[Federal Register Volume 86, Number 190 (Tuesday, October 5, 2021)]
[Rules and Regulations]
[Pages 55300-55439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21011]
Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 /
Rules and Regulations
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1100, 1107 and 1114
[Docket No. FDA-2019-N-2854]
RIN 0910-AH44
Premarket Tobacco Product Applications and Recordkeeping
Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, us, or we)
is issuing a final rule that sets forth requirements for premarket
tobacco product applications (PMTAs) and requires manufacturers to
maintain records establishing that their tobacco products are legally
marketed. The rule will help ensure that PMTAs contain sufficient
information for FDA to determine whether a marketing granted order
should be issued for a new tobacco product. The rule codifies the
general procedures FDA will follow when evaluating PMTAs and creates
postmarket reporting requirements for applicants that receive marketing
granted orders. The rule also requires tobacco product manufacturers to
keep records establishing that their tobacco products are legally
marketed, such as documents showing that a tobacco product is not
required to undergo premarket review or has received premarket
authorization.
DATES: This rule is effective November 4, 2021.
FOR FURTHER INFORMATION CONTACT: Paul Hart, Office of Regulations,
Center for Tobacco Products (CTP), Food and Drug Administration,
Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335,
Silver Spring, MD 20993, 877-287-1373, [email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
Executive Summary
A. Purpose of the Regulatory Action
B. Legal Authority
C. Summary of Major Provisions
D. Costs and Benefits
Table of Abbreviations/Commonly Used Acronyms
I. Background
II. Legal Authority
III. General Description of Comments on the Proposed Rule
IV. Description of the Final Regulations for, and the Comments on
and FDA's Responses Regarding, the Maintenance of Records
Demonstrating That a Tobacco Product Was Commercially Marketed in
the United States as of February 15, 2007 (Part 1100, Subpart C)
A. Purpose and Scope (Sec. 1100.200)
B. Definitions (Sec. 1100.202)
C. Recordkeeping Requirements (Sec. 1100.204)
V. Description of the Final Regulations for, and the Comments and
FDA's Responses Regarding, the Maintenance of Records Relating to
Exemptions From the Requirements of Demonstrating Substantial
Equivalence (Sec. 1107.3)
A. Definition
B. Record Maintenance
C. Record Quality
D. Record Retention
VI. Description of the Final Regulations for, and the Comments and
FDA's Responses Regarding, Premarket Tobacco Product Applications
(Part 1114)
VII. General (Part 1114, Subpart A)
A. Scope (Sec. 1114.1)
B. Definitions (Sec. 1114.3)
VIII. Premarket Tobacco Product Applications (Part 1114, Subpart B)
A. Application Submission (Sec. 1114.5)
B. Required Content and Format (Sec. 1114.7)
C. Amendments (Sec. 1114.9)
D. Withdrawal by Applicant (Sec. 1114.11)
E. Change in Ownership of an Application (Sec. 1114.13)
F. Supplemental Application Submission (Sec. 1114.15)
G. Resubmissions (Sec. 1114.17)
IX. FDA Review (Part 1114, Subpart C)
A. Communications Between FDA and Applicants (Sec. 1114.25)
B. Review Procedure (Sec. 1114.27)
C. FDA Action on an Application (Sec. 1114.29)
D. Issuance of a Marketing Granted Order (Sec. 1114.31)
[[Page 55301]]
E. Issuance of a Marketing Denial Order (Sec. 1114.33)
F. Withdrawal of a Marketing Granted Order (Sec. 1114.35)
G. Temporary Suspension of a Marketing Granted Order (Sec.
1114.37)
X. Postmarket Requirements (Part 1114, Subpart D)
A. Postmarket Changes (Sec. 1114.39)
B. Reporting Requirements (Sec. 1114.41)
C. Requirements for Periodic Reports
D. Serious and Unexpected Adverse Experience Reporting
E. Submission of Additional Information
XI. Miscellaneous (Part 1114, Subpart E)
A. Record Retention (Sec. 1114.45)
B. Confidentiality (Sec. 1114.47)
C. Electronic Submission (Sec. 1114.49)
XII. Paperwork Reduction Act of 1995
XIII. Federalism: Executive Order 13132
XIV. Congressional Review Act
XV. Consultation and Coordination with Indian Tribal Governments
XVI. Analysis of Environmental Impact
XVII. Economic Analysis of Impacts
A. Introduction
B. Summary of Costs and Benefits
XVIII. Effective Date
XIX. References
Executive Summary
A. Purpose of the Regulatory Action
FDA is issuing this final rule to improve the efficiency of the
submission and review of PMTAs. We are finalizing this rule after
reviewing comments to the proposed rule (84 FR 50566, September 25,
2019) (hereinafter referred to as the proposed rule) and are basing
this rule on the experience the Agency has gained by reviewing several
types of premarket applications submitted by industry, including
substantial equivalence (SE) reports, requests for exemptions from the
SE requirements, modified risk tobacco product applications (MRTPAs),
and PMTAs. As described in the proposed rule, FDA has received
thousands of premarket applications that range widely in the level of
detail they contain. This rule describes and sets forth requirements
related to the content and format of PMTAs and will provide applicants
with a better understanding of the information a PMTA must contain. The
rule requires an applicant to submit detailed information regarding the
physical aspects of its new tobacco product and full reports of
information regarding investigations that may show the health risks of
the new tobacco product and whether it presents the same or different
risks compared to other tobacco products. FDA is requiring the
submission of these health risk investigations to ensure it understands
the full scope of what is known about the potential health risks of a
new tobacco product.
The rule also addresses issues such as the procedures by which FDA
reviews a PMTA, retention of records related to a PMTA, confidentiality
of application information, electronic submission of the PMTA and
amendments, and postmarket reporting requirements. FDA will announce
the withdrawal of its September 2011 draft guidance entitled
``Applications for Premarket Review of New Tobacco Products'' in the
Federal Register. Additionally, FDA will update the guidance for
industry entitled ``Premarket Tobacco Product Applications for
Electronic Nicotine Delivery Systems'' (the ENDS PMTA Guidance) \1\ to
ensure the product-specific recommendations on preparing and submitting
PMTAs for ENDS are consistent with the requirements of this rule.
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\1\ Available at https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance.
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Additionally, the rule creates requirements for the maintenance of
records demonstrating the legal marketing status of Pre-Existing
Tobacco Products (i.e., tobacco products, including those products in
test markets) that were commercially marketed in the United States as
of February 15, 2007) and products that are exempt from the
requirements of demonstrating substantial equivalence. These
recordkeeping requirements will allow FDA to more efficiently determine
the legal marketing status of a tobacco product.
B. Legal Authority
This rule is being issued under FDA's authority to require
premarket review of new tobacco products under section 910 of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387j), FDA's
authority to require records and reports under section 909(a) of the
FD&C Act (21 U.S.C. 387i(a)), FDA's authorities related to adulterated
and misbranded tobacco products under sections 902 and 903 (21 U.S.C.
387b and 387c), as well as FDA's rulemaking and inspection authorities
under sections 701(a) and 704 of the FD&C Act (21 U.S.C. 371(a) and
374).
C. Summary of Major Provisions
This rule describes and sets forth content and format requirements
for PMTAs and includes FDA's interpretations of various provisions in
section 910 of the FD&C Act. Under the rule, a PMTA must contain
information necessary for FDA to determine whether it should issue a
marketing granted order for a new tobacco product under section
910(c)(1)(A) of the FD&C Act. Specifically, the PMTA must enable FDA to
find whether: (1) There is a showing that permitting the marketing of
the new tobacco product would be appropriate for the protection of the
public health; (2) the methods used in, or the facilities and controls
used for, the manufacture, processing, or packing of the product
conform to the requirements of section 906(e) of the FD&C Act (21
U.S.C. 387f(e)); (3) the product labeling is not false or misleading in
any particular; and (4) the product complies with any applicable
product standard in effect under section 907 of the FD&C Act (21 U.S.C.
387g) or there is adequate information to justify a deviation from such
standard. The rule will also allow applicants to submit a supplemental
PMTA or a resubmission, which will improve the efficiency of submitting
and reviewing an application in certain instances. A supplemental PMTA
can be submitted in situations where an applicant is seeking
authorization for a new tobacco product that is a modified version of a
tobacco product for which they have already received a marketing
granted order. A resubmission can be submitted to address application
deficiencies following the issuance of a marketing denial order.
In addition, the rule explains how an applicant can amend or
withdraw a PMTA and how an applicant may transfer ownership of a PMTA
to a new owner. The rule also addresses FDA communications with
applicants and identifies the actions that FDA may take after receipt
of a PMTA. Where an applicant receives a marketing granted order, the
rule requires the submission of postmarket reports, addresses when FDA
may withdraw a marketing granted order, and explains how long an
applicant will be required to maintain the records related to the PMTA
and postmarket reports. The rule also sets forth FDA's disclosure
procedures regarding PMTAs and requires the electronic submission of
PMTAs, unless the applicant requests and obtains a waiver.
Additionally, the rule requires tobacco product manufacturers to
maintain records related to the legal marketing of Pre-Existing Tobacco
Products and products that are exempt from the requirements of
demonstrating substantial equivalence.
D. Costs and Benefits
The final rule will require manufacturers of Pre-Existing Tobacco
Products and manufacturers of products that are exempt from the
requirements of demonstrating SE to maintain records to demonstrate
that they can legally market their products. For products that receive
a PMTA marketing granted
[[Page 55302]]
order, the final rule will require certain postmarket reporting,
including periodic reporting and adverse experience reporting. The
final rule will also implement and set forth requirements for the
content and format of PMTAs and the general procedures we intend to
follow in reviewing and communicating with applicants.
The final rule will make the review of PMTAs more efficient. As a
result, the final rule will create cost savings for FDA related to the
review of some PMTAs. The final rule will also create cost savings for
FDA and for PMTA applicants by reducing the number of PMTAs submitted.
We estimate that annualized benefits over 20 years will equal $2.04
million at a 7 percent discount rate, with a low estimate of $1.36
million and a high estimate of $2.85 million. We estimate that
annualized benefits over 20 years will equal $2.08 million at a 3
percent discount rate, with a low estimate of $1.43 million and a high
estimate of $2.84 million.
This is the first regulation to address the costs of PMTA
requirements for new, originally regulated tobacco products. While we
already included the costs to submit and review PMTAs for deemed
tobacco products \2\ in the final regulatory impact analysis (RIA) for
the deeming final rule, no RIA includes the costs to submit and review
PMTAs for originally regulated tobacco products. Therefore, we include
the costs to prepare and review PMTAs for these tobacco products in
this analysis.
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\2\ Note that for the purposes of this final rule, ``deemed
tobacco products'' are those tobacco products subject to Chapter IX
of the FD&C Act as a result of regulations enacted by FDA (Deeming
Tobacco Products To Be Subject to the Federal Food, Drug, and
Cosmetic Act, as Amended by the Family Smoking Prevention and
Tobacco Control Act; Restrictions on the Sale and Distribution of
Tobacco Products and Required Warning Statements for Tobacco
Products, 81 FR 28974, May 10, 2016 (``deeming final rule'')). These
products include cigars, pipe tobacco, waterpipe tobacco, electronic
nicotine delivery systems (ENDS), and other novel tobacco products.
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The final rule will increase the cost for applicants to prepare a
PMTA. As a result, the final rule will generate incremental costs
related to the preparation of PMTAs for ENDS products. Firms will incur
costs to maintain and submit postmarket reports and we will incur costs
to review these reports. Finally, firms will incur costs to read and
understand the rule and costs to maintain records for some Pre-Existing
Tobacco Products. We estimate that annualized costs over 20 years will
equal $4.73 million at a 7 percent discount rate, with a low estimate
of $2.63 million and a high estimate of $7.45 million. We estimate that
annualized costs over 20 years will equal $4.86 million at a 3 percent
discount rate, with a low estimate of $2.50 million and a high estimate
of $7.95 million.
Table of Abbreviations/Commonly Used Acronyms
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Abbreviation acronym What it means
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APPH................................ Appropriate for the protection of
public health
CAS................................. Chemical Abstracts Service
CCI................................. Confidential commercial
information
CCS................................. Container Closure System
CGMP................................ Current good manufacturing
practices
CORESTA............................. Cooperation Centre for Scientific
Research Relative to Tobacco
CTP................................. Center for Tobacco Products
DPF................................. Denier per filament
EA.................................. Environmental assessment
ENDS................................ Electronic nicotine delivery
systems
FDA................................. Food and Drug Administration
FD&C Act............................ Federal Food, Drug, and Cosmetic
Act
FEI................................. Facility Establishment Identifier
FOIA................................ Freedom of Information Act
GLP................................. Good laboratory practice
HACCP............................... Hazard analysis and critical
control point
HCI................................. Health Canada Intense
HHS................................. Department of Health and Human
Services
HPHC................................ Harmful or potentially harmful
constituent
HTP................................. Heated tobacco products
IUPAC............................... International Union of Pure and
Applied Chemistry
ICH................................. International Council for
Harmonization
IRB................................. Institutional Review Board
ISO................................. International Organization for
Standardization
MDSS................................ Manufacturing Data Sheet
Specification
mL.................................. Milliliters
mm.................................. Minimum and maximum diameter
MRTP................................ Modified risk tobacco product
MRTPA............................... Modified risk tobacco product
application
NCI................................. National Cancer Institute
NEPA................................ National Environmental Policy Act
of 1969
NNK................................. 4-(methylnitrosamino)-1-(3-
pyridyl)-1-butanone
NNN................................. N-nitrosonornicotine
NTRM................................ Nontobacco related material
NYTS................................ National Youth Tobacco Survey
OMB................................. Office of Management and Budget
OTDN................................ Oral tobacco-derived nicotine
OV.................................. Oven volatiles
PDU................................. Power delivery unit
PK.................................. Pharmacokinetic
PM.................................. Particulate matter
PMTA................................ Premarket tobacco product
application
RIA................................. Regulatory Impact Analysis
RTA................................. Refuse to accept
RTF................................. Refuse to file
RYO................................. Roll-your-own
SAS................................. Statistical Analysis Software
SE.................................. Substantial equivalence
Secretary........................... Secretary of Health and Human
Services
SES................................. Socioeconomic status
STN................................. Submission tracking number
TAMC................................ Total aerobic microbial count
TPMF................................ Tobacco product master file
TSNA................................ Tobacco specific nitrosamine
TYMC................................ Total yeast and mold count
TPSAC............................... Tobacco Products Scientific
Advisory Committee
UNII................................ Unique ingredients identifier
aw.................................. Water activity
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I. Background
The Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111-31) provides FDA with the authority to
regulate tobacco products under the FD&C Act. The FD&C Act, as amended
by the Tobacco Control Act, generally requires that a new tobacco
product undergo premarket review by FDA before it may be introduced or
delivered for introduction into interstate commerce. Section 910(a)(1)
of the FD&C Act defines a ``new tobacco product'' as: (1) Any tobacco
product (including those products in test markets) that was not
commercially marketed in the United States as of February 15, 2007, or
(2) any modification (including a change in design, any component, any
part, or any constituent, including a smoke constituent, or in the
content, delivery or form of nicotine, or any other additive or
ingredient) of a tobacco product where the modified product was
commercially marketed in the United States after February 15, 2007 (21
U.S.C. 387j(a)(1)).
The FD&C Act establishes three premarket review pathways for a new
tobacco product:
Submission of a PMTA under section 910(b);
submission of a report intended to demonstrate that the
new tobacco product is substantially equivalent to a predicate tobacco
product under section 905(j)(1)(A) (21 U.S.C. 387e(j)(1)(A)) (SE
Report); \3\ and
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\3\ Additionally, section 910(a)(2)(B) of the FD&C Act also
allows for the continued marketing of new tobacco products first
introduced or delivered for introduction into interstate commerce
for commercial distribution after February 15, 2007, and prior to
March 22, 2011, for which a manufacturer submitted an SE Report
prior to March 23, 2011 (``provisional tobacco products''), unless
FDA issues an order that the tobacco product is not substantially
equivalent.
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submission of a request for an exemption under section
905(j)(3) (implemented at 21 CFR 1107.1) (exemption request).
Generally, if a new tobacco product is marketed without either a
marketing granted order (for PMTAs), a
[[Page 55303]]
substantially equivalent order (for SE reports), or a finding of
exemption from SE (for exemption requests), it is adulterated under
section 902 of the FD&C Act and misbranded under section 903 of the
FD&C Act and subject to enforcement action.
Since 2010, FDA has received a large volume of premarket
applications for tobacco products, thousands of which have been PMTAs.
Of these PMTAs, FDA has completed its full substantive review and acted
on several sets of bundled PMTAs, which are single submissions
containing PMTAs for a number of similar or related tobacco products.
To assist manufacturers in preparing PMTAs, FDA has issued guidance,
conducted webinars, met with manufacturers, hosted public meetings
regarding premarket submissions, and posted the technical project lead
reviews (which describe the reviews completed on specific PMTAs) and
marketing granted orders issued to date. FDA has also completed review
and issued decisions on hundreds of exemption requests, thousands of SE
reports, and thousands of voluntarily submitted requests for Pre-
Existing Tobacco Product status review, which has provided FDA with
information and experience to use when implementing the PMTA program
and establishing recordkeeping requirements.
FDA issued the proposed rule on September 25, 2019, to set forth
proposed requirements related to the PMTA premarket pathway and outline
the information needed for FDA to determine whether it will issue a
marketing granted order under the pathway. FDA received about 1,000
comments to the docket for the proposed rule, including comments from
individuals, academia, healthcare professionals, consumer advocacy
groups, industry, public health groups, and trade associations. We
summarize and respond to these comments in section III of this rule.
After considering these comments, FDA developed this final rule, which
includes changes made in response to the comments.
II. Legal Authority
As described in the following paragraphs, FDA is describing and
setting forth requirements for the content, format, submission, and
review of PMTAs, as well as other requirements related to PMTAs,
including recordkeeping requirements, and postmarket reporting. FDA is
also creating recordkeeping requirements regarding the legal marketing
of Pre-Existing Tobacco Products and products that are exempt from the
requirements of demonstrating substantial equivalence. In accordance
with section 5 of the Tobacco Control Act, FDA intends that the
requirements that are established by this rule be severable and that
the invalidation of any provision of this rule would not affect the
validity of any other part of this rule.
Section 910(a)(2) of the FD&C Act requires that a new tobacco
product be the subject of a marketing granted order unless FDA has
issued an order finding it to be substantially equivalent to a
predicate product, or exempt from the requirements of demonstrating
substantial equivalence.\4\ A manufacturer may choose to submit a PMTA
under section 910(b) of the FD&C Act to satisfy the requirements of
premarket review. Section 910(b)(1) describes the required contents of
a PMTA and, in addition to the items specified in section 910(b)(1)(A)
through (F), allows FDA to require applicants to submit other
information relevant to the subject matter of the application under
section 910(b)(1)(G). Section 910(c)(2) of the FD&C Act requires FDA to
issue an order denying a PMTA if it finds that the applicant has not
made a showing that permitting the marketing of the new tobacco product
would be appropriate for the protection of the public health; the
methods used in, or the facilities or controls used for, the
manufacture, processing, or packing of the product do not conform to
the requirements of section 906(e) of the FD&C Act; the proposed
labeling is false or misleading in any particular; or the product has
not been shown to meet the requirements of a product standard in effect
and there is a lack of adequate information to justify a deviation from
the standard, if applicable.
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\4\ See section I for a discussion of provisional tobacco
products and their relation to the premarket review requirements.
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Section 909(a) of the FD&C Act authorizes FDA to issue regulations
requiring tobacco product manufacturers or importers to maintain
records, make reports, and provide information as may be reasonably
required to assure that their tobacco products are not adulterated or
misbranded and to otherwise protect public health. Section 910(f) of
the FD&C Act allows FDA to require that applicants who receive
marketing granted orders establish and maintain records, and submit
reports to enable FDA to determine, or facilitate a determination of,
whether there are or may be grounds for withdrawing or temporarily
suspending an order.
Section 910(d)(1) of the FD&C Act grants FDA authority to issue an
order withdrawing a marketing granted order if FDA finds:
That the continued marketing of such tobacco product no
longer is appropriate for the protection of the public health;
that the application contained or was accompanied by an
untrue statement of a material fact;
that the applicant:
[cir] Has failed to establish a system for maintaining records, or
has repeatedly or deliberately failed to maintain records or to make
reports, required by an applicable regulation under section 909 of the
FD&C Act;
[cir] has refused to permit access to, or copying or verification
of, such records as required by section 704 of the FD&C Act; or
[cir] has not complied with the requirements of section 905 of the
FD&C Act;
on the basis of new information before the Secretary of
Health and Human Services (the Secretary) with respect to such tobacco
product, evaluated together with the evidence before the Secretary when
the application was reviewed, that the methods used in, or the
facilities and controls used for, the manufacture, processing, packing,
or installation of such tobacco product do not conform with the
requirements of section 906(e) of the FD&C Act and were not brought
into conformity with such requirements within a reasonable time after
receipt of written notice from the Secretary of nonconformity;
on the basis of new information before the Secretary,
evaluated together with the evidence before the Secretary when the
application was reviewed, that the labeling of such tobacco product,
based on a fair evaluation of all material facts, is false or
misleading in any particular and was not corrected within a reasonable
time after receipt of written notice from the Secretary of such fact;
or
on the basis of new information before the Secretary,
evaluated together with the evidence before the Secretary when such
order was issued, that such tobacco product is not shown to conform in
all respects to a tobacco product standard which is in effect under
section 907 of the FD&C Act, compliance with which was a condition to
the issuance of an order relating to the application, and that there is
a lack of adequate information to justify the deviation from such
standard, if applicable.
Under section 902(6) of the FD&C Act, a tobacco product is
adulterated if it is required to have premarket review and does not
have an order in effect under
[[Page 55304]]
section 910(c)(1)(A)(i), or if it is in violation of an order under
section 910(c)(1)(A) of the FD&C Act. Under section 903(a)(6) of the
FD&C Act, a tobacco product is misbranded if a notice or other
information respecting it was not provided as required by section
905(j) of the FD&C Act. In addition, a tobacco product is misbranded if
there is a failure or refusal to furnish any material or information
required under section 909 (section 903(a)(10)(B) of the FD&C Act).
Section 701(a) of the FD&C Act also gives FDA general rulemaking
authority to issue regulations for the efficient enforcement of the
FD&C Act and section 704 of the FD&C Act provides FDA with general
inspection authority.
III. General Description of Comments on the Proposed Rule
FDA received over 1,000 comments on the proposed rule. The comments
came from individuals, academia, healthcare professionals, consumer
advocacy groups, industry, public health groups, and trade
associations. In addition to the comments specific to this rulemaking
that we address in sections IV through XVIII, we received many general
comments expressing support or opposition to the rule. Some of these
comments express broad policy views and do not address specific points
related to this rulemaking. Therefore, these general comments do not
require a response. Other comments addressed topics outside the scope
of this rulemaking, such as requests for product standards under
section 907 of the FD&C Act, recommendations regarding the compliance
date for manufacturers of deemed tobacco products to submit premarket
applications, statements that ENDS and pipes should not be regulated as
tobacco products, and that pipes should not be subject to the
requirements of premarket review.
We describe and respond to comments in the description of the final
rule in sections IV through XVIII. To make it easier to identify
comments and our responses, the word ``Comment,'' in parentheses, will
appear before each comment, and the word ``Response,'' in parentheses,
will appear before each response. We have numbered the comments to make
it easier to distinguish between comments; the numbers are for
organizational purposes only and do not reflect the order in which we
received the comments or any value associated with the comment. We have
combined similar comments, or comments on similar topics that can be
addressed by a single response, under one numbered comment.
IV. Description of the Final Regulations for, and Comments and FDA's
Responses Regarding, the Maintenance of Records Demonstrating That a
Tobacco Product Was Commercially Marketed in the United States as of
February 15, 2007 (Part 1100, Subpart C)
The rule adds subpart C regarding records to part 1100 of
subchapter K of Title 21. Other than the comments and changes described
in this section regarding the proposed definition of the term
``grandfathered tobacco product,'' (now referred to as a ``Pre-Existing
Tobacco Product''), FDA received no comments regarding proposed part
1100 and FDA is finalizing the requirements as proposed without
additional changes.
A. Purpose and Scope (Sec. 1100.200)
Subpart C of part 1100 establishes requirements for the maintenance
of records by tobacco product manufacturers who introduce a Pre-
Existing Tobacco Product, or deliver it for introduction, into
interstate commerce. These requirements are created under the authority
of section 909 of the FD&C Act, which authorizes FDA to require tobacco
product manufacturers to establish and maintain records to assure that
a tobacco product is not adulterated or misbranded and to otherwise
protect public health. Under section 902(6)(A), a tobacco product is
adulterated if it is required by section 910(a) of the FD&C Act to have
premarket review and does not have an order in effect under section
910(c)(1)(A)(i). In addition, under section 903(a)(6) of the FD&C Act,
a tobacco product is misbranded if a notice or other information
respecting it was not provided as required by section 905(j) of the
FD&C Act. The records that are required under this subpart demonstrate
that a tobacco product is a Pre-Existing Tobacco Product and,
therefore, not required by section 910(a) to have premarket review and
not adulterated or misbranded if marketed without an FDA order. FDA is
basing these requirements on its experience gained by performing
thousands of Pre-Existing Tobacco Product status reviews conducted
during its review of SE reports and at manufacturers' voluntary
requests. These requirements are needed because currently manufacturers
do not always maintain sufficient documentation to demonstrate that
their tobacco product is a Pre-Existing Tobacco Product. The records
that are required under this rule will allow FDA to more quickly and
efficiently determine whether a tobacco product is a Pre-Existing
Tobacco Product.
B. Definitions (Sec. 1100.202)
Section 1100.202 sets forth the meaning of terms as they apply to
part 1100:
1. Tobacco Product
The rule defines the term ``tobacco product'' consistent with
section 201(rr)(1) of the FD&C Act (21 U.S.C. 321(rr)(1))
2. Tobacco Product Manufacturer
The rule defines the term ``tobacco product manufacturer''
consistent with section 900(20) of the FD&C Act (21 U.S.C. 387(20)).
FDA interprets the phrase ``manufactures, fabricates, assembles,
processes, or labels'' in the definition as including, but not being
limited to: (1) Repackaging or otherwise changing the container,
wrapper, or labeling of any tobacco product package; (2) reconstituting
tobacco leaves; or (3) applying any chemical, additive, or substance to
the tobacco leaf other than potable water in the form of steam or mist.
