the intended group. If the product is
for persons within more than one group, the percent of Daily Value for
each group shall be presented in separate columns as shown in paragraph
(e)(10)(ii) of this section.
(F) For declared subcomponents that have no DRV's and, on the labels
of dietary supplements of vitamins and minerals that are represented or
purported to be for use by infants, children less that 4 years of age,
or pregnant or lactating women, for total fat, saturated fat,
cholesterol, total carbohydrate, dietary fiber, vitamin K, selenium,
manganese, chromium, molybdenum, chloride, sodium, or potassium, a
symbol (e.g., an asterisk) shall be placed in the ``Percent Daily
Value'' column that shall refer to the same symbol that is placed at the
bottom of the nutrition label, below the last
[[Page 82]]
heavy bar and inside the box, and followed by the statement ``Daily
Value not established.''
(G) When calories, calories from fat, or calories from saturated fat
are declared, the space under the ``% Daily Value'' column shall be left
blank for these items. When there are no other (b)(2)-dietary
ingredients listed for which a value must be declared in the ``% Daily
Value'' column, the column may be omitted as shown in paragraph
(e)(10)(vii) of this section. When the ``% Daily Value'' column is not
required, but the dietary ingredients listed are subject to paragraph
(b)(2)(iii)(F) of this section, the symbol required in that paragraph
shall immediately follow the quantitative amount by weight for each
dietary ingredient listed under ``Amount Per Serving.''
(3) Information on dietary ingredients for which RDI's and DRV's
have not been established. (i) Dietary ingredients for which FDA has not
established RDI's or DRV's and that are not subject to regulation under
paragraph (b)(2) of this section (hereinafter referred to as ``other
dietary ingredients'') shall be declared by their common or usual name
when they are present in a dietary supplement, in a column that is under
the column of names described in paragraph (b)(2)(i)(B) of this section
or, as long as the constituents of an other dietary ingredient are not
listed, in a linear display, under the heavy bar described in paragraph
(e)(6) of this section, except that if no (b)(2)-dietary ingredients are
declared, other dietary ingredients shall be declared directly beneath
the heading ``Amount Per Serving'' described in paragraph (b)(2)(i)(A)
of this section.
(ii) The quantitative amount by weight per serving of other dietary
ingredients shall be presented in the same manner as the corresponding
information required in paragraph (b)(2)(ii) of this section or, when a
linear display is used, shall be presented immediately following the
name of the other dietary ingredient. The quantitative amount by weight
shall be the weight of the other dietary ingredient listed and not the
weight of any component, or the source, of that dietary ingredient.
(A) These amounts shall be expressed using metric measures in
appropriate units (i.e., 1,000 or more units shall be declared in the
next higher set of units, e.g., 1,100 mg shall be declared as 1.1 g).
(B) For any dietary ingredient that is a liquid extract from which
the solvent has not been removed, the quantity listed shall be the
volume or weight of the total extract. Information on the condition of
the starting material shall be indicated when it is fresh and may be
indicated when it is dried. Information may be included on the
concentration of the dietary ingredient and the solvent used, e.g.,
``fresh dandelion root extract, x (y:z) in 70% ethanol,'' where x is the
number of milliliters (mL) or mg of the entire extract, y is the weight
of the starting material and z is the volume (mL) of solvent. Where the
solvent has been partially removed (not to dryness), the final
concentration, when indicated, shall be stated (e.g., if the original
extract was 1:5 and 50 percent of the solvent was removed, then the
final concentration shall be stated as 1:2.5). Where the name of the
solvent used is not included in the nutrition label, it is required to
be listed in the ingredient statement in accordance with Sec. 101.4(g).
(C) For a dietary ingredient that is an extract from which the
solvent has been removed, the weight of the ingredient shall be the
weight of the dried extract.
(iii) The constituents of a dietary ingredient described in
paragraph (b)(3)(i) of this section may be listed indented under the
dietary ingredient and followed by their quantitative amounts by weight
per serving, except that dietary ingredients described in paragraph
(b)(2) of this section shall be listed in accordance with that section.
When the constituents of a dietary ingredient described in paragraph
(b)(3)(i) of this section are listed, all other dietary ingredients
shall be declared in a column; however, the constituents themselves may
be declared in a column or in a linear display.
(iv) Other dietary ingredients shall bear a symbol (e.g., an
asterisk) in the column under the heading of ``% Daily Value'' that
refers to the same symbol placed at the bottom of the nutrition label
and followed by the statement
[[Page 83]]
``Daily Value not established,'' except that when the heading ``% Daily
Value'' is not used, the symbol shall follow the quantitative amount by
weight for each dietary ingredient listed.
(c) A proprietary blend of dietary ingredients shall be included in
the list of dietary ingredients described in paragraph (b)(3)(i) of this
section and identified by the term ``Proprietary Blend'' or other
appropriately descriptive term or fanciful name and may be highlighted
by bold type. Except as specified in this paragraph, all other
requirements for the listing of dietary ingredients in dietary
supplements are applicable.
(1) Dietary ingredients contained in the proprietary blend that are
listed under paragraph (b)(2) of this section shall be declared in
accordance with paragraph (b)(2) of this section.
(2) Dietary ingredients contained in the proprietary blend that are
listed under paragraph (b)(3) of this section (i.e., ``other dietary
ingredients'') shall be declared in descending order of predominance by
weight, in a column or linear fashion, and indented under the term
``Proprietary Blend'' or other appropriately descriptive term or
fanciful name.
(3) The quantitative amount by weight specified for the proprietary
blend shall be the total weight of all other dietary ingredients
contained in the proprietary blend and shall be placed on the same line
to the right of the term ``Proprietary Blend'' or other appropriately
descriptive term or fanciful name underneath the column of amounts
described in paragraph (b)(2)(ii) of this section. A symbol (e.g.,
asterisk), which refers to the same symbol placed at the bottom of the
nutrition label that is followed by the statement ``Daily Value not
established,'' shall be placed under the heading ``% Daily Value,'' if
present, or immediately following the quantitative amount by weight for
the proprietary blend.
(4) The sample label shown in paragraph (e)(10)(v) of this section
illustrates one method of nutrition labeling a proprietary blend of
dietary ingredients.
(d) The source ingredient that supplies a dietary ingredient may be
identified within the nutrition label in parentheses immediately
following or indented beneath the name of a dietary ingredient and
preceded by the words ``as'' or ``from'', e.g., ``Calcium (as calcium
carbonate),'' except that manner of presentation is unnecessary when the
name of the dietary ingredient (e.g., Oriental ginseng) or its synonym
(e.g., ascorbic acid) is itself the source ingredient. When a source
ingredient is identified in parentheses within the nutrition label, or
when the name of the dietary ingredient or its synonym is the source
ingredient, it shall not be required to be listed again in the
ingredient statement that appears outside of the nutrition label. When a
source ingredient is not identified within the nutrition label, it shall
be listed in an ingredient statement in accordance with Sec. 101.4(g),
which shall appear outside and immediately below the nutrition label or,
if there is insufficient space below the nutrition label, immediately
contiguous and to the right of the nutrition label.
(1) Source ingredients shall be identified in accordance with Sec.
101.4 (i.e., shall be listed by common or usual name, and the listing of
botanicals shall specify the part of the plant from which the ingredient
is derived) regardless of whether they are listed in an ingredient
statement or in the nutrition label.
(2) When source ingredients are listed within the nutrition label,
and two or more are used to provide a single dietary ingredient, all of
the sources shall be listed within the parentheses in descending order
by weight.
(3) Representations that the source ingredient conforms to an
official compendium may be included either in the nutrition label or in
the ingredient list (e.g., ``Calcium (as calcium carbonate USP)'').
(e) Nutrition information specified in this section shall be
presented as follows:
(1) The title, ``Supplement Facts,'' shall be set in a type size
larger than all other print size in the nutrition label and, unless
impractical, shall be set full width of the nutrition label. The title
and all headings shall be
[[Page 84]]
bolded to distinguish them from other information.
(2) The nutrition information shall be enclosed in a box by using
hairlines.
(3) All information within the nutrition label shall utilize:
(i) A single easy-to-read type style,
(ii) All black or one color type, printed on a white or other
neutral contrasting background whenever practical,
(iii) Upper- and lowercase letters, except that all uppercase
lettering may be utilized for packages that have a total surface area
available to bear labeling of less than 12 square inches,
(iv) At least one point leading (i.e., space between lines of text),
and
(v) Letters that do not touch.
(4) Except as provided for small and intermediate-sized packages
under paragraph (i)(2) of this section, information other than the
title, headings, and footnotes shall be in uniform type size no smaller
than 8 point. Type size no smaller than 6 point may be used for column
headings (e.g., ``Amount Per Serving'' and ``% Daily Value'') and for
footnotes (e.g., ``Percent Daily Values are based on a 2,000 calorie
diet'').
(5) A hairline rule that is centered between the lines of text shall
separate each dietary ingredient required in paragraph (b)(2) and (b)(3)
of this section from the dietary ingredient above and beneath it, as
shown in paragraph (e)(10) of this section.
(6) A heavy bar shall be placed:
(i) Beneath the subheading ``Servings Per Container'' except that if
``Servings Per Container'' is not required and, as a result, not
declared, the bar shall be placed beneath the subheading ``Serving
Size,''
(ii) Beneath the last dietary ingredient to be listed under
paragraph (b)(2)(i) of this section, if any, and
(iii) Beneath the last other dietary ingredient to be listed under
paragraph (b)(3) of this section, if any.
(7) A light bar shall be placed beneath the headings ``Amount Per
Serving'' and ``% Daily Value.''
(8) If the product contains two or more separately packaged dietary
supplements that differ from each other (e.g., the product has a packet
of supplements to be taken in the morning and a different packet to be
taken in the afternoon), the quantitative amounts and percent of Daily
Value may be presented as specified in this paragraph in individual
nutrition labels or in one aggregate nutrition label as illustrated in
paragraph (e)(10)(iii) of this section.
(9)(i) The quantitative amount by weight (or volume, if permitted)
and the percent of Daily Value of each dietary ingredient may be
presented on a ``per unit'' basis in addition to the ``per serving''
basis required by paragraphs (b)(2)(ii) and (b)(2)(iii) of this section
for (b)(2)-dietary ingredients and (b)(3)(ii) and (b)(3)(iv) of this
section for other dietary ingredients. If ``per unit'' information is
provided, it must be presented in additional columns to the right of the
``per serving'' information and be clearly identified by appropriate
headings.
(ii) Alternatively, if a recommendation is made in other parts of
the label that a dietary supplement be consumed more than once per day,
the total quantitative amount by weight (or volume, if permitted) and
the percent of Daily Value of each dietary ingredient may be presented
on a ``per day'' basis in addition to the ``per serving'' basis required
by paragraphs (b)(2)(ii) and (b)(2)(iii) of this section for (b)(2)-
dietary ingredients and (b)(3)(ii) and (b)(3)(iv) of this section for
other dietary ingredients. If ``per day'' information is provided, it
must be presented in additional columns to the right of the ``per
serving'' information and be clearly identified by appropriate headings
and/or be presented in a parenthetical statement as part of the
``Serving Size'' declaration. A sample illustration for ``per day''
information in a column format is provided in paragraph (e)(11)(viii) of
this section. As illustrated, the additional ``Per Day'' column heading
is followed parenthetically by the number of servings recommended per
day in other parts of the label (e.g., ``Per Day (3 Caplets)''). When
the parenthetical statement format following the ``Serving Size''
declaration is used as an alternative to the column format, the
statement must provide no more than simple instructions regarding how to
calculate the ``per day'' amount for the number of servings per day
recommended in
[[Page 85]]
other parts of the label (e.g., ``Serving Size: 1 Caplet (Multiply
amounts by 3 for total daily amount)''). When the parenthetical
statement format following the ``Serving Size'' declaration is used in
addition to the column format, the statement must provide no more than a
simple declaration of the number of servings recommended in other parts
of the label (e.g., ``Serving Size: 1 Caplet (Total daily amount: 3
caplets per day)'').
(10) In the interest of uniformity of presentation, FDA urges that
the information be presented using the graphic specifications set forth
in appendix B to part 101, as applicable.
(11) The following sample labels are presented for the purpose of
illustration:
[[Page 86]]
[GRAPHIC] [TIFF OMITTED] TR23SE97.010
[[Page 87]]
[GRAPHIC] [TIFF OMITTED] TR23SE97.011
[[Page 88]]
[GRAPHIC] [TIFF OMITTED] TR23SE97.012
[[Page 89]]
[GRAPHIC] [TIFF OMITTED] TR23SE97.013
(viii) Dietary supplement illustrating ``per serving'' and ``per
day'' information:
[[Page 90]]
[GRAPHIC] [TIFF OMITTED] TR13DE06.001
(12) If space is not adequate to list the required information as
shown in the sample labels in paragraph (e)(11) of this section, the
list may be split and continued to the right as long as the headings are
repeated. The list to the right must be set off by a line that
distinguishes it and sets it apart from the dietary ingredients and
percent of Daily Value information given to the left. The following
sample label illustrates this display:
[[Page 91]]
[GRAPHIC] [TIFF OMITTED] TR23SE97.014
(f)(1) Compliance with this section will be determined in accordance
with Sec. 101.9(g)(1) through (g)(8), except that the sample for
analysis shall consist of a composite of 12 subsamples (consumer
packages) or 10 percent of the
[[Page 92]]
number of packages in the same inspection lot, whichever is smaller,
randomly selected to be representative of the lot. The criteria on class
I and class II nutrients given in Sec. 101.9(g)(3) and (g)(4) also are
applicable to other dietary ingredients described in paragraph (b)(3)(i)
of this section. Reasonable excesses of these other dietary ingredients
over labeled amounts are acceptable within current good manufacturing
practice.
(2) When it is not technologically feasible, or some other
circumstance makes it impracticable, for firms to comply with the
requirements of this section, FDA may permit alternative means of
compliance or additional exemptions to deal with the situation in
accordance with Sec. 101.9(g)(9). Firms in need of such special
allowances shall make their request in writing to the Office of
Nutritional Products, Labeling and Dietary Supplements (HFS-800), Food
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740.
(g) Except as provided in paragraphs (i)(2) and (i)(5) of this
section, the location of nutrition information on a label shall be in
compliance with Sec. 101.2.
(h) Dietary supplements are subject to the exemptions specified as
follows in:
(1) Section 101.9(j)(1) for foods that are offered for sale by a
person who makes direct sales to consumers (i.e., a retailer) who has
annual gross sales or business done in sales to consumers that is not
more than $500,000 or has annual gross sales made or business done in
sales of food to consumers of not more than $50,000, and whose labels,
labeling, and advertising do not provide nutrition information or make a
nutrient content or health claim;
(2) Section 101.9(j)(18) for foods that are low-volume products
(that is, they meet the requirements for units sold in Sec.
101.9(j)(18)(i) or (j)(18)(ii)); that, except as provided in Sec.
101.9(j)(18)(iv), are the subject of a claim for an exemption that
provides the information required under Sec. 101.9(j)(18)(iv), that is
filed before the beginning of the time period for which the exemption is
claimed, and that is filed by a person, whether it is the manufacturer,
packer, or distributor, that qualifies to claim the exemption under the
requirements for average full-time equivalent employees in Sec.
101.9(j)(18)(i) or (j)(18)(ii), and whose labels, labeling, and
advertising do not provide nutrition information or make a nutrient
content or health claim;
(3) Section 101.9(j)(9) for foods shipped in bulk form that are not
for distribution to consumers in such form and that are for use solely
in the manufacture of other dietary supplements or that are to be
processed, labeled, or repacked at a site other than where originally
processed or packed.
(i) Dietary supplements are subject to the special labeling
provisions specified in:
(1) Section 101.9(j)(5)(i) for foods, other than infant formula,
represented or purported to be specifically for infants and children
less than 2 years of age, in that nutrition labels on such foods shall
not include calories from fat, calories from saturated fat, saturated
fat, polyunsaturated fat, monounsaturated fat, and cholesterol;
(2) Section 101.9(j)(13) for foods in small or intermediate-sized
packages, except that:
(i) All information within the nutrition label on small-sized
packages, which have a total surface area available to labeling of less
than 12 square inches, shall be in type size no smaller than 4.5 point;
(ii) All information within the nutrition label on intermediate-
sized packages, which have from 12 to 40 square inches of surface area
available to bear labeling, shall be in type size no smaller than 6
point, except that type size no smaller than 4.5 point may be used on
packages that have less than 20 square inches available for labeling and
more than 8 dietary ingredients to be listed and on packages that have
20 to 40 square inches available for labeling and more than 16 dietary
ingredients to be listed.
(iii) When the nutrition information is presented on any panel under
Sec. 101.9(j)(13)(ii)(D), the ingredient list shall continue to be
located immediately below the nutrition label, or, if there is
insufficient space below the nutrition label, immediately contiguous and
to the right of the nutrition label as specified in Sec. 101.4(g).
[[Page 93]]
(iv) When it is not possible for a small or intermediate-sized
package that is enclosed in an outer package to comply with these type
size requirements, the type size of the nutrition label on the primary
(inner) container may be as small as needed to accommodate all of the
required label information provided that the primary container is
securely enclosed in outer packaging, the nutrition labeling on the
outer packaging meets the applicable type size requirements, and such
outer packaging is not intended to be separated from the primary
container under conditions of retail sale.
(v) Where there is not sufficient space on a small or intermediate-
sized package for a nutrition label that meets minimum type size
requirements of 4.5 points if hairlines are used in accordance with
paragraph (e)(5) of this section, the hairlines may be omitted and
replaced by a row of dots connecting the columns containing the name of
each dietary ingredient and the quantitative amounts (by weight and as a
percent of Daily Value).
(3) Section 101.9(j)(15) for foods in multiunit food containers;
(4) Section 101.9(j)(16) for foods sold in bulk containers; and
(5) Section 101.9(j)(17) for foods in packages that have a total
surface area available to bear labeling greater than 40 square inches
but whose principal display panel and information panel do not provide
sufficient space to accommodate all required label information, except
that the ingredient list shall continue to be located immediately below
the nutrition label, or, if there is insufficient space below the
nutrition label, immediately contiguous and to the right of the
nutrition label as specified in Sec. 101.4(g).
(j) Dietary supplements shall be subject to the misbranding
provisions of Sec. 101.9(k).
[62 FR 49849, Sept. 23, 1997, as amended at 63 FR 30620, June 5, 1998;
66 FR 56035, Nov. 6, 2001; 71 FR 51726, Aug. 31, 2006; 71 FR 74791, Dec.
13, 2006]
Sec. 101.42 Nutrition labeling of raw fruit, vegetables, and fish.
(a) The Food and Drug Administration (FDA) urges food retailers to
provide nutrition information, as provided in Sec. 101.9(c), for raw
fruit, vegetables, and fish at the point-of-purchase. If retailers
choose to provide such information, they should do so in a manner that
conforms to the guidelines in Sec. 101.45.
(b) In Sec. 101.44, FDA has listed the 20 varieties of raw fruit,
vegetables, and fish that are most frequently consumed during a year and
to which the guidelines apply.
(c) FDA has also defined in Sec. 101.43, the circumstances that
constitute substantial compliance by food retailers with the guidelines.
(d) By May 8, 1993, FDA will issue a report on actions taken by food
retailers to provide consumers with nutrition information for raw fruit,
vegetables, and fish under the guidelines established in Sec. 101.45.
(1) The report will include a determination of whether there is
substantial compliance, as defined in Sec. 101.43, with the guidelines.
(2) In evaluating substantial compliance, FDA will consider only the
20 varieties of raw fruit, vegetables, and fish most frequently consumed
as identified in Sec. 101.44.
(e) If FDA finds that there is substantial compliance with the
guidelines for the nutrition labeling of raw fruit and vegetables or of
fish, the agency will so state in the report, and the guidelines will
remain in effect. FDA will reevaluate the market place for substantial
compliance every 2 years.
(f) If FDA determines that there is not substantial compliance with
the guidelines for raw fruit and vegetables or for raw fish, the agency
will at that time issue proposed regulations requiring that any person
who offers raw fruit and vegetables or fish to consumers provide, in a
manner prescribed by regulations, the nutrition information required by
Sec. 101.9. Final regulations would have to be issued 6 months after
issuance of proposed regulations, and they would become effective 6
months after the date of their promulgation.
[[Page 94]]
Sec. 101.43 Substantial compliance of food retailers with the guidelines for
the voluntary nutrition labeling of raw fruit, vegetables, and fish.
(a) The Food and Drug Administration (FDA) will judge a food
retailer who sells raw agricultural commodities or raw fish to be in
compliance with the guidelines in Sec. 101.45 with respect to raw
agricultural commodities if the retailer displays or provides nutrition
labeling for at least 90 percent of the raw agricultural commodities
listed in Sec. 101.44 that it sells, and with respect to raw fish if
the retailer displays or provides nutrition labeling for at least 90
percent of the types of raw fish listed in Sec. 101.44 that it sells.
To be in compliance, the nutrition labeling shall:
(1) Be presented in the store or other type of establishment in a
manner that is consistent with Sec. 101.45(a)(1);
(2) Be presented in content and format that are consistent with
Sec. 101.45 (a)(2), (a)(3), and (a)(4); and
(3) Include data that have been provided by FDA in appendices C and
D to part 101 of this chapter, except that the information on potassium
is voluntary.
(b) To determine whether there is substantial compliance by food
retailers with the guidelines in Sec. 101.45 for the voluntary
nutrition labeling of raw fruit and vegetables and of raw fish, FDA will
select a representative sample of 2,000 stores, allocated by store type
and size, for raw fruit and vegetables and for raw fish.
(c) FDA will find that there is substantial compliance with the
guidelines in Sec. 101.45 if it finds based on paragraph (a) of this
section that at least 60 percent of all stores that are evaluated are in
compliance.
(d) FDA will evaluate substantial compliance separately for raw
agricultural commodities and for raw fish.
[55 FR 60890, Nov. 27, 1991, as amended at 61 FR 42759, Aug. 16, 1996]
Sec. 101.44 What are the 20 most frequently consumed raw fruits, vegetables,
and fish in the United States?
(a) The 20 most frequently consumed raw fruits are: Apple, avocado
(California), banana, cantaloupe, grapefruit, grapes, honeydew melon,
kiwifruit, lemon, lime, nectarine, orange, peach, pear, pineapple,
plums, strawberries, sweet cherries, tangerine, and watermelon.
(b) The 20 most frequently consumed raw vegetables are: Asparagus,
bell pepper, broccoli, carrot, cauliflower, celery, cucumber, green
(snap) beans, green cabbage, green onion, iceberg lettuce, leaf lettuce,
mushrooms, onion, potato, radishes, summer squash, sweet corn, sweet
potato, and tomato.
(c) The 20 most frequently consumed raw fish are: Blue crab,
catfish, clams, cod, flounder/sole, haddock, halibut, lobster, ocean
perch, orange roughy, oysters, pollock, rainbow trout, rockfish, salmon
(Atlantic/coho/Chinook/sockeye, chum/pink), scallops, shrimp, swordfish,
tilapia, and tuna.
[71 FR 42044, July 25, 2006]
Sec. 101.45 Guidelines for the voluntary nutrition labeling of raw fruits,
vegetables, and fish.
(a) Nutrition labeling for raw fruits, vegetables, and fish listed
in Sec. 101.44 should be presented to the public in the following
manner:
(1) Nutrition labeling information should be displayed at the point
of purchase by an appropriate means such as by a label affixed to the
food or through labeling including shelf labels, signs, posters,
brochures, notebooks, or leaflets that are readily available and in
close proximity to the foods. The nutrition labeling information may
also be supplemented by a video, live demonstration, or other media.
(2) Serving sizes should be determined, and nutrients declared, in
accordance with Sec. 101.9 (b) and (c), respectively, except that the
nutrition labeling data should be based on the raw edible portion for
fruits and vegetables and on the cooked edible portion for fish. The
methods used to cook fish should be those that do not add fat, breading,
or seasoning (e.g., salt or spices).
(3) When nutrition labeling information is provided for more than
one raw fruit, vegetable, or fish on signs, posters, brochures,
notebooks, or leaflets, it may be presented in charts with horizontal or
vertical columns or as a compilation of individual nutrition labels.
Nutrition labeling that is presented in a linear display (see
[[Page 95]]
Sec. 101.9(j)(13)(ii)(A)(2)) will not be considered to be in
compliance. The heading ``Nutrition Facts'' must be in a type size
larger than all other print in the nutrition label. The required
information (i.e., headings, serving sizes, list of nutrients,
quantitative amounts by weight (except for vitamins and minerals), and
percent of Daily Values (DV's) (except for sugars and protein) must be
clearly presented and of sufficient type size and color contrast to be
plainly legible, with numeric values for percent of DV highlighted in
contrast to the quantitative amounts by weight and hairlines between all
nutrients.
(i) Declaration of the number of servings per container need not be
included in the nutrition labeling of raw fruits, vegetables, and fish.
(ii) Except for the statement ``Percent Daily Values are based on a
2,000 calorie diet,'' the footnote required in Sec. 101.9(d)(9) is not
required. However, when labeling is provided in brochures, notebooks,
leaflets, or similar types of materials, retailers are encouraged to
include the footnote.
(iii) When retailers provide nutrition labeling information for more
than one raw fruit or vegetable on signs or posters or in brochures,
notebooks, or leaflets, the listings for saturated fat, trans fat, and
cholesterol may be omitted from the charts or individual nutrition
labels if a footnote states that most fruits and vegetables provide
negligible amounts of these nutrients, but that avocados contain 0.5
gram (g) of saturated fat per ounce (e.g., ``Most fruits and vegetables
provide negligible amounts of saturated fat, trans fat, and cholesterol;
avocados provide 0.5 g of saturated fat per ounce''). The footnote also
may contain information about the polyunsaturated and monounsaturated
fat content of avocados.
(iv) When retailers provide nutrition labeling information for more
than one raw fish on signs or posters or in brochures, notebooks, or
leaflets, the listings for trans fat, dietary fiber, and sugars may be
omitted from the charts or individual nutrition labels if the following
footnote is used, ``Fish provide negligible amounts of trans fat,
dietary fiber, and sugars.''
(4) When nutrition labeling is provided for individual raw fruits,
vegetables, or fish on packages or on signs, posters, brochures,
notebooks, or leaflets, it should be displayed in accordance with Sec.
101.9, except that the declaration of the number of servings per
container need not be included. For individual labels provided by
retailers on signs and posters, the footnote required in Sec.
101.9(d)(9) may be shortened to ``Percent Daily Values are based on a
2,000 calorie diet.''
(b) Nutrition label values provided by the Food and Drug
Administration (FDA) in Appendices C and D to part 101 for the 20 most
frequently consumed raw fruits, vegetables, and fish listed in Sec.
101.44 shall be used to ensure uniformity in declared values. FDA will
publish proposed updates of the 20 most frequently consumed raw fruits,
vegetables, and fish and nutrition label data for these foods (or a
notice that the data sets have not changed from the previous
publication) at least every 4 years in the Federal Register.
(1) The agency encourages the submission of data bases with new or
additional nutrient data for any of the most frequently consumed raw
fruits, vegetables, and fish to the Office of Nutritional Products,
Labeling and Dietary Supplements (HFS-800), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, for review and evaluation. FDA may
incorporate these data in the next revision of the nutrition labeling
information for the top 20 raw fruits, vegetables, and fish.
(i) Guidance in the development of data bases may be found in the
``FDA Nutrition Labeling Manual: A Guide for Developing and Using Data
Bases,'' available from the FDA Office of Food Labeling.
(ii) The submission to FDA should include, but need not be limited
to, information on the following: Source of the data (names of
investigators, name of organization, place of analyses, dates of
analyses), number of samples, sampling design, analytical methods, and
statistical treatment of the data. Proposed quantitative label
declarations may be included. The proposed values for declaration should
be determined in
[[Page 96]]
accordance with the ``FDA Nutrition Labeling Manual: A Guide for
Developing and Using Data Bases.''
(2) [Reserved]
(c) Data bases of nutrient values for raw fruits, vegetables, and
fish that are not among the 20 most frequently consumed may be used to
develop nutrition labeling values for these foods. This includes data
bases of nutrient values for specific varieties, species, or cultivars
of raw fruits, vegetables, and fish not specifically identified among
the 20 most frequently consumed.
(1) The food names and descriptions for the fruits, vegetables, and
fish should clearly identify these foods as distinct from foods among
the most frequently consumed list for which FDA has provided data.
(2) Guidance in the development of data bases may be found in the
``FDA Nutrition Labeling Manual: A Guide for Developing and Using Data
Bases.''
(3) Nutrition labeling values computed from data bases are subject
to the compliance provisions of Sec. 101.9(g).
(i) Compliance with the provisions of Sec. 101.9(g) may be achieved
by use of a data base that has been developed following FDA guideline
procedures and approved by FDA.
(A) The submission to FDA for approval should include but need not
be limited to information on the following: Source of the data (names of
investigators, name of organization, place of analyses, dates of
analyses), number of samples, sampling design, analytical methods,
statistical treatment of the data, and proposed quantitative label
declarations. The values for declaration should be determined in
accordance with the ``FDA Nutrition Labeling Manual: A Guide for
Developing and Using Databases.''
(B) FDA approval of a data base and nutrition labeling values shall
not be considered granted until the Center for Food Safety and Applied
Nutrition has agreed to all aspects of the data base in writing.
Approvals will be in effect for a limited time, e.g., 10 years, and will
be eligible for renewal in the absence of significant changes in
agricultural or industry practices (e.g., a change occurs in a
predominant variety produced). FDA will take steps to revoke its
approval of the data base and nutrition labeling values if FDA
monitoring suggests that the data base or nutrition labeling values are
no longer representative of the item sold in this country. Approval
requests shall be submitted in accordance with the provision of Sec.
101.30 of this chapter.
(ii) [Reserved]
[61 FR 42760, Aug. 16, 1996, as amended at 66 FR 56035, Nov. 6, 2001; 71
FR 42044, July 25, 2006]
Subpart D_Specific Requirements for Nutrient Content Claims
Source: 58 FR 2413, Jan. 6, 1993, unless otherwise noted.
Sec. 101.54 Nutrient content claims for ``good source,'' ``high,'' ``more,''
and ``high potency.''
(a) General requirements. Except as provided in paragraph (e) of
this section, a claim about the level of a nutrient in a food in
relation to the Reference Daily Intake (RDI) established for that
nutrient in Sec. 101.9(c)(8)(iv) or Daily Reference Value (DRV)
established for that nutrient in Sec. 101.9(c)(9), (excluding total
carbohydrates) may only be made on the label or in labeling of the food
if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 101.13; and
(3) The food for which the claim is made is labeled in accordance
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable.
(b) ``High'' claims. (1) The terms ``high,'' ``rich in,'' or
``excellent source of'' may be used on the label and in the labeling of
foods, except meal products as defined in Sec. 101.13(l) and main dish
products as defined in Sec. 101.13(m), provided that the food contains
20 percent or more of the RDI or the DRV per reference amount
customarily consumed.
(2) The terms defined in paragraph (b)(1) of this section may be
used on the label and in the labeling of meal products as defined in
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m),
provided that:
(i) The product contains a food that meets the definition of
``high'' in paragraph (b)(1) of this section; and
[[Page 97]]
(ii) The label or labeling clearly identifies the food that is the
subject of the claim (e.g., the serving of broccoli in this product is
high in vitamin C).
(c) ``Good Source'' claims. (1) The terms ``good source,''
``contains,'' or ``provides'' may be used on the label and in the
labeling of foods, except meal products as defined in Sec. 101.13(l)
and main dish products as defined in Sec. 101.13(m), provided that the
food contains 10 to 19 percent of the RDI or the DRV per reference
amount customarily consumed.
(2) The terms defined in paragraph (c)(1) of this section may be
used on the label and in the labeling of meal products as defined in
Sec. 101.13(l) and main dish products as defined in 101.13(m), provided
that:
(i) The product contains a food that meets the definition of ``good
source'' in paragraph (c)(1) of this section; and
(ii) The label or labeling clearly identifies the food that is the
subject of the claim (e.g., the serving of sweet potatoes in this
product is a ``good source'' of fiber).
(d) ``Fiber'' claims. (1) If a nutrient content claim is made with
respect to the level of dietary fiber, that is, that the product is high
in fiber, a good source of fiber, or that the food contains ``more''
fiber, and the food is not ``low'' in total fat as defined in Sec.
101.62(b)(2) or, in the case of a meal product, as defined in Sec.
101.13(l), or main dish product, as defined in Sec. 101.13(m), is not
``low'' in total fat as defined in Sec. 101.62(b)(3), then the label
shall disclose the level of total fat per labeled serving.
(2) The disclosure shall appear in immediate proximity to such
claim, be in a type size no less than one-half the size of the claim and
precede any disclosure statement required under Sec. 101.13(h) (e.g.,
``contains [x amount] of total fat per serving. See nutrition
information for fat content'').
(e) ``More'' claims. (1) A relative claim using the terms ``more,''
``fortified,'' ``enriched,'' ``added,'' ``extra,'' and ``plus'' may be
used on the label or in labeling of foods to describe the level of
protein, vitamins, minerals, dietary fiber, or potassium, except as
limited by Sec. 101.13(j)(1)(i) and except meal products as defined in
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m),
provided that:
(i) The food contains at least 10 percent more of the RDI for
vitamins or minerals or of the DRV for protein, dietary fiber, or
potassium (expressed as a percent of the Daily Value) per reference
amount customarily consumed than an appropriate reference food; and
(ii) Where the claim is based on a nutrient that has been added to
the food, that fortification is in accordance with the policy on
fortification of foods in Sec. 104.20 of this chapter; and
(iii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percentage (or
fraction) that the nutrient is greater relative to the RDI or DRV are
declared in immediate proximity to the most prominent such claim (e.g.,
``contains 10 percent more of the Daily Value for fiber than white
bread''); and
(B) Quantitative information comparing the level of the nutrient in
the product per labeled serving with that of the reference food that it
replaces (e.g., ``Fiber content of white bread is 1 gram (g) per
serving; (this product) 3.5 g per serving'') is declared adjacent to the
most prominent claim or to the nutrition label, except that if the
nutrition label is on the information panel, the quantitative
information may be located elsewhere on the information panel in
accordance with Sec. 101.2.
(2) A relative claim using the terms ``more,'' ``fortified,''
``enriched,'' ``added,'' ``extra,'' and ``plus'' may be used on the
label or in labeling to describe the level of protein, vitamins,
minerals, dietary fiber or potassium, except as limited in Sec.
101.13(j)(1)(i), in meal products as defined in Sec. 101.13(l) or main
dish products as defined in Sec. 101.13(m), provided that:
(i) The food contains at least 10 percent more of the RDI for
vitamins or minerals or of the DRV for protein, dietary fiber, or
potassium (expressed as a percent of the Daily Value) per 100 g of food
than an appropriate reference food.
(ii) Where the claim is based on a nutrient that has been added to
the food, that fortification is in accordance with the policy on
fortification of foods in Sec. 104.20 of this chapter; and
[[Page 98]]
(iii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percentage (or
fraction) that the nutrient was increased relative to the RDI or DRV are
declared in immediate proximity to the most prominent such claim (e.g.,
``contains 10 percent more of the Daily Value for fiber per 3 oz than
does `X brand of product' ''), and
(B) Quantitative information comparing the level of the nutrient in
the product per specified weight with that of the reference food that it
replaces (e.g., ``The fiber content of `X brand of product' is 2 g per 3
oz. This product contains 4.5 g per 3 oz.'') is declared adjacent to the
most prominent claim or to the nutrition label, except that if the
nutrition label is on the information panel, the quantitative
information may be located elsewhere on the information panel in
accordance with Sec. 101.2.
(f) ``High potency'' claims. (1)(i) The term ``high potency'' may be
used on the label or in the labeling of foods to describe individual
vitamins or minerals that are present at 100 percent or more of the RDI
per reference amount customarily consumed.
(ii) When the term ``high potency'' is used to describe individual
vitamins or minerals in a product that contains other nutrients or
dietary ingredients, the label or labeling shall clearly identify which
vitamin or mineral is described by the term ``high potency'' (e.g.,
``Botanical `X' with high potency vitamin E'').
(2) The term ``high potency'' may be used on the label or in the
labeling of a multiingredient food product to describe the product if
the product contains 100 percent or more of the RDI for at least two-
thirds of the vitamins and minerals that are listed in Sec.
101.9(c)(8)(iv) and that are present in the product at 2 percent or more
of the RDI (e.g., ``High potency multivitamin, multimineral dietary
supplement tablets'').
(3) Where compliance with paragraphs (f)(1)(i), (f)(1)(ii), or
(f)(2) of this section is based on a nutrient that has been added to a
food (other than a dietary supplement), that fortification shall be in
accordance with the policy on fortification of foods in Sec. 104.20 of
this chapter.
(g) Nutrient content claims using the term ``antioxidant.'' A
nutrient content claim that characterizes the level of antioxidant
nutrients present in a food may be used on the label or in the labeling
of that food when:
(1) An RDI has been established for each of the nutrients;
(2) The nutrients that are the subject of the claim have recognized
antioxidant activity; that is, when there exists scientific evidence
that, following absorption from the gastrointestinal tract, the
substance participates in physiological, biochemical, or cellular
processes that inactivate free radicals or prevent free radical-
initiated chemical reactions;
(3) The level of each nutrient that is the subject of the claim is
sufficient to qualify for the Sec. 101.54 (b), (c), or (e) claim (e.g.,
to bear the claim ''high in antioxidant vitamin C,'' the product must
contain 20 percent or more of the RDI for vitamin C). Beta-carotene may
be a subject of the claim when the level of vitamin A present as beta-
carotene in the food that bears the claim is sufficient to qualify for
the claim. For example, for the claim ``good source of antioxidant beta-
carotene,'' 10 percent or more of the RDI for vitamin A must be present
as beta-carotene per reference amount customarily consumed; and
(4) The names of the nutrients that are the subject of the claim are
included as part of the claim (e.g., ``high in antioxidant vitamins C
and E''). Alternatively, when used as part of a nutrient content claim,
the term ``antioxidant'' or ``antioxidants'' (as in ``high in
antioxidants'') may be linked by a symbol (e.g., an asterisk) that
refers to the same symbol that appears elsewhere on the same panel of a
product label followed by the name or names of the nutrients with
recognized antioxidant activity. The list of nutrients shall appear in
letters of a type size height no smaller than the larger
[[Page 99]]
of one-half of the type size of the largest nutrient content claim or 1/
16 inch.
[58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, 1993, as amended at 59
FR 394, Jan. 4, 1994; 59 FR 15051, Mar. 31, 1994; 60 FR 17206, Apr. 5,
1995; 61 FR 11731, Mar. 22, 1996; 62 FR 31339, June 9, 1997; 62 FR
49867, 49880, Sept. 23, 1997; 63 FR 26980, May 15, 1998; 66 FR 17358,
Mar. 30, 2001]
Sec. 101.56 Nutrient content claims for ``light'' or ``lite.''
(a) General requirements. A claim using the term light or lite to
describe a food may only be made on the label or in labeling of the food
if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 101.13; and
(3) The food is labeled in accordance with Sec. 101.9 or Sec.
101.10, where applicable.
(b) ``Light'' claims. The terms ``light'' or ``lite'' may be used on
the label or in the labeling of foods, except meal products as defined
in Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m),
without further qualification, provided that:
(1) If the food derives 50 percent or more of its calories from fat,
its fat content is reduced by 50 percent or more per reference amount
customarily consumed compared to an appropriate reference food as
specified in Sec. 101.13(j)(1); or
(2) If the food derives less than 50 percent of its calories from
fat:
(i) The number of calories is reduced by at least one-third (33 1/3
percent) per reference amount customarily consumed compared to an
appropriate reference food; or
(ii) Its fat content is reduced by 50 percent or more per reference
amount customarily consumed compared to the reference food that it
resembles or for which it substitutes as specified in Sec.
101.13(j)(1); and
(3) As required in Sec. 101.13(j)(2) for relative claims:
(i) The identity of the reference food and the percent (or fraction)
that the calories and the fat were reduced are declared in immediate
proximity to the most prominent such claim, (e.g., ``1/3 fewer calories
and 50 percent less fat than our regular cheese cake'');
(ii) Quantitative information comparing the level of calories and
fat content in the product per labeled serving size with that of the
reference food that it replaces (e.g., ``lite cheesecake--200 calories,
4 grams (g) fat per serving; regular cheesecake--300 calories, 8 g fat
per serving'') is declared adjacent to the most prominent claim or to
the nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located elsewhere
on the information panel in accordance with Sec. 101.2; and
(iii) If the labeled food contains less than 40 calories or less
than 3 g fat per reference amount customarily consumed, the percentage
reduction for that nutrient need not be declared.
(4) A ``light'' claim may not be made on a food for which the
reference food meets the definition of ``low fat'' and ``low calorie.''
(c)(1)(i) A product for which the reference food contains 40
calories or less and 3 g fat or less per reference amount customarily
consumed may use the term ``light'' or ``lite'' without further
qualification if it is reduced by 50 percent or more in sodium content
compared to the reference food; and
(ii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percent (or fraction)
that the sodium was reduced shall be declared in immediate proximity to
the most prominent such claim (e.g., 50 percent less sodium than our
regular soy sauce); and
(B) Quantitative information comparing the level of sodium per
labeled serving size with that of the reference food that it replaces
(e.g., ``lite soy sauce 500 milligrams (mg) sodium per serving; regular
soy sauce 1,000 mg per serving'') is declared adjacent to the most
prominent claim or to the nutrition label, except that if the nutrition
label is on the information panel, the quantitative information may be
located elsewhere on the information panel in accordance with Sec.
101.2.
(2)(i) A product for which the reference food contains more than 40
calories or more than 3 g fat per reference amount customarily consumed
may use the term ``light in sodium'' or ``lite
[[Page 100]]
in sodium'' if it is reduced by 50 percent or more in sodium content
compared to the reference food, provided that ``light'' or ``lite'' is
presented in immediate proximity with ``in sodium'' and the entire term
is presented in uniform type size, style, color, and prominence; and
(ii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percent (or fraction)
that the sodium was reduced shall be declared in immediate proximity to
the most prominent such claim (e.g., 50 percent less sodium than our
regular canned peas); and
(B) Quantitative information comparing the level of sodium per
labeled serving size with that of the reference food that it replaces
(e.g., ``lite canned peas, 175 mg sodium per serving; regular canned
peas 350 mg per serving'') is declared adjacent to the most prominent
claim or to the nutrition label, except that if the nutrition label is
on the information panel, the quantitative information may be located
elsewhere on the information panel in accordance with Sec. 101.2.
(iii) Except for meal products as defined in Sec. 101.13(l) and
main dish products as defined in Sec. 101.13(m), a ``light in sodium''
claim may not be made on a food for which the reference food meets the
definition of ``low in sodium''.
(d)(1) The terms ``light'' or ``lite'' may be used on the label or
in the labeling of a meal product as defined in Sec. 101.13(l) and a
main dish product as defined in Sec. 101.13(m), provided that:
(i) The food meets the definition of:
(A) ``Low in calories'' as defined in Sec. 101.60(b)(3); or
(B) ``Low in fat'' as defined in Sec. 101.62(b)(3); and
(ii)(A) A statement appears on the principal display panel that
explains whether ``light'' is used to mean ``low fat,'' ``low
calories,'' or both (e.g., ``Light Delight, a low fat meal''); and
(B) The accompanying statement is no less than one-half the type
size of the ``light'' or ``lite'' claim.
(2)(i) The term ``light in sodium'' or ``lite in sodium'' may be
used on the label or in the labeling of a meal product as defined in
Sec. 101.13(l) and a main dish product as defined in Sec. 101.13(m),
provided that the food meets the definition of ``low in sodium'' as
defined in Sec. 101.61(b)(5)(i); and
(ii) ``Light'' or ``lite'' and ``in sodium'' are presented in
uniform type size, style, color, and prominence.
(e) Except as provided in paragraphs (b) through (d) of this
section, the term ``light'' or ``lite'' may not be used to refer to a
food that is not reduced in fat by 50 percent, or, if applicable, in
calories by 1/3 or, when properly qualified, in sodium by 50 percent
unless:
(1) It describes some physical or organoleptic attribute of the food
such as texture or color and the information (e.g., ``light in color''
or ``light in texture'') so stated, clearly conveys the nature of the
product; and
(2) The attribute (e.g., ``color'' or ``texture'') is in the same
style, color, and at least one-half the type size as the word ``light''
and in immediate proximity thereto.
(f) If a manufacturer can demonstrate that the word ``light'' has
been associated, through common use, with a particular food to reflect a
physical or organoleptic attribute (e.g., light brown sugar, light corn
syrup, or light molasses) to the point where it has become part of the
statement of identity, such use of the term ``light'' shall not be
considered a nutrient content claim subject to the requirements in this
part.
(g) The term ``lightly salted'' may be used on a product to which
has been added 50 percent less sodium than is normally added to the
reference food as described in Sec. 101.13(j)(1)(i)(B) and
(j)(1)(ii)(B), provided that if the product is not ``low in sodium'' as
defined in Sec. 101.61(b)(4), the statement ``not a low sodium food,''
shall appear adjacent to the nutrition label of the food bearing the
claim, or, if the nutrition label is on the information panel, it may
appear elsewhere on the information panel in accordance with Sec. 101.2
and the information required to accompany a relative claim shall appear
on the label or labeling as specified in Sec. 101.13(j)(2).
[58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, 1993, as amended at 60
FR 17206, Apr. 5, 1995]
[[Page 101]]
Sec. 101.60 Nutrient content claims for the calorie content of foods.
(a) General requirements. A claim about the calorie or sugar content
of a food may only be made on the label or in the labeling of a food if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 101.13;
(3) The food for which the claim is made is labeled in accordance
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable; and
(4) For dietary supplements, claims regarding calories may not be
made on products that meet the criteria in Sec. 101.60(b)(1) or (b)(2)
for ``calorie free'' or ``low calorie'' claims except when an equivalent
amount of a similar dietary supplement (e.g., another protein
supplement) that the labeled food resembles and for which it
substitutes, normally exceeds the definition for ``low calorie'' in
Sec. 101.60(b)(2).
(b) Calorie content claims. (1) The terms ``calorie free,'' ``free
of calories,'' ``no calories,'' ``zero calories,'' ``without calories,''
``trivial source of calories,'' ``negligible source of calories,'' or
``dietarily insignificant source of calories'' may be used on the label
or in the labeling of foods, provided that:
(i) The food contains less than 5 calories per reference amount
customarily consumed and per labeled serving.
(ii) As required in Sec. 101.13(e)(2), if the food meets this
condition without the benefit of special processing, alteration,
formulation, or reformulation to lower the caloric content, it is
labeled to disclose that calories are not usually present in the food
(e.g., ``cider vinegar, a calorie free food'').
(2) The terms ``low calorie,'' ``few calories,'' ``contains a small
amount of calories,'' ``low source of calories,'' or ``low in calories''
may be used on the label or in labeling of foods, except meal products
as defined in Sec. 101.13(l) and main dish products as defined in Sec.
101.13(m), provided that:
(i)(A) The food has a reference amount customarily consumed greater
than 30 grams (g) or greater than 2 tablespoons and does not provide
more than 40 calories per reference amount customarily consumed; or
(B) The food has a reference amount customarily consumed of 30 g or
less or 2 tablespoons or less and does not provide more than 40 calories
per reference amount customarily consumed and, except for sugar
substitutes, per 50 g (for dehydrated foods that must be reconstituted
before typical consumption with water or a diluent containing an
insignificant amount, as defined in Sec. 101.9(f)(1), of all nutrients
per reference amount customarily consumed, the per 50 g criterion refers
to the ``as prepared'' form).
(ii) If a food meets these conditions without the benefit of special
processing, alteration, formulation, or reformulation to vary the
caloric content, it is labeled to clearly refer to all foods of its type
and not merely to the particular brand to which the label attaches
(e.g., ``celery, a low calorie food'').
(3) The terms defined in paragraph (b)(2) of this section may be
used on the label or in labeling of meal products as defined in Sec.
101.13(l) or main dish products as defined in Sec. 101.13(m), provided
that:
(i) The product contains 120 calories or less per 100 g; and
(ii) If the product meets this condition without the benefit of
special processing, alteration, formulation, or reformulation to lower
the calorie content, it is labeled to clearly refer to all foods of its
type and not merely to the particular brand to which it attaches.
(4) The terms ``reduced calorie,'' ``reduced in calories,''
``calorie reduced,'' ``fewer calories,'' ``lower calorie,'' or ``lower
in calories'' may be used on the label or in the labeling of foods,
except as limited by Sec. 101.13(j)(1)(i) and except meal products as
defined in Sec. 101.13(l) and main dish products as defined in Sec.
101.13(m), provided that:
(i) The food contains at least 25 percent fewer calories per
reference amount customarily consumed than an appropriate reference food
as described in Sec. 101.13(j)(1); and
(ii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percent (or fraction)
that the calories differ between the two foods
[[Page 102]]
are declared in immediate proximity to the most prominent such claim
(e.g., reduced calorie cupcakes ``33 1/3 percent fewer calories than
regular cupcakes''); and
(B) Quantitative information comparing the level of the nutrient per
labeled serving size with that of the reference food that it replaces
(e.g., ``Calorie content has been reduced from 150 to 100 calories per
serving.'') is declared adjacent to the most prominent claim or to the
nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located elsewhere
on the information panel in accordance with Sec. 101.2.
(iii) Claims described in paragraph (b)(4) of this section may not
be made on the label or labeling of foods if the reference food meets
the definition for ``low calorie.''
(5) The terms defined in paragraph (b)(4) of this section may be
used on the label or in the labeling of meal products as defined in
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m),
provided that:
(i) The food contains at least 25 percent fewer calories per 100 g
of food than an appropriate reference food as described in Sec.
101.13(j)(1); and
(ii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percent (or fraction)
that the calories differ between the two foods are declared in immediate
proximity to the most prominent such claim (e.g., Larry's Reduced
Calorie Lasagna, ``25 percent fewer calories per oz (or 3 oz) than our
regular Lasagna''); and
(B) Quantitative information comparing the level of the nutrient in
the product per specified weight with that of the reference food that it
replaces (e.g., ``Calorie content has been reduced from 108 calories per
3 oz to 83 calories per 3 oz.'') is declared adjacent to the most
prominent claim or to the nutrition label, except that if the nutrition
label is on the information panel, the quantitative information may be
located elsewhere on the information panel in accordance with Sec.
101.2.
(iii) Claims described in paragraph (b)(5) of this section may not
be made on the label or labeling of food if the reference food meets the
definition for ``low calorie.''
(c) Sugar content claims--(1) Use of terms such as ``sugar free,''
``free of sugar,'' ``no sugar,'' ``zero sugar,'' ``without sugar,''
``sugarless,'' ``trivial source of sugar,'' ``negligible source of
sugar,'' or ``dietarily insignificant source of sugar.'' Consumers may
reasonably be expected to regard terms that represent that the food
contains no sugars or sweeteners e.g., ``sugar free,'' or ``no sugar,''
as indicating a product which is low in calories or significantly
reduced in calories. Consequently, except as provided in paragraph
(c)(2) of this section, a food may not be labeled with such terms
unless:
(i) The food contains less than 0.5 g of sugars, as defined in Sec.
101.9(c)(6)(ii), per reference amount customarily consumed and per
labeled serving or, in the case of a meal product or main dish product,
less than 0.5 g of sugars per labeled serving; and
(ii) The food contains no ingredient that is a sugar or that is
generally understood by consumers to contain sugars unless the listing
of the ingredient in the ingredient statement is followed by an asterisk
that refers to the statement below the list of ingredients, which states
``adds a trivial amount of sugar,'' ``adds a negligible amount of
sugar,'' or ``adds a dietarily insignificant amount of sugar;'' and
(iii)(A) It is labeled ``low calorie'' or ``reduced calorie'' or
bears a relative claim of special dietary usefulness labeled in
compliance with paragraphs (b)(2), (b)(3), (b)(4), or (b)(5) of this
section, or, if a dietary supplement, it meets the definition in
paragraph (b)(2) of this section for ``low calorie'' but is prohibited
by Sec. Sec. 101.13(b)(5) and 101.60(a)(4) from bearing the claim; or
(B) Such term is immediately accompanied, each time it is used, by
either the statement ``not a reduced calorie food,'' ``not a low calorie
food,'' or ``not for weight control.''
(2) The terms ``no added sugar,'' ``without added sugar,'' or ``no
sugar added'' may be used only if:
(i) No amount of sugars, as defined in Sec. 101.9(c)(6)(ii), or any
other ingredient that contains sugars that functionally substitute for
added sugars is added during processing or packaging; and
[[Page 103]]
(ii) The product does not contain an ingredient containing added
sugars such as jam, jelly, or concentrated fruit juice; and
(iii) The sugars content has not been increased above the amount
present in the ingredients by some means such as the use of enzymes,
except where the intended functional effect of the process is not to
increase the sugars content of a food, and a functionally insignificant
increase in sugars results; and
(iv) The food that it resembles and for which it substitutes
normally contains added sugars; and
(v) The product bears a statement that the food is not ``low
calorie'' or ``calorie reduced'' (unless the food meets the requirements
for a ``low'' or ``reduced calorie'' food) and that directs consumers'
attention to the nutrition panel for further information on sugar and
calorie content.
(3) Paragraph (c)(1) of this section shall not apply to a factual
statement that a food, including foods intended specifically for infants
and children less than 2 years of age, is unsweetened or contains no
added sweeteners in the case of a food that contains apparent
substantial inherent sugar content, e.g., juices.
(4) The claims provided for in paragraph (c)(1) and (c)(2) of this
section may be used on labels or in labeling of dietary supplements of
vitamins or minerals that are intended specifically for use by infants
and children less than 2 years of age.
(5) The terms ``reduced sugar,'' ``reduced in sugar,'' ``sugar
reduced,'' ``less sugar,'' ``lower sugar'' or ``lower in sugar'' may be
used on the label or in labeling of foods, except meal products as
defined in Sec. 101.13(l), main dish products as defined in Sec.
101.13(m), and dietary supplements of vitamins or minerals, provided
that:
(i) The food contains at least 25 percent less sugar per reference
amount customarily consumed than an appropriate reference food as
described in Sec. 101.13(j)(1); and
(ii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percent (or fraction)
that the sugar differs between the two foods are declared in immediate
proximity to the most prominent such claim (e.g., ``these corn flakes
contain 25 percent less sugar than our sugar coated corn flakes''); and
(B) Quantitative information comparing the level of the sugar in the
product per labeled serving with that of the reference food that it
replaces (e.g., ``Sugar content has been lowered from 8 g to 6 g per
serving.'') is declared adjacent to the most prominent claim or to the
nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located elsewhere
on the information panel in accordance with Sec. 101.2.
(6) The terms defined in paragraph (c)(5) of this section may be
used on the label or in the labeling of a meal product as defined in
Sec. 101.13(l) and a main dish product as defined in Sec. 101.13(m),
provided that:
(i) The food contains at least 25 percent less sugars per 100 g of
food than an appropriate reference food as described in Sec.
101.13(j)(1), and
(ii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percent (or fraction)
that the sugars differ between the two foods are declared in immediate
proximity to the most prominent such claim (e.g., reduced sweet and sour
shrimp dinner, ``25 percent less sugar per 3 oz than our regular sweet
and sour shrimp dinner''); and
(B) Quantitative information comparing the level of the nutrient in
the product per specified weight with that of the reference food that it
replaces (e.g., ``Sugar content has been reduced from 17 g per 3 oz to
13 g per 3 oz.'') is declared adjacent to the most prominent claim or to
the nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located elsewhere
on the information panel in accordance with Sec. 101.2.
[58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, 1993, as amended at 58
FR 44031, Aug. 18, 1993; 59 FR 394, Jan. 4, 1994; 60 FR 17206, Apr. 5,
1995; 62 FR 15342, Mar. 31, 1997; 62 FR 49881, Sept. 23, 1997]
[[Page 104]]
Sec. 101.61 Nutrient content claims for the sodium content of foods.
(a) General requirements. A claim about the level of sodium or salt
in a food may only be made on the label or in the labeling of the food
if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 101.13; and
(3) The food for which the claim is made is labeled in accordance
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable.
(b) Sodium content claims. (1) The terms ``sodium free,'' ``free of
sodium,'' ``no sodium,'' ``zero sodium,'' ``without sodium,'' ``trivial
source of sodium,'' ``negligible source of sodium,'' or ``dietary
insignificant source of sodium'' may be used on the label or in the
labeling of foods, provided that:
(i) The food contains less than 5 milligrams (mg) of sodium per
reference amount customarily consumed and per labeled serving or, in the
case of a meal product or a main dish product, less than 5 mg of sodium
per labeled serving; and
(ii) The food contains no ingredient that is sodium chloride or is
generally understood by consumers to contain sodium, unless the listing
of the ingredient in the ingredient statement is followed by an asterisk
that refers to the statement below the list of ingredients, which
states: ``Adds a trivial amount of sodium,'' ``adds a negligible amount
of sodium'' or ``adds a dietarily insignificant amount of sodium;'' and
(iii) As required in Sec. 101.13(e)(2) if the food meets these
conditions without the benefit of special processing, alteration,
formulation, or reformulation to lower the sodium content, it is labeled
to disclose that sodium is not usually present in the food (e.g., ``leaf
lettuce, a sodium free food'').
(2) The terms ``very low sodium,'' or ``very low in sodium,'' may be
used on the label or in labeling of foods, except meal products as
defined in Sec. 101.13(l) and main dish products as defined in Sec.
101.13(m), provided that:
(i)(A) The food has a reference amount customarily consumed greater
than 30 grams (g) or greater than 2 tablespoons and contains 35 mg or
less sodium per reference amount customarily consumed; or
(B) The food has a reference amount customarily consumed of 30 g or
less or 2 tablespoons or less and contains 35 mg or less sodium per
reference amount customarily consumed and per 50 g (for dehydrated foods
that must be reconstituted before typical consumption with water or a
diluent containing an insignificant amount, as defined in Sec.
101.9(f)(1), of all nutrients per reference amount customarily consumed,
the per 50-g criterion refers to the ``as prepared'' form);
(ii) If the food meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to vary
the sodium content, it is labeled to clearly refer to all foods of its
type and not merely to the particular brand to which the label attaches
(e.g., ``potatoes, a very low-sodium food'').
(3) The terms defined in paragraph (b)(2) of this section may be
used on the label or in labeling of meal products as defined in Sec.
101.13(l) and main dish products as defined in Sec. 101.13(m), provided
that:
(i) The product contains 35 mg or less of sodium per 100 g of
product; and
(ii) If the product meets this condition without the benefit of
special processing, alteration, formulation, or reformulation to lower
the sodium content, it is labeled to clearly refer to all foods of its
type and not merely to the particular brand to which the label attaches.
(4) The terms ``low sodium,'' or ``low in sodium,'' ``little
sodium,'' ``contains a small amount of sodium,'' or ``low source of
sodium'' may be used on the label or in the labeling of foods, except
meal products as defined in Sec. 101.13(l) and main dish products as
defined in Sec. 101.13(m), provided that:
(i)(A) The food has a reference amount customarily consumed greater
than 30 g or greater than 2 tablespoons and contains 140 mg or less
sodium per reference amount customarily consumed; or
(B) The food has a reference amount customarily consumed of 30 g or
less or 2 tablespoons or less and contains 140 mg or less sodium per
reference amount customarily consumed and per
[[Page 105]]
50 g (for dehydrated foods that must be reconstituted before typical
consumption with water or a diluent containing an insignificant amount,
as defined in Sec. 101.9(f)(1), of all nutrients per reference amount
customarily consumed, the per 50-g criterion refers to the ``as
prepared'' form); and
(ii) If the food meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to vary
the sodium content, it is labeled to clearly refer to all foods of its
type and not merely to the particular brand to which the label attaches
(e.g., ``fresh spinach, a low sodium food''); and
(5) The terms defined in paragraph (b)(4) of this section may be
used on the label or in labeling of meal products as defined in Sec.
101.13(l) and main dish products as defined in Sec. 101.13(m), provided
that:
(i) The product contains 140 mg or less sodium per 100 g; and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the sodium content, it is labeled to clearly refer to all foods of its
type and not merely to the particular brand to which the label attaches.
(6) The terms ``reduced sodium,'' ``reduced in sodium,'' ``sodium
reduced,'' ``less sodium,'' ``lower sodium,'' or ``lower in sodium'' may
be used on the label or in labeling of foods, except meal products as
defined in Sec. 101.13(l) and main dish products as defined in Sec.
101.13(m), provided that:
(i) The food contains at least 25 percent less sodium per reference
amount customarily consumed than an appropriate reference food as
described in Sec. 101.13(j)(1).
(ii) As required for Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percent (or fraction)
that the sodium differs from the labeled food are declared in immediate
proximity to the most prominent such claim (e.g., ``reduced sodium ----
--, 50 percent less sodium than regular ------''); and
(B) Quantitative information comparing the level of the sodium in
the product per labeled serving with that of the reference food that it
replaces (e.g., ``Sodium content has been lowered from 300 to 150 mg per
serving.'') is declared adjacent to the most prominent claim or to the
nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located elsewhere
on the information panel in accordance with Sec. 101.2.
(iii) Claims described in paragraph (b)(6) of this section may not
be made on the label or in the labeling of a food if the nutrient
content of the reference food meets the definition for ``low sodium.''
(7) The terms defined in paragraph (b)(6) of this section may be
used on the label or in the labeling of meal products as defined in
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m),
provided that:
(i) The food contains at least 25 percent less sodium per 100 g of
food than an appropriate reference food as described in Sec.
101.13(j)(1), and
(ii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percent (or fraction)
that the sodium differs from the reference food are declared in
immediate proximity to the most prominent such claim (e.g., reduced
sodium eggplant parmigiana dinner ``30 percent less sodium per oz (or 3
oz) than our regular eggplant parmigiana dinner'').
(B) Quantitative information comparing the level of sodium in the
product per specified weight with that of the reference food that it
replaces (e.g., ``Sodium content has been reduced from 217 mg per 3 oz
to 150 mg per 3 oz.'') is declared adjacent to the most prominent claim
or to the nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located elsewhere
on the information panel in accordance with Sec. 101.2.
(iii) Claims described in paragraph (b)(7) of this section may not
be made on the label or in the labeling of a food if the nutrient
content of the reference food meets the definition for ``low sodium.''
(c) The term ``salt'' is not synonymous with ``sodium.'' Salt refers
to sodium chloride. However, references to salt content such as
``unsalted,'' ``no
[[Page 106]]
salt,'' ``no salt added'' are potentially misleading.
(1) The term ``salt free'' may be used on the label or in labeling
of foods only if the food is ``sodium free'' as defined in paragraph
(b)(1) of this section.
(2) The terms ``unsalted,'' ``without added salt,'' and ``no salt
added'' may be used on the label or in labeling of foods only if:
(i) No salt is added during processing;
(ii) The food that it resembles and for which it substitutes is
normally processed with salt; and
(iii) If the food is not sodium free, the statement, ``not a sodium
free food'' or ``not for control of sodium in the diet'' appears
adjacent to the nutrition label of the food bearing the claim, or, if
the nutrition label is on the information panel, it may appear elsewhere
on the information panel in accordance with Sec. 101.2.
(3) Paragraph (c)(2) of this section shall not apply to a factual
statement that a food intended specifically for infants and children
less than 2 years of age is unsalted, provided such statement refers to
the taste of the food and is not otherwise false and misleading.
[58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, 1993, as amended at 58
FR 44032, Aug. 18, 1993; 59 FR 394, Jan. 4, 1994; 60 FR 17206, Apr. 5,
1995]
Sec. 101.62 Nutrient content claims for fat, fatty acid, and cholesterol
content of foods.
(a) General requirements. A claim about the level of fat, fatty
acid, and cholesterol in a food may only be made on the label or in the
labeling of foods if:
(1) The claim uses one of the terms defined in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 101.13;
(3) The food for which the claim is made is labeled in accordance
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable; and
(4) For dietary supplements, claims for fat, saturated fat, and
cholesterol may not be made on products that meet the criteria in Sec.
101.60(b)(1) or (b)(2) for ``calorie free'' or ``low calorie'' claims.
(b) Fat content claims. (1) The terms ``fat free,'' ``free of fat,''
``no fat,'' ``zero fat,'' ``without fat,'' ``negligible source of fat,''
or ``dietarily insignificant source of fat'' or, in the case of milk
products, ``skim'' may be used on the label or in labeling of foods,
provided that:
(i) The food contains less than 0.5 gram (g) of fat per reference
amount customarily consumed and per labeled serving or, in the case of a
meal product or main dish product, less than 0.5 g of fat per labeled
serving; and
(ii) The food contains no added ingredient that is a fat or is
generally understood by consumers to contain fat unless the listing of
the ingredient in the ingredient statement is followed by an asterisk
that refers to the statement below the list of ingredients, which states
``adds a trivial amount of fat,'' ``adds a negligible amount of fat,''
or ``adds a dietarily insignificant amount of fat;'' and
(iii) As required in Sec. 101.13(e)(2), if the food meets these
conditions without the benefit of special processing, alteration,
formulation, or reformulation to lower fat content, it is labeled to
disclose that fat is not usually present in the food (e.g., ``broccoli,
a fat free food'').
(2) The terms ``low fat,'' ``low in fat,'' ``contains a small amount
of fat,'' ``low source of fat,'' or ``little fat'' may be used on the
label or in labeling of foods, except meal products as defined in Sec.
