[Title 21 CFR 101.36]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED]
[Subchapter B - FOOD FOR HUMAN CONSUMPTION]
[Part 101 - FOOD LABELING]
[Subpart C - Specific Nutrition Labeling Requirements and Guidelines]
[Sec. 101.36 - Nutrition labeling of dietary supplements of vitamins and minerals.]
[From the U.S. Government Publishing Office]
21
FOOD AND DRUGS
2
1996-04-01
1996-04-01
false
Nutrition labeling of dietary supplements of vitamins and minerals.
101.36
Sec. 101.36
FOOD AND DRUGS
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED
FOOD FOR HUMAN CONSUMPTION
FOOD LABELING
Specific Nutrition Labeling Requirements and Guidelines
Sec. 101.36 Nutrition labeling of dietary supplements of vitamins and minerals.
(a) The label of a dietary supplement of a vitamin or mineral that
has a Reference Daily Intake (RDI) as established in
Sec. 101.9(c)(8)(iv) or a Daily Reference Value (DRV) as established in
Sec. 101.9(c)(9), shall bear nutrition labeling in accordance with this
regulation, as illustrated in paragraph (c)(9) of this section, unless
an exemption is provided for the product in paragraph (f) of this
section. Dietary supplements of herbs or other similar nutritional
substances shall bear nutrition labeling in accordance with Sec. 101.9.
(b) The declaration of nutrition information on the label and in
labeling shall contain the following information, using the headings and
format specified, under the heading of ``Nutrition Facts''. The
nutrition information shall be enclosed in a box by use of lines, shall
be all black or one color type, and shall be printed on a white or other
neutral contrasting background whenever practical.
(1) The subheading ``Serving Size'' shall be placed under the
heading and aligned on the left side of the nutrition label. The serving
size shall be determined in accordance with Sec. 101.9(b) and
Sec. 101.12(b), Table 2. Serving size shall be expressed using a term
that is appropriate for the form of the supplement, such as ``tablets,''
``capsules,'' ``packets,'' or ``teaspoonfuls.''
(2) 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.
(3) A listing of all nutrients required in Sec. 101.9(c) that are
present in the dietary supplement in quantitative amounts by weight that
exceed the amount that can be declared as zero in Sec. 101.9(c). Those
nutrients that are not present, or present in amounts that would be
declared as zero, shall not be declared. In addition, potassium shall be
declared except when present in quantitative amounts by weight that
allow a declaration of zero. The name of each nutrient listed shall be
immediately followed by the quantitative amount by weight of the
nutrient. Nutrient names and quantitative amounts shall be presented in
a column under the heading ``Amount Per Serving'' and aligned on the
left side of the nutrition label. The heading ``Amount Per Serving''
shall be separated from other information on the label by a bar above
and beneath it, except that when calories are listed, the bar shall be
placed beneath the calorie declaration. When the serving size of the
product is one unit (e.g., 1 tablet), a heading consistent with the
declaration of serving size, such as ``Amount per Tablet'' or ``Each
Tablet Contains,'' may be used in place of the heading ``Amount per
Serving.'' Other appropriate terms, such as capsule, packet, or
teaspoonful, may be used in place of the term ``Serving.''
(i) These amounts shall be expressed in the increments specified in
Sec. 101.9(c), except that the amounts of vitamins and minerals,
excluding sodium and potassium, declared on the nutrition label shall be
the actual amount of the vitamin or mineral included in the dietary
supplement, using the units of measure and the levels of significance
given in Sec. 101.9(c). In declaring the amounts of vitamins and
minerals, 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
copper is given in whole milligrams, but the quantitative amount may be
declared in tenths of a milligram). Amounts for chloride and manganese
shall be expressed in mg,
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and, amounts for chromium, molybdenum, selenium, and vitamin K shall be
expressed in micrograms. These values shall be expressed in whole
numbers.