For the purposes of the definition, ``finished tobacco product'' means
a tobacco product, including all components and parts, sealed in final
packaging (e.g., filters or filter tubes sold to consumers separately
or as part of kits) or in the final form in which it is intended to be
sold to consumers.
3. Commercially Marketed
In the proposed rule, FDA proposed to define ``commercially
marketed'' as ``selling or offering a tobacco product for sale to
consumers in all or in parts of the United States.''
(Comment 1) Several comments discussed specific changes to the
proposed definition of the term ``commercially marketed.'' One comment
stated that the proposed definition of commercially marketed departs
from the plain meaning of the statutory language and FDA's historical
approach to evaluating whether a product is a Pre-Existing Tobacco
Product. Specifically, comments raised concerns that inclusion of ``in
all or in parts of the United States'' seems to depart from the plain
meaning of the statutory phrase ``commercially marketed in the United
States'' and requires that firms demonstrate that a product was offered
nationwide, in multiple regions, or even across State lines. The
comments also argue that, for example, the statutory definition of
``new tobacco product'' does not state or imply that a product offered
for sale within a particular State cannot qualify as ``commercially
marketed in the United States.'' The comments state that FDA should
define ``commercially marketed'' as ``offered for sale in the
[[Page 55305]]
United States to any individual or entity by advertising or by any
other manner used to communicate that the tobacco product is available
for purchase.'' Another comment expressed similar concerns, stating
that the definition seems to require the selling or marketing of
products directly to consumers as well as offering it for sale
nationwide.
(Response 1) After reviewing the comments related to commercially
marketed, we have added a definition of this term to the final rule,
which reflects the input we received. Given the wide variety of input
we have received on this term as well as the dictionary definition, we
do not believe that the term ``commercially marketed'' has a plain
meaning. Instead, we have added a definition stating that
``commercially marketed'' means selling or offering for sale a tobacco
product in the United States to consumers or to any person for the
eventual purchase by consumers in the United States. This definition
clarifies that tobacco products that are not sold or offered for sale
in order to reach consumers within the United States, such as tobacco
products sold solely for export, fall outside of the definition of
commercial marketing. Examples of products that may not be covered by
the definition of commercially marketed include investigational tobacco
products and free samples. Examples of documentation of commercial
marketing may include the following items listed in Sec. 1100.204(a):
dated bills of lading, dated freight bills, dated waybills, dated
invoices, dated purchase orders, dated advertisements, dated catalog
pages, dated promotional material, dated trade publications, dated
manufacturing documents, inventory lists, or any other document
demonstrating that the product was commercially marketed in the United
States as of February 15, 2007.
(Comment 2) One comment requested clarification as to whether
limited edition products would be considered test marketed products or
commercially marketed products.
(Response 2) ``Limited edition'' products are considered
commercially marketed if they were sold or offered for sale in the
United States to consumers or to any person for the eventual purchase
by consumers in the United States--regardless of whether they were
solely sold or offered for sale in a test market. Therefore, if a
``limited edition'' product was commercially marketed--even if only in
a test market--as of February 15, 2007, it would be a Pre-Existing
Tobacco Product. We note that considering test marketed products to be
commercially marketed is a change in FDA's interpretation of section
910(a)(1)(A) of the FD&C Act, which is discussed further in the
response to comment 3. However, a product that was solely in a test
market as of February 15, 2007, cannot serve as a predicate product
under section 905(j) of the FD&C Act. Test marketed products may
include, for example, products that were sold or offered for sale to
determine the commercial viability of a product through the collection
of consumer reaction data.
4. Pre-Existing Tobacco Product
In the proposed rule, we proposed to define the term
``grandfathered tobacco product'' as ``a tobacco product that was
commercially marketed in the United States as of February 15, 2007''
and does not include a tobacco product exclusively in test markets as
of that date. A grandfathered tobacco product is not subject to the
premarket requirements of section 910 of the FD&C Act.'' In the final
rule, we have changed this term from ``grandfathered tobacco product''
to ``Pre-Existing Tobacco Product'' because it more appropriately
describes these products by using the more precise ``Pre-Existing'' in
place of ``grandfathered.'' FDA received many comments regarding the
definition of ``Pre-Existing Tobacco Product,'' \5\ which are discussed
as follows.
---------------------------------------------------------------------------
\5\ Although comments were submitted regarding the term
``grandfathered tobacco product,'' we describe them using the new
term, ``Pre-Existing Tobacco Product,'' throughout this document for
clarity.
---------------------------------------------------------------------------
(Comment 3) Multiple comments discussed the proposed definition of
the term ``commercially marketed'' as well as the definition of the
term ``test marketing'' set forth in the preamble of the proposed rule
as used in, or to inform, the definitions of ``Pre-Existing Tobacco
Product'' and ``new tobacco product'' in the proposed rule. Some
comments argued that Congress was intentional in its use of test
markets in the definition of new tobacco product and, as such, a
product in test market as of February 15, 2007 (if not subsequently
modified within the meaning of section 910(a)(1)(B)), of the FD&C Act
is not a new tobacco product and is not subject to premarket review.
These comments also stated that because section 905(j)(1)(A)(i) of the
FD&C Act explicitly excludes test marketed products from the
commercially marketed products that may serve as valid predicate
products, it demonstrates that the term ``commercially marketed''
encompasses products that are test marketed (i.e., if test marketed
products did not constitute commercially marketed products, there would
have been no need for Congress to exclude them from the types of
commercially marketed products that may qualify for use as predicate
products under the substantial equivalence premarket pathway). Some
comments requested FDA include the definitions as they were defined in
the proposed rule, including as they relate to the definition of the
term ``new tobacco product'' in proposed part 1114 (21 CFR part 1114).
Other comments stated that the proposed definitions should not be
included in the final rule because they are unnecessary, confusing,
conflicting, and not useful. Specifically, some comments argued that
FDA did not provide a workable or rational basis to distinguish ``test
marketing'' from ``commercially marketed'' and the proposed definitions
do not reflect industry realities.
(Response 3) Following our consideration of these comments, we have
revised the definitions related to ``Pre-Existing Tobacco Product'' to
remove language related to ``exclusively'' test marketed.
Upon reviewing comments received, we reassessed our interpretation
of section 910(a)(1)(A) of the FD&C Act, and we agree with the comment
indicating that a tobacco product test marketed in the United States as
of February 15, 2007, is not a new tobacco product. Section
910(a)(1)(A) defines a ``new tobacco product'' to include ``any tobacco
product (including those in test markets) that was not commercially
marketed in the United States as of February 15, 2007.'' The
parenthetical ``including those in test markets'' in section
910(a)(1)(A) of the FD&C Act modifies the phrase directly before it--
``any tobacco product''--and is intended to clarify that tobacco
products commercially marketed in test markets in the United States as
of February 15, 2007, should be treated the same way as any other
tobacco product that was commercially marketed as of February 15, 2007,
i.e., they are not ``new tobacco products.'' We also agree that section
905 of the FD&C Act provides additional context that supports this
interpretation. Section 905(j)(1)(A)(i) of the FD&C Act describes
products that can serve as valid predicate tobacco products: A tobacco
product commercially marketed (other than for test marketing) in the
United States as of February 15, 2007, or a tobacco product that the
Secretary by delegation to FDA has previously determined, pursuant to
section 910(a)(3), is substantially equivalent. Here, Congress'
inclusion of the parenthetical ``(other than for test marketing)''
supports a reading of the term ``commercially marketed'' as
[[Page 55306]]
including products that were test marketed; otherwise, there would not
be the need to specifically carve out test marketed products from the
commercially marketed products that can serve as valid predicate
products.
In addition, in the preamble to the proposed rule, we explained
that FDA was considering whether to add the following definition of
test marketing: ``test marketing'' means distributing or offering for
sale (which may be shown by advertisements, etc.) a tobacco product in
the United States for the purpose of determining consumer response or
other consumer reaction to the tobacco product, with or without the
user knowing it is a test product, in which any of the following
criteria apply: (1) Offered in a limited number of regions; (2) offered
for a limited time; or (3) offered to a chosen set of the population or
specific demographic group (84 FR 50566 at 50571).
We agree with the commenter that further discussion of the term,
test marketing, is needed to more accurately capture the scope of this
term; accordingly, we are not including a definition of test marketing
in the final rule.
After reviewing these comments and for the purposes of consistency,
FDA is finalizing the definition of ``Pre-Existing Tobacco Product''
with changes to better align with the statute, first, by adding
``(including those products in test markets)'', and, second, by
removing ``and does not include a tobacco product exclusively in test
markets as of that date.'' Specifically, FDA defines a ``Pre-Existing
Tobacco Product'' to mean a tobacco product (including those products
in test markets) that was commercially marketed in the United States as
of February 15, 2007. The definition of ``Pre-Existing Tobacco
Product'' in this rule reflects FDA's interpretation that ``as of''
means ``on'', which has been included as part of previously issued
regulations and guidance.\6\ For more information on this topic, see
the response to comment 5 explaining FDA's interpretation that ``as
of'' means ``on.'' A Pre-Existing Tobacco Product is not subject to the
premarket review requirements of section 910 of the FD&C Act.
---------------------------------------------------------------------------
\6\ See the final rule entitled ``Deeming Tobacco Products To Be
Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by
the Family Smoking Prevention and Tobacco Control Act; Restrictions
on the Sale and Distribution of Tobacco Products and Required
Warning Statements for Tobacco Products'' (81 FR 28973 at 28978, May
10, 2016) and the guidance entitled ``Establishing That a Tobacco
Product Was Commercially Marketed in the United States as of
February 15, 2007'' (79 FR 58358, September 29, 2014). Available at
https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance.
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C. Recordkeeping Requirements (Sec. 1100.204)
1. Required Records
Consistent with the authority to require recordkeeping under
section 909 of the FD&C Act, Sec. 1100.204(a) requires any tobacco
product manufacturer that introduces a Pre-Existing Tobacco Product, or
delivers it for introduction, into interstate commerce to maintain
records and information necessary to adequately demonstrate that the
tobacco product was commercially marketed in the United States as of
February 15, 2007. This requirement will ensure, among other things,
that records are available to FDA during an inspection. The rule does
not require tobacco product manufacturers to maintain records for all
of the types of information listed in Sec. 1100.204(a); rather, the
list provides examples of the types of records that may be used to
demonstrate that a tobacco product was commercially marketed in the
United States as of February 15, 2007.
2. Record Maintenance
Section 1100.204(b) requires that all records maintained under this
part be legible, in the English language, and available for inspection
and copying by officers or employees duly designated by the Secretary.
This section also requires documents that have been translated from
another language into English to be accompanied by: (1) The original
language version of the document; (2) a signed statement by an
authorized representative of the manufacturer certifying that the
English language translation is complete and accurate; and (3) a brief
statement of the qualifications of the person who made the translation
(e.g., education and experience). This information will help FDA ensure
that the English language translations of documents are complete and
accurately reflect the content of the original documents.
3. Record Retention
Section 1100.204(c) requires that the records and documents
demonstrating that the tobacco product was commercially marketed as of
February 15, 2007, be retained for a period of at least 4 years from
the date that either FDA makes a Pre-Existing Tobacco Product
determination or the tobacco product manufacturer permanently ceases
the introduction or delivery for introduction into interstate commerce
of the tobacco product, whichever occurs sooner. FDA has selected 4
years to help ensure that the records will be available for at least
one biennial FDA inspection under sections 704 and 905(g) of the FD&C
Act. FDA's biennial inspections under section 905(g) of the FD&C Act
are required to occur at least once in every 2-year period after a
manufacturer registers an establishment with FDA, which could result in
inspections occurring nearly 4 years apart. Retaining records for 4
years after a manufacturer permanently ceases introduction or delivery
for introduction into interstate commerce of the tobacco product will
allow FDA to verify the Pre-Existing Tobacco Product status of the
product during the time period in which it is offered for sale to
consumers. Manufacturers that only temporarily cease the introduction
or delivery for introduction into interstate commerce of the tobacco
product must retain the records to allow FDA to verify the Pre-Existing
Tobacco Product status of the product when they resume marketing the
product. Additionally, manufacturers might want to retain records for
longer than 4 years to help establish their product is a Pre-Existing
Tobacco Product and may be eligible as a predicate product in an SE
Report if it was commercially marketed (other than for test marketing)
in the United States as of February 15, 2007.
V. Description of the Final Regulations for, and the Comments and FDA's
Responses Regarding, the Maintenance of Records Relating to Exemptions
From the Requirements of Demonstrating Substantial Equivalence (Sec.
1107.3)
The rule adds Sec. 1107.3 to part 1107 of subchapter K of Title
21. Other than the comments and changes described in this section
regarding the proposed definition of the term ``grandfathered tobacco
product'' (now referred to as a ``Pre-Existing Tobacco Product''), FDA
received no comments regarding proposed Sec. 1107.3, FDA is finalizing
the requirements as proposed with one other change; we have removed the
proposed requirement to maintain product labeling a part of Sec.
1107.3 because it is not necessary to support an abbreviated report.
Section 1107.3 establishes recordkeeping requirements related to
tobacco products that are exempt from the requirements of demonstrating
SE under section 910(a)(2)(A)(ii) of the FD&C Act. Consistent with the
authority to require recordkeeping under section 909 of the FD&C Act,
Sec. 1107.3 requires applicants that submitted an abbreviated report
under section 905(j)(1)(A)(ii) of the FD&C Act, and received a letter
from FDA
[[Page 55307]]
acknowledging the receipt of an abbreviated report, to maintain all
records necessary to support the exemption for at least 4 years from
the date FDA issues an acknowledgement letter in response to an
abbreviated report. The rule requires the applicant to maintain records
that are legible, written in English, and available for inspection and
copying by officers or employees designated by the Secretary.
Applicants may want to retain the records for a longer period if, for
example they intend to submit a subsequent exemption request for a
modification to the tobacco product.
A. Definition
Section 1107.3(a) defines ``Pre-Existing Tobacco Product'' \7\ as a
tobacco product (including those products in test markets) that was
commercially marketed in the United States as of February 15, 2007. FDA
has considered the comments described in section IV and revised this
term as described in the responses in that section. As described in
section IV.B.4., FDA interprets the phrase ``as of February 15, 2007,''
as meaning that the tobacco product was commercially marketed in the
United States ``on February 15, 2007.'' See the response to comment 5
explaining FDA's interpretation that ``as of'' means ``on.''
---------------------------------------------------------------------------
\7\ As described in section IV.B, we have changed the term
``grandfathered tobacco product'' to ``Pre-Existing Tobacco
Product.''
---------------------------------------------------------------------------
B. Record Maintenance
The rule requires applicants to maintain all documents that support
their abbreviated report, which includes the documents listed in Sec.
1107.3(b)(1). The rule does not require an applicant to create new or
additional records; rather, it requires an applicant to maintain the
records it has, obtains, or creates (including those created on its
behalf, such as by a contract research organization) that support its
abbreviated report. This includes documents that an applicant creates
under other regulatory or statutory sections such as the submission of
exemption requests under Sec. 1107.1, PMTAs under part 1114, SE
Reports under section 905(j) of the FD&C Act, and tobacco product
manufacturing practice requirements issued under section 906(e) of the
FD&C Act. The records an applicant is required to maintain include, but
are not limited to:
A copy of the abbreviated report and, if applicable, the
exemption request and all amendments thereto;
a copy of the acknowledgement letter issued in response to
an abbreviated report and, if applicable, a copy of the exemption order
issued by FDA;
documents related to formulation of product, product
specifications, packaging, and related items. Product formulation
includes, for example, items such as the types of information described
in Sec. 1114.7(i) as described in section VIII.B.;
documents showing that design specifications are
consistently met. This could include, for example, information about
testing procedures that are carried out before the product is released
to market, such as the information described in Sec. 1114.7(j) as
described in section VIII.B.;
documents related to product packing and storage
conditions;
analytical test method records, including:
[cir] Performance criteria;
[cir] validation or verification documentation; and
[cir] reports/results from these test methods; and
source data and related summaries.
In addition to the documents specified in Sec. 1107.3(b)(1),
paragraphs (b)(2) through (b)(4) require tobacco product manufacturers
to maintain records that support a determination that their exemption
request meets the requirements of section 905(j)(3)(A)(i) of the FD&C
Act that the modification to a product additive described in the
exemption request was a minor modification made to a tobacco product
that can be sold under the FD&C Act. This means that applicants need to
maintain records demonstrating that the modification is being made to
either a Pre-Existing Tobacco Product or a new tobacco product that has
satisfied the premarket review requirements of section 910(a)(2) of the
FD&C Act. For abbreviated reports based on a modification to a Pre-
Existing Tobacco Product, Sec. 1107.3(b)(2) requires applicants to
maintain the documentation in Sec. 1100.204 to demonstrate that the
product that is being modified is legally marketed. For abbreviated
reports based on a modification to a tobacco product that has
previously received an exemption order in response to a request under
Sec. 1107.1 (and for which the applicant has submitted an abbreviated
report under 905(j)(1)(A)(ii)), or a substantially equivalent order or
a marketing granted order from FDA, Sec. 1107.3(b)(3) requires
applicants to maintain a copy of the exemption order, substantially
equivalent order, or marketing granted order to demonstrate the product
being modified is legally marketed. For abbreviated reports based on a
modification to a tobacco product that is being marketed pursuant to
section 910(a)(2)(B) of the FD&C Act for which FDA has not issued a
substantially equivalent order, an applicant must maintain all
communications to and from FDA relating to the pending SE Report, such
as a letter acknowledging receipt of the report.
C. Record Quality
Section 1107.3(c) requires the records to be legible, in the
English language, and available for inspection and copying by officers
or employees duly designated by the Secretary. FDA also requires
documents that have been translated from another language into English
be accompanied by: (1) The original language version of the document,
(2) a signed statement by an authorized representative of the
manufacturer certifying that the English language translation is
complete and accurate, and (3) a brief statement of the qualifications
of the person who made the translation (e.g., education and
experience). This information helps FDA ensure that the English
language translations of documents are complete and accurately reflect
the content of the original documents.
D. Record Retention
Section 1107.3(d) requires the records described in Sec. 1107.3(b)
to be maintained for a period of not less than 4 years from the date on
which FDA issues an acknowledgement letter in response to an
abbreviated report. FDA has selected 4 years as a means to help ensure
that the records are available for at least one biennial FDA inspection
under sections 704 and 905(g) of the FD&C Act. FDA's biennial
inspections under section 905(g) of the FD&C Act are required to occur
at least once in every 2-year period after a manufacturer registers an
establishment with FDA, which could result in inspections occurring
nearly 4 years apart.
VI. Description of the Final Regulations for, and the Comments and
FDA's Responses Regarding, Premarket Tobacco Product Applications (Part
1114)
The rule adds part 1114 to subchapter K of Title 21. The
requirements set forth in this part apply to PMTAs for new tobacco
products. Subpart A sets out the scope and definitions that apply to
this part. Subpart B sets out the criteria for PMTA submission, content
and format of PMTAs, application amendments, withdrawal of an
application by an applicant, supplemental PMTAs, resubmissions, and
change in ownership or contact information for a
[[Page 55308]]
PMTA. Subpart C describes FDA review and actions on applications,
including provisions for withdrawal and temporary suspension of orders.
Subpart D describes postmarket restrictions and reporting requirements.
Subpart E sets miscellaneous requirements such as record retention,
confidentiality, and electronic submission.
VII. General (Part 1114, Subpart A)
A. Scope (Sec. 1114.1)
Section 1114.1 describes the scope of part 1114 and its
applicability to the submission and review of, and postmarket
requirements related to, PMTAs. Section 1114.1 provides that part 1114
does not apply to MRTPAs, except instances where a single application
is submitted to seek both a marketing granted order and a modified risk
order instead of a separate PMTA and MRTPA. Under the rule, a single
application seeking both a marketing granted order and a modified risk
order under section 911(g) of the FD&C Act needs to meet the content
and format requirements of both part 1114 and section 911 of the FD&C
Act (21 U.S.C. 387k) (and any implementing regulations). This section
also notes that references in the rule to regulatory sections of the
Code of Federal Regulations (CFR) are to chapter I of Title 21, unless
otherwise noted. Therefore, any CFR reference that begins with
``part,'' ``section,'' or the section symbol (Sec. ) should be read as
if it were preceded by ``21 CFR'' (e.g., Sec. 1114.1 refers to 21 CFR
1114.1, part 58 refers to 21 CFR part 58), unless another source is
cited (e.g., the FD&C Act).
(Comment 4) Some comments requested that ``premium'' cigars be
exempt from the PMTA premarket pathway or that a different premarket
pathway be created for them. Several comments describe the difference
between ``premium'' cigars and other products, such as cigarettes or
ENDS, and argue that these differences make it more difficult for
``premium'' cigars to comply with PMTA requirements. These comments
request that FDA exempt ``premium'' cigars from premarket requirements,
create a different premarket pathway for ``premium'' cigars, or delay
the effective date for submitting premarket applications.
(Response 4) FDA received a range of comments related to
``premium'' cigars. A recent court decision ``remand[ed] the [deeming
final rule] to the FDA to consider developing a streamlined substantial
equivalence process for premium cigars'' and ``enjoin[ed] the FDA from
enforcing the premarket review requirements against premium cigars . .
. until the agency has completed its review.'' \8\ Under the terms of
the court's order, a ``premium'' cigar is defined as a cigar that meets
all of the following eight criteria:
---------------------------------------------------------------------------
\8\ Cigar Ass'n of Am., et al. v. Food and Drug Admin., et al.,
Case No. 1:16-cv-01460 (APM), (D.D.C. August 19, 2020), Dkt. No. 214
(Cigar Ass'n of Am.).
---------------------------------------------------------------------------
Is wrapped in whole tobacco leaf;
contains a 100 percent leaf tobacco binder;
contains at least 50 percent (of the filler by weight)
long filler tobacco (i.e., whole tobacco leaves that run the length of
the cigar);
is handmade or hand rolled; \9\
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\9\ A product is ``handmade or hand rolled'' if no machinery was
used apart from simple tools, such as a scissors to cut the tobacco
prior to rolling.
---------------------------------------------------------------------------
has no filter, nontobacco tip, or nontobacco mouthpiece;
does not have a characterizing flavor other than tobacco;
contains only tobacco, water, and vegetable gum with no
other ingredients or additives; and
weighs more than 6 pounds per 1,000 units.
As directed by the court in the Cigar Ass'n of Am. decision, FDA is
further considering the comments submitted to the deeming final rule
docket that requested FDA create a streamlined SE process for
``premium'' cigars. Additionally, FDA notes that a Committee of the
National Academies of Science, Engineering, and Medicine is conducting
a study on such products. FDA intends to consider the findings of that
Committee as well as any additional research specific to ``premium''
cigars (as defined in the preceding paragraph) and their health
effects, patterns of use (such as frequency of use and usage patterns
among underage persons), and other factors. Such information will
inform the Agency's regulatory policy with respect to premarket review
of ``premium'' cigars. Although the court opinion specifically
discusses considering comments on the SE pathway, FDA's research
efforts may also inform issues related to the review of applications
for premium cigars under the PMTA pathway. Because these are ongoing
efforts, at this time, FDA is not finalizing the proposed PMTA rule
with respect to ``premium'' cigars. Rather, FDA will take appropriate
action once it has further considered this matter, including the
results from additional research. As such, the codified language has
been revised to exclude ``premium'' cigars from the scope of this final
rule, and the Cigar Ass'n of Am. court's definition of ``premium''
cigars has been added to section Sec. 1114.3.
B. Definitions (Sec. 1114.3)
Section 1114.3 provides the meaning of terms as they apply to part
1114:
1. Additive
As defined in section 900(1) of the FD&C Act, ``additive'' means
any substance the intended use of which results or may reasonably be
expected to result, directly or indirectly, in its becoming a component
or otherwise affecting the characteristic of any tobacco product
(including any substances intended for use as a flavoring or coloring
or in producing, manufacturing, packing, processing, preparing,
treating, packaging, transporting, or holding), except that such term
does not include tobacco, or a pesticide chemical residue in or on raw
tobacco, or a pesticide chemical.
An additive can be a type of ingredient in a tobacco product; an
example is methyl salicylate in smokeless tobacco, which can serve as
an absorption enhancer and affect the characteristics of the tobacco
product by changing the rate of absorption into the body. Tobacco is
not an additive.
2. Brand
As defined in section 900(2) of the FD&C Act, ``brand'' means a
variety of tobacco product distinguished by the tobacco used, tar
content, nicotine content, flavoring used, size, filtration, packaging,
logo, registered trademark, brand name(s), identifiable pattern of
colors, or any combination of such attributes.
3. Characteristics
As defined in section 910(a)(3)(B) of the FD&C Act,
``characteristics'' means the materials, ingredients, design,
composition, heating source, or other features of a tobacco product.
The terms used in the definition of characteristic (materials,
ingredients, design, etc.) are defined in Sec. 1114.3.
4. Label
As defined in section 201(k) of the FD&C Act, ``label'' means a
display of written, printed, or graphic matter upon the immediate
container of any article; and a requirement made by or under authority
of the FD&C Act that any word, statement, or other information appear
on the label shall not be considered to be complied with unless such
word, statement, or other information also appears on the outside
container or wrapper, if any there be, of the retail package of such
article, or is
[[Page 55309]]
easily legible through the outside container or wrapper.
5. Labeling
As defined in section 201(m) of the FD&C Act, ``labeling'' means
all labels and other written, printed, or graphic matter: (1) Upon any
article or any of its containers or wrappers or (2) accompanying such
article.
6. New Tobacco Product
As defined in section 910(a)(1) of the FD&C Act, ``new tobacco
product'' means: (1) Any tobacco product (including those products in
test markets) that was not commercially marketed in the United States
as of February 15, 2007, or (2) any modification (including a change in
design, any component, any part, or any constituent, including a smoke
constituent, or in the content, delivery or form of nicotine, or any
other additive or ingredient) of a tobacco product where the modified
product was commercially marketed in the United States after February
15, 2007.
FDA received many comments regarding the proposed definition of
``new tobacco product,'' as discussed below.
(Comment 5) Multiple comments questioned FDA's interpretation of
the phrase ``as of February 15, 2007'' as used in the definition of the
terms ``Pre-Existing Tobacco Product'' and ``new tobacco product'' and
stated that there is a lack of rationale for its interpretation.
Comments argue that the plain meaning of the term ``as of'' support the
interpretation that ``as of'' means ``on or before'' rather than
``on''. As such, a tobacco product must qualify as a Pre-Existing
Tobacco Product if it was commercially marketed in the United States at
any time on or before February 15, 2007.