101.13(l) and main dish products as defined in Sec. 101.13(m), provided
that:
(i)(A) The food has a reference amount customarily consumed greater
than 30 g or greater than 2 tablespoons and contains 3 g or less of fat
per reference amount customarily consumed; or
(B) The food has a reference amount customarily consumed of 30 g or
less or 2 tablespoons or less and contains 3 g or less of fat per
reference amount customarily consumed and per 50 g of food (for
dehydrated foods that must be reconstituted before typical consumption
with water or a diluent containing an insignificant amount, as defined
in Sec. 101.9(f)(1), of all nutrients per reference amount customarily
consumed, the per 50-g criterion refers to the ``as prepared'' form);
and
[[Page 107]]
(ii) If the food meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
fat content, it is labeled to clearly refer to all foods of its type and
not merely to the particular brand to which the label attaches (e.g.,
``frozen perch, a low fat food'').
(3) The terms defined in paragraph (b)(2) of this section may be
used on the label or in labeling of meal products as defined in Sec.
101.13(l) or main dish products as defined in Sec. 101.13(m), provided
that:
(i) The product contains 3 g or less of total fat per 100 g and not
more than 30 percent of calories from fat; and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
fat content, it is labeled to clearly refer to all foods of its type and
not merely to the particular brand to which the label attaches.
(4) The terms ``reduced fat,'' ``reduced in fat,'' ``fat reduced,''
``less fat,'' ``lower fat,'' or ``lower in fat'' may be used on the
label or in the labeling of foods, except meal products as defined in
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m),
provided that:
(i) The food contains at least 25 percent less fat per reference
amount customarily consumed than an appropriate reference food as
described in Sec. 101.13(j)(1); and
(ii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percent (or fraction)
that the fat differs between the two foods and are declared in immediate
proximity to the most prominent such claim (e.g., ``reduced fat--50
percent less fat than our regular brownies''); and
(B) Quantitative information comparing the level of fat in the
product per labeled serving with that of the reference food that it
replaces (e.g., ``Fat content has been reduced from 8 g to 4 g per
serving.'') is declared adjacent to the most prominent claim or to the
nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located elsewhere
on the information panel in accordance with Sec. 101.2.
(iii) Claims described in paragraph (b)(4) of this section may not
be made on the label or in the labeling of a food if the nutrient
content of the reference food meets the definition for ``low fat.''
(5) The terms defined in paragraph (b)(4) of this section may be
used on the label or in the labeling of meal products as defined in
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m),
provided that:
(i) The food contains at least 25 percent less fat per 100 g of food
than an appropriate reference food as described in Sec. 101.13(j)(1);
and
(ii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percent (or fraction)
that the fat differs between the two foods are declared in immediate
proximity to the most prominent such claim (e.g., reduced fat spinach
souffle, ``33 percent less fat per 3 oz than our regular spinach
souffle''); and
(B) Quantitative information comparing the level of fat in the
product per specified weight with that of the reference food that it
replaces (e.g., ``Fat content has been reduced from 7.5 g per 3 oz to 5
g per 3 oz.'') is declared adjacent to the most prominent claim, to the
nutrition label, or, if the nutrition label is located on the
information panel, it may appear elsewhere on the information panel in
accordance with Sec. 101.2.
(iii) Claims described in paragraph (b)(5) of this section may not
be made on the label or in the labeling of a food if the nutrient
content of the reference food meets the definition for ``low fat.''
(6) The term ``-- percent fat free'' may be used on the label or in
the labeling of foods, provided that:
(i) The food meets the criteria for ``low fat'' in paragraph (b)(2)
or (b)(3) of this section;
(ii) The percent declared and the words ``fat free'' are in uniform
type size; and
(iii) A ``100 percent fat free'' claim may be made only on foods
that meet the criteria for ``fat free'' in paragraph (b)(1) of this
section, that contain less than 0.5 g of fat per 100 g, and that contain
no added fat.
(c) Fatty acid content claims. The label or labeling of foods that
bear claims
[[Page 108]]
with respect to the level of saturated fat shall disclose the level of
total fat and cholesterol in the food in immediate proximity to such
claim each time the claim is made and in type that shall be no less than
one-half the size of the type used for the claim with respect to the
level of saturated fat. Declaration of cholesterol content may be
omitted when the food contains less than 2 milligrams (mg) of
cholesterol per reference amount customarily consumed or in the case of
a meal or main dish product less than 2 mg of cholesterol per labeled
serving. Declaration of total fat may be omitted with the term defined
in paragraph (c)(1) of this section when the food contains less than 0.5
g of total fat per reference amount customarily consumed or, in the case
of a meal product or a main dish product, when the product contains less
than 0.5 g of total fat per labeled serving. The declaration of total
fat may be omitted with the terms defined in paragraphs (c)(2) through
(c)(5) of this section when the food contains 3 g or less of total fat
per reference amount customarily consumed or in the case of a meal
product or a main dish product, when the product contains 3 g or less of
total fat per 100 g and not more than 30 percent calories from fat.
(1) The terms ``saturated fat free,'' ``free of saturated fat,''
``no saturated fat,'' ``zero saturated fat,'' ``without saturated fat,''
``trivial source of saturated fat,'' ``negligible source of saturated
fat,'' or ``dietarily insignificant source of saturated fat'' may be
used on the label or in the labeling of foods, provided that:
(i) The food contains less than 0.5 g of saturated fat and less than
0.5 g trans fatty acid per reference amount customarily consumed and per
labeled serving, or in the case of a meal product or main dish product,
less than 0.5 g of saturated fat and less than 0.5 g trans fatty acid
per labeled serving; and
(ii) The food contains no ingredient that is generally understood by
consumers to contain saturated fat unless the listing of the ingredient
in the ingredient statement is followed by an asterisk that refers to
the statement below the list of ingredients which states, ``adds a
trivial amount of saturated fat,'' ``adds a negligible amount of
saturated fat,'' or ``adds a dietarily insignificant amount of saturated
fat;'' and
(iii) As required in Sec. 101.13(e)(2), if the food meets these
conditions without the benefit of special processing, alteration,
formulation, or reformulation to lower saturated fat content, it is
labeled to disclose that saturated fat is not usually present in the
food.
(2) The terms ``low in saturated fat,'' ``low saturated fat,''
``contains a small amount of saturated fat,'' ``low source of saturated
fat,'' or ``a little saturated fat'' may be used on the label or in the
labeling of foods, except meal products as defined in Sec. 101.13(l)
and main dish products as defined in Sec. 101.13(m), provided that:
(i) The food contains 1 g or less of saturated fatty acids per
reference amount customarily consumed and not more than 15 percent of
calories from saturated fatty acids; and
(ii) If a food meets these conditions without benefit of special
processing, alteration, formulation, or reformulation to lower saturated
fat content, it is labeled to clearly refer to all foods of its type and
not merely to the particular brand to which the label attaches (e.g.,
``raspberries, a low saturated fat food'').
(3) The terms defined in paragraph (c)(2) of this section may be
used on the label or in the labeling of meal products as defined in
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m),
provided that:
(i) The product contains 1 g or less of saturated fatty acids per
100 g and less than 10 percent calories from saturated fat; and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
saturated fat content, it is labeled to clearly refer to all foods of
its type and not merely to the particular brand to which the label
attaches.
(4) The terms ``reduced saturated fat,'' ``reduced in saturated
fat,'' ``saturated fat reduced,'' ``less saturated fat,'' ``lower
saturated fat,'' or ``lower in saturated fat'' may be used on the label
or in the labeling of foods, except as limited by Sec. 101.13(j)(1)(i)
and
[[Page 109]]
except meal products as defined in Sec. 101.13(l) and main dish
products as defined in Sec. 101.13(m), provided that:
(i) The food contains at least 25 percent less saturated fat per
reference amount customarily consumed than an appropriate reference food
as described in Sec. 101.13(j)(1); and
(ii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food and the percent (or fraction)
that the saturated fat differs between the two foods are declared in
immediate proximity to the most prominent such claim (e.g., ``reduced
saturated fat. Contains 50 percent less saturated fat than the national
average for nondairy creamers''); and
(B) Quantitative information comparing the level of saturated fat in
the product per labeled serving with that of the reference food that it
replaces (e.g., ``Saturated fat reduced from 3 g to 1.5 g per serving'')
is declared adjacent to the most prominent claim or to the nutrition
label, except that if the nutrition label is on the information panel,
the quantitative information may be located elsewhere on the information
panel in accordance with Sec. 101.2.
(iii) Claims described in paragraph (c)(4) of this section may not
be made on the label or in the labeling of a food if the nutrient
content of the reference food meets the definition for ``low saturated
fat.''
(5) The terms defined in paragraph (c)(4) of this section may be
used on the label or in the labeling of meal products as defined in
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m),
provided that:
(i) The food contains at least 25 percent less saturated fat per 100
g of food than an appropriate reference food as described in Sec.
101.13(j)(1), and
(ii) As required in Sec. 101.13(j)(2) for relative claims:
(A) The identity of the reference food, and the percent (or
fraction) that the fat differs between the two foods are declared in
immediate proximity to the most prominent such claim (e.g., reduced
saturated fat Macaroni and Cheese, ``33 percent less saturated fat per 3
oz than our regular Macaroni and Cheese'').
(B) Quantitative information comparing the level of saturated fat in
the product per specified weight with that of the reference food that it
replaces (e.g., ``Saturated fat content has been reduced from 2.5 g per
3 oz to 1.7 g per 3 oz.'') is declared adjacent to the most prominent
claim or to the nutrition label, except that if the nutrition label in
on the information panel, the quantitative information may be located
elsewhere on the information panel in accordance with Sec. 101.2.
(iii) Claims described in paragraph (c)(5) of this section may not
be made on the label or in the labeling of a food if the nutrient
content of the reference food meets the definition for ``low saturated
fat.''
(d) Cholesterol content claims. (1) The terms ``cholesterol free,''
``free of cholesterol,'' ``zero cholesterol,'' ``without cholesterol,''
``no cholesterol,'' ``trivial source of cholesterol,'' ``negligible
source of cholesterol,'' or ``dietarily insignificant source of
cholesterol'' may be used on the label or in the labeling of foods,
provided that:
(i) For foods that contain 13 g or less of total fat per reference
amount customarily consumed, per labeled serving, and per 50 g if the
reference amount customarily consumed is 30 g or less or 2 tablespoons
or less (for dehydrated foods that must be reconstituted before typical
consumption with water or a diluent containing an insignificant amount,
as defined in Sec. 101.9(f)(1), of all nutrients per reference amount
customarily consumed, the per 50-g criterion refers to the ``as
prepared'' form), or, in the case of meal products, 26.0 g or less total
fat per labeled serving, or, in the case of main dish products, 19.5 g
or less total fat per labeled serving:
(A) The food contains less than 2 mg of cholesterol per reference
amount customarily consumed and per labeling serving or, in the case of
a meal product or main dish product, less than 2 mg of cholesterol per
labeled serving; and
(B) The food contains no ingredient that is generally understood by
consumers to contain cholesterol, unless the listing of the ingredient
in the ingredient statement is followed by an asterisk that refers to
the statement
[[Page 110]]
below the list of ingredients, which states ``adds a trivial amount of
cholesterol,'' ``adds a negligible amount of cholesterol,'' or ``adds a
dietarily insignificant amount of cholesterol;'' and
(C) The food contains 2 g or less of saturated fatty acids per
reference amount customarily consumed or, in the case of a meal product
or main dish product, 2 g or less of saturated fatty acids per labeled
serving; and
(D) As required in Sec. 101.13(e)(2), if the food contains less
than 2 mg of cholesterol per reference amount customarily consumed or in
the case of a meal product or main dish product, less than 2 mg of
cholesterol per labeled serving without the benefit of special
processing, alteration, formulation, or reformulation to lower
cholesterol content, it is labeled to disclose that cholesterol is not
usually present in the food (e.g., ``applesauce, a cholesterol-free
food'').
(ii) For food that contain more than 13 g of total fat per reference
amount customarily consumed, per labeling serving, or per 50 g if the
reference amount customarily consumed is 30 g or less or 2 tablespoons
or less (for dehydrated foods that must be reconstituted before typical
consumption with water or a diluent containing an insignificant amount,
as defined in Sec. 101.9(f)(1), of all nutrients per reference amount
customarily consumed, the per 50-g criterion refers to the ``as
prepared'' form), or in the case of a meal product, more than 26 g of
total fat per labeled serving, or, in the case of a main dish product
more than 19.5 g of total fat per labeled serving:
(A) The food contains less than 2 mg of cholesterol per reference
amount customarily consumed and per labeling serving or, in the case of
a meal product or main dish product, less than 2 mg of cholesterol per
labeled serving; and
(B) The food contains no ingredient that is generally understood by
consumers to contain cholesterol, unless the listing of the ingredient
in the ingredient statement is followed by an asterisk that refers to
the statement below the list of ingredients, which states ``adds a
trivial amount of cholesterol,'' ``adds a negligible amount of
cholesterol,'' or ``adds a dietarily insignificant amount of
cholesterol;'' and
(C) The food contains 2 g or less of saturated fatty acids per
reference amount cutomarily consumed or, in the case of a meal product
or main dish product less than 2 g of saturated fatty acids per labeled
serving; and
(D) The label or labeling discloses the level of total fat in a
serving (as declared on the label) of the food. Such disclosure shall
appear in immediate proximity to such claim preceding any disclosure
statement required under Sec. 101.13(h) in type that shall be no less
than one-half the size of the type used for such claim. If the claim
appears on more than one panel, the disclosure shall be made on each
panel except for the panel that bears nutrition labeling. If the claim
appears more than once on a panel, the disclosure shall be made in
immediate proximity to the claim that is printed in the largest type;
and
(E) As required in Sec. 101.13(e)(2), if the food contains less
than 2 mg of cholesterol per reference amount customarily consumed or in
the case of a meal product or main dish product less than 2 mg of
cholesterol per labeled serving without the benefit of special
processing, alteration, formulation, or reformulation to lower
cholesterol content, it is labeled to disclose that cholesterol is not
usually present in the food (e.g., ``canola oil, a cholesterol-free
food, contains 14 g of fat per serving''); or
(F) If the food contains less than 2 mg of cholesterol per reference
amount customarily consumed or in the case of a meal product or main
dish product less than 2 mg of cholesterol per labeled serving only as a
result of special processing, alteration, formulation, or reformulation,
the amount of cholesterol is substantially less (i.e., meets
requirements of paragraph (d)(4)(ii)(A) of this section) than the food
for which it substitutes as specified in Sec. 101.13(d) that has a
significant (e.g., 5 percent or more of a national or regional market)
market share. As required in Sec. 101.13(j)(2) for relative claims:
(1) The identity of the reference food and the percent (or fraction)
that the cholesterol was reduced are declared in immediate proximity to
the most
[[Page 111]]
prominent such claim (e.g., ``cholesterol-free margarine, contains 100
percent less cholesterol than butter''); and
(2) Quantitative information comparing the level of cholesterol in
the product per labeled serving with that of the reference food that it
replaces (e.g., ``Contains no cholesterol compared with 30 mg
cholesterol in one serving of butter. Contains 13 g of fat per
serving.'') is declared adjacent to the most prominent claim or to the
nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located elsewhere
on the information panel in accordance with Sec. 101.2.
(2) The terms ``low in cholesterol,'' ``low cholesterol,''
``contains a small amount of cholesterol,'' ``low source of
cholesterol,'' or ``little cholesterol'' may be used on the label or in
the labeling of foods, except meal products as defined in Sec.
101.13(l) and main dish products as defined in Sec. 101.13(m), provided
that:
(i) For foods that have a reference amount customarily consumed
greater than 30 g or greater than 2 tablespoons and contain 13 g or less
of total fat per reference amount customarily consumed and per labeled
serving:
(A) The food contains 20 mg or less of cholesterol per reference
amount customarily consumed;
(B) The food contains 2 g or less of saturated fatty acids per
reference amount customarily consumed; and
(C) As required in Sec. 101.13(e)(2), if the food meets these
conditions without the benefit of special processing, alteration,
formulation, or reformulation to lower cholesterol content, it is
labeled to clearly refer to all foods of that type and not merely to the
particular brand to which the label attaches (e.g., ``low fat cottage
cheese, a low cholesterol food.'').
(ii) For foods that have a reference amount customarily consumed of
30 g or less or 2 tablespoons or less and contain 13 g or less of total
fat per reference amount customarily consumed, per labeled serving, and
per 50 g (for dehydrated foods that must be reconstituted before typical
consumption with water or a diluent containing an insignificant amount,
as defined in Sec. 101.9(f)(1), of all nutrients per reference amount
customarily consumed, the per 50-g criterion refers to the ``as
prepared'' form);
(A) The food contains 20 mg or less of cholesterol per reference
amount customarily consumed and per 50 g (for dehydrated foods that must
be reconstituted before typical consumption with water or a diluent
containing an insignificant amount, as defined in Sec. 101.9(f)(1), of
all nutrients per reference amount customarily consumed, the per 50-g
criterion refers to the ``as prepared'' form);
(B) The food contains 2 g or less of saturated fatty acids per
reference amount customarily consumed; and
(C) As required in Sec. 101.13(e)(2), if the food meets these
conditions without the benefit of special processing, alteration,
formulation, or reformulation to lower cholesterol content, it is
labeled to clearly refer to all foods of that type and not merely to the
particular brand to which the label attaches (e.g., ``low fat cottage
cheese, a low cholesterol food'').
(iii) For foods that have a reference amount customarily consumed
greater than 30 g or greater than 2 tablespoons and contain more than 13
g of total fat per reference amount customarily consumed or per labeled
serving,
(A) The food contains 20 mg or less of cholesterol per reference
amount customarily consumed;
(B) The food contains 2 g or less of saturated fatty acids per
reference amount customarily consumed;
(C) The label or labeling discloses the level of total fat in a
serving (as declared on the label) of the food. Such disclosure shall
appear in immediate proximity to such claim preceding any disclosure
statement required under Sec. 101.13(h) in type that shall be no less
than one-half the size of the type used for such claim. If the claim
appears on more than one panel, the disclosure shall be made on each
panel except for the panel that bears nutrition labeling. If the claim
is made more than once on a panel, the disclosure shall be made in
immediate proximity to the claim that is printed in the largest type;
and
(D) As required in Sec. 101.13(e)(2), if the food meets these
conditions without the benefit of special processing, alteration,
formulation, or reformulation to
[[Page 112]]
lower cholesterol content, it is labeled to clearly refer to all foods
of that type and not merely to the particular brand to which the label
attaches; or
(E) If the food contains 20 mg or less of cholesterol only as a
result of special processing, alteration, formulation, or reformulation,
the amount of cholesterol is substantially less (i.e., meets
requirements of paragraph (d)(4)(ii)(A) of this section) than the food
for which it substitutes as specified in Sec. 101.13(d) that has a
significant (e.g., 5 percent or more of a national or regional market)
market share. As required in Sec. 101.13(j)(2) for relative claims:
(1) The identity of the reference food and the percent (or fraction)
that the cholesterol has been reduced are declared in immediate
proximity to the most prominent such claim (e.g., ``low-cholesterol
peanut butter sandwich crackers, contains 83 percent less cholesterol
than our regular peanut butter sandwich crackers''); and
(2) Quantitative information comparing the level of cholesterol in
the product per labeled serving with that of the reference food that it
replaces (e.g., ``Cholesterol lowered from 30 mg to 5 mg per serving;
contains 13 g of fat per serving.'') is declared adjacent to the most
prominent claim or to the nutrition label, except that if the nutrition
label is on the information panel, the quantitative information may be
located elsewhere on the information panel in accordance with Sec.
101.2.
(iv) For foods that have a reference amount customarily consumed of
30 g or less or 2 tablespoons or less and contain more than 13 g of
total fat per reference amount customarily consumed, per labeled
serving, or per 50 g (for dehydrated foods that must be reconstituted
before typical consumption with water or a diluent containing an
insignificant amount, as defined in Sec. 101.9(f)(1), of all nutrients
per reference amount customarily consumed, the per 50-g criterion refers
to the ``as prepared'' form),
(A) The food contains 20 mg or less of cholesterol per reference
amount customarily consumed and per 50 g (for dehydrated foods that must
be reconstituted before typical consumption with water or a diluent
containing an insignificant amount, as defined in Sec. 101.9(f)(1), of
all nutrients per reference amount customarily consumed, the per 50-g
criterion refers to the ``as prepared'' form),
(B) The food contains 2 g or less of saturated fatty acids per
reference amount customarily consumed;
(C) The label or labeling discloses the level of total fat in a
serving (as declared on the label) of the food. Such disclosure shall
appear in immediate proximity to such claim preceding any disclosure
statement required under Sec. 101.13(h) in type that shall be no less
than one-half the size of the type used for such claim. If the claim
appears on more than one panel, the disclosure shall be made on each
panel except for the panel that bears nutrition labeling. If the claim
is made more than once on a panel, the disclosure shall be made in
immediate proximity to the claim that is printed in the largest type;
and
(D) As required in Sec. 101.13(e)(2), if the food meets these
conditions without the benefit of special processing, alteration,
formulation, or reformulation to lower cholesterol content, it is
labeled to clearly refer to all foods of that type and not merely to the
particular brand to which the label attaches; or
(E) If the food contains 20 mg or less of cholesterol only as a
result of special processing, alteration, formulation, or reformulation,
the amount of cholesterol is substantially less (i.e., meets
requirements of paragraph (d)(4)(ii)(A) of this section) than the food
for which it substitutes as specified in Sec. 101.13(d) that has a
significant (i.e., 5 percent or more of a national or regional market)
market share. As required in Sec. 101.13(j)(2) for relative claims:
(1) The identity of the reference food and the percent (or fraction)
that the cholesterol has been reduced are declared in immediate
proximity to the most prominent such claim (e.g., ``low-cholesterol
peanut butter sandwich crackers, contains 83 percent less cholesterol
than our regular peanut butter sandwich crackers''); and
(2) Quantitative information comparing the level of cholesterol in
the product per labeled serving with that of the reference food that it
replaces (e.g., ``Cholesterol lowered from 30 mg
[[Page 113]]
to 5 mg per serving; contains 13 g of fat per serving.'') is declared
adjacent to the most prominent claim or to the nutrition label, except
that if the nutrition label is on the information panel, the
quantitative information may be located elsewhere on the information
panel in accordance with Sec. 101.2.
(3) The terms defined in paragraph (d)(2) of this section may be
used on the label and in labeling of meal products as defined in Sec.
101.13(l) or a main dish product as defined in Sec. 101.13(m) provided
that the product meets the requirements of paragraph (d)(2) of this
section except that the determination as to whether paragraph (d)(2)(i)
or (d)(2)(iii) of this section applies to the product will be made only
on the basis of whether the meal product contains 26 g or less of total
fat per labeled serving or the main dish product contain 19.5 g or less
of total fat per labeled serving, the requirement in paragraphs
(d)(2)(i)(A) and (d)(2)(iii)(A) of this section shall be limited to 20
mg of cholesterol per 100 g, and the requirement in paragraphs
(d)(2)(i)(B) and (d)(2)(iii)(B) of this section shall be modified to
require that the food contain 2 g or less of saturated fat per 100 g
rather than per reference amount customarily consumed.
(4) The terms ``reduced cholesterol,'' ``reduced in cholesterol,''
``cholesterol reduced,'' ``less cholesterol,'' ``lower cholesterol,'' or
``lower in cholesterol'' except as limited by Sec. 101.13(j)(1)(i) may
be used on the label or in labeling of foods or foods that substitute
for those foods as specified in Sec. 101.13(d), excluding meal products
as defined in Sec. 101.13(l) and main dish products as defined in Sec.
101.13(m), provided that:
(i) For foods that contain 13 g or less of total fat per reference
amount customarily consumed, per labeled serving, and per 50 g if the
reference amount customarily consumed is 30 g or less or 2 tablespoons
or less (for dehydrated foods that must be reconstituted before typical
consumption with water or a diluent containing an insignificant amount,
as defined in Sec. 101.9(f)(1), of all nutrients per reference amount
customarily consumed, the per 50-g criterion refers to the ``as
prepared'' form):
(A) The food has been specifically formulated, altered, or processed
to reduce its cholesterol by 25 percent or more from the reference food
it resembles as defined in Sec. 101.13(j)(1) and for which it
substitutes as specified in Sec. 101.13(d) that has a significant
(i.e., 5 percent or more) market share; and
(B) The food contains 2 g or less of saturated fatty acids per
reference amount customarily consumed; and
(C) As required in Sec. 101.13(j)(2) for relative claims:
(1) The identity of the reference food and the percent (or fraction)
that the cholesterol has been reduced are declared in immediate
proximity to the most prominent such claim; and
(2) Quantitative information comparing the level of cholesterol in
the product per labeled serving with that of the reference food that it
replaces (e.g., ``[labeled product] 50 mg cholesterol per serving;
[reference product] 30 mg cholesterol per serving'') is declared
adjacent to the most prominent claim or to the nutrition label, except
that if the nutrition label is on the information panel, the
quantitative information may be located elsewhere on the information
panel in accordance with Sec. 101.2.
(ii) For foods that contain more than 13 g of total fat per
reference amount customarily consumed, per labeled serving, or per 50 g
if the reference amount customarily consumed is 30 g or less or 2
tablespoons or less (for dehydrated foods that must be reconstituted
before typical consumption with water or a diluent containing an
insignificant amount, as defined in Sec. 101.9(f)(1), of all nutrients
per reference amount customarily consumed, the per 50-g criterion refers
to the ``as prepared'' form):
(A) The food has been specifically formulated, altered, or processed
to reduce its cholesterol by 25 percent or more from the reference food
it resembles as defined in Sec. 101.13(j)(1) and for which it
substitutes as specified in Sec. 101.13(d) that has a significant
(i.e., 5 percent or more of a national or regional market) market share;
(B) The food contains 2 g or less of saturated fatty acids per
reference amount customarily consumed;
[[Page 114]]
(C) The label or labeling discloses the level of total fat in a
serving (as declared on the label) of the food. Such disclosure shall
appear in immediate proximity to such claim preceding any disclosure
statement required under Sec. 101.13(h) in type that shall be no less
than one-half the size of the type used for such claim. If the claim
appears on more than one panel, the disclosure shall be made on each
panel except for the panel that bears nutrition labeling. If the claim
is made more than once on a panel, the disclosure shall be made in
immediate proximity to the claim that is printed in the largest type;
and
(D) As required in Sec. 101.13(j)(2) for relative claims:
(1) The identity of the reference food and the percent (or fraction)
that the cholesterol has been reduced are declared in immediate
proximity to the most prominent such claim (e.g., 25 percent less
cholesterol than ------); and
(2) Quantitative information comparing the level of cholesterol in
the product per labeled serving with that of the reference food that it
replaces (e.g., ``Cholesterol lowered from 55 mg to 30 mg per serving.
Contains 13 g of fat per serving.'') is declared adjacent to the most
prominent claim or to the nutrition label, except that if the nutrition
label is on the information panel, the quantitative information may be
located elsewhere on the information panel in accordance with Sec.
101.2.
(iii) Claims described in paragraph (d)(4) of this section may not
be made on the label or in labeling of a food if the nutrient content of
the reference food meets the definition for ``low cholesterol.''
(5) The terms defined in paragraph (d)(4) of this section may be
used on the label or in the labeling of meal products as defined in
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m),
provided that:
(i) For meal products that contain 26.0 g or less of total fat per
labeled serving or for main dish products that contain 19.5 g or less of
total fat per labeled serving;
(A) The food has been specifically formulated, altered, or processed
to reduce its cholesterol by 25 percent or more from the reference food
it resembles as defined in Sec. 101.13(j)(1) and for which it
substitutes as specified in Sec. 101.13(d) that has a significant
(e.g., 5 percent or more of a national or regional market) market share;
(B) The food contains 2 g or less of saturated fatty acids per 100
g; and
(C) As required in Sec. 101.13(j)(2) for relative claims:
(1) The identity of the reference food, and the percent (or
fraction) that the cholesterol has been reduced are declared in
immediate proximity to the most prominent such claim (e.g., ``25% less
cholesterol per 3 oz than ------); and
(2) Quantitative information comparing the level of cholesterol in
the product per specified weight with that of the reference food that it
replaces (e.g., ``Cholesterol content has been reduced from 35 mg per 3
oz to 25 mg per 3 oz.'') is declared adjacent to the most prominent
claim or to the nutrition label, except that if the nutrition label is
on the information panel, the quantitative information may be located
elsewhere on the information panel in accordance with Sec. 101.2.
(ii) For meal products that contain more than 26.0 g of total fat
per labeled serving or for main dish products that contain more than
19.5 g of total fat per labeled serving:
(A) The food has been specifically formulated, altered, or processed
to reduce its cholesterol by 25 percent or more from the reference food
it resembles as defined in Sec. 101.13(j)(1) and for which it
substitutes as specified in Sec. 101.13(d) that has a significant
(e.g., 5 percent or more of a national or regional market) market share.
(B) The food contains 2 g or less of saturated fatty acids per 100
g;
(C) The label or labeling discloses the level of total fat in a
serving (as declared on the label) of the food. Such disclosure shall
appear in immediate proximity to such claim preceding any disclosure
statement required under Sec. 101.13(h) in type that shall be no less
than one-half the size of the type used for such claim. If the claim
appears on more than one panel the disclosure shall be made on each
panel except for the panel that bears nutrition labeling. If the claim
is made more than once on a panel, the disclosure shall be made in
[[Page 115]]
immediate proximity to the claim that is printed in the largest type;
and
(D) As required in Sec. 101.13(j)(2) for relative claims:
(1) The identity of the reference food and the percent (or fraction)
that the cholesterol has been reduced are declared in immediate
proximity to the most prominent such claim (e.g., 25 percent less
cholesterol than ------); and
(2) Quantitative information comparing the level of cholesterol in
the product per specified weight with that of the reference food that it
replaces (e.g., ``Cholesterol lowered from 30 mg to 22 mg per 3 oz of
product.'') is declared adjacent to the most prominent claim or to the
nutrition label, except that if the nutrition label is on the
information panel, the quantitative information may be located elsewhere
on the information panel in accordance with Sec. 101.2.
(iii) Claims described in paragraph (d)(5) of this section may not
be made on the label or in the labeling of a food if the nutrient
content of the reference food meets the definition for ``low
cholesterol.''
(e) ``Lean'' and ``extra lean'' claims. (1) The term ``lean'' may be
used on the label or in labeling of foods except meal products as
defined in Sec. 101.13(l) and main dish products as defined in Sec.
101.13(m) provided that the food is a seafood or game meat product and
as packaged contains less than 10 g total fat, 4.5 g or less saturated
fat, and less than 95 mg cholesterol per reference amount customarily
consumed and per 100 g;
(2) The term defined in paragraph (e)(1) of this section may be used
on the label or in labeling of a mixed dish not measurable with a cup as
defined in Sec. 101.12(b) in table 2, provided that the food contains
less than 8 g total fat, 3.5 g or less saturated fat and less than 80 mg
cholesterol per reference amount customarily consumed;
(3) The term defined in paragraph (e)(1) of this section may be used
on the label or in the labeling of meal products as defined in Sec.
101.13(l) or main dish products as defined in Sec. 101.13(m) provided
that the food contains less than 10 g total fat, 4.5 g or less saturated
fat, and less than 95 mg cholesterol per 100 g and per labeled serving;
(4) The term ``extra lean'' may be used on the label or in the
labeling of foods except meal products as defined in Sec. 101.13(l) and
main dish products as defined in Sec. 101.13(m) provided that the food
is a discrete seafood or game meat product and as packaged contains less
than 5 g total fat, less than 2 g saturated fat, and less than 95 mg
cholesterol per reference amount customarily consumed and per 100 g; and
(5) The term defined in paragraph (e)(4) of this section may be used
on the label or in labeling of meal products as defined in Sec.
101.13(l) and main dish products as defined in Sec. 101.13(m) provided
that the food contains less than 5 g of fat, less than 2 g of saturated
fat, and less than 95 mg of cholesterol per 100 g and per labeled
serving.
(f) Misbranding. Any label or labeling containing any statement
concerning fat, fatty acids, or cholesterol that is not in conformity
with this section shall be deemed to be misbranded under sections
201(n), 403(a), and 403(r) of the Federal Food, Drug, and Cosmetic Act.
[58 FR 2413, Jan. 6, 1993; 58 FR 17342, 17343, Apr. 2, 1993, as amended
at 58 FR 44032, Aug. 18, 1993; 58 FR 60105, Nov. 15, 1993; 59 FR 394,
Jan. 4, 1994; 60 FR 17207, Apr. 5, 1995; 61 FR 59001, Nov. 20, 1996; 63
FR 26980, May 15, 1998; 72 FR 1459, Jan. 12, 2007]
Sec. 101.65 Implied nutrient content claims and related label statements.
(a) General requirements. An implied nutrient content claim can only
be made on the label and in labeling of the food if:
(1) The claim uses one of the terms described in this section in
accordance with the definition for that term;
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 101.13; and
(3) The food for which the claim is made is labeled in accordance
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable.
(b) Label statements that are not implied claims. Certain label
statements about the nature of a product are not nutrient content claims
unless such statements are made in a context that would make them an
implied claim under Sec. 101.13(b)(2). The following types
[[Page 116]]
of label statements are generally not implied nutrient content claims
and, as such, are not subject to the requirements of Sec. 101.13 and
this section:
(1) A claim that a specific ingredient or food component is absent
from a product, provided that the purpose of such claim is to facilitate
avoidance of the substances because of food allergies (see Sec. 105.62
of this chapter), food intolerance, religious beliefs, or dietary
practices such as vegetarianism or other nonnutrition related reason,
e.g., ``100 percent milk free;''
(2) A claim about a substance that is nonnutritive or that does not
have a nutritive function, e.g., ``contains no preservatives,'' ``no
artificial colors;''
(3) A claim about the presence of an ingredient that is perceived to
add value to the product, e.g., ``made with real butter,'' ``made with
whole fruit,'' or ``contains honey,'' except that claims about the
presence of ingredients other than vitamins or minerals or that are
represented as a source of vitamins and minerals are not allowed on
labels or in labeling of dietary supplements of vitamins and minerals
that are not in conventional food form.
(4) A statement of identity for a food in which an ingredient
constitutes essentially 100 percent of a food (e.g., ``corn oil,'' ``oat
bran,'' ``dietary supplement of vitamin C 60 mg tablet'').
(5) A statement of identity that names as a characterizing
ingredient, an ingredient associated with a nutrient benefit (e.g.,
``corn oil margarine,'' ``oat bran muffins,'' or ``whole wheat
bagels''), unless such claim is made in a context in which label or
labeling statements, symbols, vignettes, or other forms of communication
suggest that a nutrient is absent or present in a certain amount; and
(6) A label statement made in compliance with a specific provision
of part 105 of this chapter, solely to note that a food has special
dietary usefulness relative to a physical, physiological, pathological,
or other condition, where the claim identifies the special diet of which
the food is intended to be a part.
(c) Particular implied nutrient content claims. (1) Claims about the
food or an ingredient therein that suggest that a nutrient or an
ingredient is absent or present in a certain amount (e.g., ``high in oat
bran'') are implied nutrient content claims and must comply with
paragraph (a) of this section.
(2) The phrases ``contains the same amount of [nutrient] as a
[food]'' and ``as much [nutrient] as a [food]'' may be used on the label
or in the labeling of foods, provided that the amount of the nutrient in
the reference food is enough to qualify that food as a ``good source''
of that nutrient, and the labeled food, on a per serving basis, is an
equivalent, good source of that nutrient (e.g., ``as much fiber as an
apple,'' ``Contains the same amount of Vitamin C as an 8 oz glass of
orange juice.'').
(3) Claims may be made that a food contains or is made with an
ingredient that is known to contain a particular nutrient, or is
prepared in a way that affects the content of a particular nutrient in
the food, if the finished food is either ``low'' in or a ``good source''
of the nutrient that is associated with the ingredient or type of
preparation. If a more specific level is claimed (e.g., ``high in ------
), that level of the nutrient must be present in the food. For example,
a claim that a food contains oat bran is a claim that it is a good
source of dietary fiber; that a food is made only with vegetable oil is
a claim that it is low in saturated fat; and that a food contains no oil
is a claim that it is fat free.
(d) General nutritional claims. (1) This paragraph covers labeling
claims that are implied nutrient content claims because they:
(i) Suggest that a food because of its nutrient content may help
consumers maintain healthy dietary practices; and
(ii) Are made in connection with an explicit or implicit claim or
statement about a nutrient (e.g., ``healthy, contains 3 grams of fat'').
(2) You may use the term ``healthy'' or related terms (e.g.,
``health,'' ``healthful,'' ``healthfully,'' ``healthfulness,''
``healthier,'' ``healthiest,'' ``healthily,'' and ``healthiness'') as an
implied nutrient content claim on the label or in labeling of a food
that is useful in creating a diet that is consistent with dietary
recommendations if:
[[Page 117]]
(i) The food meets the following conditions for fat, saturated fat,
cholesterol, and other nutrients:
------------------------------------------------------------------------
The The
If the food The fat saturated cholesterol The food
is... level must fat level level must must
be... must be... be... contain...
------------------------------------------------------------------------
(A) A raw fruit Low fat as Low The N/A
or vegetable defined in saturated disclosure
Sec. fat as level for
101.62(b)( defined in cholesterol
2) Sec. specified in
101.62(c)(2 Sec.
) 101.13(h) or
less
------------------------------------------------------------------------
(B) A single- Low fat as Low The N/A
ingredient or a defined in saturated disclosure
mixture of Sec. fat as level for
frozen or 101.62(b)( defined in cholesterol
canned fruits 2) Sec. specified in
and 101.62(c)(2 Sec.
vegetables\1\ ) 101.13(h) or
less
------------------------------------------------------------------------
(C) An enriched Low fat as Low The N/A
cereal-grain defined in saturated disclosure
product that Sec. fat as level for
conforms to a 101.62(b)( defined in cholesterol
standard of 2) Sec. specified in
identity in 101.62(c)(2 Sec.
part 136, 137 ) 101.13(h) or
or 139 of this less
chapter
------------------------------------------------------------------------
(D) A raw, Less than 5 Less than 2 Less than 95 At least 10
single- grams (g) g saturated mg percent of
ingredient total fat fat per RA cholesterol the RDI\3\
seafood or game per RA\2\ and per 100 per RA and or the
meat and per g per 100 g DRV\4\ per
100 g RA of one
or more of
vitamin A,
vitamin C,
calcium,
iron,
protein, or
fiber
------------------------------------------------------------------------
(E) A meal Low fat as Low 90 mg or less At least 10
product as defined in saturated cholesterol percent of
defined in Sec. Sec. fat as per LS\5\ the RDI or
101.13(l) or 101.62(b)( defined in DRV per LS
a main dish 3) Sec. of two
product as 101.62(c)(3 nutrients
defined in Sec. ) (for a main
101.13(m) dish
product) or
of three
nutrients
(for a meal
product)
of: vitamin
A, vitamin
C, calcium,
iron,
protein, or
fiber
------------------------------------------------------------------------
(F) A food not Low fat as Low The At least 10
specifically defined in saturated disclosure percent of
listed in this Sec. fat as level for the RDI or
table 101.62(b)( defined in cholesterol the DRV per
2) Sec. specified in RA of one
101.62(c)(2 Sec. or more of
) 101.13(h) or vitamin A,
less vitamin C,
calcium,
iron,
protein or
fiber
------------------------------------------------------------------------
\1\ May include ingredients whose addition does not change the nutrient
profile of the fruit or vegetable.
\2\ RA means Reference Amount Customarily Consumed per Eating Occasion
(Sec. 101.12(b)).
\3\ RDI means Reference Daily Intake (Sec. 101.9(c)(8)(iv)).
\4\ DRV means Daily Reference Value (Sec. 101.9(c)(9)).
\5\ LS means Labeled Serving, i.e., the serving size that is specified
in the nutrition information on the product label (Sec. 101.9(b)).
(ii) The food meets the following conditions for sodium:
------------------------------------------------------------------------
If the food is... The sodium level must be...
------------------------------------------------------------------------
(A) A food with a RA that is 480 mg or less sodium per RA and
greater than 30 g or 2 tablespoons per LS
(tbsp.)
------------------------------------------------------------------------
(B) A food with a RA that is equal 480 mg or less sodium per 50 g\1\
to or less than 30 g or 2 tbsp.
------------------------------------------------------------------------
(C) A meal product as defined in 600 mg or less sodium per LS
Sec. 101.13(l) or a main dish
product as defined in Sec.
101.13(m)
------------------------------------------------------------------------
\1\ For dehydrated food that is typically reconstituted with water or a
liquid that contains insignificant amounts per RA of all nutrients (as
defined in Sec. 101.9(f)(1)), the 50 g refers to the ``prepared''
form of the product.
(iii) The food complies with the definition and declaration
requirements in this part 101 for any specific nutrient content claim on
the label or in labeling, and
(iv) If you add a nutrient to the food specified in paragraphs
(d)(2)(i)(D), (d)(2)(i)(E), or (d)(2)(i)(F) of this section to meet the
10 percent requirement, that addition must be in accordance
[[Page 118]]
with the fortification policy for foods in Sec. 104.20 of this chapter.
[58 FR 2413, Jan. 6, 1993; 58 FR 17343, Apr. 2, 1993, as amended at 59
FR 394, Jan. 4, 1994; 59 FR 24249, May 10, 1994; 59 FR 50828, Oct. 6,
1994; 62 FR 49858, Sept. 23, 1997; 63 FR 14355, Mar. 25, 1998; 70 FR
56848, Sept. 29, 2005]
Sec. 101.67 Use of nutrient content claims for butter.
(a) Claims may be made to characterize the level of nutrients,
including fat, in butter if:
(1) The claim complies with the requirements of Sec. 101.13 and
with the requirements of the regulations in this subpart that define the
particular nutrient content claim that is used and how it is to be
presented. In determining whether a claim is appropriate, the
calculation of the percent fat reduction in milkfat shall be based on
the 80 percent milkfat requirement provided by the statutory standard
for butter (21 U.S.C. 321a);
(2) The product contains cream or milk, including milk constituents
(including, but not limited to, whey, casein, modified whey, and salts
of casein), or both, with or without added salt, with or without safe
and suitable colorings, with or without nutrients added to comply with
paragraph (a)(3) of this section, and with or without safe and suitable
bacterial cultures. The product may contain safe and suitable
ingredients to improve texture, prevent syneresis, add flavor, extend
shelf life, improve appearance, and add sweetness. The product may
contain water to replace milkfat although the amount of water in the
product shall be less than the amount of cream, milk, or milk
constituents;
(3) The product is not nutritionally inferior, as defined in Sec.
101.3(e)(4), to butter as produced under 21 U.S.C. 321a; and
(4) If the product would violate 21 U.S.C. 321a but for the nutrient
content claim that characterizes the level of nutrients, that claim
shall be an explicit claim that is included as part of the common or
usual name of the product.
(b) Deviations from the ingredient provisions of 21 U.S.C. 321a must
be the minimum necessary to achieve similar performance characteristics
as butter as produced under 21 U.S.C. 321a, or the food will be deemed
to be adulterated under section 402(b) of the act. The performance
characteristics (e.g., physical properties, organoleptic
characteristics, functional properties, shelf life) of the product shall
be similar to butter as produced under 21 U.S.C. 321a. If there is a
significant difference in performance characteristics (that materially
limits the uses of the product compared to butter,) the label shall
include a statement informing the consumer of such difference (e.g., if
appropriate, ``not recommended for baking purposes''). Such statement
shall comply with the requirements of Sec. 101.13(d). The modified
product shall perform at least one of the principal functions of butter
substantially as well as butter as produced under 21 U.S.C. 321a.
(c)(1) Each of the ingredients used in the food shall be declared on
the label as required by the applicable sections of this part.
(2) Safe and suitable ingredients added to improve texture, prevent
syneresis, add flavor, extend shelf life, improve appearance, or add
sweetness and water added to replace milkfat shall be identified with an
asterisk in the ingredient statement. The statement ``*Ingredients not
in regular butter'' shall immediately follow the ingredient statement in
the same type size.
[58 FR 2455, Jan. 6, 1993]
Sec. 101.69 Petitions for nutrient content claims.
(a) This section pertains to petitions for claims, expressed or
implied, that:
(1) Characterize the level of any nutrient which is of the type
required to be in the label or labeling of food by section 403(q)(1) or
(q)(2) of the Federal Food, Drug, and Cosmetic Act (the act); and
(2) That are not exempted under section 403(r)(5)(A) through
(r)(5)(C) of the act from the requirements for such claims in section
403(r)(2).
(b) Petitions included in this section are:
(1) Petitions for a new (heretofore unauthorized) nutrient content
claim;
(2) Petitions for a synonymous term (i.e., one that is consistent
with a term defined by regulation) for characterizing the level of a
nutrient; and
[[Page 119]]
(3) Petitions for the use of an implied claim in a brand name.
(c) An original and one copy of the petition to be filed under the
provisions of section 403(r)(4) of the act shall be submitted, or the
petitioner may submit an original and a computer readable disk
containing the petition. Contents of the disk should be in a standard
format, such as ASCII format. Petitioners interested in submitting a
disk should contact the Food and Drug Administration's (FDA) Center for
Food Safety and Applied Nutrition for details. If any part of the
material submitted is in a foreign language, it shall be accompanied by
an accurate and complete English translation. The petition shall state
the petitioner's post office address to which published notices as
required by section 403 of the act may be sent.
(d) Pertinent information may be incorporated in, and will be
considered as part of, a petition on the basis of specific reference to
such information submitted to and retained in the files of FDA. However,
any reference to unpublished information furnished by a person other
than the applicant will not be considered unless use of such information
is authorized (with the understanding that such information may in whole
or part be subject to release to the public) in a written statement
signed by the person who submitted it. Any reference to published
information should be accompanied by reprints or photostatic copies of
such references.
(e) If nonclinical laboratory studies are included in a petition
submitted under section 403(r)(4) of the act, the petition shall
include, with respect to each nonclinical study contained in the
petition, either a statement that the study has been, or will be,
conducted in compliance with the good laboratory practice regulations as
set forth in part 58 of this chapter or, if any such study was not
conducted in compliance with such regulations, a brief statement of the
reason for the noncompliance.
(f) If clinical investigations are included in a petition submitted
under section 403(r)(4) of the act, the petition shall include a
statement regarding each such clinical investigation relied upon in the
petition that the study either was conducted in compliance with the
requirements for institutional review set forth in part 56 of this
chapter or was not subject to such requirements in accordance with Sec.
56.104 or Sec. 56.105 of this chapter, and that it was conducted in
compliance with the requirements for informed consent set forth in part
50 of this chapter.
(g) The availability for public disclosure of petitions submitted to
the agency under this section will be governed by the rules specified in
Sec. 10.20(j) of this chapter.
(h) All petitions submitted under this section shall include either
a claim for a categorical exclusion under Sec. 25.30 or 25.32 of this
chapter or an environmental assessment under Sec. 25.40 of this
chapter.
(i) The data specified under the several lettered headings should be
submitted on separate sheets or sets of sheets, suitably identified. If
such data have already been submitted with an earlier application from
the petitioner, the present petition may incorporate it by specific
reference to the earlier petition.
(j) The petition must be signed by the petitioner or by his attorney
or agent, or (if a corporation) by an authorized official.
(k) The petition shall include a statement signed by the person
responsible for the petition, that to the best of his knowledge, it is a
representative and balanced submission that includes unfavorable
information, as well as favorable information, known to him pertinent to
the evaluation of the petition.
(l) All applicable provisions of part 10--Administrative Practices
and Procedures, may be used by FDA, the petitioner or any outside party
with respect to any agency action on the petition.
(m)(1) Petitions for a new nutrient content claim shall include the
following data and be submitted in the following form.
(Date) ------------
Name of petitioner ------------
Post office address ------------
Subject of the petition ------------
Office of Nutritional Products, Labeling and Dietary Supplements (HFS-
800)
Food and Drug Administration,
Department of Health and Human Services,
Washington, DC 20204.
To Whom It May Concern:
[[Page 120]]
The undersigned, ------------------------ submits this petition
under section 403(r)(4) of the Federal Food, Drug, and Cosmetic Act (the
act) with respect to (statement of the claim and its proposed use).
Attached hereto and constituting a part of this petition, are the
following:
A. A statement identifying the descriptive term and the nutrient
that the term is intended to characterize with respect to the level of
such nutrient. The statement should address why the use of the term as
proposed will not be misleading. The statement should provide examples
of the nutrient content claim as it will be used on labels or labeling,
as well as the types of foods on which the claim will be used. The
statement shall specify the level at which the nutrient must be present
or what other conditions concerning the food must be met for the use of
the term in labels or labeling to be appropriate, as well as any factors
that would make the use of the term inappropriate.
B. A detailed explanation, supported by any necessary data, of why
use of the food component characterized by the claim is of importance in
human nutrition by virtue of its presence or absence at the levels that
such claim would describe. This explanation shall also state what
nutritional benefit to the public will derive from use of the claim as
proposed, and why such benefit is not available through the use of
existing terms defined by regulation under section 403(r)(2)(A)(i) of
the act. If the claim is intended for a specific group within the
population, the analysis should specifically address nutritional needs
of such group, and should include scientific data sufficient for such
purpose.
C. Analytical data that shows the amount of the nutrient that is the
subject of the claim and that is present in the types of foods for which
the claim is intended. The assays should be performed on representative
samples using the AOAC INTERNATIONAL (AOAC International) methods where
available. If no AOAC International method is available, the petitioner
shall submit the assay method used, and data establishing the validity
of the method for assaying the nutrient in the particular food. The
validation data should include a statistical analysis of the analytical
and product variability.
D. A detailed analysis of the potential effect of the use of the
proposed claim on food consumption and of any corresponding changes in
nutrient intake. The latter item shall specifically address the intake
of nutrients that have beneficial and negative consequences in the total
diet. If the claim is intended for a specific group within the
population, the above analysis shall specifically address the dietary
practices of such group and shall include data sufficient to demonstrate
that the dietary analysis is representative of such group.
E. The petitioner is required to submit either a claim for
categorical exclusion under Sec. 25.30 or Sec. 25.32 of this chapter
or an environmental assessment under Sec. 25.40 of this chapter.
Yours very truly,
Petitioner ------------
By ------------
(Indicate authority)
(2) Within 15 days of receipt of the petition, the petitioner will
be notified by letter of the date on which the petition was received by
the agency. Such notice will inform the petitioner:
(i) That the petition is undergoing agency review (in which case a
docket number will be assigned to the petition), and the petitioner will
subsequently be notified of the agency's decision to file or deny the
petition; or
(ii) That the petition is incomplete, e.g., it lacks any of the data
required by this part, it presents such data in a manner that is not
readily understood, or it has not been submitted in quadruplicate, in
which case the petition will be denied, and the petitioner will be
notified as to what respect the petition is incomplete.
(3) Within 100 days of the date of receipt of the petition, FDA will
notify the petitioner by letter that the petition has either been filed
or denied. If denied, the notification shall state the reasons therefor.
If filed, the date of the notification letter becomes the date of filing
for the purposes of section 403(r)(4)(A)(i) of the act. If FDA does not
act within such 100 days, the petition shall be deemed to be denied
unless an extension is mutually agreed upon by the FDA and the
petitioner. A petition that has been denied, or has been deemed to be
denied, without filing shall not be made available to the public. A
filed petition shall be available to the public as provided under
paragraph (g) of this section.
(4) Within 90 days of the date of filing FDA will by letter of
notification to the petitioner:
(i) Deny the petition; or
(ii) Inform the petitioner that a proposed regulation to provide for
the requested use of the new term will be published in the Federal
Register. FDA will publish the proposal to amend the regulations to
provide for the requested use of the nutrient content claim in the
Federal Register
[[Page 121]]
within 90 days of the date of filing. The proposal will also announce
the availability of the petition for public disclosure.
(iii) If FDA does not act within 90 days of the date of filing, the
petition shall be deemed to be denied unless an extension is mutually
agreed upon by FDA and the petitioner.
(5) If FDA issues a proposal, the rulemaking shall be completed
within 540 days of the date of receipt of the petition.
(n)(1) Petitions for a synonymous term shall include the following
data and be submitted in the following form.
(Date)------------
Name of petitioner ------------
Post office address ------------
Subject of the petition ------------
Office of Nutritional Products, Labeling and Dietary Supplements (HFS-
800)
Food and Drug Administration,
Department of Health and Human Services,
Washington, DC 20204.
To Whom It May Concern:
The undersigned, ------------ submits this petition under section
403(r)(4) of the Federal Food, Drug, and Cosmetic Act (the act) with
respect to (statement of the synonymous term and its proposed use in a
nutrient content claim that is consistent with an existing term that has
been defined under section 403(r)(2) of the act).
Attached hereto and constituting a part of this petition, are the
following:
A. A statement identifying the synonymous descriptive term, the
existing term defined by a regulation under section 403(r)(2)(A)(i) of
the act with which the synonymous term is claimed to be consistent. The
statement should address why the proposed synonymous term is consistent
with the term already defined by the agency, and why the use of the
synonymous term as proposed will not be misleading. The statement should
provide examples of the nutrient content claim as it will be used on
labels or labeling, as well as the types of foods on which the claim
will be used. The statement shall specify whether any limitations not
applicable to the use of the defined term are intended to apply to the
use of the synonymous term.
B. A detailed explanation, supported by any necessary data, of why
use of the proposed term is requested, including an explanation of
whether the existing defined term is inadequate for the purpose of
effectively characterizing the level of a nutrient. This item shall also
state what nutritional benefit to the public will derive from use of the
claim as proposed, and why such benefit is not available through the use
of existing term defined by regulation. If the claim is intended for a
specific group within the population, the analysis should specifically
address nutritional needs of such group, and should include scientific
data sufficient for such purpose.
C. The petitioner is required to submit either a claim for
categorical exclusion under Sec. 25.30 or Sec. 25.32 of this chapter
or an environmental assessment under Sec. 25.40 of this chapter.
Yours very truly,
Petitioner ------------
By ------------
(Indicate authority)
(2) Within 15 days of receipt of the petition the petitioner will be
notified by letter of the date on which the petition was received. Such
notice will inform the petitioner:
(i) That the petition is undergoing agency review (in which case a
docket number will be assigned to the petition) and the petitioner will
subsequently be notified of the agency's decision to grant the
petitioner permission to use the proposed term or to deny the petition;
or
(ii) That the petition is incomplete, e.g., it lacks any of the data
required by this part, it presents such data in a manner that is not
readily understood, or it has not been submitted in quadruplicate, in
which case the petition will be denied, and the petitioner will be
notified as to what respect the petition is incomplete.
(3) Within 90 days of the date of receipt of the petition that is
accepted for review (i.e., that has not been found to be incomplete and
consequently denied, FDA will notify the petitioner by letter of the
agency's decision to grant the petitioner permission to use the proposed
term, with any conditions or limitations on such use specified, or to
deny the petition, in which case the letter shall state the reasons
therefor. Failure of the petition to fully address the requirements of
this section shall be grounds for denial of the petition.
(4) As soon as practicable following the agency's decision to either
grant or deny the petition, FDA will publish a notice in the Federal
Register informing the public of his decision. If the petition is
granted the Food and Drug Administration will list, the approved
synonymous term in the regulations listing terms permitted for use in
nutrient content claims.
[[Page 122]]
(o)(1) Petitions for the use of an implied nutrient content claim in
a brand name shall include the following data and be submitted in the
following form:
(Date)------------
Name of petitioner ------------
Post office address ------------
Subject of the petition ------------
Office of Nutritional Products, Labeling and Dietary Supplements (HFS-
800),
Food and Drug Administration,
Department of Health and Human Services,
Washington, DC 20204.
To Whom It May Concern:
The undersigned, ---------------------- submits this petition under
section 403(r)(4) of the Federal Food, Drug, and Cosmetic Act (the act)
with respect to (statement of the implied nutrient content claim and its
proposed use in a brand name).
Attached hereto and constituting a part of this petition, are the
following:
A. A statement identifying the implied nutrient content claim, the
nutrient the claim is intended to characterize, the corresponding term
for characterizing the level of such nutrient as defined by a regulation
under section 403(r)(2)(A)(i) of the act, and the brand name of which
the implied claim is intended to be a part. The statement should address
why the use of the brandname as proposed will not be misleading. It
should address in particular what information is required to accompany
the claim or other ways in which the claim meets the requirements of
sections 201(n) and 403(a) of the act. The statement should provide
examples of the types of foods on which the brand name will appear. It
shall also include data showing that the actual level of the nutrient in
the food qualifies the food to bear the corresponding term defined by
regulation. Assay methods used to determine the level of a nutrient
should meet the requirements stated under petition format item C in
paragraph (k)(1) of this section.
B. A detailed explanation, supported by any necessary data, of why
use of the proposed brand name is requested. This item shall also state
what nutritional benefit to the public will derive from use of the brand
name as proposed. If the branded product is intended for a specific
group within the population, the analysis should specifically address
nutritional needs of such group and should include scientific data
sufficient for such purpose.
C. The petitioner is required to submit either a claim for
categorical exclusion under Sec. 25.30 or Sec. 25.32 of this chapter
or an environmental assessment under Sec. 25.40 of this chapter.
Yours very truly,
Petitioner ------------
By ------------
(2) Within 15 days of receipt of the petition the petitioner will be
notified by letter of the date on which the petition was received. Such
notice will inform the petitioner:
(i) That the petition is undergoing agency review (in which case a
docket number will be assigned to the petition); or
(ii) That the petition is incomplete, e.g., it lacks any of the data
required by this part, it presents such data in a manner that is not
readily understood, or it has not been submitted in quadruplicate, in
which case the petition will be denied, and the petitioner will be
notified as to what respect the petition is incomplete.
(3) FDA will publish a notice of the petition in the Federal
Register announcing its availability to the public and seeking comment
on the petition. The petition shall be available to the public to the
extent provided under paragraph (g) of this section. The notice shall
allow 30 days for comments.
(4) Within 100 days of the date of receipt of the petition that is
accepted for review (i.e., that has not been found to be incomplete and
subsequently returned to the petitioner), FDA will:
(i) Notify the petitioner by letter of the agency's decision to
grant the petitioner permission to use the proposed brand name if such
use is not misleading, with any conditions or limitations on such use
specified; or
(ii) Deny the petition, in which case the letter shall state the
reasons therefor. Failure of the petition to fully address the
requirements of this section shall be grounds for denial of the
petition. Should FDA not notify the petitioner of his decision on the
petition within 100 days, the petition shall be considered to be
granted.
(5) As soon as practicable following the granting of a petition, the
Commissioner of Food and Drugs will publish a notice in the Federal
Register informing the public of such fact.
[58 FR 2413, Jan. 6, 1993; 58 FR 17343, Apr. 2, 1993, as amended at 58
FR 44033, Aug. 18, 1993; 62 FR 40598, July 29, 1997; 63 FR 26718, May
14, 1998; 63 FR 40024, July 27, 1998; 67 FR 9585, Mar. 4, 2002; 69 FR
16481, Mar. 30, 2004]
[[Page 123]]
Subpart E_Specific Requirements for Health Claims
Sec. 101.70 Petitions for health claims.
(a) Any interested person may petition the Food and Drug
Administration (FDA) to issue a regulation regarding a health claim. An
original and one copy of the petition shall be submitted, or the
petitioner may submit an original and a computer readable disk
containing the petition. Contents of the disk should be in a standard
format, such as ASCII format. (Petitioners interested in submitting a
disk should contact the Center for Food Safety and Applied Nutrition for
details.) If any part of the material submitted is in a foreign
language, it shall be accompanied by an accurate and complete English
translation. The petition shall state the petitioner's post office
address to which any correspondence required by section 403 of the
Federal Food, Drug, and Cosmetic Act may be sent.
(b) Pertinent information may be incorporated in, and will be
considered as part of, a petition on the basis of specific reference to
such information submitted to and retained in the files of FDA. Such
information may include any findings, along with the basis of the
findings, of an outside panel with expertise in the subject area. Any
reference to published information shall be accompanied by reprints, or
easily readable copies of such information.
(c) If nonclinical laboratory studies are included in a petition,
the petition shall include, with respect to each nonclinical study
contained in the petition, either a statement that the study has been
conducted in compliance with the good laboratory practice regulations as
set forth in part 58 of this chapter, or, if any such study was not
conducted in compliance with such regulations, a brief statement of the
reason for the noncompliance.
(d) If clinical or other human investigations are included in a
petition, the petition shall include a statement that they were either
conducted in compliance with the requirements for institutional review
set forth in part 56 of this chapter, or were not subject to such
requirements in accordance with Sec. 56.104 or Sec. 56.105, and a
statement that they were conducted in compliance with the requirements
for informed consent set forth in part 50 of this chapter.
(e) All data and information in a health claim petition are
available for public disclosure after the notice of filing of petition
is issued to the petitioner, except that clinical investigation reports,
adverse reaction reports, product experience reports, consumer
complaints, and other similar data and information shall only be
available after deletion of:
(1) Names and any information that would identify the person using
the product.
(2) Names and any information that would identify any third party
involved with the report, such as a physician or hospital or other
institution.
(f) Petitions for a health claim shall include the following data
and be submitted in the following form:
(Date)------------
Name of petitioner ------------
Post office address ------------
Subject of the petition ------------
Food and Drug Administration,
Office of Nutritional Products, Labeling and Dietary Supplements (HFS-
800),
5100 Paint Branch Pkwy.,
College Park, MD 20740,
The undersigned, ------------------ submits this petition pursuant
to section 403(r)(4) or 403(r)(5)(D) of the Federal Food, Drug, and
Cosmetic Act with respect to (statement of the substance and its health
claim).
Attached hereto, and constituting a part of this petition, are the
following:
A. Preliminary requirements. A complete explanation of how the
substance conforms to the requirements of Sec. 101.14(b) (21 CFR
101.14(b)). For petitions where the subject substance is a food
ingredient or a component of a food ingredient, the petitioner should
compile a comprehensive list of the specific ingredients that will be
added to the food to supply the substance in the food bearing the health
claim. For each such ingredient listed, the petitioner should state how
the ingredient complies with the requirements of Sec. 101.14(b)(3)(ii),
e.g., that its use is generally recognized as safe (GRAS), listed as a
food additive, or authorized by a prior sanction issued by the agency,
and what the basis is for the GRAS claim, the food additive status, or
prior sanctioned status.
B. Summary of scientific data. The summary of scientific data
provides the basis upon which authorizing a health claim can be
justified as providing the health benefit. The summary must establish
that, based on
[[Page 124]]
the totality of publicly available scientific evidence (including
evidence from well-designed studies conducted in a manner which is
consistent with generally recognized scientific procedures and
principles), there is significant scientific agreement among experts
qualified by scientific training and experience to evaluate such claims,
that the claim is supported by such evidence.
The summary shall state what public health benefit will derive from
use of the claim as proposed. If the claim is intended for a specific
group within the population, the summary shall specifically address
nutritional needs of such group and shall include scientific data
showing how the claim is likely to assist in meeting such needs.
The summary shall concentrate on the findings of appropriate review
articles, National Institutes of Health consensus development
conferences, and other appropriate resource materials. Issues addressed
in the summary shall include answers to such questions as:
1. Is there an optimum level of the particular substance to be
consumed beyond which no benefit would be expected?
2. Is there any level at which an adverse effect from the substance
or from foods containing the substance occurs for any segment of the
population?
3. Are there certain populations that must receive special
consideration?
4. What other nutritional or health factors (both positive and
negative) are important to consider when consuming the substance?
In addition, the summary of scientific data shall include a detailed
analysis of the potential effect of the use of the proposed claim on
food consumption, specifically any change due to significant alterations
in eating habits and corresponding changes in nutrient intake resulting
from such changes in food consumption. The latter item shall
specifically address the effect on the intake of nutrients that have
beneficial and negative consequences in the total diet.
If the claim is intended for a significant subpopulation within the
general U.S. population, the analysis shall specifically address the
dietary practices of such group, and shall include data sufficient to
demonstrate that the dietary analysis is representative of such group
(e.g., adolescents or the elderly).
If appropriate, the petition shall explain the prevalence of the
disease or health-related condition in the U.S. population and the
relevance of the claim in the context of the total daily diet.
Also, the summary shall demonstrate that the substance that is the
subject of the proposed claim conforms to the definition of the term
``substance'' in Sec. 101.14(a)(2).
C. Analytical data that show the amount of the substance that is
present in representative foods that would be candidates to bear the
claim should be obtained from representative samples using methods from
the AOAC INTERNATIONAL (AOAC), where available. If no AOAC method is
available, the petitioner shall submit the assay method used and data
establishing the validity of the method for assaying the substance in
food. The validation data should include a statistical analysis of the
analytical and product variability.
D. Model health claim. One or more model health claims that
represent label statements that may be used on a food label or in
labeling for a food to characterize the relationship between the
substance in a food to a disease or health-related condition that is
justified by the summary of scientific data provided in section C of the
petition. The model health claim shall include:
1. A brief capsulized statement of the relevant conclusions of the
summary, and
2. A statement of how this substance helps the consumer to attain a
total dietary pattern or goal associated with the health benefit that is
provided.
E. The petition shall include the following attachments:
1. Copies of any computer literature searches done by the petitioner
(e.g., Medline).
2. Copies of articles cited in the literature searches and other
information as follows:
a. All information relied upon for the support of the health claim,
including copies of publications or other information cited in review
articles and used to perform meta-analyses.
b. All information concerning adverse consequences to any segment of
the population (e.g., sensitivity to the substance).
c. All information pertaining to the U.S. population.