(ii) Nutrients that are present shall be listed in the order
specified in Sec. 101.9(c); except that, when present, vitamin K shall
follow vitamin E; calcium and iron shall follow pantothenic acid;
selenium shall follow zinc; and manganese, chromium, molybdenum,
chloride, sodium, and potassium shall follow copper. 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. A bar shall
separate the last nutrient to be listed from the bottom of the nutrition
label, as shown in the sample labels in paragraph (c)(9) of this
section.
(iii) If the product contains two or more separately packaged
dietary supplements of vitamins and minerals (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 may be presented
as specified in this paragraph in individual nutrition labels or in one
aggregate nutrition label with separate columns declaring the
quantitative amounts for each package as illustrated in paragraph
(c)(9)(iii) of this section.
(iv) The percent of vitamin A that is present as beta-carotene may
be declared, to the nearest whole percent, immediately adjacent to or
beneath the nutrient name (e.g., ``Vitamin A 5000 IU (90 percent as
beta-carotene)''), except that the declaration is required when a claim
is made about 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 5000 IU (90 percent (4500 IU) as
beta-carotene)'').
(v) The following synonyms may be added in parenthesis immediately
following the name of these nutrients: Vitamin C (ascorbic acid),
thiamin (vitamin B1), riboflavin (vitamin B2), folate--either folic acid
or folacin may be used, and calories (energy). Energy content per
serving may be expressed in kilojoules units, added in parentheses
immediately following the statement of caloric content.
(vi) All nutrients shall be displayed with uniform type size, style,
color, and prominence.
(4) A listing of the percent of the Daily Value (i.e., the percent
of the RDI as established in Sec. 101.9(c)(8)(iv) or DRV as established
in Sec. 101.9(c)(9)), where appropriate, of all nutrients listed in the
nutrition label, except that the percent for protein may be omitted as
provided in Sec. 101.9(c)(7), no percent shall be given for 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 vitamin K, selenium, manganese, chromium, molybdenum, or chloride.
This information shall be presented in one column aligned under the
heading of ``% Daily Value'' and to the right of the column of nutrient
names and 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'' or placed beneath this
heading and the bar underneath it, except that ``% Daily Value'' shall
be placed beneath this bar when calorie information is required to be
declared. Calorie information shall be placed beneath ``Amount Per
Serving'' and above the bar.
(i) The percent of Daily Value 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 RDI or DRV for
the specified nutrient and multiplying by 100, except that the percent
for protein shall be calculated as specified in Sec. 101.9(c)(7)(ii).
The numerical value shall be followed by the symbol for percent (i.e.,
%).
(ii) The percentages based on RDI's and on DRV's shall be expressed
to the nearest whole percent, except that ``Less than 1%'' may be used
in place of
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``0%'' when the declaration of the quantitative amount by weight is a
value greater than zero.
(iii) The percent of Daily Value for vitamins and minerals shall be
based on RDI 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 (c)(9)(ii) of this section.
(iv) If the product contains two or more separately packaged dietary
supplements of vitamins and minerals (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 percent of Daily Value may be presented as
specified in paragraph (b)(4) of this section in individual nutrition
labels or in one aggregate nutrition label with separate columns
declaring the percent of Daily Value for each package as illustrated in
paragraph (c)(9)(iii) of this section.
(v) If the percent of Daily Value is declared for total fat,
saturated fat, total carbohydrate, dietary fiber, or protein, the value
shall be followed by an asterisk that refers to another asterisk at the
bottom of the nutrition label that states ``Percent Daily Values are
based on a 2,000 calorie diet.''
(vi) When no percent is given for sugars, or 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, when no percent is given for vitamin K, selenium,
manganese, chromium, molybdenum, or chloride, an asterisk shall be
placed in the ``Percent Daily Value'' column that shall refer to another
asterisk that is placed at the bottom of the nutrition label and
followed by the statement ``Daily Value not established.''
(c) Nutrition information specified in this section shall be
presented as follows:
(1) The title of ``Nutrition 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 highlighted (reverse printing is not permitted
as a form of highlighting) to distinguish them from other information.
(2) All information within the nutrition label shall utilize a
single easy-to-read type style.
(3) All information within the nutrition label shall utilize upper
and lower case 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.