(Response 5) As previously stated, FDA's longstanding
interpretation is that the statutory phrase ``as of February 15,
2007,'' means that the tobacco product was commercially marketed in the
United States ``on February 15, 2007'' (see the final guidance entitled
``Establishing That a Tobacco Product Was Commercially Marketed in the
United States as of February 15, 2007'' (79 FR 58358, September 29,
2014)). Contrary to the comments, the term ``as of '' does not have a
clear plain meaning. The dictionary definitions of ``as of'' include:
``on; at'' (Webster's II New Riverside University Dictionary, 1988);
``beginning on; on and after'' (Webster's Unabridged Dictionary Random
House 1997); ``from, at, or until a given time'' (The American Heritage
Dictionary of Idioms 2003); ``on, at, from--used to indicate a time or
date at which something begins or ends'' (Merriam Webster's Online
Dictionary). As evidenced from these varying definitions (e.g., compare
``until'' with ``from''), the term is ambiguous. Even assuming ``as
of'' could be interpreted as ``at any time prior to and not necessarily
including on the particular date'' (in short referred to as the ``on or
before'' interpretation), interpreting ``as of '' to mean ``on'' gives
a firm line of demarcation that provides clarity. Additionally, reading
``as of'' to mean ``on or before'' would mean that obsolete, abandoned,
or discontinued tobacco products could return to the market without any
premarket review and could serve as predicates under the SE provision.
It is reasonable to conclude that Congress did not intend to allow an
immeasurable number of obsolete, abandoned, or discontinued products
that were marketed before February 15, 2007, to return to the market
without any premarket review or serve as predicates under the SE
provision, but rather intended to confine this number to those products
that were commercially marketed in the United States on February 15,
2007. Thus, we decline to adopt the interpretation the comments
suggest.
Under section 910(a)(1) of the FD&C Act, and as reflected in the
definition, new tobacco products include those that are new because
they have been rendered new through any modification (including a
change in design, any component, any part, or any constituent,
including a smoke constituent, or in the content, delivery or form of
nicotine, or any other additive or ingredient) of a tobacco product
where the modified product was commercially marketed in the United
States after February 15, 2007 (21 U.S.C. 387j(a)(1)(B)). For example,
modifications to cigarette paper, container closure systems (e.g.,
change from glass to plastic e-liquid vials or from plastic to tin
container closures), product quantity, or tobacco cut size would result
in a new tobacco product.
(Comment 6) One comment stated that the term ``co-packaging,''
which is included in the discussion of the definition of the term ``new
tobacco product,'' is confusing and does not provide a basis for
regulating co-packaged products as part of premarket review.
(Response 6) Manufacturers sometimes co-package tobacco products,
and FDA seeks to clarify what effect co-packaging tobacco products may
have on whether those products are required to undergo premarket
review. If there has been a change to the packaging of co-packaged
tobacco products that is intended or reasonably expected to affect or
alter the performance, composition, constituents, or characteristics of
the tobacco product, then it is a change to the container closure
system and, therefore, is a new tobacco product. Under section
910(a)(1)(B) of the FD&C Act, new tobacco products include those that
are new because they have been rendered new through any modification
(including a change in design, any component, any part, or any
constituent, including a smoke constituent, or in the content, delivery
or form of nicotine, or any other additive or ingredient) of a tobacco
product where the modified product was commercially marketed in the
United States after February 15, 2007. Therefore, if two or more
products are co-packaged together within a container closure system, it
results in a new tobacco product requiring premarket authorization.
However, co-packaging two or more legally marketed tobacco products,
where there are no changes, including no change to the container
closure system(s), does not result in a new tobacco product.
In addition, for purposes of determining whether a tobacco product
is new under section 910 of the FD&C Act, and therefore requires
premarket authorization prior to marketing, a ``tobacco product''
encompasses the whole product (e.g., a pack of cigarettes or a tin of
loose tobacco), and is not limited to a single unit or portion of the
whole product (e.g., a single cigarette or a single snus pouch). See
Philip Morris USA Inc. v. U.S. Food & Drug Admin., 202 F. Supp. 3d 31,
55-57 (D.D.C. 2016). If a premarket application includes information on
only a portion of a new tobacco product, FDA would have an incomplete
understanding of the tobacco product (e.g., FDA may not get information
on the container closure system, which could impact the consumable
product) and would not be able to determine, for example, potential
impacts on initiation and cessation of tobacco.
7. Package or Packaging
As defined in section 900(13) of the FD&C Act, the term
``package,'' also referred to in the rule as ``packaging,'' means a
pack, box, carton, or container of any kind or, if no other container,
any wrapping (including cellophane), in which a tobacco product is
offered for sale, sold, or otherwise distributed to consumers. A subset
of package is the container closure system (also defined in this rule).
For example, the carton holding multiple soft packs of cigarettes is
considered the package, and each soft
[[Page 55310]]
pack with surrounding cellophane is considered the container closure
system. Packaging that constitutes the container closure system is
intended or reasonably expected to affect or alter the performance,
composition, constituents, or characteristics of the tobacco product
(e.g., leaching substances that are then incorporated into a consumable
tobacco product), but packaging that is not the container closure
system is not intended or reasonably expected to affect or alter the
performance, composition, constituents, or characteristics of the
tobacco product and is, therefore, not a component or part of a tobacco
product.
8. Tobacco Product
As defined in section 201(rr) of the FD&C Act, the term ``tobacco
product'' means any product that is made or derived from tobacco that
is intended for human consumption, including any component, part, or
accessory of a tobacco product (except for raw materials other than
tobacco used in manufacturing a component, part, or accessory of a
tobacco product). The term ``tobacco product'' does not mean an article
that is a drug under section 201(g)(1), a device under section 201(h),
or a combination product described in section 503(g) of the FD&C Act
(21 U.S.C. 353(g)).
9. Tobacco Product Manufacturer
As defined in section 900(20) of the FD&C Act, the term ``tobacco
product manufacturer'' means any person, including any repacker or
relabeler, who: (1) Manufactures, fabricates, assembles, processes, or
labels a tobacco product or (2) imports a finished tobacco product for
sale or distribution in the United States. FDA interprets
``manufactures, fabricates, assembles, processes, or labels'' as
including, but not being limited to, (1) repackaging or otherwise
changing the container, wrapper, or labeling of any tobacco product
package; (2) reconstituting tobacco leaves; or (3) applying any
chemical, additive, or substance to the tobacco leaf other than potable
water in the form of steam or mist. A definition for the term
``finished tobacco product'' is also included in the rule.
10. Accessory
FDA defines ``accessory'' as any product that is intended or
reasonably expected to be used with or for the human consumption of a
tobacco product; does not contain tobacco and is not made or derived
from tobacco; and meets either of the following:
Is not intended or reasonably expected to affect or alter
the performance, composition, constituents, or characteristics of a
tobacco product or
is intended or reasonably expected to affect or maintain
the performance, composition, constituents, or characteristics of a
tobacco product, but:
[cir] Solely controls moisture and/or temperature of a stored
product or
[cir] solely provides an external heat source to initiate but not
maintain combustion of a tobacco product.
This matches the definition of accessory set forth in Sec. 1100.3.
Examples of accessories are ashtrays and spittoons because they do not
contain tobacco, are not derived from tobacco, and do not affect or
alter the performance, composition, constituents, or characteristics of
a tobacco product. Examples of accessories also include humidors or
refrigerators that solely control the moisture and/or temperature of a
stored product and conventional matches and lighters that solely
provide an external heat source to initiate but not maintain combustion
of a tobacco product.
11. Adverse Experience
FDA defines ``adverse experience'' as any unfavorable physical or
psychological effect in a person that is temporally associated with the
use of or exposure to a tobacco product, whether or not the person uses
the tobacco product, and whether or not the effect is considered to be
related to the use of or exposure to the tobacco product. FDA received
many comments regarding this definition, as discussed below.
(Comment 7) Multiple comments requested changes to the definition
of what constitutes an adverse experience. One comment requested FDA
amend the definition to explicitly include increased use by youth or
young adults. Another comment stated that the definition of adverse
experience is too broad and subjective, and should be revised to refer
to a health-related event associated with the use of or exposure to
(intended or incidental) a tobacco product.
(Response 7) FDA declines to change the definition of adverse
experience because this widely understood definition is generally
consistent with language used throughout the Agency and is designed to
capture a broad swath of information related to health effects from FDA
regulated products. Due to the fact that the experience may not relate
to the individual user but could also affect the general public or
bystander, it is FDA's intent that the definition remain broad to
ensure we receive the potential wide variety of voluntary reports of
adverse experiences involving tobacco products from investigators,
consumers, healthcare professionals and concerned members of the
public. Additionally, FDA declines to revise the definition to include
use by youth and young adults because it constitutes a behavior, not a
health effect related to an adverse experience. Increases in use by
individuals under the minimum age of sale will be monitored through the
review of periodic reports submitted under Sec. 1114.41, among other
means.
FDA notes that it is important to also include information
regarding adverse experiences associated with use of or exposure to a
product where the individual suffering the adverse experience did not
use the product because it can help FDA determine health risks for
nonusers, such as the effects of second-hand exposure or accidental
exposure (e.g., skin burns from accidental exposure to liquid nicotine,
harmful effects resulting from a child drinking an e-liquid,
respiratory difficulties from second-hand exposure to an e-cigarette).
Additionally, reporting information regarding all adverse experiences
that are temporally associated with the use of or exposure to the
product will help the applicant avoid self-selection bias of what is
reported to FDA and help identify harmful effects that are not
obviously attributable to the product.
12. Applicant
FDA defines ``applicant'' as any person that submits a PMTA to
receive a marketing granted order for a new tobacco product.
13. Commercially Marketed
In the proposed rule, FDA proposed to define ``commercially
marketed'' as ``selling or offering a tobacco product for sale to
consumers in all or in parts of the United States.'' After reviewing
comments described in section IV, FDA has decided to finalize the
definition of ``commercially marketed'' to mean selling or offering for
sale a tobacco product in the United States to consumers or to any
person for the eventual purchase by consumers in the United States.
Examples of products that may not be covered by the definition of
commercially marketed include investigational tobacco products and free
samples. Examples of documentation of commercial marketing may include
dated bills of lading, dated freight bills, dated waybills, dated
invoices, dated purchase orders, dated advertisements, dated catalog
pages, dated promotional material, dated trade publications, dated
manufacturing documents, inventory lists, or any other document
demonstrating that the
[[Page 55311]]
product was commercially marketed in the United States as of February
15, 2007. See discussion in section IV.B.3.
14. Component or Part
FDA defines ``component or part'' as any software or assembly of
materials intended or reasonably expected: (1) To alter or affect the
tobacco product's performance, composition, constituents, or
characteristics or (2) to be used with or for the human consumption of
a tobacco product. Component or part excludes anything that is an
accessory of a tobacco product. A container closure system (which is
also defined in this section) is considered a component or part. With
respect to these definitions, FDA notes that ``component'' and ``part''
are separate and distinct terms within chapter IX of the FD&C Act.
However, for purposes of this rule, FDA is using the terms
``component'' and ``part'' interchangeably and without emphasizing a
distinction between the terms. FDA may clarify the distinctions between
``component'' and ``part'' in the future. This definition matches the
definition in Sec. 1100.3.
15. Composition
FDA defines ``composition'' as the materials in a tobacco product,
including ingredients, additives, and biological organisms. The term
includes the manner in which the materials, for example, ingredients,
additives, and biological organisms, are arranged and integrated to
produce a tobacco product. Composition refers primarily to the chemical
and biological properties of a tobacco product, whereas design refers
to the physical properties of a tobacco product. A biological organism
refers to any living biological entity, such as an animal, plant,
fungus, or bacterium.
16. Constituent
In this final rule, we have updated the definition of constituent
on our own initiative to clarify the meaning. FDA defines
``constituent'' as any chemical or chemical compound in a tobacco
product that is or potentially is inhaled, ingested, or absorbed into
the body, any chemical or chemical compound in an emission (e.g.,
smoke, aerosol, droplets) from a tobacco product, that either transfers
from any component or part of the tobacco product to the emission or
that is formed by the product, including through combustion or heating
of tobacco, additives, or other components of the tobacco product.
17. Container Closure System
FDA defines ``container closure system'' as any packaging materials
that are a component or part of a tobacco product. FDA received several
comments regarding the proposed definition, as discussed below.
(Comment 8) A few comments suggested related revisions to both the
definitions of the terms ``container closure system'' (CCS),
``packaging,'' and ``component or part,'' as well as what modifications
to a CCS FDA considers to result in a new tobacco product. The comments
requested that the definition of CCS be limited to only the product
packaging that is designed or reasonably expected to alter the product
characteristics after the time of manufacture. Comments stated that
failure to make such a change would be inconsistent with the court's
decision in Philip Morris v. FDA, 202 F. Supp. 3d 31, 51 (D.D.C. 2016).
Citing this case, which in the course of distinguishing between a
product and its labeling, referenced ``the physical attributes of the
product itself, as distinct from its label or the package in which it
is contained,'' the comments argue that the law's requirements for new
tobacco products apply only when there are changes in ``the physical
attributes of a tobacco product--not its labeling or packaging.'' Id.
Likewise, the comments stated that modifications to the CCS should
result in a new tobacco product only if modifications are intended or
reasonably expected to alter the characteristics of the product. The
comments maintained that if the packaging's purpose is merely to
maintain or preserve the characteristics of the product, it should only
be considered packaging, not a CCS.
(Response 8) As described in the rule, FDA defines ``component or
part'' as any software or assembly of materials intended or reasonably
expected: (1) To alter or affect the tobacco product's performance,
composition, constituents, or characteristics or (2) to be used with or
for the human consumption of a tobacco product. Contrary to the
commenter's assertion, packaging that constitutes the container closure
system is intended or reasonably expected to affect or alter the
performance, composition, constituents, or characteristics of the
tobacco product (e.g., leaching substances that are then incorporated
into a tobacco product), and is thus a component or part of a tobacco
product. This is consistent with the holding of Philip Morris, 202 F.
Supp. at 51, as is its converse: Packaging that is not the container
closure system and is not intended or reasonably expected to affect or
alter the performance, composition, constituents, or characteristics of
the tobacco product is, therefore, not a component or part of a tobacco
product. As such, packaging that is, for example, the packaging around
a blister pack is not part of the PMTA review process if it is not
intended or reasonably expected to alter or affect the performance,
composition, constituents, or characteristics of the tobacco product
within the blister pack. However, where a change in the container
closure system could affect the chemistry of the product, FDA requires
the applicant, where it submits a PMTA, to demonstrate that permitting
marketing of the product with the change in the container closure
system is appropriate for the protection of public health.
For example, packaging materials constitute a container closure
system if substances within that packaging are intended or reasonably
expected to affect product moisture, e.g., when the manufacturer
changes the package of a moist snuff from plastic to fiberboard, which
can affect microbial stability and tobacco-specific nitrosamine (TSNA)
formation during storage. Another example of this is when menthol or
other ingredients are applied to the inner foil to become incorporated
into the consumed product (Ref. 1). Packaging materials may also be
intended or reasonably expected to affect the characteristics of a
tobacco product by impacting the rate of leaching into, and ultimately,
the amount of substances found in, the consumable tobacco product. In
fact, it has been demonstrated that compounds in packaging materials
may diffuse into snuff and affect its characteristics (Ref. 2). Thus,
packaging material that affects the characteristics of a tobacco
product by impacting the moisture level or shelf life of a tobacco
product is a container closure system (e.g., a plastic versus a metal
container of smokeless tobacco). A difference in tobacco moisture is
reasonably expected to affect microbial growth in the product,
extraction efficiency, and total exposure to nicotine or the
carcinogens N-nitrosonornicotine (NNN) or 4-(methylnitrosamino)-1-(3-
pyridyl)-1-butanone (NNK) (Ref. 3).
Considering a distinct subset of packaging (i.e., container closure
system) to be a component or part is consistent with the FD&C Act and
furthers the fundamental purpose of the Tobacco Control Act to protect
the public health. For example, section 900(1) of the FD&C Act defines
an ``additive'' as any substance the intended use of which results or
may reasonably be expected to result, directly or indirectly, in its
becoming a component or otherwise affecting the characteristic of any
tobacco product
[[Page 55312]]
(including any substance intended for use as a flavoring or coloring or
in producing, manufacturing, packing, processing, preparing, treating,
packaging, transporting, or holding), except that such term does not
include tobacco or a pesticide chemical residue in or on raw tobacco or
a pesticide chemical. Congress specifically included a broad definition
of ``additive'' that encompasses not just substances that do in fact
have such effects but also those that may reasonably be expected to
have such effects. Similarly, if FDA were to adopt a narrow
construction of ``tobacco product'' to exclude these materials, the
Agency's ability to evaluate whether permitting the marketing of the
new tobacco product was appropriate for the protection of public health
(APPH) would be impeded, thereby leaving the Agency unable to fully
execute its mission to protect the public health. The definition of
``package'' in section 900(13) of the FD&C Act does not dictate a
contrary result and can be reasonably interpreted to mean that a
distinct subset of packaging is also a component or part of a tobacco
product.
18. Design
FDA defines ``design'' to mean the form and structure concerning,
and the manner in which components or parts, ingredients, software, and
materials are integrated to produce a tobacco product. This term refers
to the physical properties of a tobacco product. Examples of design
parameters include ventilation, paper porosity, filter efficiency,
battery voltage and current operating range, and electrical heater coil
resistance. FDA received one comment on this definition, as discussed
below.
(Comment 9) One comment stated that the definition of the term
``design'' does not take into account the inherent variability that can
occur in tobacco crops over the years. The comment stated that such
variability may require manufacturers to alter, in a limited capacity,
certain characteristics of the product, in order to minimize
variability of constituent levels in its final aerosol. The comment
concluded that the proposed definition was rather narrow and did not
allow for the control of emission levels through design adjustments.
The comment recommended that the definition be amended to allow
applicants to adjust design features for the sole purpose of
accommodating natural variability of tobacco plants, without requiring
the submission of a new PMTA or a supplemental PMTA.
(Response 9) FDA declines to make changes as a result of this
comment. At this time, FDA does not intend to enforce the requirement
of premarket review in section 910 for tobacco blending changes
required to address the natural variation of tobacco (e.g., blending
changes due to variation in growing conditions) to maintain a
consistent product.\10\ Where an applicant changes other
characteristics of a tobacco product (i.e., characteristics other than
tobacco blend) to minimize variability of the product, FDA intends to
enforce the premarket authorization requirements, and the PMTA must
contain all appropriate information for the distinct new tobacco
product that would result from such changes.
---------------------------------------------------------------------------
\10\ For more information on FDA's enforcement of premarket
review for tobacco blending changes, see the guidance entitled
``Demonstrating the Substantial Equivalence of a New Tobacco
Product: Responses to Frequently Asked Questions'' available at
https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance.
---------------------------------------------------------------------------
19. Finished Tobacco Product
FDA defines ``finished tobacco product'' to mean a tobacco product,
including all components and parts, sealed in final packaging (e.g.,
filters or filter tubes sold to consumers separately or as part of
kits, or e-liquids sealed in final packaging sold to consumers either
separately or as part of kits) or in the final form in which it is
intended to be sold to consumers. FDA received one comment on this
definition, as discussed below.
(Comment 10) One comment stated that the definition of the term
``finished tobacco product'' should conform to the definition
previously used in the registration and listing guidance, which
included the phrase ``intended for consumer use.''
(Response 10) FDA has edited the definition of the term ``finished
tobacco product'' to include the phrase ``or in the final form in which
it is intended to be sold to consumers'' to help clarify the meaning of
the term ``finished.'' We believe that by including products sold in
the final form in which it is intended to be sold to consumers, we are
capturing a variety of products including those intended for consumer
use as requested by the commenter.
20. Harmful or Potentially Harmful Constituent (HPHC)
FDA defines ``harmful or potentially harmful constituent'' as any
chemical or chemical compound in a tobacco product or tobacco smoke or
emission that: (1) Is or potentially is inhaled, ingested, or absorbed
into the body, including as an aerosol or any other emission and (2)
causes or has the potential to cause direct or indirect harm to users
or nonusers of tobacco products. This definition aligns with the
definition provided for in the guidance for industry entitled
```Harmful and Potentially Harmful Constituents' in Tobacco Products as
Used in Section 904(e) of the FD&C Act.''
The established list of HPHCs can be found on FDA's website at
https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/harmful-and-potentially-harmful-constituents-tobacco-products-and-tobacco-smoke-established-list (77 FR 20034, April 3, 2012). FDA issued
a notice in the Federal Register of August 5, 2019 (84 FR 38032),
seeking public comment on the proposed addition of 19 constituents to
the established list of HPHCs. FDA is proposing these additions to
reflect the range of tobacco products now subject to FDA's tobacco
product authorities, including deemed tobacco products such as ENDS.
FDA will finalize the addition of these HPHCs to the established list,
as appropriate, after reviewing public comment and generally intends to
make any future updates to the established list of HPHCs through a
similar notice and comment process.
FDA received one comment on this definition, as discussed below.
(Comment 11) One comment stated that FDA should either change the
definition of the term ``harmful or potentially harmful constituent''
(HPHC) to include a list of all HPHCs for which testing results must be
submitted in a PMTA or include a list of all such HPHCs elsewhere in
the rule.
(Response 11) FDA declines to revise the definition of HPHC. In
defining this term, FDA is describing criteria for what constitutes an
HPHC and is not attempting to identify specific constituents. In
contrast, section 904 of the FD&C Act requires FDA to establish, and
periodically revise, a list of HPHCs. More importantly for PMTA
content, as discussed in section VIII.B.9.a.v., an application would
not be required to contain testing for all HPHCs; rather, it would be
required to contain testing for constituents, including HPHCs, that are
contained within and can be delivered by the type of product and
contain a description of why the HPHCs that were tested are appropriate
for the type of product.
FDA similarly declines to set forth a list of constituents that
must be tested because it would be overly broad as it pertains to most
tobacco products. It is FDA's understanding that manufacturers have
information concerning what constituents might be
[[Page 55313]]
emitted from their specific tobacco products. FDA believes that
allowing applicants to use this knowledge in selecting the appropriate
constituents for testing would result in a more efficient process for
preparing PMTAs than requiring manufacturers to test for each
constituent in a broad list, including HPHCs that might not pertain to
the applicant's specific product.
21. Heating Source
FDA defines ``heating source'' as the source of energy used to burn
or heat the tobacco product. Examples of a heating source include a
flame or a rechargeable battery.
22. Ingredient
FDA defines ``ingredient'' as tobacco, substances, compounds, or
additives added to the tobacco, paper, filter, or any other component
or part of a tobacco product, including substances and compounds
reasonably expected to be formed through a chemical reaction during
tobacco product manufacturing. For example, an ingredient may be a
single chemical substance, leaf tobacco, or the product of a reaction,
such as a chemical reaction, in manufacturing. Examples of substances
and compounds (ingredients) reasonably expected to be formed through a
chemical reaction during tobacco product manufacturing include the
following:
The reaction of sugars with amines to form families of
compounds with new carbon-nitrogen bonds, including Maillard reaction
products and Amadori compounds;
the reaction of sodium hydroxide with citric acid to form
sodium citrate;
the production of ethyl alcohol, a residual solvent, from
ethyl acetate during production of tipping paper adhesive;
products of thermolytic reactions, such as the production
of carboxylic acids from sugar esters;
products of enzymatically or nonenzymatically catalyzed
reactions, such as the hydrolytic production of flavor or aroma
precursors from nonvolatile glucosides; and
products of acid-base reactions, such as removal of a
proton from protonated nicotine to generate the basic form of nicotine
(``free'' nicotine).
23. Line Data
FDA defines ``line data'' to mean an analyzable dataset of
observations for each individual study participant, laboratory animal,
or test replicate. Line data typically provides information that is
more useful to FDA's review of an application than data in its more
``raw'' forms because it allows information about time, people, and
places involved in investigations to be organized and reviewed quickly,
and it facilitates tracking of different categories of cases. FDA is
requiring an applicant to submit line data rather than source data
(also referred to as raw data) to allow for a more efficient review
process. As described in Sec. 1114.45, applicants are required to
retain all source data in the event that FDA needs to inspect the data
as part of its application review.
24. Material
FDA defines ``material'' to mean an assembly of ingredients.
Materials are assembled to form a tobacco product, or components or
parts of tobacco product. For example, material includes the glue or
paper pulp for a cigarette where the paper pulp includes multiple
ingredients (e.g., multiple types of tobacco, water, and flavors)
assembled into the paper (or pulp depending on the water content).
Another example of a material is a plastic composed of chemical
substances that houses electrical components.
25. Marketing Granted Order
FDA defines ``marketing granted order'' to mean the order described
in section 910(c)(1)(A)(i) of the FD&C Act that authorizes the new
tobacco product to be introduced or delivered for introduction into
interstate commerce.
26. Marketing Denial Order
FDA defines ``marketing denial order'' to mean the order described
in section 910(c)(1)(A)(ii) of the FD&C Act that the product may not be
introduced or delivered for introduction into interstate commerce.
27. Other Features
FDA defines ``other features'' to mean any distinguishing qualities
of a tobacco product similar to those specifically enumerated in
section 910(a)(3)(B) of the FD&C Act. The definition includes: (1)
HPHCs (the definition of new tobacco product includes any modification
to any constituents, including smoke constituents; section 910(a)(1)(B)
of the FD&C Act) and (2) any other product characteristics that relate
to the chemical, biological, or physical properties of the tobacco
product. The term ``other features'' also encompasses other product
characteristics that relate to the chemical, biological, and physical
properties of the product that would not be included as a material,
ingredient, design, composition, or heating source.
28. Premarket Tobacco Product Application or PMTA
FDA defines ``premarket tobacco product application'' or ``PMTA''
to mean the application described in section 910(b) of the FD&C Act.
This term includes the initial premarket tobacco product application
and all subsequent amendments.
29. ``Premium'' Cigar
As discussed in section VI.A., we are adding the Cigar Ass'n of Am.
court's definition of ``premium'' cigars to Sec. 1114.3. ``Premium''
cigars means a type of cigar that: (1) Is wrapped in whole tobacco
leaf; (2) contains a 100 percent leaf tobacco binder; (3) contains at
least 50 percent (of the filler by weight) long filler tobacco (i.e.,
whole tobacco leaves that run the length of the cigar); (4) is handmade
or hand rolled (i.e., no machinery was used apart from simple tools,
such as scissors to cut the tobacco prior to rolling); (5) has no
filter, nontobacco tip, or nontobacco mouthpiece; (6) does not have a
characterizing flavor other than tobacco; (7) contains only tobacco,
water, and vegetable gum with no other ingredients or additives; and
(8) weighs more than 6 pounds per 1,000 units.