F. The petitioner is required to submit either a claim for
categorical exclusion under Sec. 25.30 or Sec. 25.32 of this chapter
or an environmental assessment under Sec. 25.40 of this chapter.
Yours very truly,
Petitioner ------------
By ------------
(Indicate authority)
(g) The data specified under the several lettered headings should be
submitted on separate pages or sets of pages, suitably identified. If
such data have already been submitted with an earlier application from
the petitioner or any other final petition, the present petition may
incorporate it by specific reference to the earlier petition.
(h) The petition shall include a statement signed by the person
responsible for the petition that, to the best of his/her knowledge, it
is a representative and balanced submission that includes
[[Page 125]]
unfavorable information as well as favorable information, known to him/
her to be pertinent to the evaluation of the proposed health claim.
(i) The petition shall be signed by the petitioner or by his/her
attorney or agent, or (if a corporation) by an authorized official.
(j) Agency action on the petition. (1) Within 15 days of receipt of
the petition, the petitioner will be notified by letter of the date on
which the petition was received. Such notice will inform the petitioner
that the petition is undergoing agency review and that the petitioner
will subsequently be notified of the agency's decision to file for
comprehensive review or deny the petition.
(2) Within 100 days of the date of receipt of the petition, FDA will
notify the petitioner by letter that the petition has either been filed
for comprehensive review or denied. The agency will deny a petition
without reviewing the information contained in ``B. Summary of
Scientific Data'' if the information in ``A. Preliminary Requirements''
is inadequate in explaining how the substance conforms to the
requirements of Sec. 101.14(b). If the petition is denied, the
notification will state the reasons therefor, including justification of
the rejection of any report from an authoritative scientific body of the
U.S. Government. If filed, the date of the notification letter becomes
the date of filing for the purposes of this regulation. If FDA does not
act within such 100 days, the petition shall be deemed to be denied
unless an extension is mutually agreed upon by FDA and the petitioner. A
petition that has been denied, or has been deemed to be denied, without
filing will not be made available to the public. A filed petition will
be available to the public to the extent provided under paragraph (e) of
this section.
(3) Within 90 days of the date of filing, FDA will by letter of
notification to the petitioner:
(i) Deny the petition, or
(ii) Inform the petitioner that a proposed regulation to provide for
the requested use of the health claim will be published in the Federal
Register. If the petition is denied, the notification will state the
reasons therefor, including justification for the rejection of any
report from an authoritative scientific body of the U.S. Government. FDA
will publish the proposal to amend the regulations to provide for the
requested use of the health claim in the Federal Register within 90 days
of the date of filing. The proposal will also announce the availability
of the petition for public review.
(iii) If FDA does not act within 90 days of the date of filing, the
petition shall be deemed to be denied unless an extension is mutually
agreed upon by FDA and the petitioner.
(4)(i) Within 270 of the date of publication of the proposal, FDA
will publish a final rule that either authorizes use of the health claim
or explains why the agency has decided not to authorize one.
(ii) For cause, FDA may extend, no more than twice, the period in
which it will publish a final rule; each such extension will be for no
more than 90 days. FDA will publish a notice of each extension in the
Federal Register. The document will state the basis for the extension,
the length of the extension, and the date by which the final rule will
be published, which date shall be within 540 days of the date of receipt
of the petition.
[58 FR 2534, Jan. 6, 1993; 58 FR 17097, Apr. 1, 1993, as amended at 59
FR 425, Jan. 4, 1994; 62 FR 28232, May 22, 1997; 62 FR 40599, July 29,
1997; 63 FR 26719, May 14, 1998; 63 FR 40024, July 27, 1998; 66 FR
56035, Nov. 6, 2001]
Sec. 101.71 Health claims: claims not authorized.
Health claims not authorized for foods in conventional food form or
for dietary supplements of vitamins, minerals, herbs, or other similar
substances:
(a) Dietary fiber and cardiovascular disease.
(b) Zinc and immune function in the elderly.
[58 FR 2534, Jan. 6, 1993, as amended at 58 FR 2548, 2578, 2620, 2639,
2664, 2714, Jan. 6, 1993; 58 FR 17100, Apr. 1, 1993; 59 FR 437, Jan. 4,
1994; 65 FR 58918, Oct. 3, 2000]
Sec. 101.72 Health claims: calcium, vitamin D, and osteoporosis.
(a) Relationship between calcium, vitamin D, and osteoporosis. An
inadequate
[[Page 126]]
intake of calcium or calcium and vitamin D contributes to low peak bone
mass, which has been identified as one of many risk factors in the
development of osteoporosis. Peak bone mass is the total quantity of
bone present at maturity, and experts believe that it has the greatest
bearing on whether a person will be at risk of developing osteoporosis
and related bone fractures later in life. Another factor that influences
total bone mass and susceptibility to osteoporosis is the rate of bone
loss after skeletal maturity. Vitamin D is required for normal
absorption of calcium and to prevent the occurrence of high serum
parathyroid hormone (PTH) concentration, which stimulates mobilization
of calcium from the skeleton and can lower bone mass. Calcium, along
with vitamin D and several other nutrients, is required for normal bone
mineralization. While vitamin D is required for optimal bone
mineralization, it is more effective when calcium intake is adequate. An
adequate intake of calcium and vitamin D is thought to exert a positive
effect during adolescence and early adulthood in optimizing the amount
of bone that is laid down. However, the upper limit of peak bone mass is
genetically determined. The mechanism through which adequate intakes of
calcium and vitamin D and optimal peak bone mass reduce the risk of
osteoporosis is thought to be as follows. All persons lose bone with
age. Hence, those with higher bone mass at maturity take longer to reach
the critically reduced mass at which bones can fracture easily. The rate
of bone loss after skeletal maturity also influences the amount of bone
present at old age and can influence an individual's risk of developing
osteoporosis. Maintenance of adequate intakes of calcium and vitamin D
later in life is thought to be important in reducing the rate of bone
loss particularly in the elderly and in women during the first decade
following menopause, but a significant protective effect is also seen
among men and younger women.
(b) Significance of calcium or calcium and vitamin D. Adequate
calcium intake, or adequate calcium and vitamin D intake, is not the
only recognized risk factor in the development of osteoporosis, which is
a multifactorial bone disease. Maintenance of adequate calcium and
vitamin D intakes throughout life is necessary to achieve optimal peak
bone mass and to reduce the risk of osteoporosis in later life. However,
vitamin D is most effective in this regard when calcium intake is
adequate. Increasing intake of calcium has been shown to have beneficial
effects on bone health independent of dietary vitamin D.
(c) Requirements. (1) All requirements set forth in Sec. 101.14
shall be met.
(2) Specific requirements--(i) Nature of the claim. A health claim
associating calcium or, when appropriate, calcium and vitamin D with a
reduced risk of osteoporosis may be made on the label or labeling of a
food described in paragraphs (c)(2)(ii) and (d)(1) of this section,
provided that:
(A) The claim makes clear the importance of adequate calcium intake,
or when appropriate, adequate calcium and vitamin D intake, throughout
life, in a healthful diet, are essential to reduce osteoporosis risk.
The claim does not imply that adequate calcium intake, or when
appropriate, adequate calcium and vitamin D intake, is the only
recognized risk factor for the development of osteoporosis;
(B) The claim does not attribute any degree of reduction in risk of
osteoporosis to maintaining an adequate dietary calcium intake, or when
appropriate, an adequate dietary calcium and vitamin D intake,
throughout life.
(ii) Nature of the food. (A) The food shall meet or exceed the
requirements for a ``high'' level of calcium as defined in Sec.
101.54(b);
(B) The calcium content of the product shall be assimilable;
(C) Dietary supplements shall meet the United States Pharmacopeia
(USP) standards for disintegration and dissolution applicable to their
component calcium salts, except that dietary supplements for which no
USP standards exist shall exhibit appropriate assimilability under the
conditions of use stated on the product label;
(D) A food or total daily recommended supplement intake shall not
contain more phosphorus than calcium on a weight per weight basis.
[[Page 127]]
(d) Optional information. (1) The claim may include the term
``vitamin D'' if the food meets or exceeds the requirements for a
``high'' level of vitamin D as defined in Sec. 101.54(b);
(2) The claim may include information from paragraphs (a) and (b) of
this section.
(3) The claim may make reference to physical activity.
(4) The claim may include information on the number of people in the
United States, including the number of people in certain subpopulations
in the United States, who have osteoporosis or low bone density. The
sources of this information must be identified, and it must be current
information from the National Center for Health Statistics, the National
Institutes of Health, or the National Osteoporosis Foundation.
(5) The claim may state that the role of adequate calcium intake, or
when appropriate, the role of adequate calcium and vitamin D intake,
throughout life is linked to reduced risk of osteoporosis through the
mechanism of optimizing peak bone mass during adolescence and early
adulthood. The phrase ``build and maintain good bone health'' may be
used to convey the concept of optimizing peak bone mass. The claim may
also state that adequate intake of calcium, or when appropriate,
adequate intake of calcium and vitamin D, is linked to reduced risk of
osteoporosis through the mechanism of slowing the rate of bone loss for
persons with a family history of the disease, post-menopausal women, and
elderly men and women.
(e) Model health claims. The following model health claims may be
used in food labeling to describe the relationship between calcium and
osteoporosis:
Adequate calcium throughout life, as part of a well-balanced diet, may
reduce the risk of osteoporosis.
Adequate calcium as part of a healthful diet, along with physical
activity, may reduce the risk of osteoporosis in later life.
(f) Model additional health claims for calcium and vitamin D. The
following model health claims may be used in food labeling to describe
the relationship between calcium, vitamin D, and osteoporosis:
Adequate calcium and vitamin D throughout life, as part of a well-
balanced diet, may reduce the risk of osteoporosis.
Adequate calcium and vitamin D as part of a healthful diet, along with
physical activity, may reduce the risk of osteoporosis in later life.
[73 FR 56486, Sept. 29, 2008]
Sec. 101.73 Health claims: dietary lipids and cancer.
(a) Relationship between fat and cancer. (1) Cancer is a
constellation of more than 100 different diseases, each characterized by
the uncontrolled growth and spread of abnormal cells. Cancer has many
causes and stages in its development. Both genetic and environmental
risk factors may affect the risk of cancer. Risk factors include a
family history of a specific type of cancer, cigarette smoking, alcohol
consumption, overweight and obesity, ultraviolet or ionizing radiation,
exposure to cancer-causing chemicals, and dietary factors.
(2) Among dietary factors, the strongest positive association has
been found between total fat intake and risk of some types of cancer.
Based on the totality of the publicly available scientific evidence,
there is significant scientific agreement among experts, qualified by
training and experience to evaluate such evidence, that diets high in
total fat are associated with an increased cancer risk. Research to
date, although not conclusive, demonstrates that the total amount of
fats, rather than any specific type of fat, is positively associated
with cancer risk. The mechanism by which total fat affects cancer has
not yet been established.
(3) A question that has been the subject of considerable research is
whether the effect of fat on cancer is site-specific. Neither human nor
animal studies are consistent in the association of fat intake with
specific cancer sites.
(4) Another question that has been raised is whether the association
of total fat intake to cancer risk is independently associated with
energy intakes, or whether the association of fat with cancer risk is
the result of the higher energy (caloric) intake normally associated
with high fat intake. FDA has concluded that evidence from
[[Page 128]]
both animal and human studies indicates that total fat intake alone,
independent of energy intake, is associated with cancer risk.
(b) Significance of the relationship between fat intake and risk of
cancer. (1) Cancer is ranked as a leading cause of death in the United
States. The overall economic costs of cancer, including direct health
care costs and losses due to morbidity and mortality, are very high.
(2) U.S. diets tend to be high in fat and high in calories. The
average U.S. diet is estimated to contain 36 to 37 percent of calories
from total fat. Current dietary guidelines from the Federal Government
and other national health professional organizations recommend that
dietary fat intake be reduced to a level of 30 percent or less of energy
(calories) from total fat. In order to reduce intake of total fat,
individuals should choose diets which are high in vegetables, fruits,
and grain products (particularly whole grain products), choose lean cuts
of meats, fish, and poultry, substitute low-fat dairy products for
higher fat products, and use fats and oils sparingly.
(c) Requirements. (1) All requirements set forth in Sec. 101.14
shall be met.
(2) Specific requirements--(i) Nature of the claim. A health claim
associating diets low in fat with reduced risk of cancer may be made on
the label or labeling of a food described in paragraph (c)(2)(ii) of
this section, provided that:
(A) The claim states that diets low in fat ``may'' or ``might''
reduce the risk of some cancers;
(B) In specifying the disease, the claim uses the following terms:
``some types of cancer'' or ``some cancers'';
(C) In specifying the nutrient, the claim uses the term ``total
fat'' or ``fat'';
(D) The claim does not specify types of fat or fatty acid that may
be related to the risk of cancer;
(E) The claim does not attribute any degree of cancer risk reduction
to diets low in fat; and
(F) The claim indicates that the development of cancer depends on
many factors.
(ii) Nature of the food. The food shall meet all of the nutrient
content requirements of Sec. 101.62 for a ``low fat'' food; except that
fish and game meats (i.e., deer, bison, rabbit, quail, wild turkey,
geese, ostrich) may meet the requirements for ``extra lean'' in Sec.
101.62.
(d) Optional information. (1) The claim may identify one or more of
the following risk factors for development of cancer: Family history of
a specific type of cancer, cigarette smoking, alcohol consumption,
overweight and obesity, ultraviolet or ionizing radiation, exposure to
cancer-causing chemicals, and dietary factors.
(2) The claim may include information from paragraphs (a) and (b) of
this section which summarize the relationship between dietary fat and
cancer and the significance of the relationship.
(3) The claim may indicate that it is consistent with ``Nutrition
and Your Health: Dietary Guidelines for Americans,'' U.S. Department of
Agriculture (USDA) and Department of Health and Human Services (DHHS),
Government Printing Office.
(4) The claim may include information on the number of people in the
United States who have cancer. The sources of this information must be
identified, and it must be current information from the National Center
for Health Statistics, the National Institutes of Health, or ``Nutrition
and Your Health: Dietary Guidelines for Americans,'' USDA and DHHS,
Government Printing Office.
(e) Model health claims. The following model health claims may be
used in food labeling to describe the relationship between dietary fat
and cancer:
(1) Development of cancer depends on many factors. A diet low in
total fat may reduce the risk of some cancers.
(2) Eating a healthful diet low in fat may help reduce the risk of
some types of cancers. Development of cancer is associated with many
factors, including a family history of the disease, cigarette smoking,
and what you eat.
[58 FR 2801, Jan. 6, 1993; 58 FR 17343, Apr. 2, 1993]
Sec. 101.74 Health claims: sodium and hypertension.
(a) Relationship between sodium and hypertension (high blood
pressure). (1) Hypertension, or high blood pressure,
[[Page 129]]
generally means a systolic blood pressure of greater than 140
millimeters of mercury (mm Hg) or a diastolic blood pressure of greater
than 90 mm Hg. Normotension, or normal blood pressure, is a systolic
blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm
Hg. Sodium is specified here as the chemical entity or electrolyte
``sodium'' and is distinguished from sodium chloride, or salt, which is
39 percent sodium by weight.
(2) The scientific evidence establishes that diets high in sodium
are associated with a high prevalence of hypertension or high blood
pressure and with increases in blood pressure with age, and that diets
low in sodium are associated with a low prevalence of hypertension or
high blood pressure and with a low or no increase of blood pressure with
age.
(b) Significance of sodium in relation to high blood pressure. (1)
High blood pressure is a public health concern primarily because it is a
major risk factor for mortality from coronary heart disease and stroke.
Early management of high blood pressure is a major public health goal
that can assist in reducing mortality associated with coronary heart
disease and stroke. There is a continuum of mortality risk that
increases as blood pressures rise. Individuals with high blood pressure
are at greatest risk, and individuals with moderately high, high normal,
and normal blood pressure are at steadily decreasing risk. The
scientific evidence indicates that reducing sodium intake lowers blood
pressure and associated risks in many but not all hypertensive
individuals. There is also evidence that reducing sodium intake lowers
blood pressure and associated risks in many but not all normotensive
individuals as well.
(2) The populations at greatest risk for high blood pressure, and
those most likely to benefit from sodium reduction, include those with
family histories of high blood pressure, the elderly, males because they
develop hypertension earlier in life than females, and black males and
females. Although some population groups are at greater risk than
others, high blood-pressure is a disease of public health concern for
all population groups. Sodium intake, alcohol consumption, and obesity
are identified risk factors for high blood pressure.
(3) Sodium intakes exceed recommended levels in almost every group
in the United States. One of the major public health recommendations
relative to high blood pressure is to decrease consumption of salt. On a
population-wide basis, reducing the average sodium intake would have a
small but significant effect on reducing the average blood pressure,
and, consequently, reducing mortality from coronary heart disease and
stroke.
(4) Sodium is an essential nutrient, and experts have recommended a
safe minimum level of 500 milligrams (mg) sodium per day and an upper
level of 2,400 mg sodium per day, the FDA Daily Value for sodium.
(c) Requirements. (1) All requirements set forth in Sec. 101.14
shall be met.
(2) Specific requirements--(i) Nature of the claim. A health claim
associating diets low in sodium with reduced risk of high blood pressure
may be made on the label or labeling of a food described in paragraph
(c)(2)(ii) of this section, provided that:
(A) The claim states that diets low in sodium ``may'' or ``might''
reduce the risk of high blood pressure;
(B) In specifying the disease, the claim uses the term ``high blood
pressure'';
(C) In specifying the nutrient, the claim uses the term ``sodium'';
(D) The claim does not attribute any degree of reduction in risk of
high blood pressure to diets low in sodium; and
(E) The claim indicates that development of high blood pressure
depends on many factors.
(ii) Nature of the food. The food shall meet all of the nutrient
content requirements of Sec. 101.61 for a ``low sodium'' food.
(d) Optional information. (1) The claim may identify one or more of
the following risk factors for development of high blood pressure in
addition to dietary sodium consumption: Family history of high blood
pressure, growing older, alcohol consumption, and excess weight.
(2) The claim may include information from paragraphs (a) and (b) of
this
[[Page 130]]
section, which summarizes the relationship between dietary sodium and
high blood pressure and the significance of the relationship.
(3) The claim may include information on the number of people in the
United States who have high blood pressure. The sources of this
information must be identified, and it must be current information from
the National Center for Health Statistics, the National Institutes of
Health, or ``Nutrition and Your Health: Dietary Guidelines for
Americans,'' U.S. Department of Health and Human Services (DHHS) and
U.S. Department of Argiculture (USDA), Government Printing Office.
(4) The claim may indicate that it is consistent with ``Nutrition
and Your Health: U.S. Dietary Guidelines for Americans, DHHS and USDA,
Government Printing Office.
(5) In specifying the nutrient, the claim may include the term
``salt'' in addition to the term ``sodium.''
(6) In specifying the disease, the claim may include the term
``hypertension'' in addition to the term ``high blood pressure.''
(7) The claim may state that individuals with high blood pressure
should consult their physicians for medical advice and treatment. If the
claim defines high or normal blood pressure, then the health claim must
state that individuals with high blood pressure should consult their
physicians for medical advice and treatment.
(e) Model health claims. The following are model health claims that
may be used in food labeling to describe the relationship between
dietary sodium and high blood pressure:
(1) Diets low in sodium may reduce the risk of high blood pressure,
a disease associated with many factors.
(2) Development of hypertension or high blood pressure depends on
many factors. [This product] can be part of a low sodium, low salt diet
that might reduce the risk of hypertension or high blood pressure.
[58 FR 2836, Jan. 6, 1993; 58 FR 17100, Apr. 1, 1993]
Sec. 101.75 Health claims: dietary saturated fat and cholesterol and risk of
coronary heart disease.
(a) Relationship between dietary saturated fat and cholesterol and
risk of coronary heart disease. (1) Cardiovascular disease means
diseases of the heart and circulatory system. Coronary heart disease is
the most common and serious form of cardiovascular disease and refers to
diseases of the heart muscle and supporting blood vessels. High blood
total- and low density lipoprotein (LDL)- cholesterol levels are major
modifiable risk factors in the development of coronary heart disease.
High coronary heart disease rates occur among people with high blood
cholesterol levels of 240 milligrams/decaliter (mg/dL) (6.21 millimoles
per liter (mmol/L)) or above and LDL-cholesterol levels of 160 mg/dL
(4.13 mmol/L) or above. Borderline high risk blood cholesterol levels
range from 200 to 239 mg/dL (5.17 to 6.18 mmol/L) and 130 to 159 mg/dL
(3.36 to 4.11 mmol/L) of LDL-cholesterol. Dietary lipids (fats) include
fatty acids and cholesterol. Total fat, commonly referred to as fat, is
composed of saturated fat (fatty acids containing no double bonds), and
monounsaturated and polyunsaturated fat (fatty acids containing one or
more double bonds).
(2) The scientific evidence establishes that diets high in saturated
fat and cholesterol are associated with increased levels of blood total-
and LDL-cholesterol and, thus, with increased risk of coronary heart
disease. Diets low in saturated fat and cholesterol are associated with
decreased levels of blood total- and LDL-cholesterol, and thus, with
decreased risk of developing coronary heart disease.
(b) Significance of the relationship between dietary saturated fat
and cholesterol and risk of coronary heart disease. (1) Coronary heart
disease is a major public health concern in the United States, primarily
because it accounts for more deaths than any other disease or group of
diseases. Early management of risk factors for coronary heart disease is
a major public health goal that can assist in reducing risk of coronary
heart disease. There is a continuum of mortality risk from coronary
heart disease that increases with
[[Page 131]]
increasing levels of blood LDL-cholesterol. Individuals with high blood
LDL-cholesterol are at greatest risk. A larger number of individuals
with more moderately elevated cholesterol also have increased risk of
coronary events; such individuals comprise a substantial proportion of
the adult U.S. population. The scientific evidence indicates that
reducing saturated fat and cholesterol intakes lowers blood LDL-
cholesterol and risk of heart disease in most individuals. There is also
evidence that reducing saturated fat and cholesterol intakes in persons
with blood cholesterol levels in the normal range also reduces risk of
heart disease.
(2) Other risk factors for coronary heart disease include a family
history of heart disease, high blood pressure, diabetes, cigarette
smoking, obesity (body weight 30 percent greater than ideal body
weight), and lack of regular physical exercise.
(3) Intakes of saturated fat exceed recommended levels in many
people in the United States. Intakes of cholesterol are, on average, at
or above recommended levels. One of the major public health
recommendations relative to coronary heart disease risk is to consume
less than 10 percent of calories from saturated fat, and an average of
30 percent or less of total calories from all fat. Recommended daily
cholesterol intakes are 300 mg or less per day.
(c) Requirements. (1) All requirements set forth in Sec. 101.14
shall be met.
(2) Specific requirements--(i) Nature of the claim. A health claim
associating diets low in saturated fat and cholesterol with reduced risk
of coronary heart disease may be made on the label or labeling of a food
described in paragraph (c)(2)(ii) of this section provided that:
(A) The claim states that diets low in saturated fat and cholesterol
``may'' or ``might'' reduce the risk of heart disease;
(B) In specifying the disease, the claim uses the terms ``heart
disease'' or ``coronary heart disease;''
(C) In specifying the nutrient, the claim uses the terms ``saturated
fat'' and ``cholesterol'' and lists both;
(D) The claim does not attribute any degree of risk reduction for
coronary heart disease to diets low in dietary saturated fat and
cholesterol; and
(E) The claim states that coronary heart disease risk depends on
many factors.
(ii) Nature of the food. The food shall meet all of the nutrient
content requirements of Sec. 101.62 for a ``low saturated fat,'' ``low
cholesterol,'' and ``low fat'' food; except that fish and game meats
(i.e., deer, bison, rabbit, quail, wild turkey, geese, and ostrich) may
meet the requirements for ``extra lean'' in Sec. 101.62.
(d) Optional information. (1) The claim may identify one or more of
the following risk factors in addition to saturated fat and cholesterol
about which there is general scientific agreement that they are major
risk factors for this disease: A family history of coronary heart
disease, elevated blood total and LDL-cholesterol, excess body weight,
high blood pressure, cigarette smoking, diabetes, and physical
inactivity.
(2) The claim may indicate that the relationship of saturated fat
and cholesterol to heart disease is through the intermediate link of
``blood cholesterol'' or ``blood total- and LDL cholesterol.''
(3) The claim may include information from paragraphs (a) and (b) of
this section, which summarize the relationship between dietary saturated
fat and cholesterol and risk of coronary heart disease, and the
significance of the relationship.
(4) In specifying the nutrients, the claim may include the term
``total fat'' in addition to the terms ``saturated fat'' and
``cholesterol''.
(5) The claim may include information on the number of people in the
United States who have coronary heart disease. The sources of this
information shall be identified, and it shall be current information
from the National Center for Health Statistics, the National Institutes
of Health, or ``Nutrition and Your Health: Dietary Guidelines for
Americans,'' U.S. Department of Health and Human Services (DHHS) and
U.S. Department of Agriculture (USDA), Government Printing Office.
[[Page 132]]
(6) The claim may indicate that it is consistent with ``Nutrition
and Your Health: Dietary Guidelines for Americans,'' DHHS and USDA,
Government Printing Office.
(7) The claim may state that individuals with elevated blood total-
or LDL-cholesterol should consult their physicians for medical advice
and treatment. If the claim defines high or normal blood total- or LDL-
cholesterol levels, then the claim shall state that individuals with
high blood cholesterol should consult their physicians for medical
advice and treatment.
(e) Model health claims.The following are model health claims that
may be used in food labeling to describe the relationship between
dietary saturated fat and cholesterol and risk of heart disease:
(1) While many factors affect heart disease, diets low in saturated
fat and cholesterol may reduce the risk of this disease;
(2) Development of heart disease depends upon many factors, but its
risk may be reduced by diets low in saturated fat and cholesterol and
healthy lifestyles;
(3) Development of heart disease depends upon many factors,
including a family history of the disease, high blood LDL-cholesterol,
diabetes, high blood pressure, being overweight, cigarette smoking, lack
of exercise, and the type of dietary pattern. A healthful diet low in
saturated fat, total fat, and cholesterol, as part of a healthy
lifestyle, may lower blood cholesterol levels and may reduce the risk of
heart disease;
(4) Many factors, such as a family history of the disease, increased
blood- and LDL-cholesterol levels, high blood pressure, cigarette
smoking, diabetes, and being overweight, contribute to developing heart
disease. A diet low in saturated fat, cholesterol, and total fat may
help reduce the risk of heart disease; and
(5) Diets low in saturated fat, cholesterol, and total fat may
reduce the risk of heart disease. Heart disease is dependent upon many
factors, including diet, a family history of the disease, elevated blood
LDL-cholesterol levels, and physical inactivity.
[58 FR 2757, Jan. 6, 1993]
Sec. 101.76 Health claims: fiber-containing grain products, fruits, and
vegetables and cancer.
(a) Relationship between diets low in fat and high in fiber-
containing grain products, fruits, and vegetables and cancer risk. (1)
Cancer is a constellation of more than 100 different diseases, each
characterized by the uncontrolled growth and spread of abnormal cells.
Cancer has many causes and stages in its development. Both genetic and
environmental risk factors may affect the risk of cancer. Risk factors
include: A family history of a specific type of cancer, cigarette
smoking, overweight and obesity, alcohol consumption, ultraviolet or
ionizing radiation, exposure to cancer-causing chemicals, and dietary
factors.
(2) The scientific evidence establishes that diets low in fat and
high in fiber-containing grain products, fruits, and vegetables are
associated with a reduced risk of some types of cancer. Although the
specific role of total dietary fiber, fiber components, and the multiple
nutrients and other substances contained in these foods are not yet
fully understood, many studies have shown that diets low in fat and high
in fiber-containing foods are associated with reduced risk of some types
of cancer.
(b) Significance of the relationship between consumption of diets
low in fat and high in fiber-containing grain products, fruits, and
vegetables and risk of cancer. (1) Cancer is ranked as a leading cause
of death in the United States. The overall economic costs of cancer,
including direct health care costs and losses due to morbidity and
mortality, are very high.
(2) U.S. diets tend to be high in fat and low in grain products,
fruits, and vegetables. Studies in various parts of the world indicate
that populations who habitually consume a diet high in plant foods have
lower risks of some cancers. These diets generally are low in fat and
rich in many nutrients, including, but not limited to, dietary fiber.
Current dietary guidelines from Federal government agencies and
nationally recognized health professional organizations recommend
decreased
[[Page 133]]
consumption of fats (less than 30 percent of calories), maintenance of
desirable body weight, and increased consumption of fruits and
vegetables (five or more servings daily), and grain products (six or
more servings daily).
(c) Requirements. (1) All requirements set forth in Sec. 101.14
shall be met.
(2) Specific requirements--(i) Nature of the claim. A health claim
associating diets low in fat and high in fiber-containing grain
products, fruits, and vegetables with reduced risk of cancer may be made
on the label or labeling of a food described in paragraph (c)(2)(ii) of
this section, provided that:
(A) The claim states that diets low in fat and high in fiber-
containing grain products, fruits, and vegetables ``may'' or ``might''
reduce the risk of some cancers;
(B) In specifying the disease, the claim uses the following terms:
``some types of cancer,'' or ``some cancers'';
(C) The claim is limited to grain products, fruits, and vegetables
that contain dietary fiber;
(D) The claim indicates that development of cancer depends on many
factors;
(E) The claim does not attribute any degree of cancer risk reduction
to diets low in fat and high in fiber-containing grain products, fruits,
and vegetables;
(F) In specifying the dietary fiber component of the labeled food,
the claim uses the term ``fiber'', ``dietary fiber'' or ``total dietary
fiber''; and
(G) The claim does not specify types of dietary fiber that may be
related to risk of cancer.
(ii) Nature of the food. (A) The food shall be or shall contain a
grain product, fruit, or vegetable.
(B) The food shall meet the nutrient content requirements of Sec.
101.62 for a ``low fat'' food.
(C) The food shall meet, without fortification, the nutrient content
requirements of Sec. 101.54 for a ``good source'' of dietary fiber.
(d) Optional information. (1) The claim may include information from
paragraphs (a) and (b) of this section, which summarize the relationship
between diets low in fat and high in fiber-containing grain products,
fruits, and vegetables, and some types of cancer and the significance of
the relationship.
(2) The claim may identify one or more of the following risk factors
for development of cancer: Family history of a specific type of cancer,
cigarette smoking, overweight and obesity, alcohol consumption,
ultraviolet or ionizing radiation, exposure to cancer causing chemicals,
and dietary factors.
(3) The claim may indicate that it is consistent with ``Nutrition
and Your Health: Dietary Guidelines for Americans,'' U.S. Department of
Agriculture (USDA) and Department of Health and Human Services (DHHS),
Government Printing Office.
(4) The claim may include information on the number of people in the
United States who have cancer. The sources of this information must be
identified, and it must be current information from the National Center
for Health Statistics, the National Institutes of Health, or ``Nutrition
and Your Health: Dietary Guidelines for Americans,'' USDA and DHHS,
Government Printing Office.
(e) Model health claims. The following model health claims may be
used in food labeling to characterize the relationship between diets low
in fat and high in fiber-containing grain products, fruits, and
vegetables and cancer risk:
(1) Low fat diets rich in fiber-containing grain products, fruits,
and vegetables may reduce the risk of some types of cancer, a disease
associated with many factors.
(2) Development of cancer depends on many factors. Eating a diet low
in fat and high in grain products, fruits, and vegetables that contain
dietary fiber may reduce your risk of some cancers.
[58 FR 2548, Jan. 6, 1993]
Sec. 101.77 Health claims: fruits, vegetables, and grain products that
contain fiber, particularly soluble fiber, and risk of coronary heart disease.
(a) Relationship between diets low in saturated fat and cholesterol
and high in fruits, vegetables, and grain products that contain fiber,
particularly soluble fiber, and risk of coronary heart disease. (1)
Cardiovascular disease means diseases of the heart and circulatory
system. Coronary heart disease is the most
[[Page 134]]
common and serious form of cardiovascular disease and refers to diseases
of the heart muscle and supporting blood vessels. High blood total- and
low density lipoprotein (LDL)- cholesterol levels are major modifiable
risk factors in the development of coronary heart disease. High coronary
heart disease rates occur among people with high blood cholesterol
levels of 240 milligrams per deciliter (mg/dL) (6.21 (mmol/L)) or above
and LDL-cholesterol levels of 160 mg/dL (4.13 mmol/L) or above.
Borderline high risk blood cholesterol levels range from 200 to 239 mg/
dL (5.17 to 6.18 mmol/L) and 130 to 159 mg/dL (3.36 to 4.11 mmol/L) of
LDL-cholesterol. Dietary lipids (fats) include fatty acids and
cholesterol. Total fat, commonly referred to as fat, is composed of
saturated fat (fatty acids containing no double bonds), and
monounsaturated and polyunsaturated fat (fatty acids containing one or
more double bonds).
(2) The scientific evidence establishes that diets high in saturated
fat and cholesterol are associated with increased levels of blood total-
and LDL-cholesterol and, thus, with increased risk of coronary heart
disease. Diets low in saturated fat and cholesterol are associated with
decreased levels of blood total- and LDL-cholesterol, and thus, with
decreased risk of developing coronary heart disease.
(3) Populations with relatively low blood cholesterol levels tend to
have dietary patterns that are not only low in total fat, especially
saturated fat and cholesterol, but are also relatively high in fruits,
vegetables, and grain products. Although the specific roles of these
plant foods are not yet fully understood, many studies have shown that
diets high in plant foods are associated with reduced risk of coronary
heart disease. These studies correlate diets rich in fruits, vegetables,
and grain products and nutrients from these diets, such as some types of
fiber, with reduced coronary heart disease risk. Persons consuming these
diets frequently have high intakes of dietary fiber, particularly
soluble fibers. Currently, there is not scientific agreement as to
whether a particular type of soluble fiber is beneficial, or whether the
observed protective effects of fruits, vegetables, and grain products
against heart disease are due to other components, or a combination of
components, in these diets, including, but not necessarily limited to,
some types of soluble fiber, other fiber components, other
characteristics of the complex carbohydrate content of these foods,
other nutrients in these foods, or displacement of saturated fat and
cholesterol from the diet.
(b) Significance of the relationship between diets low in saturated
fat and cholesterol, and high in fruits, vegetables, and grain products
that contain fiber, particularly soluble fiber, and risk of coronary
heart disease. (1) Coronary heart disease is a major public health
concern in the United States, primarily because it accounts for more
deaths than any other disease or group of diseases. Early management of
risk factors for coronary heart disease is a major public health goal
that can assist in reducing risk of coronary heart disease. There is a
continuum of mortality risk from coronary heart disease that increases
with increasing levels of blood LDL-cholesterol. Individuals with high
blood LDL-cholesterol are at greatest risk. A larger number of
individuals with more moderately elevated cholesterol also have
increased risk of coronary events; such individuals comprise a
substantial proportion of the adult U.S. population. The scientific
evidence indicates that reducing saturated fat and cholesterol intakes
lowers blood LDL-cholesterol and risk of heart disease in most
individuals, including persons with blood cholesterol levels in the
normal range. Additionally, consuming diets high in fruits, vegetables,
and grain products, foods that contain soluble fiber, may be a useful
adjunct to a low saturated fat and low cholesterol diet.
(2) Other risk factors for coronary heart disease include a family
history of heart disease, high blood pressure, diabetes, cigarette
smoking, obesity (body weight 30 percent greater than ideal body
weight), and lack of regular physical exercise.
(3) Intakes of saturated fat exceed recommended levels in many
people in
[[Page 135]]
the United States. Intakes of cholesterol are, on average, at or above
recommended levels. Intakes of fiber-containing fruits, vegetables, and
grain products are about half of recommended intake levels. One of the
major public health recommendations relative to coronary heart disease
risk is to consume less than 10 percent of calories from saturated fat,
and an average of 30 percent or less of total calories from all fat.
Recommended daily cholesterol intakes are 300 mg or less per day.
Recommended total dietary fiber intakes are about 25 grams (g) daily, of
which about 25 percent (about 6 g) should be soluble fiber.
(4) Current dietary guidance recommendations encourage decreased
consumption of dietary fat, especially saturated fat and cholesterol,
and increased consumption of fiber-rich foods to help lower blood LDL-
cholesterol levels. Results of numerous studies have shown that fiber-
containing fruits, vegetables, and grain products can help lower blood
LDL-cholesterol.
(c) Requirements. (1) All requirements set forth in Sec. 101.14
shall be met.
(2) Specific requirements--(i) Nature of the claim. A health claim
associating diets low in saturated fat and cholesterol and high in
fruits, vegetables, and grain products that contain fiber, particularly
soluble fiber, with reduced risk of heart disease may be made on the
label or labeling of a food described in paragraph (c)(2)(ii) of this
section, provided that:
(A) The claim states that diets low in saturated fat and cholesterol
and high in fruits, vegetables, and grain products that contain fiber
``may'' or ``might'' reduce the risk of heart disease;
(B) In specifying the disease, the claim uses the following terms:
``heart disease'' or ``coronary heart disease;''
(C) The claim is limited to those fruits, vegetables, and grains
that contain fiber;
(D) In specifying the dietary fiber, the claim uses the term
``fiber,'' ``dietary fiber,'' ``some types of dietary fiber,'' ``some
dietary fibers,'' or ``some fibers;'' the term ``soluble fiber'' may be
used in addition to these terms;
(E) In specifying the fat component, the claim uses the terms
``saturated fat'' and ``cholesterol;'' and
(F) The claim indicates that development of heart disease depends on
many factors; and
(G) The claim does not attribute any degree of risk reduction for
coronary heart disease to diets low in saturated fat and cholesterol and
high in fruits, vegetables, and grain products that contain fiber.
(ii) Nature of the food. (A) The food shall be or shall contain a
fruit, vegetable, or grain product.
(B) The food shall meet the nutrient content requirements of Sec.
101.62 for a ``low saturated fat,'' ``low cholesterol,'' and ``low fat''
food.
(C) The food contains, without fortification, at least 0.6 g of
soluble fiber per reference amount customarily consumed;
(D) The content of soluble fiber shall be declared in the nutrition
information panel, consistent with Sec. 101.9(c)(6)(i)(A).
(d) Optional information. (1) The claim may identify one or more of
the following risk factors for heart disease about which there is
general scientific agreement: A family history of coronary heart
disease, elevated blood-, total- and LDL-cholesterol, excess body
weight, high blood pressure, cigarette smoking, diabetes, and physical
inactivity.
(2) The claim may indicate that the relationship of diets low in
saturated fat and cholesterol, and high in fruits, vegetables, and grain
products that contain fiber to heart disease is through the intermediate
link of ``blood cholesterol'' or ``blood total- and LDL-cholesterol.''
(3) The claim may include information from paragraphs (a) and (b) of
this section, which summarize the relationship between diets low in
saturated fat and cholesterol and high in fruits, vegetables, and grain
products that contain fiber and coronary heart disease, and the
significance of the relationship.
(4) In specifying the nutrients, the claim may include the term
``total fat'' in addition to the terms ``saturated fat'' and
``cholesterol.''
[[Page 136]]
(5) The claim may indicate that it is consistent with ``Nutrition
and Your Health: Dietary Guidelines for Americans,'' U.S. Department of
Agriculture (USDA) and Department of Health and Human Services (DHHS),
Government Printing Office (GPO).
(6) The claim may state that individuals with elevated blood total-
and LDL-cholesterol should consult their physicians for medical advice
and treatment. If the claim defines high or normal blood total- and LDL-
cholesterol levels, then the claim shall state that individuals with
high blood cholesterol should consult their physicians for medical
advice and treatment.
(7) The claim may include information on the number of people in the
United States who have heart disease. The sources of this information
shall be identified, and it shall be current information from the
National Center for Health Statistics, the National Institutes of
Health, or ``Nutrition and Your Health: Dietary Guidelines for
Americans,'' USDA and DHHS, GPO.
(e) Model health claims. The following model health claims may be
used in food labeling to characterize the relationship between diets low
in saturated fat and cholesterol and high in fruits, vegetables, and
grain products that contain soluble fiber:
(1) Diets low in saturated fat and cholesterol and rich in fruits,
vegetables, and grain products that contain some types of dietary fiber,
particularly soluble fiber, may reduce the risk of heart disease, a
disease associated with many factors.
(2) Development of heart disease depends on many factors. Eating a
diet low in saturated fat and cholesterol and high in fruits,
vegetables, and grain products that contain fiber may lower blood
cholesterol levels and reduce your risk of heart disease.
[58 FR 2578, Jan. 6, 1993]
Sec. 101.78 Health claims: fruits and vegetables and cancer.
(a) Relationship between substances in diets low in fat and high in
fruits and vegetables and cancer risk. (1) Cancer is a constellation of
more than 100 different diseases, each characterized by the uncontrolled
growth and spread of abnormal cells. Cancer has many causes and stages
in its development. Both genetic and environmental risk factors may
affect the risk of cancer. Risk factors include a family history of a
specific type of cancer, cigarette smoking, alcohol consumption,
overweight and obesity, ultraviolet or ionizing radiation, exposure to
cancer-causing chemicals, and dietary factors.
(2) Although the specific roles of the numerous potentially
protective substances in plant foods are not yet understood, many
studies have shown that diets high in plant foods are associated with
reduced risk of some types of cancers. These studies correlate diets
rich in fruits and vegetables and nutrients from these diets, such as
vitamin C, vitamin A, and dietary fiber, with reduced cancer risk.
Persons consuming these diets frequently have high intakes of these
nutrients. Currently, there is not scientific agreement as to whether
the observed protective effects of fruits and vegetables against cancer
are due to a combination of the nutrient components of diets rich in
fruits and vegetables, including but not necessarily limited to dietary
fiber, vitamin A (as beta-carotene) and vitamin C, to displacement of
fat from such diets, or to intakes of other substances in these foods
which are not nutrients but may be protective against cancer risk.
(b) Significance of the relationship between consumption of diets
low in fat and high in fruits and vegetables and risk of cancer. (1)
Cancer is ranked as a leading cause of death in the United States. The
overall economic costs of cancer, including direct health care costs and
losses due to morbidity and mortality, are very high.
(2) U.S. diets tend to be high in fat and low in fruits and
vegetables. Studies in various parts of the world indicate that
populations who habitually consume a diet high in plant foods have lower
risks of some cancers. These diets generally are low in fat and rich in
many nutrients, including, but not limited to, dietary fiber, vitamin A
(as beta-carotene), and vitamin C. Current dietary guidelines from
Federal Government agencies and nationally recognized health
professional organizations recommend decreased consumption of fats (less
than 30 percent of calories),
[[Page 137]]
maintenance of desirable body weight, and increased consumption of
fruits and vegetables (5 or more servings daily), particularly those
fruits and vegetables which contain dietary fiber, vitamin A, and
vitamin C.
(c) Requirements. (1) All requirements set forth in Sec. 101.14
shall be met.
(2) Specific requirements--(i) Nature of the claim. A health claim
associating substances in diets low in fat and high in fruits and
vegetables with reduced risk of cancer may be made on the label or
labeling of a food described in paragraph (c)(2)(ii) of this section,
provided that:
(A) The claim states that diets low in fat and high in fruits and
vegetables ``may'' or ``might'' reduce the risk of some cancers;
(B) In specifying the disease, the claim uses the following terms:
``some types of cancer'', or ``some cancers'';
(C) The claim characterizes fruits and vegetables as foods that are
low in fat and may contain vitamin A, vitamin C, and dietary fiber;
(D) The claim characterizes the food bearing the claim as containing
one or more of the following, for which the food is a good source under
Sec. 101.54: dietary fiber, vitamin A, or vitamin C;
(E) The claim does not attribute any degree of cancer risk reduction
to diets low in fat and high in fruits and vegetables;
(F) In specifying the fat component of the labeled food, the claim
uses the term ``total fat'' or ``fat'';
(G) The claim does not specify types of fats or fatty acids that may
be related to risk of cancer;
(H) In specifying the dietary fiber component of the labeled food,
the claim uses the term ``fiber'', ``dietary fiber'', or ``total dietary
fiber'';
(I) The claim does not specify types of dietary fiber that may be
related to risk of cancer; and
(J) The claim indicates that development of cancer depends on many
factors.
(ii) Nature of the food. (A) The food shall be or shall contain a
fruit or vegetable.
(B) The food shall meet the nutrient content requirements of Sec.
101.62 for a ``low fat'' food.
(C) The food shall meet, without fortification, the nutrient content
requirements of Sec. 101.54 for a ``good source'' of at least one of
the following: vitamin A, vitamin C, or dietary fiber.
(d) Optional information. (1) The claim may include information from
paragraphs (a) and (b) of this section, which summarize the relationship
between diets low in fat and high in fruits and vegetables and some
types of cancer and the significance of the relationship.
(2) The claim may identify one or more of the following risk factors
for development of cancer: Family history of a specific type of cancer,
cigarette smoking, alcohol consumption, overweight and obesity,
ultraviolet or ionizing radiation, exposure to cancer-causing chemicals,
and dietary factors.
(3) The claim may use the word ``beta-carotene'' in parentheses
after the term vitamin A, provided that the vitamin A in the food
bearing the claim is beta-carotene.
(4) The claim may indicate that it is consistent with ``Nutrition
and Your Health: Dietary Guidelines for Americans,'' U.S. Department of
Agriculture (USDA) and the Department of Health and Human Services
(DHHS), Government Printing Office.
(5) The claim may include information on the number of people in the
United States who have cancer. The sources of this information must be
identified, and it must be current information from the National Center
for Health Statistics, the National Institutes of Health, or ``Nutrition
and Your Health: Dietary Guidelines for Americans,'' USDA and DHHS,
Government Printing Office.
(e) Model health claims. The following model health claims may be
used in food labeling to characterize the relationship between
substances in diets low in fat and high in fruits and vegetables and
cancer:
(1) Low fat diets rich in fruits and vegetables (foods that are low
in fat and may contain dietary fiber, vitamin A, and vitamin C) may
reduce the risk of some types of cancer, a disease associated with many
factors. Broccoli is high in vitamins A and C, and it is a good source
of dietary fiber.
[[Page 138]]
(2) Development of cancer depends on many factors. Eating a diet low
in fat and high in fruits and vegetables, foods that are low in fat and
may contain vitamin A, vitamin C, and dietary fiber, may reduce your
risk of some cancers. Oranges, a food low in fat, are a good source of
fiber and vitamin C.
[58 FR 2639, Jan. 6, 1993]
Sec. 101.79 Health claims: Folate and neural tube defects.
(a) Relationship between folate and neural tube defects--(1)
Definition. Neural tube defects are serious birth defects of the brain
or spinal cord that can result in infant mortality or serious
disability. The birth defects anencephaly and spina bifida are the most
common forms of neural tube defects and account for about 90 percent of
these defects. These defects result from failure of closure of the
covering of the brain or spinal cord during early embryonic development.
Because the neural tube forms and closes during early pregnancy, the
defect may occur before a woman realizes that she is pregnant.
(2) Relationship. The available data show that diets adequate in
folate may reduce the risk of neural tube defects. The strongest
evidence for this relationship comes from an intervention study by the
Medical Research Council of the United Kingdom that showed that women at
risk of recurrence of a neural tube defect pregnancy who consumed a
supplement containing 4 milligrams (mg)(4,000 micrograms (mcg)) folic
acid daily before conception and continuing into early pregnancy had a
reduced risk of having a child with a neural tube defect. (Products
containing this level of folic acid are drugs). In addition, based on
its review of a Hungarian intervention trial that reported
periconceptional use of a multivitamin and multimineral preparation
containing 800 mcg (0.8 mg) of folic acid, and its review of the
observational studies that reported periconceptional use of
multivitamins containing 0 to 1,000 mcg of folic acid, the Food and Drug
Administration concluded that most of these studies had results
consistent with the conclusion that folate, at levels attainable in
usual diets, may reduce the risk of neural tube defects.
(b) Significance of folate--(1) Public health concern. Neural tube
defects occur in approximately 0.6 of 1,000 live births in the United
States (i.e., approximately 6 of 10,000 live births; about 2,500 cases
among 4 million live births annually). Neural tube defects are believed
to be caused by many factors. The single greatest risk factor for a
neural tube defect-affected pregnancy is a personal or family history of
a pregnancy affected with a such a defect. However, about 90 percent of
infants with a neural tube defect are born to women who do not have a
family history of these defects. The available evidence shows that diets
adequate in folate may reduce the risk of neural tube defects but not of
other birth defects.
(2) Populations at risk. Prevalence rates for neural tube defects
have been reported to vary with a wide range of factors including
genetics, geography, socioeconomic status, maternal birth cohort, month
of conception, race, nutrition, and maternal health, including maternal
age and reproductive history. Women with a close relative (i.e.,
sibling, niece, nephew) with a neural tube defect, those with insulin-
dependent diabetes mellitus, and women with seizure disorders who are
being treated with valproic acid or carbamazepine are at significantly
increased risk compared with women without these characteristics. Rates
for neural tube defects vary within the United States, with lower rates
observed on the west coast than on the east coast.
(3) Those who may benefit. Based on a synthesis of information from
several studies, including those which used multivitamins containing
folic acid at a daily dose level of =400 mcg (=0.4
mg), the Public Health Service has inferred that folate alone at levels
of 400 mcg (0.4 mg) per day may reduce the risk of neural tube defects.
The protective effect found in studies of lower dose folate measured by
the reduction in neural tube defect incidence, ranges from none to
substantial; a reasonable estimate of the expected reduction in the
United States is 50 percent. It is expected that consumption of adequate
[[Page 139]]
folate will avert some, but not all, neural tube defects. The underlying
causes of neural tube defects are not known. Thus, it is not known what
proportion of neural tube defects will be averted by adequate folate
consumption. From the available evidence, the Public Health Service
estimates that there is the potential for averting 50 percent of cases
that now occur (i.e., about 1,250 cases annually). However, until
further research is done, no firm estimate of this proportion will be
available.
(c) Requirements. The label or labeling of food may contain a
folate/neural tube defect health claim provided that:
(1) General requirements. The health claim for a food meets all of
the general requirements of Sec. 101.14 for health claims, except that
a food may qualify to bear the health claim if it meets the definition
of the term ``good source.''
(2) Specific requirements--(i) Nature of the claim--(A)
Relationship. A health claim that women who are capable of becoming
pregnant and who consume adequate amounts of folate daily during their
childbearing years may reduce their risk of having a pregnancy affected
by spina bifida or other neural tube defects may be made on the label or
labeling of food provided that:
(B) Specifying the nutrient. In specifying the nutrient, the claim
shall use the terms ``folate,'' ``folic acid,'' ``folacin,'' ``folate, a
B vitamin,'' ``folic acid, a B vitamin,'' or ``folacin, a B vitamin.''
(C) Specifying the condition. In specifying the health- related
condition, the claim shall identify the birth defects as ``neural tube
defects,'' ``birth defects spina bifida or anencephaly,'' ``birth
defects of the brain or spinal cord anencephaly or spina bifida,''
``spina bifida and anencephaly, birth defects of the brain or spinal
cord,'' ``birth defects of the brain or spinal cord;'' or ``brain or
spinal cord birth defects.''
(D) Multifactorial nature. The claim shall not imply that folate
intake is the only recognized risk factor for neural tube defects.
(E) Reduction in risk. The claim shall not attribute any specific
degree of reduction in risk of neural tube defects from maintaining an
adequate folate intake throughout the childbearing years. The claim
shall state that some women may reduce their risk of a neural tube
defect pregnancy by maintaining adequate intakes of folate during their
childbearing years. Optional statements about population-based estimates
of risk reduction may be made in accordance with paragraph (c)(3)(vi) of
this section.
(F) Safe upper limit of daily intake. Claims on foods that contain
more than 100 percent of the Daily Value (DV) (400 mcg) when labeled for
use by adults and children 4 or more years of age, or 800 mcg when
labeled for use by pregnant or lactating women) shall identify the safe
upper limit of daily intake with respect to the DV. The safe upper limit
of daily intake value of 1,000 mcg (1 mg) may be included in
parentheses.
(G) The claim shall state that folate needs to be consumed as part
of a healthful diet.
(ii) Nature of the food--(A) Requirements. The food shall meet or
exceed the requirements for a ``good source'' of folate as defined in
Sec. 101.54;
(B) Dietary supplements. Dietary supplements shall meet the United
States Pharmacopeia (USP) standards for disintegration and dissolution,
except that if there are no applicable USP standards, the folate in the
dietary supplement shall be shown to be bioavailable under the
conditions of use stated on the product label.
(iii) Limitation. The claim shall not be made on foods that contain
more than 100 percent of the RDI for vitamin A as retinol or preformed
vitamin A or vitamin D per serving or per unit.
(iv) Nutrition labeling. The nutrition label shall include
information about the amount of folate in the food. This information
shall be declared after the declaration for iron if only the levels of
vitamin A, vitamin C, calcium, and iron are provided, or in accordance
with Sec. 101.9 (c)(8) and (c)(9) if other optional vitamins or
minerals are declared.
(3) Optional information--(i) Risk factors. The claim may
specifically identify risk factors for neural tube defects. Where such
information is provided, it may consist of statements from Sec.
101.79(b)(1) or (b)(2) (e.g., Women at increased risk include those with
a
[[Page 140]]
personal history of a neural tube defect-affected pregnancy, those with
a close relative (i.e., sibling, niece, nephew) with a neural tube
defect; those with insulin-dependent diabetes mellitus; those with
seizure disorders who are being treated with valproic acid or
carbamazepine) or from other parts of this paragraph (c)(3)(i).
(ii) Relationship between folate and neural tube defects. The claim
may include statements from paragraphs (a) and (b) of this section that
summarize the relationship between folate and neural tube defects and
the significance of the relationship except for information specifically
prohibited from the claim.
(iii) Personal history of a neural tube defect-affected pregnancy.
The claim may state that women with a history of a neural tube defect
pregnancy should consult their physicians or health care providers
before becoming pregnant. If such a statement is provided, the claim
shall also state that all women should consult a health care provider
when planning a pregnancy.
(iv) Daily value. The claim may identify 100 percent of the DV (100%
DV; 400 mcg) for folate as the target intake goal.
(v) Prevalence. The claim may provide estimates, expressed on an
annual basis, of the number of neural tube defect-affected births among
live births in the United States. Current estimates are provided in
Sec. 101.79(b)(1), and are approximately 6 of 10,000 live births
annually (i.e., about 2,500 cases among 4 million live births annually).
Data provided in Sec. 101.79(b)(1) shall be used, unless more current
estimates from the U.S. Public Health Service are available, in which
case the latter may be cited.
(vi) Reduction in risk. An estimate of the reduction in the number
of neural tube defect-affected births that might occur in the United
States if all women consumed adequate folate throughout their
childbearing years may be included in the claim. Information contained
in paragraph (b)(3) of this section may be used. If such an estimate
(i.e., 50 percent) is provided, the estimate shall be accompanied by
additional information that states that the estimate is population-based
and that it does not reflect risk reduction that may be experienced by
individual women.
(vii) Diets adequate in folate. The claim may identify diets
adequate in folate by using phrases such as ``Sources of folate include
fruits, vegetables, whole grain products, fortified cereals, and dietary
supplements.'' or ``Adequate amounts of folate can be obtained from
diets rich in fruits, dark green leafy vegetables, legumes, whole grain
products, fortified cereals, or dietary supplements.'' or ``Adequate
amounts of folate can be obtained from diets rich in fruits, including
citrus fruits and juices, vegetables, including dark green leafy
vegetables, legumes, whole grain products, including breads, rice, and
pasta, fortified cereals, or a dietary supplement.''
(d) Model health claims. The following are examples of model health
claims that may be used in food labeling to describe the relationship
between folate and neural tube defects:
(1) Examples 1 and 2. Model health claims appropriate for foods
containing 100 percent or less of the DV for folate per serving or per
unit (general population). The examples contain only the required
elements:
(i) Healthful diets with adequate folate may reduce a woman's risk
of having a child with a brain or spinal cord birth defect.
(ii) Adequate folate in healthful diets may reduce a woman's risk of
having a child with a brain or spinal cord birth defect.
(2) Example 3. Model health claim appropriate for foods containing
100 percent or less of the DV for folate per serving or per unit. The
example contains all required elements plus optional information: Women
who consume healthful diets with adequate folate throughout their
childbearing years may reduce their risk of having a child with a birth
defect of the brain or spinal cord. Sources of folate include fruits,
vegetables, whole grain products, fortified cereals, and dietary
supplements.
(3) Example 4. Model health claim appropriate for foods intended for
use by the general population and containing more than 100 percent of
the DV of folate per serving or per unit: Women
[[Page 141]]
who consume healthful diets with adequate folate may reduce their risk
of having a child with birth defects of the brain or spinal cord. Folate
intake should not exceed 250% of the DV (1,000 mcg).
[61 FR 8779, Mar. 5, 1996; 61 FR 48529, Sept. 13, 1996, as amended at 65
FR 58918, Oct. 3, 2000]
Sec. 101.80 Health claims: dietary noncariogenic carbohydrate sweeteners and
dental caries.
(a) Relationship between dietary carbohydrates and dental caries.
(1) Dental caries, or tooth decay, is a disease caused by many factors.
Both environmental and genetic factors can affect the development of
dental caries. Risk factors include tooth enamel crystal structure and
mineral content, plaque quantity and quality, saliva quantity and
quality, individual immune response, types and physical characteristics
of foods consumed, eating behaviors, presence of acid producing oral
bacteria, and cultural influences.
(2) The relationship between consumption of fermentable
carbohydrates, i.e., dietary sugars and starches, and tooth decay is
well established. Sucrose, also known as sugar, is one of the most, but
not the only, cariogenic sugars in the diet. Bacteria found in the mouth
are able to metabolize most dietary carbohydrates, producing acid and
forming dental plaque. The more frequent and longer the exposure of
teeth to dietary sugars and starches, the greater the risk for tooth
decay.
(3) Dental caries continues to affect a large proportion of
Americans. Although there has been a decline in the prevalence of dental
caries among children in the United States, the disease remains
widespread throughout the population, imposing a substantial burden on
Americans. Recent Federal government dietary guidelines recommend that
Americans choose diets that are moderate in sugars and avoid excessive
snacking. Frequent between-meal snacks that are high in sugars and
starches may be more harmful to teeth than eating such foods at meals
and then brushing.
(4) Noncariogenic carbohydrate sweeteners, such as sugar alcohols,
can be used to replace dietary sugars, such as sucrose and corn
sweeteners, in foods such as chewing gums and certain confectioneries.
Noncariogenic carbohydrate sweeteners are significantly less cariogenic
than dietary sugars and other fermentable carbohydrates.
(b) Significance of the relationship between noncariogenic
carbohydrate sweeteners and dental caries. Noncariogenic carbohydrate
sweeteners do not promote dental caries. The noncariogenic carbohydrate
sweeteners listed in paragraph (c)(2)(ii) of this section are slowly
metabolized by bacteria to form some acid. The rate and amount of acid
production is significantly less than that from sucrose and other
fermentable carbohydrates and does not cause the loss of important
minerals from tooth enamel.
(c) Requirements. (1) All requirements set forth in Sec. 101.14
shall be met, except that noncariogenic carbohydrate sweetener-
containing foods listed in paragraph (c)(2)(ii) of this section are
exempt from Sec. 101.14(e)(6).
(2) Specific requirements--(i) Nature of the claim. A health claim
relating noncariogenic carbohydrate sweeteners, compared to other
carbohydrates, and the nonpromotion of dental caries may be made on the
label or labeling of a food described in paragraph (c)(2)(iii) of this
section, provided that:
(A) The claim shall state that frequent between-meal consumption of
foods high in sugars and starches can promote tooth decay.
(B) The claim shall state that the noncariogenic carbohydrate
sweetener present in the food ``does not promote,'' ``may reduce the
risk of,'' ``useful [or is useful] in not promoting,'' or ``expressly
[or is expressly] for not promoting'' dental caries.
(C) In specifying the nutrient, the claim shall state ``sugar
alcohol,'' ``sugar alcohols,'' or the name or names of the substances
listed in paragraph (c)(2)(ii) of this section, e.g., ``sorbitol.'' D-
tagatose may be identified as ``tagatose.''
(D) In specifying the disease, the claim uses the following terms:
``dental caries'' or ``tooth decay.''
[[Page 142]]
(E) The claim shall not attribute any degree of the reduction in
risk of dental caries to the use of the noncariogenic carbohydrate
sweetener-containing food.
(F) The claim shall not imply that consuming noncariogenic
carbohydrate sweetener-containing foods is the only recognized means of
achieving a reduced risk of dental caries.
(G) Packages with less than 15 square inches of surface area
available for labeling are exempt from paragraphs (A) and (C) of this
section.
(H) When the substance that is the subject of the claim is a
noncariogenic sugar, the claim shall identify the substance as a sugar
that, unlike other sugars, does not promote the development of dental
caries.
(ii) Nature of the substance. Eligible noncariogenic carbohydrate
sweeteners are:
(A) The sugar alcohols xylitol, sorbitol, mannitol, maltitol,
isomalt, lactitol, hydrogenated starch hydrolysates, hydrogenated
glucose syrups, and erythritol, or a combination of these.
(B) The sugars D-tagatose and isomaltulose.
(C) Sucralose.
(iii) Nature of the food. (A) The food shall meet the requirement in
Sec. 101.60(c)(1)(i) with respect to sugars content, except that the
food may contain D-tagatose or isomaltulose.
(B) A food whose labeling includes a health claim under this section
shall contain one or more of the noncariogenic carbohydrate sweeteners
listed in paragraph (c)(2)(ii) of this section.
(C) When carbohydrates other than those listed in paragraph
(c)(2)(ii) of this section are present in the food, the food shall not
lower plaque pH below 5.7 by bacterial fermentation either during
consumption or up to 30 minutes after consumption, as measured by the
indwelling plaque pH test found in ``Identification of Low Caries Risk
Dietary Components,'' dated 1983, by T. N. Imfeld, in Volume 11,
Monographs in Oral Science, 1983. The Director of the Office of the
Federal Register has approved the incorporation by reference of this
material in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may
obtain copies from Karger AG Publishing Co., P.O. Box, Ch-4009 Basel,
Switzerland, or you may examine a copy at the Center for Food Safety and
Applied Nutrition's Library, Harvey W. Wiley Federal Building, 5100
Paint Branch Pkwy., College Park, MD, or at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html.
(d) Optional information. (1) The claim may include information from
paragraphs (a) and (b) of this section, which describe the relationship
between diets containing noncariogenic carbohydrate sweeteners and
dental caries.
(2) The claim may indicate that development of dental caries depends
on many factors and may identify one or more of the following risk
factors for dental caries: Frequent consumption of fermentable
carbohydrates, such as dietary sugars and starches; presence of oral
bacteria capable of fermenting carbohydrates; length of time fermentable
carbohydrates are in contact with the teeth; lack of exposure to
fluoride; individual susceptibility; socioeconomic and cultural factors;
and characteristics of tooth enamel, saliva, and plaque.
(3) The claim may indicate that oral hygiene and proper dental care
may help to reduce the risk of dental disease.
(4) The claim may indicate that a substance listed in paragraph
(c)(2)(ii) of this section serves as a sweetener.
(e) Model health claim. The following model health claims may be
used in food labeling to describe the relationship between noncariogenic
carbohydrate sweetener-containing foods and dental caries.
(1) Examples of the full claim:
(i) Frequent eating of foods high in sugars and starches as between-
meal snacks can promote tooth decay. The sugar alcohol [name, optional]
used to sweeten this food may reduce the risk of dental caries.
[[Page 143]]
(ii) Frequent between-meal consumption of foods high in sugars and
starches promotes tooth decay. The sugar alcohols in [name of food] do
not promote tooth decay.
(iii) Frequent eating of foods high in sugars and starches as
between-meal snacks can promote tooth decay. [Name of sugar from
paragraph (c)(2)(ii)(B) of this section], the sugar used to sweeten this
food, unlike other sugars, may reduce the risk of dental caries.
(iv) Frequent between-meal consumption of foods high in sugars and
starches promotes tooth decay. [Name of sugar from paragraph
(c)(2)(ii)(B) of this section], the sugar in [name of food], unlike
other sugars, does not promote tooth decay.
(v) Frequent eating of foods high in sugars and starches as between-
meal snacks can promote tooth decay. Sucralose, the sweetening
ingredient used to sweeten this food, unlike sugars, does not promote
tooth decay.
(2) Example of the shortened claim for small packages:
(i) Does not promote tooth decay.
(ii) May reduce the risk of tooth decay.
(iii) [Name of sugar from paragraph (c)(2)(ii)(B) of this section]
sugar does not promote tooth decay.
(iv) [Name of sugar from paragraph (c)(2)(ii)(B) of this section]
sugar may reduce the risk of tooth decay.
[61 FR 43446, Aug. 23, 1996, as amended at 62 FR 63655, Dec. 2, 1997; 66
FR 66742, Dec. 27, 2001; 67 FR 71470, Dec. 2, 2002; 71 FR 15563, Mar.
29, 2006; 72 FR 52789, Sept. 17, 2007]
Sec. 101.81 Health claims: Soluble fiber from certain foods and risk of
coronary heart disease (CHD).
(a) Relationship between diets that are low in saturated fat and
cholesterol and that include soluble fiber from certain foods and the
risk of CHD. (1) Cardiovascular disease means diseases of the heart and
circulatory system. Coronary heart disease (CHD) is one of the most
common and serious forms of cardiovascular disease and refers to
diseases of the heart muscle and supporting blood vessels. High blood
total cholesterol and low density lipoprotein (LDL)-cholesterol levels
are associated with increased risk of developing coronary heart disease.