(4) All information within the nutrition label shall have at least
one point leading (i.e., space between two lines of text).
(5) Letters should never touch.
(6) All information within the nutrition label on packages that have
a total surface area available to bear labeling of less than 12 square
inches shall have type size no smaller than 4.5 point; packages that
have from 12 to 40 square inches of surface area available to bear
labeling shall have type size no smaller than 6 point; and packages with
more than 40 square inches of surface area available to bear labeling
shall have type size no smaller than 8 point, except that on packages
with more than 40 square inches of available surface area, type size no
smaller than 6 point may be used for the listing of information on beta-
carotene, as specified in paragraph (b)(3)(iv) of this section, for the
headings required by paragraphs (b)(3) and (b)(4) of this section (i.e.,
``Amount Per Serving'' and ``% Daily Value''), and for the footnote
required by paragraph (b)(4)(v) of this section.
(7) A hairline rule that is centered between the lines of text shall
separate each nutrient and its corresponding percent Daily Value
required in paragraph (b)(4) of this section from the nutrient and
percent Daily Value above and beneath it, as shown in paragraph (c)(9)
of this section, and shall separate
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``Amount Per Serving'' from the calorie statement, when the listing of
calories is required.
(8) 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.
(9) The following sample labels are presented for the purpose of
illustration:
(i) Multiple vitamin.
[GRAPHIC] [TIFF OMITTED] TR01JA93.358
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(ii) Multiple vitamin for children and adults.
[GRAPHIC] [TIFF OMITTED] TR01JA93.359
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(iii) Multiple vitamins in packets.
[GRAPHIC] [TIFF OMITTED] TR01JA93.360
(10) If space is not adequate to list the required information as
shown in the sample labels in paragraph (c)(9) 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 shall be set off by a line that
distinguishes it and sets it apart from the nutrients and percent of
Daily Value information given to the left. The following sample label
illustrates this display:
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[GRAPHIC] [TIFF OMITTED] TR01JA93.361
(d)(1) Compliance with this section shall be determined in
accordance with Sec. 101.9(g)(1) through (g)(8).
(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 Food
Labeling (HFS-150), Food and Drug Administration, 200 C St. SW.,
Washington, DC 20204.
(e) Except as provided in paragraph (g) of this section, the
location of nutrition information on a label shall be in compliance with
Sec. 101.2.
(f)(1) Dietary supplements of vitamins or minerals are exempt from
this section when they are offered for sale by a manufacturer, packer,
or distributor 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 on a label or labeling or in advertising.
(2) For purposes of the paragraph, calculation of the amount of
sales shall 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.
(g) Dietary supplements of vitamins and minerals shall be subject to
the special labeling conditions specified in Sec. 101.9(j)(5)(i) and
(j)(5)(ii) for food, other than infant formula, represented or purported
to be specifically for infants and children less than 2 years of age and
4 years of age, respectively; in Sec. 101.9(j)(9) for food products
shipped in bulk form that are not for distribution
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to consumers; in Sec. 101.9(j)(13) for foods in small or intermediate-
sized packages; in Sec. 101.9(j)(15) for foods in multiunit food
containers; and, in Sec. 101.9(j)(16) for foods sold in bulk containers.
(h) Dietary supplements of vitamins and minerals shall be subject to
the misbranding provisions of Sec. 101.9(k).
[59 FR 373, Jan. 4, 1994; 59 FR 24039, May 10, 1994, as amended at 60 FR
67175, Dec. 28, 1995; 61 FR 8779, Mar. 5, 1996; 61 FR 10280, Mar. 13,
1996]
Effective Date Notes: 1. At 60 FR 67175, Dec. 28, 1995, in
Sec. 101.36, paragraphs (b)(3) introductory text, (i), (ii), (b)(4)
introductory text, and (vi) were revised, effective January 1, 1997. At
61 FR 10280, Mar. 13, 1996, in Sec. 101.36(b)(3)(ii) the terms ``vitamin
B6'' and ``vitamin B12'' was corrected to make the numbers subscript,
effective January 1, 1997. For the convenience of the reader, the
superseded text is set forth below.