30. Serious Adverse Experience
FDA defines ``serious adverse experience'' to mean an adverse
experience that results in any of the following outcomes: (1) Death;
(2) a life-threatening condition or illness; (3) inpatient
hospitalization or prolongation of existing hospitalization; (4) a
persistent or significant incapacity or substantial disruption of the
ability to conduct normal life functions (e.g., seizures that do not
result in hospitalization, burns that result in damage to a limb or
nerve damage); (5) a congenital anomaly/birth defect; or (6) any other
adverse experience that, based upon appropriate medical judgment, may
jeopardize the health of a person and may require medical or surgical
intervention to prevent one of the other outcomes listed in this
definition. This could include, for example, carbon monoxide poisoning,
which if left untreated, could result in long term and possibly delayed
brain damage or heart damage.
FDA received one comment on this definition, as discussed below.
(Comment 12) One comment stated that the definition of the term
``serious adverse experience'' needs to be clarified, recommending that
it be aligned with a similar definition used by FDA for drugs.
Specifically, the comment requested that FDA further
[[Page 55314]]
define the term ``life-threatening condition or illness'' in paragraph
(b) of the definition to mean, as it does in the drug context, any
adverse experience that places the patient, in the view of the initial
reporter, at immediate risk of death from the adverse experience as it
occurred, i.e., it does not include an adverse experience that, had it
occurred in a more severe form, might have caused death. The comment
also requested that FDA restrict the ``catch-all'' in paragraph (f) of
the definition so that it focuses on ``important medical events,''
similar to the definition for drugs, rather than ``adverse
experiences'' as the definition currently does.
(Response 12) FDA declines to revise the definition of serious
adverse experience because it captures the events for which FDA would
need prompt notification once a product is on the market. Through
paragraph (b) of the definition of ``serious adverse experience,'' FDA
is seeking information about adverse experiences carrying an immediate
risk of death. In contrast, through paragraph (f) of the definition of
``serious adverse experience,'' FDA is interested in receiving prompt
notification of a condition that could have delayed consequences, for
example, one that that could cause death or severe organ damage if left
untreated, or immediate death had it occurred in a more severe form so
we can investigate whether the condition could occur in a more severe
form and cause death in different individuals. We believe that having
paragraph (f) focus on adverse experiences appropriately captures this
scope. Applicants with questions regarding whether an adverse
experience qualifies as a serious adverse experience are encouraged to
promptly contact FDA.
31. Submission Tracking Number or STN
FDA defines ``submission tracking number'' or ``STN'' to mean the
number that FDA assigns to submissions that are received from an
applicant, such as a PMTA and a supplemental PMTA. FDA has added this
definition to the final rule on its own initiative to help clarify
requirements to specify submission tracking numbers.
32. Unexpected Adverse Experience
FDA defines ``unexpected adverse experience'' to mean an adverse
experience occurring in one or more persons in which the nature,
severity, or frequency of the experience is not consistent with: (1)
The known or foreseeable risks associated with the use or exposure to
the tobacco product as described in the PMTA (including the results of
human subject investigations) and other relevant sources of
information, such as the product labeling and postmarket reports; (2)
the expected natural progression of any underlying disease, disorder,
or condition of the persons(s) experiencing the adverse experience and
the person's predisposing risk factor profile for the adverse
experience; or (3) the results of nonclinical investigations.
FDA received one comment regarding this definition, as discussed
below.
(Comment 13) One comment stated that the definition of unexpected
adverse experience is unnecessarily complex and would likely lead to
unduly burdensome reporting. The comment noted potential difficulties
with assessing what constitutes a ``foreseeable'' risk and expressed a
belief that the definition should be aligned with those found in other
product groups that focus on unexpected adverse experiences being those
that are not currently listed on product packaging and not previously
observed.
(Response 13) FDA declines to revise the definition of unexpected
adverse experience because it captures the events and information that
should be disclosed. This information is important to FDA's ongoing
monitoring of a tobacco product because it would alert the Agency to
the potential scope and frequency for health risks that were not
previously considered as part of application review and may inform a
determination of whether the marketing granted order should be
withdrawn or temporarily suspended. Foreseeable risks are harms that
could reasonably be predicted based upon the content of the PMTA and
other available sources of information and is largely based on
mechanism of action or composition of the tobacco product.
33. Vulnerable populations
The proposed rule did not expressly discuss vulnerable populations.
However, FDA received several comments regarding this issue, as
discussed below.
(Comment 14) Multiple comments raised concerns related to the lack
of reference to vulnerable populations in the proposed rule. One
comment stated that the tobacco industry has a history of marketing its
products to individuals with specific characteristics, including, but
not limited to veterans, individuals with a low socioeconomic status
(SES), and vulnerable populations. The comment requested that FDA
require applicants to specify detailed demographic information in their
marketing plans, including the targeting of its marketing by SES as
part of a PMTA. Another comment stated that a definition of vulnerable
populations should be included in the final rule. In addition, multiple
comments requested FDA require PMTAs to contain a consideration of the
effects of permitting the marketing of the new tobacco product on
vulnerable or sensitive subpopulations (e.g., individuals whose health
has been compromised).
(Response 14) FDA agrees that consideration of vulnerable
populations is an important part of determining whether permitting the
marketing of a new tobacco product would be APPH. As discussed in
section IX.D.1., FDA considers many factors when making its APPH
determination, including the likelihood that existing users of tobacco
products will stop using such products and the likelihood that nonusers
of tobacco products will start using. This could include information
regarding the marketing of a new tobacco product that may produce a
positive effect for some subpopulations while producing differential
effects for other subpopulations. For example, a non-combusted tobacco
product that may help current adult smokers transition away from
cigarettes may appeal to and lead to tobacco product initiation among
youth and young adults who have never used tobacco products.
To ensure FDA understands the full health impact of the product, it
is important for FDA to consider vulnerable populations and how the
marketing of the new tobacco product can impact the likelihood that
existing users of tobacco products will stop using such products and
the likelihood that nonusers will start using the product. FDA has
revised the rule to emphasize the importance of considering the effect
of marketing a new tobacco product would have on vulnerable populations
as well defined the term ``vulnerable populations'' in Sec. 1114.3 to
mean groups that are susceptible to tobacco product risk and harm due
to disproportionate rates of tobacco product initiation, use, burden of
tobacco-related diseases, or decreased cessation. Relevant vulnerable
populations will vary depending on the type of tobacco product and may
change over time, and can include, but are not limited to, youth and
young adults, those who are of low SES, certain racial or ethnic
populations, underserved rural populations, people with co-morbid
mental health conditions or substance use disorders, military or
veteran populations, people who are pregnant or are trying to become
pregnant, and sexual or gender minorities (Refs. 4-9).
[[Page 55315]]
Also note that section VIII.B.6.b. includes SES as an example
demographic characteristic to clarify the range of potential
characteristics that may be included in descriptions of marketing
plans.
VIII. Premarket Tobacco Product Applications (Part 1114, Subpart B)
A. Application Submission (Sec. 1114.5)
As described in Sec. 1114.5, if an applicant seeks a marketing
granted order under the PMTA pathway for its new tobacco product, it
would be required to submit a PMTA to FDA and receive a marketing
granted order before the tobacco product may be introduced or delivered
for introduction into interstate commerce. An applicant submitting a
PMTA to FDA should include all information required to be in a PMTA as
part of its initial submission, including all sections specified in
Sec. 1114.7(a), except for product samples which, if required, must be
submitted after a PMTA is accepted for review as described in the
discussion Sec. 1114.7(e) in section VII.B.5. Submitting a complete
application as part of an initial submission is important because, as
explained in the discussion of Sec. 1114.27 in section VIII.B, FDA may
refuse to accept or file an incomplete application for review.
FDA received several comments regarding the scope of products
required to submit a PMTA.
(Comment 15) Some comments request that certain tobacco products,
such as ENDS and oral tobacco derived nicotine, be exempt from the PMTA
premarket pathway or that a different premarket pathway be created for
them. The comments described certain products as significantly less
harmful than other products, which they contended justifies either an
exemption from the requirements of the PMTA pathway or a creation of a
streamlined pathway under which products can be authorized based upon a
few approaches, such as the submission of significantly less
information that would be required under this rule. Other comments
requested a similar streamlined pathway for small businesses due to the
cost of preparing a PMTA.
(Response 15) As described in detail throughout this rule, the
information required by part 1114 is necessary to ensure FDA has
sufficient information to consider, as required by section 910(c) of
the FD&C Act, the potential risks and benefits of a new tobacco product
to the health of the population as a whole in determining whether the
marketing of that product would be appropriate for the protection of
public health. FDA declines to create a streamlined pathway for certain
tobacco product categories or manufacturers that permits the submission
of significantly less information than required by this rule because it
would result in FDA having insufficient information to make its
statutorily required determinations under section 910(c) of the FD&C
Act. Consistent with the deeming final rule,\11\ we also decline the
request to exempt products from the requirements of PMTA or from
premarket review more broadly. Section 910 of the FD&C Act establishes
the procedures that must be followed before a new tobacco product can
be authorized for marketing and it applies to all new tobacco products.
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\11\ See the deeming final rule (81 FR 28974) for responses to
similar comments requesting alternative or abbreviated PMTA pathways
and exemptions from the requirements of premarket review.
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B. Required Content and Format (Sec. 1114.7)
1. General
As explained in Sec. 1114.7(a), the rule requires each PMTA to
contain sufficient information necessary for FDA to determine whether
the grounds for denial of an application listed in section 910(c)(2) of
the FD&C Act apply to the PMTA, which includes the following sections:
General information (as described in Sec. 1114.7(c));
descriptive information (as described in Sec. 1114.7(d));
product samples (as described in Sec. 1114.7(e));
labeling (as described in Sec. 1114.7(f));
statement of compliance with part 25 (21 CFR part 25) (as
described in Sec. 1114.7(g));
summary (as described in Sec. 1114.7(h));
product formulation (as described in Sec. 1114.7(i));
manufacturing (as described in Sec. 1114.7(j));
health risk investigations (as described in Sec.
1114.7(k));
the effect on the population as a whole (as described in
Sec. 1114.7(l)); and
certification statement (as described in Sec. 1114.7(m)).
As described in section VIII.B, if the application does not appear
to contain these sections and the information required therein (except
for product samples), the Agency may refuse to accept the application
for review under Sec. 1114.27(a)(1). As described in section VIII.B,
if a PMTA does not contain sufficient information required by these
sections to permit a substantive review, including substantive
information regarding broad areas of scientific information noted where
appropriate in this document, FDA may refuse to file the application
under Sec. 1114.27(b)(1).
2. Format
Section 1114.7(b) provides the general requirements for the format
of the application and would require the applicant to submit the
application with the appropriate FDA form(s) (i.e., Form FDA 4057 (Ref.
10) and Form FDA 4057b (Ref. 11)). Section Sec. 1114.7(b)(1) would
require the application and any amendments to contain a comprehensive
index and table of contents and be well organized, legible, and written
in the English language. The comprehensive index would include the
listing of files and data associated with those files (e.g., for an
application that is electronically submitted, the comprehensive index
would include the listing of files and associated metadata). FDA is
also requiring that documents that have been translated from another
language into English must be accompanied by the original language
version of the document, a signed statement by an authorized
representative of the manufacturer certifying that the English language
translation is complete and accurate, and a brief statement of the
qualifications of the person who made the translation (e.g., education
and experience). This information would help FDA ensure that the
English language translations of documents are complete and accurately
reflect the content of the original documents.
As described in Sec. 1114.49, FDA is requiring that the PMTA and
all supporting documents be submitted to FDA in an electronic format
that the Agency can process, review, and archive, unless the Agency has
previously granted a waiver from these requirements. An application
would not be considered received until CTP's Document Control Center
has received an application that the Agency can process, review, and
archive. Applicants that are unable to submit their applications in
electronic format may seek a waiver from the electronic filing
requirement, in accordance with Sec. 1114.49.
FDA received several comments regarding PMTA format, as discussed
below.
(Comment 16) One comment stated that FDA must address
inconsistencies between the ENDS PMTA Guidance and the PMTA Proposed
Rule, citing
[[Page 55316]]
differences such as marketing plans and application organization.
(Response 16) FDA will update the ENDS PMTA Guidance to ensure it
is consistent with the requirements and recommendations in this
rulemaking. When updated, the ENDS PMTA Guidance will provide updated
important product-specific recommendations for applicants submitting
PMTAs for ENDS. In addition, if applicants wish to discuss the
development of a PMTA, the applicant may request a meeting as set forth
in the guidance for industry and investigators entitled ``Meetings with
Industry and Investigators on the Research and Development of Tobacco
Products.'' \12\
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\12\ Available at https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance
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(Comment 17) One commenter stated that while the proposed rule
notes FDA's intent to provide information regarding acceptable
technical specifications for electronic submissions, it was not aware
of FDA having done so and requested that the final rule contain clear
and consistent expectations for electronic submissions so that industry
can properly plan and prepare applications in advance of submission.
(Response 17) Applicants can visit FDA's web page for more
information on electronic submission, including electronic submission
file formats and specifications. As of the date of the publication of
this rule, this information is located at: https://www.fda.gov/industry/fda-esubmitter/using-esubmitter-prepare-tobacco-product-submissions. This web page also contains a link to the document
``Electronic Submission File Formats and Specifications,'' which
provides additional helpful information. As mentioned in the proposed
rule, FDA intends to update this information as needed to accommodate
changes in technology.
FDA has created these format requirements using its authority under
sections 701 and 910 of the FD&C Act to efficiently enforce premarket
review requirements. The requirements in Sec. 1114.7(b) are intended
to address some of the problems we have seen with applications to date.
For example, some applications have been submitted to FDA in a
proprietary or password protected format without providing FDA access
or password information. Following up with an applicant to obtain
access or password information takes time and contributes to delays. In
addition, some electronic submission files have not been of a static
format, and thus, the pages reformat, repaginate, rebullet, or redate
each time the document is accessed. For example, Microsoft Word files
can change upon opening by FDA reviewers, while PDF files remain as the
applicant intended. Receiving applications with these issues affects
our ability to cross-reference, share (internally), and efficiently
evaluate information. Also, FDA is required under regulations governing
Federal records to maintain many files long-term, and in a
``sustainable'' format (for more information on sustainable formats,
please refer to National Archives and Records Administration Bulletin
2014-04, https://www.archives.gov/records-mgmt/bulletins/2014/2014-04.html), Sec. 1114.7(b) will ensure that these files can be managed,
opened, and read by the Agency for the duration of the retention
period.
Finally, Sec. 1114.7(b)(2) will allow an applicant to include
content in a PMTA by cross-reference to a tobacco product master file
(TPMF) or a pending MRTPA for the same tobacco product submitted under
section 911 of the FD&C Act. A TPMF is a file that is voluntarily
submitted to CTP that contains trade secret and/or confidential
commercial information about a tobacco product or component that the
owner does not want to share with other persons. TPMFs are a beneficial
tool for manufacturers, component suppliers, and ingredient suppliers,
and can assist the tobacco product submission process. TPMFs allow
individuals to rely on the information contained in a TPMF in a
submission to FDA without the TPMF owner having to disclose the
information to those individuals. TPMFs are typically used to prevent
the disclosure of information that contains trade secrets or
confidential commercial information. One situation in which TPMFs might
be useful in submitting a PMTA is where an applicant is seeking
marketing authorization for a new tobacco product that is made using a
component or part, or ingredient that is purchased from another tobacco
product manufacturer (e.g., blended tobacco or an e-liquid). Applicants
must demonstrate they have the right to reference the TPMF to be able
to include content by cross-reference, such as by having the master
file holder provide a letter of authorization. Applicants must specify
the master file number and clearly identify the specific content that
it is incorporating into its PMTA. For FDA's current thinking on the
use of TPMFs, please consult the guidance for industry entitled
``Tobacco Product Master Files.'' \13\
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\13\ Available at: https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance.
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(Comment 18) A number of comments submitted similar concerns about
the lack of data standardization, stating that FDA should standardize
the data required to be submitted and allow companies to rely on the
same pool of standardized data where it applies to similar aspects of
their new tobacco product, such as submitting the same ingredients, to
improve the efficiency for both application submission and review.
(Response 18) When companies want to rely on the same pool of data,
FDA encourages the use of shared resources, such as tobacco product
master files, where appropriate.
Applicants may also include content in a PMTA by cross-reference to
a pending MRTPA for the same tobacco product.\14\ FDA recommends that
applicants seeking to market a new tobacco product that has not
previously received marketing authorization as a modified risk tobacco
product (MRTP) submit a single application to seek both a marketing
granted order and a modified risk granted order (i.e., a combined PMTA
and MRTPA); however, where an applicant chooses to submit a separate
PMTA and MRTPA, FDA recommends that an applicant submit the full text
of any common content (e.g., the manufacturing or product formulation
sections) in a PMTA and include it in the MRTPA by cross-reference.
This approach would prevent any transcription errors and would allow
for a more effective review by FDA because the content would only need
to be reviewed once to be considered as part of both applications.
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\14\ FDA has not included MRTPAs that resulted in a modified
risk order in the list of documents that an applicant may cross-
reference as part of a PMTA. Because a new tobacco product must
receive premarket authorization under section 910 of the FD&C to be
introduced or delivered for introduction into interstate commerce,
FDA does not intend to act on a MRTPA unless the product has a
pending application seeking, or has already received, marketing
authorization under section 910, or is a Pre-Existing Tobacco
Product. Such an approach will allow FDA to efficiently enforce
section 911 of the FD&C Act by focusing its efforts on only those
applications that could potentially result in a tobacco product
being introduced to the market.
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Under this rule, except as described in subpart B, FDA will not
consider content included by cross-reference to any other sources of
information outside of a submission. An applicant may use internal
cross-references for any content that would need to be referenced in
multiple sections of a PMTA (i.e., include the full text of the content
in one section and use cross-references to
[[Page 55317]]
the content in other sections), rather than including the full text of
the same information multiple times. If an applicant wishes to include
information it has previously submitted to FDA other than a master file
or a pending MRTPA (e.g., portions of an SE Report or previously
submitted PMTA for a different product), the applicant must include the
full text of such information in its PMTA. FDA is implementing this
restriction because cross-referencing information from other types of
applications (e.g., SE Reports, previously submitted PMTAs for
different products) can make review difficult and contribute to delays
in the review process.
(Comment 19) One comment stated that FDA should amend the
application format requirements so that it allows PMTAs to include
information by cross-reference to parts of previously filed PMTAs for
different products that contain studies applicable to the new tobacco
product.
(Response 19) The format requirements of Sec. 1114.7(b) permit an
applicant to cross-reference a tobacco product master file or a pending
MRTPA for the same tobacco product. FDA declines to revise Sec.
1114.7(b) to broadly allow an applicant to cross-reference information
contained in any previously filed PMTA because it could result in a
process in which FDA would have to pull information from a variety of
sources to have a complete PMTA for review, which would increase the
potential for error and decrease the efficiency of FDA's review.
Additionally, permitting an applicant to broadly cross-reference
information presented for different products would not necessarily
result in a more efficient review process. FDA is limiting the ability
of applicants to cross-reference content from previously reviewed PMTAs
to specific circumstances set forth in Sec. Sec. 1114.15 and 1114.17
where it would facilitate application review. Where an applicant
intends to submit the same information in multiple applications
submitted at different periods in time, FDA recommends establishing a
TPMF containing the information so that it could be included by cross-
reference in each application.
An applicant may also submit a single premarket submission for
multiple products (i.e., a bundled PMTA) and a single, combined cover
letter and table of contents across all products; however, when FDA
receives a premarket submission that covers multiple new tobacco
products, we intend to consider information on each product as a
separate, individual PMTA and it is important to identify the content
that pertains to each product.
(Comment 20) Multiple comments requested additional information
regarding how they should bundle multiple PMTAs for related or similar
tobacco products into a single submission. One comment requested that
FDA formally clarify whether e-liquid manufacturers and manufacturers
of closed-system devices may bundle applications for multiple flavors
of e-liquid that share common nicotine strengths, package sizes,
propylene glycol/vegetable glycerin ratios, or other characteristics.
Another comment requested information regarding how a manufacturer
should submit PMTAs for products that are used together but may be sold
separately (e.g., closed e-liquids, such as cartridges or pods that are
not intended to be refillable, and the e-cigarette with which the e-
liquids would be used).
(Response 20) FDA recommends that an applicant group PMTAs for
products in the same subcategory (see Sec. 1114.7(c)) that are
produced by the same manufacturer into a single submission because they
will likely share a significant amount of application content. An
applicant grouping PMTAs together by subcategory would be required to
use Form FDA 4057b to identify the products that are contained in the
grouped submission. Additionally, FDA recommends an applicant group
PMTAs for a new tobacco product and its components or parts into a
single submission where an applicant seeks to sell the components or
parts separately. As discussed in section VIII.B.3., FDA generally
considers an open e-cigarette, also referred to as a refillable e-
cigarette, to be an e-cigarette that includes a reservoir that a user
can refill with an e-liquid of their choosing. A closed e-cigarette is
an e-cigarette that includes an e-liquid reservoir that is not
refillable, such as a disposable cigalike, or that uses e-liquid
contained in replaceable cartridges or pods that are not intended to be
refillable. For example, if a manufacturer wanted to sell a closed e-
cigarette and the closed e-liquids (e.g., nonrefillable cartridges or
pods) that could be used with the e-cigarette separately, it should
group a PMTA for the e-cigarette and PMTAs for each of the e-liquids
into a single submission. FDA does not recommend grouping open e-
liquids and open ENDS devices that will be sold separately in a single
submission except for instances where the applicant is seeking a
marketing granted order for the e-liquids that have been designed by
the manufacturer to be used solely in a particular open ENDS device.
FDA reminds applicants that we intend to consider information on each
product as a separate, individual PMTA, so it is important to identify
the content that pertains to each product. If an applicant does not
clearly identify the content in the submission that makes up the PMTA
for each product, FDA may refuse to accept or refuse to file the
submission.
3. General Information
Section 1114.7(c), including table 1, lists the information that
must be included in the general information section of the PMTA. This
information consists of general administrative information that
includes the type of submission, the new tobacco product with unique
identifiers, and contact information. Specifically, table 1 to Sec.
1114.7(c)(3)(iii) provides for the information needed to help ensure
that we are able to identify and evaluate each product more accurately
and efficiently. This table includes, among other categories,
requirements to submit general information related to ENDS product
category and several subcategories of ENDS. FDA generally considers
ENDS to be electronic nicotine delivery systems that deliver
aerosolized e-liquid when inhaled. The term ``e-cigarette'' refers to
an electronic device that delivers e-liquid in aerosol form into the
mouth and lungs when inhaled; it is also sometimes referred to as an
aerosolizing apparatus. An open e-cigarette, also referred to as a
refillable e-cigarette, is an e-cigarette that includes a reservoir
that a user can refill with an e-liquid of their choosing. A closed e-
cigarette is an e-cigarette that includes an e-liquid reservoir that is
not refillable, such as a disposable cigalike, or that uses e-liquid
contained in replaceable cartridges or pods that are not intended to be
refillable. For additional information on ENDS, consult the ENDS PMTA
Guidance.
In this final rule, we have revised table 1 to Sec.
1114.7(c)(3)(iii) to help ensure that FDA is able to identify and
evaluate each product more accurately and efficiently. For example, the
table includes a waterpipe head as a subcategory of waterpipe. A
waterpipe head is a container that is typically made of materials like
clay, marble, or glass and is used to contain coal and tobacco during a
waterpipe smoking session.
Additionally, the cigarette product category no longer lists
noncombusted cigarettes as a subcategory. Instead, for purposes of PMTA
review, a ``heated tobacco product'' category has been added to the
identification tables. Under this revised taxonomy, some tobacco
[[Page 55318]]
products may fit under more than one category. This PMTA review
category should be used for (among others) tobacco products that meet
the definition of a cigarette but are not combusted (products that do
not exceed 350[deg] C). Heated tobacco products (HTP) can be used with
e-liquids, other types of tobacco filler, or consumable (e.g., wax,
oils). If, however, a tobacco product can only be used with e-liquids,
it should be captured under ``ENDS'' and not the HTP category. To
ensure we have all the information we need to efficiently and
effectively review your application, if the product that is the subject
of your application is a heated tobacco product and is not an ENDS
product, you should submit information under Sec. 1114.7(c)(3)(iii)
under the heated tobacco product category and comply with the design
parameter requirements for HTPs in table 22 to Sec.
1114.7(i)(2)(ii).\15\ FDA believes these product categorizations will
help ensure that applications include the most relevant information for
their product, which in turn will facilitate FDA's review and ability
to reach an authorization decision.
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\15\ Note that the purpose of the unique identification tables
in Sec. 1114.7(c)(3)(iii) is to explain what information we need to
identify and evaluate different types of products, and Sec.
1114.7(i)(2)(ii) explains the design parameters needed for product
characterization (see discussion below). The categorization of HTPs
in Sec. 1114.7(c)(3)(iii) and (i)(2)(ii) does not extend to other
legal requirements beyond those associated with unique
identification and product characterization for premarket review.
---------------------------------------------------------------------------
Other changes to table 1 to Sec. 1114.7(c)(3)(iii) include FDA's
clarification under the ``cigar'' category to designate ``leaf-
wrapped'' cigars as unfiltered to more accurately describe the product
category, as ``leaf-wrapped'' cigars typically do not include filters;
under the ``waterpipe'' category, ``waterpipe'' diameter has been added
to distinguish between waterpipes of different sizes (width/diameter
and height) where all other uniquely identifying information is the
same; and under the ``pipe tobacco filler'' category, ``tobacco cut
style'' has been added to distinguish between different cut pipe
tobacco filler, e.g., standard cut, such as shag cut, bugler cut, loose
cut, etc.; or a pressed cut, such as flake, cube cut, roll cake, etc.
or a mixture. Additionally, FDA has removed the requirement to provide
tobacco cut size from the unique identification requirements for
smokeless tobacco and cigar tobacco filler. A specific numerical value
for this field is not necessary to uniquely identify the specific
product to which the PMTA pertains, as it can be described further
through identification of additional properties (e.g., fine cut, long
cut). However, to fully characterize the tobacco product and evaluate
its health effects, information to determine tobacco cut size is
required under Sec. 1114.7(i)(2)(ii) for the product categories
specified in that section.