High CHD rates occur among people with high total cholesterol levels of
240 milligrams per deciliter (mg/dL) (6.21 (mmol/L)) or above and LDL-
cholesterol levels of 160 mg/dL (4.13 mmol/L) or above. Borderline high
risk total cholesterol levels range from 200 to 239 mg/dL (5.17 to 6.18
mmol/L) and 130 to 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-cholesterol.
The scientific evidence establishes that diets high in saturated fat and
cholesterol are associated with increased levels of blood total- and
LDL-cholesterol and, thus, with increased risk of CHD.
(2) Populations with a low incidence of CHD tend to have relatively
low blood total cholesterol and LDL-cholesterol levels. These
populations also tend to have dietary patterns that are not only low in
total fat, especially saturated fat and cholesterol, but are also
relatively high in fiber-containing fruits, vegetables, and grain
products, such as whole oat products.
(3) Scientific evidence demonstrates that diets low in saturated fat
and cholesterol may reduce the risk of CHD. Other evidence demonstrates
that the addition of soluble fiber from certain foods to a diet that is
low in saturated fat and cholesterol may also help to reduce the risk of
CHD.
(b) Significance of the relationship between diets that are low in
saturated fat and cholesterol and that include soluble fiber from
certain foods and the risk of CHD. (1) CHD is a major public health
concern in the United States. It accounts for more deaths than any other
disease or group of diseases. Early management of risk factors for CHD
is a major public health goal that can assist in reducing risk of CHD.
High blood total and LDL-cholesterol are major modifiable risk factors
in the development of CHD.
(2) Intakes of saturated fat exceed recommended levels in the diets
of many people in the United States. One of the major public health
recommendations relative to CHD risk is to consume less than 10 percent
of calories from saturated fat and an average of 30 percent or less of
total calories from all fat. Recommended daily cholesterol intakes are
300 milligrams (mg) or less per day. Scientific evidence demonstrates
that diets low in
[[Page 144]]
saturated fat and cholesterol are associated with lower blood total- and
LDL-cholesterol levels. Soluble fiber from certain foods, when included
in a low saturated fat and cholesterol diet, also helps to lower blood
total- and LDL-cholesterol levels.
(c) Requirements. (1) All requirements set forth in Sec. 101.14
shall be met. The label and labeling of foods containing psyllium husk
shall be consistent with the provisions of Sec. 101.17(f).
(2) Specific requirements--(i) Nature of the claim. A health claim
associating diets that are low in saturated fat and cholesterol and that
include soluble fiber from certain foods with reduced risk of heart
disease may be made on the label or labeling of a food described in
paragraph (c)(2)(iii) of this section, provided that:
(A) The claim states that diets that are low in saturated fat and
cholesterol and that include soluble fiber from certain foods ``may'' or
``might'' reduce the risk of heart disease.
(B) In specifying the disease, the claim uses the following terms:
``heart disease'' or ``coronary heart disease'';
(C) In specifying the substance, the claim uses the term ``soluble
fiber'' qualified by the name of the eligible source of soluble fiber
(provided in paragraph (c)(2)(ii)) of this section. Additionally, the
claim may use the name of the food product that contains the eligible
source of soluble fiber;
(D) In specifying the fat component, the claim uses the terms
``saturated fat'' and ``cholesterol'';
(E) The claim does not attribute any degree of risk reduction for
CHD to diets that are low in saturated fat and cholesterol and that
include soluble fiber from the eligible food sources from paragraph
(c)(2)(ii) of this section; and
(F) The claim does not imply that consumption of diets that are low
in saturated fat and cholesterol and that include soluble fiber from the
eligible food sources from paragraph (c)(2)(ii) of this section is the
only recognized means of achieving a reduced risk of CHD.
(G) The claim specifies the daily dietary intake of the soluble
fiber source that is necessary to reduce the risk of coronary heart
disease and the contribution one serving of the product makes to the
specified daily dietary intake level. Daily dietary intake levels of
soluble fiber sources listed in paragraph (c)(2)(ii) of this section
that have been associated with reduced risk coronary heart disease are:
(1) 3 g or more per day of [beta]-glucan soluble fiber from either
whole oats or barley, or a combination of whole oats and barley.
(2) 7 g or more per day of soluble fiber from psyllium seed husk.
(ii) Nature of the substance--Eligible sources of soluble fiber. (A)
Beta ([beta]) glucan soluble fiber from the whole oat and barley sources
listed below. [beta]-glucan soluble fiber will be determined by method
No. 992.28 from the ``Official Methods of Analysis of the AOAC
INTERNATIONAL,'' 16th ed. (1995), which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be
obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite
500, Gaithersburg, MD 20877, or may be examined at the Center for Food
Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College
Park, MD 20740, or at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
call 202-741-6030, or go to: http://www.archives.gov/federal--register/
code--of--federal--regulations/ibr--locations.html;
(1) Oat bran. Oat bran is produced by grinding clean oat groats or
rolled oats and separating the resulting oat flour by suitable means
into fractions such that the oat bran fraction is not more than 50
percent of the original starting material and provides at least 5.5
percent (dry weight basis (dwb)) [beta]-glucan soluble fiber and a total
dietary fiber content of 16 percent (dwb), and such that at least one-
third of the total dietary fiber is soluble fiber;
(2) Rolled oats. Rolled oats, also known as oatmeal, produced from
100 percent dehulled, clean oat groats by steaming, cutting, rolling,
and flaking, and provides at least 4 percent (dwb) of [beta]-glucan
soluble fiber and a total dietary fiber content of at least 10 percent.
[[Page 145]]
(3) Whole oat flour. Whole oat flour is produced from 100 percent
dehulled, clean oat groats by steaming and grinding, such that there is
no significant loss of oat bran in the final product, and provides at
least 4 percent (dwb) of [beta]-glucan soluble fiber and a total dietary
fiber content of at least 10 percent (dwb).
(4) Oatrim. The soluble fraction of alpha-amylase hydrolyzed oat
bran or whole oat flour, also known as oatrim. Oatrim is produced from
either oat bran as defined in paragraph (c)(2)(ii)(A)(1) of this section
or whole oat flour as defined in paragraph (c)(2)(ii)(A)(3) of this
section by solubilization of the starch in the starting material with an
alpha-amylase hydrolysis process, and then removal by centrifugation of
the insoluble components consisting of a high portion of protein, lipid,
insoluble dietary fiber, and the majority of the flavor and color
components of the starting material. Oatrim shall have a beta-glucan
soluble fiber content up to 10 percent (dwb) and not less than that of
the starting material (dwb).
(5) Whole grain barley and dry milled barley. Dehulled and hull-less
whole grain barley with a [beta]-glucan soluble fiber content of at
least 4 percent (dwb) and a total dietary fiber content of at least 10
percent (dwb). Dry milled barley grain products include barley bran,
barley flakes, barley grits, pearl barley, barley flour, barley meal,
and sieved barley meal that are produced from clean, sound dehulled or
hull-less barley grain using standard dry milling techniques, which may
include steaming or tempering, and that contain at least 4 percent (dwb)
of [beta]-glucan soluble fiber and at least 8 percent (dwb) of total
dietary fiber, except barley bran and sieved barley meal for which the
minimum [beta]-glucan soluble fiber content is 5.5 percent (dwb) and
minimum total dietary fiber content is 15 percent (dwb). Dehulled
barley, hull-less barley, barley bran, barley flakes, barley grits,
pearl barley, and barley flour are as defined in the Barley Glossary
(AACC Method 55-99), published in Approved Methods of the American
Association of Cereal Chemists, 10th ed. (2000), pp. 1 and 2, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies may be obtained from the American Association of Cereal
Chemists, Inc., 3340 Pilot Knob Rd., St. Paul, Minnesota, 55121, or may
be examined at the Center for Food Safety and Applied Nutrition Library,
5100 Paint Branch Pkwy., College Park, MD 20740, or at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html. Barley meal is unsifted, ground barley
grain not subjected to any processing to separate the bran, germ, and
endosperm. Sieved barley meal is an endosperm cell wall-enriched
fraction of ground barley separated from meal by sieving or by air
classification.
(6) Barley betafiber. Barley betafiber is the ethanol precipitated
soluble fraction of cellulase and alpha-amylase hydrolyzed whole grain
barley. Barley betafiber is produced by hydrolysis of whole grain barley
flour, as defined in paragraph (c)(2)(ii)(A)(5) of this section, with a
cellulase and alpha-amylase enzyme preparation, to produce a clear
aqueous extract that contains mainly partially hydrolyzed beta-glucan
and substantially hydrolyzed starch. The soluble, partially hydrolyzed
beta-glucan is separated from the insoluble material by centrifugation,
and after removal of the insoluble material, the partially hydrolyzed
beta-glucan soluble fiber is separated from the other soluble compounds
by precipitation with ethanol. The product is then dried, milled and
sifted. Barley betafiber shall have a beta-glucan soluble fiber content
of at least 70 percent on a dry weight basis.
(B)(1) Psyllium husk from the dried seed coat (epidermis) of the
seed of Plantago (P.) ovata, known as blond psyllium or Indian psyllium,
P. indica, or P. psyllium. To qualify for this claim, psyllium seed
husk, also known as psyllium husk, shall have a purity of no less than
95 percent, such that it contains 3 percent or less protein, 4.5 percent
or less of light extraneous matter, and 0.5 percent or less of heavy
extraneous matter, but in no case may
[[Page 146]]
the combined extraneous matter exceed 4.9 percent, as determined by U.S.
Pharmacopeia (USP) methods described in USP's ``The National
Formulary,'' USP 23, NF 18, p. 1341, (1995), which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
may be obtained from the U.S. Pharmacopeial Convention, Inc., 12601
Twinbrook Pkwy., Rockville, MD 20852, or may be examined at the Center
for Food Safety and Applied Nutrition's Library, 5100 Paint Branch
Pkwy., College Park, MD 20740, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html;
(2) FDA will determine the amount of soluble fiber that is provided
by psyllium husk by using a modification of the Association of Official
Analytical Chemists' International (AOAC's) method for soluble dietary
fiber (991.43) described by Lee et al., ``Determination of Soluble and
Insoluble Dietary Fiber in Psyllium-containing Cereal Products,''
Journal of the AOAC International, 78 (No. 3):724-729, 1995, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies may be obtained from the AOAC INTERNATIONAL, 481 North
Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at
the Center for Food Safety and Applied Nutrition's Library, 5100 Paint
Branch Pkwy., College Park, MD 20740 or at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html;
(iii) Nature of the food eligible to bear the claim. (A) The food
product shall include:
(1) One or more of the whole oat or barley foods from paragraphs
(c)(2)(ii)(A)(1), (2), (3), and (5) of this section, and the whole oat
or barley foods shall contain at least 0.75 gram (g) of soluble fiber
per reference amount customarily consumed of the food product; or
(2) The food containing the oatrim from paragraph (c)(2)(ii)(A)(4)
of this section or the barley betafiber from paragraph (c)(2)(ii)(A)(6)
of this section shall contain at least 0.75 g of beta-glucan soluble
fiber per reference amount customarily consumed of the food product; or
(3) Psyllium husk that complies with paragraph (c)(2)(ii)(B) of this
section, and the psyllium food shall contain at least 1.7 g of soluble
fiber per reference amount customarily consumed of the food product;
(B) The amount of soluble fiber shall be declared in the nutrition
label, consistent with Sec. 101.9(c)(6)(i)(A).
(C) The food shall meet the nutrient content requirement in Sec.
101.62 for a ``low saturated fat'' and ``low cholesterol'' food; and
(D) The food shall meet the nutrient content requirement in Sec.
101.62(b)(2) for a ``low fat'' food, unless the food exceeds this
requirement due to fat content derived from whole oat sources listed in
paragraph (c)(2)(ii)(A) of this section.
(d) Optional information. (1) The claim may state that the
development of heart disease depends on many factors and may identify
one or more of the following risk factors for heart disease about which
there is general scientific agreement: A family history of CHD; elevated
blood total and LDL-cholesterol; excess body weight; high blood
pressure; cigarette smoking; diabetes; and physical inactivity. The
claim may also provide additional information about the benefits of
exercise and management of body weight to help lower the risk of heart
disease;
(2) The claim may state that the relationship between intake of
diets that are low in saturated fat and cholesterol and that include
soluble fiber from the eligible food sources from paragraph (c)(2)(ii)
of this section and reduced risk of heart disease is through the
intermediate link of ``blood cholesterol'' or ``blood total- and LDL-
cholesterol;''
(3) The claim may include information from paragraphs (a) and (b) of
this
[[Page 147]]
section, which summarize the relationship between diets that are low in
saturated fat and cholesterol and that include soluble fiber from
certain foods and coronary heart disease and the significance of the
relationship;
(4) The claim may specify the name of the eligible soluble fiber;
(5) The claim may state that a diet low in saturated fat and
cholesterol that includes soluble fiber from whole oats or barley is
consistent with ``Nutrition and Your Health: Dietary Guidelines for
Americans,'' U.S. Department of Agriculture (USDA) and Department of
Health and Human Services (DHHS), Government Printing Office (GPO);
(6) The claim may state that individuals with elevated blood total-
and LDL-cholesterol should consult their physicians for medical advice
and treatment. If the claim defines high or normal blood total- and LDL-
cholesterol levels, then the claim shall state that individuals with
high blood cholesterol should consult their physicians for medical
advice and treatment;
(7) The claim may include information on the number of people in the
United States who have heart disease. The sources of this information
shall be identified, and it shall be current information from the
National Center for Health Statistics, the National Institutes of
Health, or ``Nutrition and Your Health: Dietary Guidelines for
Americans,'' USDA and DHHS, GPO.
(e) Model health claim. The following model health claims may be
used in food labeling to describe the relationship between diets that
are low in saturated fat and cholesterol and that include soluble fiber
from certain foods and reduced risk of heart disease:
(1) Soluble fiber from foods such as [name of soluble fiber source
from paragraph (c)(2)(ii) of this section and, if desired, the name of
food product], as part of a diet low in saturated fat and cholesterol,
may reduce the risk of heart disease. A serving of [ name of food]
supplies -------- grams of the [grams of soluble fiber specified in
paragraph (c)(2)(i)(G) of this section] soluble fiber from [name of the
soluble fiber source from paragraph (c)(2)(ii) of this section]
necessary per day to have this effect.
(2) Diets low in saturated fat and cholesterol that include [------
-- grams of soluble fiber specified in paragraph (c)(2)(i)(G) of this
section] of soluble fiber per day from [name of soluble fiber source
from paragraph (c)(2)(ii) of this section and, if desired, the name of
the food product] may reduce the risk of heart disease. One serving of
[name of food] provides -------- grams of this soluble fiber.
[62 FR 3600, Jan. 23, 1997, as amended at 62 FR 15344, Mar. 31, 1997; 63
FR 8119, Feb. 18, 1998; 66 FR 66742, Dec. 27, 2001; 67 FR 61782, Oct. 2,
2002; 68 FR 15355, Mar. 31, 2003; 70 FR 40880, July 15, 2005; 70 FR
76162, Dec. 23, 2005; 73 FR 9947, Feb. 25, 2008; 73 FR 23953, May 1,
2008]
Sec. 101.82 Health claims: Soy protein and risk of coronary heart disease
(CHD).
(a) Relationship between diets that are low in saturated fat and
cholesterol and that include soy protein and the risk of CHD. (1)
Cardiovascular disease means diseases of the heart and circulatory
system. CHD is one of the most common and serious forms of
cardiovascular disease and refers to diseases of the heart muscle and
supporting blood vessels. High blood total cholesterol and low density
lipoprotein (LDL)-cholesterol levels are associated with increased risk
of developing CHD. High CHD rates occur among people with high total
cholesterol levels of 240 milligrams per deciliter (mg/dL) (6.21
millimole per liter (mmol/L)) or above and LDL-cholesterol levels of 160
mg/dL (4.13 mmol/L) or above. Borderline high risk total cholesterol
levels range from 200 to 239 mg/dL (5.17 to 6.18 mmol/L) and 130 to 159
mg/dL (3.36 to 4.11 mmol/L) of LDL-cholesterol. The scientific evidence
establishes that diets high in saturated fat and cholesterol are
associated with increased levels of blood total and LDL-cholesterol and,
thus, with increased risk of CHD.
(2) Populations with a low incidence of CHD tend to have relatively
low blood total cholesterol and LDL-cholesterol levels. These
populations also tend to have dietary patterns that are not only low in
total fat, especially saturated fat and cholesterol, but are also
relatively high in plant foods that contain dietary fiber and other
components.
[[Page 148]]
(3) Scientific evidence demonstrates that diets low in saturated fat
and cholesterol may reduce the risk of CHD. Other evidence demonstrates
that the addition of soy protein to a diet that is low in saturated fat
and cholesterol may also help to reduce the risk of CHD.
(b) Significance of the relationship between diets that are low in
saturated fat and cholesterol and that include soy protein and the risk
of CHD. (1) CHD is a major public health concern in the United States.
It accounts for more deaths than any other disease or group of diseases.
Early management of risk factors for CHD is a major public health goal
that can assist in reducing risk of CHD. High blood total and LDL-
cholesterol are major modifiable risk factors in the development of CHD.
(2) Intakes of saturated fat exceed recommended levels in the diets
of many people in the United States. One of the major public health
recommendations relative to CHD risk is to consume less than 10 percent
of calories from saturated fat and an average of 30 percent or less of
total calories from all fat. Recommended daily cholesterol intakes are
300 mg or less per day. Scientific evidence demonstrates that diets low
in saturated fat and cholesterol are associated with lower blood total
and LDL-cholesterol levels. Soy protein, when included in a low
saturated fat and cholesterol diet, also helps to lower blood total and
LDL-cholesterol levels.
(c) Requirements. (1) All requirements set forth in Sec. 101.14
shall be met.
(2) Specific requirements--(i) Nature of the claim. A health claim
associating diets that are low in saturated fat and cholesterol and that
include soy protein with reduced risk of heart disease may be made on
the label or labeling of a food described in paragraph (c)(2)(iii) of
this section, provided that:
(A) The claim states that diets that are low in saturated fat and
cholesterol and that include soy protein ``may'' or ``might'' reduce the
risk of heart disease;
(B) In specifying the disease, the claim uses the following terms:
``heart disease'' or ``coronary heart disease'';
(C) In specifying the substance, the claim uses the term ``soy
protein'';
(D) In specifying the fat component, the claim uses the terms
``saturated fat'' and ``cholesterol'';
(E) The claim does not attribute any degree of risk reduction for
CHD to diets that are low in saturated fat and cholesterol and that
include soy protein;
(F) The claim does not imply that consumption of diets that are low
in saturated fat and cholesterol and that include soy protein is the
only recognized means of achieving a reduced risk of CHD; and
(G) The claim specifies the daily dietary intake of soy protein that
is necessary to reduce the risk of coronary heart disease and the
contribution one serving of the product makes to the specified daily
dietary intake level. The daily dietary intake level of soy protein that
has been associated with reduced risk of coronary heart disease is 25
grams (g) or more per day of soy protein.
(ii) Nature of the substance. (A) Soy protein from the legume seed
Glycine max.
(B) FDA will assess qualifying levels of soy protein in the
following fashion: FDA will measure total protein content by the
appropriate method of analysis given in the ``Official Methods of
Analysis of the AOAC International,'' as described at Sec. 101.9(c)(7).
For products that contain no sources of protein other than soy, FDA will
consider the amount of soy protein as equivalent to the total protein
content. For products that contain a source or sources of protein in
addition to soy, FDA will, using the measurement of total protein
content, calculate the soy protein content based on the ratio of soy
protein ingredients to total protein ingredients in the product. FDA
will base its calculation on information identified and supplied by
manufacturers, such as nutrient data bases or analyses, recipes or
formulations, purchase orders for ingredients, or any other information
that reasonably substantiates the ratio of soy protein to total protein.
Manufacturers must maintain records sufficient to substantiate the claim
for as long as the products are marketed and provide these records, on
written request, to appropriate regulatory officials.
[[Page 149]]
(iii) Nature of the food eligible to bear the claim. (A) The food
product shall contain at least 6.25 g of soy protein per reference
amount customarily consumed of the food product;
(B) The food shall meet the nutrient content requirements in Sec.
101.62 for a ``low saturated fat'' and ``low cholesterol'' food; and
(C) The food shall meet the nutrient content requirement in Sec.
101.62 for a ``low fat'' food, unless it consists of or is derived from
whole soybeans and contains no fat in addition to the fat inherently
present in the whole soybeans it contains or from which it is derived.
(d) Optional information. (1) The claim may state that the
development of heart disease depends on many factors and may identify
one or more of the following risk factors for heart disease about which
there is general scientific agreement: A family history of CHD; elevated
blood total and LDL-cholesterol; excess body weight; high blood
pressure; cigarette smoking; diabetes; and physical inactivity. The
claim may also provide additional information about the benefits of
exercise and management of body weight to help lower the risk of heart
disease;
(2) The claim may state that the relationship between intake of
diets that are low in saturated fat and cholesterol and that include soy
protein and reduced risk of heart disease is through the intermediate
link of ``blood cholesterol'' or ``blood total and LDL-cholesterol'';
(3) The claim may include information from paragraphs (a) and (b) of
this section, which summarize the relationship between diets that are
low in saturated fat and cholesterol and that include soy protein and
CHD and the significance of the relationship;
(4) The claim may state that a diet low in saturated fat and
cholesterol that includes soy protein is consistent with ``Nutrition and
Your Health: Dietary Guidelines for Americans,'' U.S. Department of
Agriculture (USDA) and Department of Health and Human Services (DHHS),
Government Printing Office (GPO);
(5) The claim may state that individuals with elevated blood total
and LDL-cholesterol should consult their physicians for medical advice
and treatment. If the claim defines high or normal blood total and LDL-
cholesterol levels, then the claim shall state that individuals with
high blood cholesterol should consult their physicians for medical
advice and treatment;
(6) The claim may include information on the number of people in the
United States who have heart disease. The sources of this information
shall be identified, and it shall be current information from the
National Center for Health Statistics, the National Institutes of
Health, or ``Nutrition and Your Health: Dietary Guidelines for
Americans,'' USDA and DHHS, GPO;
(e) Model health claim. The following model health claims may be
used in food labeling to describe the relationship between diets that
are low in saturated fat and cholesterol and that include soy protein
and reduced risk of heart disease:
(1) 25 grams of soy protein a day, as part of a diet low in
saturated fat and cholesterol, may reduce the risk of heart disease. A
serving of [name of food] supplies ---- grams of soy protein.
(2) Diets low in saturated fat and cholesterol that include 25 grams
of soy protein a day may reduce the risk of heart disease. One serving
of [name of food] provides ---- grams of soy protein.
[64 FR 57732, Oct. 26, 1999]
Effective Date Note: At 64 FR 57732, Oct. 26, 1999, Sec. 101.82 was
added. Paragraph (c)(2)(ii)(B) contains information collection and
recordkeeping requirements and will not become effective until approval
has been given by the Office of Management and Budget.
Sec. 101.83 Health claims: plant sterol/stanol esters and risk of coronary
heart disease (CHD).
(a) Relationship between diets that include plant sterol/stanol
esters and the risk of CHD. (1) Cardiovascular disease means diseases of
the heart and circulatory system. Coronary heart disease (CHD) is one of
the most common and serious forms of cardiovascular disease and refers
to diseases of the heart muscle and supporting blood vessels. High blood
total cholesterol and low density lipoprotein (LDL) cholesterol
[[Page 150]]
levels are associated with increased risk of developing coronary heart
disease. High CHD rates occur among people with high total cholesterol
levels of 240 milligrams per deciliter (mg/dL) (6.21 millimole per liter
(mmol/l)) or above and LDL cholesterol levels of 160 mg/dL (4.13 mmol/l)
or above. Borderline high risk blood cholesterol levels range from 200
to 239 mg/dL (5.17 to 6.18 mmol/l) for total cholesterol, and 130 to 159
mg/dL (3.36 to 4.11 mmol/l) of LDL cholesterol.
(2) Populations with a low incidence of CHD tend to have relatively
low blood total cholesterol and LDL cholesterol levels. These
populations also tend to have dietary patterns that are not only low in
total fat, especially saturated fat and cholesterol, but are also
relatively high in plant foods that contain dietary fiber and other
components.
(3) Scientific evidence demonstrates that diets that include plant
sterol/stanol esters may reduce the risk of CHD.
(b) Significance of the relationship between diets that include
plant sterol/stanol esters and the risk of CHD. (1) CHD is a major
public health concern in the United States. It accounts for more deaths
than any other disease or group of diseases. Early management of risk
factors for CHD is a major public health goal that can assist in
reducing risk of CHD. High blood total and LDL cholesterol are major
modifiable risk factors in the development of CHD.
(2) The scientific evidence establishes that including plant sterol/
stanol esters in the diet helps to lower blood total and LDL cholesterol
levels.
(c) Requirements--(1) General. All requirements set forth in Sec.
101.14 shall be met, except Sec. 101.14(a)(4) with respect to the
disqualifying level for total fat per 50 grams (g) in dressings for
salad and spreads and Sec. 101.14(e)(6) with respect to dressings for
salad.
(2) Specific requirements--(i) Nature of the claim. A health claim
associating diets that include plant sterol/stanol esters with reduced
risk of heart disease may be made on the label or labeling of a food
described in paragraph (c)(2)(iii) of this section, provided that:
(A) The claim states that plant sterol/stanol esters should be
consumed as part of a diet low in saturated fat and cholesterol;
(B) The claim states that diets that include plant sterol/stanol
esters ``may'' or ``might'' reduce the risk of heart disease;
(C) In specifying the disease, the claim uses the following terms:
``heart disease'' or ``coronary heart disease'';
(D) In specifying the substance, the claim uses the term ``plant
sterol esters'' or ``plant stanol esters,'' except that if the sole
source of the plant sterols or stanols is vegetable oil, the claim may
use the term ``vegetable oil sterol esters'' or ``vegetable oil stanol
esters'';
(E) The claim does not attribute any degree of risk reduction for
CHD to diets that include plant sterol/stanol esters;
(F) The claim does not imply that consumption of diets that include
plant sterol/stanol esters is the only recognized means of achieving a
reduced risk of CHD; and
(G) The claim specifies the daily dietary intake of plant sterol or
stanol esters that is necessary to reduce the risk of CHD and the
contribution one serving of the product makes to the specified daily
dietary intake level. Daily dietary intake levels of plant sterol and
stanol esters that have been associated with reduced risk of are:
(1) 1.3 g or more per day of plant sterol esters.
(2) 3.4 g or more per day of plant stanol esters.
(H) The claim specifies that the daily dietary intake of plant
sterol or stanol esters should be consumed in two servings eaten at
different times of the day with other foods.
(ii) Nature of the substance--(A) Plant sterol esters. (1) Plant
sterol esters prepared by esterifying a mixture of plant sterols from
edible oils with food-grade fatty acids. The plant sterol mixture shall
contain at least 80 percent beta-sitosterol, campesterol, and
stigmasterol (combined weight).
(2) FDA will measure plant sterol esters by the method entitled
``Determination of the Sterol Content in Margarines, Halvarines,
Dressings, Fat Blends and Sterol Fatty Acid Ester
[[Page 151]]
Concentrates by Capillary Gas Chromatography,'' developed by Unilever
United States, Inc., dated February 1, 2000. The method, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51, may be obtained from the Center for Food Safety and Applied
Nutrition, Office of Nutritional Products, Labeling, and Dietary
Supplements, Division of Nutrition Science and Policy, 5100 Paint Branch
Pkwy., College Park, MD 20740, and may be examined at the Center for
Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy.,
College Park, MD 20740, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.
(B) Plant stanol esters. (1) Plant stanol esters prepared by
esterifying a mixture of plant stanols derived from edible oils or
byproducts of the kraft paper pulping process with food-grade fatty
acids. The plant stanol mixture shall contain at least 80 percent
sitostanol and campestanol (combined weight).
(2) FDA will measure plant stanol esters by the following methods
developed by McNeil Consumer Heathcare dated February 15, 2000:
``Determination of Stanols and Sterols in Benecol Tub Spread'';
``Determination of Stanols and Sterols in Benecol Dressing'';
``Determination of Stanols and Sterols in Benecol Snack Bars''; or
``Determination of Stanols and Sterols in Benecol Softgels.'' These
methods are incorporated by reference in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. Copies may be obtained from the Center for Food
Safety and Applied Nutrition, Office of Nutritional Products, Labeling,
and Dietary Supplements, Division of Nutrition Science and Policy, 5100
Paint Branch Pkwy., College Park, MD 20740, or may be examined at the
Center for Food Safety and Applied Nutrition's Library, 5100 Paint
Branch Pkwy., College Park, MD 20740, and at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html.
(iii) Nature of the food eligible to bear the claim. (A) The food
product shall contain:
(1) At least 0.65 g of plant sterol esters that comply with
paragraph (c)(2)(ii)(A)(1) of this section per reference amount
customarily consumed of the food products eligible to bear the health
claim, specifically spreads and dressings for salad, or
(2) At least 1.7 g of plant stanol esters that comply with paragraph
(c)(2)(ii)(B)(1) of this section per reference amount customarily
consumed of the food products eligible to bear the health claim,
specifically spreads, dressings for salad, snack bars, and dietary
supplements in softgel form.
(B) The food shall meet the nutrient content requirements in Sec.
101.62 for a ``low saturated fat'' and ``low cholesterol'' food; and
(C) The food must meet the limit for total fat in Sec.
101.14(a)(4), except that spreads and dressings for salad are not
required to meet the limit for total fat per 50 g if the label of the
food bears a disclosure statement that complies with Sec. 101.13(h);
and
(D) The food must meet the minimum nutrient contribution requirement
in Sec. 101.14(e)(6) unless it is a dressing for salad.
(d) Optional information. (1) The claim may state that the
development of heart disease depends on many factors and may identify
one or more of the following risk factors for heart disease about which
there is general scientific agreement: A family history of CHD; elevated
blood total and LDL cholesterol; excess body weight; high blood
pressure; cigarette smoking; diabetes; and physical inactivity. The
claim may also provide additional information about the benefits of
exercise and management of body weight to help lower the risk of heart
disease.
(2) The claim may state that the relationship between intake of
diets that include plant sterol/stanol esters and reduced risk of heart
disease is through the intermediate link of ``blood cholesterol'' or
``blood total and LDL cholesterol.''
[[Page 152]]
(3) The claim may include information from paragraphs (a) and (b) of
this section, which summarize the relationship between diets that
include plant sterol/stanol esters and the risk of CHD and the
significance of the relationship.
(4) The claim may include information from the following paragraph
on the relationship between saturated fat and cholesterol in the diet
and the risk of CHD: The scientific evidence establishes that diets high
in saturated fat and cholesterol are associated with increased levels of
blood total and LDL cholesterol and, thus, with increased risk of CHD.
Intakes of saturated fat exceed recommended levels in the diets of many
people in the United States. One of the major public health
recommendations relative to CHD risk is to consume less than 10 percent
of calories from saturated fat and an average of 30 percent or less of
total calories from all fat. Recommended daily cholesterol intakes are
300 mg or less per day. Scientific evidence demonstrates that diets low
in saturated fat and cholesterol are associated with lower blood total
and LDL cholesterol levels.
(5) The claim may state that diets that include plant sterol or
stanol esters and are low in saturated fat and cholesterol are
consistent with ``Nutrition and Your Health: Dietary Guidelines for
Americans,'' U.S. Department of Agriculture (USDA) and Department of
Health and Human Services (DHHS), Government Printing Office (GPO).
(6) The claim may state that individuals with elevated blood total
and LDL cholesterol should consult their physicians for medical advice
and treatment. If the claim defines high or normal blood total and LDL
cholesterol levels, then the claim shall state that individuals with
high blood cholesterol should consult their physicians for medical
advice and treatment.
(7) The claim may include information on the number of people in the
United States who have heart disease. The sources of this information
shall be identified, and it shall be current information from the
National Center for Health Statistics, the National Institutes of
Health, or ``Nutrition and Your Health: Dietary Guidelines for
Americans,'' U.S. Department of Agriculture (USDA) and Department of
Health and Human Services (DHHS), Government Printing Office (GPO).
(e) Model health claim. The following model health claims may be
used in food labeling to describe the relationship between diets that
include plant sterol or stanol esters and reduced risk of heart disease:
(1) For plant sterol esters: (i) Foods containing at least 0.65 g
per serving of plant sterol esters, eaten twice a day with meals for a
daily total intake of at least 1.3 g, as part of a diet low in saturated
fat and cholesterol, may reduce the risk of heart disease. A serving of
[name of the food] supplies ------grams of vegetable oil sterol esters.
(ii) Diets low in saturated fat and cholesterol that include two
servings of foods that provide a daily total of at least 1.3 g of
vegetable oil sterol esters in two meals may reduce the risk of heart
disease. A serving of [name of the food] supplies ------grams of
vegetable oil sterol esters.
(2) For plant stanol esters: (i) Foods containing at least 1.7 g per
serving of plant stanol esters, eaten twice a day with meals for a total
daily intake of at least 3.4 g, as part of a diet low in saturated fat
and cholesterol, may reduce the risk of heart disease. A serving of
[name of the food] supplies ------grams of plant stanol esters.
(ii) Diets low in saturated fat and cholesterol that include two
servings of foods that provide a daily total of at least 3.4 g of
vegetable oil stanol esters in two meals may reduce the risk of heart
disease. A serving of [name of the food] supplies ------grams of
vegetable oil stanol esters.
[65 FR 54717, Sept. 8, 2000; 65 FR 70466, Nov. 24, 2000, as amended at
66 FR 66742, Dec. 27, 2001; 68 FR 15355, Mar. 31, 2003; 70 FR 41958,
July 21, 2005]
[[Page 153]]
Subpart F_Specific Requirements for Descriptive Claims That Are Neither
Nutrient Content Claims nor Health Claims
Sec. 101.93 Certain types of statements for dietary supplements.
(a)(1) No later than 30 days after the first marketing of a dietary
supplement that bears one of the statements listed in section 403(r)(6)
or the Federal Food, Drug, and Cosmetic Act, the manufacturer, packer,
or distributor of the dietary supplement shall notify the Office of
Nutritional Products, Labeling and Dietary Supplements (HFS-810), Center
for Food Safety and Applied Nutrition, Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, that it has included
such a statement on the label or in the labeling of its product. An
original and two copies of this notification shall be submitted.
(2) The notification shall include the following:
(i) The name and address of the manufacturer, packer, or distributor
of the dietary supplement that bears the statement;
(ii) The text of the statement that is being made;
(iii) The name of the dietary ingredient or supplement that is the
subject of the statement, if not provided in the text of the statement;
and
(iv) The name of the dietary supplement (including brand name), if
not provided in response to paragraph (a)(2)(iii) on whose label, or in
whose labeling, the statement appears.
(3) The notice shall be signed by a responsible individual or the
person who can certify the accuracy of the information presented and
contained in the notice. The individual shall certify that the
information contained in the notice is complete and accurate, and that
the notifying firm has substantiation that the statement is truthful and
not misleading.
(b) Disclaimer. The requirements in this section apply to the label
or labeling of dietary supplements where the dietary supplement bears a
statement that is provided for by section 403(r)(6) of the Federal Food,
Drug, and Cosmetic Act (the act), and the manufacturer, packer, or
distributor wishes to take advantage of the exemption to section
201(g)(1)(C) of the act that is provided by compliance with section
403(r)(6) of the act.
(c) Text for disclaimer. (1) Where there is one statement, the
disclaimer shall be placed in accordance with paragraph (d) of this
section and shall state:
This statement has not been evaluated by the Food and Drug
Administration. This product is not intended to diagnose, treat, cure,
or prevent any disease.
(2) Where there is more than one such statement on the label or in
the labeling, each statement shall bear the disclaimer in accordance
with paragraph (c)(1) of this section, or a plural disclaimer may be
placed in accordance with paragraph (d) of this section and shall state:
These statements have not been evaluated by the Food and Drug
Administration. This product is not intended to diagnose, treat, cure,
or prevent any disease.
(d) Placement. The disclaimer shall be placed adjacent to the
statement with no intervening material or linked to the statement with a
symbol (e.g., an asterisk) at the end of each such statement that refers
to the same symbol placed adjacent to the disclaimer specified in
paragraphs (c)(1) or (c)(2) of this section. On product labels and in
labeling (e.g., pamphlets, catalogs), the disclaimer shall appear on
each panel or page where there such is a statement. The disclaimer shall
be set off in a box where it is not adjacent to the statement in
question.
(e) Typesize. The disclaimer in paragraph (c) of this section shall
appear in boldface type in letters of a typesize no smaller than one-
sixteenth inch.
(f) Permitted structure/function statements. Dietary supplement
labels or labeling may, subject to the requirements in paragraphs (a)
through (e) of this section, bear statements that describe the role of a
nutrient or dietary ingredient intended to affect the structure or
function in humans or that characterize the documented mechanism by
which a nutrient or dietary ingredient acts to maintain such structure
or function, provided that such statements are not disease claims under
paragraph (g) of this section. If
[[Page 154]]
the label or labeling of a product marketed as a dietary supplement
bears a disease claim as defined in paragraph (g) of this section, the
product will be subject to regulation as a drug unless the claim is an
authorized health claim for which the product qualifies.
(g) Disease claims. (1) For purposes of 21 U.S.C. 343(r)(6), a
``disease'' is damage to an organ, part, structure, or system of the
body such that it does not function properly (e.g., cardiovascular
disease), or a state of health leading to such dysfunctioning (e.g.,
hypertension); except that diseases resulting from essential nutrient
deficiencies (e.g., scurvy, pellagra) are not included in this
definition.
(2) FDA will find that a statement about a product claims to
diagnose, mitigate, treat, cure, or prevent disease (other than a
classical nutrient deficiency disease) under 21 U.S.C. 343(r)(6) if it
meets one or more of the criteria listed below. These criteria are not
intended to classify as disease claims statements that refer to the
ability of a product to maintain healthy structure or function, unless
the statement implies disease prevention or treatment. In determining
whether a statement is a disease claim under these criteria, FDA will
consider the context in which the claim is presented. A statement claims
to diagnose, mitigate, treat, cure, or prevent disease if it claims,
explicitly or implicitly, that the product:
(i) Has an effect on a specific disease or class of diseases;
(ii) Has an effect on the characteristic signs or symptoms of a
specific disease or class of diseases, using scientific or lay
terminology;
(iii) Has an effect on an abnormal condition associated with a
natural state or process, if the abnormal condition is uncommon or can
cause significant or permanent harm;
(iv) Has an effect on a disease or diseases through one or more of
the following factors:
(A) The name of the product;
(B) A statement about the formulation of the product, including a
claim that the product contains an ingredient (other than an ingredient
that is an article included in the definition of ``dietary supplement''
under 21 U.S.C. 321(ff)(3)) that has been regulated by FDA as a drug and
is well known to consumers for its use or claimed use in preventing or
treating a disease;
(C) Citation of a publication or reference, if the citation refers
to a disease use, and if, in the context of the labeling as a whole, the
citation implies treatment or prevention of a disease, e.g., through
placement on the immediate product label or packaging, inappropriate
prominence, or lack of relationship to the product's express claims;
(D) Use of the term ``disease'' or ``diseased,'' except in general
statements about disease prevention that do not refer explicitly or
implicitly to a specific disease or class of diseases or to a specific
product or ingredient; or
(E) Use of pictures, vignettes, symbols, or other means;
(v) Belongs to a class of products that is intended to diagnose,
mitigate, treat, cure, or prevent a disease;
(vi) Is a substitute for a product that is a therapy for a disease;
(vii) Augments a particular therapy or drug action that is intended
to diagnose, mitigate, treat, cure, or prevent a disease or class of
diseases;
(viii) Has a role in the body's response to a disease or to a vector
of disease;
(ix) Treats, prevents, or mitigates adverse events associated with a
therapy for a disease, if the adverse events constitute diseases; or
(x) Otherwise suggests an effect on a disease or diseases.
[62 FR 49886, Sept. 23, 1997, as amended at 62 FR 49867, Sept. 23, 1997;
65 FR 1050, Jan. 6, 2000; 66 FR 17358, Mar. 30, 2001; 66 FR 56035, Nov.
6, 2001]
Sec. 101.95 ``Fresh,'' ``freshly frozen,'' ``fresh frozen,'' ``frozen
fresh.''
The terms defined in this section may be used on the label or in
labeling of a food in conformity with the provisions of this section.
The requirements of the section pertain to any use of the subject terms
as described in paragraphs (a) and (b) of this section that expressly or
implicitly refers to the food on labels or labeling, including use in a
brand name and use as a sensory modifier. However, the use of the term
``fresh'' on labels or labeling is
[[Page 155]]
not subject to the requirements of paragraph (a) of this section if the
term does not suggest or imply that a food is unprocessed or
unpreserved. For example, the term ``fresh'' used to describe
pasteurized whole milk is not subject to paragraph (a) of this section
because the term does not imply that the food is unprocessed (consumers
commonly understand that milk is nearly always pasteurized). However,
the term ``fresh'' to describe pasta sauce that has been pasteurized or
that contains pasteurized ingredients would be subject to paragraph (a)
of this section because the term implies that the food is not processed
or preserved. Uses of fresh not subject to this regulation will be
governed by the provisions of 403(a) of the Federal Food, Drug, and
Cosmetic Act (the act).
(a) The term ``fresh,'' when used on the label or in labeling of a
food in a manner that suggests or implies that the food is unprocessed,
means that the food is in its raw state and has not been frozen or
subjected to any form of thermal processing or any other form of
preservation, except as provided in paragraph (c) of this section.
(b) The terms ``fresh frozen'' and ``frozen fresh,'' when used on
the label or in labeling of a food, mean that the food was quickly
frozen while still fresh (i.e., the food had been recently harvested
when frozen). Blanching of the food before freezing will not preclude
use of the term ``fresh frozen'' to describe the food. ``Quickly
frozen'' means frozen by a freezing system such as blast-freezing (sub-
zero Fahrenheit temperature with fast moving air directed at the food)
that ensures the food is frozen, even to the center of the food, quickly
and that virtually no deterioration has taken place.
(c) Provisions and restrictions. (1) The following do not preclude
the food from use of the term ``fresh:''
(i) The addition of approved waxes or coatings;
(ii) The post-harvest use of approved pesticides;
(iii) The application of a mild chlorine wash or mild acid wash on
produce; or
(iv) The treatment of raw foods with ionizing radiation not to
exceed the maximum dose of 1 kiloGray in accordance with Sec. 179.26 of
this chapter.
(2) A food meeting the definition in paragraph (a) of this section
that is refrigerated is not precluded from use of ``fresh'' as provided
by this section.
[58 FR 2426, Jan. 6, 1993]
Subpart G_Exemptions From Food Labeling Requirements
Sec. 101.100 Food; exemptions from labeling.
(a) The following foods are exempt from compliance with the
requirements of section 403(i)(2) of the act (requiring a declaration on
the label of the common or usual name of each ingredient when the food
is fabricated from two or more ingredients).
(1) An assortment of different items of food, when variations in the
items that make up different packages packed from such assortment
normally occur in good packing practice and when such variations result
in variations in the ingredients in different packages, with respect to
any ingredient that is not common to all packages. Such exemption,
however, shall be on the condition that the label shall bear, in
conjunction with the names of such ingredients as are common to all
packages, a statement (in terms that are as informative as practicable
and that are not misleading) indicating by name other ingredients which
may be present.
(2) A food having been received in bulk containers at a retail
establishment, if displayed to the purchaser with either:
(i) The labeling of the bulk container plainly in view, provided
ingredient information appears prominently and conspicuously in
lettering of not less than one-fourth of an inch in height; or
(ii) A counter card, sign, or other appropriate device bearing
prominently and conspicuously, but in no case with lettering of less
than one-fourth of an inch in height, the information required to be
stated on the label pursuant to section 403(i)(2) of the Federal Food,
Drug, and Cosmetic Act (the act).
(3) Incidental additives that are present in a food at insignificant
levels
[[Page 156]]
and do not have any technical or functional effect in that food. For the
purposes of this paragraph (a)(3), incidental additives are:
(i) Substances that have no technical or functional effect but are
present in a food by reason of having been incorporated into the food as
an ingredient of another food, in which the substance did have a
functional or technical effect.
(ii) Processing aids, which are as follows:
(a) Substances that are added to a food during the processing of
such food but are removed in some manner from the food before it is
packaged in its finished form.
(b) Substances that are added to a food during processing, are
converted into constituents normally present in the food, and do not
significantly increase the amount of the constitutents naturally found
in the food.
(c) Substances that are added to a food for their technical or
functional effect in the processing but are present in the finished food
at insignificant levels and do not have any technical or functional
effect in that food.
(iii) Substances migrating to food from equipment or packaging or
otherwise affecting food that are not food additives as defined in
section 201(s) of the act; or if they are food additives as so defined,
they are used in conformity with regulations established pursuant to
section 409 of the act.
(4) For the purposes of paragraph (a)(3) of this section, any
sulfiting agent (sulfur dioxide, sodium sulfite, sodium bisulfite,
potasssium bisulfite, sodium metabisulfite, and potassium metabisulfite)
that has been added to any food or to any ingredient in any food and
that has no technical effect in that food will be considered to be
present in an insignificant amount only if no detectable amount of the
agent is present in the finished food. A detectable amount of sulfiting
agent is 10 parts per million or more of the sulfite in the finished
food. Compliance with this paragraph will be determined using sections
20.123-20.125, ``Total Sulfurous Acid,'' in ``Official Methods of
Analysis of the Association of Official Analytical Chemists,'' 14th Ed.
(1984), which is incorporated by reference and the refinements of the
``Total Sulfurous Acid'' procedure in the ``Monier-Williams Procedure
(with Modifications) for Sulfites in Foods,'' which is appendix A to
part 101. A copy of sections 20.123-20-125 of the Official Methods of
Analysis of the Association of Official Analytical Chemists'' is
available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite
500, Gaithersburg, MD 20877, or available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html.
(b) A food repackaged in a retail establishment is exempt from the
following provisions of the act if the conditions specified are met.
(1) Section 403(e)(1) of the act (requiring a statement on the label
of the name and place of business of the manufacturer, packer, or
distributor).
(2) Section 403(g)(2) of the act (requiring the label of a food
which purports to be or is represented as one for which a definition and
standard of identity has been prescribed to bear the name of the food
specified in the definition and standard and, insofar as may be required
by the regulation establishing the standard the common names of the
optional ingredients present in the food), if the food is displayed to
the purchaser with its interstate labeling clearly in view, or with a
counter card, sign, or other appropriate device bearing prominently and
conspicuously the information required by these provisions.
(3) Section 403(i)(1) of the act (requiring the label to bear the
common or usual name of the food), if the food is displayed to the
purchaser with its interstate labeling clearly in view, or with a
counter card, sign, or other appropriate device bearing prominently and
conspicuously the common or usual name of the food, or if the common or
usual name of the food is clearly revealed by its appearance.
(c) An open container (a container of rigid or semirigid
construction, which
[[Page 157]]
is not closed by lid, wrapper, or otherwise other than by an uncolored
transparent wrapper which does not obscure the contents) of a fresh
fruit or fresh vegetable, the quantity of contents of which is not more
than 1 dry quart, shall be exempt from the labeling requirements of
sections 403(e), (g)(2) (with respect to the name of the food specified
in the definition and standard), and (i)(1) of the act; but such
exemption shall be on the condition that if two or more such containers
are enclosed in a crate or other shipping package, such crate or package
shall bear labeling showing the number of such containers enclosed
therein and the quantity of the contents of each.
(d) Except as provided by paragraphs (e) and (f) of this section, a
shipment or other delivery of a food which is, in accordance with the
practice of the trade, to be processed, labeled, or repacked in
substantial quantity at an establishment other than that where
originally processed or packed, shall be exempt, during the time of
introduction into and movement in interstate commerce and the time of
holding in such establishment, from compliance with the labeling
requirements of section 403 (c), (e), (g), (h), (i), (k), and (q) of the
act if:
(1) The person who introduced such shipment or delivery into
interstate commerce is the operator of the establishment where such food
is to be processed, labeled, or repacked; or
(2) In case such person is not such operator, such shipment or
delivery is made to such establishment under a written agreement, signed
by and containing the post office addresses of such person and such
operator, and containing such specifications for the processing,
labeling, or repacking, as the case may be, of such food in such
establishment as will ensure, if such specifications are followed, that
such food will not be adulterated or misbranded within the meaning of
the act upon completion of such processing, labeling, or repacking. Such
person and such operator shall each keep a copy of such agreement until
2 years after the final shipment or delivery of such food from such
establishment, and shall make such copies available for inspection at
any reasonable hour to any officer or employee of the Department who
requests them.
(3) The article is an egg product subject to a standard of identity
promulgated in part 160 of this chapter, is to be shipped under the
conditions specified in paragraph (d) (1) or (2) of this section and for
the purpose of pasteurization or other treatment as required in such
standard, and each container of such egg product bears a conspicuous tag
or label reading ``Caution--This egg product has not been pasteurized or
otherwise treated to destroy viable Salmonella microorganisms''. In
addition to safe and suitable bactericidal processes designed
specifically for Salmonella destruction in egg products, the term
``other treatment'' in the first sentence of this paragraph shall
include use in acidic dressings in the processing of which the pH is not
above 4.1 and the acidity of the aqueous phase, expressed as acetic
acid, is not less than 1.4 percent, subject also to the conditions that:
(i) The agreement required in paragraph (d)(2) of this section shall
also state that the operator agrees to utilize such unpasteurized egg
products in the processing of acidic dressings according to the
specifications for pH and acidity set forth in this paragraph, agrees
not to deliver the acidic dressing to a user until at least 72 hours
after such egg product is incorporated in such acidic dressing, and
agrees to maintain for inspection adequate records covering such
processing for 2 years after such processing.
(ii) In addition to the caution statement referred to above, the
container of such egg product shall also bear the statement
``Unpasteurized ------ for use in acidic dressings only'', the blank
being filled in with the applicable name of the eggs or egg product.
(e) Conditions affecting expiration of exemptions:
(1) An exemption of a shipment or other delivery of a food under
paragraph (d) (1) or (3) of this section shall, at the beginning of the
act of removing such shipment or delivery, or any part thereof, from
such establishment become void ab initio if the food comprising such
shipment, delivery, or part is adulterated or misbranded within
[[Page 158]]
the meaning of the act when so removed.
(2) An exemption of a shipment or other delivery of a food under
paragraph (d) (2) or (3) of this section shall become void ab initio
with respect to the person who introduced such shipment or delivery into
interstate commerce upon refusal by such person to make available for
inspection a copy of the agreement, as required by paragraph (d) (2) or
(3) of this section.
(3) An exemption of a shipment or other delivery of a food under
paragraph (d) (2) or (3) of this section shall expire:
(i) At the beginning of the act of removing such shipment or
delivery, or any part thereof, from such establishment if the food
constituting such shipment, delivery, or part is adulterated or
misbranded within the meaning of the act when so removed; or
(ii) Upon refusal by the operator of the establishment where such
food is to be processed, labeled, or repacked, to make available for
inspection a copy of the agreement, as required by such paragraph.
(f) The word ``processed'' as used in this paragraph shall include
the holding of cheese in a suitable warehouse at a temperature of not
less than 35 [deg]F for the purpose of aging or curing to bring the
cheese into compliance with requirements of an applicable definition and
standard of identity. The exemptions provided for in paragraph (d) of
this section shall apply to cheese which is, in accordance with the
practice of the trade, shipped to a warehouse for aging or curing, on
condition that the cheese is identified in the manner set forth in one
of the applicable following paragraphs, and in such case the provisions
of paragraph (e) of this section shall also apply:
(1) In the case of varieties of cheese for which definitions and
standards of identity require a period of aging whether or not they are
made from pasteurized milk, each such cheese shall bear on the cheese a
legible mark showing the date at which the preliminary manufacturing
process has been completed and at which date curing commences, and to
each cheese, on its wrapper or immediate container, shall be affixed a
removable tag bearing the statement ``Uncured ------ cheese for
completion of curing and proper labeling'', the blank being filled in
with the applicable name of the variety of cheese. In the case of swiss
cheese, the date at which the preliminary manufacturing process had been
completed and at which date curing commences is the date on which the
shaped curd is removed from immersion in saturated salt solution as
provided in the definition and standard of identity for swiss cheese,
and such cheese shall bear a removable tag reading, ``To be cured and
labeled as `swiss cheese,' but if eyes do not form, to be labeled as
`swiss cheese for manufacturing' ''.
(2) In the case of varieties of cheeses which when made from
unpasteurized milk are required to be aged for not less than 60 days,
each such cheese shall bear a legible mark on the cheese showing the
date at which the preliminary manufacturing process has been completed
and at which date curing commences, and to each such cheese or its
wrapper or immediate container shall be affixed a removable tag reading,
``------ cheese made from unpasteurized milk. For completion of curing
and proper labeling'', the blank being filled in with the applicable
name of the variety of cheese.
(3) In the case of cheddar cheese, washed curd cheese, colby cheese,
granular cheese, and brick cheese made from unpasteurized milk, each
such cheese shall bear a legible mark on the cheese showing the date at
which the preliminary manufacturing process has been completed and at
which date curing commences, and to each such cheese or its wrapper or
immediate container shall be affixed a removable tag reading ``------
cheese made from unpasteurized milk. For completion of curing and proper
labeling, or for labeling as ------ cheese for manufacturing'', the
blank being filled in with the applicable name of the variety of cheese.
(g) The label declaration of a harmless marker used to identify a
particular manufacturer's product may result in unfair competition
through revealing a trade secret. Exemption from the label declaration
of such a marker is granted, therefore, provided that the following
conditions are met:
[[Page 159]]
(1) The person desiring to use the marker without label declaration
of its presence has submitted to the Commissioner of Food and Drugs full
information concerning the proposed usage and the reasons why he
believes label declaration of the marker should be subject to this
exemption; and
(2) The person requesting the exemption has received from the
Commissioner of Food and Drugs a finding that the marker is harmless and
that the exemption has been granted.
(h) Wrapped fish fillets of nonuniform weight intended to be
unpacked and marked with the correct weight at or before the point of
retail sale in an establishment other than that where originally packed
shall be exempt from the requirement of section 403(e)(2) of the act
during introduction and movement in interstate commerce and while held
for sale prior to weighing and marking:
(1) Provided, That (i) The outside container bears a label
declaration of the total net weight; and
(ii) The individual packages bear a conspicuous statement ``To be
weighed at or before time of sale'' and a correct statement setting
forth the weight of the wrapper;
(2) Provided further, That it is the practice of the retail
establishment to weigh and mark the individual packages with a correct
net-weight statement prior to or at the point of retail sale. A
statement of the weight of the wrapper shall be set forth so as to be
readily read and understood, using such term as ``wrapper tare--ounce'',
the blank being filled in with the correct average weight of the wrapper
used.
(3) The act of delivering the wrapped fish fillets during the retail
sale without the correct net-weight statement shall be deemed an act
which results in the product's being misbranded while held for sale.
Nothing in this paragraph shall be construed as requiring net-weight
statements for wrapped fish fillets delivered into institutional trade
provided the outside container bears the required information.
(i) Wrapped clusters (consumer units) of bananas of nonuniform
weight intended to be unpacked from a master carton or container and
weighed at or before the point of retail sale in an establishment other
than that where originally packed shall be exempt from the requirements
of section 403(e)(2) of the act during introduction and movement in
interstate commerce and while held for sale prior to weighing:
(1) Provided, That (i) The master carton or container bears a label
declaration of the total net weight; and
(ii) The individual packages bear a conspicuous statement ``To be
weighed at or before the time of sale'' and a correct statement setting
forth the weight of the wrapper; using such term as ``wrapper tare --
ounce'', the blank being filled in with the correct average weight of
the wrapper used;
(2) Provided further, That it is the practice of the retail
establishment to weigh the individual packages either prior to or at the
time of retail sale.
(3) The act of delivering the wrapped clusters (consumer units)
during the retail sale without an accurate net weight statement or
alternatively without weighing at the time of sale shall be deemed an
act which results in the product's being misbranded while held for sale.
Nothing in this paragraph shall be construed as requiring net-weight
statements for clusters (consumer units) delivered into institutional
trade, provided that the master container or carton bears the required
information.
[42 FR 14308, Mar. 15, 1977, as amended at 51 FR 25017, July 9, 1986; 58
FR 2188, 2876, Jan. 6, 1993; 66 FR 17358, Mar. 30, 2001]
Sec. 101.105 Declaration of net quantity of contents when exempt.
(a) The principal display panel of a food in package form shall bear
a declaration of the net quantity of contents. This shall be expressed
in the terms of weight, measure, numerical count, or a combination of
numerical count and weight or measure. The statement shall be in terms
of fluid measure if the food is liquid, or in terms of weight if the
food is solid, semisolid, or viscous, or a mixture of solid and liquid;
except that such statement may be in terms of dry measure if the food is
a fresh fruit, fresh vegetable, or other dry commodity that is
customarily sold by dry measure. If there is a firmly established
general
[[Page 160]]
consumer usage and trade custom of declaring the contents of a liquid by
weight, or a solid, semisolid, or viscous product by fluid measure, it
may be used. Whenever the Commissioner determines that an existing
practice of declaring net quantity of contents by weight, measure,
numerical count, or a combination in the case of a specific packaged
food does not facilitate value comparisons by consumers and offers
opportunity for consumer confusion, he will by regulation designate the
appropriate term or terms to be used for such commodity.
(b)(1) Statements of weight shall be in terms of avoirdupois pound
and ounce.
(2) Statements of fluid measure shall be in terms of the U.S. gallon
of 231 cubic inches and quart, pint, and fluid ounce subdivisions
thereof, and shall:
(i) In the case of frozen food that is sold and consumed in a frozen
state, express the volume at the frozen temperature.
(ii) In the case of refrigerated food that is sold in the
refrigerated state, express the volume at 40 [deg]F (4 [deg]C).
(iii) In the case of other foods, express the volume at 68 [deg]F
(20 [deg]C).
(3) Statements of dry measure shall be in terms of the U.S. bushel
of 2,150.42 cubic inches and peck, dry quart, and dry pint subdivisions
thereof.
(c) When the declaration of quantity of contents by numerical count
does not give adequate information as to the quantity of food in the
package, it shall be combined with such statement of weight, measure, or
size of the individual units of the foods as will provide such
information.
(d) The declaration may contain common or decimal fractions. A
common fraction shall be in terms of halves, quarters, eighths,
sixteenths, or thirty-seconds; except that if there exists a firmly
established general consumer usage and trade custom of employing
different common fractions in the net quantity declaration of a
particular commodity, they may be employed. A common fraction shall be
reduced to its lowest terms; a decimal fraction shall not be carried out
to more than two places. A statement that includes small fractions of an
ounce shall be deemed to permit smaller variations than one which does
not include such fractions.
(e) The declaration shall be located on the principal display panel
of the label, and with respect to packages bearing alternate principal
panels it shall be duplicated on each principal display panel.
(f) The declaration shall appear as a distinct item on the principal
display panel, shall be separated (by at least a space equal to the
height of the lettering used in the declaration) from other printed
label information appearing above or below the declaration and (by at
least a space equal to twice the width of the letter ``N'' of the style
of type used in the quantity of contents statement) from other printed
label information appearing to the left or right of the declaration. It
shall not include any term qualifying a unit of weight, measure, or
count (such as ``jumbo quart'' and ``full gallon'') that tends to
exaggerate the amount of the food in the container. It shall be placed
on the principal display panel within the bottom 30 percent of the area
of the label panel in lines generally parallel to the base on which the
package rests as it is designed to be displayed: Provided, That on
packages having a principal display panel of 5 square inches or less,
the requirement for placement within the bottom 30 percent of the area
of the label panel shall not apply when the declaration of net quantity
of contents meets the other requirements of this part.
(g) The declaration shall accurately reveal the quantity of food in
the package exclusive of wrappers and other material packed therewith:
Provided, That in the case of foods packed in containers designed to
deliver the food under pressure, the declaration shall state the net
quantity of the contents that will be expelled when the instructions for
use as shown on the container are followed. The propellant is included
in the net quantity declaration.
(h) The declaration shall appear in conspicuous and easily legible
boldface print or type in distinct contrast (by typography, layout,
color, embossing, or molding) to other matter on the package; except
that a declaration of
[[Page 161]]
net quantity blown, embossed, or molded on a glass or plastic surface is
permissible when all label information is so formed on the surface.
Requirements of conspicuousness and legibility shall include the
specifications that:
(1) The ratio of height to width (of the letter) shall not exceed a
differential of 3 units to 1 unit (no more than 3 times as high as it is
wide).
(2) Letter heights pertain to upper case or capital letters. When
upper and lower case or all lower case letters are used, it is the lower
case letter ``o'' or its equivalent that shall meet the minimum
standards.
(3) When fractions are used, each component numeral shall meet one-
half the minimum height standards.
(i) The declaration shall be in letters and numerals in a type size
established in relationship to the area of the principal display panel
of the package and shall be uniform for all packages of substantially
the same size by complying with the following type specifications:
(1) Not less than one-sixteenth inch in height on packages the
principal display panel of which has an area of 5 square inches or less.
(2) Not less than one-eighth inch in height on packages the
principal display panel of which has an area of more than 5 but not more
than 25 square inches.
(3) Not less than three-sixteenths inch in height on packages the
principal display panel of which has an area of more than 25 but not
more than 100 square inches.
(4) Not less than one-fourth inch in height on packages the
principal display panel of which has an area of more than 100 square
inches, except not less than \1/2\ inch in height if the area is more
than 400 square inches.
Where the declaration is blown, embossed, or molded on a glass or
plastic surface rather than by printing, typing, or coloring, the
lettering sizes specified in paragraphs (h)(1) through (4) of this
section shall be increased by one-sixteenth of an inch.
(j) On packages containing less than 4 pounds or 1 gallon and
labeled in terms of weight or fluid measure:
(1) The declaration shall be expressed both in ounces, with
identification by weight or by liquid measure and, if applicable (1
pound or 1 pint or more) followed in parentheses by a declaration in
pounds for weight units, with any remainder in terms of ounces or common
or decimal fractions of the pound (see examples set forth in paragraphs
(m) (1) and (2) of this section), or in the case of liquid measure, in
the largest whole units (quarts, quarts and pints, or pints, as
appropriate) with any remainder in terms of fluid ounces or common or
decimal fractions of the pint or quart (see examples in paragraphs (m)
(3) and (4) of this section).
(2) If the net quantity of contents declaration appears on a random
package, that is a package which is one of a lot, shipment, or delivery
of packages of the same consumer commodity with varying weights and with
no fixed weight pattern, it may, when the net weight exceeds 1 pound, be
expressed in terms of pounds and decimal fractions of the pound carried
out to not more than two decimal places. When the net weight does not
exceed 1 pound, the declaration on the random package may be in decimal
fractions of the pound in lieu of ounces (see example in paragraph
(m)(5) of this section).
(3) The declaration may appear in more than one line. The term ``net
weight'' shall be used when stating the net quantity of contents in
terms of weight. Use of the terms ``net'' or ``net contents'' in terms
of fluid measure or numerical count is optional. It is sufficient to
distinguish avoirdupois ounce from fluid ounce through association of
terms; for example, ``Net wt. 6 oz'' or ``6 oz Net wt.'' and ``6 fl oz''
or ``Net contents 6 fl oz''.
(k) On packages containing 4 pounds or 1 gallon or more and labeled
in terms of weight or fluid measure, the declaration shall be expressed
in pounds for weight units with any remainder in terms of ounces or
common or decimal fraction of the pound, or in the case of fluid
measure, it shall be expressed in the largest whole unit (gallons
followed by common or decimal fraction of a gallon or by the next
smaller whole unit or units (quarts, or quarts and pints)) with any
remainder in terms of fluid ounces or common or decimal fractions of the
pint or quart (see paragraph (m)(6) of this section).
[[Page 162]]
(l) [Reserved]
(m) Examples:
(1) A declaration of 1\1/2\ pounds weight shall be expressed as
``Net Wt. 24 oz (1 lb 8 oz),'' ``Net Wt. 24 oz (1\1/2\ lb),'' or ``Net
Wt. 24 oz (1.5 lb)''.
(2) A declaration of three-fourths pound avoirdupois weight shall be
expressed as ``Net Wt. 12 oz''.
(3) A declaration of 1 quart liquid measure shall be expressed as
``Net 32 fl oz (1 qt)''.
(4) A declaration of 1\3/4\ quarts liquid measure shall be expressed
as ``Net contents 56 fluid ounces (1 quart 1\1/2\ pints)'' or as ``Net
56 fluid oz (1 qt 1 pt 8 oz)'', but not in terms of quart and ounce such
as ``Net 56 fluid oz (1 quart 24 ounces)''.
(5) On a random package, declaration of three-fourths pound
avoirdupois may be expressed as ``Net Wt. .75 lb''.
(6) A declaration of 2\1/2\ gallons liquid measure shall be
expressed as ``Net contents 2\1/2\ gallons,'' ``Net contents 2.5
gallons,'' or ``Net contents 2 gallons 2 quarts'' and not as ``2 gallons
4 pints''.