Sec. 101.35 Nutrition labeling of dietary supplements of vitamins and
minerals.
* * * * *
(b) * * *
(3) A listing of all nutrients required in Sec. 101.9(c) that are
present in the dietary supplement in quantitative amounts by weight that
exceed the amount that can be declared as zero in Sec. 101.9(c). Those
nutrients that are not present, or that are present in amounts that
would be declared as zero, shall not be declared. In addition,
potassium, vitamin K, chloride, chromium, fluoride, manganese,
molybdenum, and selenium shall be declared, except when present in
quantitative amounts by weight that allow a declaration of zero. The
name of each nutrient listed shall be immediately followed by the
quantitative amount by weight of the nutrient. Nutrient names and
quantitative amounts shall be presented in a column under the heading of
``Amount Per Serving'' and aligned on the left side of the nutrition
label. The heading ``Amount Per Serving'' shall be separated from other
information on the label by a bar above and beneath it, except that when
calories are listed, the bar shall be placed beneath the calorie
declaration. When the serving size of the product is one unit (e.g., one
tablet), a heading consistent with the declaration of the serving size,
such as ``Amount Per Tablet'' or ``Each Tablet Contains,'' may be used
in place of the heading ``Amount Per Serving.'' Other appropriate terms,
such as capsule, packet, or teaspoonful, may be used in place of the
term ``Serving.''
(i) These amounts shall be expressed in the increments specified in
Sec. 101.9(c), except that the amounts of vitamins and minerals,
excluding sodium and potassium, declared on the nutrition label shall be
the actual amount of the vitamin or mineral included in the dietary
supplement, using the units of measure and the levels of significance
given in Sec. 101.9(c). In declaring the amounts of vitamins and
minerals, 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
copper is given in whole milligrams (mg), but the quantitative amount
may be declared in tenths of a mg). Amounts for chloride, fluoride, and
manganese shall be expressed in mg, and, amounts for chromium,
molybdenum, selenium, and vitamin K shall be expressed in micrograms.
These values shall be expressed in whole numbers, except that tenths may
be used for fluoride.
(ii) Nutrients that are present shall be listed in the order
specified in Sec. 101.9(c); except that, when present, vitamin K shall
follow vitamin E; calcium and iron shall follow pantothenic acid;
selenium shall follow zinc; and manganese, fluoride, chromium,
molybdenum, chloride, sodium, and potassium shall follow copper. 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,
fluoride, chromium, molybdenum, chloride, sodium, and potassium. A bar
shall separate the last nutrient to be listed from the bottom of the
nutrition label, as shown in the sample labels in paragraph (c)(9) of
this section.
* * * * *
(4) A listing of the percent of the Daily Value (i.e., the percent
of the RDI as established in Sec. 101.9(c)(8)(iv) or DRV as established
in Sec. 101.9(c)(9)), where appropriate, of all nutrients listed in the
nutrition label, except that the percent for protein may be omitted as
provided in Sec. 101.9(c)(7) and no percent shall be given for sugars,
vitamin K, chloride, chromium, fluoride, manganese, molybdenum, and
selenium. This information shall be presented in one column aligned
under the heading of``% Daily Value'' and to the right of the column of
nutrient names and 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'' or placed beneath this
heading and the bar underneath it, except that ``% Daily Value'' shall
be placed beneath this bar when calorie information is required to be
declared. Calorie information
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shall be placed beneath ``Amount Per Serving'' and above the bar.
* * * * *
(vi) When no percent is given for sugars, vitamin K, chloride,
chromium, fluoride, manganese, molybdenum, or selenium, an asterisk
shall be placed in the ``% Daily Value'' column that shall refer to
another asterisk that is placed at the bottom of the nutrition label and
is followed by the statement ``Daily Value not established.''
* * * * *
2. At 61 FR 8779, Mar. 5, 1996, in Sec. 101.36, paragraph (b)(3)(v)
was amended by removing the words ``folate (folacin)'' and by adding in
their place the words ``folate--either folic acid or folacin may be
used'', effective April 19, 1996.