Additionally, across all product categories, the subcategory of
``co-package'' has been removed from Sec. 1114.7(c). If an applicant
submits a PMTA for a co-packaged tobacco product, the unique
identification of this co-packaged product would require the specific
items needed to identify each product within the co-package. For
example, if the co-package is a pouch of roll-your-own (RYO) tobacco
filler that contains rolling papers inside the pouch, the applicant
would identify the tobacco product as a co-packaged product and provide
the unique identification for both the RYO tobacco filler and the
rolling papers.
The PMTA must contain the following information using the FDA-
provided form(s) (i.e., Form FDA 4057 (Ref. 10) and Form FDA 4057b
(Ref. 11)), as appropriate:
Applicant name, address, and contact information;
the name, address, and contact information for the
authorized representative or U.S. agent (for a foreign applicant). As
required by Sec. 1105.10(a)(5) for application acceptance, a foreign
applicant must identify a U.S. agent (i.e., an individual located in
the United States who is authorized to act on behalf of the applicant
for the submission) to help FDA ensure adequate notice is provided to
applicants for official Agency communications, assist FDA in
communicating with the foreign applicant, and help the Agency to
efficiently process applications and avoid delays; and
information to uniquely identify the product. Providing
unique identifying information is important to aid in FDA's review
because it ensures FDA has information readily available to distinguish
the tobacco product from other tobacco products, including additional
new tobacco products in a bundled submission (i.e., more than one
application contained in a single submission), and assists FDA in
performing its acceptance and filing reviews. The required unique
identifying information includes:
[cir] The manufacturer;
[cir] product name(s), including the brand and subbrand (or other
commercial name(s) used in commercial distribution); and
[cir] product category; product subcategory; and product
properties, as provided by the table in Sec. 1114.7(c). The applicant
must select and provide the appropriate category, subcategory, and
product properties for the new tobacco product. As discussed
previously, if an applicant submits a PMTA for a co-packaged tobacco
product, the unique identification of this co-packaged product must
include the specific items needed to identify each product within the
co-package. For example, if the co-package is a pouch of RYO tobacco
filler that contains rolling papers inside the pouch, the applicant
must identify the tobacco product as a co-packaged product and provide
the unique identification for both the RYO tobacco filler and the
rolling papers. This product-specific information is required under
sections 910(b)(1)(B) and (G) of the FD&C Act and this rule requires
its inclusion in the general information section of the submission to
help FDA quickly check whether the product is within CTP's purview and
identify the specific product that is the subject of the submission.
For more information regarding product properties and why specific
properties are a required part of an application, see the discussion of
Sec. 1114.7(i)(1) in section VIII.B.9. It is important to note that
for the characterizing flavor product property, the applicant must
state ``none'' if it does not consider the product to have a
characterizing flavor. FDA encourages applicants that have questions
regarding how to describe their product's characterizing flavor to
contact FDA prior to submission.
For each type of tobacco product, the applicant should also include
any additional properties to fully identify the tobacco product, if
applicable. For example, use of product descriptors such as ``extra-
long'' should be identified. While failure to include such additional
properties to help uniquely identify the tobacco product would not
serve as the basis for FDA refusing to accept an application under
Sec. 1114.27(a)(1), it would likely slow down the substantive review
process.
FDA received a few comments regarding Sec. 1114.7(c)(3), as
discussed below.
(Comment 21) One comment stated that Sec. 1114.7(c)(3)(iii) should
be amended to require disclosure of all flavoring agents regardless of
whether they constitute characterizing flavors and all solvents rather
than just propylene glycol and glycerin in all new tobacco products.
(Response 21) We decline to make this proposed edit, because such
information is already required as part of the full listing of all of
the product's ingredients, additives, and constituents
[[Page 55319]]
in Sec. 1114.7(i)(1)(ii). Section 1114.7(c)(3)(iii), entitled
``general information,'' is intended to allow FDA to quickly determine
whether the product is under CTP's jurisdiction and readily identify
the specific product that is the subject of the application. A complete
listing of all flavoring agents and solvents in this section would not
further the purpose of this section.
(Comment 22) One comment requested that FDA amend Sec.
1114.7(c)(3)(iii) to remove the ``dissolvable'' tobacco product
subcategory and replace it with design parameters for an ``oral
tobacco-derived nicotine (OTDN)'' subcategory. The comment stated that
not only does ``dissolvable'' more appropriately describe a product
trait, dissolvable products are less prevalent on the market today than
OTDN products.
(Response 22) FDA declines to remove the ``dissolvable'' tobacco
product subcategory and replace it with ``oral tobacco-derived nicotine
(OTDN).'' In 2009, the Family Smoking Prevention and Tobacco Control
Act authorized FDA to regulate, among other things, smokeless tobacco
products, the definition of which includes some dissolvables that
contain finely ground tobacco. While design parameters of the
dissolvable tobacco products may resemble those of OTDN, the OTDN
subcategory could imply that such products only contain nicotine that
is derived from tobacco, and not finely ground tobacco. This narrow
definition would exclude dissolvable tobacco products that contain
finely ground tobacco. As discussed in section VIII.B.3., applicants
are required to identify the product category and subcategory in a PMTA
to help FDA quickly check whether the product is within CTP's purview
and identify the specific product that is the subject of the
submission. Where an applicant believes its new tobacco product, such
as OTDN, does not fit within a product category set forth in the rule,
it should identify the product category as ``other.''
(Comment 23) One comment stated that FDA should remove the
requirement to identify the category and subcategory of the tobacco
product in Sec. 1114.7(c)(3), because applications should compare
their products to all other tobacco products and product categories are
not contemplated under section 910(b) of the FD&C Act. The comment also
stated that there is no justification to support the potential for
users to switch between products within categories when real-world
evidence shows that current users may switch to products from different
categories.
(Response 23) FDA declines to remove the requirement to identify a
product's category and subcategory. Not only does this information
allow FDA to identify the product, it provides important context for
information contained in the application, including but not limited to
health risks associated with product design and its constituents,
product and packaging design risks and misuse hazards, principles of
operation, and warning statement requirements. Specifically,
identifying a product's category and subcategory ensures that FDA is
able to distinguish between products that have the same brand and
subbrand, but a different category or subcategory, which may be
associated with different health risks, design risks or even have
different warning statement requirements. For example, if an applicant
submits a PMTA for a product that has the same brand and subbrand as
another product but has been identified as smokeless tobacco, FDA will
review the product labeling to ensure it complies with category
specific applicable requirements such as the Comprehensive Smokeless
Tobacco Health and Education Act. Additionally, understanding the
category will allow FDA to determine whether the application meets the
requirement in Sec. 1114.27(b)(1)(ii)(B) to compare the health risks
of the new tobacco product to the health risks of products in the same
product category and products in at least one different product
category.
Section 1114.7(c) also includes the following requirements:
The type of PMTA. The applicant is required to state the
type of PMTA the applicant is submitting (i.e., PMTA, supplemental
PMTA, or resubmission);
whether the applicant requests that FDA refer the PMTA to
the Tobacco Products Scientific Advisory Committee (TPSAC). An
applicant should briefly describe its justification for a request to
refer the PMTA to TPSAC. FDA retains the discretion to refer an
application to TPSAC but will consider an applicant's request as part
of its determination;
identifying information regarding any prior submissions
relating to the new tobacco product, including STNs, where applicable.
The types of prior submissions include premarket applications, such as
PMTAs, SE Reports, and exemption requests, as well as other submissions
to FDA including MRTPAs and submissions related to investigational
tobacco products. The regulatory history of a tobacco product can
provide useful context for FDA's review of a submission;
dates and purpose of any prior meetings with FDA regarding
the new tobacco product;
if the tobacco product has previously been commercially
marketed \16\ in the U.S., the dates during which the tobacco product
was marketed;
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\16\ As described in Section IV.B.4., this includes products
that were commercially marketed in test markets.
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address and the Facility Establishment Identifier (FEI)
number(s), if available, of the establishment(s) involved in the
manufacturer of the new tobacco product. This information will assist
the Agency with environmental impact considerations and determinations
under part 25 by helping FDA understand the location of manufacturing
and scale of products that would be manufactured. Additionally, it
helps FDA schedule and conduct facility inspections;
a brief statement regarding how the PMTA satisfies the
content requirements of section 910(b)(1) of the FD&C Act. This could
consist of a table reproducing the section 910(b)(1) requirements and
listing the sections or page numbers of the PMTA that satisfy the
requirements. FDA is requiring this brief statement under authority of
sections 701(a) and 910(b)(1)(G) of the FD&C Act, which will allow FDA
to more quickly locate application content necessary to determine
whether a PMTA should be accepted and filed for further review under
Sec. 1114.27;
a brief description of how permitting the marketing of the
new tobacco product is expected to be appropriate for the APPH. This
description should be no more than a sentence or two that highlights
the key product characteristics and study results the applicant
believes would make the marketing of the product APPH (e.g., the
product delivers significantly lower levels of a specific HPHCs to
users than the tobacco products they are currently consuming, which
studies indicate may result in decreased morbidity and mortality); and
a list identifying all enclosures, labels, and labeling
being submitted with the application. This list will help FDA identify
application content and ensure a PMTA contains all the information the
applicant intended to submit.
FDA received several comments regarding these requirements (Sec.
1114.7(c)(4) through (12)), as discussed below:
(Comment 24) One comment stated that FDA should refer all PMTAs to
[[Page 55320]]
TPSAC and should make all PMTAs available for public comment. The
comment stated that if referring all applications to TPSAC is
unfeasible, FDA should at least refer applications from major tobacco
companies and representative applications from smaller companies.
(Response 24) We decline to take the comment's suggestion. Under
section 910(b)(2) of the FD&C Act, FDA has the discretion, on its own
initiative or upon the request of an applicant, to refer a PMTA to
TPSAC for reference and for submission of a report and recommendation
respecting the application. Referring an application to TPSAC is a
lengthy process that requires extensive time and resources, including
the significant back-and-forth process with an applicant to redact
trade secrets and confidential commercial information in an application
before it can be made publicly available. Receiving and reviewing
public comments also requires significant time and resources. It would
not be feasible to redact all PMTAs, receive and consider public
comments, and receive and consider TPSAC's report and recommendations
prior to acting on the expected high volume of applications the comment
is suggesting go to TPSAC within the 180-day review period required by
section 910(c) of the FD&C Act.
(Comment 25) Multiple comments stated that FDA should require
applicants to specify whether the new tobacco product is a deemed
tobacco product that has been on the market prior to the deadline for
submitting a PMTA and, if so, require the submission of information
regarding the marketing of the product prior to application submission,
including items such as prior sales, labeling, advertising, and
marketing strategy. One comment also requested that FDA require an
applicant describe whether the prior marketing of its product has been
APPH and deny applications where this has not been the case.
(Response 25) FDA has amended the rule to require a PMTA to specify
the prior dates, if any, during which the tobacco product was initially
marketed. Additionally, the requirement in Sec. 1114.7(k) to submit
full reports of investigations that are published or known to, or which
should reasonably be known to, an applicant includes the time period
during which an applicant previously marketed a deemed tobacco product.
While information relating to the prior marketing of a tobacco product
may inform FDA review of a PMTA, FDA declines to require an applicant
to describe whether it believed its prior marketing of a product was
APPH, or necessarily deny an application where prior marketing was not
APPH. FDA will make its own determination as to whether permitting the
marketing of the new tobacco product is APPH based on all of the
contents of the application. In addition, FDA has authority to include
postmarket requirements to help ensure that marketing of the product
after authorization continues to be APPH.
4. Descriptive Information
Section 1114.7(d) requires applicants to provide descriptive
information that outlines the major aspects of the new tobacco product,
which is required to be submitted under section 910(b)(1)(A), (D), and
(G) of the FD&C Act. This information includes:
A concise description of the new tobacco product (e.g.,
the product is a portioned smokeless tobacco product made using a blend
of burley and bright tobacco);
a statement identifying all tobacco product standards
issued under section 907 of the FD&C Act that are applicable to the new
tobacco product and a brief description of how the new tobacco product
fully meets the identified tobacco product standard(s). If the new
tobacco product deviates from such standard(s), if applicable, the rule
requires the application to include adequate information to identify
and justify those deviations;
the product name(s) as designated on the product's label;
a description of problems identified in prototypes that
are the subject of studies contained in the application, or previous or
similar versions of the new tobacco product that were marketed, if any.
This includes information regarding any health risks such as
overheating, fires, or explosions as well any information regarding
manufacturing issues related to the product, such as packaging defects
that could pose a health risk. If there are previous or similar
versions that were marketed or that are the subject of studies in the
application, the rule requires the applicant to include a bibliography
of all reports regarding the previous or similar version of the
product, whether adverse or supportive. FDA requires this information
under section 910(b)(1)(A) and (G) of the FD&C Act to assess whether
any known issues with a predecessor product that could affect the
health risks of the new tobacco product have been addressed; and
any restrictions on the sale, distribution, advertising,
or promotion of the new tobacco product (as described in section
910(c)(1)(B) of the FD&C Act) that the applicant proposes to be
included as part of a marketing granted order, if issued. The applicant
may choose to propose restrictions on the sales and distribution of the
tobacco product to help support a showing that the marketing of the
product is appropriate for the protection of the public health (e.g., a
restriction that decreases the likelihood that those who do not
currently use tobacco products will initiate tobacco product use with
the new tobacco product). If an applicant does not wish to propose any
additional restrictions, it must explicitly state that it proposes no
restrictions. As described in Sec. 1114.31, FDA may consider these
proposed restrictions during its review of the PMTA and, where
appropriate, include applicant proposed restrictions in the marketing
granted order for the product together with any additional restrictions
FDA may require.
FDA received many comments regarding the descriptive information
requirements, as discussed below.
(Comment 26) Multiple comments requested that FDA revise the
requirement in Sec. 1114.7(d)(4). One comment stated that section
910(b)(1)(B) of the FD&C Act limits review to the new tobacco product
that is the subject of the application and does not permit review of
other products. The comments also stated that the terms ``previous or
similar version,'' ``prototype,'' and ``problem'' are so vague that
they would leave applicants guessing at what information must be
included. The comments concluded by stating that a product's effects on
public health should be determined based on data about the product in
its current form.
(Response 26) FDA disagrees with the comments statement that FDA
cannot require this information or consider it during product review.
FDA is requiring the submission of information regarding prototypes and
previous or similar versions of the tobacco product to assess whether
an applicant has addressed any known issues with a predecessor product
that could affect the health risks of the new tobacco product. The
terms ``previous or similar version,'' or ``prototype,'' mean any
previous generation, model, or version of a tobacco product that has
undergone testing or was on the market in other countries, such as
first-generation ENDS products that underwent aerosols or battery
testing, and was subsequently modified as a result of testing, adverse
experiences, or other design concerns that could impact the public
health. Rather than using section 910(b)(1)(B) of the FD&C Act, as
cited by the comments as authority for this requirement, FDA
[[Page 55321]]
bases its authority for this provision on section 910(b)(1)(G) of the
FD&C Act, which requires applicants to submit other information
relevant to the subject matter of the application as the Secretary may
require.
The information required in Sec. 1114.7(d)(4) will allow FDA to
review information regarding risks present in closely related products
and determine whether the applicant has addressed such risks in the
development of the product that is the subject of the PMTA. FDA
declines to adopt the comments' proposed approach that would require
FDA to ignore information about known problems and related health risks
that could be present in the tobacco product under review. We note that
information about known problems and related health risks (e.g.,
product class effects such as mouth ulcers in moist tobacco) would be
informative and could be used to bridge health effect information.
Specifically, this information could help FDA to determine the validity
and applicability of the studies that relied on a prototype.
5. Samples of New Tobacco Products and Components or Parts
Section 910(b)(1)(E) of the FD&C Act requires an applicant to
submit samples of a tobacco product and its components as FDA may
reasonably require. After FDA accepts a submission, FDA will determine
whether it will require product samples and, if so, issue instructions
on how and where to submit the samples, and the number of samples that
are required. Section 1114.7(e) requires an applicant to submit samples
of the finished tobacco product and its components in accordance with
instructions issued to the applicant after a PMTA is accepted for
review, as well as to submit additional samples if required by FDA
during application review. FDA generally expects that product samples
will be a required part of a PMTA and that an applicant should be
prepared to submit them in accordance with FDA instructions within 30
days after submitting a PMTA. There may be situations in which sample
submission may not be necessary, including, in some circumstances,
PMTAs that are resubmitted for the same product after a marketing
denial order (such as resubmissions as described in Sec. 1114.17) or
PMTAs submitted for modifications to an authorized product where the
modifications do not require review of new samples as part of the PMTA
evaluation process. Presubmission meetings with FDA may help provide
additional information about whether product samples will need to be
included in a PMTA; however, in most situations, FDA will only be able
to determine the need for product samples after a PMTA is accepted for
review.
FDA received many comments regarding product samples, as discussed
below.
(Comment 27) One comment agreed that requesting samples after a
PMTA submission has been accepted makes sense; however, it stated that
providing information regarding the quantity and type of samples that
will be required for submission in advance is important to ensure that
the samples FDA requires are actually available at the time of request.
(Response 27) As described in section VIII.B.5, FDA generally
expects that product samples will be a required part of a PMTA and that
an applicant should be prepared to submit them in accordance with FDA
instructions within 30 days after submitting a PMTA. Because the
quantity and type of samples need for testing may vary based upon a
number of factors including product category and specific product
characteristics, FDA intends to determine the quantity and type that
will be required after application acceptance. However, as noted in
section VIII.B.5., presubmission meetings with FDA may help provide
additional information about whether product samples will need to be
included in a PMTA.
(Comment 28) We received multiple comments regarding FDA's proposal
to require an applicant to submit product samples only after an
application is accepted for review. One comment stated that the start
of FDA's 180-day review period should not be postponed until samples
are received and should instead begin at the time the application is
otherwise complete except for samples. Another comment requested that
FDA amend the rule to allow applicants to submit product samples as
part of its initial PMTA to avoid delays. The comment stated that the
costs of the delaying the start of substantive review outweigh any
minor savings gained by postponing inevitable product sample
submission. The comment also noted that under FDA's proposed approach,
FDA could indefinitely delay filing an application for review by not
requesting product samples after application acceptance.
(Response 28) We decline to make the requested revisions. FDA will
have applicants submit samples (if required by FDA) after acceptance of
an application rather than as part of an initial submission. This
timing will help FDA to determine the need for samples, allow the
samples to be tracked and identified as part of the correct
application, and facilitate the submission of samples to testing
facilities that are adequately prepared to accept them (e.g., one that
has a refrigerated unit if the product needs to be stored at a certain
temperature). Additionally, by having applicants submit samples after
FDA accepts an application, applicants will be able to avoid the effort
and expense of submitting samples if the application is not accepted
for review or if samples are not required. It will also allow FDA to
avoid similar concerns with respect to storage and the return of
samples for applications where FDA refuses to accept a PMTA. As
described in Sec. 1114.27, if required by FDA, product samples will be
necessary for application filing and FDA intends to refuse to file a
PMTA for a lack of product samples if the applicant has not submitted
samples in accordance with FDA's instructions by the time FDA is
prepared to make its filing determination.
FDA intends to notify an applicant if it determines after PMTA
acceptance that product samples are not required for PMTA filing;
however, even in such a situation, FDA may request product samples
during substantive review after an application is filed, as needed. FDA
generally expects that, where required, samples will be requested
within 30 days after application submission. Applicants may discuss the
need for product samples during a presubmission meeting with FDA, which
may speed up the sample submission process.
6. Labeling and Description of Marketing Plans
Section 1114.7(f) of the rule requires that a PMTA contain
specimens of labeling and describe the applicant's marketing plans for
the new tobacco product.
a. Labeling. Section 910(b)(1)(F) of the FD&C Act requires that a
PMTA contain specimens of the proposed labeling to be used for the
tobacco product. Section 1114.7(f)(1) elaborates on this requirement
and requires the application to contain specimens of all proposed
labeling for the new tobacco product, including labels, inserts,
onserts, instructions, and other accompanying information.
FDA received comments regarding the submission of labeling, as
described below.
(Comment 29) One comment stated that FDA's proposal to require
``specimens of all proposed labeling'' in Sec. 1114.7(f)(1) is outside
the scope of its authority under section 910 of the FD&C
[[Page 55322]]
Act and requested that FDA remove the word ``all'' from the
requirement. The comment stated that the statute requires the
submission of specimens proposed to be used, which connotes a typical
example of a larger whole and, as such, is not compatible with the
requirement to provide ``all'' proposed labeling.
(Response 29) FDA disagrees with the assertion that Sec.
1114.7(f)(1) is outside of its authority and declines to interpret the
term ``specimens'' as used in section 910(b)(1)(F) of the FD&C Act to
mean a representative sample. FDA's interpretation of section
910(b)(1)(F) in Sec. 1114.7(f)(1) is consistent with how it interprets
similar statutory requirements to submit specimens of labeling for both
new drug applications and premarket approval applications for medical
devices.\17\ Not only did FDA's interpretation of these requirements
for drugs and devices exist when Congress enacted the same requirement
in the Tobacco Control Act, section 905(i)(1)(B) of the FD&C Act
demonstrates Congress understands how to require a representative
sample when it intends to do so. It did not do so here. Furthermore,
requiring specimens of all proposed labeling is important to FDA's
review of an application, because FDA must deny a PMTA under section
910(c)(2)(C) of the FD&C Act where it finds, based on a fair evaluation
of all material facts, the proposed labeling is false or misleading in
any particular. This requirement to deny a PMTA based upon any
particular of the proposed labeling is at odds with the comment's
suggestion that Congress intended FDA to review only a general
representation of what an applicant proposes to use.
---------------------------------------------------------------------------
\17\ See the interpretation of section 505(b)(1)(F) of the FD&C
Act (21 U.S.C. 355(b)(1)) in 21 CFR 314.50(e)(2)(ii) (50 FR 7493,
February 22, 1985) for new drug application, and the interpretation
of 515(c)(1)(F) (21 U.S.C. 360e(c)(1)(F)) in 21 CFR 814.20(b)(10)
for premarket approval applications for medical devices.
---------------------------------------------------------------------------
The labeling specimens are required to include all panels and
reflect the actual size and color proposed to be used for such tobacco
product. The labels must include any warning statements required by
statute or regulation, such as the Federal Cigarette Labeling and
Advertising Act, the Comprehensive Smokeless Tobacco Health and
Education Act, or the minimum required warning statements contained in
21 CFR part 1143. For products that are required to provide rotational
warning statements, the applicant should submit labeling with each of
the required warnings in the rotation.\18\
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\18\ For more information on rotational warning statement
requirements, see https://www.fda.gov/tobacco-products/products-guidance-regulations/labeling-and-warning-statements-tobacco-products.
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As described in Sec. 1114.33, product labeling is an important
part of FDA's review of an application, because FDA must deny a PMTA
under section 910(c)(2)(C) of the FD&C Act where it finds, based on a
fair evaluation of all material facts, the proposed labeling is false
or misleading in any particular. Additionally, product labeling can be
an important part of FDA's determination under section 910(c)(2)(A) of
the FD&C Act of whether there is a showing that permitting the
marketing of the product would be APPH because it can be used to help
show perception of the risks of the product and the ability of
individuals to understand the labeling, including any instructions for
use, as described in Sec. 1114.7(k)(1)(iv).
b. Description of Marketing Plans.--i. General. In the proposed
rule, the marketing plans provision in proposed Sec. 1114.7(f)(2)
would have required an applicant to submit detailed information about
all plans it had developed to market its new tobacco product. In
response to comments and on FDA's own initiative, we have revised the
requirement to submit information concerning the applicant's plans to
market the new tobacco product. Rather than requiring all of the
detailed information required in proposed Sec. 1114.7(f)(2), FDA has
revised this section to require only a high-level description of
several key aspects of these plans that directly inform FDA's APPH
determination. FDA notes that, pursuant to Section 910(b)(1)(G) of the
FD&C Act, the Agency may require additional information related to
marketing plans on a case-by-case basis, if the agency determines
during review that additional information is needed to help determine
if a product is appropriate for the protection of the public health.
FDA's discussion of the comments is included below.
(Comment 30) One comment stated that FDA should clarify the scope
of marketing information it expects to see in a PMTA and explain how it
plans to engage in a science-based review of labeling and marketing
plans, noting that the rule provides little detail as to what specific
marketing information the Agency expects to see. The comment stated
that it is unclear whether FDA is proposing to require submission of
information about top-line product messaging or specific pieces of the
advertising and marketing strategies for their use. The comment noted
that it is also unclear to what extent FDA expects to see results of
consumer research. In addition, the comment stated that it remains
unknown how the Agency plans to review labeling and marketing plans and
what specific considerations or methodologies will guide assessment of
consumer risk perception, comprehension, and use intentions.
(Response 30) FDA has revised Sec. 1114.7(f)(2) to require only
high-level marketing plan information that it generally expects
applicants will have developed prior to seeking marketing authorization
for their products. The description of marketing plans now required by
Sec. 1114.7(f)(2)--including intended audience, how the applicant
would target the intended audience and what other groups would
foreseeably be exposed, and how exposure would be limited for
individuals below the minimum age of sale--seeks information necessary
for FDA to properly evaluate the extent of youth exposure to marketing
materials for the product and youth access to the product. Discussion
of these items will not require applicants to conduct consumer
research; however, where an applicant had undertaken such research, the
results of such research will be required by Sec. 1114.7(f)(2) or
(k)(1)(iv). As discussed in section VIII.B.6.b., this information will
allow FDA to consider whether an applicant has addressed potential
concerns about the marketing of its product, such as tobacco product
use initiation by individuals under the minimum age of sale, and will
help FDA to assess whether the plans to market the product are
consistent with the applicant's discussion of the likelihood of changes
in tobacco product use behavior in the application. These
considerations will help FDA to determine whether there is a showing
that permitting the tobacco product to be marketed is appropriate for
the protection of public health.
(Comment 31) One comment stated that the marketing plan
requirements seem to be based on the premise that companies will have
developed marketing plans by the time of application submission, which
fails to account for the small vape shops that currently serve as both
retailers and manufacturers who are unlikely to have undertaken
consumer research. The comment requested that FDA edit the marketing
plan requirements to apply only ``as applicable'' to companies that
have conducted such research.
(Response 31) The requirement to provide descriptions of marketing
plans does not require applicants to undertake market or consumer
research. Rather,
[[Page 55323]]
Sec. 1114.7(f)(2) requires PMTAs to contain a discussion of several
key high-level aspects of the applicant's plans to market the product.