(n) For quantities, the following abbreviations and none other may
be employed (periods and plural forms are optional):
weight wt
ounce oz
pound lb
gallon gal
pint pt
quart qt
fluid fl
(o) Nothing in this section shall prohibit supplemental statements
at locations other than the principal display panel(s) describing in
nondeceptive terms the net quantity of contents; Provided, that such
supplemental statements of net quantity of contents shall not include
any term qualifying a unit of weight, measure, or count that tends to
exaggerate the amount of the food contained in the package; for example,
``jumbo quart'' and ``full gallon''. Dual or combination declarations of
net quantity of contents as provided for in paragraphs (a), (c), and (j)
of this section (for example, a combination of net weight plus numerical
count, net contents plus dilution directions of a concentrate, etc.) are
not regarded as supplemental net quantity statements and may be located
on the principal display panel.
(p) A separate statement of the net quantity of contents in terms of
the metric system is not regarded as a supplemental statement and an
accurate statement of the net quantity of contents in terms of the
metric system of weight or measure may also appear on the principal
display panel or on other panels.
(q) The declaration of net quantity of contents shall express an
accurate statement of the quantity of contents of the package.
Reasonable variations caused by loss or gain of moisture during the
course of good distribution practice or by unavoidable deviations in
good manufacturing practice will be recognized. Variations from stated
quantity of contents shall not be unreasonably large.
(r) The declaration of net quantity of contents on pickles and
pickle products, including relishes but excluding one or two whole
pickles in clear plastic bags which may be declared by count, shall be
expressed in terms of the U.S. gallon of 231 cubic inches and quart,
pint, and fluid ounce subdivisions thereof.
(s) On a multiunit retail package, a statement of the quantity of
contents shall appear on the outside of the package and shall include
the number of individual units, the quantity of each individual unit,
and, in parentheses, the total quantity of contents of the multiunit
package in terms of avoirdupois or fluid ounces, except that such
declaration of total quantity need not be followed by an additional
parenthetical declaration in terms of the largest whole units and
subdivisions thereof, as required by paragraph (j)(1) of this section. A
multiunit retail package may thus be properly labeled: ``6-16 oz
bottles--(96 fl oz)'' or ``3-16 oz cans--(net wt. 48 oz)''. For the
purposes of this section, ``multiunit retail package'' means a package
containing two or more individually packaged units of the identical
commodity and in the same quantity, intended to be sold as part of the
multiunit retail package but capable of being individually sold in full
compliance with all requirements of the regulations in this part. Open
multiunit retail packages that do not obscure the number of units or
prevent examination of the labeling on each of the individual units are
not
[[Page 163]]
subject to this paragraph if the labeling of each individual unit
complies with the requirements of paragraphs (f) and (i) of this
section. The provisions of this section do not apply to that butter or
margarine covered by the exemptions in Sec. 1.24(a) (10) and (11) of
this chapter.
(t) Where the declaration of net quantity of contents is in terms of
net weight and/or drained weight or volume and does not accurately
reflect the actual quantity of the contents or the product falls below
the applicable standard of fill of container because of equipment
malfunction or otherwise unintentional product variation, and the label
conforms in all other respects to the requirements of this chapter
(except the requirement that food falling below the applicable standard
of fill of container shall bear the general statement of substandard
fill specified in Sec. 130.14(b) of this chapter), the mislabeled food
product, including any food product that fails to bear the general
statement of substandard fill specified in Sec. 130.14(b) of this
chapter, may be sold by the manufacturer or processor directly to
institutions operated by Federal, State or local governments (schools,
prisons, hospitals, etc.): Provided, That:
(1) The purchaser shall sign a statement at the time of sale stating
that he is aware that the product is mislabeled to include
acknowledgment of the nature and extent of the mislabeling, (e.g.,
``Actual net weight may be as low as --% below labeled quantity'') and
that any subsequent distribution by him of said product except for his
own institutional use is unlawful. This statement shall be kept on file
at the principal place of business of the manufacturer or processor for
2 years subsequent to the date of shipment of the product and shall be
available to the Food and Drug Administration upon request.
(2) The product shall be labeled on the outside of its shipping
container with the statement(s):
(i) When the variation concerns net weight and/or drained weight or
volume, ``Product Mislabeled. Actual net weight (drained weight or
volume where appropriate) may be as low as --% below labeled quantity.
This Product Not for Retail Distribution'', the blank to be filled in
with the maximum percentage variance between the labeled and actual
weight or volume of contents of the individual packages in the shipping
container, and
(ii) When the variation is in regard to a fill of container
standard, ``Product Mislabeled. Actual fill may be as low as --% below
standard of fill. This Product Not for Retail Distribution''.
(3) The statements required by paragraphs (t)(2) (i) and (ii) of
this section, which may be consolidated where appropriate, shall appear
prominently and conspicuously as compared to other printed matter on the
shipping container and in boldface print or type on a clear, contrasting
background in order to render them likely to be read and understood by
the purchaser under ordinary conditions of purchase.
[42 FR 14308, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]
Sec. 101.108 Temporary exemptions for purposes of conducting authorized food
labeling experiments.
(a) The food industry is encouraged to experiment voluntarily, under
controlled conditions and in collaboration with the Food and Drug
Administration, with and other formats for presenting nutrition and
other related food labeling information that is consistent with the
current quantitative system in Sec. Sec. 101.9 and 105.66 of this
chapter.
(b) Any firm that intends to undertake a labeling experiment that
requires exemptions from certain requirements of Sec. Sec. 101.9 and
105.66 of this chapter should submit a written proposal containing a
thorough discussion of each of the following information items that
apply to the particular experiment:
(1) A description of the labeling format to be tested;
(2) A statement of the criteria to be used in the experiment for
assigning foods to categories, e.g., nutrient or other values defining
``low'' and ``reduced'';
(3) A draft of the material to be used in the store, e.g., shelf
tags, booklets, posters, etc.;
(4) The dates on which the experiment will begin and end and on
which
[[Page 164]]
a written report of analysis of the experimental data will be submitted
to FDA, together with a commitment not to continue the experiment beyond
the proposed ending date without FDA approval;
(5) The geographic area or areas in which the experiment is to be
conducted;
(6) The mechanism to measure the effectiveness of the experiment;
(7) The method for conveying to consumers the required nutrition and
other labeling information that is exempted from the label during the
experiment;
(8) The method that will be or has been used to determine the actual
nutritional characteristics of foods for which a claim is made; and
(9) A statement of the sections of the regulations for which an
exemption is sought.
(c) The written proposal should be sent to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. The proposal should be clearly identified
as a request for a temporary exemption for purposes of conducting
authorized food labeling experiments and submitted as a citizen petition
under Sec. 10.30 of this chapter.
(d) Approval for food labeling experiments will be given by FDA in
writing. Foods labeled in violation of existing regulations will be
subject to regulatory action unless an FDA-approved exemption to the
specific regulation has been granted for that specific product.
(e) Reporting requirements contained in Sec. 101.108(b) have been
approved by this Office of Management and Budget and assigned number
0910-0151.
[48 FR 15240, Apr. 8, 1983, as amended at 59 FR 14364, Mar. 28, 1994; 62
FR 15343, Mar. 31, 1997]
Sec. Appendix A to Part 101--Monier-Williams Procedure (With
Modifications) for Sulfites in Food, Center for Food Safety and Applied
Nutrition, Food and Drug Administration (November 1985)
The AOAC official method for sulfites (Official Methods of Analysis,
14th Edition, 20.123-20.125, AOAC INTERNATIONAL) has been modified, in
FDA laboratories, to facilitate the determination of sulfites at or near
10 ppm in food. Method instructions, including modifications, are
described below.
Apparatus--The apparatus shown diagrammatically (Figure 1) is
designed to accomplish the selective transfer of sulfur dioxide from the
sample in boiling aqueous hydrochloric acid to a solution of 3% hydrogen
peroxide. This apparatus is easier to assemble than the official
apparatus and the back pressure inside the apparatus is limited to the
unavoidable pressure due to the height of the 3%
H2O2 solution above the tip of the bubbler (F).
Keeping the backpressure as low as possible reduces the likelihood that
sulfur dioxide will be lost through leaks.
The apparatus should be assembled as shown in Fig. 1 with a thin
film of stopcock grease on the sealing surfaces of all the joints except
the joint between the separatory funnel and the flask. Each joint should
be clamped together to ensure a complete seal throughout the analysis.
The separatory funnel, B, should have a capacity of 100 ml or greater.
An inlet adapter, A, with a hose connector (Kontes K-183000 or
equivalent) is required to provide a means of applying a head of
pressure above the solution. (A pressure equalizing dropping funnel is
not recommended because condensate, perhaps with sulfur dioxide, is
deposited in the funnel and the side arm.) The round bottom flask, C, is
a 1000 ml flask with three 24/40 tapered joints. The gas inlet tube, D,
(Kontes K-179000 or equivalent) should be of sufficient length to permit
introduction of the nitrogen within 2.5 cm of the bottom of the flask.
The Allihn condenser, E, (Kontes K-431000-2430 or equivalent) has a
jacket length of 300 mm. The bubbler, F, was fabricated from glass
according to the dimensions given in Fig. 2. The 3% hydrogen peroxide
solution can be contained in a vessel, G, with an i.d. of ca. 2.5 cm and
a depth of 18 cm.
Buret--A 10 ml buret (Fisher Cat. No. 03-848-2A or equivalent) with
overflow tube and hose connections for an Ascarite tube or equivalent
air scrubbing apparatus. This will permit the maintenance of a carbon
dioxide-free atmosphere over the standardized 0.01N sodium hydroxide.
Chilled Water Circulator--The condensor must be chilled with a
coolant, such as 20% methanol-water, maintained at 5 [deg]C. A
circulating pump equivalent to the Neslab Coolflow 33 is suitable.
Reagents
(a) Aqueous hydrochloric acid, 4N.--For each analysis prepare 90 ml
of hydrochloric acid by adding 30 ml of concentrated hydrochloric acid
(12N) to 60 ml of distilled water.
(b) Methyl red indicator--Dissolve 250 mg of methyl red in 100 ml
ethanol.
(c) Hydrogen peroxide solution, 3%--Dilute ACS reagent grade 30%
hydrogen peroxide to
[[Page 165]]
3% with distilled water. Just prior to use, add three drops of methyl
red indicator and titrate to a yellow end-point using 0.01N sodium
hydroxide. If the end-point is exceeded discard the solution and prepare
another 3% H2O2 solution.
(d) Standardized titrant, 0.01N NaOH--Certified reagent may be used
(Fisher SO-5-284). It should be standardized with reference standard
potassium hydrogen phthalate.
(e) Nitrogen--A source of high purity nitrogen is required with a
flow regulator that will maintain a flow of 200 cc per minute. To guard
against the presence of oxygen in the nitrogen, an oxygen scrubbing
solution such as an alkaline pyrogallol trap may be used. Prepare
pyrogallol trap as follows:
1. Add 4.5 g pyrogallol to the trap.
2. Purge trap with nitrogen for 2 to 3 minutes.
3. Prepare a KOH solution prepared by adding 65g KOH to 85 ml
distilled water (caution: heat).
4. Add the KOH solution to the trap while maintaining an atmosphere
of nitrogen in the trap.
Determination
Assemble the apparatus as shown in Fig. 1. The flask C must be
positioned in a heating mantle that is controlled by a power regulating
device such as Variac or equivalent. Add 400 ml of distilled water to
flask C. Close the stopcock of separatory funnel, B, and add 90 ml of 4N
hydrochloric acid to the separatory funnel. Begin the flow of nitrogen
at a rate of 20010 cc/min. The condenser coolant
flow must be initiated at this time. Add 30 ml of 3% hydrogen peroxide,
which has been titrated to a yellow end-point with 0.01N NaOH, to
container G. After fifteen minutes the apparatus and the distilled water
will be thoroughly de-oxygenated and the apparatus is ready for sample
introduction.
Sample preparation (solids)--Transfer 50 g of food, or a quantity of
food with a convenient quantity of SO2 (500 to 1500 mcg
SO2), to a food processor or blender. Add 100 ml of 5%
ethanol in water and briefly grind the mixture. Grinding or blending
should be continued only until the food is chopped into pieces small
enough to pass through the 24/40 point of flask C.
Sample preparation (liquids)--Mix 50 g of the sample, or a quantity
with a convenient quantity of SO2 (500 to 1500 mcg
SO2), with 100 ml of 5% ethanol in water.
Sample introduction and distillation--Remove the separatory funnel
B, and quantitatively transfer the food sample in aqueous ethanol to
flask C. Wipe the tapered joint clean with a laboratory tissue, apply
stopcock grease to the outer joint of the separatory funnel, and return
the separatory funnel, B, to tapered joint flask C. The nitrogen flow
through the 3% hydrogen peroxide solution should resume as soon as the
funnel, B, is re-inserted into the appropriate joint in flask C. Examine
each joint to ensure that it is sealed.
Apply a head pressure above the hydrochloric acid solution in B with
a rubber bulb equipped with a valve. Open the stopcock in B and permit
the hydrochloric acid solution to flow into flask C. Continue to
maintain sufficient pressure above the acid solution to force the
solution into the flask C. The stopcock may be closed, if necessary, to
pump up the pressure above the acid and then opened again. Close the
stopcock before the last few milliliters drain out of the separatory
funnel, B, to guard against the escape of sulfur dioxide into the
separatory funnel.
Apply the power to the heating mantle. Use a power setting which
will cause 80 to 90 drops per minute of condensate to return to the
flask from condenser, E. After 1.75 hours of boiling the contents of the
1000 ml flask and remove trap G.
Titration.--Titrate the contents with 0.01N sodium hydroxide.
Titrate with 0.01N NaOH to a yellow end-point that persists for at least
twenty seconds. Compute the sulfite content, expressed as micrograms
sulfur dioxide per gram of food (ppm) as follows:
ppm=(32.03xVB xNx1000)/Wt
where 32.03=milliequivalent weight of sulfur dioxide;
VB=volume of sodium hydroxide titrant of normality, N,
required to reach endpoint; the factor, 1000, converts milliequivalents
to microequivalents and Wt=weight (g) of food sample introduced into the
1000 ml flask.
[[Page 166]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.362
Figure 1. The optimized Monier-Williams apparatus. Component
identification is given in text.
[[Page 167]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.363
Figure 2. Diagram of bubbler (F in Figure 1). Lengths are given in mm.
[42 FR 14308, Mar. 15, 1977, as amended at 51 FR 25017, July 9, 1986]
Appendix B to Part 101--Graphic Enhancements Used by the FDA
[[Page 168]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.364
[[Page 169]]
[GRAPHIC] [TIFF OMITTED] TR11JY03.006
[58 FR 17332, Apr. 2, 1993, as amended at 70 FR 41506, July 11, 2005]
[[Page 170]]
Sec. Appendix C to Part 101--Nutrition Facts for Raw Fruits and
Vegetables
[GRAPHIC] [TIFF OMITTED] TR17AU06.007
[[Page 171]]
[GRAPHIC] [TIFF OMITTED] TR17AU06.008
[71 FR 47439, Aug. 17, 2006]
[[Page 172]]
Sec. Appendix D to Part 101--Nutrition Facts for Cooked Fish
[GRAPHIC] [TIFF OMITTED] TR17AU06.009
[71 FR 47439, Aug. 17, 2006]
[[Page 173]]
PART 102_COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS--Table of Contents
Subpart A_General Provisions
Sec.
102.5 General principles.
102.19 Petitions.
Subpart B_Requirements for Specific Nonstandardized Foods
102.22 Protein hydrolysates.
102.23 Peanut spreads.
102.26 Frozen ``heat and serve'' dinners.
102.28 Foods packaged for use in the preparation of ``main dishes'' or
``dinners.''
102.33 Beverages that contain fruit or vegetable juice.
102.37 Mixtures of edible fat or oil and olive oil.
102.39 Onion rings made from diced onion.
102.41 Potato chips made from dried potatoes.
102.45 Fish sticks or portions made from minced fish.
102.46 Pacific whiting.
102.47 Bonito.
102.49 Fried clams made from minced clams.
102.50 Crabmeat.
102.54 Seafood cocktails.
102.55 Nonstandardized breaded composite shrimp units.
102.57 Greenland turbot (Reinhardtius hippoglossoides).
Authority: 21 U.S.C. 321, 343, 371.
Source: 42 FR 14322, Mar. 15, 1977, unless otherwise noted.
Subpart A_General Provisions
Sec. 102.5 General principles.
(a) The common or usual name of a food, which may be a coined term,
shall accurately identify or describe, in as simple and direct terms as
possible, the basic nature of the food or its characterizing properties
or ingredients. The name shall be uniform among all identical or similar
products and may not be confusingly similar to the name of any other
food that is not reasonably encompassed within the same name. Each class
or subclass of food shall be given its own common or usual name that
states, in clear terms, what it is in a way that distinguishes it from
different foods.
(b) The common or usual name of a food shall include the
percentage(s) of any characterizing ingredient(s) or component(s) when
the proportion of such ingredient(s) or component(s) in the food has a
material bearing on price or consumer acceptance or when the labeling or
the appearance of the food may otherwise create an erroneous impression
that such ingredient(s) or component(s) is present in an amount greater
than is actually the case. The following requirements shall apply unless
modified by a specific regulation in subpart B of this part.
(1) The percentage of a characterizing ingredient or component shall
be declared on the basis of its quantity in the finished product (i.e.,
weight/weight in the case of solids, or volume/volume in the case of
liquids).
(2) The percentage of a characterizing ingredient or component shall
be declared by the words ``containing (or contains) -- percent (or %) --
----'' or ``-- percent (or %) ------'' with the first blank filled in
with the percentage expressed as a whole number not greater than the
actual percentage of the ingredient or component named and the second
blank filled in with the common or usual name of the ingredient or
component. The word ``containing'' (or ``contains''), when used, shall
appear on a line immediately below the part of the common or usual name
of the food required by paragraph (a) of this section. For each
characterizing ingredient or component, the words ``-- percent or %) --
----'' shall appear following or directly below the word ``containing''
(or contains), or directly below the part of the common or usual name of
the food required by paragraph (a) of this section when the word
``containing'' (or contains) is not used, in easily legible boldface
print or type in distinct contrast to other printed or graphic matter,
and in a height not less than the larger of the following alternatives:
(i) Not less than one-sixteenth inch in height on packages having a
principal display panel with an area of 5 square inches or less and not
less than one-eighth inch in height if the area of the principal display
panel is greater than 5 square inches; or
(ii) Not less than one-half the height of the largest type appearing
in the part of the common or usual name of
[[Page 174]]
the food required by paragraph (a) of this section.
(c) The common or usual name of a food shall include a statement of
the presence or absence of any characterizing ingredient(s) or
component(s) and/or the need for the user to add any characterizing
ingredient(s) or component(s) when the presence or absence of such
ingredient(s) or component(s) in the food has a material bearing on
price or consumer acceptance or when the labeling or the appearance of
the food may otherwise create an erroneous impression that such
ingredient(s) or component(s) is present when it is not, and consumers
may otherwise be misled about the presence or absence of the
ingredient(s) or component(s) in the food. The following requirements
shall apply unless modified by a specific regulation in subpart B of
this part.
(1) The presence or absence of a characterizing ingredient or
component shall be declared by the words ``containing (or contains) ----
--'' or ``containing (or contains) no ------'' or ``no ------'' or
``does not contain ------'', with the blank being filled in with the
common or usual name of the ingredient or component.
(2) The need for the user of a food to add any characterizing
ingredient(s) or component(s) shall be declared by an appropriate
informative statement.
(3) The statement(s) required under paragraph (c)(1) and/or (2) of
this section shall appear following or directly below the part of the
common or usual name of the food required by paragraphs (a) and (b) of
this section, in easily legible boldface print or type in distinct
contrast to other printed or graphic matter, and in a height not less
than the larger of the alternatives established under paragraphs (b)(2)
(i) and (ii) of this section.
(d) A common or usual name of a food may be established by common
usage or by establishment of a regulation in subpart B of this part, in
part 104 of this chapter, in a standard of identity, or in other
regulations in this chapter.
Sec. 102.19 Petitions.
(a) The Commissioner of Food and Drugs, either on his own initiative
or on behalf of any interested person who has submitted a petition, may
publish a proposal to issue, amend, or revoke, under this part, a
regulation prescribing a common or usual name for a food, pursuant to
part 10 of this chapter.
(b) If the principal display panel of a food for which a common or
usual name regulation is established is too small to accommodate all
mandatory requirements, the Commissioner may establish by regulation an
acceptable alternative, e.g., a smaller type size. A petition requesting
such a regulation, which would amend the applicable regulation, shall be
submitted pursuant to part 10 of this chapter.
[42 FR 14322, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]
Subpart B_Requirements for Specific Nonstandardized Foods
Sec. 102.22 Protein hydrolysates.
The common or usual name of a protein hydrolysate shall be specific
to the ingredient and shall include the identity of the food source from
which the protein was derived.
(a) ``Hydrolyzed wheat gluten,'' ``hydrolyzed soy protein,'' and
``autolyzed yeast extract'' are examples of acceptable names.
``Hydrolyzed casein'' is also an example of an acceptable name, whereas
``hydrolyzed milk protein'' is not an acceptable name for this
ingredient because it is not specific to the ingredient (hydrolysates
can be prepared from other milk proteins). The names ``hydrolyzed
vegetable protein'' and ``hydrolyzed protein'' are not acceptable
because they do not identify the food source of the protein.
(b) [Reserved]
[58 FR 2876, Jan. 6, 1993]
Sec. 102.23 Peanut spreads.
(a) The common or usual name of a spreadable peanut product that
does not conform to Sec. 164.150 of this chapter, and more than 10
percent of which consists of nonpeanut ingredients, shall consist of the
term ``peanut spread'' and a statement of the percentage by weight of
peanuts in the product in the manner set forth in Sec. 102.5(b), except
[[Page 175]]
that peanut percentages shall be based on the amount of peanuts used to
make the finished food and shall be declared in 5-percent increments
expressed as a multiple of 5, not to exceed the actual percentage of
peanuts in the products.
(b) A spreadable peanut product that is nutritionally inferior to
peanut butter shall be labeled as an imitation of peanut butter under
Sec. 101.3(e)(2) of this chapter; a spreadable peanut product shall be
considered nutritionally equivalent to peanut butter if it meets all of
the following conditions:
(1) Protein. (i) The protein content of the product is at least 24
percent by weight of the finished product, and the overall biological
quality of the protein contained in the product is at least 68 percent
that of casein; or
(ii) The protein content of the product is at least 16.6 percent by
weight of the finished product, and the overall biological quality of
the protein contained in the product is equal to or greater than that of
casein.
(2) Other nutrients. The product contains the following levels of
nutrients per 100 grams of product:
------------------------------------------------------------------------
Amount
Nutrient (milligrams)
------------------------------------------------------------------------
Niacin.................................................... 15.3
Vitamin B6................................................ 0.33
Folic acid................................................ 0.08
Iron...................................................... 2.0
Zinc...................................................... 2.9
Magnesium................................................. 173.0
Copper.................................................... 0.6
------------------------------------------------------------------------
(c) Compliance with the requirements of paragraph (b) of this
section shall be determined by methods described in the following
references except that in determining protein quantity in products with
mixed protein sources a nitrogen conversion factor of 6.25 may be used.
(1) Protein quantity: ``Official Methods of Analysis of the
Association of Official Analytical Chemists'' (AOAC), 13th Ed. (1980),
using the method described in section 27.007, which is incorporated by
reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North
Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at
the National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call 202-741-6030, or go
to: http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html.
(2) Biological quality of protein: AOAC, 13th Ed. (1980), using the
method described in sections 43.212-43.216, which is incorporated by
reference. The availability of this incorporation by reference is given
in paragraph (c)(1) of this section.
(3) Niacin: AOAC, 13th Ed. (1980), using the method described in
sections 43.044-43.046, which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(c)(1) of this section.
(4) Vitamin B6: AOAC, 13th Ed. (1980), using the method
described in sections 43.188-43.193, which is incorporated by reference.
The availability of this incorporation by reference is given in
paragraph (c)(1) of this section.
(5) Folic acid: Using the method described in U.S. Department of
Agriculture Handbook No. 29, modified by use of ascorbate buffer as
described by Ford and Scott, Journal of Dairy Research, 35:85-90 (1968),
which is incorporated by reference. Copies are available from the Center
for Food Safety and Applied Nutrition (HFS-800), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
available for inspection at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.
(6) Iron: AOAC, 13th Ed. (1980), using the method described in
sections 43.217-43.219, which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(c)(1) of this section.
(7) Zinc: AOAC, 13th Ed. (1980), using the method described in
sections 25.150-25.153, which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(c)(1) of this section.
(8) Copper: AOAC, 13th Ed. (1980), using the method described in
sections 25.038-25.043, which is incorporated by
[[Page 176]]
reference. The availability of this incorporation by reference is given
in paragraph (c)(1) of this section.
(9) Magnesium: AOAC, 13th Ed. (1980), using the method described in
sections 2.109-2.113, which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(c)(1) of this section.
[42 FR 36455, July 15, 1977, as amended at 47 FR 11821, Mar. 19, 1982;
49 FR 5609, Feb. 14, 1984; 54 FR 24891, June 12, 1989; 61 FR 14479, Apr.
2, 1996; 63 FR 14035, Mar. 24, 1998; 66 FR 17358, Mar. 30, 2001; 66 FR
56035, Nov. 6, 2001]
Sec. 102.26 Frozen ``heat and serve'' dinners.
(a) A frozen ``heat and serve'' dinner:
(1) Shall contain at least three components, one of which shall be a
significant source of protein and each of which shall consist of one or
more of the following: meat, poultry, fish, cheese, eggs, vegetables,
fruit, potatoes, rice, or other cereal based products (other than bread
or rolls).
(2) May also contain other servings of food (e.g., soup, bread or
rolls, beverage, dessert).
(b) The common or usual name of the food consists of all of the
following:
(1) The phrase ``frozen `heat and serve' dinner,'' except that the
name of the predominant characterizing ingredient or other appropriately
descriptive term may immediately precede the word ``dinner'' (e.g.,
``frozen chicken dinner'' or ``frozen heat and serve beef dinner''). The
words ``heat and serve'' are optional. The word ``frozen'' is also
optional, provided that the words ``Keep Frozen'' or the equivalent are
prominently and conspicuously placed on the principal display panel in
type size not less than that specified in Sec. 102.5(b)(2)(i).
(2) The phrase ``containing (or contains) ------'' the blank to be
filled in with an accurate description of each of the three or more dish
components listed in paragraph (a)(1) of this section in their order of
descending predominance by weight (e.g., ham, mashed potatoes, and
peas), followed by any of the other servings specified in paragraph
(a)(2) of this section contained in the package (e.g., onion soup,
enriched white bread, and artificially flavored vanilla pudding) in
their order of descending predominance by weight. This part of the name
shall be placed immediately following or directly below the part
specified in paragraph (b)(1) of this section in the manner set forth in
Sec. 102.5(c)(3). The words ``contains'' or ``containing'' are
optional.
(3) If the labeling implies that the package contains other foods
and these foods are not present in the package, e.g., if a vignette on
the package depicts a ``serving suggestion'' which includes any foods
not present in the package, the principal display panel shall bear a
statement that such foods are not present, in type size not less than
that specified in Sec. 102.5(b)(2)(i).
Sec. 102.28 Foods packaged for use in the preparation of ``main dishes'' or
``dinners.''
(a) The common or usual name of a packaged food which is represented
on the principal display panel by word or vignette to be used in the
preparation of a ``main dish'', ``dinner'', or other such food serving,
and to which some other important characterizing ingredient(s) or
component(s) not present in the package must be added, consists of all
the following:
(1) The common or usual name of each important ingredient or
component in the package, in descending order of predominance by weight
(e.g., ``noodles and tomato sauce'').
(2) An appropriate informative statement identifying the food to be
prepared by use of the package contents (e.g., ``for preparation of
chicken casserole'').
(3) An appropriate informative statement that additional
characterizing ingredient(s) or component(s) must be added and which
names the additional characterizing ingredient(s) or component(s) (e.g.,
``you must add ------ to complete the recipe,'' the blank to be filled
in with the name(s) of the important characterizing ingredient(s) or
component(s) that must be added).
(b) The labeling required by paragraph (a) of this section shall
appear on the principal display panel.
(1) No word in the statement required by paragraph (a)(2) of this
section may appear on the principal display panel more conspicuously or
in larger type
[[Page 177]]
than the smallest and least conspicuous type employed on the panel for
any word, phrase or statement within the scope of paragraph (a)(1) of
this section.
(2) Every word in the statement required by paragraph (a)(3) of this
section shall appear on the principal display panel in easily legible
bold face print or type in distinct contrast to other printed or graphic
matter, and in a height not less than the larger of the following
alternatives:
(i) Not less than one-sixteenth inch in height on packages having a
principal display panel with an area of 5 square inches or less and not
less than one-eighth inch in height if the area of the principal display
panel is greater than 5 square inches; or
(ii) Not less than one-half the height of the largest type appearing
in the part of the common or usual name of the food required by
paragraphs (a) (1) and (2) of this section.
(c) Any vignette which shows any food or characterizing
ingredient(s) or component(s) not included in the package shall be
accompanied either by the statement required by paragraph (a)(3) of this
section or by a separate statement specifying the food or characterizing
ingredient(s) or component(s) shown in the vignette but not included in
the package.
(d) If the statement specified in paragraph (a)(2) of this section
is used on any panel in addition to the principal display panel as a
product identification statement, the complete common or usual name
shall appear on such panel in the manner specified in paragraph (b) of
this section.
(e) When a brand name or other prominent product designation
contains a word or words that includes or suggests an important
characterizing ingredient(s) or component(s) that must be added, or
otherwise states or implies that the package contains a complete main
dish, dinner, or other food serving, the part of the common or usual
name of the food required by paragraph (a)(3) of this section shall
appear in direct conjunction with such brand name or other designation
and in type size not less than one-half the height of the largest type
appearing in such brand name or other designation.
Sec. 102.33 Beverages that contain fruit or vegetable juice.
(a) For a carbonated or noncarbonated beverage that contains less
than 100 percent and more than 0 percent fruit or vegetable juice, the
common or usual name shall be a descriptive name that meets the
requirements of Sec. 102.5(a) and, if the common or usual name uses the
word ``juice,'' shall include a qualifying term such as ``beverage,''
``cocktail,'' or ``drink'' appropriate to advise the consumer that the
product is less than 100 percent juice (e.g., ``diluted grape juice
beverage'' or ``grape juice drink'').
(b) If the product is a diluted multiple-juice beverage or blend of
single-strength juices and names, other than in the ingredient
statement, more than one juice, then the names of those juices, except
in the ingredient statement, must be in descending order of predominance
by volume unless the name specifically shows that the juice with the
represented flavor is used as a flavor (e.g., raspberry-flavored apple
and pear juice drink). In accordance with Sec. 101.22(i)(1)(iii) of
this chapter, the presence of added natural flavors is not required to
be declared in the name of the beverage unless the declared juices alone
do not characterize the product before the addition of the added
flavors.
(c) If a diluted multiple-juice beverage or blend of single-strength
juices contains a juice that is named or implied on the label or
labeling other than in the ingredient statement (represented juice), and
also contains a juice other than the named or implied juice
(nonrepresented juice), then the common or usual name for the product
shall indicate that the represented juice is not the only juice present
(e.g., ``Apple blend; apple juice in a blend of two other fruit
juices.'')
(d) In a diluted multiple-juice beverage or blend of single-strength
juices where one or more, but not all, of the juices are named on the
label other than in the ingredient statement, and where the named juice
is not the predominant juice, the common or usual name for the product
shall:
(1) Indicate that the named juice is present as a flavor or
flavoring (e.g.,
[[Page 178]]
``Raspcranberry''; raspberry and cranberry flavored juice drink); or
(2) Include the amount of the named juice, declared in a 5- percent
range (e.g., Raspcranberry; raspberry and cranberry juice beverage, 10-
to 15-percent cranberry juice and 3- to 8-percent raspberry juice). The
5-percent range, when used, shall be declared in the manner set forth in
Sec. 102.5(b)(2).
(e) The common or usual name of a juice that has been modified shall
include a description of the exact nature of the modification (e.g.,
``acid-reduced cranberry juice,'' ``deflavored, de colored grape
juice'').
(f) If the product is a beverage that contains a juice whose color,
taste, or other organoleptic properties have been modified to the extent
that the original juice is no longer recognizable at the time processing
is complete, or if its nutrient profile has been diminished to a level
below the normal nutrient range for the juice, then the source fruits or
vegetables from which the modified juice was derived may not be depicted
on the label by vignette or other pictorial representation.
(g)(1) If one or more juices in a juice beverage is made from
concentrate, the name of the juice must include a term indicating that
fact, such as ``from concentrate,'' or ``reconstituted.'' Such terms
must be included in the name of each individual juice or it may be
stated once adjacent to the product name so that it applies to all the
juices, (e.g., ``cherry juice (from concentrate) in a blend of two other
juices'' or ``cherry juice in a blend of 2 other juices (from
concentrate)''). The term shall be in a type size no less than one-half
the height of the letters in the name of the juice.
(2) If the juice is 100 percent single species juice consisting of
juice directly expressed from a fruit or vegetable whose Brix level has
been raised by the addition of juice concentrate from the same fruit or
vegetable, the name of the juice need not include a statement that the
juice is from concentrate. However, if water is added to this 100
percent juice mixture to adjust the Brix level, the product shall be
labeled with the term ``from concentrate'' or ``reconstituted.''
[58 FR 2926, Jan. 6, 1993; 58 FR 17103, Apr. 1, 1993, as amended at 58
FR 44063, Aug. 18, 1993; 62 FR 15343, Mar. 31, 1997]
Sec. 102.37 Mixtures of edible fat or oil and olive oil.
The common or usual name of a mixture of edible fats and oils
containing less than 100 percent and more than 0 percent olive oil shall
be as follows:
(a) A descriptive name for the product meeting the requirements of
Sec. 102.5(a), e.g., ``cottonseed oil and olive oil'' or another
descriptive phrase, and
(b) When the label bears any representation, other than in the
ingredient listing, of the presence of olive oil in the mixture, the
descriptive name shall be followed by a statement of the percentage of
olive oil contained in the product in the manner set forth in Sec.
102.5(b)(2).
Sec. 102.39 Onion rings made from diced onion.
(a) The common or usual name of the food product that resembles and
is of the same composition as onion rings, except that it is composed of
comminuted onions, shall be as follows:
(1) When the product is composed of dehydrated onions, the name
shall be ``onion rings made from dried diced onions.''
(2) When the product is composed of any form of onion other than
dehydrated, the name shall be ``onion rings made from diced onions.''
(b) The words ``made from dried diced onions'' or ``made from diced
onions'' shall immediately follow or appear on a line(s) immediately
below the words ``onion rings'' in easily legible boldface print or type
in distinct contrast to other printed or graphic matter, and in a height
not less than the larger of the following alternatives:
(1) Not less than one-sixteenth inch in height on packages having a
principal display panel with an area of 5 square inches or less and not
less than one-eighth inch in height if the area of the principal display
panel is greater than 5 square inches; or
(2) Not less than one-half the height of the largest type used in
the words ``onion rings.''
[[Page 179]]
Sec. 102.41 Potato chips made from dried potatoes.
(a) The common or usual name of the food product that resembles and
is of the same composition as potato chips, except that it is composed
of dehydrated potatoes (buds, flakes, granules, or other form), shall be
``potato chips made from dried potatoes.''
(b) The words ``made from dried potatoes'' shall immediately follow
or appear on a line(s) immediately below the words ``potato chips'' in
easily legible boldface print or type in distinct contrast to other
printed or graphic matter, and in a height not less than the larger of
the following alternatives:
(1) Not less than one-sixteenth inch in height on packages having a
principal display panel with an area of 5 square inches or less and not
less than one-eighth inch in height if the area of the principal display
panel is greater than 5 square inches; or
(2) Not less than one-half the height of the largest type used in
the words ``potato chips.''
Sec. 102.45 Fish sticks or portions made from minced fish.
(a) The common or usual name of the food product that resembles and
is of the same composition as fish sticks or fish portions, except that
it is composed of comminuted fish flesh, shall be ``fish ------ made
from minced fish,'' the blank to be filled in with the word ``sticks''
or ``portions'' as the case may be.
(b) The words ``made from minced fish'' shall immediately follow or
appear on a line(s) immediately below the words ``fish ------'' in
easily legible boldface print or type in distinct contrast to other
printed or graphic matter, and in a height not less than the larger of
the following alternatives:
(1) Not less than one-sixteenth inch in height on packages having a
principal display panel with an area of 5 square inches or less and not
less than one-eighth inch in height if the area of the principal display
panel is greater than 5 square inches; or
(2) Not less than one-half the height of the largest type used in
the words ``fish ------.''
Sec. 102.46 Pacific whiting.
``Pacific whiting'' or ``North Pacific whiting'' is the common or
usual name of the food fish Merluccius productus.
[44 FR 45617, Aug. 3, 1979]
Sec. 102.47 Bonito.
``Bonito'' or ``bonito fish'' is the common or usual name of the
following food fishes:
Cybiosarda elegans (Whitely, 1935)--Leaping bonito
Gymnosarda unicolor (Ruppell, 1838)--Dogtooth tuna
Orcynopsis unicolor (Geoffroy St. Hilaire, 1817)--Plain bonito
Sarda australis (Macleay, 1880)--Australian bonito
Sarda chiliensis (Cuvier, 1831)--Eastern Pacific bonito
Sarda orientalis (Temminck and Schlegel, 1844)--Striped bonito
Sarda sarda (Bloch, 1793)--Atlantic bonito
[55 FR 45797, Oct. 31, 1990]
Sec. 102.49 Fried clams made from minced clams.
(a) The common or usual name of the food product that resembles and
is of the same composition as fried clams, except that it is composed of
comminuted clams, shall be ``fried clams made from minced clams.''
(b) The words ``made from minced clams'' shall immediately follow or
appear on a line(s) immediately below the words ``fried clams'' and in
easily legible boldface print or type in distinct contrast to other
printed or graphic matter, and in a height not less than the larger of
the following alternatives:
(1) Not less than one-sixteenth inch in height on packages having a
principal display panel with an area of 5 square inches or less and not
less than one-eighth inch in height if the area of the principal display
panel is greater than 5 square inches; or
(2) Not less than one-half the height of the largest type used in
the words ``fried clams.''
Sec. 102.50 Crabmeat.
The common or usual name of crabmeat derived from each of the
following designated species of crabs shall be as follows:
[[Page 180]]
------------------------------------------------------------------------
Common or usual name of
Scientific name of crab crabmeat
------------------------------------------------------------------------
Chionoecetes opilio, Snow crabmeat.
Chionoecetes tanneri,
Chionoecetes bairdii, and
Chionoecetes angulatus
Erimacrus isenbeckii Korean variety crabmeat or
Kegani crabmeat.
Lithodes aequispina Brown King crabmeat.
Paralithodes brevipes King crabmeat or Hanasaki
crabmeat.
Paralithodes camtschaticus King crabmeat and
Paralithodes Platypus.
------------------------------------------------------------------------
[42 FR 14322, Mar. 15, 1977, as amended at 60 FR 34460, July 3, 1995]
Sec. 102.54 Seafood cocktails.
The common or usual name of a seafood cocktail in package form
fabricated with one or more seafood ingredients shall be:
(a) When the cocktail contains only one seafood ingredient, the name
of the seafood ingredient followed by the word ``cocktail'' (e.g.,
shrimp cocktail, crabmeat cocktail) and a statement of the percentage by
weight of that seafood ingredient in the product in the manner set forth
in Sec. 102.5(b).
(b) When the cocktail contains more than one seafood ingredient, the
term ``seafood cocktail'' and a statement of the percentage by weight of
each seafood ingredient in the product in the manner set forth in Sec.
102.5(b).
Sec. 102.55 Nonstandardized breaded composite shrimp units.
(a) The common on usual name of the food product that conforms to
the definition and standard of identity described by Sec. 161.175(c)(6)
of this chapter, except that the food is made from comminuted shrimp and
is not in raw frozen form, shall be ``------ made from minced shrimp,''
the blank to be filled in with the words ``breaded shrimp sticks'' or
``breaded shrimp cutlets'' depending upon the shape of the product, or
if prepared in a shape other than that of sticks or cutlets ``breaded
shrimp ------ made from minced shrimp,'' the blank to be filled by a
word or phrase that accurately describes the shape and that is not
misleading.
(b) The words ``made from minced shrimp'' shall immediately follow
or appear on a line(s) immediately below the other words required by
this section in easily legible boldface print or type in distinct
contrast to other printed or graphic matter, and in a height not less
than the larger of the following alternatives:
(1) Not less than one-sixteenth inch in height on packages having a
principal display panel with an area of 5 square inches or less and no
less than one-eighth inch in height if the area of the principal display
panel is greater than 5 square inches; or
(2) Not less than one-half the height of the largest type used in
the words ``breaded shrimp sticks'' or the other comparable words
required by this section.
Sec. 102.57 Greenland turbot (Reinhardtius hippoglossoides).
``Greenland turbot'' is the common or usual name of the food fish
Reinhardtius hippoglossoides, a species of Pleuronectidae right-eye
flounders. The term ``halibut'' may be associated only with Atlantic
halibut (Hippoglossus hippoglossus) or Pacific halibut (Hippoglossus
stenolepis).
PART 104_NUTRITIONAL QUALITY GUIDELINES FOR FOODS--Table of Contents
Subpart A_General Provisions
Sec.
104.5 General principles.
Subpart B_Fortification Policy
104.20 Statement of purpose.
Subpart C_Specific Nutritional Quality Guidelines
104.47 Frozen ``heat and serve'' dinner.
Authority: 21 U.S.C. 321, 343, 371(a).
Source: 42 FR 14327, Mar. 15, 1977, unless otherwise noted.
Subpart A_General Provisions
Sec. 104.5 General principles.
(a) A nutritional quality guideline prescribes the minimum level or
range of nutrient composition (nutritional quality) appropriate for a
given class of food.
(b) Labeling for a product which complies with all of the
requirements of
[[Page 181]]
the nutritional quality guideline established for its class of food may
state ``This product provides nutrients in amounts appropriate for this
class of food as determined by the U.S. Government,'' except that the
words ``this product'' are optional. This statement, if used, shall be
printed on the principal display panel, and may also be printed on the
information panel, in letters not larger than twice the size of the
minimum type required for the declaration of net quantity of contents by
Sec. 101.105 of this chapter. Labeling of noncomplying products may not
include any such statement or otherwise represent, suggest, or imply the
product as being, in whole or in part, in compliance with a guideline.
(c) A product bearing the statement provided for in paragraph (b) of
this section, in addition to meeting the requirements of the applicable
nutritional quality guideline, shall comply with the following
requirements:
(1) The label of the product shall bear the common or usual name of
the food in accordance with the provisions of the guideline and
Sec. Sec. 101.3 and 102.5(a) of this chapter.
(2) The label of the product shall bear nutrition labeling in
accordance with Sec. Sec. 101.2 and 101.9 of this chapter and all other
labeling required by applicable sections of part 101 of this chapter.
(d) No claim or statement may be made on the label or in labeling
representing, suggesting, or implying any nutritional or other
differences between a product to which nutrient addition has or has not
been made in order to meet the guideline, except that a nutrient
addition shall be declared in the ingredient statement.
(e) Compliance with a nutrient level specified in a nutritional
quality guideline shall be determined by the procedures and requirements
established in Sec. 101.9(g) of this chapter.
(f) A product within a class of food for which a nutritional quality
guideline has been established and to which has been added a discrete
nutrient either for which no minimum nutrient level or nutrient range or
other allowance has been established as appropriate in the nutritional
quality guideline, or at a level that exceeds any maximum established as
appropriate in the guideline, shall be ineligible to bear the guideline
statement provided for in paragraph (b) of this section, and such a
product shall also be deemed to be misbranded under the act unless the
label and all labeling bear the following prominent and conspicuous
statement: ``The addition of ------ to (or ``The addition of ------ at
the level contained in) this product has been determined by the U.S.
Government to be unnecessary and inappropriate and does not increase the
dietary value of the food,'' the blank to be filled in with the common
or usual name of the nutrient(s) involved.
[42 FR 14327, Mar. 15, 1977, as amended at 63 FR 14818, Mar. 27, 1998]
Subpart B_Fortification Policy
Sec. 104.20 Statement of purpose.
(a) The fundamental objective of this subpart is to establish a
uniform set of principles that will serve as a model for the rational
addition of nutrients to foods. The achievement and maintenance of a
desirable level of nutritional quality in the nation's food supply is an
important public health objective. The addition of nutrients to specific
foods can be an effective way of maintaining and improving the overall
nutritional quality of the food supply. However, random fortification of
foods could result in over- or underfortification in consumer diets and
create nutrient imbalances in the food supply. It could also result in
deceptive or misleading claims for certain foods. The Food and Drug
Administration does not encourage indiscriminate addition of nutrients
to foods, nor does it consider it appropriate to fortify fresh produce;
meat, poultry, or fish products; sugars; or snack foods such as candies
and carbonated beverages. To preserve a balance of nutrients in the
diet, manufacturers who elect to fortify foods are urged to utilize
these principles when adding nutrients to food. It is reasonable to
anticipate that the Reference Daily Intakes (RDI's) as delineated in
Sec. 101.9 of this chapter and in paragraph (d) of this section will be
amended from time to time to list additional nutrients and/or to change
the levels of specific RDI's as improved
[[Page 182]]
knowledge about human nutrient requirements and allowances develops. The
policy set forth in this section is based on U.S. dietary practices and
nutritional needs and may not be applicable in other countries.
(b) A nutrient(s) listed in paragraph (d)(3) of this section may
appropriately be added to a food to correct a dietary insufficiency
recognized by the scientific community to exist and known to result in
nutritional deficiency disease if:
(1) Sufficient information is available to identify the nutritional
problem and the affected population groups, and the food is suitable to
act as a vehicle for the added nutrients. Manufacturers contemplating
using this principle are urged to contact the Food and Drug
Administration before implementing a fortification plan based on this
principle.
(2) The food is not the subject of any other Federal regulation for
a food or class of food that requires, permits, or prohibits nutrient
additions. (Other Federal regulations include, but are not limited to,
standards of identity promulgated under section 401 of the Federal Food,
Drug, and Cosmetic Act, nutritional quality guidelines established in
subpart C of this part, and common or usual name regulations established
in part 102 of this chapter.)
(c) A nutrient(s) listed in paragraph (d)(3) of this section may
appropriately be added to a food to restore such nutrient(s) to a
level(s) representative of the food prior to storage, handling, and
processing, when:
(1) The nutrient is shown by adequate scientific documentation to
have been lost in storage, handling, or processing in a measurable
amount equal to at least 2 percent of the Daily Reference Value (DRV) of
protein and of potassium and 2 percent of the Reference Daily Intake
(RDI) in a normal serving of the food.
(2) Good manufacturing practices and normal storage and handling
procedures cannot prevent the loss of such nutrient(s),
(3) All nutrients, including protein, iodine and vitamin D, that are
lost in a measurable amount are restored and all ingredients of the food
product that contribute nutrients are considered in determining
restoration levels; and
(4) The food is not the subject of any other Federal regulation that
requires or prohibits nutrient addition(s), or the food has not been
fortified in accordance with any other Federal regulation that permits
voluntary nutrient additions.
(d) A nutrient(s) listed in paragraph (d)(3) of this section may be
added to a food in proportion to the total caloric content of the food,
to balance the vitamin, mineral, and protein content if:
(1) A normal serving of the food contains at least 40 kilocalories
(that is, 2 percent of a daily intake of 2,000 kilocalories);
(2) The food is not the subject of any other Federal regulation for
a food or class of food that requires, permits, or prohibits nutrient
additions; and
(3) The food contains all of the following nutrients per 100
calories based on 2,000 calorie total intake as a daily standard:
------------------------------------------------------------------------
Amount
Nutrient Unit of measurement DRV or per 100
RDI \1\ calories
------------------------------------------------------------------------
Protein................... grams (g)................ 50 2.5
Vitamin A................. International Unit (IU).. 5,000 250
Vitamin C................. milligrams (mg).......... 60 3
Calcium................... g........................ 1 0.05
Iron...................... mg....................... 18 0.9
Vitamin D................. IU....................... 400 20
Vitamin E................. do....................... 30 1.5
Thiamin................... mg....................... 1.5 0.08
Riboflavin................ do....................... 1.7 0.09
Niacin.................... do....................... 20 1
Vitamin B6................ do....................... 2.0 0.1
Folate.................... micrograms ([micro]g).... 400 20
Vitamin B12............... do....................... 6.0 0.3
Biotin.................... mg....................... 0.3 0.015
Pantothenic acid.......... do....................... 10 0.5
Phosphorus................ g........................ 1.0 0.05
Magnesium................. mg....................... 400 20
Zinc...................... do....................... 15 0.8
Iodine.................... [micro]g................. 150 7.5
Copper.................... mg....................... 2.0 0.1
Potassium................. do....................... 3,500 175
------------------------------------------------------------------------
\1\ RDI's for adults and children 4 or more years of age.
(e) A nutrient(s) may appropriately be added to a food that replaces
traditional food in the diet to avoid nutritional inferiority in
accordance with Sec. 101.3(e)(2) of this chapter.
(f) Nutrient(s) may be added to foods as permitted or required by
applicable regulations established elsewhere in this chapter.
(g) A nutrient added to a food is appropriate only when the
nutrient:
[[Page 183]]
(1) Is stable in the food under customary conditions of storage,
distribution, and use;
(2) Is physiologically available from the food;
(3) Is present at a level at which there is a reasonable assurance
that consumption of the food containing the added nutrient will not
result in an excessive intake of the nutrient, considering cumulative
amounts from other sources in the diet; and
(4) Is suitable for its intended purpose and is in compliance with
applicable provisions of the act and regulations governing the safety of
substances in food.
(h) Any claims or statements in the labeling of food about the
addition of a vitamin, mineral, or protein to a food shall be made only
if the claim or statement is not false or misleading and otherwise
complies with the act and any applicable regulations. The following
label claims are acceptable:
(1) The labeling claim ``fully restored with vitamins and minerals''
or ``fully restored with vitamins and minerals to the level of
unprocessed ------'' (the blank to be filled in with the common or usual
name of the food) may be used to describe foods fortified in accordance
with the principles established in paragraph (c) of the section.
(2) The labeling claim, ``vitamins and minerals (and ``protein''
when appropriate) added are in proportion to caloric content'' may be
used to describe food fortified in accordance with the principles
established in paragraph (d) of this section.
(3) When labeling claims are permitted, the term ``enriched,''
``fortified,'' ``added,'' or similar terms may be used interchangeably
to indicate the addition of one or more vitamins or minerals or protein
to a food, unless an applicable Federal regulation requires the use of
specific words or statements.
(i) It is inappropriate to make any claim or statement on a label or
in labeling, other than in a listing of the nutrient ingredients as part
of the ingredient statement, that any vitamin, mineral, or protein has
been added to a food to which nutrients have been added pursuant to
paragraph (e) of this section.
[45 FR 6323, Jan. 25, 1980, as amended at 58 FR 2228, Jan. 6, 1993]
Subpart C_Specific Nutritional Quality Guidelines
Sec. 104.47 Frozen ``heat and serve'' dinner.
(a) A product, for which a common or usual name is established in
Sec. 102.26 of this chapter, in order to be eligible to bear the
guideline statement set forth at Sec. 104.5(b), shall contain at least
the following three components:
(1) One or more sources of protein derived from meat, poultry, fish,
cheese, or eggs.
(2) One or more vegetables or vegetable mixtures other than
potatoes, rice, or cereal-based product.
(3) Potatoes, rice, or cereal-based product (other than bread or
rolls) or another vegetable or vegetable mixture.
(b) The three or more components named in paragraph (a) of this
section, including their sauces, gravies, breading, etc.:
(1) Shall contribute not less than the minimum levels of nutrients
prescribed in paragraph (d) of this section.
(2) Shall be selected so that one or more of the listed protein
sources of paragraph (a)(1) of this section, excluding their sauces,
gravies, breading, etc., shall provide not less than 70 percent of the
total protein supplied by the components named in paragraph (a) of this
section.
(c) If it is necessary to add any nutrient(s) in order to meet the
minimum nutrient levels prescribed in paragraph (d) of this section, the
addition of each such nutrient may not result in a total nutrient level
exceeding 150 percent of the minimum level prescribed. Nutrients used
for such addition shall be biologically available in the final product.
(d) Minimum levels of nutrients for a frozen ``heat and serve''
dinner are as follows:
[[Page 184]]
------------------------------------------------------------------------
Minimum levels for
frozen ``heat and
serve'' dinner--
-----------------------
For each
100
Nutrient Calories For the
(keal) of total
the total components
components specified
specified in par.
in par. (a)
(a)
------------------------------------------------------------------------
Protein, grams.................................. 4.60 16.0
Vitamin A, IU................................... 150.00 520.0
Thiamine, mg.................................... .05 .2
Riboflavin, mg.................................. .06 .2
Niacin, mg...................................... .99 3.4
Pantothenic acid, mg............................ .32 1.1
Vitamin, B6, mg................................. .15 .5
Vitamin, B1..................................... .33 1.1
Iron, mg........................................ .62 2.2
------------------------------------------------------------------------
(1) A frozen ``heat and serve'' dinner prepared from conventional
food ingredients listed in paragraph (a) of this section will also
contain folic acid, magnesium, iodine, calcium, and zinc. Minimum levels
for these nutrients cannot be established at the present time but may be
specified as additional data are obtained.
(2) The minimum levels for pantothenic acid, vitamin B-6, and
vitamin B-12 are tentative. Final levels will be established when
sufficient data are available. Until final levels are established, a
product containing less than the tentative levels will not be deemed to
be misbranded when labeled in accordance with Sec. 104.5(b).
(3) When technologically practicable, iodized salt shall be used or
iodine shall be present at a level equivalent to that which would be
present if iodized salt were used in the manufacture of the product.
(4) When technologically practicable, product components and
ingredients shall be selected to obtain the desirable calcium to
phosphorous ratio of 1:1. Technological addition of phosphates shall be
minimized and shall not exceed the amount necessary for the intended
effect.
(e) If the product includes servings of food which are not
prescribed by paragraph (a) of this section (e.g., soup, bread or rolls,
beverage, or dessert), their contribution shall not be considered in
determining compliance with the nutrient levels established in paragraph
(d) of this section but shall be included in any nutrition labeling.
(f) For the purposes of labeling, an ``average serving'' shall be
one entire frozen ``heat and serve'' dinner.
[42 FR 14327, Mar. 5, 1977]
PART 105_FOODS FOR SPECIAL DIETARY USE--Table of Contents
Subpart A_General Provisions
Sec.
105.3 Definitions and interpretations.
Subpart B_Label Statements
105.62 Hypoallergenic foods.
105.65 Infant foods.
105.66 Label statements relating to usefulness in reducing or
maintaining body weight.
Subpart C [Reserved]
Subpart D--Standards of Identity [Reserved]
Authority: 21 U.S.C. 321, 341, 343, 348, 350, 371, 379e.
Source: 42 FR 14328, Mar. 15, 1977, unless otherwise noted.
Subpart A_General Provisions
Sec. 105.3 Definitions and interpretations.
The definitions and interpretations of terms contained in section
201 of the Federal Food, Drug, and Cosmetic Act (hereafter ``the act'')
shall be applicable with the following additions:
(a)(1) The term special dietary uses, as applied to food for man,
means particular (as distinguished from general) uses of food, as
follows:
(i) Uses for supplying particular dietary needs which exist by
reason of a physical, physiological, pathological or other condition,
including but not limited to the conditions of diseases, convalescence,
pregnancy, lactation, allergic hypersensitivity to food, underweight,
and overweight;
(ii) Uses for supplying particular dietary needs which exist by
reason of age, including but not limited to the ages of infancy and
childhood;
(iii) Uses for supplementing or fortifying the ordinary or usual
diet with any vitamin, mineral, or other dietary property. Any such
particular use of a food is a special dietary use, regardless
[[Page 185]]
of whether such food also purports to be or is represented for general
use.
(2) The use of an artificial sweetener in a food, except when
specifically and solely used for achieving a physical characteristic in
the food which cannot be achieved with sugar or other nutritive
sweetener, shall be considered a use for regulation of the intake of
calories and available carbohydrate, or for use in the diets of
diabetics and is therefore a special dietary use.
(b)-(d) [Reserved]
(e) For the purposes of the regulations in this part, the terms
infant, child, and adult mean persons not more than 12 months old, more
than 12 months but less than 12 years old, and 12 years or more old,
respectively.
[42 FR 14328, Mar. 15, 1977, as amended at 44 FR 16006, Mar. 16, 1979;
44 FR 49665, Aug. 24, 1979]
Subpart B_Label Statements
Sec. 105.62 Hypoallergenic foods.
If a food purports to be or is represented for special dietary use
by reason of the decrease or absence of any allergenic property or by
reason of being offered as food suitable as a substitute for another
food having an allergenic property, the label shall bear:
(a) The common or usual name and the quantity or proportion of each
ingredient (including spices, flavoring, and coloring) in case the food
is fabricated from two or more ingredients.
(b) A qualification of the name of the food, or the name of each
ingredient thereof in case the food is fabricated from two or more
ingredients, to reveal clearly the specific plant or animal that is the
source of such food or of such ingredient, if such food or such
ingredient consists in whole or in part of plant or animal matter and
such name does not reveal clearly the specific plant or animal that is
such a source.
(c) An informative statement of the nature and effect of any
treatment or processing of the food or any ingredient thereof, if the
changed allergenic property results from such treatment or processing.
Sec. 105.65 Infant foods.
(a) If a food (other than a dietary supplement of vitamins and/or
minerals alone) purports to be or is represented for special dietary use
for infants, the label shall bear, if such food is fabricated from two
or more ingredients, the common or usual name of each ingredient,
including spices, flavoring, and coloring.
(b) If such food, or any ingredient thereof, consists in whole or in
part of plant or animal matter and the name of such food or ingredient
does not clearly reveal the specific plant or animal which is its
source, such name shall be so qualified as to reveal clearly the
specific plant or animal that is such source.
[42 FR 14328, Mar. 15, 1977, as amended at 47 FR 947, Jan. 8, 1982; 49
FR 10090, Mar. 19, 1984; 50 FR 1840, Jan. 14, 1985]
Sec. 105.66 Label statements relating to usefulness in reducing or
maintaining body weight.
(a) General requirements. Any food that purports to be or is
represented for special dietary use because of usefulness in reducing or
maintaining body weight shall bear:
(1) Nutrition labeling in conformity with Sec. 101.9, or, where
applicable, Sec. 101.36 of this chapter, unless exempt under that
section; and
(2) A conspicuous statement of the basis upon which the food claims
to be of special dietary usefulness.
(b) Nonnutritive ingredients. (1) Any food subject to paragraph (a)
of this section that achieves its special dietary usefulness by use of a
nonnutritive ingredient (i.e., one not utilized in normal metabolism)
shall bear on its label a statement that it contains a nonnutritive
ingredient and the percentage by weight of the nonnutritive ingredient.
(2) A special dietary food may contain a nonnutritive sweetener or
other ingredient only if the ingredient is safe for use in the food
under the applicable law and regulations of this chapter. Any food that
achieves its special dietary usefulness in reducing or maintaining body
weight through the use of a nonnutritive sweetener shall bear on its
label the statement required by paragraph (b)(1) of this section, but
need not state the percentage by weight of the nonnutritive sweetener.
If a nutritive sweetener(s) as well as
[[Page 186]]
nonnutritive sweetener(s) is added, the statement shall indicate the
presence of both types of sweetener, e.g., ``Sweetened with nutritive
sweetener(s) and nonnutritive sweetener(s).''
(c) ``Low calorie'' foods. A food purporting to be ``low calorie''
must comply with the criteria set forth for such foods in Sec.
101.60(b)(2) and (b)(3) of this chapter.
(d) ``Reduced calorie'' foods and other comparative calorie claims.
A food purporting to be ``reduced calorie'' or otherwise containing
fewer calories than a reference food must comply with the criteria set
forth for such food in Sec. 101.60(b)(4) and (b)(5) of this chapter.
(e) Label terms suggesting usefulness as low calorie or reduced
calorie foods. (1) Except as provided in paragraphs (e)(2) and (e)(3) of
this section, and in Sec. 101.13(q)(2) of this chapter for soft drinks,
a food may be labeled with terms such as ``diet,'' ``dietetic,''
``artificially sweetened,'' or ``sweetened with nonnutritive sweetener''
only if the claim is not false and misleading, and the food is labeled
``low calorie'' or ``reduced calorie'' or bears another comparative
calorie claim in compliance with part 101 of this chapter and this
section.
(2) Paragraph (e)(1) of this section shall not apply to any use of
such terms that is specifically authorized by regulation governing a
particular food, or, unless otherwise restricted by regulation, to any
use of the term ``diet'' that clearly shows that the food is offered
solely for a dietary use other than regulating body weight, e.g., ``for
low-sodium diets.''
(3) Paragraph (e)(1) of this section shall not apply to any use of
such terms on a formulated meal replacement or other food that is
represented to be of special dietary use as a whole meal, pending the
issuance of a regulation governing the use of such terms on foods.
(f) ``Sugar free,'' and ``no added sugar.'' Criteria for the use of
the terms ``sugar free'' and ``no added sugar'' are provided for in
Sec. 101.60(c) of this chapter.
[58 FR 2430, Jan. 6, 1993]
Subpart C [Reserved]
Subpart D--Standards of Identity [Reserved]
PART 106_INFANT FORMULA QUALITY CONTROL PROCEDURES--Table of Contents
Subpart A_General Provisions
Sec.
106.1 Status and applicability of the quality control procedures
regulation.
106.3 Definitions.
Subpart B_Quality Control Procedures for Assuring Nutrient Content of
Infant Formulas
106.20 Ingredient control.
106.25 In-process control.
106.30 Finished product evaluation.
106.90 Coding.
Subpart C_Records and Reports
106.100 Records.
Subpart D_Notification Requirements
106.120 New formulations and reformulations.
Authority: 21 U.S.C. 321, 350a, 371.
Source: 47 FR 17025, Apr. 20, 1982, unless otherwise noted.
Subpart A_General Provisions
Sec. 106.1 Status and applicability of the quality control procedures
regulation.
(a) The criteria set forth in Sec. Sec. 106.20, 106.25, 106.30,
106.90, and 106.100 shall apply in determining whether an infant formula
meets the safety, quality, and nutrient requirements of section 412 of
the act and the requirements of regulations promulgated under section
412(a)(2) of the act.
(b) The failure to comply with any regulation set forth in
Sec. Sec. 106.20, 106.25, 106.30, 106.90, and 106.100 applicable to the
manufacturing, processing, and packaging of an infant formula shall
render such formula adulterated under section 412(a)(1)(C) of the act.
(c) References in this part to regulatory sections of the Code of
Federal Regulations are to chapter I of title 21 unless otherwise noted.
[[Page 187]]
Sec. 106.3 Definitions.
The definitions and interpretations contained in section 201 of the
act are applicable to such terms when used in this part. The following
definitions shall also apply:
(a) Indicator nutrient. An indicator nutrient is a nutrient whose
concentration is measured during the manufacture of an infant formula to
confirm complete addition and/or uniform distribution of a premix or
other substance of which the indicator nutrient is a part.
(b) In-process batch. An in-process batch is a combination of
ingredients at any point in the manufacturing process before packaging.
(c) Manufacturer. A manufacturer is a person who prepares,
reconstitutes, or otherwise changes the physical or chemical
characteristics of an infant formula and/or packages the product in a
container for distribution.
(d) Nutrient. A nutrient is any vitamin, mineral, or other substance
required in accordance with the table set out in section 412(g) of the
act or by regulations promulgated under section 412(a)(2)(A) of the act.
(e) Nutrient premix. A nutrient premix is a combination of
ingredients containing two or more nutrients. A nutrient premix either
may be received from a supplier or be prepared by an infant formula
manufacturer.
Subpart B_Quality Control Procedures for Assuring Nutrient Content of
Infant Formulas
Sec. 106.20 Ingredient control.
(a) Except as provided in Sec. 106.20(b), no analysis before use in
manufacturing is needed for ingredients that are generally stable in
shipping and storage, and that either are received under a supplier's
guarantee or certification that the mixture has been analyzed as to
nutrient composition or are labeled as having nutrient compositions
complying with specifications in the U.S. Pharmacopeia, the National
Formulary, the Food Chemicals Codex, or other similar recognized
standards.
(b) Unless each batch of finished product is analyzed as specified
in Sec. 106.30(b)(1) before release of product for commercial or
charitable distribution, the following shall apply:
(1) When an ingredient is relied upon as a source of a nutrient(s)
and when evidence indicates that such nutrient(s) in that ingredient is
likely to be affected adversely by shipping or storage conditions, the
manufacturer shall analyze that ingredient for each relied-upon nutrient
that may be affected, using validated analytical methods.
(2) Ingredients, including nutrient premixes, that are either
without a supplier's guarantee or certification, or not labeled as
complying with prescribed standards, shall be sampled and analyzed for
each relied-upon nutrient by the manufacturer, except that ingredients
used as a major source of protein or fat need not be analyzed for each
relied-upon nutrient if the manufacturer has records to show that each
relied-upon nutrient is present at a reasonably constant level. Nutrient
premixes prepared by the infant formula manufacturer shall be sampled
and analyzed for each relied-upon nutrient. Nutrient premixes which are
received from suppliers shall be sampled and analyzed for each relied-
upon nutrient unless the supplier has sampled and analyzed each batch of
premix for each relied-upon nutrient and has so certified in writing.
Sec. 106.25 In-process control.