The discussion of these items will not require consumer research;
however, be aware that Sec. 1114.7(k)(1)(iv) requires applicants to
submit reports of all information published or known to, or which
should reasonably be known to, the applicant concerning investigations
regarding the impact of the product and its label, labeling, and
advertising, to the extent that advertising has been studied, on
individuals' perception of the product and use intentions. This will
include any consumer research that the applicant has undertaken or used
to develop the aspects of its marketing plan identified in Sec.
1114.7(f)(2).
(Comment 32) One comment stated that FDA should amend the marketing
plan requirements in Sec. 1114.7(f)(2) to include specific language
about dual use because the reality is that most adult users of tobacco
products become dual users.
(Response 32) We have edited Sec. 1114.7(f)(2) to include polyuse
as an example tobacco use behavior that descriptions of marketing plans
may address in describing target audiences. FDA requires descriptions
of marketing plans to inform our determination of whether the new
product is appropriate for the protection of public health. As part of
FDA's determination of the risks and benefits to the health of the
population as a whole (which includes youth, young adults, and other
vulnerable populations), FDA will consider the potential for long-term
dual use among current users. FDA reviews the descriptions of marketing
plans in conjunction with the other submitted information, which can
include tobacco product perception and use intention studies and actual
use studies to assess the likelihood that current users will switch
completely to the new product or become a dual or polyuser of tobacco
products. To the extent that the description of marketing plans
contains information about the target audience by psychographic
characteristics including tobacco use patterns, FDA will consider
whether dual use is likely given the description of the marketing plans
and the other submitted information.
(Comment 33) One commenter stated that the marketing plan
requirements are outside of what the FD&C Act allows FDA to review as
part of a PMTA. The commenter stated that the structure of the FD&C Act
shows that Congress did not intend for FDA to review marketing plan
information as part of a PMTA because where Congress found such
information to be relevant to FDA's analysis, it expressly added such a
requirement to the statute (e.g., section 905(i)(1) of the FD&C Act).
The commenter stated that in contrast, in section 910 of the FD&C Act
Congress required that PMTAs must contain only ``specimens of the
proposed labeling to be used for [the] tobacco product.'' The commenter
concluded that the fact that Congress omitted a broader requirement for
advertisements in section 910 of the FD&C Act but included the
requirement for only ``specimens'' of labeling shows that Congress did
not consider broader information relevant to FDA's evaluation of a
PMTA. The commenter also states that FDA's claim of authority under
section 910(b)(1)(G) is ineffective because it does not grant FDA the
limitless authority to require content; rather, FDA only has the
authority to require information under 910(b)(1)(G) of the FD&C Act
that is reasonable and reasonably explained, which the commenter
maintains that FDA has failed to do here.
(Response 33) As discussed in Response 30, FDA has revised Sec.
1114.7(f)(2) to require only high-level marketing plan information that
it generally expects applicants will have developed prior to seeking
marketing authorization for their products. But even so, we disagree
with the commenter's position that FDA lacks statutory authority to
require marketing plans as part of a PMTA. In describing the required
contents of a PMTA in section 910(b)(1)(G), Congress explicitly
authorized FDA to require ``such other information relevant to the
subject matter of the application.'' This provision demonstrates that
Congress intended for FDA to apply its expertise with respect to review
of scientific applications and the overall administration of the
Tobacco Control Act to determine what additional information would be
``relevant'' to whether the application meets the requirements to
receive marketing authorization.
We have determined that the description of marketing plans required
by Sec. 1114.7(f)(2) is relevant to the subject matter of a PMTA. To
issue a marketing granted order for a new tobacco product, FDA must
determine that permitting such tobacco product to be marketed would be
APPH, which requires FDA to consider the likelihood that those who do
not use tobacco products, including youth, will start using them.
Determining the extent to which youth will be exposed to marketing
materials for the product is critical to that consideration. As
explained by Congress in enacting the Tobacco Control Act, tobacco
advertising, marketing, and promotion substantially contribute to youth
trial and uptake of tobacco use. See, e.g., Tobacco Control Act section
2(5) (tobacco advertising and marketing contribute significantly to the
use of tobacco products by adolescents.); id. section 2(15)
(advertising, marketing and promotion of tobacco products have resulted
in increased use of such products by youth.); id. section 2(20)
(children are exposed to substantial and unavoidable tobacco
advertising that increases the number of young people who begin to use
tobacco); id. section 2(22) (tobacco advertising expands the size of
the tobacco market by increasing consumption of tobacco products
including tobacco use by young people). Congress enacted the Tobacco
Control Act against the backdrop of years of litigation exposing
previous tobacco product marketing campaigns in which companies
successfully targeted and recruited new youth smokers. See, e.g.,
United States v. Philip Morris USA, Inc., 449 F. Supp. 2d 1, 616
(D.D.C. 2006) (``As the following evidence demonstrates, Defendants
have utilized the vast amount of research and tracking data they
accumulated on youth smoking initiation, tastes and preferences by
employing themes which resonate with youth in their marketing
campaigns. Defendants have focused their attention on young people
under the age of twenty-one in order to recruit replacement smokers and
have emphasized the popularity, physical attractiveness, and `coolness'
of their youth brands. Above all, Defendants have burnished the image
of their youth brands to convey rugged independence, rebelliousness,
love of life, adventurousness, confidence, self-assurance, and
belonging to the `in' crowd.'' (internal citation omitted)), aff'd in
part, rev'd in part on other grounds, 566 F.3d 1095 (D.C. Cir. 2009);
see also 449 F. Supp. 2d at 616-39.
A well-established body of scientific evidence confirms the
continuing impact of tobacco product marketing on initiation and use by
individuals under the minimum age of sale. See, e.g., Dep't of Health &
Human Servs., E-Cigarette Use Among Youth and Young Adults: A Report of
the Surgeon General 170 (2016) (``An analysis of the 2011 National
Youth Tobacco Survey found that adolescents who reported frequent
exposure to protobacco advertising at the point of sale and on the
internet (e.g., seeing ads most of the time or always) had
significantly higher odds of ever using e-cigarettes, and there was a
dose-response association between the number of marketing channels to
which
[[Page 55324]]
they were exposed and ever use[.]''); Dep't of Health & Human Servs.,
Preventing Tobacco Use Among Youth and Young Adults: A Report of the
Surgeon General 598 (2012) (``[T]here is strong empirical evidence,
along with the tobacco industry's own internal documents and trial
testimony, as well as widely accepted principles of advertising and
marketing that support the conclusion that tobacco manufacturers'
advertising, marketing, and promotions recruit new users as youth and
continue to reinforce use among young adults[.]''). Companies marketing
newer forms of tobacco products have employed some of the same
techniques, as well as newer innovations, to attract the youth market.
For example, ENDS manufacturers have used social media, including
influencers, to help create an image for their products as being cool
and having sex appeal, sponsored music festivals, and created products
with youth-appealing cartoon images (see, e.g., Refs. 12 through 15).
The descriptions of marketing plans required by Sec.
1114.7(f)(2)--including intended audience, how the applicant would
target the intended audience and what other groups would foreseeably be
exposed, and how exposure would be limited for individuals below the
minimum age of sale (e.g., avoiding online social media without access
restrictions)--seeks information necessary for FDA to properly evaluate
the extent of youth exposure to marketing materials for the product and
youth access to the product. Accordingly, this information is directly
relevant to the subject matter of a PMTA, including FDA's consideration
of the likelihood that youth will use the tobacco product and its
determination that permitting the product to be marketed would be APPH.
Because Congress clearly and unambiguously authorized FDA to
require additional relevant information, that should be ``the end of
[the] analysis.'' Zuni Pub. Sch. Dist. No. 89 v. Dep't of Educ., 550
U.S. 81, 93 (2007) (citing Chevron, U.S.A., Inc. v. Natural Res. Def.
Council, Inc., 467 U.S. 837 (1984)). But even if Congress has not
``directly'' addressed ``the precise question at issue,'' FDA's
interpretation is a ``permissible construction of the statute,''
Chevron, 467 U.S. 837 at 843, on a matter where the Agency's expertise
plays a significant role in resolving important questions related to
the administration of the statute. Barnhart v. Walton, 535 U.S. 212,
222 (2002).
In determining to require the submission of descriptions of
marketing plans as part of a PMTA, FDA considered the information it
needed to be able to evaluate whether the statutory requirements for
PMTA authorization are met, as well as the context and purpose of the
PMTA requirement. As discussed above, a well-established body of
historical and scientific evidence and Congress's own findings in
enacting the Tobacco Control Act support FDA's reasonable conclusion
that potential exposure to tobacco product advertising, marketing, and
promotion is relevant to, and indeed a critical factor in, FDA's
statutorily required determination of the likelihood that nonusers,
including youth, will use a new tobacco product. Moreover, based on
this evidence, as well as the expertise it has developed regarding
tobacco product marketing over more than a decade of administering the
Tobacco Control Act, FDA has rationally concluded that the required
descriptions of marketing plans will directly inform its assessment of
who may be exposed to the applicant's labeling, advertising, marketing,
and promotion and, as a result, its consideration of the potential
impact on youth initiation and use. FDA's assessment of who may be
exposed to tobacco product marketing materials and activities will
include individuals below the minimum age of sale, recently raised from
18 to 21 years. For example, information regarding how the applicant
will target the intended audience, such as the marketing channels and
tactics an applicant expects to use, will permit FDA to determine the
extent to which youth would be exposed to and influenced by marketing
for the product. (See, e.g., Refs. 13, 16, and 17) As another example,
a description of the ways in which an applicant would limit exposure to
tobacco product marketing materials and activities for individuals
below the minimum age of sale will inform FDA's assessment of the
potential for youth exposure to these materials and activities.
Submission of descriptions of marketing plans also supports the
Tobacco Control Act's mandate that FDA protect youth from the dangers
of tobacco use. See, e.g., Tobacco Control Act section 3(2), (7)
(purposes of the Tobacco Control Act include to ensure that FDA has
authority to address issues of particular concern to public health
officials, especially the use of tobacco by young people, and to ensure
that tobacco products are not sold or accessible to underage
purchasers). In enacting the Tobacco Control Act and giving FDA this
mandate, Congress recognized the substantial impact of exposure to
tobacco product advertising, marketing, and promotion on youth tobacco
use. See, e.g., Tobacco Control Act section 2(15) (advertising,
marketing and promotion of tobacco products have resulted in increased
use of such products by youth.). Based on this context and the ample
scientific evidence supporting the powerful impact of marketing on
youth tobacco use, FDA reasonably concluded that determining the extent
to which youth may be exposed to marketing materials for a new tobacco
product is critical to its evaluation of the potential for youth to use
the new tobacco product and to its ability to fulfill its mandate to
protect youth from the dangers of tobacco use. To that end, the
requirement for descriptions of marketing plans seeks information that
directly informs FDA's assessment of the extent to which youth may be
exposed to marketing materials for the new tobacco product, as well as
information to help FDA determine whether any concerns about youth use
of the product and the corresponding increases in health risks would be
mitigated, such as information regarding the extent to which an
applicant would restrict access to the tobacco product for individuals
below the minimum age of sale.
Contrary to the comment, Congress's inclusion of an advertising
requirement in non-PMTA-related sections of the FD&C Act, such as
section 905(i)(1), and omission of the requirement in section
910(b)(1)(F) of the FD&C Act, does not demonstrate Congress's intent to
exclude description of marketing plans from PMTAs. Congress's explicit
authorization in 910(b)(1)(G) of the FD&C Act that FDA may require
``such other information relevant to the subject matter of the
application'' defeats the commenter's inference by omission argument.
See Adirondack Med. Ctr. v. Sebelius, 740 F.3d 692, 697 (D.C. Cir.
2014) (the ``expressio unius canon'' is a ``poor indicator of Congress'
intent'' where there is a ``broad grant of authority'' to the Agency;
instead, `` `Congress is presumed to have left to reasonable agency
discretion questions that it has not directly resolved' '' (quoting
Cheney R.R. Co. v. I.C.C., 902 F.2d 66, 68-69 (D.C. Cir. 1990)).
Indeed, Congress did not ``omit'' an advertising requirement from
section 910(b)(1) but rather left its inclusion to FDA's discretion and
judgment. As explained above, FDA has reasonably exercised its
discretion in construing section 910(b)(1)(G) of the FD&C Act to
require descriptions of marketing plans based on the Tobacco Control
Act's context and purpose, ample scientific evidence,
[[Page 55325]]
and the Agency's own expertise developed over a decade of administering
the statute.
(Comment 34) The commenter also stated that the marketing plans
requirement potentially limits speech, raising First Amendment
concerns. The commenter stated that the requirement places more than an
incidental burden on protected expression, and the government cannot
show it directly advances a substantial government interest that is
drawn narrowly to achieve that interest. In terms of the alleged
burden, the commenter stated that the requirement would distract and
deter manufacturers from the focused development and implementation of
robust marketing plans--ultimately burdening the right of consumers to
receive, and manufacturers to provide, information about products
determined by FDA to be appropriate for the protection of the public
health. Additionally, the commenter asserted that the requirement would
significantly chill protected speech due to the threat that FDA might
disclose information about applicants' marketing plans to TPSAC or the
public and thereby compromise an applicant's competitive strategy.
The commenter also asserted that the proposed requirement for
manufacturers to report ``total dollar amount(s) of media buys and
marketing and promotional activities'' would have been particularly
burdensome and lacked justification. It stated that there was no
evidence in the record that reporting such information for truthful
advertising and marketing of a product with a PMTA order would directly
advance the government's interest. The commenter also asserted that
FDA's proposed request for marketing plans would not yield meaningful
information given the amount of time it could take for FDA to review an
application, the evolving tobacco product landscape, and the likelihood
that the applicant's marketing plans would change.
In arguing that the government has not justified these burdens, the
commenter asserts that the marketing plans requirement is a content-
based burden on speech in that it applies only to applicants who wish
to engage in the marketing of tobacco products, and therefore the
government's justification is subject to strict scrutiny under Reed v.
Town of Gilbert, 135 S. Ct. 2218, 2226 (2015), or at least heightened
scrutiny under Sorrell v. IMS Health Inc., 564 U.S. 552 (2011). The
commenter states that FDA's required marketing disclosures are not
narrowly tailored nor do they directly advance a compelling government
interest, so they cannot meet the higher standard for content-based
restrictions.
(Response 34) As discussed in Response 30, FDA has revised Sec.
1114.7(f)(2) to require only high-level marketing plan information that
it generally expects applicants will have developed prior to seeking
marketing authorization for their products. That noted, we do not agree
that the requirement for descriptions of marketing plans raises First
Amendment concerns for several reasons. First, we disagree that the
requirement to submit descriptions of marketing plans burdens speech.
Federal Agencies routinely require regulated industry to disclose
information to the government. The FD&C Act contains several premarket
authorization requirements, including for drugs and devices, which have
existed for decades, and whose constitutionality is not seriously
questioned. Indeed, in the proliferation of lawsuits challenging
various aspects of the Tobacco Control Act, there have been few direct
challenges to the PMTA requirements, and any related challenges have
been resolved in the government's favor. See Nicopure Labs., LLC v.
FDA, 266 F. Supp. 3d 360, 391-95, 409 (D.D.C. 2017) (upholding FDA's
decision to apply PMTA requirements to deemed tobacco products as
permissible under the Administrative Procedure Act, and upholding the
statutory PMTA requirement under the Due Process clause of the
Constitution), aff'd on other grounds, 944 F.3d 267 (D.C. Cir. 2019)
(PMTA rulings were not appealed); see also, e.g., Nicopure Labs., 944
F.3d at 284-90 (D.C. Cir. 2019) (rejecting First Amendment challenge to
the Tobacco Control Act requirement that manufacturers obtain premarket
review of MRTPs).
To the extent that the commenter contends that the requirement to
provide a description of its marketing plans to FDA would impinge on an
applicant's ability to market its tobacco products, FDA is not aware of
any evidence to support that contention (and the commenter cites none).
The comment's assertion that the requirement would distract and deter
manufacturers from the focused development and implementation of robust
marketing plans strains credulity given tobacco manufacturers'
incentives to market their products and the significant resources
tobacco product manufacturers commit to marketing their products each
year. See Edenfield v. Fane, 507 U.S. 761, 766 (1993) (``A seller has a
strong financial incentive to educate the market and stimulate demand
for his product or service.''). The Federal Trade Commission reported
that advertising and promotional expenditures by major cigarette
manufacturers totaled $8.401 billion in 2018 (Ref. 18).
FDA has considered the comment's position regarding the proposed
Sec. 1114.7(f)(2) requirement that applicants provide ``total dollar
amount(s) of media buys and marketing and promotional activities.'' FDA
has revised Sec. 1114.7(f)(2) to no longer require total dollar
amounts of media buys and marketing and promotional activities. In
addition, FDA has revised this section to require only high-level
information that it expects applicants will generally have developed
prior to seeking marketing authorization for their products. For
example, revised Sec. 1114.7(f)(2)(i) and (ii) require an applicant to
provide a discussion of the intended audience for the marketing
materials and activities for the tobacco product and how the applicant
would target those marketing materials and activities to the intended
audience. Based on its experience, FDA expects that an applicant will
generally have considered its intended audience and how it will target
its marketing materials and activities to that audience by the time it
submits its PMTA. Discussion of these items will not require applicants
to conduct consumer research; however, where an applicant has
undertaken such research, such as conducting tobacco product perception
and intention studies, it will be required to be included in the PMTA
as set forth in Sec. 1114.7(k)(1)(iii), where applicable. Applicants
will be required to provide the descriptions of marketing plans
identified in this section based on the plans they have developed as of
the time of submitting their PMTA, and where an applicant has not
developed plans relating to one or more items in Sec. 1114.7(f)(2),
they would be required to state that in their application.
The comment's concern that commercial speech would be chilled due
to the perceived risk that FDA would disclose an applicant's
description of its marketing plans to TPSAC or the public and thereby
compromise confidential commercial information (CCI) in those marketing
plans is unwarranted. FDA generally may not make information in an
application publicly available to the extent that the information
constitutes trade secrets or CCI. See 5 U.S.C. 552(b)(4); 18 U.S.C.
1905; 21 U.S.C. 387f(c); 21 CFR 20.61(c); id. Sec. 1114.47(a) (FDA
will determine the public availability of any part of a PMTA under this
section and part 20 (21 CFR part 20)). The Tobacco Control Act does not
require FDA to refer PMTAs (or any
[[Page 55326]]
information contained therein) to TPSAC, instead committing that
decision to the Secretary's discretion. See 21 U.S.C. 387j(b)(2)
(providing that the Secretary ``may'' refer PMTAs to TPSAC ``on the
Secretary's own initiative; or . . . upon the request of an
applicant''). If the Secretary finds it appropriate to consult the
TPSAC on an issue that requires consideration of CCI contained in the
description of marketing plans, FDA may share that information only
with TPSAC members who are subject to the same restrictions with
respect to disclosure of CCI as any other FDA employee. See 21 CFR
20.84; id. 21 CFR 14.86(a)(2). Additionally, if the Secretary refers a
PMTA to TPSAC, Sec. 1114.47(b)(4) of this rule provides that CCI
contained in the application generally will not be available for public
disclosure. FDA may close a portion of a TPSAC meeting to allow
discussion of an applicant's CCI to take place without disclosing the
CCI to the public. See 21 CFR 14.27(b)(3) (allowing portions of an
advisory committee meeting to be closed if they concern the review of
trade secrets and CCI).
FDA also disagrees with the commenter's assertion that FDA's
requirement for marketing plans as originally proposed would not yield
meaningful information given the amount of time it might take for FDA
to review an application, the evolving tobacco product landscape, and
the likelihood that the applicant's marketing plans would change.
Because we have revised Sec. 1114.7(f)(2) to require a discussion of
high-level items, rather than the submission of details that are more
subject to change (e.g., media buys, dollar amount, specific tactics),
we generally do not expect the information contained in the applicant's
description of marketing plans to change significantly after the
submission of the application. However, under Sec. 1114.9, FDA may
request, or an applicant may submit on its own initiative, an amendment
to its PMTA containing information that is necessary for FDA to
complete its review of the application, including information regarding
any alterations or updates to the required description of marketing
plans. As described in section VIII.C., so long as such an amendment
does not require significant review time, it will not be considered a
major amendment for which the review period will be extended by up to
180 days and even where such an amendment is major amendment, FDA
anticipates it would generally take less than 180 days to complete
review thereof.
Second, even if the requirements of Sec. 1114.7(f)(2) restricted
speech, they would readily pass muster under the intermediate scrutiny
test for commercial speech articulated in Central Hudson Gas & Elec.
Corp. v. Pub. Serv. Comm'n, 447 U.S. 557 (1980). Under that test,
Agencies may regulate speech where the regulation advances a
substantial government interest and the regulation is no more extensive
than necessary to serve that interest.
It is well established that FDA has a substantial interest in
protecting youth from tobacco products. See Lorillard Tobacco Co. v.
Reilly, 533 U.S. 525, 564-66 (2001); see also Discount Tobacco City &
Lottery, Inc. v. United States, 674 F.3d 509, 519-20, 541 (6th Cir.
2012). Youth are a significant population of concern for reasons that
have been extensively documented in scientific research and in the
Tobacco Control Act. For example, youth are especially susceptible to
addiction due to their ongoing and incomplete brain development. See
2012 Surgeon General's Report. In addition, most tobacco use is
established in adolescence and age of initiation plays a significant
role in the progression from tobacco experimentation to regular use.
See id.; see also, e.g., Tobacco Control Act section 2(1) (``The use of
tobacco products by the Nation's children is a pediatric disease of
considerable proportions that results in new generations of tobacco-
dependent children and adults.''); id. section 2(4) (``Virtually all
new users of tobacco products are under the minimum legal age to
purchase such products.''). FDA has a statutory mandate to protect
youth from these dangers of tobacco product use. See, e.g., Tobacco
Control Act section 3(2), (7) (purposes of the Tobacco Control Act
include to ensure that FDA has authority to address issues of
particular concern to public health officials, especially the use of
tobacco by young people, and to ensure that (tobacco products) are not
sold or accessible to underage purchasers).
The requirement for applications to contain descriptions of
marketing plans clearly and directly advances FDA's substantial
interest in protecting youth from the dangers of tobacco product use.
As explained in section VIII.B.6.b, it is well established that
exposure to tobacco product labeling, advertising, marketing, and
promotion has a direct and powerful impact on youth trial and uptake of
tobacco product use. See, e.g., Tobacco Control Act section 2(5)
(``Tobacco advertising and marketing contribute significantly to the
use of nicotine-containing tobacco products by adolescents.''); 2016
Surgeon General's Report at 170 (``An analysis of the 2011 National
Youth Tobacco Survey found that adolescents who reported frequent
exposure to protobacco advertising at the point of sale and on the
internet (e.g., seeing ads most of the time or always) had
significantly higher odds of ever using e-cigarettes, and there was a
dose-response association between the number of marketing channels to
which they were exposed and ever use[.]''); 2012 Surgeon General's
Report at 598 (``[T]here is strong empirical evidence, along with the
tobacco industry's own internal documents and trial testimony, as well
as widely accepted principles of advertising and marketing that support
the conclusion that tobacco manufacturers' advertising, marketing, and
promotions recruit new users as youth and continue to reinforce use
among young adults[.]'').
Accordingly, determining the extent to which youth may be exposed
to marketing materials for a new tobacco product is critical to FDA's
evaluation of the potential for youth use of the new tobacco product.
The requirement for descriptions of marketing plans seeks information
that directly informs the extent to which youth may be exposed to these
marketing materials, including information regarding the intended
audience for the materials, how the applicant plans to target the
materials to that audience and what other groups would foreseeably be
exposed to those materials, and how the applicant plans to limit youth
exposure to the materials. In addition, the requirement seeks
information to help FDA determine whether any concerns about youth use
of the product and the corresponding increases in health risks may be
mitigated, such as information regarding how the applicant plans to
limit youth access to the product. Moreover, the requirement for
descriptions of marketing plans is no more extensive than necessary to
permit FDA to make these determinations, as it requires minimal, high-
level information that FDA expects an applicant to have at the time of
submitting its application.
In addition, the requirement for descriptions of marketing plans
clearly and directly advances FDA's substantial government interest in
ensuring that permitting the marketing of new tobacco products would be
APPH. Under section 910(c)(2)(4) of the FD&C Act, a key consideration
of the APPH determination is whether permitting the marketing of the
product would increase or decrease the likelihood that those who do not
use tobacco products, including youth, will start using them. Among
nonusers, youth are a significant population of concern for the reasons
already explained above. Determining the extent to which youth would be
[[Page 55327]]
exposed to marketing materials for the product is therefore critical to
FDA's evaluation of the likelihood that youth will initiate tobacco use
with the new tobacco product. Accordingly, by providing FDA with
certain high-level information necessary to help determine potential
youth exposure to marketing materials for a new tobacco product, the
requirement for descriptions of marketing plans directly advances and
is reasonably tailored to FDA's substantial interest in ensuring that
permitting the marketing of the new tobacco product is APPH.
Finally, we disagree with the commenter's assertion that Sec.
1114.7(f)(2)'s disclosure requirements are subject to strict scrutiny
under Reed v. Town of Gilbert, 135 S. Ct. 2218, 2226 (2015), or at
least heightened scrutiny under Sorrell v. IMS Health Inc., 564 U.S.
552 (2011). In Reed v. Town of Gilbert, the Court applied strict
scrutiny to content-based restrictions on noncommercial speech in
public fora. Reed had nothing to do with commercial speech doctrines,
see 135 S. Ct. at 2224-25, and it has not been understood to alter the
applicability of Central Hudson. Likewise, Sorrell ``did not mark a
fundamental departure from Central Hudson's four-factor test, and
Central Hudson continues to apply'' to regulations of commercial
speech, regardless of whether they are content based. Retail Digital
Network, LLC v. Prieto, 861 F.3d 839, 846 (9th Cir. 2017) (en banc);
accord Vugo, Inc. v. City of New York, 931 F.3d 42, 50 (2d Cir. 2019),
cert. denied, 140 S. Ct. 2717 (2020) (``No Court of Appeals has
concluded that Sorrell overturned Central Hudson. We agree with our
sister circuits that have held that Sorrell leaves the Central Hudson
regime in place, and accordingly we assess the constitutionality of the
City's ban under the Central Hudson standard.''); Missouri Broad. Ass'n
v. Lacy, 846 F.3d 295, 300 n.5 (8th Cir. 2017) (``The upshot [of
Sorrell] is that when a court determines commercial speech restrictions
are content- or speaker-based, it should then assess their
constitutionality under Central Hudson.'') (quotation marks omitted;
alteration in original); Nicopure Labs., LLC v. FDA, 266 F. Supp. 3d
360, 411 (D.D.C. 2017) (``[T]he Sorrell opinion did not alter or
replace the Central Hudson intermediate scrutiny standard to be applied
to commercial speech.''), aff'd, 944 F.3d 267, 290 (D.C. Cir. 2019)
(``Sorrell's concerns about suppression of advertising messages in the
marketplace of ideas are inapposite here.'').
(Comment 35) Multiple comments expressed concerns about the
difficulty of creating marketing plans for the first year of product
marketing given that the time it has taken FDA to review PMTAs to date
has been unpredictable. Specifically, comments stated that the
requirement for marketing plans in proposed Sec. 1114.7(f)(2) did not
take into account the considerable external variables that inform
marketing plan decisions including competitor activities, FDA actions
and State or Federal legislation. Comments noted that FDA's evaluation
of the IQOS PMTA, for example, stretched over 2 years. The comments
requested more flexibility in their marketing plans, including the
potential to amend their plans during application review, to avoid
being locked into outdated plans that do not account for the use of new
technology or to allow for adjustment.
(Response 35) FDA has revised and narrowed the scope of Sec.
1114.7(f)(2) to require an applicant's description of its marketing
plans to discuss certain key, high-level aspects of its plans to market
the product for the first year after receiving a marketing granted
order. FDA notes that the applicant's description of its marketing
plans does not by itself create rigid requirements regarding the way in
which an applicant must market its new tobacco product; however, where
an applicant proposes a specific restriction on its marketing of the
new tobacco product to support an APPH finding as part of its
description of its marketing plans (e.g., avoiding online social media
without access restrictions), FDA might incorporate such proposals into
the restrictions on the sales and distribution of a new tobacco product
in a marketing granted order as set forth in Sec. 1114.31(b).
Additionally, FDA will monitor an applicant's implementation of its
marketing plans as described in the application to ensure the marketing
of the new tobacco product continues to be APPH. Applicants are
required to report information about the marketing of their product
under Sec. 1114.41(a)(1)(xi), and FDA may require submission of
marketing plan changes in advance of implementation under Sec.
1114.31(b)(3).
An applicant may alter or update its description of its marketing
plans during the course of application review by submitting an
amendment; however, as described in the response to comment 34, we
generally do not expect an applicant's approach to the high-level items
in Sec. 1114.7(f)(2) to change significantly after the submission of
an application. As described in section VIII.C., where such an
amendment requires significant review time (e.g., significant changes
to the intended audience(s) and how the marketing material and tactics
would be targeted thereto), it will be considered a major amendment for
which the review period will be extended by up to 180 days; however,
FDA will review such amendments promptly and generally expects review
of such changes will require fewer than 180 days.
ii. Requirements for description of marketing plans. Section
1114.7(f)(2) requires a PMTA to contain a description of the
applicant's plans to market the new tobacco product, for at least the
first year the product would be marketed after receiving a marketing
granted order, in a way that permits FDA to determine whether this
information is consistent with the applicant's discussion of the
increased or decreased likelihood of changes in tobacco product use
behavior, including switching (i.e., complete transition to a different
tobacco product), initiation, cessation, and polyuse (i.e., using the
new tobacco product in conjunction with one or more other tobacco
products), under Sec. 1114.7(l), and whether permitting the new
tobacco product to be marketed would be APPH. This section requires
descriptions of actions to market the new tobacco product that would be
taken by the applicant, on behalf of the applicant, or at the
applicant's direction, and of any restrictions on the sales and
distribution of the new tobacco product that the applicant is proposing
to be included in the marketing granted order under section
910(c)(1)(B) of the FD&C Act. As set forth below, the description of an
applicant's plans to market a product will contain information that is
important to FDA's consideration of the likelihood of changes in
tobacco product use behavior (including initiation and cessation) under
section 910(c)(4) of the FD&C Act. The described changes in tobacco
product use behavior, when considered as part of FDA's determination of
the risks and benefits of the new tobacco product to the population as
a whole under section 910(c)(4) of the FD&C Act, form part of the basis
upon which FDA must make its finding of whether there is a showing that
permitting the marketing of the new tobacco product would be APPH under
section 910(c)(2)(A) of the FD&C Act. While the criteria for FDA to
accept and file the application in Sec. 1114.27 can be satisfied with
only some discussion of the four items in Sec. 1114.7(f)(2)(i) through
(iv), FDA encourages applicants to provide more detailed information to
help inform FDA's substantive APPH determination.
[[Page 55328]]
An understanding of how an applicant plans to market a new tobacco
product for at least an initial period of time will help FDA determine
the potential for increases in health risks related to marketing of the
new tobacco product, such as the potential for youth initiation. If FDA
determines that the potential increases in health risks outweigh the
potential benefits, FDA would not be able to determine that the
marketing of the new tobacco product would be APPH and would issue a
marketing denial order.
Section 1114.7(f)(2)(i) requires a PMTA to contain a description of
the specific group(s) to which the labeling, advertising, marketing,
promotion, and other consumer-directed activities for the new tobacco
product would be targeted (i.e., the intended audience(s)). As used in
Sec. 1114.7(f)(2), the term ``other consumer-directed activities''
includes any other types of action regarding the new tobacco product
taken by the applicant, on behalf of the applicant, or at the
applicant's direction that may directly or indirectly impact
information about the tobacco product that reaches consumers (e.g., use
of third parties or social media influencers to reach consumers).
Additionally, the labeling, advertising, marketing, promotion, and
other consumer-directed activities for a new tobacco product are
collectively referred to as ``marketing materials and activities'' in
this document for ease of reference. An applicant would need to provide
the characteristics it has used to identify the specific group(s) to
which its marketing materials and activities would be targeted, such as
age-range(s) (including young adult audiences ages 21 to 24 years, if
applicable) and other demographic characteristics, details of tobacco
use behaviors (e.g., dual use), and psychographic characteristics.
Examples of other demographic characteristics include, but are not
limited to, race, ethnicity, socioeconomic status and geographic
location (e.g., urban, rural). Such information will be informative to
FDA in identifying potential impacts of marketing on specific
populations, including vulnerable populations. Examples of types of
psychographic characteristics include, but are not limited to, hobbies,
interests, risk-taking behaviors, purchase behaviors, and online search
behaviors. Based on our experience, FDA generally expects that
applicants will have conducted or otherwise obtained market or consumer
research to determine its intended audience(s). Where an applicant has
conducted such research and has used the results to determine its
intended audience, FDA recommends an applicant discuss such information
in this section.
As a general example, the description of the intended audience(s)
could include, for example, a statement that the applicant would target
its marketing materials and activities for the new tobacco product to
all current adult cigarette smokers, with a focus on cigarette smokers
aged 26 to 54 years who are seeking alternatives to combustible
cigarettes.
Section 1114.7(f)(2)(ii) requires the applicant's description of
its marketing plans to contain a discussion of the ways in which the
applicant would target its marketing materials and activities for the
new tobacco product to reach the intended audience(s) described in
paragraph (i) and what other group(s) would foreseeably be exposed to
the marketing materials and activities as a result. A discussion of
these aspects of the plans can provide information that is important to
FDA's evaluation of the increased or decreased likelihood of changes in
tobacco product use behavior under section 910(c)(4) of the FD&C Act.
Describing how an applicant would target the marketing materials and
activities for the new tobacco product to intended audiences could help
FDA determine whether the applicant's descriptions of its marketing
plans are consistent with information in the application regarding the
likelihood of changes in tobacco product use behaviors, such as current
tobacco product users switching to the new tobacco product.
A discussion of the ways in which the applicant would target the
marketing materials and activities for a new tobacco product to reach
the intended audience(s) can include items such as: how the applicant
would use key insights about its intended audience(s) to tailor its
marketing approach; the types and sources of data, technologies, and
methodologies the applicant would use to develop, implement, and track
targeted paid media plans (e.g., first and second-party age-verified
data, public records, industry-standard syndicated research services,
and embedded tracking pixels in digital advertising); and the marketing
channels and tactics an applicant expects to use.
Additionally, this information will help FDA determine whether the
identified audiences and not other audiences, such as individuals below
the minimum age of sale, would be exposed to the marketing materials
and activities for the new tobacco product. Describing the other groups
that would foreseeably be exposed to the marketing materials and
activities for the new tobacco product will help FDA understand the
potential for other groups to be affected by the plans to market the
new tobacco product. For example, where an applicant's plans to target
its marketing materials and activities to an intended audience of adult
consumers has the potential to reach individuals below the minimum age
of sale, an applicant would have to note that potential and describe
whether the potential would be limited under paragraph (iii). FDA is
requiring a discussion of an applicant's plans to target its marketing
materials and activities to the intended audience(s) and the other
groups that could foreseeably be exposed to those materials as a result
of such targeting because, as discussed in the following paragraphs,
there is a well-established body of scientific evidence regarding the
effect of advertising and marketing on tobacco product behavior (see
e.g., Refs. 19-22).
Section 1114.7(f)(2)(iii) requires the applicant's description of
its marketing plans to contain a discussion of the ways in which, for
individuals below the minimum age of sale, access to the new tobacco
product would be restricted and exposure to the marketing materials and
activities for the new tobacco product would be limited. Describing the
ways in which an applicant would restrict access to the new tobacco
product by individuals below the minimum age of sale would be an
important part of FDA's consideration under section 910(c)(4) of the
FD&C Act regarding the increased or decreased likelihood that persons
who do not use tobacco products will start using the tobacco product
that is the subject of the application. Limiting the potential for
youth to access the new tobacco product is one way to help mitigate the
potential for youth initiation with the new tobacco product (Refs. 23
and 24). For example, an applicant could propose to restrict the sale
and distribution of its new tobacco product to adult-only facilities
and limit the quantity of its product that an adult customer (other
than scientific researchers or research institutions) may purchase
within a given period of time to limit the potential for resale to
youth.
Describing the ways in which an applicant would plan to limit the
exposure of individuals below the minimum age of sale to the marketing
materials and activities for the new tobacco product would also help
FDA assess the potential for initiation with the new tobacco product by
this group. Examples of how applicants could limit the exposure of
individuals below the
[[Page 55329]]
minimum age of sale to the marketing materials and activities could
include actions such as utilizing services that compare consumer
information against independent, competent, and reliable data sources,
such as public records, before granting users access to the applicant's
tobacco product website(s), using only first- or second-party age-
verified data to target paid digital advertising, and limiting sales to
adult-only stores. Applicants could also restrict or avoid the use of
marketing practices that are not or cannot be targeted in ways that
would limit exposure of individuals below the minimum age of sale and
choose tactics more narrowly targeted to current adult users of tobacco
products, such as avoiding online social media without access
restrictions to promote the tobacco product and, instead, choose
actions such as paper or electronic mail directed only to current
smokers at or above the minimum age of sale.
FDA is requiring the description of an applicant's plans to market
the new tobacco product to contain a discussion of an applicant's plans
to target the marketing materials and activities to reach the intended
audience(s) and limit the exposure of individuals below the minimum age
of sale to such materials and activities, because there is a well-
established body of scientific evidence regarding their effect on
tobacco product use behavior (see e.g., Refs. 19-22). The impact of
tobacco marketing tactics on youth and young adult tobacco use behavior
in particular has been well documented. The 2012 Surgeon General's
report entitled ``Preventing Tobacco Use Among Youth and Young
Adults,'' (the 2012 SGR) synthesizes more than 30 years of research on
the topic and outlines the findings demonstrating that product
labeling, advertising, marketing, and promotion influence youth tobacco
use by shaping attitudes, beliefs, and risk perceptions, and promoting
pro-tobacco social and cultural norms (Ref. 9). The 2012 SGR states
that the strong empirical evidence, along with the tobacco industry's
own internal documents and trial testimony, as well as widely accepted
principles of advertising and marketing, support the conclusion that
tobacco manufacturers' advertising, marketing, and promotions recruit
new users as youth and continue to reinforce use among young adults
(Ref. 9). The 2012 SGR states that this evidence is sufficient to
conclude that marketing efforts and promotion by tobacco companies show
a consistent dose-response relationship in the initiation and
progression of tobacco use among young people (Ref. 9). The 2012 SGR
also states that research conducted by the tobacco industry
consistently demonstrates that the brand imagery portrayed on packages
is particularly influential during youth and young adulthood--the
period in which smoking behavior and brand preferences develop. The
2016 Surgeon General's report entitled, ``E-Cigarette Use Among Youth
and Young Adults,'' similarly synthesizes research on e-cigarettes and
concluded that e-cigarette manufacturers used tactics similar to those
used to market conventional cigarettes to youth and young adults (Ref.
15).
The National Cancer Institute (NCI) made a similar conclusion in
its monograph, ``The Role of the Media in Promoting and Reducing
Tobacco Use,'' that the total weight of evidence--from multiple types
of studies, conducted by investigators from different disciplines, and
using data from many countries--demonstrates a causal relationship
between tobacco advertising and promotion and increased tobacco use
(Ref. 20). As such, the direct role of tobacco product marketing and
related activities in increasing tobacco use in the United States,
especially among youth, and the high rates of youth-exposure to tobacco
marketing due to its ubiquity, are two key rationales cited by NCI for
restricting tobacco product marketing and related activities (Ref. 20).
A variety of research has found that exposure to advertising is
associated with susceptibility to use tobacco products and the actual
use of tobacco products (see e.g., Refs. 25-33). For example, research
has found that the use of certain kinds of imagery, such as logos and
cartoons, have an impact on youth tobacco initiation (see, e.g., Refs.
34-36) and that a key tactic of tobacco companies seeking to attract
and recruit youth users is to use advertising and marketing with
aspirational imagery and themes known to resonate with younger
audiences, such as independence, popularity, rebelliousness,
attractiveness, and being cool (Ref. 9).
An analysis of the 2011 National Youth Tobacco Survey (NYTS) found
that adolescents who reported frequent exposure to tobacco advertising
at the point of sale and on the internet had significantly higher odds
of ever using e-cigarettes and that there was a dose-response
association between the number of marketing channels to which they were
exposed and whether they used tobacco products (Refs. 15 and 33). An
analysis of 2014 NYTS data assessing exposure to e-cigarette
advertising in different channels (i.e., internet, print, television
and movies, retail stores) found that as the number of channels of e-
cigarette marketing exposure increased, the likelihood of use and
susceptibility also increased (Refs. 15, 37, and 38). Thus, providing
information regarding the ways in which an applicant would target the
marketing materials and activities for the new tobacco product to reach
the intended audience(s) and limit the exposure of individuals below
the minimum age of sale to such items can provide valuable insight into
the potential that youth would initiate tobacco product use.
Finally, Sec. 1114.7(f)(2)(iv) requires the description of an
applicant's marketing plans to contain a concluding summary discussing
how the applicant's plans for marketing the new tobacco product are
consistent with the applicant's discussion regarding the increased or
decreased likelihood of changes in tobacco product use behavior
(including switching, initiation, cessation, and polyuse) under Sec.
1114.7(l) and permits FDA to determine whether permitting the marketing
of the new tobacco product would be APPH. This section requires an
application to contain a discussion of how each of the items in Sec.
1114.7(f)(2)(i) through (iii) are consistent with the applicant's
discussion regarding the increased or decreased likelihood of changes
in tobacco product use behavior by both current users and nonusers of
tobacco products. This includes, but is not limited to: How the planned
targeting of intended audience(s) is consistent with discussions
regarding the likelihood of changes in tobacco product use behavior
such as by current adult users, including switching, quitting, and
polyuse; and how, for individuals below the minimum age of sale,
restrictions on access to the new tobacco product and limitations on
exposure to the marketing materials and activities for the new tobacco
product are consistent with discussions regarding the likelihood of
tobacco product use initiation, including among youth. For example,
where an applicant expects current adult cigarette smokers to use its
new tobacco product, the applicant would be required to explain its
basis for concluding that its planned marketing is consistent with that
expectation, such as providing an explanation of how the applicant
determined its selected marketing channels and tactics would reasonably
reach its intended users. Similarly, if an applicant claims its
marketing plans would adequately prevent or reduce youth initiation,
the applicant would be required to explain its basis for such a
conclusion by
[[Page 55330]]
providing explanations of any measures or controls the applicant would
use to restrict youth access to the product (e.g., selling the product
only in brick-mortar retail locations), using competent and reliable
third-party services to verify the age and identity of product
purchasers, implementing purchase quantity limits) and limit youth
exposure to the product's marketing materials and activities (e.g.,
restricting its marketing to channels and tactics where it is possible
to target delivery of advertising to only age-verified adults).
An applicant can use this portion of the summary as an opportunity
to help show the description of its marketing plans are consistent with
its expectations for the potential initiation by current nonusers of
tobacco products. For example, where conclusions drawn from tobacco
product perception and use intention studies contained in a PMTA show
the potential for current nonusers to initiate tobacco product use with
the new tobacco product, an applicant could discuss how its plans to
market the tobacco product, such as advertising at only point-of-sale
locations for tobacco products or sending direct mail marketing to
individuals of legal purchasing age who have opted-in to such
communications, would mitigate the potential for initiation by nonusers
and aligns with the applicant's discussion of such potential under
Sec. 1114.7(l).
In addition to the basic requirements of Sec. 1114.7(f)(2), to
help inform FDA's APPH determination, applicants may develop and submit
more detailed plans to implement specific marketing campaigns. Not only
would this provide an applicant the opportunity to further address any
concerns about the potential for youth to initiate tobacco product use
with the new tobacco product, it would be an opportunity for an
applicant to more concretely show how it would target its marketing
materials and activities to reach the intended audience(s).
The types of more detailed marketing plan information an applicant
could develop and submit as part of a PMTA include materials such as
strategic creative briefs, media and distribution channels, specific
tactics, and the intended scope of each marketing activity (e.g.,
information such as the expected reach and frequency of audience
exposures to the marketing, and timing and duration of the marketing
activities), and the information described in the items listed below.
These details, if provided, should be provided as part of the
appropriate discussion under Sec. 1114.7(f)(2) (if applicable) and can
include:
A description of specific insights about the intended
audience(s) (e.g., findings from consumer research) that have informed
the applicant's marketing plans, including its strategic approach, key
messages and themes, creative direction, and potential tactics or
marketing channels. This could include product-specific insights (e.g.,
an audience's impressions of one product being just as harmful as
another, preference of a certain brand), as well as other beliefs,
interests, motivations, or behaviors that can be used to tailor an
applicant's approach to marketing the product. This could also include
information regarding where the intended audience(s) tends to consume
marketing and advertising (e.g., television programs the intended
audience(s) watches, social media influencers the intended audience(s)
follows, websites and retail locations the intended audience(s)
frequents) that can be used to tailor an applicant's approach, select
relevant marketing tactics, and use relevant marketing channels. The
applicant should describe such insights in either paragraph (i) or
(ii), as appropriate, and state the source of such data;
plans to use owned, earned, shared, or paid media to
create labeling for, advertise, market, or promote the tobacco product.
While media categories overlap, owned media typically consists of a
company's own media properties and content they control, such as the
company's product-branded website or mobile application. Earned media
typically consists of unpaid media publicity or coverage of a company's
brand or product that the company did not commission or pay for, such
as a news article about the product or an influencer talking about a
company's product without compensation. Examples of plans to use earned
media can include, but are not limited to, pitching articles to news
outlets, using unsolicited consumer reviews or testimonials to promote
the product, and inviting influencers or reporters to attend a product
launch event. Shared media typically consists of social media
properties, such as a company's social media accounts and content,
including interactions with other social media users and their content,
such as comments, ``likes,'' and responses to comments. Paid media
typically consists of content that a company pays to place and promote
in media properties it does not own, such as advertising appearing on
television and radio, in and around retail stores, and in digital
media, including content shared by a celebrity who a company pays to
promote the tobacco product;
plans to use (or not use) partners, influencers (e.g.,
celebrities, cultural icons, individuals with substantial followers on
social media), bloggers, or brand ambassadors to create labeling for,
advertise, market, or promote the tobacco product;
plans to conduct (or not conduct) consumer engagements,
including events at which the tobacco product will be demonstrated; and
plans to use public relations or other communications
outreach to promote the tobacco product. Public relations could consist
of actions such as using a public relations firm to promote the tobacco
product. Other communications to promote the product could consist of
actions such as direct mail to consumers.
7. Statement of Compliance With Part 25
A PMTA must contain an environmental assessment (EA) prepared in
accordance with Sec. 25.40 or a valid claim of a categorical
exclusion, if applicable. Pursuant to Sec. 25.15(a), all submissions
requesting FDA action require the submission of either a claim of
categorical exclusion or an EA. In accordance with Sec. 25.40(a), an
EA must include, at a minimum, brief discussions of: The need for the
proposed action; alternatives to the proposed action as required by
section 102(2)(E) of the National Environmental Policy Act of 1969
(NEPA); the environmental impacts of the proposed action and
alternatives; the Agencies and persons consulted during the preparation
of the EA; and the relevant environmental issues relating to the use
and disposal of the tobacco product. Although applicants may wish to
review the categorical exclusions specific to tobacco product
applications at Sec. 25.35, the only categorical exclusion currently
available for a marketing order is for provisional SE reports that
receive an SE order in the SE premarket pathway, not for PMTAs. If the
applicant believes the action would qualify for an available
categorical exclusion, the applicant must state under Sec. 25.15(a)
and (d) that the action qualifies for a categorical exclusion, cite to
the claimed exclusion, and state that to the applicant's knowledge no
extraordinary circumstances exist under Sec. 25.21.
Failure to include an EA in a PMTA is grounds for FDA to refuse to
accept an application and failure to include an adequate EA is
sufficient grounds under Sec. 25.15 for FDA to refuse to file the PMTA
or refuse to issue a marketing
[[Page 55331]]
granted order. (See the discussion of Sec. Sec. 1114.27 and 1114.29 in
section IX.)
8. Summary
Section 1114.7(h) requires the application to contain a summary of
the application contents in sufficient detail to provide FDA with an
adequate understanding of the data and information in the application.
FDA requires the summary under authority of sections 701(a) and
910(b)(1)(G) of the FD&C Act because it provides FDA with an
understanding of the information contained in the PMTA and allows FDA
to plan and conduct a more efficient review of the detailed technical
information the summary describes. The summary also helps reviewers
understand the product and the accompanying scientific data more
quickly and allows applicants to highlight information they believe
demonstrates their product should receive a marketing granted order.
The summary should discuss all aspects of the PMTA and synthesize
the application in a well-structured, unified manner. The summary
should serve as a briefing document that highlights the most important
aspects of the application, with each section of the summary consisting
of a brief explanation of information that the applicant believes
contributes to a finding that permitting the marketing of the product
would be APPH. The applicant must summarize the content included in the
PMTA in a manner that describes the operation of the product, the
health risks of the new tobacco product, the product's effect on
tobacco use behavior of current users, the product's effect on tobacco
use initiation by nonusers, and the product's effect on the population
as a whole. The summary must describe the new tobacco product's
potential effects on youth, young adults, and other relevant vulnerable
populations. After reviewing comments on the proposed rule, FDA has
added vulnerable populations to this requirement in the final rule to
ensure the summary specifically accounts for those groups that may be
disproportionately affected or more likely to use the new tobacco
product. The summary must contain the following items, where
applicable:
A summary of the product formulation section of the
application. This section should provide a high-level description of
the product formulation section of the application, highlighting
information such as key ingredients, constituent levels, and design
aspects of the product. See the discussion of Sec. 1114.7(i) in
section VIII.B.9;
a summary of the manufacturing section of the application.
This section should provide an overview of the manufacturing section of
the application, including activities at each facility, and highlight
information such as major aspects of the manufacturing and controls,
especially those that the applicant believes contribute to a finding
that permitting the marketing of the product would be APPH (e.g., an
aspect of the manufacturing process that results in lower levels of
HPHCs than other tobacco products in the same category). See the
discussion of Sec. 1114.7(j) in section VIII.B.12;
a summary of the health risk investigations section of the
application. This section should briefly describe and synthesize the
findings of each investigation describing the following items, and
explicitly identify areas in which there is a lack of information, if
any:
[cir] The health risks of the tobacco product to both users and
nonusers of the product (including youth, young adults, and other
relevant vulnerable populations) and whether the tobacco product
presents less health risk than other tobacco products, such as the risk
of cancers (e.g., lung, mouth, pancreatic), heart disease, stroke, or
lung disease, compared to other categories of tobacco products and
other tobacco products within the category, if known. See the
discussion of Sec. 1114.7(k)(1)(i) in section VIII.B.13.a.iii.;
[cir] The impact the product and its marketing will have on the
likelihood of changes in tobacco use behavior of tobacco product users
(including youth, young adults, and other relevant vulnerable
populations), including cessation, switching (i.e., to a different
tobacco product), and polyuse (i.e., using the new tobacco product in
conjunction with one or more other tobacco products). See the
discussion of Sec. 1114.7(k)(1)(ii) in section VIII.B.13.a.iv.;
[cir] the impact the product and its marketing will have on the
likelihood of tobacco use initiation by tobacco products nonusers,
especially youth, young adults, and other relevant vulnerable
populations, including among never users and former users, and the
likelihood of polyuse and switching behaviors. See the discussion of
Sec. 1114.7(k)(1)(iii) in section VIII.B.13.a.v.;
[cir] How users and nonusers perceive the risk of the tobacco
product based upon label, labeling, and advertising (if any has been
studied). This includes how the label, labeling, and advertising affect
use intentions. See the discussion of Sec. 1114.7(k)(1)(iv) in section
VIII.B.13.a.vi.;
[cir] whether users are able to understand the labeling and
instructions for use, and use the product in accordance with those
instructions. See the discussion of Sec. 1114.7(k)(1)(iv) in section
VIII.B.13.a.vi.; and
[cir] the impact of human factors on the health risks to product
users and nonusers including, for example, how various use and misuse
scenarios may impact the health risks posed by the product. See the
discussion of Sec. 1114.7(k)(1)(v)) in section VIII.B.13.a.vii..
The rule also requires the summary to contain a concluding
discussion demonstrating how the data and information contained in the
PMTA both constitute valid scientific evidence and establish that
permitting the marketing of the new tobacco product would be APPH as
determined with respect to the risks and benefits to the population as
a whole, including users and nonusers of the tobacco product. The rule
also requires the summary to identify any key or pivotal studies on
which an applicant is relying to establish that permitting the
marketing of the new tobacco product would be APPH. FDA recommends that
this discussion include estimates of the effect that the new tobacco
product may have on the health of the population as a whole, such as
effects on tobacco use initiation switching and cessation, and
reductions in premature mortality, or increases in life-years lived.