(a) For each infant formula, a master manufacturing order shall be
prepared and approved by a responsible official of the manufacturer. The
manufacturer shall establish a quality control system that assures and
verifies the addition of each ingredient specified in the manufacturing
order.
(b) Unless each batch of finished product is analyzed as specified
in Sec. 106.30(b)(1), the manufacturer shall analyze each in-process
batch for:
(1) Solids;
(2) Protein, fat, and carbohydrates (carbohydrates either by
analysis or by mathematical difference);
(3) The indicator nutrient(s) in each nutrient premix;
(4) Each nutrient added independently of nutrient premixes during
formulation of the product, except for linoleic acid, vitamin D, vitamin
K, choline, inositol, and biotin; and
[[Page 188]]
(5) Solids or an appropriate nutrient to confirm proper dilution
when final dilution is made after performance of the analyses in
paragraph (b) (1) through (4) of this section.
Sec. 106.30 Finished product evaluation.
(a) The manufacturer shall establish criteria for sampling and
testing to ensure that each batch of infant formula meets the nutrient
requirements of section 412(g) of the act or of regulations promulgated
under section 412(a)(2) of the act before release of product for
commercial or charitable distribution.
(b)(1) Immediate analysis. Before release of product for commercial
or charitable distribution, the manufacturer shall analyze
representative samples of each batch of finished product for:
(i) Specific nutrient(s) to assess process degradation; and
(ii) All nutrients not previously analyzed for by the manufacturers,
unless each in-process batch is analyzed for nutrients as specified in
Sec. 106.25(b) and the ingredients are analyzed as specified in Sec.
106.20(b). No analyses are needed for linoleic acid, vitamin D, vitamin
K, choline, inositol, and biotin; and for nutrients that are added as a
part of a nutrient premix analyzed by the manufacturer or having a
supplier's guarantee or certification and for which an indicator
nutrient(s) was analyzed by the manufacturer.
(2) Periodic analysis. The manufacturer shall sample at least one
newly processed finished product batch every 3 months and shall analyze
representative samples for all nutrients except those that the
manufacturers measured in the immediate analysis of that product batch.
(3) Stability analysis. Using representative samples collected from
finished product batches, the manufacturer shall conduct stability
analysis for selected nutrients with sufficient frequency to
substantiate the maintenance of nutrient content throughout the shelf
life of the product.
(c) The manufacturer shall evaluate new formulations and the effect
of changes in ingredients or processing conditions that could affect the
level of nutrients by means of a testing program designed to confirm
uniformity of batches and to determine the effects of such changes. The
following shall apply:
(1) A minor change is a minor reduction in nutrient levels, a minor
increase in levels of nutrients that are subject to maximum limits
established under section 412(g) of the act or in regulations
established under section 412(a)(2) of the act, or any other change
where experience or theory would not predict a possible significant
adverse impact on nutrient levels or nutrient availability. After a
minor change the manufacturer shall analyze representative samples for
all nutrients so changed and those possibly affected by the change.
(2) A major change is any new formulation, or any change of
ingredients or processes where experience or theory would predict a
possible significant adverse impact on levels of nutrients or
availability of nutrients. After a major change the manufacturer shall
analyze representative samples for osmolality, all nutrients, and the
biological quality of the protein. A protein biological quality analysis
is not necessary for a formulation change that is not expected to have
an adverse effect on the biological quality of the protein. Vitamin D
shall be determined by the rat bioassay method as prescribed in
``Official Methods of Analysis of the Association of Official Analytical
Chemists'' (AOAC), 13th Ed. (1980), sections 43.195-43.208, ``Vitamin D
(30)--Official Final Action,'' which is incorporated by reference.
Copies are available from the AOAC INTERNATIONAL, 481 North Frederick
Ave., suite 500, Gaithersburg, MD 20877, or available for inspection at
the National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call 202-741-6030, or go
to: http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html.Before release of the product for
commercial or charitable distribution, the manufacturer shall have
completed all appropriate analyses except that shipment of the product
need not be delayed until results of
[[Page 189]]
the vitamin D bioassay and, if required, a protein biological quality
bioassay are complete, provided such bioassays have been initiated, and
if another analysis for the vitamin D has been run and the protein
content has been determined by a suitable method. The biological quality
of the protein shall be determined by an appropriate modification of the
AOAC bioassay method of analysis. The manufacturer shall analyze
additional samples from the same batch for vitamin D, by any suitable
method, and for the biological quality of the protein. The manufacturer
shall perform such analyses at least annually for a period not to exceed
the expected shelf life of the product.
(d) A simple adjustment in the level of an ingredient to accommodate
inconsistencies in processing is considered to be neither a minor nor a
major change.
[47 FR 17025, Apr. 20, 1982, as amended at 54 FR 24891, June 12, 1989;
63 FR 14035, Mar. 24, 1998]
Sec. 106.90 Coding.
The manufacturer shall code all infant formulas in conformity with
the coding requirements that are applicable to thermally processed low-
acid foods packaged in hermetically sealed containers as prescribed in
Sec. 113.60(c).
Subpart C_Records and Reports
Sec. 106.100 Records.
(a) Every manufacturer of infant formula shall maintain the records
specified in this regulation in order to permit the Food and Drug
Administration to determine whether each manufacturer is in compliance
with section 412 of the Federal Food, Drug, and Cosmetic Act (the act).
(b) The manufacturer shall maintain all records that pertain to
food-packaging materials subject to Sec. 174.5 of this chapter and that
bear on whether such materials would cause an infant formula to be
adulterated within the meaning of section 402(a)(2)(C) of the act.
(c) The manufacturer shall maintain all records that pertain to
nutrient premix testing that it generates or receives. Such records
shall include, but are not limited to:
(1) Any results of testing conducted to ensure that each nutrient
premix is in compliance with the premix certificate and guarantee and
specifications that have been provided to the manufacturer by the premix
supplier, including tests conducted when nutrients exceed their
expiration date or shelf life (retest date).
(2) All certificates and guarantees given by premix suppliers
concerning the nutrients required by section 412(i) of the act and Sec.
107.100 of this chapter.
(d) The premix supplier shall maintain the results of all testing
conducted to provide all certificates and guarantees concerning nutrient
premixes for infant formulas. Such records shall include but are not
limited to:
(1) The results of tests conducted to determine the purity of each
nutrient required by section 412(i) of the act or Sec. 107.100 of this
chapter and any other nutrient listed in the certificate and guarantee;
(2) The weight of each nutrient added;
(3) The results of any quantitative tests conducted to determine the
amount of each nutrient certified or guaranteed; and
(4) The results of any quantitative tests conducted to identify the
nutrient levels present when nutrient premixes exceed their expiration
date or shelf life (retest date).
(e) The manufacturer shall maintain all records necessary to ensure
proper nutrient quality control in the manufacture of infant formula
products. Such records shall include the results of any testing
conducted to verify that each nutrient required by section 412(i) of the
act or Sec. 107.100 of this chapter is present in each batch of infant
formula at the appropriate concentration. This requirement pertains to
ingredients, in process batch and finished product from the time of
manufacture through its expiration date.
(f) The manufacturer shall maintain all records necessary to ensure
required nutrient content at the final product stage. Such records shall
include, but are not limited to, testing results for vitamins A,
B1 (thiamine),
[[Page 190]]
C, and E for each batch of infant formula. ``Final product stage'' means
the point in the manufacturing process prior to distribution at which
the infant formula is homogenous and not subject to further degradation
from the manufacturing process.
(g) The manufacturer shall maintain all records pertaining to
distribution of the infant formula. Such records shall include, but not
be limited to, all information and data necessary to effect and monitor
recalls of the manufacturer's infant formula products in accordance with
subpart E of part 107 of this chapter.
(h) The manufacturer shall maintain all records pertaining to the
microbiological quality and purity of raw materials and finished
powdered infant formula.
(i) [Reserved]
(j) The manufacturer shall maintain all records pertaining to
regularly scheduled audits, including audit plans and procedures. Audit
plans identify the specific manufacturing and quality control procedures
to be reviewed. Audit procedures are the methods used to review the
manufacturing and quality control procedures. Records of audits shall
include the information and data necessary for a determination as to
whether the manufacturer complies with the current good manufacturing
practices and quality procedures identified in parts 106, 107, 109, 110,
and 113 of this chapter. The records shall include written assurances
from the manufacturer that regularly scheduled audits are being
conducted by appropriately trained individuals who do not have any
direct responsibility for the manufacture or production of infant
formula, and that the complete audit plans and procedures for the firm
have been followed. The actual written reports of the audits need not be
made available.
(k) The manufacturer shall maintain procedures describing how all
written and oral complaints regarding infant formula will be handled.
The manufacturer shall follow these procedures and shall include in them
provisions for the review of any complaint involving an infant formula
and for determining the need for an investigation of the possible
existence of a hazard to health.
(1) For purposes of this section, every manufacturer shall interpret
a ``complaint'' as any communication that contains any allegation,
written or oral, expressing dissatisfaction with a product for any
reason, including concerns about the possible existence of a hazard to
health and about appearance, taste, odor, and quality. Correspondence
about prices, package size or shape, or other matters that could not
possibly reveal the existence of a hazard to health shall not, for
compliance purposes, be considered a complaint and therefore need not be
made available to an FDA investigator.
(2) When a complaint shows that a hazard to health possibly exists,
the manufacturer shall conduct an investigation into the validity of the
complaint. Where such an investigation is conducted, the manufacturer
shall include in its file on the complaint the determination as to
whether a hazard to health exists and the basis for that determination.
No investigation is necessary when the manufacturer determines that
there is no possibility of a hazard to health. When no investigation is
necessary, the manufacturer shall include in the record the reason that
an investigation was found to be unnecessary and the name of the
responsible person making that determination.
(3) When there is a reasonable possibility of a causal relationship
between the consumption of an infant formula and an infant's death, the
manufacturer shall, within 15 days of receiving such information,
conduct an investigation and notify the agency as required in Sec.
106.120(b).
(4) The manufacturer shall maintain in designated files all records
pertaining to the complaints it receives. The manufacturer shall
separate the files into two classes:
(i) Those complaints that allege that the infant became ill from
consuming the product or required treatment by a physician or health-
care provider.
(ii) Those complaints that may involve a possible existence of a
hazard to health but do not refer to an infant becoming ill or the need
for treatment by physician or a health care provider.
[[Page 191]]
(5) The manufacturer shall include in a complaint file the following
information concerning the complaint:
(i) The name of the infant formula;
(ii) The batch number;
(iii) The name of complainant;
(iv) A copy of the complaint or a memo of the telephone conversation
or meeting and all correspondence with the complainant;
(v) By reference or copy, all the associated manufacturing records
and complaint investigation records needed to evaluate the complaint.
When copies of such records are not maintained in the complaint file,
they must be available within 24 hours when requested by an FDA
official.
(vi) All actions taken to follow up on the complaint; and
(vii) All findings and evaluations of the complaint.
(6) The manufacturer should maintain the files regarding infant
formula complaints at the establishment where the infant formula was
manufactured, processed, or packed. When the manufacturer wishes to
maintain all consumer complaints for the entire firm at one location
other than at the facility where an infant formula was manufactured,
processed, or packed, the manufacturer may do so as long as all records
required by this section are available within 24 hours of request for
inspection at that facility. However, all records of consumer
complaints, including summaries, any reports, and any files, maintained
at the manufacturing facility or at any other facility shall be made
available to investigators for review and copying upon request.
(l) The manufacturer shall make readily available for authorized
inspection all records required under this part or copies of such
records. Records shall be available at any reasonable time at the
establishment where the activities described in such records occurred.
(Infant formula complaint files may be maintained at one facility, as
provided in Sec. 106.100(k)(6), if all required records are readily
available at that facility.) These records or copies thereof shall be
subject to photocopying or other means of reproduction as part of such
inspection. Records that can be immediately retrieved from another
location by electronic means shall be considered as meeting the
requirements of this paragraph.
(m) Records required under this part may be retained either as
original records or as true copies such as photocopies, microfilm,
microfiche, or other accurate reproductions of the original records.
Where reduction techniques, such as microfilming are used, suitable
reader and photocopying equipment shall be readily available.
(n) Production control, product testing, testing results,
complaints, and distribution records necessary to verify compliance with
parts 106, 107, 109, 110, and 113 of this chapter, or with other
appropriate regulations, shall be retained for 1 year after the
expiration of the shelf life of the infant formula or 3 years from the
date of manufacture, whichever is greater.
(o) The manufacturer shall maintain quality control records that
contain sufficient information to permit a public health evaluation of
any batch of infant formula.
[56 FR 66571, Dec. 24, 1991; 57 FR 7435, Mar. 2, 1992]
Subpart D_Notification Requirements
Sec. 106.120 New formulations and reformulations.
(a) Information required by section 412(b)(2) and (3) of the act
shall be submitted to Center for Food Safety and Applied Nutrition (HFS-
830), Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740.
(b) The manufacturer shall promptly notify the Food and Drug
Administration when the manufacturer has knowledge (as defined in
section 412(c)(2) of the act) that reasonably supports the conclusion
that an infant formula that has been processed by the manufacturer and
that has left an establishment subject to the control of the
manufacturer may not provide the nutrients required by section 412(g) of
the act and by regulations promulgated under section 412(a)(2) of the
act, or when there is an infant formula that is otherwise adulterated or
misbranded and that may present risk to human health. This notification
shall be made,
[[Page 192]]
by telephone, to the Director of the appropriate Food and Drug
Administration district office specified in part 5, subpart M of this
chapter. After normal business hours (8 a.m. to 4:30 p.m.), contact the
FDA Emergency Call Center at 866-300-4374. The manufacturer shall send a
followup written confirmation to the Center for Food Safety and Applied
Nutrition (HFS-605), Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, and to the appropriate Food and Drug
Administration district office specified in part 5, subpart M of this
chapter.
[47 FR 17025, Apr. 20, 1982, as amended at 54 FR 24891, June 12, 1989;
61 FR 14479, Apr. 2, 1996; 66 FR 17358, Mar. 30, 2001; 66 FR 56035, Nov.
6, 2001; 75 FR 32658, June 9, 2010]
PART 107_INFANT FORMULA--Table of Contents
Subpart A_General Provisions
Sec.
107.3 Definitions.
Subpart B_Labeling
107.10 Nutrient information.
107.20 Directions for use.
107.30 Exemptions.
Subpart C_Exempt Infant Formulas
107.50 Terms and conditions.
Subpart D_Nutrient Requirements
107.100 Nutrient specifications.
Subpart E_Infant Formula Recalls
107.200 Food and Drug Administration-required recall.
107.210 Firm-initiated product removals.
107.220 Scope and effect of infant formula recalls.
107.230 Elements of an infant formula recall.
107.240 Notification requirements.
107.250 Termination of an infant formula recall.
107.260 Revision of an infant formula recall.
107.270 Compliance with this subpart.
107.280 Records retention.
Authority: 21 U.S.C. 321, 343, 350a, 371.
Source: 50 FR 1840, Jan. 14, 1985, unless otherwise noted.
Subpart A_General Provisions
Sec. 107.3 Definitions.
The following definitions shall apply, in addition to the
definitions contained in section 201 of the Federal Food, Drug, and
Cosmetic Act (the act):
Exempt formula. An exempt infant formula is an infant formula
intended for commercial or charitable distribution that is represented
and labeled for use by infants who have inborn errors of metabolism or
low birth weight, or who otherwise have unusual medical or dietary
problems.
Manufacturer. A manufacturer is a person who prepares,
reconstitutes, or otherwise changes the physical or chemical
characteristics of an infant formula or packages the infant formula in
containers for distribution.
References. References in this part to regulatory sections of the
Code of Federal Regulations are to chapter I of title 21, unless
otherwise noted.
[50 FR 48186, Nov. 22, 1985]
Subpart B_Labeling
Sec. 107.10 Nutrient information.
(a) The labeling of infant formulas, as defined in section 201(aa)
of the Federal Food, Drug, and Cosmetic Act, shall bear in the order
given, in the units specified, and in tabular format, the following
information regarding the product as prepared in accordance with label
directions for infant consumption:
(1) A statement of the number of fluid ounces supplying 100
kilocalories (in case of food label statements, a kilocalorie is
represented by the word ``Calorie''); and
(2) A statement of the amount of each of the following nutrients
supplied by 100 kilocalories:
------------------------------------------------------------------------
Nutrients Unit of measurement
------------------------------------------------------------------------
Protein................................... Grams.
Fat....................................... Do.
Carbohydrate.............................. Do.
Water..................................... Do.
Linoleic acid............................. Milligrams.
Vitamins:
Vitamin A............................... International units.
Vitamin D............................... Do.
Vitamin E............................... Do.
Vitamin K............................... Micrograms.
Thiamine (Vitamin B 1).................. Do.
Riboflavin (Vitamin B 2................. Do.
[[Page 193]]
Vitamin B 6............................. Do.
Vitamin B 12............................ Do.
Niacin.................................. Do.
Folic acid (Folacin).................... Do.
Pantothenic acid........................ Do.
Biotin.................................. Do.
Vitamin C (Ascorbic acid)............... Milligrams.
Choline................................. Do.
Inositol................................ Do.
Minerals:
Calcium................................. Milligrams.
Phosphorus.............................. Do.
Magnesium............................... Do.
Iron.................................... Do.
Zinc.................................... Do.
Manganese............................... Micrograms.
Copper.................................. Do.
Iodine.................................. Do.
Sodium.................................. Milligrams.
Potassium............................... Do.
Chloride................................ Do.
------------------------------------------------------------------------
(b) In addition the following apply:
(1) Vitamin A content may also be declared on the label in units of
microgram retinol equivalents, vitamin D content in units of micrograms
cholecalciferol, vitamin E content in units of milligram alpha-
tocopherol equivalents, and sodium, potassium, and chloride content in
units of millimoles, micromoles, or milliequivalents. When these
declarations are made they shall appear in parentheses immediately
following the declarations in International Units for vitamins A, D, and
E, and immediately following the declarations in milligrams for sodium,
potassium, and chloride.
(2) Biotin, choline, and inositol content shall be declared except
when they are not added to milk-based infant formulas.
(3) Each of the listed nutrients, and the caloric density, may also
be declared on the label on other bases, such as per 100 milliliters or
per liter, as prepared for infant consumption.
(4) One of the following statements shall appear on the principal
display panel, as appropriate:
(i) The statement ``Infant Formula With Iron'', or a similar
statement, if the product contains 1 milligram or more of iron in a
quantity of product that supplies 100 kilocalories when prepared in
accordance with label directions for infant consumption.
(ii) The statement ``Additional Iron May Be Necessary'', or a
similar statement, if the product contains less than 1 milligram of iron
in a quantity of product that supplies 100 kilocalories when prepared in
accordance with label directions for infant consumption.
(5) Any additional vitamin may be declared at the bottom of the
vitamin list and any additional minerals may be declared between iodine
and sodium, provided that any additionally declared nutrient (i) has
been identified as essential by the National Academy of Sciences through
its development of a recommended dietary allowance or an estimated safe
and adequate daily dietary intake range, or has been identified as
essential by the Food and Drug Administration through a Federal Register
publication or establishment of a U.S. Recommended Daily Allowance, and
(ii) is provided at a level considered in these publications as having
biological significance, when these levels are known.
[50 FR 1840, Jan. 14, 1985, as amended at 67 FR 9585, Mar. 4, 2002]
Sec. 107.20 Directions for use.
In addition to the applicable labeling requirements in parts 101 and
105 of this chapter, the product label shall bear:
(a) Under the heading ``Directions For Preparation and Use'',
directions for:
(1) Storage of infant formula before and after the container has
been opened, including a statement indicating that prolonged storage at
excessive temperatures should be avoided;
(2) Agitating liquid infant formula before opening the container,
such as ``Shake Well Before Opening'';
(3) ``Sterilization'' of water, bottle, and nipples when necessary
for preparing infant formula for use;
(4) Dilution of infant formula, when appropriate. Directions for
powdered infant formula shall contain the weight and volume of powdered
formula to be reconstituted.
(b) In close proximity to the ``Directions for Preparation and Use''
a pictogram depicting the major steps for preparation of that infant
formula, such as (for a concentrated formula):
[[Page 194]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.366
(c) A ``Use by ------'' date, the blank to be filled in with the
month and year selected by the manufacturer, packer, or distributor of
the infant formula on the basis of tests or other information showing
that the infant formula, until that date, under the conditions of
handling, storage, preparation, and use prescribed by label directions,
will: (1) when consumed, contain not less than the quantity of each
nutrient, as set forth on its label; and (2) otherwise be of an
acceptable quality (e.g., pass through an ordinary bottle nipple).
(d) The statement ``Add Water'' or ``Do Not Add Water'', as
appropriate, to appear on the principal display panel of concentrated or
ready-to-feed infant formulas. In close proximity to the statement ``Add
Water'', a symbol such as
[GRAPHIC] [TIFF OMITTED] TC01MR93.000
if the addition of water is necessary. The symbol shall be placed on a
white background encircled by a dark border.
(e) A warning statement beneath or in close proximity to the
``Directions For Preparation and Use'' that cautions against improper
preparation or use of an infant formula, such as ``THE HEALTH OF YOUR
INFANT DEPENDS ON CAREFULLY FOLLOWING THE DIRECTIONS FOR PREPARATION AND
USE''.
(f) A statement indicating that parents should consult their
physicians about the use of infant formulas, such as ``USE AS DIRECTED
BY A PHYSICIAN''.
[50 FR 1840, Jan. 14, 1985, as amended at 67 FR 9585, Mar. 4, 2002]
Sec. 107.30 Exemptions.
When containers of ready-to-feed infant formula, to be sold at the
retail level, are contained within a multiunit package, the labels of
the individual containers shall contain all of the label information
required by section 403 of the Federal Food, Drug, and Cosmetic Act (the
act), Sec. Sec. 107.10 and 107.20, and all appropriate sections of part
101 of this chapter, except that the labels of the individual containers
contained within the outer package shall be exempt from compliance with
the requirements of section 403 (e)(1) and (i)(2) of the act; and
Sec. Sec. 107.10 (a) and (b)(2) and 107.20 (b), (e), and (f), provided
that (a) the multiunit package meets all the requirements of this part;
(b) individual containers are securely enclosed within and are not
intended to be separated
[[Page 195]]
from the retail package under conditions of retail sale; and (c) the
label on each individual container includes the statement ``This Unit
Not Intended For Individual Sale'' in type size not less than one-
sixteenth inch in height. The word ``Retail'' may be used in lieu of or
immediately following the word ``Individual'' in the statement.
Subpart C_Exempt Infant Formulas
Sec. 107.50 Terms and conditions.
(a) Terms and conditions. Section 412(f)(1) of the act exempts from
the requirements of section 412(a), (b), and (c)(1)(A) of the act infant
formulas that are represented and labeled for use by an infant who has
an inborn error of metabolism or low brith weight or who otherwise has
an unusual medical or dietary problem, if such formulas comply with
regulations prescribed by the Secretary. The regulations in this subpart
establish the terms and conditions that a manufacturer must meet with
respect to such infant formulas.
(b) Infant formulas generally available at the retail level. (1)
These exempt infant formulas can generally be purchased from retail
store shelves that are readily available to the public. Such formulas
are also typically represented and labeled for use to provide dietary
management for diseases or conditions that are not clinically serious or
life-threatening, even though such formulas may also be represented and
labeled for use in clinically serious or life-threatening disorders.
(2) Except as provided in paragraphs (b)(4) and (5) of this section,
an infant formula manufacturer shall, with respect to each formula
covered by this paragraph, comply with the nutrient requirements of
section 412(g) of the act or of regulations promulgated under section
412(a)(2) of the act, the quality control procedure requirements of part
106, and the labeling requirements of subpart B of this part.
(3) To retain the exempt status of an infant formula covered by this
paragraph, the manufacturer shall submit to the Food and Drug
Administration (FDA), at the address specified in paragraph (e)(1) of
this section, on or before May 21, 1986, or on or before the 90th day
before the first processing of the infant formula for commercial or
charitable distribution, whichever occurs later, the label and other
labeling of the infant formula, a complete quantitative formulation for
the infant formula, and a detailed description of the medical conditions
for which the infant formula is represented. FDA will review the
information under paragraph (d) of this section.
(4) To retain the exempt status of an infant formula covered by this
paragraph, when any change in ingredients or processes that may result
in an adverse impact on levels of nutrients or availability of nutrients
is instituted, the manufacturer shall submit to FDA at the address
specified in paragraph (e)(1) of this section, before the first
processing of the infant formula, the label and other labeling of the
infant formula, a complete quantitative formulation for the infant
formula, a detailed description of the reformulation and the rationale
for the reformulation, a complete description of the change in
processing, and a detailed description of the medical conditions for
which the infant formula is represented. FDA will review that
information under paragraph (d) of this section.
(5) A manufacturer may deviate from the requirements of paragraph
(b)(2) of this section only with respect to those specific requirements
for which it submits to FDA, at the address specified in paragraph
(e)(1) of this section, the medical, nutritional, scientific, or
technological rationale (including any appropriate animal or human
clinical studies). FDA will review that information under paragraph (d)
of this section.
(c) Infant formulas not generally available at the retail level. (1)
These exempt infant formulas are not generally found on retail shelves
for general consumer purchase. Such formulas typically are prescribed by
a physician, and must be requested from a pharmacist or are distributed
directly to institutions such as hospitals, clinics, and State or
Federal agencies. Such formulas are also generally represented and
labeled solely to provide dietary management for specific diseases or
conditions that are clinically serious or life-threatening
[[Page 196]]
and generally are required for prolonged periods of time. Exempt infant
formulas distributed directly to institutions such as hospitals,
clinics, and State or Federal agencies that are of the same formulation
as those generally available at the retail level are subject to the
requirements of paragraph (b) of this section rather than to the
requirements of this paragraph.
(2) Except as provided for in paragraph (c)(5) of this section, an
infant formula manufacturer shall, with respect to each formula covered
by this paragraph, comply with the nutrient requirements of section
412(g) of the act or of regulations promulgated under section 412(a)(2)
of the act, and the labeling requirements of subpart B of this part.
(3) Each manufacturer of an infant formula covered by this paragraph
shall establish quality control procedures designed to ensure that the
infant formula meets applicable nutrient requirements of this section,
including any special nutritional characteristics for the specific
disorders or conditions for which the formula is represented for use.
Each manufacturer shall maintain records of such quality control
procedures sufficient to permit a public health evaluation of each
manufactured batch of infant formula and shall permit any authorized FDA
employee at all reasonable times to have access to and to copy and
verify the records referred to in this paragraph.
(4) To retain the exempt status of an infant formula covered by this
paragraph, the manufacturer shall submit the information required by
paragraphs (b)(3) and (4) of this section.
(5) A manufacturer may deviate from the requirements of paragraph
(c)(2) of this section only with respect to those specific requirements
for which it submits to FDA, at the address specified in paragraph
(e)(1) of this section, the medical, nutritional, scientific, or
technological rationale (including any appropriate animal or human
clinical studies). FDA will review that information under paragaraph (d)
of this section.
(6) The requirements of this section do not apply to an infant
formula specially and individually prepared for one or more specific
infants on a physician's request.
(d) FDA review of exempt status. (1) FDA's Center for Food Safety
and Applied Nutrition will review information submitted by infant
formula manufacturers under paragraph (b) (3), (b) (4), or (c)(4) of
this section. On the basis of such review and other information
available to the agency, the Center for Food Safety and Applied
Nutrition may impose additional conditions on, or modify requirements
for, the quality control procedures, nutrient specifications, or
labeling of an infant formula, or withdraw a product's exempt status.
Such determinations will be made by the Director of the Center for Food
Safety and Applied Nutrition.
(2)(i) If after completing its review of all information submitted,
the Center for Food Safety and Applied Nutrition concludes that
additional or modified quality control, nutrient, or labeling
requirements are needed, or that a product's exempt status is withdrawn,
the Center for Food Safety and Applied Nutrition will so notify the
manufacturer and this notification will specify the reasons therefor.
Upon receipt of this notification, the manufacturer has 10 working days
to have the decision reviewed under Sec. 10.75 by the office of the
Commissioner of Food and Drugs. A determination by the Director of the
Center for Food Safety and Applied Nutrition that is not appealed
becomes a final agency decision.
(ii) After a final decision by the Director or by the office of the
Commissioner that a product's exempt status is withdrawn, the
manufacturer shall comply with the nutrient requirements of section
412(g) of the act or of regulations promulgated under section 412(a)(2)
of the act, the quality control requirements of part 106, and the
labeling requirements of subpart B of this part.
(iii) The compliance date for the withdrawal of a product's exempt
status or the imposition of additional or modified quality control,
nutrient, or labeling requirements is 60 calendar days after issuance of
the final decision except as otherwise provided for reasons stated in
the decision. If the agency determines that a health hazard
[[Page 197]]
may exist and so notifies the manufacturer, withdrawal of a product's
exempt status shall be effective on the date of receipt of notification
from the Director of the Center for Food Safety and Applied Nutrition.
Additional or modified requirements, or the withdrawal of an exemption,
apply only to those formulas that are manufactured after the compliance
date. A postponement of the compliance date may be granted for good
cause.
(3) FDA may decide that withdrawal of an exemption is necessary
when, on the basis of its review under paragraph (d)(1) of this section,
it concludes that quality control procedures are not adequate to ensure
that the formula contains all required nutrients, that deviations in
nutrient levels are not supported by generally accepted scientific,
nutritional, or medical rationale, or that deviations from subpart B of
this part are not necessary to provide appropriate directions for
preparation and use of the infant formula, or that additional labeling
information is necessary.
(4) FDA will use the following criteria in determining whether
deviations from the requirements of this subpart are necessary and will
adequately protect the public health:
(i) A deviation from the nutrient requirements of section 412(g) of
the act or of regulations promulgated under section 412(a)(2) of the act
is necessary to provide an infant formula that is appropriate for the
dietary management of a specific disease, disorder, or medical
condition;
(ii) For exempt infant formulas subject to paragraph (b) of this
section, a deviation from the quality control procedures requirements of
part 106 is necessary because of unusal or difficult technological
problems in manufacturing the infant formula; and
(iii) A deviation from the labeling requirements of subpart B of
this part is necessary because label information, including pictograms
and symbols required by those regulations, could lead to inappropriate
use of the product.
(e) Notification requirements. (1) Information required by
paragraphs (b) and (c) of this section shall be submitted to Center for
Food Safety and Applied Nutrition (HFS-830), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740.
(2) The manufacturer shall promptly notify FDA when the manufacturer
has knowledge (as defined in section 412(c)(2) of the act) that
reasonably supports the conclusion that an exempt infant formula that
has been processed by the manufacturer and that has left an
establishment subject to the control of the manufacturer may not provide
the nutrients required by paragraph (b) or (c) of this section, or when
there is an exempt infant formula that may be otherwise adulterated or
misbranded and if so adulterated or misbranded presents a risk of human
health. This notification shall be made, by telephone, to the Director
of the appropriate FDA district office specified in part 5, subpart M of
this chapter. After normal business hours (8 a.m. to 4:30 p.m.), contact
the FDA Emergency Call Center at 866-300-4374. The manufacturer shall
send a followup written confirmation to the Center for Food Safety and
Applied Nutrition (HFS-605), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, and to the appropriate FDA
district office specified in part 5, subpart M of this chapter.
[50 FR 48187, Nov. 22, 1985, as amended at 61 FR 14479, Apr. 2, 1996; 66
FR 17358, Mar. 30, 2001; 66 FR 56035, Nov. 6, 2001; 67 FR 9585, Mar. 4,
2002; 75 FR 32659, June 9, 2010]
Subpart D_Nutrient Requirements
Sec. 107.100 Nutrient specifications.
(a) An infant formula shall contain the following nutrients at a
level not less than the minimum level specified and not more than the
maximum level specified for each 100 kilocalories of the infant formula
in the form prepared for consumption as directed on the container:
------------------------------------------------------------------------
Minimum Maximum
Nutrients Unit of measurement level level
------------------------------------------------------------------------
Protein Grams 1.8 4.5
Fat do 3.3 6.0
Percent calories 30 54
Linoleic acid Milligrams 300 .......
Percent calories 2.7 .......
------------------------------------------------------------------------
Vitamins
------------------------------------------------------------------------
Vitamin A International Units 250 750
[[Page 198]]
Vitamin D do 40 100
Vitamin E do 0.7 .......
Vitamin K Micrograms 4 .......
Thiamine (vitamin B1) do 40 .......
Riboflavin (vitamin B2) do 60 .......
Vitamin B6 do 35 .......
Vitamin B12 do 0.15 .......
Niacin \1\ do 250 .......
Folic acid (folacin) do 4 .......
Pantothenic acid do 300 .......
Biotin \2\ do 1.5 .......
Vitamin C (ascorbic Milligrams 8 .......
acid)
Choline \2\ do 7 .......
Inositol \2\ do 4 .......
------------------------------------------------------------------------
Minerals
------------------------------------------------------------------------
Calcium do 60 .......
Phosphorus do 30 .......
Magnesium do 6 .......
Iron do 0.15 3.0
Zinc do 0.5 .......
Manganese Micrograms 5 .......
Copper Micrograms 60 .......
Iodine do 5 75
Sodium Milligrams 20 60
Potassium do 80 200
Chloride do 55 150
------------------------------------------------------------------------
\1\ The generic term ``niacin'' includes niacin (nicotinic acid) and
niacinamide (nicotinamide).
\2\ Required only for non-milk-based infant formulas.
In addition to the specifications established in the table in this
paragraph for vitamins and minerals, the following also apply:
(b) Vitamin E shall be present at a level of at least 0.7
International Unit of vitamin E per gram of linoleic acid.
(c) Any vitamin K added shall be in the form of phylloquinone.
(d) Vitamin B6 shall be present at a level of at least 15
micrograms of vitamin B6 for each gram of protein in excess
of 1.8 grams of protein per 100 kilocalories of infant formula in the
form prepared for consumption as directed on the container.
(e) The ratio of calcium to phosphorus in infant formula in the form
prepared for consumption as directed on the container shall be no less
than 1.1 and not more than 2.0.
(f) Protein shall be present in an amount not to exceed 4.5 grams
per 100 kilocalories regardless of quality, and not less than 1.8 grams
per 100 kilocalories of infant formula in the form prepared for
consumption as directed on the container when its biological quality is
equivalent to or better than that of casein. If the biological quality
of the protein is less than that of casein, the minimum amount of
protein shall be increased proportionately to compensate for its lower
biological quality. For example, an infant formula containing protein
with a biological quality of 75 percent of casein shall contain at least
2.4 grams of protein (1.8/0.75). No protein with a biological quality
less than 70 percent of casein shall be used.
[50 FR 45108, Oct. 30, 1985]
Subpart E_Infant Formula Recalls
Source: 54 FR 4008, Jan. 27, 1989, unless otherwise noted.
Sec. 107.200 Food and Drug Administration-required recall.
When the Food and Drug Administration determines that an adulterated
or misbranded infant formula presents a risk to human health, a
manufacturer shall immediately take all actions necessary to recall that
formula, extending to and including the retail level, consistent with
the requirements of this subpart.
Sec. 107.210 Firm-initiated product removals.
(a) If a manufacturer has determined to recall voluntarily from the
market an infant formula that is not subject to Sec. 107.200 but that
otherwise violates the laws and regulations administered by the Food and
Drug Administration (FDA) and that would be subject to legal action, the
manufacturer, upon prompt notification to FDA, shall administer such
voluntary recall consistent with the requirements of this subpart.
(b) If a manufacturer has determined to withdraw voluntarily from
the market an infant formula that is adulterated or misbranded in only a
minor way and that would not be subject to legal action, such removal
from the market is deemed to be a market withdrawal, as defined in Sec.
7.3(j) of this chapter. As required by Sec. 107.240(a), the
manufacturer shall promptly notify FDA of such violative formula and
may, but is not required to, conduct such market withdrawal consistent
with the requirements of this subpart pertaining to product recalls.
[[Page 199]]
Sec. 107.220 Scope and effect of infant formula recalls.
(a) The requirements of this subpart apply:
(1) When the Food and Drug Administration has determined that it is
necessary to remove from the market a distributed infant formula that is
in violation of the laws and regulations administered by the Food and
Drug Administration and that poses a risk to human health; or
(2) When a manufacturer has determined that it is necessary to
remove from the market a distributed infant formula that:
(i) Is no longer subject to the manufacturer's control;
(ii) Is in violation of the laws and regulations administered by the
Food and Drug Administration and against which the agency could initiate
legal or regulatory action; and
(iii) Does not present a human risk.
(b) The Food and Drug Administration will monitor continually the
recall action and will take appropriate actions to ensure that the
violative infant formula is removed from the market.
Sec. 107.230 Elements of an infant formula recall.
A recalling firm shall conduct an infant formula recall with the
following elements:
(a) The recalling firm shall evaluate in writing the hazard to human
health associated with the use of the infant formula. This health hazard
evaluation shall include consideration of any disease, injury, or other
adverse physiological effect that has been or that could be caused by
the infant formula and of the seriousness, likelihood, and consequences
of the diseases, injury, or other adverse physiological effect. The Food
and Drug Administration will conduct its own health hazard evaluation
and promptly notify the recalling firm of the results of that evaluation
if the criteria for recall under Sec. 107.200 have been met.
(b) The recalling firm shall devise a written recall strategy suited
to the individual circumstances of the particular recall. The recall
strategy shall take into account the health hazard evaluation and
specify the following: The extent of the recall; if necessary, the
public warning to be given about any hazard presented by the infant
formula; the disposition of the recalled infant formula; and the
effectiveness checks that will be made to determine that the recall is
carried out.
(c) The recalling firm shall promptly notify each of its affected
direct accounts about the recall. The format of a recall communication
shall be distinctive, and the content and extent of a recall
communication shall be commensurate with the hazard of the infant
formula being recalled and the strategy developed for the recall. The
recall communication shall instruct consignees to report back quickly to
the recalling firm about whether they are in possession of the recalled
infant formula and shall include a means of doing so. The recalled
communication shall also advise consignees how to return the recall
infant formula to the manufacturer or otherwise dispose of it. The
recalling firm shall send a followup recall communication to any
consignee that does not respond to the initial recall communication.
(d) If the infant formula presents a risk to human health, the
recalling firm shall request that each establishment, at which such
infant formula is sold or available for sale, post at the point of
purchase of such formula a notice of such recall at such establishment.
The notice shall be provided by the recalling firm after approval of the
notice by the Food and Drug Administration. The recalling firm shall
also request that each retail establishment maintain such notice on
display until such time as the Food and Drug Administration notifies the
recalling firm that the agency considers the recall completed.
(e) The recalling firm shall furnish promptly to the appropriate
Food and Drug Administration district office listed in part 5, subpart M
of this chapter, as they are available, copies of the health hazard
evaluation, the recall strategy, and all recall communications
(including, for a recall under Sec. 107.200, the notice to be displayed
at
[[Page 200]]
retail establishments) directed to consignees, distributors, retailers,
and members of the public.
[54 FR 4008, Jan. 27, 1989, as amended at 66 FR 17358, Mar. 30, 2001; 69
FR 17291, Apr. 2, 2004]
Sec. 107.240 Notification requirements.
(a) Notification of a violative infant formula. A manufacturer shall
promptly notify the Food and Drug Administration when the manufacturer
has knowledge (as defined in section 412(e)(2) of the Federal Food,
Drug, and Cosmetic Act (the act)) that reasonably supports the
conclusion that an infant formula that has been processed by the
manufacturer and that has left an establishment subject to the control
of the manufacturer:
(1) May not provide the nutrients required by section 412(i) of the
act and by regulations promulgated under section 412(i)(2) of the act;
or
(2) May be otherwise adulterated or misbranded.
(b) Method of notification. The notification made pursuant to Sec.
107.240(a) shall be made, by telephone, to the Director of the
appropriate Food and Drug Administration district office listed in part
5, subpart M of this chapter. After normal business hours (8 a.m. to
4:30 p.m.), contact the FDA Emergency Call Center at 866-300-4374. The
manufacturer shall send written confirmation of the notification to the
Center for Food Safety and Applied Nutrition (HFS-605), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and to
the appropriate Food and Drug Administration district office listed in
part 5, subpart M of this chapter.
(c) Reports about an infant formula recall--(1) Telephone report.
When a determination is made that an infant formula is to be recalled,
the recalling firm shall telephone within 24 hours the appropriate Food
and Drug Administration district office listed in part 5, subpart M of
this chapter and shall provide relevant information about the infant
formula that is to be recalled.
(2) Initial written report. Within 14 days after the recall has
begun, the recalling firm shall provide a written report to the
appropriate Food and Drug Administration district office. The report
shall contain relevant information, including the following cumulative
information concerning the infant formula that is being recalled:
(i) Number of consignees notified of the recall, and date and method
of notification, including, for a recall pursuant to Sec. 107.200
information about the notice provided for retail display and the request
for its display.
(ii) Number of consignees responding to the recall communication and
quantity of recalled infant formula on hand at the time it was received.
(iii) Quantity of recalled infant formula returned or corrected by
each consignee contacted and the quantity of recalled infant formula
accounted for.
(iv) Number and results of effectiveness checks that were made.
(v) Estimated timeframes for completion of the recall.
(3) Status reports. The recalling firm shall submit to the
appropriate Food and Drug Administration district office a written
status report on the recall at least every 14 days until the recall is
terminated. The status report shall describe the steps taken by the
recalling firm to carry out the recall since the last report and the
results of these steps.
[54 FR 4008, Jan. 27, 1989, as amended at 61 FR 14479, Apr. 2, 1996; 66
FR 17359, Mar. 30, 2001; 66 FR 56035, Nov. 6, 2001; 75 FR 32659, June 9,
2010]
Sec. 107.250 Termination of an infant formula recall.
The recalling firm may submit a recommendation for termination of
the recall to the appropriate Food and Drug Administration district
office listed in part 5, subpart M of this chapter for transmittal to
the Center for Food Safety and Applied Nutrition (HFS-605), for action.
Any such recommendation shall contain information supporting a
conclusion that the recall strategy has been effective. The agency will
respond within 15 days of receipt by the Center for Food Safety and
Applied Nutrition (HFS-605), of the request for termination. The
recalling firm shall continue to implement the recall strategy until it
receives final written notification from the agency that the recall has
been terminated.
[[Page 201]]
The agency will send such a notification unless it has information, from
FDA's own audits or from other sources, demonstrating that the recall
has not been effective. The agency may conclude that a recall has not
been effective if:
(a) The recalling firm's distributors have failed to retrieve the
recalled infant formula; or
(b) Stocks of the recalled infant formula remain in distribution
channels that are not in direct control of the recalling firm.
[54 FR 4008, Jan. 27, 1989, as amended at 61 FR 14479, Apr. 2, 1996; 66
FR 17359, Mar. 30, 2001; 69 FR 17291, Apr. 2, 2004]
Sec. 107.260 Revision of an infant formula recall.
If after a review of the recalling firm's recall strategy or
periodic reports or other monitoring of the recall, the Food and Drug
Administration concludes that the actions of the recalling firm are
deficient, the agency shall notify the recalling firm of any serious
deficiency. The agency may require the firm to:
(a) Change the extent of the recall, if the agency concludes on the
basis of available data that the depth of the recall is not adequate in
light of the risk to human health presented by the infant formula.
(b) Carry out additional effectiveness checks, if the agency's
audits, or other information, demonstrate that the recall has not been
effective.
(c) Issue additional notifications to the firm's direct accounts, if
the agency's audits, or other information demonstrate that the original
notifications were not received, or were disregarded in a significant
number of cases.
Sec. 107.270 Compliance with this subpart.
A recalling firm may satisfy the requirements of this subpart by any
means reasonable calculated to meet the obligations set forth in this
Subpart E. The recall guidance in subpart C of part 7 of this chapter
specify procedures that may be useful to a recalling firm in determining
how to comply with these regulations.
[54 FR 4008, Jan. 27, 1989, as amended at 65 FR 56479, Sept. 19, 2000]
Sec. 107.280 Records retention.
Each manufacturer of an infant formula shall make and retain such
records respecting the distribution of the infant formula through any
establishment owned or operated by such manufacturer as may be necessary
to effect and monitor recalls of the formula. Such records shall be
retained for at least 1 year after the expiration of the shelf life of
the infant formula.
[54 FR 4008, Jan. 27, 1989, as amended at 67 FR 9585, Mar. 4, 2002]
PART 108_EMERGENCY PERMIT CONTROL--Table of Contents
Subpart A_General Provisions
Sec.
108.3 Definitions.
108.5 Determination of the need for a permit.
108.6 Revocation of determination of need for permit.
108.7 Issuance or denial of permit.
108.10 Suspension and reinstatement of permit.
108.12 Manufacturing, processing, or packing without a permit, or in
violation of a permit.
108.19 Establishment of requirements for exemption from section 404 of
the act.
Subpart B_Specific Requirements and Conditions for Exemption From or
Compliance With an Emergency Permit
108.25 Acidified foods.
108.35 Thermal processing of low-acid foods packaged in hermetically
sealed containers.
Authority: 21 U.S.C. 342, 344, 371.
Source: 42 FR 14334, Mar. 15, 1977, unless otherwise noted.
Subpart A_General Provisions
Sec. 108.3 Definitions.
(a) The definitions contained in section 201 of the Federal Food,
Drug, and Cosmetic Act are applicable to such terms when used in this
part.
(b) Commissioner means the Commissioner of Food and Drugs.
(c) Act means the Federal Food, Drug, and Cosmetic Act, as amended.
(d) Permit means an emergency permit issued by the Commissioner
pursuant to section 404 of the act for such
[[Page 202]]
temporary period of time as may be necessary to protect the public
health.
(e) Manufacture, processing, or packing of food in any locality
means activities conducted in a single plant or establishment, a series
of plants under a single management, or all plants in an industry or
region, by a manufacturer, processor, or packer.
Sec. 108.5 Determination of the need for a permit.
(a) Whenever the Commissioner determines after investigation that a
manufacturer, processor, or packer of a food for which a regulation has
been promulgated in subpart B of this part does not meet the mandatory
conditions and requirements established in such regulation, he shall
issue to such manufacturer, processor, or packer an order determining
that a permit shall be required before the food may be introduced or
delivered for introduction into interstate commerce by that person. The
order shall specify the mandatory conditions and requirements with which
there is a lack of compliance.
(1) The manufacturer, processor, or packer shall have 3 working days
after receipt of such order within which to file objections. Such
objections may be filed by telegram, telex, or any other mode of written
communication addressed to the Center for Food Safety and Applied
Nutrition, Food and Drug Administration (HFS-605), 5100 Paint Branch
Pkwy., College Park, MD 20740. If such objections are filed, the
determination is stayed pending a hearing to be held within 5 working
days after the filing of objections on the issues involved unless the
Commissioner determines that the objections raise no genuine and
substantial issue of fact to justify a hearing.
(2) If the Commissioner finds that there is an imminent hazard to
health, the order shall contain this finding and the reasons therefor,
and shall state that the determination of the need for a permit is
effective immediately pending an expedited hearing.
(b) A hearing under this section shall be conducted by the
Commissioner or his designee at a location agreed upon by the objector
and the Commissioner or, if such agreement cannot be reached, at a
location designated by the Commissioner. The manufacturer, processor, or
packer shall have the right to cross-examine the Food and Drug
Administration's witnesses and to present witnesses on his own behalf.
(c) Within 5 working days after the hearing, and based on the
evidence presented at the hearing, the Commissioner shall determine
whether a permit is required and shall so inform the manufacturer,
processor, or packer in writing, with the reasons for his decision.
(d) The Commissioner's determination of the need for a permit
constitutes final agency action from which appeal lies to the courts.
The Commissioner will not stay a determination of the need for a permit
pending court appeal except in unusual circumstances, but will
participate in expediting any such appeal.
[42 FR 14334, Mar. 15, 1977, as amended at 54 FR 24891, June 12, 1989;
61 FR 14479, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001]
Sec. 108.6 Revocation of determination of need for permit.
(a) A permit shall be required only during such temporary period as
is necessary to protect the public health.
(b) Whenever the Commissioner has reason to believe that a permit
holder is in compliance with the mandatory requirements and conditions
established in subpart B of this part and is likely to remain in
compliance, he shall, on his own initiative or on the application of the
permit holder, revoke both the determination of need for a permit and
the permit that had been issued. If denied, the applicant shall, upon
request, be afforded a hearing conducted in accordance with Sec. 108.5
(b) and (c) as soon as practicable. Such revocation is without prejudice
to the initiation of further permit proceedings with respect to the same
manufacturer, processor, or packer should later information again show
the need for a permit.
Sec. 108.7 Issuance or denial of permit.
(a) After a determination and notification by the Commissioner in
accordance with the provisions of Sec. 108.5 that a manufacturer,
processor, or packer requires a permit, such manufacturer,
[[Page 203]]
processor, or packer may not thereafter introduce or deliver for
introduction into interstate commerce any such food manufactured,
processed, or packed by him unless he holds a permit issued by the
Commissioner or obtains advance written approval of the Food and Drug
Administration pursuant to Sec. 108.12(a).
(b) Any manufacturer, processor, or packer for whom the Commissioner
has made a determination that a permit is necessary may apply to the
Commissioner for the issuance of such a permit. The application shall
contain such data and information as is necessary to show that all
mandatory requirements and conditions for the manufacturer, processing
or packing of a food for which regulations are established in subpart B
of this part are met and, in particular, shall show that the deviations
specified in the Commissioner's determination of the need for a permit
have been corrected or suitable interim measures established. Within 10
working days after receipt of such application, (except that the
Commissioner may extend such time an additional 10 working days where
necessary), the Commissioner shall issue a permit, deny the permit, or
offer the applicant a hearing conducted in accordance with Sec. 108.5
(b) and (c) as to whether the permit should be issued. The Commissioner
shall issue such a permit to which shall be attached, in addition to the
mandatory requirements and conditions of subpart B of this part, any
additional requirements or conditions which may be necessary to protect
the public health if he finds that all mandatory requirements and
conditions of subpart B of this part are met or suitable interim
measures are established.
(c) Denial of a permit constitutes final agency action from which
appeal lies to the courts. The Commissioner will not stay such denial
pending court appeal except in unusual circumstances, but will
participate in expediting any such appeal.
Sec. 108.10 Suspension and reinstatement of permit.
(a) Whenever the Commissioner finds that a permit holder is not in
compliance with the mandatory requirements and conditions established by
the permit, he shall immediately suspend the permit and so inform the
permit holder, with the reasons for the suspension.
(b) Upon application for reinstatement of a permit, the Commissioner
shall, within 10 working days, reinstate the permit if he finds that the
person is in compliance with the mandatory requirements and conditions
established by the permit or deny the application.
(c) Any person whose permit has been suspended or whose application
for reinstatement has been denied may request a hearing. The hearing
shall be conducted by the Commissioner or his designee within 5 working
days of receipt of the request at a location agreed upon by the objector
and the Commissioner or, if an agreement cannot be reached, at a
location designated by the Commissioner. The permit holder shall have
the right to present witnesses on his own behalf and to cross-examine
the Food and Drug Administration's witnesses.
(d) Within 5 working days after the hearing, and based on the
evidence presented at the hearing, the Commissioner shall determine
whether the permit shall be reinstated and shall so inform the permit
holder, with the reasons for his decision.
(e) Denial of an application for reinstatement of a permit
constitutes final agency action from which appeal lies to the courts.
The Commisioner will not stay such denial pending court appeal except in
unusual circumstances, but will participate in expediting any such
appeal.
Sec. 108.12 Manufacturing, processing, or packing without a permit, or in
violation of a permit.
(a) A manufacturer, processor, or packer may continue at his own
risk to manufacture, process, or pack without a permit a food for which
the Commissioner has determined that a permit is required. All food so
manufactured, processed, or packed during such period without a permit
shall be retained by the manufacturer, processor, or packer and may not
be introduced or delivered for introduction into interstate commerce
without the advance written approval of the Food and Drug
Administration. Such approval may be granted only upon an adequate
showing that
[[Page 204]]
such food is free from microorganisms of public health significance. The
manufacturer, processor, or packer may provide to the Commissioner, for
his consideration in making any such determination, an evaluation of the
potential public health significance of such food by a competent
authority in accordance with procedures recognized as being adequate to
detect any potential hazard to public health. Within 20 working days
after receipt of a written request for such written approval the Food
and Drug Administration shall either issue such written approval or deny
the request. If the request is denied, the applicant shall, upon
request, be afforded a prompt hearing conducted in accordance with Sec.
108.5 (b) and (c).
(b) Except as provided in paragraph (a) of this section, no
manufacturer, processor, or packer may introduce or deliver for
introduction into interstate commerce without a permit or in violation
of a permit a food for which the Commissioner has determined that a
permit is required. Where a manufacturer, processor, or packer utilizes
a consolidation warehouse or other storage facility under his control,
interstate shipment of any such food from the point of production to
that warehouse or storage facility shall not violate this paragraph,
provided that no further introduction or delivery for introduction into
interstate commerce is made from that consolidated warehouse or storage
facility except as provided in paragraph (a) of this section.
Sec. 108.19 Establishment of requirements for exemption from section 404 of
the act.
(a) Whenever the Commissioner finds after investigation that the
distribution in interstate commerce of any class of food may, by reason
of contamination with microorganisms during the manufacture, processing,
or packing thereof in any locality, be injurious to health, and that
such injurious nature cannot be adequately determined after such
articles have entered interstate commerce, he shall promulgate
regulations in Subpart B of this part establishing requirements and
conditions governing the manufacture, processing, or packing of the food
necessary to protect the public health. Such regulations may be proposed
by the Commissioner on his own initiative or in response to a petition
from any interested person pursuant to part 10 of this chapter.
(b) A manufacturer, processor, or packer of a food for which a
regulation has been promulgated in subpart B of this part shall be
exempt from the requirement for a permit only if he meets all of the
mandatory requirements and conditions established in that regulation.
[42 FR 14334, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]
Subpart B_Specific Requirements and Conditions for Exemption From or
Compliance With an Emergency Permit
Sec. 108.25 Acidified foods.
(a) Inadequate or improper manufacture, processing, or packing of
acidified foods may result in the distribution in interstate commerce of
processed foods that may be injurious to health. The harmful nature of
such foods cannot be adequately determined after these foods have
entered into interstate commerce. The Commissioner of Food and Drugs
therefore finds that, to protect the public health, it may be necessary
to require any commericial processor, in any establishment engaged in
the manufacture, processing, or packing of acidified foods, to obtain
and hold a temporary emergency permit provided for under section 404 of
the Federal Food, Drug, and Cosmetic Act. Such a permit may be required
whenever the Commissioner finds, after investigation, that the
commercial processor has failed to fulfill all the requirements of this
section, including registration and filing of process information, and
the mandatory portions of Sec. Sec. 114.10, 114.80(a) (1) and (2), and
(b), 114.83, 114.89, and 114.100 (b), (c), and (d) of this chapter as
they relate to acidified foods. These requirements are intended to
ensure safe manufacturing, processing, and packing processes and to
permit the Food and Drug Administration to verify that these processes
are being followed. Failure to meet these requirements shall constitute
a
[[Page 205]]
prima facie basis for the immediate application of the emergency permit
control provisions of section 404 of the act to that establishment,
under the procedures established in subpart A of this part.
(b) The definitions in Sec. 114.3 of this chapter are applicable
when those terms are used in this section.
(c)(1) Registration. A commercial processor, when first engaging in
the manufacture, processing, or packing of acidified foods in any State,
as defined in section 201(a)(1) of the act, shall, not later than 10
days after first so engaging, register and file with the Food and Drug
Administration on Form FDA 2541 (food canning establishment
registration) information including, but not limited to, the name of the
establishment, principal place of business, the location of each
establishment in which that processing is carried on, the processing
method in terms of acidity and pH control, and a list of foods so
processed in each establishment. These forms are available from the LACF
Registration Coordinator (HFS-618), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740, or at any Food and Drug Administration district
office. The completed form shall be submitted to the Center for Food
Safety and Applied Nutrition (HFS-565), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740. Commercial processors
presently so engaged shall register within 120 days after the effective
date of this regulation. Foreign processors shall register within 120
days after the effective date of this regulation or before any offering
of foods for import into the United States, whichever is later.
Commercial processors duly registered under this section shall notify
the Food and Drug Administration not later than 90 days after the
commercial processor ceases or discontinues the manufacture, processing,
or packing of the foods in any establishment, except that this
notification shall not be required for temporary cessations due to the
seasonal character of an establishment's production or by temporary
conditions including, but not limited to, labor disputes, fire, or acts
of God.
(2) Process filing. A commercial processor engaged in the processing
of acidified foods shall, not later than 60 days after registration, and
before packing any new product, provide the Food and Drug Administration
information on the scheduled processes including, as necessary,
conditions for heat processing and control of pH, salt, sugar, and
preservative levels and source and date of the establishment of the
process, for each acidified food in each container size. Filing of this
information does not constitute approval of the information by the Food
and Drug Administration, and information concerning processes and other
data so filed shall be regarded as trade secrets within the meaning of
21 U.S.C. 331(j) and 18 U.S.C. 1905. This information shall be submitted
on form FDA 2541a (food canning establishment process filing form for
all methods except aseptic). Forms are available from the LACF
Registration Coordinator (HFS-618), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740, or at Food and Drug Administration district
office. The completed form shall be submitted to the LACF Registration
Coordinator (HFS-618), Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740.
(3) Process adherence and information--(i) Scheduling. A commercial
processor engaged in processing acidified foods in any registered
establishment shall process each food in conformity with at least the
scheduled processes filed under paragraph (c)(2) of this section.
(ii) Process and pH information availability. When requested by the
Food and Drug Administration in writing, a commercial processor engaged
in the processing of acidified foods shall provide the Food and Drug
Administration with any process and procedure information that the Food
and Drug Administration deems necessary to determine the adequacy of the
process. Furnishing of this information does not constitute approval by
the Food and Drug Administration of the content of the information
filed, and the information concerning processes and other data so
furnished shall be considered
[[Page 206]]
trade secrets within the meaning of 21 U.S.C. 331(j) and 18 U.S.C. 1905
(to the extent that they qualify under those provisions).
(d) A commercial processor engaged in the processing of acidified
foods shall promptly report to the Food and Drug Administration any
instance of spoilage, process deviation, or contamination with
microorganisms, the nature of which has potential health-endangering
significance, where any lot of such food has in whole or in part entered
distribution in commerce.
(e) A commercial processor engaged in the processing of acidified
foods shall prepare and maintain files on a current procedure for use
for products under the processor's control, which that processor will
ask the distributor to follow, including plans for recalling products
that may be injurious to health; for identifying, collecting, ware
housing, and controlling products; for determining the effectiveness of
recalls; for notifying the Food and Drug Administration of any recalls;
and for implementing recall programs.
(f) All plant personnel involved in acidification, pH control, heat
treatment, or other critical factors of the operation shall be under the
operating supervision of a person who has attended a school approved by
the Commissioner for giving instruction in food-handling techniques,
food protection principles, personal hygiene, plant sanitation
practices, pH controls, and critical factors in acidification, and who
has satisfactorily completed the prescribed course of instruction. The
Commissioner will consider students who have satisfactorily completed
the required portions of the courses presented under Sec. 108.35 and
part 113 of this chapter before March 16, 1979, as having satisfactorily
completed the prescribed course of instruction under this section and
part 114 of this chapter. The Commissioner will not withhold approval of
any school qualified to give such instruction.
(g) A commercial processor engaged in the processing of acidified
foods shall prepare, review, and retain at the processing plant or other
reasonably accessible location for a period of 3 years from the date of
manufacture, all records of processing, deviations in processing, pH,
and other records specified in part 114 of this chapter. Upon written
demand during the course of a factory inspection under section 704 of
the act by a duly authorized employee of the Food and Drug
Administration, a commercial processor shall permit the inspection and
copying by that employee of these records to verify the pH and the
adequacy of processing.
(h) This section shall not apply to the commercial processing of any
food processed under the continuous inspection of the meat and poultry
inspection program of the Food Safety and Inspection Service of the
Department of Agriculture under the Federal Meat Inspection Act (34
Stat. 1256, as amended by 81 Stat. 584 (21 U.S.C. 601 et seq.)) and the
Poultry Products Inspection Act (71 Stat. 441, as amended by 82 Stat.
791 (21 U.S.C. 451 et seq.)).
(i) Wherever the Commissioner finds that any State regulates the
commercial processing of acidified foods under effective regulations
specifying at least the requirements of part 114 of this chapter, the
Commissioner shall issue a notice stating that compliance with such
State regulations shall constitute compliance with this section, if the
State through its regulatory agency or each processor of acidified foods
in the State files with the Food and Drug Administration the
registration information and the processing information prescribed in
paragraph (c) of this section.
(j) Imports. (1) This section applies to any foreign commercial
processor engaged in the processing of acidified foods and offering
those foods for import into the United States except that, in lieu of
providing for the issuance of an emergency permit under paragraph (a) of
this section, the Commissioner will request the Secretary of the
Treasury to refuse admission into the United States, under section 801
of the act, to any acidified foods which the Commissioner determines,
after investigation, may result in the distribution in interstate
commerce of processed foods that may be injurious to health as set forth
in paragraph (a) of this section.
(2) Any acidified food so refused admission shall not be admitted
until the Commissioner determines that the
[[Page 207]]
commercial processor offering the food for import has complied with the
requirements of this section and that the food is not injurious to
health. To assist the Commissioner in making this determination, a duly
authorized employee of the Food and Drug Administration shall be
permitted to inspect the commercial processor's manufacturing,
processing, and packing facilities.
(k) The following information submitted to the Food and Drug
Administration under this section is not available for public disclosure
unless it has been previously disclosed to the public as defined in
Sec. 20.81 of this chapter or it relates to a product or ingredient
that has been abandoned and no longer represents a trade secret or
confidential commercial or financial information as defined in Sec.
20.61 of this chapter:
(1) Manufacturing methods or processes, including quality control
information.
(2) Production, sales, distribution, and similar information, except
that any compilation of the information aggregated and prepared in a way
that does not reveal information which is not available for public
disclosure under this provision is available for public disclosure.
(3) Quantitative or semiquantitative formulas.
[44 FR 16207, Mar. 16, 1979, as amended at 54 FR 24891, June 12, 1989;
61 FR 14479, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001]
Sec. 108.35 Thermal processing of low-acid foods packaged in hermetically
sealed containers.
(a) Inadequate or improper manufacture, processing, or packing of
thermally processed low-acid foods in hermetically sealed containers may
result in the distribution in interstate commerce of processed foods
that may be injurious to health. The harmful nature of such foods cannot
be adequately determined after these foods have entered into interstate
commerce. The Commissioner of Food and Drugs therefore finds that, in
order to protect the public health, it may be necessary to require any
commercial processor, in any establishment engaged in the manufacture,
processing, or packing of thermally processed low-acid foods in
hermetically sealed containers, to obtain and hold a temporary emergency
permit provided for under section 404 of the Federal Food, Drug, and
Cosmetic Act. Such a permit may be required whenever the Commissioner
finds, after investigation, that the commercial processor has failed to
fulfill all the requirements of this section, including registration and
the filing of process information, and the mandatory portions of part
113 of this chapter. These requirements are intended to ensure safe
manufacture, processing, and packing procedures and to permit the Food
and Drug Administration to verify that these procedures are being
followed. Such failure shall constitute a prima facie basis for the
immediate application of the emergency permit control provisions of
section 404 of the act to that establishment, pursuant to the procedures
established in subpart A of this part.
(b) The definitions in Sec. 113.3 of this chapter are applicable
when such terms are used in this section.
(c) Registration and process filing--(1) Registration. A commercial
processor when first engaging in the manufacture, processing, or packing
of thermally processed low-acid foods in hermetically sealed containers
in any state, as defined in section 201(a)(1) of the act, shall, not
later than 10 days after first so engaging, register with the Food and
Drug Administration on Form FDA 2541 (food canning establishment
registration) information including (but not limited to) his name,
principal place of business, the location of each establishment in which
such processing is carried on, the processing method in terms of the
type of processing equipment employed, and a list of the low-acid foods
so processed in each such establishment. These forms are available from
the LACF Registration Coordinator (HFS-618), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or at any Food and Drug Administration
district office. The completed form shall be submitted to the LACF
Registration Coordinator (HFS-618), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park,
[[Page 208]]
MD 20740. Commercial processors presently so engaged shall register not
later than July 13, 1973. Commercial processors duly registered in
accordance with this section shall notify the Food and Drug
Administration not later than 90 days after such commercial processor
ceases or discontinues the manufacture, processing, or packing of
thermally processed foods in any establishment: Provided, That such
notification shall not be required as to the temporary cessation
necessitated by the seasonal character of the particular establishment's
production or caused by temporary conditions including but not limited
to strikes, lockouts, fire, or acts of God.
(2) Process filing. A commercial processor engaged in the thermal
processing of low-acid foods packaged in hermetically sealed containers
shall, not later than 60 days after registration and prior to the
packing of a new product, provide the Food and Drug Administration
information as to the scheduled processes including but not limited to
the processing method, type of retort or other thermal processing
equipment employed, minimum initial temperatures, times and temperatures
of processing, sterilizing value (Fo), or other equivalent scientific
evidence of process adequacy, critical control factors affecting heat
penetration, and source and date of the establishment of the process,
for each such low-acid food in each container size: Provided, That the
filing of such information does not constitute approval of the
information by the Food and Drug Administration, and that information
concerning processes and other data so filed shall be regarded as trade
secrets within the meaning of 21 U.S.C. 331(j) and 18 U.S.C. 1905. This
information shall be submitted on the following forms as appropriate:
Form FDA 2541a (food canning establishment process filing for all
methods except aseptic), or Form FDA 2541c (food canning establishment
process filing for aseptic systems). These forms are available from the
LACF Registration Coordinator (HFS-618), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or at any Food and Drug Administration
district office. The completed form(s) shall be submitted to the LACF
Registration Coordinator (HFS-618), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740.
(i) If all the necessary information is not available for existing
products, the processor shall, at the time the existing information is
provided to the Food and Drug Administration request in writing an
extension of time for submission of such information, specifying what
additional information is to be supplied and the date by which it is to
be submitted. Within 30 working days after receipt of such request the
Food and Drug Administration shall either grant or deny such request in
writing.
(ii) If a packer intentionally makes a change in a previously filed
scheduled process by reducing the initial temperature or retort
temperature, reducing the time of processing, or changing the product
formulation, the container, or any other condition basic to the adequacy
of scheduled process, he shall prior to using such changed process
obtain substantiation by qualified scientific authority as to its
adequacy. Such substantiation may be obtained by telephone, telegram, or
other media, but must be promptly recorded, verified in writing by the
authority, and contained in the packer's files for review by the Food
and Drug Administration. Within 30 days after first use, the packer
shall submit to the Center for Food Safety and Applied Nutrition (HFS-
617), Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740 a complete description of the modifications made and
utilized, together with a copy of his file record showing prior
substantiation by a qualified scientific authority as to the safety of
the changed process. Any intentional change of a previously filed
scheduled process or modification thereof in which the change consists
solely of a higher initial temperature, a higher retort temperature, or
a longer processing time, shall not be considered a change subject to
this paragraph, but if that modification is thereafter to be regularly
scheduled, the modified process shall be promptly
[[Page 209]]
filed as a scheduled process, accompanied by full information on the
specified forms as provided in this paragraph.
(iii) Many packers employ an ``operating'' process in which retort
operators are instructed to use retort temperatures and/or processing
times slightly in excess of those specified in the scheduled process as
a safety factor to compensate for minor fluctuations in temperature or
time to assure that the minimum times and temperatures in the scheduled
process are always met. This would not constitute a modification of the
scheduled process.
(3) Process adherence and information. (i) A commercial processor
engaged in the thermal processing of low-acid foods packaged in
hermetically sealed containers in any registered establishment shall
process each low-acid food in each container size in conformity with at
least the scheduled processes and modifications filed pursuant to
paragraph (c)(2) of this section.
(ii) Process information availability: When requested by the Food
and Drug Administration in writing, a commercial processor engaged in
thermal processing of low-acid foods packaged in hermetically sealed
containers shall provide the Food and Drug Administration with any
information concerning processes and procedures which is deemed
necessary by the Food and Drug Administration to determine the adequacy
of the process: Provided, That the furnishing of such information does
not constitute approval of the information by the Food and Drug
Administration, and that the information concerning processes and other
data so furnished shall be regarded as trade secrets within the meaning
of 21 U.S.C. 331(j) and 18 U.S.C. 1905.
(d) A commercial processor engaged in the thermal processing of low-
acid foods packaged in hermetically sealed containers shall promptly
report to the Food and Drug Administration any instance of spoilage or
process deviation the nature of which indicates potential health
significance where any lot of such food has in whole or in part entered
distribution.
(e) A commercial processor engaged in thermal processing of low-acid
foods packaged in hermetically sealed containers shall promptly report
to the Food and Drug Administration any instance wherein any lot of such
food, which may be injurious to health by reason of contamination with
microorganisms, has in whole or in part entered distribution.
(f) A commercial processor engaged in the thermal processing of low-
acid foods packaged in hermetically sealed containers shall have
prepared and in his files a current procedure which he will use for
products under his control and which he will ask his distributor to
follow, including plans for effecting recalls of any product that may be
injurious to health; for identifying, collecting, warehousing, and
controlling the product; for determining the effectiveness of such
recall; for notifying the Food and Drug Administration of any such
recall; and for implementing such recall program.
(g) All operators of retorts, thermal processing systems, aseptic
processing and packaging systems, or other thermal processing systems,
and container closure inspectors shall be under the operating
supervision of a person who has attended a school approved by the
Commissioner for giving instruction in retort operations, aseptic
processing and packaging systems operations or other thermal processing
systems operations, and container closure inspections, and has
satisfactorily completed the prescribed course of instruction: Provided,
That this requirement shall not apply in the State of California as
listed in paragraph (j) of this section. The Commissioner will not
withhold approval of any school qualified to give such instruction.
(h) A commercial processor engaged in the thermal processing of low-
acid foods packaged in hermetically sealed containers shall prepare,
review, and retain at the processing plant for a period of not less than
one year, and at the processing plant or other reasonably accessible
location for an additional two years, all records of processing,
deviations in processing, container closure inspections, and other
records specified in part 113 of this chapter. If during the first year
of the three-year record retention period the processing plant is closed
for a prolonged period between seasonal packs,
[[Page 210]]
the records may be transferred to some other reasonably accessible
location at the end of the seasonal pack. Upon written demand during the
course of a factory inspection pursuant to section 704 of the act by a
duly authorized employee of the Food and Drug Administration, a
commercial processor shall permit the inspection and copying by such
employee of these records to verify the adequacy of processing, the
integrity of container closures, and the coding of the products.
(i) This section shall not apply to the commercial processing of any
food processed under the continuous inspection of the meat and poultry
inspection program of the Animal and Plant Health Inspection Service of
the Department of Agriculture under the Federal Meat Inspection Act (34
Stat. 1256, as amended by 81 Stat. 584 (21 U.S.C. 601 et seq.)) and the
Poultry Products Inspection Act (71 Stat. 441, as amended by 82 Stat.
791 (21 U.S.C. 451 et seq.)).
(j) Compliance with State regulations. (1) Wherever the Commissioner
finds that any State regulates the commercial thermal processing of low-
acid foods in accordance with effective regulations specifying at least
the requirements of part 113 of this chapter, he shall issue a notice
stating that compliance with such State regulations shall constitute
compliance with part 113 of this chapter. However, the provisions of
this section shall remain applicable to the commercial processing of
low-acid foods in any such State, except that, either the State through
its regulatory agency or each processor of low-acid foods in such State
shall file with the Center for Food Safety and Applied Nutrition the
registration information and the processing information prescribed in
paragraph (c) of this section.
(2) The Commissioner finds that the regulations adopted by the State
of California under the laws relating to cannery inspections governing
thermal processing of low-acid foods packaged in hermetically sealed
containers satisfy the requirements of part 113 of this chapter.
Accordingly, processors, who under the laws relating to cannery
inspections are licensed by the State of California and who comply with
such state regulations, shall be deemed to comply with the requirements
of part 113 of this chapter.
(k) Imports. (1) This section shall apply to any foreign commercial
processor engaged in the thermal processing of low-acid foods packaged
in hermetically sealed containers and offering such foods for import
into the United States except that, in lieu of providing for the
issuance of an emergency permit under paragraph (a) of this section, the
Commissioner will request the Secretary of the Treasury to refuse
admission into the United States, pursuant to section 801 of the act, of
any such low-acid foods which the Commissioner determines, after
investigation, may result in the distribution in interstate commerce of
processed foods that may be injurious to health as set forth in
paragraph (a) of this section.
(2) Any such food refused admission shall not be admitted until such
time as the Commissioner may determine that the commercial processor
offering the food for import is in compliance with the requirements and
conditions of this section and that such food is not injurious to
health. For the purpose of making such determination, the Commissioner
reserves the right for a duly authorized employee of the Food and Drug
Administration to inspect the commercial processor's manufacturing,
processing, and packing facilities.
(l) The following data and information submitted to the Food and
Drug Administration pursuant to this section are not available for
public disclosure unless they have been previously disclosed to the
public as defined in Sec. 20.81 of this chapter or they relate to a
product or ingredient that has been abandoned and they no longer
represent a trade secret or confidential commercial or financial
information as defined in Sec. 20.81 of this chapter:
(1) Manufacturing methods or processes, including quality control
information.
(2) Production, sales, distribution, and similar data and
information, except that any compilation of such data and information
aggregated and prepared in a way that does not reveal data or
information which is not available for public disclosure under this
[[Page 211]]
provision is available for public disclosure.
(3) Quantitative or semiquantitative formulas.
[42 FR 14334, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977;
54 FR 24891, June 12, 1989; 61 FR 14480, Apr. 2, 1996; 66 FR 56035, Nov.
6, 2001]
PART 109_UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-
PACKAGING MATERIAL--Table of Contents
Subpart A_General Provisions
Sec.
109.3 Definitions and interpretations.
109.4 Establishment of tolerances, regulatory limits, and action levels.
109.6 Added poisonous or deleterious substances.
109.7 Unavoidability.
109.15 Use of polychlorinated biphenyls (PCB's) in establishments
manufacturing food-packaging materials.
109.16 Ornamental and decorative ceramicware.
Subpart B_Tolerances for Unavoidable Poisonous or Deleterious Substances
109.30 Tolerances for polychlorinated biphenyls (PCB's).
Subpart C--Regulatory Limits for Added Poisonous or Deleterious Substances
[Reserved]
Subpart D--Naturally Occurring Poisonous or Deleterious Substances
[Reserved]
Authority: 21 U.S.C. 321, 336, 342, 346, 346a, 348, 371.
Source: 42 FR 52819, Sept. 30, 1977, unless otherwise noted.
Subpart A_General Provisions
Sec. 109.3 Definitions and interpretations.
(a) Act means the Federal Food, Drug, and Cosmetic Act.
(b) The definitions of terms contained in section 201 of the act are
applicable to such terms when used in this part unless modified in this
section.
(c) A naturally occurring poisonous or deleterious substance is a
poisonous or deleterious substance that is an inherent natural
constituent of a food and is not the result of environmental,
agricultural, industrial, or other contamination.
(d) An added poisonous or deleterious substance is a poisonous or
deleterious substance that is not a naturally occurring poisonous or
deleterious substance. When a naturally occurring poisonous or
deleterious substance is increased to abnormal levels through
mishandling or other intervening acts, it is an added poisonous or
deleterious substance to the extent of such increase.
(e) Food includes human food and substances migrating to food from
food-contact articles.
Sec. 109.4 Establishment of tolerances, regulatory limits, and action levels.
(a) When appropriate under the criteria of Sec. 109.6, a tolerance
for an added poisonous or deleterious substance, which may be a food
additive, may be established by regulation in subpart B of this part
under the provisions of section 406 of the act. A tolerance may prohibit
any detectable amount of the substance in food.
(b) When appropriate under the criteria of Sec. 109.6, and under
section 402(a)(1) of the act, a regulatory limit for an added poisonous
or deleterious substance, which may be a food additive, may be
established by regulation in subpart C of this part under the provisions
of sections 402(a)(1) and 701(a) of the act. A regulatory limit may
prohibit any detectable amount of the substance in food. The regulatory
limit established represents the level at which food is adulterated
within the meaning of section 402(a)(1) of the act.
(c)(1) When appropriate under the criteria of Sec. 109.6, an action
level for an added poisonous or deleterious substance, which may be a
food additive, may be established to define a level of contamination at
which a food may be regarded as adulterated.
(2) Whenever an action level is established or changed, a notice
shall be published in the Federal Register as soon as practicable
thereafter. The notice shall call attention to the material supporting
the action level which shall be on file with the Division of Dockets
Management before the notice
[[Page 212]]
is published. The notice shall invite public comment on the action
level.
(d) A regulation may be established in subpart D of this part to
identify a food containing a naturally occurring poisonous or
deleterious substance which will be deemed to be adulterated under
section 402(a)(1) of the act. These regulations do not constitute a
complete list of such foods.
[42 FR 52819, Sept. 30, 1977, as amended at 55 FR 20785, May 21, 1990]
Sec. 109.6 Added poisonous or deleterious substances.
(a) Use of an added poisonous or deleterious substance, other than a
pesticide chemical, that is also a food additive, will be controlled by
a regulation issued under section 409 of the act when possible. When
such a use cannot be approved under the criteria of section 409 of the
act, or when the added poisonous or deleterious substance is not a food
additive, a tolerance, regulatory limit, or action level may be
established pursuant to the criteria in paragraphs (b), (c), or (d) of
this section. Residues resulting from the use of an added poisonous or
deleterious substance that is also a pesticide chemical will ordinarily
be controlled by a tolerance established in a regulation issued under
sections 406, 408, or 409 of the act by the U.S. Environmental
Protection Agency (EPA). When such a regulation has not been issued, an
action level for an added poisonous or deleterious substance that is
also a pesticide chemical may be established by the Food and Drug
Administration. The Food and Drug Administration will request EPA to
recommend such an action level pursuant to the criteria established in
paragraph (d) of this section.
(b) A tolerance for an added poisonous or deleterious substance in
any food may be established when the following criteria are met:
(1) The substance cannot be avoided by good manufacturing practice.
(2) The tolerance established is sufficient for the protection of
the public health, taking into account the extent to which the presence
of the substance cannot be avoided and the other ways in which the
consumer may be affected by the same or related poisonous or deleterious
substances.
(3) No technological or other changes are foreseeable in the near
future that might affect the appropriateness of the tolerance
established. Examples of changes that might affect the appropriateness
of the tolerance include anticipated improvements in good manufacturing
practice that would change the extent to which use of the substance is
unavoidable and anticipated studies expected to provide significant new
toxicological or use data.
(c) A regulatory limit for an added poisonous or deleterious
substance in any food may be established when each of the following
criteria is met:
(1) The substance cannot be avoided by current good manufacturing
practices.
(2) There is no tolerance established for the substance in the
particular food under sections 406, 408, or 409 of the act.
(3) There is insufficient information by which a tolerance may be
established for the substance under section 406 of the act or
technological changes appear reasonably possible that may affect the
appropriateness of a tolerance. The regulatory limit established
represents the level at which food is adulterated within the meaning of
section 402(a)(1) of the act.
(d) An action level for an added poisonous or deleterious substance
in any food may be established when the criteria in paragraph (b) of
this section are met, except that technological or other changes that
might affect the appropriateness of the tolerance are foreseeable in the
near future. An action level for an added poisonous or deleterious
substance in any food may be established at a level at which the Food
and Drug Administration may regard the food as adulterated within the
meaning of section 402(a)(1) of the act, without regard to the criteria
in paragraph (b) of this section or in section 406 of the act. An action
level will be withdrawn when a tolerance or regulatory limit for the
same substance and use has been established.
(e) Tolerances will be established under authority appropriate for
action levels (sections 306, 402(a), and 701(a) of the act, together
with section 408 or 409 of the act, if appropriate) as well as under
authority appropriate for tolerances (sections 406 and 701 of the act).
[[Page 213]]
In the event the effectiveness of a tolerance is stayed pursuant to
section 701(e)(2) of the act by the filing of an objection, the order
establishing the tolerance shall be deemed to be an order establishing
an action level until final action is taken upon such objection.
[42 FR 52819, Sept. 30, 1977, as amended at 55 FR 20785, May 21, 1990]
Sec. 109.7 Unavoidability.
(a) Tolerances and action levels in this part are established at
levels based on the unavoidability of the poisonous or deleterious
substance concerned and do not establish a permissible level of
contamination where it is avoidable.
(b) Compliance with tolerances, regulatory limits, and action levels
does not excuse failure to observe either the requirement in section
402(a)(4) of the act that food may not be prepared, packed, or held
under insanitary conditions or the other requirements in this chapter
that food manufacturers must observe current good manufacturing
practices. Evidence obtained through factory inspection or otherwise
indicating such a violation renders the food unlawful, even though the
amounts of poisonous or deleterious substances are lower than the
currently established tolerances, regulatory limits, or action levels.
The manufacturer of food must at all times utilize quality control
procedures which will reduce contamination to the lowest level currently
feasible.
[42 FR 52819, Sept. 30, 1977, as amended at 55 FR 20785, May 21, 1990]
Sec. 109.15 Use of polychlorinated biphenyls (PCB's) in establishments
manufacturing food-packaging materials.
(a) Polychlorinated biphenyls (PCB's) represent a class of toxic
industrial chemicals manufactured and sold under a variety of trade
names, including: Aroclor (United States); Phenoclor (France); Colphen
(Germany); and Kanaclor (Japan). PCB's are highly stable, heat
resistant, and nonflammable chemicals. Industrial uses of PCB's include,
or did include in the past, their use as electrical transformer and
capacitor fluids, heat transfer fluids, hydraulic fluids, and
plasticizers, and in formulations of lubricants, coatings, and inks.
Their unique physical and chemical properties and widespread,
uncontrolled industrial applications have caused PCB's to be a
persistent and ubiquitous contaminant in the environment, causing the
contamination of certain foods. In addition, incidents have occurred in
which PCB's have directly contaminated animal feeds as a result of
industrial accidents (leakage or spillage of PCB fluids from plant
equipment). These accidents in turn caused the contamination of food
products intended for human consumption (meat, milk and eggs).
Investigations by the Food and Drug Administration have revealed that a
significant percentage of paper food-packaging material contains PCB's
which can migrate to the packaged food. The origin of PCB's in such
material is not fully understood. Reclaimed fibers containing carbonless
copy paper (contains 3 to 5 percent PCB's) have been identified as a
primary source of PCB's in paper products. Some virgin paper products
have also been found to contain PCB's, the source of which is generally
attributed to direct contamination from industrial accidents from the
use of PCB-containing equipment and machinery in food packaging
manufacturing establishments. Since PCB's are toxic chemicals, the PCB
contamination of food-packaging materials as a result of industrial
accidents, which can cause the PCB contamination of food, represents a
hazard to public health. It is therefore necessary to place certain
restrictions on the industrial uses of PCB's in establishments
manufacturing food-packaging materials.
(b) The following special provisions are necessary to preclude the
accidental PCB contamination of food-packaging materials:
(1) New equipment or machinery for manufacturing food-packaging
materials shall not contain or use PCB's.
(2) On or before September 4, 1973, the management of establishments
manufacturing food-packaging materials shall:
(i) Have the heat exchange fluid used in existing equipment for
manufacturing food-packaging materials sampled and tested to determine
whether it contains PCB's or verify the absence of
[[Page 214]]
PCB's in such formulations by other appropriate means. On or before
Sept. 4, 1973, any such fluid formulated with PCB's must to the fullest
extent possible commensurate with current good manufacturing practices
be replaced with a heat exchange fluid that does not contain PCB's.
(ii) Eliminate to the fullest extent possible commensurate with
current good manufacturing practices from the establishment any other
PCB-containing equipment, machinery and materials wherever there is a
reasonable expectation that such articles could cause food-packaging
materials to become contaminated with PCB's either as a result of normal
use or as a result of accident, breakage, or other mishap.
(iii) The toxicity and other characteristics of fluids selected as
PCB replacements must be adequately determined so that the least
potentially hazardous replacement is used. In making this determination
with respect to a given fluid, consideration should be given to (a) its
toxicity; (b) the maximum quantity that could be spilled onto a given
quantity of food before it would be noticed, taking into account its
color and odor; (c) possible signaling devices in the equipment to
indicate a loss of fluid, etc.; and (d) its environmental stability and
tendency to survive and be concentrated through the food chain. The
judgment as to whether a replacement fluid is sufficiently non-hazardous
is to be made on an individual installation and operation basis.
(c) The provisions of this section do not apply to electrical
transformers and condensers containing PCB's in sealed containers.
Sec. 109.16 Ornamental and decorative ceramicware.
(a) Lead is a toxic metal that is used as a component of glazes and
decorative decals on ceramics, including some ornamental and decorative
ceramicware. The use of ornamental or decorative ceramicware to prepare,
serve, or hold food may result in the leaching of lead from the glaze or
decoration into the food. The provisions of paragraph (b) of this
section are necessary to ensure that ornamental or decorative
ceramicware bear adequate indications that they are not to be used for
food-handling purposes.
(b) Ornamental or decorative ceramicware initially introduced or
initially delivered for introduction into interstate commerce on or
after July 13, 1994 appears to be suitable for food use will be
considered to be for food use unless:
(1) It bears:
(i) A conspicuous stick-on label on a surface clearly visible to
consumers that states in legible script in letters at least 3.2
millimeters (0.125 inch) in height one of the following messages: ``Not
for Food Use. May Poison Food,'' ``Not for Food Use. Glaze contains
lead. Food Use May Result in Lead Poisoning,'' and ``Not for Food Use--
Food Consumed from this Vessel May be Harmful,'' and
(ii) A conspicuous and legible permanent statement of the message
selected from paragraph (b)(1)(i) of this section molded or fired onto
the exterior surface of the base or, when the ceramicware is not fired
after decoration, permanently painted onto the exterior surface of the
base. This permanent statement shall be in letters at least 3.2
millimeters (0.125 inch) in height, except that if insufficient space
exists for the permanent statement in letters of such height, the
statement shall be in the largest letters that will allow it to fit on
the base of the piece, provided that the letters are at least 1.6
millimeters (0.062 inch) in height; or
(2) A hole is bored through the potential food-contact surface.
(c) In addition to steps required under paragraphs (b)(1) and (b)(2)
of this section, the following optional information may be provided on
the ware:
(1) A further explanatory statement concerning the decorative nature
of the piece, such as ``Decorative'' or ``For Decorative Purposes
Only,'' may be used; however, such additional statement shall be placed
after the required statement.
(2) A symbol may be used to advise that a piece of ornamental or
decorative ceramicware is not to be used with food, as illustrated
below.
[[Page 215]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.368
The circle of the above symbol should be at least 2.54 centimeters (1
inch) in diameter. The symbol may be used on the temporary label or
applied to the base of the piece in the same manner as the permanent
statement.
[59 FR 1641, Jan. 12, 1994]
Subpart B_Tolerances for Unavoidable Poisonous or Deleterious Substances
Sec. 109.30 Tolerances for polychlorinated biphenyls (PCB's).
(a) Polychlorinated biphenyls (PCB's) are toxic, industrial
chemicals. Because of their widespread, uncontrolled industrial
applications, PCB's have become a persistent and ubiquitous contaminant
in the environment. As a result, certain foods and animal feeds,
principally those of animal and marine origin, contain PCB's as
unavoidable, environmental contaminants. PCB's are transmitted to the
food portion (meat, milk, and eggs) of food-producing animals ingesting
PCB-contaminated animal feed. In addition, a significant percentage of
paper food-packaging materials contain PCB's which may migrate to the
packaged food. The source of PCB's in paper food-packaging materials is
primarily of certain types of carbonless copy paper (containing 3 to 5
percent PCB's) in waste paper stocks used for manufacturing recycled
paper. Therefore, temporary tolerances for residues of PCB's as
unavoidable environmental or industrial contaminants are established for
a sufficient period of time following the effective date of this
paragraph to permit the elimination of such contaminants at the earliest
practicable time. For the purposes of this paragraph, the term
``polychlorinated biphenyls (PCB's)'' is applicable to mixtures of
chlorinated biphenyl compounds, irrespective of which mixture of PCB's
is present as the residue. The temporary tolerances for residues of
PCB's are as follows:
(1) 1.5 parts per million in milk (fat basis).
(2) 1.5 parts per million in manufactured dairy products (fat
basis).
(3) 3 parts per million in poultry (fat basis).
(4) 0.3 parts per million in eggs.
(5) 0.2 parts per million in finished animal feed for food-producing
animals (except the following finished animal feeds: feed concentrates,
feed supplements, and feed premixes).
(6) 2 parts per million in animal feed components of animal origin,
including fishmeal and other by-products of marine origin and in
finished animal feed concentrates, supplements, and premixes intended
for food producing animals.
(7) 2 parts per million in fish and shellfish (edible portion). The
edible portion of fish excludes head, scales, viscera, and inedible
bones.
(8) 0.2 parts per million in infant and junior foods.
(9) 10 parts per million in paper food-packaging material intended
for or used with human food, finished animal feed and any components
intended for animal feeds. The tolerance shall not apply to paper food-
packaging material separated from the food therein by a functional
barrier which is impermeable to migration of PCB's.
(b) A compilation entitled ``Analytical Methodology for
Polychlorinated Biphenyls, June 1979'' for determining compliance with
the tolerances established in this section is available from the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
(c) A barrier is functional for purposes of paragraph (a)(9) of this
section if the barrier limits migration of PCB's from the packaging
material to food to a level not exceeding the migration which occurs
under the same test conditions from packaging material containing 10
parts per million PCB without the use of a barrier. A class of barrier
material is functional for purposes of paragraph (a)(9) of this section
if a
[[Page 216]]
representative barrier of the class limits migration of PCB's from the
packaging material to food to a level not exceeding the migration which
occurs under the same test conditions from packaging material containing
10 parts per million PCB without the use of a barrier. Migration levels
shall be determined for purpose of this paragraph solely by use of
testing conditions described in ``Test Procedures for Determination of
PCB Permeability of Food Packaging, Inner-Wraps, September 1976, revised
May 1983'', which is incorporated by reference. Copies are available
from the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or
available for inspection at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html. A
class of barrier material shall be deemed functional only if the
definition of the class and the designation of one or more
representative barriers has been approved by the Director, Center for
Food Safety and Applied Nutrition, Food and Drug Administration. In the
event that the Director, Center for Food Safety and Applied Nutrition,
does not approve a proposal made to the Center regarding the definition
of a class of barrier material or the designation of representative
barriers, the Director shall advise the person making the proposal of
the reasons for the Center's disapproval within 90 days of receipt of
the proposal. All proposals for definition of classes and determinations
of the Food and Drug Administration regarding such proposals shall be on
file with the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
(d) Any person who asserts that a barrier or class of barriers is
functional shall submit the results of tests conducted to determine the
functionality of the barrier or class of barriers to Center for Food
Safety and Applied Nutrition (HFS-308), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740. All barriers or classes
of barriers shall be tested with the four solid food receptors specified
in ``Test Procedures for Determination of PCB Permeability of Food
Packaging, Inner-Wraps, September 1976, revised May 1983'', which is
incorporated by reference. The availability of this reference is given
in paragraph (c) of this section. The test results as to each barrier
shall be accompanied by (1) a description of the barrier's composition
adequate to enable identification; and (2) a specific definition of the
barrier by relevant technical characteristics. The Center for Food
Safety and Applied Nutrition shall review submitted test results
promptly. Within 60 days of the receipt of test results, the Director,
Center for Food Safety and Applied Nutrition, shall notify the person
submitting the test results whether the tests were conducted in
accordance with the ``Analytical Methodology for Polychlorinated
Biphenyls; June 1979'', which is incorporated by reference, or the
``Test Procedures for Determination of PCB Permeability of Food
Packaging, Inner-Wraps, September 1976, revised May 1983'' and whether,
therefore, the barrier or class of barriers is deemed functional within
the meaning of paragraph (c) of this section. The test results and any
response of the Food and Drug Administration shall be placed on file
with the Division of Dockets Management, Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
[42 FR 52819, Sept. 30, 1977, as amended at 44 FR 38340, June 29, 1979;
46 FR 8459, Jan. 27, 1981; 48 FR 10811, Mar. 15, 1983; 48 FR 37021, Aug.
16, 1983; 54 FR 24892, June 12, 1989; 59 FR 14364, Mar. 28, 1994; 61 FR
14480, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001]
Effective Date Note: At 38 FR 22794, Aug. 24, 1973, the following
appeared concerning Sec. 109.30(a)(9) (formerly 122.10(a)(9)):
* * * Sec. 109.30(a)(9) is hereby stayed pending full review of the
objections and requests for hearing. * * *
In the interim, as stated in the final order (38 FR 18098) the Food
and Drug Administration will enforce the temporary tolerance level
established by Sec. 109.30(a)(9) by seizing any paper food-packaging
material shipped in interstate commerce after September 4, 1973
containing higher than the specified
[[Page 217]]
level of PCB's as adulterated in violation of sec. 402 of the act.
Subpart C--Regulatory Limits for Added Poisonous or Deleterious Substances
[Reserved]
Subpart D--Naturally Occurring Posionous or Deleterious Substances
[Reserved]
PART 110_CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR
HOLDING HUMAN FOOD--Table of Contents
Subpart A_General Provisions
Sec.
110.3 Definitions.
110.5 Current good manufacturing practice.
110.10 Personnel.
110.19 Exclusions.
Subpart B_Buildings and Facilities
110.20 Plant and grounds.
110.35 Sanitary operations.
110.37 Sanitary facilities and controls.
Subpart C_Equipment
110.40 Equipment and utensils.
Subpart D [Reserved]
Subpart E_Production and Process Controls
110.80 Processes and controls.
110.93 Warehousing and distribution.
Subpart F [Reserved]
Subpart G_Defect Action Levels
110.110 Natural or unavoidable defects in food for human use that
present no health hazard.
Authority: 21 U.S.C. 342, 371, 374; 42 U.S.C. 264.
Source: 51 FR 24475, June 19, 1986, unless otherwise noted.
Subpart A_General Provisions
Sec. 110.3 Definitions.
The definitions and interpretations of terms in section 201 of the
Federal Food, Drug, and Cosmetic Act (the act) are applicable to such
terms when used in this part. The following definitions shall also
apply:
(a) Acid foods or acidified foods means foods that have an
equilibrium pH of 4.6 or below.
(b) Adequate means that which is needed to accomplish the intended
purpose in keeping with good public health practice.
(c) Batter means a semifluid substance, usually composed of flour
and other ingredients, into which principal components of food are
dipped or with which they are coated, or which may be used directly to
form bakery foods.
(d) Blanching, except for tree nuts and peanuts, means a
prepackaging heat treatment of foodstuffs for a sufficient time and at a
sufficient temperature to partially or completely inactivate the
naturally occurring enzymes and to effect other physical or biochemical
changes in the food.
(e) Critical control point means a point in a food process where
there is a high probability that improper control may cause, allow, or
contribute to a hazard or to filth in the final food or decomposition of
the final food.
(f) Food means food as defined in section 201(f) of the act and
includes raw materials and ingredients.
(g) Food-contact surfaces are those surfaces that contact human food
and those surfaces from which drainage onto the food or onto surfaces
that contact the food ordinarily occurs during the normal course of
operations. ``Food-contact surfaces'' includes utensils and food-contact
surfaces of equipment.
(h) Lot means the food produced during a period of time indicated by
a specific code.
(i) Microorganisms means yeasts, molds, bacteria, and viruses and
includes, but is not limited to, species having public health
significance. The term ``undesirable microorganisms'' includes those
microorganisms that are of public health significance, that subject food
to decomposition, that indicate that food is contaminated with filth, or
that otherwise may cause food to be adulterated within the meaning of
the act. Occasionally in these regulations, FDA used the adjective
``microbial'' instead of using an adjectival
[[Page 218]]
phrase containing the word microorganism.
(j) Pest refers to any objectionable animals or insects including,
but not limited to, birds, rodents, flies, and larvae.
(k) Plant means the building or facility or parts thereof, used for
or in connection with the manufacturing, packaging, labeling, or holding
of human food.
(l) Quality control operation means a planned and systematic
procedure for taking all actions necessary to prevent food from being
adulterated within the meaning of the act.
(m) Rework means clean, unadulterated food that has been removed
from processing for reasons other than insanitary conditions or that has
been successfully reconditioned by reprocessing and that is suitable for
use as food.
(n) Safe-moisture level is a level of moisture low enough to prevent
the growth of undesirable microorganisms in the finished product under
the intended conditions of manufacturing, storage, and distribution. The
maximum safe moisture level for a food is based on its water activity
(aw). An aw will be considered safe for a food if
adequate data are available that demonstrate that the food at or below
the given aw will not support the growth of undesirable
microorganisms.
(o) Sanitize means to adequately treat food-contact surfaces by a
process that is effective in destroying vegetative cells of
microorganisms of public health significance, and in substantially
reducing numbers of other undesirable microorganisms, but without
adversely affecting the product or its safety for the consumer.
(p) Shall is used to state mandatory requirements.
(q) Should is used to state recommended or advisory procedures or
identify recommended equipment.
(r) Water activity (aw) is a measure of the free moisture
in a food and is the quotient of the water vapor pressure of the
substance divided by the vapor pressure of pure water at the same
temperature.
Sec. 110.5 Current good manufacturing practice.
(a) The criteria and definitions in this part shall apply in
determining whether a food is adulterated (1) within the meaning of
section 402(a)(3) of the act in that the food has been manufactured
under such conditions that it is unfit for food; or (2) within the
meaning of section 402(a)(4) of the act in that the food has been
prepared, packed, or held under insanitary conditions whereby it may
have become contaminated with filth, or whereby it may have been
rendered injurious to health. The criteria and definitions in this part
also apply in determining whether a food is in violation of section 361
of the Public Health Service Act (42 U.S.C. 264).
(b) Food covered by specific current good manufacturing practice
regulations also is subject to the requirements of those regulations.
Sec. 110.10 Personnel.
The plant management shall take all reasonable measures and
precautions to ensure the following:
(a) Disease control. Any person who, by medical examination or
supervisory observation, is shown to have, or appears to have, an
illness, open lesion, including boils, sores, or infected wounds, or any
other abnormal source of microbial contamination by which there is a
reasonable possibility of food, food-contact surfaces, or food-packaging
materials becoming contaminated, shall be excluded from any operations
which may be expected to result in such contamination until the
condition is corrected. Personnel shall be instructed to report such
health conditions to their supervisors.
(b) Cleanliness. All persons working in direct contact with food,
food-contact surfaces, and food-packaging materials shall conform to
hygienic practices while on duty to the extent necessary to protect
against contamination of food. The methods for maintaining cleanliness
include, but are not limited to:
(1) Wearing outer garments suitable to the operation in a manner
that protects against the contamination of food, food-contact surfaces,
or food-packaging materials.
[[Page 219]]
(2) Maintaining adequate personal cleanliness.
(3) Washing hands thoroughly (and sanitizing if necessary to protect
against contamination with undesirable microorganisms) in an adequate
hand-washing facility before starting work, after each absence from the
work station, and at any other time when the hands may have become
soiled or contaminated.
(4) Removing all unsecured jewelry and other objects that might fall
into food, equipment, or containers, and removing hand jewelry that
cannot be adequately sanitized during periods in which food is
manipulated by hand. If such hand jewelry cannot be removed, it may be
covered by material which can be maintained in an intact, clean, and
sanitary condition and which effectively protects against the
contamination by these objects of the food, food-contact surfaces, or
food-packaging materials.
(5) Maintaining gloves, if they are used in food handling, in an
intact, clean, and sanitary condition. The gloves should be of an
impermeable material.
(6) Wearing, where appropriate, in an effective manner, hair nets,
headbands, caps, beard covers, or other effective hair restraints.
(7) Storing clothing or other personal belongings in areas other
than where food is exposed or where equipment or utensils are washed.
(8) Confining the following to areas other than where food may be
exposed or where equipment or utensils are washed: eating food, chewing
gum, drinking beverages, or using tobacco.
(9) Taking any other necessary precautions to protect against
contamination of food, food-contact surfaces, or food-packaging
materials with microorganisms or foreign substances including, but not
limited to, perspiration, hair, cosmetics, tobacco, chemicals, and
medicines applied to the skin.
(c) Education and training. Personnel responsible for identifying
sanitation failures or food contamination should have a background of
education or experience, or a combination thereof, to provide a level of
competency necessary for production of clean and safe food. Food
handlers and supervisors should receive appropriate training in proper
food handling techniques and food-protection principles and should be
informed of the danger of poor personal hygiene and insanitary
practices.
(d) Supervision. Responsibility for assuring compliance by all
personnel with all requirements of this part shall be clearly assigned
to competent supervisory personnel.
[51 FR 24475, June 19, 1986, as amended at 54 FR 24892, June 12, 1989]
Sec. 110.19 Exclusions.
(a) The following operations are not subject to this part:
Establishments engaged solely in the harvesting, storage, or
distribution of one or more ``raw agricultural commodities,'' as defined
in section 201(r) of the act, which are ordinarily cleaned, prepared,
treated, or otherwise processed before being marketed to the consuming
public.
(b) FDA, however, will issue special regulations if it is necessary
to cover these excluded operations.
Subpart B_Buildings and Facilities
Sec. 110.20 Plant and grounds.
(a) Grounds. The grounds about a food plant under the control of the
operator shall be kept in a condition that will protect against the
contamination of food. The methods for adequate maintenance of grounds
include, but are not limited to:
(1) Properly storing equipment, removing litter and waste, and
cutting weeds or grass within the immediate vicinity of the plant
buildings or structures that may constitute an attractant, breeding
place, or harborage for pests.
(2) Maintaining roads, yards, and parking lots so that they do not
constitute a source of contamination in areas where food is exposed.
(3) Adequately draining areas that may contribute contamination to
food by seepage, foot-borne filth, or providing a breeding place for
pests.
(4) Operating systems for waste treatment and disposal in an
adequate manner so that they do not constitute a source of contamination
in areas where food is exposed.
[[Page 220]]
If the plant grounds are bordered by grounds not under the operator's
control and not maintained in the manner described in paragraph (a) (1)
through (3) of this section, care shall be exercised in the plant by
inspection, extermination, or other means to exclude pests, dirt, and
filth that may be a source of food contamination.
(b) Plant construction and design. Plant buildings and structures
shall be suitable in size, construction, and design to facilitate
maintenance and sanitary operations for food-manufacturing purposes. The
plant and facilities shall:
(1) Provide sufficient space for such placement of equipment and
storage of materials as is necessary for the maintenance of sanitary
operations and the production of safe food.
(2) Permit the taking of proper precautions to reduce the potential
for contamination of food, food-contact surfaces, or food-packaging
materials with microorganisms, chemicals, filth, or other extraneous
material. The potential for contamination may be reduced by adequate
food safety controls and operating practices or effective design,
including the separation of operations in which contamination is likely
to occur, by one or more of the following means: location, time,
partition, air flow, enclosed systems, or other effective means.
(3) Permit the taking of proper precautions to protect food in
outdoor bulk fermentation vessels by any effective means, including:
(i) Using protective coverings.
(ii) Controlling areas over and around the vessels to eliminate
harborages for pests.
(iii) Checking on a regular basis for pests and pest infestation.
(iv) Skimming the fermentation vessels, as necessary.
(4) Be constructed in such a manner that floors, walls, and ceilings
may be adequately cleaned and kept clean and kept in good repair; that
drip or condensate from fixtures, ducts and pipes does not contaminate
food, food-contact surfaces, or food-packaging materials; and that
aisles or working spaces are provided between equipment and walls and
are adequately unobstructed and of adequate width to permit employees to
perform their duties and to protect against contaminating food or food-
contact surfaces with clothing or personal contact.
(5) Provide adequate lighting in hand-washing areas, dressing and
locker rooms, and toilet rooms and in all areas where food is examined,
processed, or stored and where equipment or utensils are cleaned; and
provide safety-type light bulbs, fixtures, skylights, or other glass
suspended over exposed food in any step of preparation or otherwise
protect against food contamination in case of glass breakage.
(6) Provide adequate ventilation or control equipment to minimize
odors and vapors (including steam and noxious fumes) in areas where they
may contaminate food; and locate and operate fans and other air-blowing
equipment in a manner that minimizes the potential for contaminating
food, food-packaging materials, and food-contact surfaces.
(7) Provide, where necessary, adequate screening or other protection
against pests.
Sec. 110.35 Sanitary operations.
(a) General maintenance. Buildings, fixtures, and other physical
facilities of the plant shall be maintained in a sanitary condition and
shall be kept in repair sufficient to prevent food from becoming
adulterated within the meaning of the act. Cleaning and sanitizing of
utensils and equipment shall be conducted in a manner that protects
against contamination of food, food-contact surfaces, or food-packaging
materials.
(b) Substances used in cleaning and sanitizing; storage of toxic
materials. (1) Cleaning compounds and sanitizing agents used in cleaning
and sanitizing procedures shall be free from undesirable microorganisms
and shall be safe and adequate under the conditions of use. Compliance
with this requirement may be verified by any effective means including
purchase of these substances under a supplier's guarantee or
certification, or examination of these substances for contamination.
Only the following toxic materials may be used or stored in a plant
where food is processed or exposed:
[[Page 221]]
(i) Those required to maintain clean and sanitary conditions;
(ii) Those necessary for use in laboratory testing procedures;
(iii) Those necessary for plant and equipment maintenance and
operation; and
(iv) Those necessary for use in the plant's operations.
(2) Toxic cleaning compounds, sanitizing agents, and pesticide
chemicals shall be identified, held, and stored in a manner that
protects against contamination of food, food-contact surfaces, or food-
packaging materials. All relevant regulations promulgated by other
Federal, State, and local government agencies for the application, use,
or holding of these products should be followed.
(c) Pest control. No pests shall be allowed in any area of a food
plant. Guard or guide dogs may be allowed in some areas of a plant if
the presence of the dogs is unlikely to result in contamination of food,
food-contact surfaces, or food-packaging materials. Effective measures
shall be taken to exclude pests from the processing areas and to protect
against the contamination of food on the premises by pests. The use of
insecticides or rodenticides is permitted only under precautions and
restrictions that will protect against the contamination of food, food-
contact surfaces, and food-packaging materials.
(d) Sanitation of food-contact surfaces. All food-contact surfaces,
including utensils and food-contact surfaces of equipment, shall be
cleaned as frequently as necessary to protect against contamination of
food.
(1) Food-contact surfaces used for manufacturing or holding low-
moisture food shall be in a dry, sanitary condition at the time of use.
When the surfaces are wet-cleaned, they shall, when necessary, be
sanitized and thoroughly dried before subsequent use.
(2) In wet processing, when cleaning is necessary to protect against
the introduction of microorganisms into food, all food-contact surfaces
shall be cleaned and sanitized before use and after any interruption
during which the food-contact surfaces may have become contaminated.
Where equipment and utensils are used in a continuous production
operation, the utensils and food-contact surfaces of the equipment shall
be cleaned and sanitized as necessary.
(3) Non-food-contact surfaces of equipment used in the operation of
food plants should be cleaned as frequently as necessary to protect
against contamination of food.
(4) Single-service articles (such as utensils intended for one-time
use, paper cups, and paper towels) should be stored in appropriate
containers and shall be handled, dispensed, used, and disposed of in a
manner that protects against contamination of food or food-contact
surfaces.
(5) Sanitizing agents shall be adequate and safe under conditions of
use. Any facility, procedure, or machine is acceptable for cleaning and
sanitizing equipment and utensils if it is established that the
facility, procedure, or machine will routinely render equipment and
utensils clean and provide adequate cleaning and sanitizing treatment.
(e) Storage and handling of cleaned portable equipment and utensils.
Cleaned and sanitized portable equipment with food-contact surfaces and
utensils should be stored in a location and manner that protects food-
contact surfaces from contamination.
[51 FR 24475, June 19, 1986, as amended at 54 FR 24892, June 12, 1989]
Sec. 110.37 Sanitary facilities and controls.
Each plant shall be equipped with adequate sanitary facilities and
accommodations including, but not limited to:
(a) Water supply. The water supply shall be sufficient for the
operations intended and shall be derived from an adequate source. Any
water that contacts food or food-contact surfaces shall be safe and of
adequate sanitary quality. Running water at a suitable temperature, and
under pressure as needed, shall be provided in all areas where required
for the processing of food, for the cleaning of equipment, utensils, and
food-packaging materials, or for employee sanitary facilities.
(b) Plumbing. Plumbing shall be of adequate size and design and
adequately installed and maintained to:
[[Page 222]]
(1) Carry sufficient quantities of water to required locations
throughout the plant.
(2) Properly convey sewage and liquid disposable waste from the
plant.
(3) Avoid constituting a source of contamination to food, water
supplies, equipment, or utensils or creating an unsanitary condition.
(4) Provide adequate floor drainage in all areas where floors are
subject to flooding-type cleaning or where normal operations release or
discharge water or other liquid waste on the floor.
(5) Provide that there is not backflow from, or cross-connection
between, piping systems that discharge waste water or sewage and piping
systems that carry water for food or food manufacturing.
(c) Sewage disposal. Sewage disposal shall be made into an adequate
sewerage system or disposed of through other adequate means.
(d) Toilet facilities. Each plant shall provide its employees with
adequate, readily accessible toilet facilities. Compliance with this
requirement may be accomplished by:
(1) Maintaining the facilities in a sanitary condition.
(2) Keeping the facilities in good repair at all times.
(3) Providing self-closing doors.
(4) Providing doors that do not open into areas where food is
exposed to airborne contamination, except where alternate means have
been taken to protect against such contamination (such as double doors
or positive air-flow systems).
(e) Hand-washing facilities. Hand-washing facilities shall be
adequate and convenient and be furnished with running water at a
suitable temperature. Compliance with this requirement may be
accomplished by providing:
(1) Hand-washing and, where appropriate, hand-sanitizing facilities
at each location in the plant where good sanitary practices require
employees to wash and/or sanitize their hands.
(2) Effective hand-cleaning and sanitizing preparations.
(3) Sanitary towel service or suitable drying devices.
(4) Devices or fixtures, such as water control valves, so designed
and constructed to protect against recontamination of clean, sanitized
hands.
(5) Readily understandable signs directing employees handling
unproteced food, unprotected food-packaging materials, of food-contact
surfaces to wash and, where appropriate, sanitize their hands before
they start work, after each absence from post of duty, and when their
hands may have become soiled or contaminated. These signs may be posted
in the processing room(s) and in all other areas where employees may
handle such food, materials, or surfaces.
(6) Refuse receptacles that are constructed and maintained in a
manner that protects against contamination of food.
(f) Rubbish and offal disposal. Rubbish and any offal shall be so
conveyed, stored, and disposed of as to minimize the development of
odor, minimize the potential for the waste becoming an attractant and
harborage or breeding place for pests, and protect against contamination
of food, food-contact surfaces, water supplies, and ground surfaces.
Subpart C_Equipment
Sec. 110.40 Equipment and utensils.
(a) All plant equipment and utensils shall be so designed and of
such material and workmanship as to be adequately cleanable, and shall
be properly maintained. The design, construction, and use of equipment
and utensils shall preclude the adulteration of food with lubricants,
fuel, metal fragments, contaminated water, or any other contaminants.
All equipment should be so installed and maintained as to facilitate the
cleaning of the equipment and of all adjacent spaces. Food-contact
surfaces shall be corrosion-resistant when in contact with food. They
shall be made of nontoxic materials and designed to withstand the
environment of their intended use and the action of food, and, if
applicable, cleaning compounds and sanitizing agents. Food-contact
surfaces shall be maintained to protect food from being contaminated by
any source, including unlawful indirect food additives.
[[Page 223]]
(b) Seams on food-contact surfaces shall be smoothly bonded or
maintained so as to minimize accumulation of food particles, dirt, and
organic matter and thus minimize the opportunity for growth of
microorganisms.
(c) Equipment that is in the manufacturing or food-handling area and
that does not come into contact with food shall be so constructed that
it can be kept in a clean condition.
(d) Holding, conveying, and manufacturing systems, including
gravimetric, pneumatic, closed, and automated systems, shall be of a
design and construction that enables them to be maintained in an
appropriate sanitary condition.
(e) Each freezer and cold storage compartment used to store and hold
food capable of supporting growth of microorganisms shall be fitted with
an indicating thermometer, temperature-measuring device, or temperature-
recording device so installed as to show the temperature accurately
within the compartment, and should be fitted with an automatic control
for regulating temperature or with an automatic alarm system to indicate
a significant temperature change in a manual operation.
(f) Instruments and controls used for measuring, regulating, or
recording temperatures, pH, acidity, water activity, or other conditions
that control or prevent the growth of undesirable microorganisms in food
shall be accurate and adequately maintained, and adequate in number for
their designated uses.
(g) Compressed air or other gases mechanically introduced into food
or used to clean food-contact surfaces or equipment shall be treated in
such a way that food is not contaminated with unlawful indirect food
additives.
Subpart D [Reserved]
Subpart E_Production and Process Controls
Sec. 110.80 Processes and controls.
All operations in the receiving, inspecting, transporting,
segregating, preparing, manufacturing, packaging, and storing of food
shall be conducted in accordance with adequate sanitation principles.
Appropriate quality control operations shall be employed to ensure that
food is suitable for human consumption and that food-packaging materials
are safe and suitable. Overall sanitation of the plant shall be under
the supervision of one or more competent individuals assigned
responsibility for this function. All reasonable precautions shall be
taken to ensure that production procedures do not contribute
contamination from any source. Chemical, microbial, or extraneous-
material testing procedures shall be used where necessary to identify
sanitation failures or possible food contamination. All food that has
become contaminated to the extent that it is adulterated within the
meaning of the act shall be rejected, or if permissible, treated or
processed to eliminate the contamination.
(a) Raw materials and other ingredients. (1) Raw materials and other
ingredients shall be inspected and segregated or otherwise handled as
necessary to ascertain that they are clean and suitable for processing
into food and shall be stored under conditions that will protect against
contamination and minimize deterioration. Raw materials shall be washed
or cleaned as necessary to remove soil or other contamination. Water
used for washing, rinsing, or conveying food shall be safe and of
adequate sanitary quality. Water may be reused for washing, rinsing, or
conveying food if it does not increase the level of contamination of the
food. Containers and carriers of raw materials should be inspected on
receipt to ensure that their condition has not contributed to the
contamination or deterioration of food.
(2) Raw materials and other ingredients shall either not contain
levels of microorganisms that may produce food poisoning or other
disease in humans, or they shall be pasteurized or otherwise treated
during manufacturing operations so that they no longer contain levels
that would cause the product to be adulterated within the meaning of the
act. Compliance with this requirement may be verified by any effective
means, including purchasing raw materials and other ingredients under a
supplier's guarantee or certification.
[[Page 224]]
(3) Raw materials and other ingredients susceptible to contamination
with aflatoxin or other natural toxins shall comply with current Food
and Drug Administration regulations and action levels for poisonous or
deleterious substances before these materials or ingredients are
incorporated into finished food. Compliance with this requirement may be
accomplished by purchasing raw materials and other ingredients under a
supplier's guarantee or certification, or may be verified by analyzing
these materials and ingredients for aflatoxins and other natural toxins.
(4) Raw materials, other ingredients, and rework susceptible to
contamination with pests, undesirable microorganisms, or extraneous
material shall comply with applicable Food and Drug Administration
regulations and defect action levels for natural or unavoidable defects
if a manufacturer wishes to use the materials in manufacturing food.
Compliance with this requirement may be verified by any effective means,
including purchasing the materials under a supplier's guarantee or
certification, or examination of these materials for contamination.
(5) Raw materials, other ingredients, and rework shall be held in
bulk, or in containers designed and constructed so as to protect against
contamination and shall be held at such temperature and relative
humidity and in such a manner as to prevent the food from becoming
adulterated within the meaning of the act. Material scheduled for rework
shall be identified as such.
(6) Frozen raw materials and other ingredients shall be kept frozen.
If thawing is required prior to use, it shall be done in a manner that
prevents the raw materials and other ingredients from becoming
adulterated within the meaning of the act.
(7) Liquid or dry raw materials and other ingredients received and
stored in bulk form shall be held in a manner that protects against
contamination.
(b) Manufacturing operations. (1) Equipment and utensils and
finished food containers shall be maintained in an acceptable condition
through appropriate cleaning and sanitizing, as necessary. Insofar as
necessary, equipment shall be taken apart for thorough cleaning.
(2) All food manufacturing, including packaging and storage, shall
be conducted under such conditions and controls as are necessary to
minimize the potential for the growth of microorganisms, or for the
contamination of food. One way to comply with this requirement is
careful monitoring of physical factors such as time, temperature,
humidity, aw, pH, pressure, flow rate, and manufacturing
operations such as freezing, dehydration, heat processing,
acidification, and refrigeration to ensure that mechanical breakdowns,
time delays, temperature fluctuations, and other factors do not
contribute to the decomposition or contamination of food.
(3) Food that can support the rapid growth of undesirable
microorganisms, particularly those of public health significance, shall
be held in a manner that prevents the food from becoming adulterated
within the meaning of the act. Compliance with this requirement may be
accomplished by any effective means, including:
(i) Maintaining refrigerated foods at 45 [deg]F (7.2 [deg]C) or
below as appropriate for the particular food involved.
(ii) Maintaining frozen foods in a frozen state.
(iii) Maintaining hot foods at 140 [deg]F (60 [deg]C) or above.
(iv) Heat treating acid or acidified foods to destroy mesophilic
microorganisms when those foods are to be held in hermetically sealed
containers at ambient temperatures.
(4) Measures such as sterilizing, irradiating, pasteurizing,
freezing, refrigerating, controlling pH or controlling aw
that are taken to destroy or prevent the growth of undesirable
microorganisms, particularly those of public health significance, shall
be adequate under the conditions of manufacture, handling, and
distribution to prevent food from being adulterated within the meaning
of the act.
(5) Work-in-process shall be handled in a manner that protects
against contamination.
(6) Effective measures shall be taken to protect finished food from
contamination by raw materials, other ingredients, or refuse. When raw
materials,
[[Page 225]]
other ingredients, or refuse are unprotected, they shall not be handled
simultaneously in a receiving, loading, or shipping area if that
handling could result in contaminated food. Food transported by conveyor
shall be protected against contamination as necessary.
(7) Equipment, containers, and utensils used to convey, hold, or
store raw materials, work-in-process, rework, or food shall be
constructed, handled, and maintained during manufacturing or storage in
a manner that protects against contamination.
(8) Effective measures shall be taken to protect against the
inclusion of metal or other extraneous material in food. Compliance with
this requirement may be accomplished by using sieves, traps, magnets,
electronic metal detectors, or other suitable effective means.
(9) Food, raw materials, and other ingredients that are adulterated
within the meaning of the act shall be disposed of in a manner that
protects against the contamination of other food. If the adulterated
food is capable of being reconditioned, it shall be reconditioned using
a method that has been proven to be effective or it shall be reexamined
and found not to be adulterated within the meaning of the act before
being incorporated into other food.
(10) Mechanical manufacturing steps such as washing, peeling,
trimming, cutting, sorting and inspecting, mashing, dewatering, cooling,
shredding, extruding, drying, whipping, defatting, and forming shall be
performed so as to protect food against contamination. Compliance with
this requirement may be accomplished by providing adequate physical
protection of food from contaminants that may drip, drain, or be drawn
into the food. Protection may be provided by adequate cleaning and
sanitizing of all food-contact surfaces, and by using time and
temperature controls at and between each manufacturing step.
(11) Heat blanching, when required in the preparation of food,
should be effected by heating the food to the required temperature,
holding it at this temperature for the required time, and then either
rapidly cooling the food or passing it to subsequent manufacturing
without delay. Thermophilic growth and contamination in blanchers should
be minimized by the use of adequate operating temperatures and by
periodic cleaning. Where the blanched food is washed prior to filling,
water used shall be safe and of adequate sanitary quality.
(12) Batters, breading, sauces, gravies, dressings, and other
similar preparations shall be treated or maintained in such a manner
that they are protected against contamination. Compliance with this
requirement may be accomplished by any effective means, including one or
more of the following:
(i) Using ingredients free of contamination.
(ii) Employing adequate heat processes where applicable.
(iii) Using adequate time and temperature controls.
(iv) Providing adequate physical protection of components from
contaminants that may drip, drain, or be drawn into them.
(v) Cooling to an adequate temperature during manufacturing.
(vi) Disposing of batters at appropriate intervals to protect
against the growth of microorganisms.
(13) Filling, assembling, packaging, and other operations shall be
performed in such a way that the food is protected against
contamination. Compliance with this requirement may be accomplished by
any effective means, including:
(i) Use of a quality control operation in which the critical control
points are identified and controlled during manufacturing.
(ii) Adequate cleaning and sanitizing of all food-contact surfaces
and food containers.
(iii) Using materials for food containers and food- packaging
materials that are safe and suitable, as defined in Sec. 130.3(d) of
this chapter.
(iv) Providing physical protection from contamination, particularly
airborne contamination.
(v) Using sanitary handling procedures.
(14) Food such as, but not limited to, dry mixes, nuts, intermediate
moisture food, and dehydrated food, that relies on the control of
aw for preventing the
[[Page 226]]
growth of undesirable microorganisms shall be processed to and
maintained at a safe moisture level. Compliance with this requirement
may be accomplished by any effective means, including employment of one
or more of the following practices:
(i) Monitoring the aw of food.
(ii) Controlling the soluble solids-water ratio in finished food.
(iii) Protecting finished food from moisture pickup, by use of a
moisture barrier or by other means, so that the aw of the
food does not increase to an unsafe level.
(15) Food such as, but not limited to, acid and acidified food, that
relies principally on the control of pH for preventing the growth of
undesirable microorganisms shall be monitored and maintained at a pH of
4.6 or below. Compliance with this requirement may be accomplished by
any effective means, including employment of one or more of the
following practices:
(i) Monitoring the pH of raw materials, food in process, and
finished food.
(ii) Controlling the amount of acid or acidified food added to low-
acid food.
(16) When ice is used in contact with food, it shall be made from
water that is safe and of adequate sanitary quality, and shall be used
only if it has been manufactured in accordance with current good
manufacturing practice as outlined in this part.
(17) Food-manufacturing areas and equipment used for manufacturing
human food should not be used to manufacture nonhuman food-grade animal
feed or inedible products, unless there is no reasonable possibility for
the contamination of the human food.
[51 FR 24475, June 19, 1986, as amended at 65 FR 56479, Sept. 19, 2000]
Sec. 110.93 Warehousing and distribution.
Storage and transportation of finished food shall be under
conditions that will protect food against physical, chemical, and
microbial contamination as well as against deterioration of the food and
the container.
Subpart F [Reserved]
Subpart G_Defect Action Levels
Sec. 110.110 Natural or unavoidable defects in food for human use that
present no health hazard.
(a) Some foods, even when produced under current good manufacturing
practice, contain natural or unavoidable defects that at low levels are
not hazardous to health. The Food and Drug Administration establishes
maximum levels for these defects in foods produced under current good
manufacturing practice and uses these levels in deciding whether to
recommend regulatory action.
(b) Defect action levels are established for foods whenever it is
necessary and feasible to do so. These levels are subject to change upon
the development of new technology or the availability of new
information.
(c) Compliance with defect action levels does not excuse violation
of the requirement in section 402(a)(4) of the act that food not be
prepared, packed, or held under unsanitary conditions or the
requirements in this part that food manufacturers, distributors, and
holders shall observe current good manufacturing practice. Evidence
indicating that such a violation exists causes the food to be
adulterated within the meaning of the act, even though the amounts of
natural or unavoidable defects are lower than the currently established
defect action levels. The manufacturer, distributor, and holder of food
shall at all times utilize quality control operations that reduce
natural or unavoidable defects to the lowest level currently feasible.
(d) The mixing of a food containing defects above the current defect
action level with another lot of food is not permitted and renders the
final food adulterated within the meaning of the act, regardless of the
defect level of the final food.
(e) A compilation of the current defect action levels for natural or
unavoidable defects in food for human use that present no health hazard
may be obtained upon request from the Center for Food Safety and Applied
Nutrition
[[Page 227]]
(HFS-565), Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740.
[51 FR 24475, June 19, 1986, as amended at 61 FR 14480, Apr. 2, 1996; 66
FR 56035, Nov. 6, 2001]
PART 111_CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING,
LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS--Table of Contents
Subpart A_General Provisions
Sec.
111.1 Who is subject to this part?
111.3 What definitions apply to this part?
111.5 Do other statutory provisions and regulations apply?
Subpart B_Personnel
111.8 What are the requirements under this subpart B for written
procedures?
111.10 What requirements apply for preventing microbial contamination
from sick or infected personnel and for hygienic practices?
111.12 What personnel qualification requirements apply?
111.13 What supervisor requirements apply?
111.14 Under this subpart B, what records must you make and keep?
Subpart C_Physical Plant and Grounds
111.15 What sanitation requirements apply to your physical plant and
grounds?
111.16 What are the requirements under this subpart C for written
procedures?
111.20 What design and construction requirements apply to your physical
plant?
111.23 Under this subpart C, what records must you make and keep?
Subpart D_Equipment and Utensils
111.25 What are the requirements under this subpart D for written
procedures?
111.27 What requirements apply to the equipment and utensils that you
use?
111.30 What requirements apply to automated, mechanical, or electronic
equipment?
111.35 Under this subpart D, what records must you make and keep?
Subpart E_Requirement to Establish a Production and Process Control
System
111.55 What are the requirements to implement a production and process
control system?
111.60 What are the design requirements for the production and process
control system?
111.65 What are the requirements for quality control operations?
111.70 What specifications must you establish?
111.73 What is your responsibility for determining whether established
specifications are met?
111.75 What must you do to determine whether specifications are met?
111.77 What must you do if established specifications are not met?
111.80 What representative samples must you collect?
111.83 What are the requirements for reserve samples?
111.87 Who conducts a material review and makes a disposition decision?
111.90 What requirements apply to treatments, in-process adjustments,
and reprocessing when there is a deviation or unanticipated
occurrence or when a specification established in accordance
with Sec. 111.70 is not met?
111.95 Under this subpart E, what records must you make and keep?
Subpart F_Production and Process Control System: Requirements for
Quality Control
111.103 What are the requirements under this subpart F for written
procedures?
111.105 What must quality control personnel do?
111.110 What quality control operations are required for laboratory
operations associated with the production and process control
system?
111.113 What quality control operations are required for a material
review and disposition decision?
111.117 What quality control operations are required for equipment,
instruments, and controls?
111.120 What quality control operations are required for components,
packaging, and labels before use in the manufacture of a
dietary supplement?
111.123 What quality control operations are required for the master
manufacturing record, the batch production record, and
manufacturing operations?
111.127 What quality control operations are required for packaging and
labeling operations?
111.130 What quality control operations are required for returned
dietary supplements?
111.135 What quality control operations are required for product
complaints?
[[Page 228]]
111.140 Under this subpart F, what records must you make and keep?
Subpart G_Production and Process Control System: Requirements for
Components, Packaging, and Labels and for Product That You Receive for
Packaging or Labeling as a Dietary Supplement
111.153 What are the requirements under this subpart G for written
procedures?
111.155 What requirements apply to components of dietary supplements?
111.160 What requirements apply to packaging and labels received?
111.165 What requirements apply to a product received for packaging or
labeling as a dietary supplement (and for distribution rather
than for return to the supplier)?
111.170 What requirements apply to rejected components, packaging, and
labels, and to rejected products that are received for
packaging or labeling as a dietary supplement?
111.180 Under this subpart G, what records must you make and keep?
Subpart H_Production and Process Control System: Requirements for the
Master Manufacturing Record
111.205 What is the requirement to establish a master manufacturing
record?
111.210 What must the master manufacturing record include?
Subpart I_Production and Process Control System: Requirements for the
Batch Production Record
111.255 What is the requirement to establish a batch production record?
111.260 What must the batch record include?
Subpart J_Production and Process Control System: Requirements for
Laboratory Operations
111.303 What are the requirements under this subpart J for written
procedures?
111.310 What are the requirements for the laboratory facilities that you
use?
111.315 What are the requirements for laboratory control processes?
111.320 What requirements apply to laboratory methods for testing and
examination?
111.325 Under this subpart J, what records must you make and keep?
Subpart K_Production and Process Control System: Requirements for
Manufacturing Operations
111.353 What are the requirements under this subpart K for written
procedures?
111.355 What are the design requirements for manufacturing operations?
111.360 What are the requirements for sanitation?
111.365 What precautions must you take to prevent contamination?
111.370 What requirements apply to rejected dietary supplements?
111.375 Under this subpart K, what records must you make and keep?
Subpart L_Production and Process Control System: Requirements for
Packaging and Labeling Operations
111.403 What are the requirements under this subpart L for written
procedures?
111.410 What requirements apply to packaging and labels?
111.415 What requirements apply to filling, assembling, packaging,
labeling, and related operations?
111.420 What requirements apply to repackaging and relabeling?
111.425 What requirements apply to a packaged and labeled dietary
supplement that is rejected for distribution?
111.430 Under this subpart L, what records must you make and keep?
Subpart M_Holding and Distributing
111.453 What are the requirements under this subpart M for written
procedures?
111.455 What requirements apply to holding components, dietary
supplements, packaging, and labels?
111.460 What requirements apply to holding in-process material?
111.465 What requirements apply to holding reserve samples of dietary
supplements?
111.470 What requirements apply to distributing dietary supplements?
111.475 Under this subpart M, what records must you make and keep?
Subpart N_Returned Dietary Supplements
111.503 What are the requirements under this subpart N for written
procedures?
111.510 What requirements apply when a returned dietary supplement is
received?
111.515 When must a returned dietary supplement be destroyed, or
otherwise suitably disposed of?
111.520 When may a returned dietary supplement be salvaged?
[[Page 229]]
111.525 What requirements apply to a returned dietary supplement that
quality control personnel approve for reprocessing?
111.530 When must an investigation be conducted of your manufacturing
processes and other batches?
111.535 Under this subpart N, what records must you make and keep?
Subpart O_Product Complaints
111.553 What are the requirements under this subpart O for written
procedures?
111.560 What requirements apply to the review and investigation of a
product complaint?
111.570 Under this subpart O, what records must you make and keep?
Subpart P_Records and Recordkeeping
111.605 What requirements apply to the records that you make and keep?
111.610 What records must be made available to FDA?
Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C.
264.
Source: 72 FR 34942, June 25, 2007, unless otherwise noted.
Subpart A_General Provisions
Sec. 111.1 Who is subject to this part?
(a) Except as provided by paragraph (b) of this section, you are
subject to this part if you manufacture, package, label, or hold a
dietary supplement, including:
(1) A dietary supplement you manufacture but that is packaged or
labeled by another person; and
(2) A dietary supplement imported or offered for import in any State
or territory of the United States, the District of Columbia, or the
Commonwealth of Puerto Rico.
(b) The requirements pertaining to holding dietary supplements do
not apply to you if you are holding those dietary supplements at a
retail establishment for the sole purpose of direct retail sale to
individual consumers. A retail establishment does not include a
warehouse or other storage facility for a retailer or a warehouse or
other storage facility that sells directly to individual consumers.
Sec. 111.3 What definitions apply to this part?
The definitions and interpretations of terms in section 201 of the
Federal Food, Drug, and Cosmetic Act (the act) apply to such terms when
used in this part. For the purpose of this part, the following
definitions also apply:
Actual yield means the quantity that is actually produced at any
appropriate step of manufacture or packaging of a particular dietary
supplement.
Batch means a specific quantity of a dietary supplement that is
uniform, that is intended to meet specifications for identity, purity,
strength, and composition, and that is produced during a specified time
period according to a single manufacturing record during the same cycle
of manufacture.
Batch number, lot number, or control number means any distinctive
group of letters, numbers, or symbols, or any combination of them, from
which the complete history of the manufacturing, packaging, labeling,
and/or holding of a batch or lot of dietary supplements can be
determined.
Component means any substance intended for use in the manufacture of
a dietary supplement, including those that may not appear in the
finished batch of the dietary supplement. Component includes dietary
ingredients (as described in section 201(ff) of the act) and other
ingredients.
Contact surface means any surface that contacts a component or
dietary supplement, and those surfaces from which drainage onto the
component or dietary supplement, or onto surfaces that contact the
component or dietary supplement, occurs during the normal course of
operations. Examples of contact surfaces include containers, utensils,
tables, contact surfaces of equipment, and packaging.
Ingredient means any substance that is used in the manufacture of a
dietary supplement and that is intended to be present in the finished
batch of the dietary supplement. An ingredient includes, but is not
necessarily limited to, a dietary ingredient as defined in section
201(ff) of the act.
In-process material means any material that is fabricated,
compounded, blended, ground, extracted, sifted,
[[Page 230]]
sterilized, derived by chemical reaction, or processed in any other way
for use in the manufacture of a dietary supplement.
Lot means a batch, or a specific identified portion of a batch, that
is uniform and that is intended to meet specifications for identity,
purity, strength, and composition; or, in the case of a dietary
supplement produced by continuous process, a specific identified amount
produced in a specified unit of time or quantity in a manner that is
uniform and that is intended to meet specifications for identity,
purity, strength, and composition.
Microorganisms means yeasts, molds, bacteria, viruses, and other
similar microscopic organisms having public health or sanitary concern.
This definition includes species that:
(1) May have public health significance;
(2) May cause a component or dietary supplement to decompose;
(3) Indicate that the component or dietary supplement is
contaminated with filth; or
(4) Otherwise may cause the component or dietary supplement to be
adulterated.
Must is used to state a requirement.
Pest means any objectionable insect or other animal including birds,
rodents, flies, mites, and larvae.
Physical plant means all or any part of a building or facility used
for or in connection with manufacturing, packaging, labeling, or holding
a dietary supplement.
Product complaint means any communication that contains any
allegation, written, electronic, or oral, expressing concern, for any
reason, with the quality of a dietary supplement, that could be related
to current good manufacturing practice. Examples of product complaints
are: Foul odor, off taste, illness or injury, disintegration time, color
variation, tablet size or size variation, under-filled container,
foreign material in a dietary supplement container, improper packaging,
mislabeling, or dietary supplements that are superpotent, subpotent, or
contain the wrong ingredient, or contain a drug or other contaminant
(e.g., bacteria, pesticide, mycotoxin, glass, lead).
Quality means that the dietary supplement consistently meets the
established specifications for identity, purity, strength, and
composition, and limits on contaminants, and has been manufactured,
packaged, labeled, and held under conditions to prevent adulteration
under section 402(a)(1), (a)(2), (a)(3), and (a)(4) of the act.
Quality control means a planned and systematic operation or
procedure for ensuring the quality of a dietary supplement.
Quality control personnel means any person, persons, or group,
within or outside of your organization, who you designate to be
responsible for your quality control operations.
Representative sample means a sample that consists of an adequate
number of units that are drawn based on rational criteria, such as
random sampling, and that are intended to ensure that the sample
accurately portrays the material being sampled.
Reprocessing means using, in the manufacture of a dietary
supplement, clean, uncontaminated components or dietary supplements that
have been previously removed from manufacturing and that have been made
suitable for use in the manufacture of a dietary supplement.
Reserve sample means a representative sample of product that is held
for a designated period of time.
Sanitize means to adequately treat cleaned equipment, containers,
utensils, or any other cleaned contact surface by a process that is
effective in destroying vegetative cells of microorganisms of public
health significance, and in substantially reducing numbers of other
microorganisms, but without adversely affecting the product or its
safety for the consumer.
Theoretical yield means the quantity that would be produced at any
appropriate step of manufacture or packaging of a particular dietary
supplement, based upon the quantity of components or packaging to be
used, in the absence of any loss or error in actual production.
Water activity (aw) is a measure of the free moisture in
a component or dietary supplement and is the quotient of
[[Page 231]]
the water vapor pressure of the substance divided by the vapor pressure
of pure water at the same temperature.
We means the U.S. Food and Drug Administration (FDA).
You means a person who manufactures, packages, labels, or holds
dietary supplements.
Sec. 111.5 Do other statutory provisions and regulations apply?
In addition to this part, you must comply with other applicable
statutory provisions and regulations under the act related to dietary
supplements.
Subpart B_Personnel
Sec. 111.8 What are the requirements under this subpart B for written
procedures?
You must establish and follow written procedures for fulfilling the
requirements of this subpart.
Sec. 111.10 What requirements apply for preventing microbial contamination
from sick or infected personnel and for hygienic practices?
(a) Preventing microbial contamination. You must take measures to
exclude from any operations any person who might be a source of
microbial contamination, due to a health condition, where such
contamination may occur, of any material, including components, dietary
supplements, and contact surfaces used in the manufacture, packaging,
labeling, or holding of a dietary supplement. Such measures include the
following:
(1) Excluding from working in any operations that may result in
contamination any person who, by medical examination, the person's
acknowledgement, or supervisory observation, is shown to have, or
appears to have, an illness, infection, open lesion, or any other
abnormal source of microbial contamination, that could result in
microbial contamination of components, dietary supplements, or contact
surfaces, until the health condition no longer exists; and
(2) Instructing your employees to notify their supervisor(s) if they
have or if there is a reasonable possibility that they have a health
condition described in paragraph (a)(1) of this section that could
result in microbial contamination of any components, dietary
supplements, or any contact surface.
(b) Hygienic practices. If you work in an operation during which
adulteration of the component, dietary supplement, or contact surface
could occur, you must use hygienic practices to the extent necessary to
protect against such contamination of components, dietary supplements,
or contact surfaces. These hygienic practices include the following:
(1) Wearing outer garments in a manner that protects against the
contamination of components, dietary supplements, or any contact
surface;
(2) Maintaining adequate personal cleanliness;
(3) Washing hands thoroughly (and sanitizing if necessary to protect
against contamination with microorganisms) in an adequate hand-washing
facility:
(i) Before starting work; and
(ii) At any time when the hands may have become soiled or
contaminated;
(4) Removing all unsecured jewelry and other objects that might fall
into components, dietary supplements, equipment, or packaging, and
removing hand jewelry that cannot be adequately sanitized during periods
in which components or dietary supplements are manipulated by hand. If
hand jewelry cannot be removed, it must be covered by material that is
maintained in an intact, clean, and sanitary condition and that
effectively protects against contamination of components, dietary
supplements, or contact surfaces;
(5) Maintaining gloves used in handling components or dietary
supplements in an intact, clean, and sanitary condition. The gloves must
be of an impermeable material;
(6) Wearing, where appropriate, in an effective manner, hair nets,
caps, beard covers, or other effective hair restraints;
(7) Not storing clothing or other personal belongings in areas where
components, dietary supplements, or any contact surfaces are exposed or
where contact surfaces are washed;
(8) Not eating food, chewing gum, drinking beverages, or using
tobacco products in areas where components,
[[Page 232]]
dietary supplements, or any contact surfaces are exposed, or where
contact surfaces are washed; and
(9) Taking any other precautions necessary to protect against the
contamination of components, dietary supplements, or contact surfaces
with microorganisms, filth, or any other extraneous materials, including
perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied
to the skin.
Sec. 111.12 What personnel qualification requirements apply?
(a) You must have qualified employees who manufacture, package,
label, or hold dietary supplements.
(b) You must identify who is responsible for your quality control
operations. Each person who is identified to perform quality control
operations must be qualified to do so and have distinct and separate
responsibilities related to performing such operations from those
responsibilities that the person otherwise has when not performing such
operations.
(c) Each person engaged in manufacturing, packaging, labeling, or
holding, or in performing any quality control operations, must have the
education, training, or experience to perform the person's assigned
functions.
Sec. 111.13 What supervisor requirements apply?
(a) You must assign qualified personnel to supervise the
manufacturing, packaging, labeling, or holding of dietary supplements.
(b) Each supervisor whom you use must be qualified by education,
training, or experience to supervise.
Sec. 111.14 Under this subpart B, what records must you make and keep?
(a) You must make and keep records required under this subpart B in
accordance with subpart P of this part.
(b) You must make and keep the following records:
(1) Written procedures for fulfilling the requirements of this
subpart B; and
(2) Documentation of training, including the date of the training,
the type of training, and the person(s) trained.
Subpart C_Physical Plant and Grounds
Sec. 111.15 What sanitation requirements apply to your physical plant and
grounds?
(a) Grounds. You must keep the grounds of your physical plant in a
condition that protects against the contamination of components, dietary
supplements, or contact surfaces. The methods for adequate ground
maintenance include:
(1) Properly storing equipment, removing litter and waste, and
cutting weeds or grass within the immediate vicinity of the physical
plant so that it does not attract pests, harbor pests, or provide pests
a place for breeding;
(2) Maintaining roads, yards, and parking lots so that they do not
constitute a source of contamination in areas where components, dietary
supplements, or contact surfaces are exposed;
(3) Adequately draining areas that may contribute to the
contamination of components, dietary supplements, or contact surfaces by
seepage, filth or any other extraneous materials, or by providing a
breeding place for pests;
(4) Adequately operating systems for waste treatment and disposal so
that they do not constitute a source of contamination in areas where
components, dietary supplements, or contact surfaces are exposed; and
(5) If your plant grounds are bordered by grounds not under your
control, and if those other grounds are not maintained in the manner
described in this section, you must exercise care in the plant by
inspection, extermination, or other means to exclude pests, dirt, and
filth or any other extraneous materials that may be a source of
contamination.
(b) Physical plant facilities. (1) You must maintain your physical
plant in a clean and sanitary condition; and
(2) You must maintain your physical plant in repair sufficient to
prevent components, dietary supplements, or contact surfaces from
becoming contaminated.
(c) Cleaning compounds, sanitizing agents, pesticides, and other
toxic materials. (1) You must use cleaning compounds and sanitizing
agents that are free from microorganisms of public
[[Page 233]]
health significance and that are safe and adequate under the conditions
of use.
(2) You must not use or hold toxic materials in a physical plant in
which components, dietary supplements, or contact surfaces are
manufactured or exposed, unless those materials are necessary as
follows:
(i) To maintain clean and sanitary conditions;
(ii) For use in laboratory testing procedures;
(iii) For maintaining or operating the physical plant or equipment;
or
(iv) For use in the plant's operations.
(3) You must identify and hold cleaning compounds, sanitizing
agents, pesticides, pesticide chemicals, and other toxic materials in a
manner that protects against contamination of components, dietary
supplements, or contact surfaces.
(d) Pest control. (1) You must not allow animals or pests in any
area of your physical plant. Guard or guide dogs are allowed in some
areas of your physical plant if the presence of the dogs will not result
in contamination of components, dietary supplements, or contact
surfaces;
(2) You must take effective measures to exclude pests from the
physical plant and to protect against contamination of components,
dietary supplements, and contact surfaces on the premises by pests; and
(3) You must not use insecticides, fumigants, fungicides, or
rodenticides, unless you take precautions to protect against the
contamination of components, dietary supplements, or contact surfaces.
(e) Water supply. (1) You must provide water that is safe and
sanitary, at suitable temperatures, and under pressure as needed, for
all uses where water does not become a component of the dietary
supplement.
(2) Water that is used in a manner such that the water may become a
component of the dietary supplement, e.g., when such water contacts
components, dietary supplements, or any contact surface, must, at a
minimum, comply with applicable Federal, State, and local requirements
and not contaminate the dietary supplement.
(f) Plumbing. The plumbing in your physical plant must be of an
adequate size and design and be adequately installed and maintained to:
(1) Carry sufficient amounts of water to required locations
throughout the physical plant;
(2) Properly convey sewage and liquid disposable waste from your
physical plant;
(3) Avoid being a source of contamination to components, dietary
supplements, water supplies, or any contact surface, or creating an
unsanitary condition;
(4) Provide adequate floor drainage in all areas where floors are
subject to flooding-type cleaning or where normal operations release or
discharge water or other liquid waste on the floor; and
(5) Not allow backflow from, or cross connection between, piping
systems that discharge waste water or sewage and piping systems that
carry water used for manufacturing dietary supplements, for cleaning
contact surfaces, or for use in bathrooms or hand-washing facilities.
(g) Sewage disposal. You must dispose of sewage into an adequate
sewage system or through other adequate means.
(h) Bathrooms. You must provide your employees with adequate,
readily accessible bathrooms. The bathrooms must be kept clean and must
not be a potential source of contamination to components, dietary
supplements, or contact surfaces.
(i) Hand-washing facilities. You must provide hand-washing
facilities that are designed to ensure that an employee's hands are not
a source of contamination of components, dietary supplements, or any
contact surface, by providing facilities that are adequate, convenient,
and furnish running water at a suitable temperature.
(j) Trash disposal. You must convey, store, and dispose of trash to:
(1) Minimize the development of odors;
(2) Minimize the potential for the trash to attract, harbor, or
become a breeding place for pests;
(3) Protect against contamination of components, dietary
supplements, any contact surface, water supplies, and grounds
surrounding your physical plant; and
[[Page 234]]
(4) Control hazardous waste to prevent contamination of components,
dietary supplements, and contact surfaces.
(k) Sanitation supervisors. You must assign one or more employees to
supervise overall sanitation. Each of these supervisors must be
qualified by education, training, or experience to develop and supervise
sanitation procedures.
Sec. 111.16 What are the requirements under this subpart C for written
procedures?
You must establish and follow written procedures for cleaning the
physical plant and for pest control.
Sec. 111.20 What design and construction requirements apply to your physical
plant?
Any physical plant you use in the manufacture, packaging, labeling,
or holding of dietary supplements must:
(a) Be suitable in size, construction, and design to facilitate
maintenance, cleaning, and sanitizing operations;
(b) Have adequate space for the orderly placement of equipment and
holding of materials as is necessary for maintenance, cleaning, and
sanitizing operations and to prevent contamination and mixups of
components and dietary supplements during manufacturing, packaging,
labeling, or holding;
(c) Permit the use of proper precautions to reduce the potential for
mixups or contamination of components, dietary supplements, or contact
surfaces, with microorganisms, chemicals, filth, or other extraneous
material. Your physical plant must have, and you must use, separate or
defined areas of adequate size or other control systems, such as
computerized inventory controls or automated systems of separation, to
prevent contamination and mixups of components and dietary supplements
during the following operations:
(1) Receiving, identifying, holding, and withholding from use,
components, dietary supplements, packaging, and labels that will be used
in or during the manufacturing, packaging, labeling, or holding of
dietary supplements;
(2) Separating, as necessary, components, dietary supplements,
packaging, and labels that are to be used in manufacturing from
components, dietary supplements, packaging, or labels that are awaiting
material review and disposition decision, reprocessing, or are awaiting
disposal after rejection;
(3) Separating the manufacturing, packaging, labeling, and holding
of different product types including different types of dietary
supplements and other foods, cosmetics, and pharmaceutical products;
(4) Performing laboratory analyses and holding laboratory supplies
and samples;
(5) Cleaning and sanitizing contact surfaces;
(6) Packaging and label operations; and
(7) Holding components or dietary supplements.
(d) Be designed and constructed in a manner that prevents
contamination of components, dietary supplements, or contact surfaces.
(1) The design and construction must include:
(i) Floors, walls, and ceilings that can be adequately cleaned and
kept clean and in good repair;
(ii) Fixtures, ducts, and pipes that do not contaminate components,
dietary supplements, or contact surfaces by dripping or other leakage,
or condensate;
(iii) Adequate ventilation or environmental control equipment such
as airflow systems, including filters, fans, and other air-blowing
equipment, that minimize odors and vapors (including steam and noxious
fumes) in areas where they may contaminate components, dietary
supplements, or contact surfaces;
(iv) Equipment that controls temperature and humidity, when such
equipment is necessary to ensure the quality of the dietary supplement;
and
(v) Aisles or working spaces between equipment and walls that are
adequately unobstructed and of adequate width to permit all persons to
perform their duties and to protect against contamination of components,
dietary supplements, or contact surfaces with clothing or personal
contact.
(2) When fans and other air-blowing equipment are used, such fans
and
[[Page 235]]
equipment must be located and operated in a manner that minimizes the
potential for microorganisms and particulate matter to contaminate
components, dietary supplements, or contact surfaces;
(e) Provide adequate light in:
(1) All areas where components or dietary supplements are examined,
processed, or held;
(2) All areas where contact surfaces are cleaned; and
(3) Hand-washing areas, dressing and locker rooms, and bathrooms.
(f) Use safety-type light bulbs, fixtures, skylights, or other glass
or glass-like materials when the light bulbs, fixtures, skylights or
other glass or glass-like materials are suspended over exposed
components or dietary supplements in any step of preparation, unless
your physical plant is otherwise constructed in a manner that will
protect against contamination of components or dietary supplements in
case of breakage of glass or glass-like materials.
(g) Provide effective protection against contamination of components
and dietary supplements in bulk fermentation vessels, by, for example:
(1) Use of protective coverings;
(2) Placement in areas where you can eliminate harborages for pests
over and around the vessels;
(3) Placement in areas where you can check regularly for pests, pest
infestation, filth or any other extraneous materials; and
(4) Use of skimming equipment.
(h) Use adequate screening or other protection against pests, where
necessary.
Sec. 111.23 Under this subpart C, what records must you make and keep?
(a) You must make and keep records required under this subpart C in
accordance with subpart P of this part.
(b) You must make and keep records of the written procedures for
cleaning the physical plant and for pest control.
(c) You must make and keep records that show that water, when used
in a manner such that the water may become a component of the dietary
supplement, meets the requirements of Sec. 111.15(e)(2).
Subpart D_Equipment and Utensils
Sec. 111.25 What are the requirements under this subpart D for written
procedures?
You must establish and follow written procedures for fulfilling the
requirements of this subpart D, including written procedures for:
(a) Calibrating instruments and controls that you use in
manufacturing or testing a component or dietary supplement;
(b) Calibrating, inspecting, and checking automated, mechanical, and
electronic equipment; and
(c) Maintaining, cleaning, and sanitizing, as necessary, all
equipment, utensils, and any other contact surfaces that are used to
manufacture, package, label, or hold components or dietary supplements.
Sec. 111.27 What requirements apply to the equipment and utensils that you
use?
(a) You must use equipment and utensils that are of appropriate
design, construction, and workmanship to enable them to be suitable for
their intended use and to be adequately cleaned and properly maintained.
(1) Equipment and utensils include the following:
(i) Equipment used to hold or convey;
(ii) Equipment used to measure;
(iii) Equipment using compressed air or gas;
(iv) Equipment used to carry out processes in closed pipes and
vessels; and
(v) Equipment used in automated, mechanical, or electronic systems.
(2) You must use equipment and utensils of appropriate design and
construction so that use will not result in the contamination of
components or dietary supplements with:
(i) Lubricants;
(ii) Fuel;
(iii) Coolants;
(iv) Metal or glass fragments;
(v) Filth or any other extraneous material;
(vi) Contaminated water; or
(vii) Any other contaminants.
(3) All equipment and utensils you use must be:
[[Page 236]]
(i) Installed and maintained to facilitate cleaning the equipment,
utensils, and all adjacent spaces;
(ii) Corrosion-resistant if the equipment or utensils contact
components or dietary supplements;
(iii) Made of nontoxic materials;
(iv) Designed and constructed to withstand the environment in which
they are used, the action of components or dietary supplements, and, if
applicable, cleaning compounds and sanitizing agents; and
(v) Maintained to protect components and dietary supplements from
being contaminated by any source.
(4) Equipment and utensils you use must have seams that are smoothly
bonded or maintained to minimize accumulation of dirt, filth, organic
material, particles of components or dietary supplements, or any other
extraneous materials or contaminants.
(5) Each freezer, refrigerator, and other cold storage compartment
you use to hold components or dietary supplements:
(i) Must be fitted with an indicating thermometer, temperature-
measuring device, or temperature-recording device that indicates and
records, or allows for recording by hand, the temperature accurately
within the compartment; and
(ii) Must have an automated device for regulating temperature or an
automated alarm system to indicate a significant temperature change in a
manual operation.
(6) Instruments or controls used in the manufacturing, packaging,
labeling, or holding of a dietary supplement, and instruments or
controls that you use to measure, regulate, or record temperatures,
hydrogen-ion concentration (pH), water activity, or other conditions, to
control or prevent the growth of microorganisms or other contamination
must be:
(i) Accurate and precise;
(ii) Adequately maintained; and
(iii) Adequate in number for their designated uses.
(7) Compressed air or other gases you introduce mechanically into or
onto a component, dietary supplement, or contact surface or that you use
to clean any contact surface must be treated in such a way that the
component, dietary supplement, or contact surface is not contaminated.
(b) You must calibrate instruments and controls you use in
manufacturing or testing a component or dietary supplement. You must
calibrate:
(1) Before first use; and
(2) At the frequency specified in writing by the manufacturer of the
instrument and control; or
(3) At routine intervals or as otherwise necessary to ensure the
accuracy and precision of the instrument and control.
(c) You must repair or replace instruments or controls that cannot
be adjusted to agree with the reference standard.
(d) You must maintain, clean, and sanitize, as necessary, all
equipment, utensils, and any other contact surfaces used to manufacture,
package, label, or hold components or dietary supplements.
(1) Equipment and utensils must be taken apart as necessary for
thorough maintenance, cleaning, and sanitizing.
(2) You must ensure that all contact surfaces, used for
manufacturing or holding low-moisture components or dietary supplements,
are in a dry and sanitary condition when in use. When the surfaces are
wet-cleaned, they must be sanitized, when necessary, and thoroughly
dried before subsequent use.
(3) If you use wet processing during manufacturing, you must clean
and sanitize all contact surfaces, as necessary, to protect against the
introduction of microorganisms into components or dietary supplements.
When cleaning and sanitizing is necessary, you must clean and sanitize
all contact surfaces before use and after any interruption during which
the contact surface may have become contaminated. If you use contact
surfaces in a continuous production operation or in consecutive
operations involving different batches of the same dietary supplement,
you must adequately clean and sanitize the contact surfaces, as
necessary.
(4) You must clean surfaces that do not come into direct contact
with components or dietary supplements as frequently as necessary to
protect against
[[Page 237]]
contaminating components or dietary supplements.
(5) Single-service articles (such as utensils intended for one-time
use, paper cups, and paper towels) must be:
(i) Stored in appropriate containers; and
(ii) Handled, dispensed, used, and disposed of in a manner that
protects against contamination of components, dietary supplements, or
any contact surface.
(6) Cleaning compounds and sanitizing agents must be adequate for
their intended use and safe under their conditions of use;
(7) You must store cleaned and sanitized portable equipment and
utensils that have contact surfaces in a location and manner that
protects them from contamination.
[72 FR 34942, June 25, 2007, as amended at 73 FR 13124, Mar. 12, 2008]
Sec. 111.30 What requirements apply to automated, mechanical, or electronic
equipment?
For any automated, mechanical, or electronic equipment that you use
to manufacture, package, label, or hold a dietary supplement, you must:
(a) Design or select equipment to ensure that dietary supplement
specifications are consistently met;
(b) Determine the suitability of the equipment by ensuring that your
equipment is capable of operating satisfactorily within the operating
limits required by the process;
(c) Routinely calibrate, inspect, or check the equipment to ensure
proper performance. Your quality control personnel must periodically
review these calibrations, inspections, or checks;
(d) Establish and use appropriate controls for automated,
mechanical, and electronic equipment (including software for a computer
controlled process) to ensure that any changes to the manufacturing,
packaging, labeling, holding, or other operations are approved by
quality control personnel and instituted only by authorized personnel;
and
(e) Establish and use appropriate controls to ensure that the
equipment functions in accordance with its intended use. These controls
must be approved by quality control personnel.
Sec. 111.35 Under this subpart D, what records must you make and keep?
(a) You must make and keep records required under this subpart D in
accordance with subpart P of this part.
(b) You must make and keep the following records:
(1) Written procedures for fulfilling the requirements of this
subpart, including written procedures for:
(i) Calibrating instruments and controls that you use in
manufacturing or testing a component or dietary supplement;
(ii) Calibrating, inspecting, and checking automated, mechanical,
and electronic equipment; and
(iii) Maintaining, cleaning, and sanitizing, as necessary, all
equipment, utensils, and any other contact surfaces that are used to
manufacture, package, label, or hold components or dietary supplements;
(2) Documentation, in individual equipment logs, of the date of the
use, maintenance, cleaning, and sanitizing of equipment, unless such
documentation is kept with the batch record;
(3) Documentation of any calibration, each time the calibration is
performed, for instruments and controls that you use in manufacturing or
testing a component or dietary supplement. In your documentation, you
must:
(i) Identify the instrument or control calibrated;
(ii) Provide the date of calibration;
(iii) Identify the reference standard used including the
certification of accuracy of the known reference standard and a history
of recertification of accuracy;
(iv) Identify the calibration method used, including appropriate
limits for accuracy and precision of instruments and controls when
calibrating;
(v) Provide the calibration reading or readings found;
(vi) Identify the recalibration method used, and reading or readings
found, if accuracy or precision or both accuracy and precision limits
for instruments and controls were not met; and
(vii) Include the initials of the person who performed the
calibration and any recalibration.
(4) Written records of calibrations, inspections, and checks of
automated, mechanical, and electronic equipment;
[[Page 238]]
(5) Backup file(s) of current software programs (and of outdated
software that is necessary to retrieve records that you are required to
keep in accordance with subpart P of this part, when current software is
not able to retrieve such records) and of data entered into computer
systems that you use to manufacture, package, label, or hold dietary
supplements.
(i) Your backup file (e.g., a hard copy of data you have entered,
diskettes, tapes, microfilm, or compact disks) must be an exact and
complete record of the data you entered.
(ii) You must keep your backup software programs and data secure
from alterations, inadvertent erasures, or loss; and
(6) Documentation of the controls that you use to ensure that
equipment functions in accordance with its intended use.
Subpart E_Requirement to Establish a Production and Process Control
System
Sec. 111.55 What are the requirements to implement a production and process
control system?
You must implement a system of production and process controls that
covers all stages of manufacturing, packaging, labeling, and holding of
the dietary supplement to ensure the quality of the dietary supplement
and that the dietary supplement is packaged and labeled as specified in
the master manufacturing record.
Sec. 111.60 What are the design requirements for the production and process
control system?
(a) Your production and in-process control system must be designed
to ensure that the dietary supplement is manufactured, packaged,
labeled, and held in a manner that will ensure the quality of the
dietary supplement and that the dietary supplement is packaged and
labeled as specified in the master manufacturing record; and
(b) The production and in-process control system must include all
requirements of subparts E through L of this part and must be reviewed
and approved by quality control personnel.
Sec. 111.65 What are the requirements for quality control operations?
You must implement quality control operations in your manufacturing,
packaging, labeling, and holding operations for producing the dietary
supplement to ensure the quality of the dietary supplement and that the
dietary supplement is packaged and labeled as specified in the master
manufacturing record.
Sec. 111.70 What specifications must you establish?
(a) You must establish a specification for any point, step, or stage
in the manufacturing process where control is necessary to ensure the
quality of the dietary supplement and that the dietary supplement is
packaged and labeled as specified in the master manufacturing record.
(b) For each component that you use in the manufacture of a dietary
supplement, you must establish component specifications as follows:
(1) You must establish an identity specification;
(2) You must establish component specifications that are necessary
to ensure that specifications for the purity, strength and composition
of dietary supplements manufactured using the components are met; and
(3) You must establish limits on those types of contamination that
may adulterate or may lead to adulteration of the finished batch of the
dietary supplement to ensure the quality of the dietary supplement.
(c) For the in-process production:
(1) You must establish in-process specifications for any point,
step, or stage in the master manufacturing record where control is
necessary to help ensure that specifications are met for the identity,
purity, strength, and composition of the dietary supplements and, as
necessary, for limits on those types of contamination that may
adulterate or may lead to adulteration of the finished batch of the
dietary supplement;
(2) You must provide adequate documentation of your basis for why
meeting the in-process specifications, in combination with meeting
component specifications, will help ensure that the specifications are
met for the identity,
[[Page 239]]
purity, strength, and composition of the dietary supplements and for
limits on those types of contamination that may adulterate or may lead
to adulteration of the finished batch of the dietary supplement; and
(3) Quality control personnel must review and approve the
documentation that you provide under paragraph (c)(2) of this section.
(d) You must establish specifications for dietary supplement labels
(label specifications) and for packaging that may come in contact with
dietary supplements (packaging specifications). Packaging that may come
into contact with dietary supplements must be safe and suitable for its
intended use and must not be reactive or absorptive or otherwise affect
the safety or quality of the dietary supplement.
(e) For each dietary supplement that you manufacture you must
establish product specifications for the identity, purity, strength, and
composition of the finished batch of the dietary supplement, and for
limits on those types of contamination that may adulterate, or that may
lead to adulteration of, the finished batch of the dietary supplement to
ensure the quality of the dietary supplement.
(f) If you receive a product from a supplier for packaging or
labeling as a dietary supplement (and for distribution rather than for
return to the supplier), you must establish specifications to provide
sufficient assurance that the product you receive is adequately
identified and is consistent with your purchase order.
(g) You must establish specifications for the packaging and labeling
of the finished packaged and labeled dietary supplements, including
specifications that ensure that you used the specified packaging and
that you applied the specified label.
Sec. 111.73 What is your responsibility for determining whether established
specifications are met?
You must determine whether the specifications you establish under
Sec. 111.70 are met.
Sec. 111.75 What must you do to determine whether specifications are met?
(a) Before you use a component, you must:
(1)(i) Conduct at least one appropriate test or examination to
verify the identity of any component that is a dietary ingredient,
unless you petition the agency under paragraph (a)(1)(ii) of this
section and the agency exempts you from such testing;
(ii) You may submit a petition, under 21 CFR 10.30, to request an
exemption from the testing requirements in paragraph (a)(1)(i) of this
section. The petition must set forth the scientific rationale, and must
be accompanied by the supporting data and information, for proposed
alternative testing that will demonstrate that there is no material
diminution of assurance, compared to the assurance provided by 100
percent identity testing, of the identity of the dietary ingredient
before use when the dietary ingredient is obtained from one or more
suppliers identified in the petition. If FDA grants the petition, you
must conduct the tests and examinations for the dietary ingredient,
otherwise required under Sec. 111.75(a)(1)(i), under the terms
specified by FDA when the petition is granted; and
(2) Confirm the identity of other components and determine whether
other applicable component specifications established in accordance with
Sec. 111.70(b) are met. To do so, you must either:
(i) Conduct appropriate tests or examinations; or
(ii) Rely on a certificate of analysis from the supplier of the
component that you receive, provided that:
(A) You first qualify the supplier by establishing the reliability
of the supplier's certificate of analysis through confirmation of the
results of the supplier's tests or examinations;
(B) The certificate of analysis includes a description of the test
or examination method(s) used, limits of the test or examinations, and
actual results of the tests or examinations;
(C) You maintain documentation of how you qualified the supplier;
(D) You periodically re-confirm the supplier's certificate of
analysis; and
[[Page 240]]
(E) Your quality control personnel review and approve the
documentation setting forth the basis for qualification (and re-
qualification) of any supplier.
(b) You must monitor the in-process points, steps, or stages where
control is necessary to ensure the quality of the finished batch of
dietary supplement to:
(1) Determine whether the in-process specifications are met; and
(2) Detect any deviation or unanticipated occurrence that may result
in a failure to meet specifications.
(c) For a subset of finished dietary supplement batches that you
identify through a sound statistical sampling plan (or for every
finished batch), you must verify that your finished batch of the dietary
supplement meets product specifications for identity, purity, strength,
composition, and for limits on those types of contamination that may
adulterate or that may lead to adulteration of the finished batch of the
dietary supplement. To do so:
(1) You must select one or more established specifications for
identity, purity, strength, composition, and the limits on those types
of contamination that may adulterate or that may lead to adulteration of
the dietary supplement that, if tested or examined on the finished
batches of the dietary supplement, would verify that the production and
process control system is producing a dietary supplement that meets all
product specifications (or only those product specifications not
otherwise exempted from this provision by quality control personnel
under paragraph (d) of this section);
(2) You must conduct appropriate tests or examinations to determine
compliance with the specifications selected in paragraph (c)(1) of this
section;
(3) You must provide adequate documentation of your basis for
determining that compliance with the specification(s) selected under
paragraph (c)(1) of this section, through the use of appropriate tests
or examinations conducted under paragraph (c)(2) of this section, will
ensure that your finished batch of the dietary supplement meets all
product specifications for identity, purity, strength, and composition,
and the limits on those types of contamination that may adulterate, or
that may lead to the adulteration of, the dietary supplement; and
(4) Your quality control personnel must review and approve the
documentation that you provide under paragraph (c)(3) of this section.
(d)(1) You may exempt one or more product specifications from
verification requirements in paragraph (c)(1) of this section if you
determine and document that the specifications you select under
paragraph (c)(1) of this section for determination of compliance with
specifications are not able to verify that the production and process
control system is producing a dietary supplement that meets the exempted
product specification and there is no scientifically valid method for
testing or examining such exempted product specification at the finished
batch stage. In such a case, you must document why, for example, any
component and in-process testing, examination, or monitoring, and any
other information, will ensure that such exempted product specification
is met without verification through periodic testing of the finished
batch; and
(2) Your quality control personnel must review and approve the
documentation that you provide under paragraph (d)(1) of this section.
(e) Before you package or label a product that you receive for
packaging or labeling as a dietary supplement (and for distribution
rather than for return to the supplier), you must visually examine the
product and have documentation to determine whether the specifications
that you established under Sec. 111.70 (f) are met.
(f)(1) Before you use packaging, you must, at a minimum, conduct a
visual identification of the containers and closures and review the
supplier's invoice, guarantee, or certification to determine whether the
packaging specifications are met; and
(2) Before you use labels, you must, at a minimum, conduct a visual
examination of the label and review the supplier's invoice, guarantee,
or certification to determine whether label specifications are met.
(g) You must, at a minimum, conduct a visual examination of the
packaging and labeling of the finished packaged
[[Page 241]]
and labeled dietary supplements to determine whether you used the
specified packaging and applied the specified label.
(h)(1) You must ensure that the tests and examinations that you use
to determine whether the specifications are met are appropriate,
scientifically valid methods.
(2) The tests and examinations that you use must include at least
one of the following:
(i) Gross organoleptic analysis;
(ii) Macroscopic analysis;
(iii) Microscopic analysis;
(iv) Chemical analysis; or
(v) Other scientifically valid methods.
(i) You must establish corrective action plans for use when an
established specification is not met.
[72 FR 34942, June 25, 2007, as amended at 72 FR 34968, June 25, 2007;
73 FR 27727, May 14, 2008]
Sec. 111.77 What must you do if established specifications are not met?
(a) For specifications established under Sec. 111.70(a), (b)(2),
(b)(3), (c), (d), (e), and (g) that you do not meet, quality control
personnel, in accordance with the requirements in subpart F of this
part, must reject the component, dietary supplement, package or label
unless such personnel approve a treatment, an in-process adjustment, or
reprocessing that will ensure the quality of the finished dietary
supplement and that the dietary supplement is packaged and labeled as
specified in the master manufacturing record. No finished batch of
dietary supplements may be released for distribution unless it complies
with Sec. 111.123(b).
(b) For specifications established under Sec. 111.70(b)(1) that you
do not meet, quality control personnel must reject the component and the
component must not be used in manufacturing the dietary supplement.
(c) For specifications established under Sec. 111.70(f) that you do
not meet, quality control personnel must reject the product and the
product may not be packaged or labeled for distribution as a dietary
supplement.
Sec. 111.80 What representative samples must you collect?
The representative samples that you must collect include:
(a) Representative samples of each unique lot of components,
packaging, and labels that you use to determine whether the components,
packaging, and labels meet specifications established in accordance with
Sec. 111.70(b) and (d), and as applicable, Sec. 111.70(a) (and, when
you receive components, packaging, or labels from a supplier,
representative samples of each unique shipment, and of each unique lot
within each unique shipment);
(b) Representative samples of in-process materials for each
manufactured batch at points, steps, or stages, in the manufacturing
process as specified in the master manufacturing record where control is
necessary to ensure the identity, purity, strength, and composition of
dietary supplements to determine whether the in-process materials meet
specifications established in accordance with Sec. 111.70(c), and as
applicable, Sec. 111.70(a);
(c) Representative samples of a subset of finished batches of each
dietary supplement that you manufacture, which you identify through a
sound statistical sampling plan (or otherwise every finished batch),
before releasing for distribution to verify that the finished batch of
dietary supplement meets product specifications established in
accordance with Sec. 111.70(e), and as applicable, Sec. 111.70(a);
(d) Representative samples of each unique shipment, and of each
unique lot within each unique shipment, of product that you receive for
packaging or labeling as a dietary supplement (and for distribution
rather than for return to the supplier) to determine whether the
received product meets specifications established in accordance with
Sec. 111.70(f), and as applicable, Sec. 111.70(a); and
(e) Representative samples of each lot of packaged and labeled
dietary supplements to determine whether the packaging and labeling of
the finished packaged and labeled dietary supplements meet
specifications established in accordance with Sec. 111.70(g), and as
applicable, Sec. 111.70(a).
[[Page 242]]
Sec. 111.83 What are the requirements for reserve samples?
(a) You must collect and hold reserve samples of each lot of
packaged and labeled dietary supplements that you distribute.
(b) The reserve samples must:
(1) Be held using the same container-closure system in which the
packaged and labeled dietary supplement is distributed, or if
distributing dietary supplements to be packaged and labeled, using a
container-closure system that provides essentially the same
characteristics to protect against contamination or deterioration as the
one in which it is distributed for packaging and labeling elsewhere;
(2) Be identified with the batch, lot, or control number;
(3) Be retained for 1 year past the shelf life date (if shelf life
dating is used), or for 2 years from the date of distribution of the
last batch of dietary supplements associated with the reserve sample,
for use in appropriate investigations; and
(4) Consist of at least twice the quantity necessary for all tests
or examinations to determine whether or not the dietary supplement meets
product specifications.
Sec. 111.87 Who conducts a material review and makes a disposition decision?
Quality control personnel must conduct all required material reviews
and make all required disposition decisions.
Sec. 111.90 What requirements apply to treatments, in-process adjustments,
and reprocessing when there is a deviation or unanticipated occurrence or when
a specification established in accordance with Sec. 111.70 is not met?
(a) You must not reprocess a rejected dietary supplement or treat or
provide an in-process adjustment to a component, packaging, or label to
make it suitable for use in the manufacture of a dietary supplement
unless:
(1) Quality control personnel conduct a material review and make a
disposition decision to approve the reprocessing, treatment, or in-
process adjustment; and
(2) The reprocessing, treatment, or in-process adjustment is
permitted by Sec. 111.77;
(b) You must not reprocess any dietary supplement or treat or
provide an in-process adjustment to a component to make it suitable for
use in the manufacture of a dietary supplement, unless:
(1) Quality control personnel conduct a material review and make a
disposition decision that is based on a scientifically valid reason and
approves the reprocessing, treatment, or in-process adjustment; and
(2) The reprocessing, treatment or in-process adjustment is
permitted by Sec. 111.77;
(c) Any batch of dietary supplement that is reprocessed, that
contains components that you have treated, or to which you have made in-
process adjustments to make them suitable for use in the manufacture of
the dietary supplement must be approved by quality control personnel and
comply with Sec. 111.123(b) before releasing for distribution.
Sec. 111.95 Under this subpart E, what records must you make and keep?
(a) You must make and keep records required under this subpart E in
accordance with subpart P of this part.
(b) Under this subpart E, you must make and keep the following
records:
(1) The specifications established;
(2) Documentation of your qualification of a supplier for the
purpose of relying on the supplier's certificate of analysis;
(3) Documentation for why meeting in-process specifications, in
combination with meeting component specifications, helps ensure that the
dietary supplement meets the specifications for identity, purity,
strength, and composition; and for limits on those types of
contamination that may adulterate or may lead to adulteration of the
finished batch of the dietary supplement; and
(4) Documentation for why the results of appropriate tests or
examinations for the product specifications selected under Sec.
111.75(c)(1) ensure that the dietary supplement meets all product
specifications;
[[Page 243]]
(5) Documentation for why any component and in-process testing,
examination, or monitoring, and any other information, will ensure that
a product specification that is exempted under Sec. 111.75(d) is met
without verification through periodic testing of the finished batch,
including documentation that the selected specifications tested or
examined under Sec. 111.75 (c)(1) are not able to verify that the
production and process control system is producing a dietary supplement
that meets the exempted product specification and there is no
scientifically valid method for testing or examining such exempted
product specification at the finished batch stage.
(6) Documentation of FDA's response to a petition submitted under
Sec. 111.75(a)(1)(ii) providing for an exemption from the provisions of
Sec. 111.75(a)(1)(i).
[72 FR 34942, June 25, 2007, as amended at 72 FR 34968, June 25, 2007]
Subpart F_Production and Process Control System: Requirements for
Quality Control
Sec. 111.103 What are the requirements under this subpart F for written
procedures?
You must establish and follow written procedures for the
responsibilities of the quality control operations, including written
procedures for conducting a material review and making a disposition
decision, and for approving or rejecting any reprocessing.
Sec. 111.105 What must quality control personnel do?
Quality control personnel must ensure that your manufacturing,
packaging, labeling, and holding operations ensure the quality of the
dietary supplement and that the dietary supplement is packaged and
labeled as specified in the master manufacturing record. To do so,
quality control personnel must perform operations that include:
(a) Approving or rejecting all processes, specifications, written
procedures, controls, tests, and examinations, and deviations from or
modifications to them, that may affect the identity, purity, strength,
or composition of a dietary supplement;
(b) Reviewing and approving the documentation setting forth the
basis for qualification of any supplier;
(c) Reviewing and approving the documentation setting forth the
basis for why meeting in-process specifications, in combination with
meeting component specifications, will help ensure that the identity,
purity, strength, and composition of the dietary supplement are met;
(d) Reviewing and approving the documentation setting forth the
basis for why the results of appropriate tests or examinations for each
product specification selected under Sec. 111.75(c)(1) will ensure that
the finished batch of the dietary supplement meets product
specifications;
(e) Reviewing and approving the basis and the documentation for why
any product specification is exempted from the verification requirements
in Sec. 111.75(c)(1), and for why any component and in-process testing,
examination, or monitoring, or other methods will ensure that such
exempted product specification is met without verification through
periodic testing of the finished batch;
(f) Ensuring that required representative samples are collected;
(g) Ensuring that required reserve samples are collected and held;
(h) Determining whether all specifications established under Sec.
111.70(a) are met; and
(i) Performing other operations required under this subpart.
Sec. 111.110 What quality control operations are required for laboratory
operations associated with the production and process control system?
Quality control operations for laboratory operations associated with
the production and process control system must include:
(a) Reviewing and approving all laboratory control processes
associated with the production and process control system;
(b) Ensuring that all tests and examinations required under Sec.
111.75 are conducted; and
[[Page 244]]
(c) Reviewing and approving the results of all tests and
examinations required under Sec. 111.75.
Sec. 111.113 What quality control operations are required for a material
review and disposition decision?
(a) Quality control personnel must conduct a material review and
make a disposition decision if:
(1) A specification established in accordance with Sec. 111.70 is
not met;
(2) A batch deviates from the master manufacturing record, including
when any step established in the master manufacturing record is not
completed and including any deviation from specifications;
(3) There is any unanticipated occurrence during the manufacturing
operations that adulterates or may lead to adulteration of the
component, dietary supplement, or packaging, or could lead to the use of
a label not specified in the master manufacturing record;
(4) Calibration of an instrument or control suggests a problem that
may have resulted in a failure to ensure the quality of a batch or
batches of a dietary supplement; or
(5) A dietary supplement is returned.
(b)(1) When there is a deviation or unanticipated occurrence during
the production and in-process control system that results in or could
lead to adulteration of a component, dietary supplement, or packaging,
or could lead to the use of a label not specified in the master
manufacturing record, quality control personnel must reject the
component, dietary supplement, packaging, or label unless it approves a
treatment, an in-process adjustment, or reprocessing to correct the
applicable deviation or occurrence.
(2) When a specification established in accordance with Sec. 111.70
is not met, quality control personnel must reject the component, dietary
supplement, package or label, unless quality control personnel approve a
treatment, an in-process adjustment, or reprocessing, as permitted in
Sec. 111.77.
(c) The person who conducts a material review and makes the
disposition decision must, at the time of performance, document that
material review and disposition decision.
Sec. 111.117 What quality control operations are required for equipment,
instruments, and controls?
Quality control operations for equipment, instruments, and controls
must include:
(a) Reviewing and approving all processes for calibrating
instruments and controls;
(b) Periodically reviewing all records for calibration of
instruments and controls;
(c) Periodically reviewing all records for calibrations,
inspections, and checks of automated, mechanical, or electronic
equipment; and
(d) Reviewing and approving controls to ensure that automated,
mechanical, or electronic equipment functions in accordance with its
intended use.
Sec. 111.120 What quality control operations are required for components,
packaging, and labels before use in the manufacture of a dietary supplement?
Quality control operations for components, packaging, and labels
before use in the manufacture of a dietary supplement must include:
(a) Reviewing all receiving records for components, packaging, and
labels;
(b) Determining whether all components, packaging, and labels
conform to specifications established under Sec. 111.70 (b) and (d);
(c) Conducting any required material review and making any required
disposition decision;
(d) Approving or rejecting any treatment and in-process adjustments
of components, packaging, or labels to make them suitable for use in the
manufacture of a dietary supplement; and
(e) Approving, and releasing from quarantine, all components,
packaging, and labels before they are used.
Sec. 111.123 What quality control operations are required for the master
manufacturing record, the batch production record, and manufacturing
operations?
(a) Quality control operations for the master manufacturing record,
the batch production record, and manufacturing operations must include:
(1) Reviewing and approving all master manufacturing records and all
[[Page 245]]
modifications to the master manufacturing records;
(2) Reviewing and approving all batch production-related records;
(3) Reviewing all monitoring required under subpart E;
(4) Conducting any required material review and making any required
disposition decision;
(5) Approving or rejecting any reprocessing;
(6) Determining whether all in-process specifications established in
accordance with Sec. 111.70(c) are met;
(7) Determining whether each finished batch conforms to product
specifications established in accordance with Sec. 111.70(e); and
(8) Approving and releasing, or rejecting, each finished batch for
distribution, including any reprocessed finished batch.
(b) Quality control personnel must not approve and release for
distribution:
(1) Any batch of dietary supplement for which any component in the
batch does not meet its identity specification;
(2) Any batch of dietary supplement, including any reprocessed
batch, that does not meet all product specifications established in
accordance with Sec. 111.70(e);
(3) Any batch of dietary supplement, including any reprocessed
batch, that has not been manufactured, packaged, labeled, and held under
conditions to prevent adulteration under section 402(a)(1), (a)(2),
(a)(3), and (a)(4) of the act; and
(4) Any product received from a supplier for packaging or labeling
as a dietary supplement (and for distribution rather than for return to
the supplier) for which sufficient assurance is not provided to
adequately identify the product and to determine that the product is
consistent with your purchase order.
Sec. 111.127 What quality control operations are required for packaging and
labeling operations?
Quality control operations for packaging and labeling operations
must include:
(a) Reviewing the results of any visual examination and
documentation to ensure that specifications established under Sec.
111.70(f) are met for all products that you receive for packaging and
labeling as a dietary supplement (and for distribution rather than for
return to the supplier);
(b) Approving, and releasing from quarantine, all products that you
receive for packaging or labeling as a dietary supplement (and for
distribution rather than for return to the supplier) before they are
used for packaging or labeling;
(c) Reviewing and approving all records for packaging and label
operations;
(d) Determining whether the finished packaged and labeled dietary
supplement conforms to specifications established in accordance with
Sec. 111.70(g);
(e) Conducting any required material review and making any required
disposition decision;
(f) Approving or rejecting any repackaging of a packaged dietary
supplement;
(g) Approving or rejecting any relabeling of a packaged and labeled
dietary supplement; and
(h) Approving for release, or rejecting, any packaged and labeled
dietary supplement (including a repackaged or relabeled dietary
supplement) for distribution.
Sec. 111.130 What quality control operations are required for returned
dietary supplements?
Quality control operations for returned dietary supplements must
include:
(a) Conducting any required material review and making any required
disposition decision; including:
(1) Determining whether tests or examination are necessary to
determine compliance with product specifications established in
accordance with Sec. 111.70(e); and
(2) Reviewing the results of any tests or examinations that are
conducted to determine compliance with product specifications
established in accordance with Sec. 111.70(e);
(b) Approving or rejecting any salvage and redistribution of any
returned dietary supplement;
[[Page 246]]
(c) Approving or rejecting any reprocessing of any returned dietary
supplement; and
(d) Determining whether the reprocessed dietary supplement meets
product specifications and either approving for release, or rejecting,
any returned dietary supplement that is reprocessed.
Sec. 111.135 What quality control operations are required for product
complaints?
Quality control operations for product complaints must include
reviewing and approving decisions about whether to investigate a product
complaint and reviewing and approving the findings and followup action
of any investigation performed.
Sec. 111.140 Under this subpart F, what records must you make and keep?
(a) You must make and keep the records required under this subpart F
in accordance with subpart P of this part.
(b) You must make and keep the following records:
(1) Written procedures for the responsibilities of the quality
control operations, including written procedures for conducting a
material review and making a disposition decision and written procedures
for approving or rejecting any reprocessing;
(2) Written documentation, at the time of performance, that quality
control personnel performed the review, approval, or rejection
requirements by recording the following:
(i) Date that the review, approval, or rejection was performed; and
(ii) Signature of the person performing the review, approval, or
rejection; and
(3) Documentation of any material review and disposition decision
and followup. Such documentation must be included in the appropriate
batch production record and must include:
(i) Identification of the specific deviation or the unanticipated
occurrence;
(ii) Description of your investigation into the cause of the
deviation from the specification or the unanticipated occurrence;
(iii) Evaluation of whether or not the deviation or unanticipated
occurrence has resulted in or could lead to a failure to ensure the
quality of the dietary supplement or a failure to package and label the
dietary supplement as specified in the master manufacturing record;
(iv) Identification of the action(s) taken to correct, and prevent a
recurrence of, the deviation or the unanticipated occurrence;
(v) Explanation of what you did with the component, dietary
supplement, packaging, or label;
(vi) A scientifically valid reason for any reprocessing of a dietary
supplement that is rejected or any treatment or in-process adjustment of
a component that is rejected; and
(vii) The signature of the individual(s) designated to perform the
quality control operation, who conducted the material review and made
the disposition decision, and of each qualified individual who provides
information relevant to that material review and disposition decision.
Subpart G_Production and Process Control System: Requirements for
Components, Packaging, and Labels and for Product That You Receive for
Packaging or Labeling as a Dietary Supplement
Sec. 111.153 What are the requirements under this subpart G for written
procedures?
You must establish and follow written procedures for fulfilling the
requirements of this subpart G.
Sec. 111.155 What requirements apply to components of dietary supplements?
(a) You must visually examine each immediate container or grouping
of immediate containers in a shipment that you receive for appropriate
content label, container damage, or broken seals to determine whether
the container condition may have resulted in contamination or
deterioration of the components;
(b) You must visually examine the supplier's invoice, guarantee, or
certification in a shipment you receive to ensure the components are
consistent with your purchase order;
[[Page 247]]
(c) You must quarantine components before you use them in the
manufacture of a dietary supplement until:
(1) You collect representative samples of each unique lot of
components (and, for components that you receive, of each unique
shipment, and of each unique lot within each unique shipment);
(2) Quality control personnel review and approve the results of any
tests or examinations conducted on components; and
(3) Quality control personnel approve the components for use in the
manufacture of a dietary supplement, including approval of any treatment
(including in-process adjustments) of components to make them suitable
for use in the manufacture of a dietary supplement, and releases them
from quarantine.
(d)(1) You must identify each unique lot within each unique shipment
of components that you receive and any lot of components that you
produce in a manner that allows you to trace the lot to the supplier,
the date received, the name of the component, the status of the
component (e.g., quarantined, approved, or rejected); and to the dietary
supplement that you manufactured and distributed.
(2) You must use this unique identifier whenever you record the
disposition of each unique lot within each unique shipment of components
that you receive and any lot of components that you produce.
(e) You must hold components under conditions that will protect
against contamination and deterioration, and avoid mixups.
Sec. 111.160 What requirements apply to packaging and labels received?
(a) You must visually examine each immediate container or grouping
of immediate containers in a shipment for appropriate content label,
container damage, or broken seals to determine whether the container
condition may have resulted in contamination or deterioration of the
packaging and labels.
(b) You must visually examine the supplier's invoice, guarantee, or
certification in a shipment to ensure that the packaging or labels are
consistent with your purchase order.
(c) You must quarantine packaging and labels before you use them in
the manufacture of a dietary supplement until:
(1) You collect representative samples of each unique shipment, and
of each unique lot within each unique shipment, of packaging and labels
and, at a minimum, conduct a visual identification of the immediate
containers and closures;
(2) Quality control personnel review and approve the results of any
tests or examinations conducted on the packaging and labels; and
(3) Quality control personnel approve the packaging and labels for
use in the manufacture of a dietary supplement and release them from
quarantine.
(d)(1) You must identify each unique lot within each unique shipment
of packaging and labels in a manner that allows you to trace the lot to
the supplier, the date received, the name of the packaging and label,
the status of the packaging and label (e.g., quarantined, approved, or
rejected); and to the dietary supplement that you distributed; and
(2) You must use this unique identifier whenever you record the
disposition of each unique lot within each unique shipment of packaging
and labels.
(e) You must hold packaging and labels under conditions that will
protect against contamination and deterioration, and avoid mixups.
Sec. 111.165 What requirements apply to a product received for packaging or
labeling as a dietary supplement (and for distribution rather than for return
to the supplier)?
(a) You must visually examine each immediate container or grouping
of immediate containers in a shipment of product that you receive for
packaging or labeling as a dietary supplement (and for distribution
rather than for return to the supplier) for appropriate content label,
container damage, or broken seals to determine whether the container
condition may have resulted in contamination or deterioration of the
received product.
(b) You must visually examine the supplier's invoice, guarantee, or
certification in a shipment of the received product to ensure that the
received
[[Page 248]]
product is consistent with your purchase order.
(c) You must quarantine the received product until:
(1) You collect representative samples of each unique shipment, and
of each unique lot within each unique shipment, of received product;
(2) Quality control personnel review and approve the documentation
to determine whether the received product meets the specifications that
you established under Sec. 111.70(f); and
(3) Quality control personnel approve the received product for
packaging or labeling as a dietary supplement and release the received
product from quarantine.
(d)(1) You must identify each unique lot within each unique shipment
of received product in a manner that allows you to trace the lot to the
supplier, the date received, the name of the received product, the
status of the received product (e.g., quarantined, approved, or
rejected), and to the product that you packaged or labeled and
distributed as a dietary supplement.
(2) You must use this unique identifier whenever you record the
disposition of each unique lot within each unique shipment of the
received product.
(e) You must hold the received product under conditions that will
protect against contamination and deterioration, and avoid mixups.
Sec. 111.170 What requirements apply to rejected components, packaging, and
labels, and to rejected products that are received for packaging or labeling
as a dietary supplement?
You must clearly identify, hold, and control under a quarantine
system for appropriate disposition any component, packaging, and label,
and any product that you receive for packaging or labeling as a dietary
supplement (and for distribution rather than for return to the
supplier), that is rejected and unsuitable for use in manufacturing,
packaging, or labeling operations.
Sec. 111.180 Under this subpart G, what records must you make and keep?
(a) You must make and keep records required under this subpart G in
accordance with subpart P of this part.
(b) You must make and keep the following records:
(1) Written procedures for fulfilling the requirements of this
subpart.
(2) Receiving records (including records such as certificates of
analysis, suppliers' invoices, and suppliers' guarantees) for
components, packaging, and labels and for products that you receive for
packaging or labeling as a dietary supplement (and for distribution
rather than for return to the supplier); and
(3) Documentation that the requirements of this subpart were met.
(i) The person who performs the required operation must document, at
the time of performance, that the required operation was performed.
(ii) The documentation must include:
(A) The date that the components, packaging, labels, or products
that you receive for packaging or labeling as a dietary supplement were
received;
(B) The initials of the person performing the required operation;
(C) The results of any tests or examinations conducted on
components, packaging, or labels, and of any visual examination of
product that you receive for packaging or labeling as a dietary
supplement; and
(D) Any material review and disposition decision conducted on
components, packaging, labels, or products that you receive for
packaging or labeling as a dietary supplement.
Subpart H_Production and Process Control System: Requirements for the
Master Manufacturing Record
Sec. 111.205 What is the requirement to establish a master manufacturing
record?
(a) You must prepare and follow a written master manufacturing
record for each unique formulation of dietary supplement that you
manufacture, and for each batch size, to ensure uniformity in the
finished batch from batch to batch.
(b) The master manufacturing record must:
[[Page 249]]
(1) Identify specifications for the points, steps, or stages in the
manufacturing process where control is necessary to ensure the quality
of the dietary supplement and that the dietary supplement is packaged
and labeled as specified in the master manufacturing record; and
(2) Establish controls and procedures to ensure that each batch of
dietary supplement that you manufacture meets the specifications
identified in accordance with paragraph (b)(1) of this section.
(c) You must make and keep master manufacturing records in
accordance with subpart P of this part.
Sec. 111.210 What must the master manufacturing record include?
The master manufacturing record must include:
(a) The name of the dietary supplement to be manufactured and the
strength, concentration, weight, or measure of each dietary ingredient
for each batch size;
(b) A complete list of components to be used;
(c) An accurate statement of the weight or measure of each component
to be used;
(d) The identity and weight or measure of each dietary ingredient
that will be declared on the Supplement Facts label and the identity of
each ingredient that will be declared on the ingredients list of the
dietary supplement;
(e) A statement of any intentional overage amount of a dietary
ingredient;
(f) A statement of theoretical yield of a manufactured dietary
supplement expected at each point, step, or stage of the manufacturing
process where control is needed to ensure the quality of the dietary
supplement, and the expected yield when you finish manufacturing the
dietary supplement, including the maximum and minimum percentages of
theoretical yield beyond which a deviation investigation of a batch is
necessary and material review is conducted and disposition decision is
made;
(g) A description of packaging and a representative label, or a
cross-reference to the physical location of the actual or representative
label;
(h) Written instructions, including the following:
(1) Specifications for each point, step, or stage in the
manufacturing process where control is necessary to ensure the quality
of the dietary supplement and that the dietary supplement is packaged
and labeled as specified in the master manufacturing record;
(2) Procedures for sampling and a cross-reference to procedures for
tests or examinations;
(3) Specific actions necessary to perform and verify points, steps,
or stages in the manufacturing process where control is necessary to
ensure the quality of the dietary supplement and that the dietary
supplement is packaged and labeled as specified in the master
manufacturing record.
(i) Such specific actions must include verifying the weight or
measure of any component and verifying the addition of any component;
and
(ii) For manual operations, such specific actions must include:
(A) One person weighing or measuring a component and another person
verifying the weight or measure; and
(B) One person adding the component and another person verifying the
addition.
(4) Special notations and precautions to be followed; and
(5) Corrective action plans for use when a specification is not met.
Subpart I_Production and Process Control System: Requirements for the
Batch Production Record
Sec. 111.255 What is the requirement to establish a batch production record?
(a) You must prepare a batch production record every time you
manufacture a batch of a dietary supplement;
(b) Your batch production record must include complete information
relating to the production and control of each batch;
(c) Your batch production record must accurately follow the
appropriate master manufacturing record and you
[[Page 250]]
must perform each step in the production of the batch; and
(d) You must make and keep batch production records in accordance
with subpart P of this part.
Sec. 111.260 What must the batch record include?
The batch production record must include the following:
(a) The batch, lot, or control number:
(1) Of the finished batch of dietary supplement; and
(2) That you assign in accordance with Sec. 111.415(f) for the
following:
(i) Each lot of packaged and labeled dietary supplement from the
finished batch of dietary supplement;
(ii) Each lot of dietary supplement, from the finished batch of
dietary supplement, that you distribute to another person for packaging
or labeling;
(b) The identity of equipment and processing lines used in producing
the batch;
(c) The date and time of the maintenance, cleaning, and sanitizing
of the equipment and processing lines used in producing the batch, or a
cross-reference to records, such as individual equipment logs, where
this information is retained;
(d) The unique identifier that you assigned to each component (or,
when applicable, to a product that you receive from a supplier for
packaging or labeling as a dietary supplement), packaging, and label
used;
(e) The identity and weight or measure of each component used;
(f) A statement of the actual yield and a statement of the
percentage of theoretical yield at appropriate phases of processing;
(g) The actual results obtained during any monitoring operation;
(h) The results of any testing or examination performed during the
batch production, or a cross-reference to such results;
(i) Documentation that the finished dietary supplement meets
specifications established in accordance with Sec. 111.70(e) and (g);
(j) Documentation, at the time of performance, of the manufacture of
the batch, including:
(1) The date on which each step of the master manufacturing record
was performed; and
(2) The initials of the persons performing each step, including:
(i) The initials of the person responsible for weighing or measuring
each component used in the batch;
(ii) The initials of the person responsible for verifying the weight
or measure of each component used in the batch;
(iii) The initials of the person responsible for adding the
component to the batch; and
(iv) The initials of the person responsible for verifying the
addition of components to the batch;
(k) Documentation, at the time of performance, of packaging and
labeling operations, including:
(1) The unique identifier that you assigned to packaging and labels
used, the quantity of the packaging and labels used, and, when label
reconciliation is required, reconciliation of any discrepancies between
issuance and use of labels;
(2) An actual or representative label, or a cross-reference to the
physical location of the actual or representative label specified in the
master manufacturing record; and
(3) The results of any tests or examinations conducted on packaged
and labeled dietary supplements (including repackaged or relabeled
dietary supplements), or a cross-reference to the physical location of
such results;
(l) Documentation at the time of performance that quality control
personnel:
(1) Reviewed the batch production record, including:
(i) Review of any monitoring operation required under subpart E of
this part; and
(ii) Review of the results of any tests and examinations, including
tests and examinations conducted on components, in-process materials,
finished batches of dietary supplements, and packaged and labeled
dietary supplements;
(2) Approved or rejected any reprocessing or repackaging; and
(3) Approved and released, or rejected, the batch for distribution,
including any reprocessed batch; and
[[Page 251]]
(4) Approved and released, or rejected, the packaged and labeled
dietary supplement, including any repackaged or relabeled dietary
supplement.
(m) Documentation at the time of performance of any required
material review and disposition decision.
(n) Documentation at the time of performance of any reprocessing.
Subpart J_Production and Process Control System: Requirements for
Laboratory Operations
Sec. 111.303 What are the requirements under this subpart J for written
procedures?
You must establish and follow written procedures for laboratory
operations, including written procedures for the tests and examinations
that you conduct to determine whether specifications are met.
Sec. 111.310 What are the requirements for the laboratory facilities that you
use?
You must use adequate laboratory facilities to perform whatever
testing and examinations are necessary to determine whether:
(a) Components that you use meet specifications;
(b) In-process specifications are met as specified in the master
manufacturing record; and
(c) Dietary supplements that you manufacture meet specifications.
Sec. 111.315 What are the requirements for laboratory control processes?
You must establish and follow laboratory control processes that are
reviewed and approved by quality control personnel, including the
following:
(a) Use of criteria for establishing appropriate specifications;
(b) Use of sampling plans for obtaining representative samples, in
accordance with subpart E of this part, of:
(1) Components, packaging, and labels;
(2) In-process materials;
(3) Finished batches of dietary supplements;
(4) Product that you receive for packaging or labeling as a dietary
supplement (and for distribution rather than for return to the
supplier); and
(5) Packaged and labeled dietary supplements.
(c) Use of criteria for selecting appropriate examination and
testing methods;
(d) Use of criteria for selecting standard reference materials used
in performing tests and examinations; and
(e) Use of test methods and examinations in accordance with
established criteria.
Sec. 111.320 What requirements apply to laboratory methods for testing and
examination?
(a) You must verify that the laboratory examination and testing
methodologies are appropriate for their intended use.
(b) You must identify and use an appropriate scientifically valid
method for each established specification for which testing or
examination is required to determine whether the specification is met.