The estimates should integrate all of the information in the PMTA
regarding the product and its potential effects on health, including,
but not limited to adverse experiences, tobacco use behavior, and
tobacco use initiation to provide an overall assessment of the
potential effect that permitting the product to be marketed has or may
have on overall tobacco-related morbidity and mortality.
As an illustration, an applicant may make an overall assessment of
whether the product will likely have a net benefit on population health
by accounting for potential reductions in disease risk (compared to
other tobacco products) and the potential for current tobacco users to
switch to the new tobacco product, and weighing that against the
potential for nontobacco users to use the tobacco product and the
accompanying potential increases in disease risks among those new
tobacco product users. An applicant should provide quantitative
assessments in the concluding discussion wherever possible; however, an
applicant may provide qualitative assessments where
[[Page 55332]]
appropriate for the type of investigation(s) on which the assessment is
based (e.g., focus group or interview-type studies).
The summary's concluding discussion must also briefly describe why
the data and scientific information on which the applicant relies in
concluding that permitting the marketing of the product would be APPH
constitute valid scientific evidence. Section 910(c)(5)(A) of the FD&C
Act requires FDA to make its determination of whether permitting the
marketing of a new tobacco product would be APPH, where appropriate, on
the basis of well-controlled investigations; however, under section
910(c)(5)(B) of the FD&C Act, where FDA determines that there exists
valid scientific evidence other than well-controlled investigations
that is sufficient to evaluate the product, FDA may use such evidence.
As discussed in more detail in section IX.D regarding Sec. 1114.31,
FDA considers valid scientific evidence to be evidence gathered using
well-established or standardized methodologies from which it can be
concluded by qualified experts that there is reasonable assurance of
the reliability of its findings. Thus, if an application contains
information regarding another tobacco product (e.g., published
literature, marketing information) with appropriate bridging studies
and describes the relationship to the product that is the subject of
the application, FDA will review that information to determine whether
it is valid scientific evidence sufficient to demonstrate that
permitting the marketing of a product would be APPH.
9. Product Formulation
Section 910(b)(1)(B) of the FD&C Act requires that a PMTA contain a
full statement of the components, ingredients, additives, and
properties, and of the principle or principles of operation, of such
tobacco product. Section 1114.7(i) implements FDA's interpretation of
this statutory requirement, together with its authority under section
910(b)(1)(G) of the FD&C Act, by requiring a PMTA to contain the
following information:
a. Components or parts, materials, ingredients, additives, and
constituents. Under the rule, the application is required to contain a
full statement (i.e., a listing) of the product components or parts,
materials, ingredients other than tobacco, tobacco ingredients, HPHCs,
and the container closure system.
i. Components or parts. Section 1114.7(i)(1)(i) requires the
application to state the quantity, function, and purpose of, and where
applicable, target specifications of each component or part in the
product. This information should also include an explanation of how
each component or part is, or can be, integrated into the product
design, and the purpose and function of each component or part. Where
the tobacco product contains software components, the rule requires:
A description of the software or technology (e.g.,
Bluetooth);
a description of the purpose of the software or
technology, such as monitoring where the tobacco product is located,
activated, or used;
a description of the data collected by the software and
how this information will be used by the applicant.
FDA received comments regarding this section, as discussed below.
(Comment 36) One comment stated that the rule should be amended to
state that FDA will issue a marketing denial order if the application
does not include specific assurances and evidence that there will be no
communication between the device and any external source, and that the
software would not be programmed to increase consumption.
(Response 36) We agree that understanding how any software in a
product may function is important to the review of an application. For
example, software used in or with some consumer products may have
functions and purposes that are not immediately clear, such as use
monitoring and location tracking functions, and may be able to function
in conjunction with other electronic devices, such as a smart phone. We
decline to prohibit all communication between a new tobacco product and
external sources as part of this rulemaking because product standards
are outside the scope of this rulemaking; however, we will consider
information regarding software (if applicable) as part of substantive
review. For example, if the product has software features that could
help prevent youth use of the tobacco product, FDA would review this
information as part of the determination of whether permitting the
marketing of the new tobacco product would be APPH. This information is
especially important as it may not be readily apparent from a component
or part's identity what function and purpose it may serve.
(Comment 37) One comment stated that FDA should amend Sec.
1114.7(i)(3)(ii) to also require specification of software or other
controls in an e-cigarette to limit the intensity of use, including
minimum inter-puff interval and maximum number of puffs per hour that
the device will deliver because, unlike with combusted cigarettes,
there are no obvious indicators for consumers of how quickly they are
consuming the product.
(Response 37) As discussed in section VIII.B.10., FDA requires the
PMTA to contain a full narrative description of the way in which a
typical consumer will use the new tobacco product. This includes, for
example, a description of how a consumer operates the product, where
applicable, whether and how a consumer can change the product design
and add or subtract ingredients, the length of time it takes for a user
to consume a single unit of the product, and whether the product
incorporates a heating source and, if it does, a description of the
heating source. As described above, the presence of software or other
controls in an e-cigarette to limit the intensity of use would be
relevant to FDA's review of an application and a required part of a
PMTA submission under Sec. 1114.7.(i)(1)(i); however, FDA declines to
require such controls in all e-cigarettes as part of this rule because
it would constitute a product standard that is outside the scope of
this rule.
ii. Materials. Section 1114.7(i)(1)(ii) requires the application to
contain information for each material in the product because materials
can affect the performance of the product. FDA considers materials to
be part of ``components'' under section 910(b)(1)(B) and the required
materials information is relevant to the subject matter of a PMTA under
section 910(b)(1)(G) because it is needed to fully characterize the
tobacco product and understand its health risks. For example, in
portioned smokeless tobacco products, the materials used in the pouch
can affect the rate at which nicotine is released and specifications
such as pouch fabric air permeability can provide information about how
quickly nicotine can be delivered to the consumer. For ENDS, the
material used in the construction of an electrical heater coil
influences its resistance and the temperature reached by the coil,
which in turn may affect the type and amount of HPHCs produced in
aerosol. The rule requires a PMTA to contain:
The material name and common name (if applicable);
the component or part of the tobacco product where the
material is located;
the subcomponent or subpart where the material is located
(if applicable);
the function of the material;
quantities (including ranges or means and acceptance
limits) of the materials(s) in the new tobacco product;
[[Page 55333]]
specifications (including quality, grades, and suppliers)
of the materials used for the new tobacco product (including any
specification variations, if applicable); and
any other material properties that fully characterize the
new tobacco product, such as pouch material porosity or air
permeability for portioned smokeless products. While failure to include
additional material properties to fully characterize the tobacco
product would not serve as the basis for FDA refusing to accept or file
an application under Sec. 1114.27(a)(1), it may slow down the
substantive review process.
FDA received comments regarding this section, as described below.
(Comment 38) One comment requested that FDA clarify the scope of
the materials that an applicant would have to describe in a PMTA,
specifically requesting that FDA require PMTAs for e-cigarettes to
contain information on only those materials that are reasonably
expected to have contact with the e-liquid and not materials found in
items such as the exterior plastic casing, electronic circuitry, and
batteries. The comment stated that this would align with FDA's current
approach set forth in the guidance entitled ``Listing of Ingredients in
Tobacco Products.'' \19\
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\19\ Available at https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance.
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(Response 38) FDA declines to limit the scope of the materials in
an ENDS for which an applicant would have to provide information in a
PMTA to only those materials that are reasonably expected to have
contact with the e-liquid. As discussed in section Sec. 1114.3, FDA
defines material to mean an assembly of ingredients. Materials are
assembled to form the tobacco product, or components or parts of the
tobacco product. This includes both those materials that are in contact
with the e-liquid as well as any other materials in the product, such
as those used in the exterior plastic casing, electronic circuitry, and
batteries. FDA declines to limit the scope of materials for ENDS
because they are components or parts with the potential to introduce,
diffuse, leach or extract to become part of the e-liquid formulation or
constituents during storage and use. For example, batteries and solder
joints of the product have been shown to be the potential source of
metals contamination in e-liquid or aerosol (Ref. 39). Furthermore,
defective or damaged batteries on their own may lead to battery failure
or overheating, resulting in thermal runaway; thermal runaway has been
identified as an immediate threat in e-cigarettes, particularly due to
the metal enclosure of the e-cigarette batteries that allow the
dangerous build-up of gasses (Ref. 40). In addition, the guidance for
industry, entitled ``Listing of Ingredients in Tobacco Products,''
discusses FDA's current enforcement policy for ingredient listing
submission requirements under section 904(a)(1) of the FD&C Act. While
FDA does not intend to enforce ingredient listing requirements for
component and parts such as electrical components, batteries, and
electronic circuitry, FDA recognizes that the ingredients of these
other components and parts can also be important in determining the
public health impact of tobacco products. As the guidance states, FDA
will receive ingredient information for these other components and
parts during our premarket review of new tobacco products. This is
consistent with the rule's requirement to include information on
materials in a PMTA.
iii. Ingredients other than tobacco. Section 1114.7(i)(1)(iii)
requires that the application contain information on ingredients other
than tobacco (tobacco ingredients are addressed in Sec.
1114.7(i)(1)(iv)). The application must contain:
International Union of Pure and Applied Chemistry (IUPAC)
chemical name and common name (if applicable);
Chemical Abstracts Service (CAS) number or FDA Unique
Ingredients Identifier (UNII). Both the IUPAC and CAS or UNII are
required to ensure FDA has the relevant information associated with
each identifier and to allow FDA to efficiently differentiate between
similar ingredients;
the function of the ingredient;
the quantity of the ingredient in the tobacco product,
with the unit of measure (including ranges or means, and acceptance
limits) reported as mass per gram of tobacco for nonportioned tobacco
products and as mass per portion for portioned tobacco products (with
any specification variation, if applicable);
the specifications (including purity or grade and
supplier); and
for complex purchased ingredients, each single chemical
substance reported separately.
Additionally, FDA recommends that an application contain any other
ingredient information to fully characterize the new tobacco product,
as applicable. While failure to include other ingredient information to
fully characterize the tobacco product would not serve as the basis for
FDA refusing to accept or file an application under Sec.
1114.27(a)(1), it may slow down the substantive review process.
iv. Tobacco ingredients. Section 1114.7(i)(1)(iv) requires
information regarding tobacco ingredients, including:
The type(s) of tobacco (e.g., Bright, Burley,
reconstituted). This information is important to determining the public
health impact of the products because different types of tobacco have
different constituent profiles. In the proposed rule, we also included
a requirement to specify the grade(s) of the tobacco and we have
removed this due to the general lack of standardized grading systems.
the quantity, with the unit of measure (including ranges
or means, and acceptance limits), of each tobacco ingredient in the new
tobacco product reported as mass per gram of tobacco for nonportioned
tobacco products and as mass per portion for portioned tobacco products
(with any specification variation, if applicable);
the specification(s) of tobacco used for the new tobacco
product (with any specification variation, if applicable); and
a description of any genetic engineering that impacts
characteristics of the tobacco product, such as the constituent
profile.
Additionally, FDA recommends a PMTA contain any other information
about tobacco ingredients to fully characterize the new tobacco
product, as applicable, such as country of origin, which can reflect
different constituent levels (Ref. 41). While failure to include other
information about tobacco ingredients to fully characterize the tobacco
product would not serve as the basis for FDA refusing to accept or file
an application under Sec. 1114.27(a)(1), it may slow down the
substantive review process. If the new tobacco product does not contain
tobacco (e.g., rolling paper or tipping paper), this section of the
application must specifically state that the product does not contain
tobacco.
FDA requires in Sec. 1114.7(i)(1) that ingredient quantities be
reported as mass per gram of tobacco for nonportioned tobacco products
and as mass per portion for portioned tobacco products. These specific
measurements provide consistent, complete information that allows FDA
to understand the ingredient quantities. In contrast, if ingredient
quantities were reported as percentages, FDA would have to make
assumptions about the denominator used to calculate the percentage. For
example, if xylitol were reported as 10 percent of a portioned moist
snuff, FDA would not able to determine if xylitol was 10 percent of the
mass of the tobacco filler or of the entire product (containing filler,
paper, etc.). For more information on uniquely
[[Page 55334]]
identifying components, ingredients, and additives and reporting their
quantities, please refer to FDA's guidance for industry entitled
``Listing of Ingredients in Tobacco Products.''
v. Constituents. Section 1114.7(i)(1)(v) requires a full statement
of the constituents, including HPHCs and other constituents, contained
within, or emitted from (including its smoke or aerosol), the product,
including any reaction products from leaching or aging. FDA considers
constituents to be properties of the new tobacco product, a full
statement of which is required to be in a PMTA by section 910(b)(1)(B)
of the FD&C Act. The constituents contained within, and delivered from,
the product can be detected through constituent testing on the product.
The constituent testing should reflect the various conditions under
which consumers may use the product (e.g., light use, typical use, and
heavy use) and the types of products that consumers are likely to use
in conjunction with the product. For example, an open (refillable) e-
cigarette should be tested with a variety of e-liquids that consumers
are likely to consume using the e-cigarette. The reports of constituent
testing must be conducted in the manner required by, and include all
information that is specified in, Sec. 1114.7(i)(1)(v), including the
full test data.
FDA published an initial list of the constituents that it has
identified as HPHCs in the Federal Register of April 3, 2012, which it
intends to update periodically by providing the public with notice and
the opportunity to submit comments. FDA recently proposed the addition
of 19 constituents to the established list of HPHCs.\20\
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\20\ 84 FR 38032 (August 5, 2019).
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The constituent testing data FDA requires for all products include:
The constituent names in alphabetical order;
the common name(s);
the CAS number;
the mean quantity and variance with unit of measure;
the number of samples and measurement replicates for each
sample. As stated in Sec. 1114.7(i)(4)(iv), the testing must be
conducted using a sufficient sample size and number of replicates to
substantiate the results of the type of testing conducted;
a description of method procedure, method validation
information, and rationale for selecting each test method (as required
by Sec. 1114.7(i)(4)(v));
the name and location of the testing laboratory or
laboratories and documentation showing that the laboratory or
laboratories is (or are) accredited by a nationally or internationally
recognized external accreditation organization (as required by Sec.
1114.7(i)(4)(i));
the length of time between dates of manufacture and
date(s) of testing (as required by Sec. 1114.7(i)(4)(ii));
storage conditions of the tobacco product before it was
tested. It is important for FDA to understand the storage conditions
before testing because they could affect the quantity of volatile
organic compounds or promote microbial growth in the tobacco product
(as required by Sec. 1114.7(i)(4)(iii));
reports of constituent testing that include test
protocols, any deviation(s) from the test protocols, quantitative
acceptance (pass/fail) criteria, line data, and a summary of the
results, for each applicable parameter (as required by Sec.
1114.7(i)(4)(vi)); and
complete descriptions of any smoking or aerosol generating
regimens used for analytical testing that are not standardized or
widely accepted by the scientific community, if applicable (as required
by Sec. 1114.7(i)(4)(vii)).
Multiple comments provided feedback or requested clarification
related to these provisions, as discussed below.
(Comment 39) One comment requested additional clarification
regarding the HPHCs for which an applicant must conduct testing when
submitting a PMTA for an ENDS. The comment noted the proposed addition
of 19 constituents to the established list of HPHCs and sought further
information regarding what must be submitted in a PMTA.
(Response 39) The rule requires each applicant to submit
information regarding all constituents contained in and emitted from
the product, which could include both constituents that are contained
within the established list of HPHCs and those that are not on the
list. FDA's recommendations regarding constituents in an ENDS for which
a prospective applicant might want to consider testing, as appropriate
for its specific product, are discussed elsewhere in this document (see
Response 35).
(Comment 40) One comment stated that while consideration of the
constituents on FDA's list of HPHCs is important, FDA should not give
it undue emphasis because there are other toxins in tobacco products
that are not on this list. The comment stated an application's exposure
assessment should cover the full range of exposures generated by the
new product and that FDA should revise the rule to clearly state that
evidence of biological and clinical effects of the product will be
given more weight than measures of exposure.
Another comment stated that the definitions of the terms
``constituent'' and ``HPHC'' are so broad that the requirement in Sec.
1114.7(i)(1)(v) to report all constituents contained within or emitted
from the product could be difficult for applicants. The comment stated
that there are practical constraints on the number, capacity, and
capability of laboratories equipped to conduct the testing. The comment
also expressed concern that FDA could potentially refuse to file an
application in which an applicant omitted a constituent. The comment
suggested that FDA revise the rule so that an application would be
required to contain only information for ``relevant'' constituents and
HPHCs, rather than all constituents. Specifically, the comment
recommended that the inclusion of constituent and HPHC information
should be based on a comprehensive risk assessment of the particular
product.
(Response 40) FDA declines to make revisions in response to these
comments. An application is not required to contain testing for all
HPHCs on the initial list; rather, it must contain testing for HPHCs
that are contained within and can be delivered by the type of product
and contain a description of why the HPHCs that were tested are
appropriate for the type of product. FDA declines to limit the scope of
the constituents that must be reported in a PMTA to only those that an
applicant considers to be relevant because it may impair FDA's ability
to determine the health risks of a new tobacco product. As discussed in
the rule, the constituents contained within and delivered from a
tobacco product directly relate to its health risks. The HPHC list can
be helpful to applicants in preparing a description of why the HPHCs
for which it tested are appropriate for the product type, including,
where appropriate, why an applicant did not test for certain HPHCs. For
example, a PMTA for a smokeless tobacco product would not be required
to contain testing results for HPHCs that are a byproduct of combustion
(e.g., carbon monoxide) where the product does not contain or deliver
such constituents. However, a PMTA for an inhaled tobacco product that
an applicant claims aerosolizes a substance but does not combust it,
such as an e-cigarette or heated tobacco product, should provide
evidence, such as testing for HPHCs that result from complete or
incomplete combustion, to demonstrate that the product is not
combusted. For recommendations on constituent testing
[[Page 55335]]
for ENDS products, please see the ENDS PMTA Guidance.
Additionally, FDA declines to revise the rule to assign weight to
different types of evidence. Finding that there is a showing that
permitting the marketing of a new tobacco product would be APPH is a
complex determination that must be made with respect to risks and
benefits to the population as a whole, considering the likelihood of
changes in tobacco product use behavior (including initiation and
cessation) caused by the marketing of the new tobacco product. When
determining whether the marketing of a particular new tobacco product
would be APPH, FDA will evaluate the factors in light of available
information regarding the existing tobacco product market, tobacco use
behaviors, and the associated health risks at the time of review.
(Comment 41) One comment requested FDA provide greater detail
regarding the ranges of constituents that would be acceptable in a
PMTA.
(Response 41) FDA does not set limits for what constitutes
acceptable ranges for constituents as a part of this rulemaking. FDA's
APPH determination will include a consideration of constituent levels
and their resulting health risks; however, FDA must also consider of a
variety of information related to health risk and tobacco product use
behaviors. FDA recommends that applicants take all the necessary steps
in controlling and mitigating any circumstances that may affect the
constituent yields generated from a new tobacco product as this may
impact the risks and benefits associated with the new tobacco product
on the population health as a whole, when compared to other products on
the market.
(Comment 42) One comment stated the final rule must provide greater
detail regarding the appropriate validated methodologies or regimens
required for testing.
(Response 42) As discussed in Sec. 1114.7(i)(1)(v), for combusted
or inhaled tobacco products, constituent smoke or aerosol yields from
the new product must be determined using intense and nonintense smoking
or aerosol-generating regimens, where established. Two smoking or
aerosol-generating regimens are required, where established, to
understand the way that constituent yields delivered by a tobacco
product can change over a range of different smoking conditions. If
constituent yields were only reported from a single smoking or aerosol-
generating regimen, FDA would have limited and potentially misleading
information about constituent yields produced by a given tobacco
product. Many studies demonstrate that different smoking regimens
result in different constituent yields from the same product (Refs. 42
and 43). By requiring both an intense and a nonintense smoking or
aerosol generating regimen, where established, FDA will have a better
understanding of quantities of each constituent that may be produced by
the tobacco product when used under different conditions. If no intense
and nonintense smoking or aerosol-generating regimens (e.g.,
International Organization for Standardization (ISO) and Health Canada
Intense (HCI) regimens for cigarettes, Cooperation Centre for
Scientific Research Relative to Tobacco (CORESTA) regimens for cigars)
have been established and an applicant must use an alternative regimen,
an applicant should provide an explanation as to why the alternative
regimen provides comparable results. For ENDS products, for example,
where intense and nonintense regimens may have not been established,
the application must contain an explanation of why the alternative
regimen provides comparable results to the intense and nonintense
regimens.
(Comment 43) One comment stated that manufacturers of premium
cigars should not be required to submit information regarding HPHCs and
other constituents. The comment stated that not only is there a lack of
testing standards, the variability inherent in premium cigars would
render the results of any constituent testing worthless for assessing a
product.
(Response 43) As stated in Sec. 1114.1(d) and described in section
VII.A., this rule does not apply to ``premium'' cigars. To the extent
this comment is applicable to products other than ``premium'' cigars,
such as large cigars that do not meet the definition of ``premium''
cigar, FDA disagrees with this comment. Each applicant that submits a
PMTA is required by Sec. 1114.7(i)(1)(v) to conduct constituent
testing and submit the results as part of their application.
Understanding the constituents contained within and emitted from a
tobacco product is a crucial component of being able to determine its
health effects, which is why FDA will refuse to accept a PMTA (under
Sec. 1114.27(a)(1)), as appropriate, where it lacks constituent
testing information required by Sec. 1114.7(i)(1)(v). Where a
product's ingredients have natural variability that could affect
constituent testing results, FDA recommends an applicant submit
scientific evidence justifying why the results reflect the natural
variability of the ingredients in the new tobacco product. This
evidence could include items such as scientific literature establishing
the variability of the product, information related to international or
national testing standards, or data from an investigation with
sufficient sample size to demonstrate attributes affecting variability
of the test results (e.g., weight, smoke efficiency, crop year to crop
year, region to region). Additionally, CORESTA \21\ have established
and published methods on how to generate cigar smoke to quantitatively
compare HPHCs found in cigar smoke.
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\21\ CORESTA standards that applicants might consider include
CORESTA Reference Method (CRM) 46: Atmosphere for Conditioning and
Testing Cigars of all Sizes and Shapes; CRM 47: Cigars--Sampling;
CRM 64: Routine Analytical Cigar-Smoking Machine--Specifications,
Definitions and Standard Conditions; CRM 65: Determination of Total
and Nicotine-Free Dry Particulate Matter using a Routine Analytical
Cigar-Smoking Machine--Determination of Total Particulate Matter and
Preparation for Water and Nicotine Measurements; CRM 66:
Determination of Nicotine in the Mainstream Smoke of Cigars by Gas
Chromatographic Analysis; CRM 67: Determination of Water in the
Mainstream Smoke of Cigars by Gas Chromatographic Analysis; CRM 68:
Determination of Carbon Monoxide in the Mainstream Smoke of Cigars
by Non-Dispersive Infrared Analysis.
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vi. Container closure system. Section 1114.7(i)(1)(vi) requires
that the application contain a description of the container closure
system for the new tobacco product, if applicable, including
information describing how the container closure system protects and
preserves the product from damage during transport, environmental
contaminants, and leaching and migration of constituents into the new
tobacco product. The description must also contain information
describing design features developed to prevent the risk of accidental
exposure, if any (e.g., child resistant packaging for e-liquids). These
descriptions are important to FDA's review of the product because they
help demonstrate that the product used by consumers is in the same
condition as that described in the application and manufactured by the
applicant and provide information regarding whether the container
closure system has any features that could prevent accidental exposure.
Additionally, evidence demonstrates that the container closure
system used can change the characteristics of the product. For example,
substances within the packaging materials can affect product moisture
(e.g., when the manufacturer changes the container closure system of a
moist snuff from plastic to fiberboard), which can affect microbial
stability and TSNA formation during storage (Ref. 44). Another example
is when menthol or other
[[Page 55336]]
ingredients are applied to the inner foil of a cigarette package to
become incorporated into the consumed product (Ref. 1). The container
closure system may also be intended or reasonably expected to affect
the characteristics of a tobacco product by impacting the rate of
leaching into, and ultimately, the amount of substances found in, the
consumable tobacco product. In fact, it has been demonstrated that
compounds in the container closure system may diffuse into snuff and
affect its characteristics (Ref. 2). Thus, for example, packaging
material that affects the characteristics of a tobacco product by
impacting the moisture level or shelf life of a tobacco product is a
container closure system (e.g., a plastic container compared to a metal
container of smokeless tobacco) because a difference in tobacco
moisture is reasonably expected to affect microbial growth in the
product, extraction efficiency, and total exposure to nicotine or the
carcinogens NNN or NNK. For additional examples of container closure
systems, see the ENDS PMTA Guidance.
vii. Statement of tobacco blending, reconstitution, and
manipulation. Finally, the rule requires a PMTA to contain a full
statement of the tobacco blending, reconstitution, or manipulation,
where applicable. This may include manufacturer specifications, and
tobacco types, and quantities. This information is important because it
helps FDA understand the characteristics of the tobacco product.
Information on tobacco types and quantities used by an applicant (where
applicable) will help FDA understand the composition of tobacco used,
which can provide important information since the tobacco types and
quantities may impact the tobacco chemistry (e.g., the nicotine
content) and, thereby, the chemical composition of the tobacco product
(Ref. 45).
b. Other properties. Section 1114.7(i)(2) describes additional
parts of FDA's interpretation of the requirement in section
910(b)(1)(B) of the FD&C Act to provide a full statement of the product
properties and, together with FDA's authority under section
910(b)(1)(G), requires the applicant to provide a full description of
the properties of the tobacco product that includes:
i. Product dimensions and construction. The product dimensions and
the overall construction of the product using a diagram or schematic
drawing that clearly depicts the finished product and its components
with dimensions, operating parameters, and materials. Under the
definition of finished tobacco product (which includes all components
and parts, sealed in final packaging), the dimensions and schematic
drawings are required to include the final packaging. The diagram or
schematic is an annotated graphical representation that will help FDA
understand the applicant's nomenclature, how the components and parts
function together, and the overall principles of operation of the
finished tobacco product.
ii. Design parameters and test data. All design parameters of the
product and test data, specifying nominal values or the explicit range
of values as well as the design tolerance (i.e., upper and lower range
limits), where appropriate. Changes in design parameters can change the
health impact of the tobacco product by affecting the level of
constituents that reach the user or nonuser and are also necessary to
fully characterize a tobacco product. Given the potential health
impacts associated with changes in design parameters as well as the
importance of design parameters in fully characterizing a product, the
PMTA review process does not simply note or link these parameters to
the product and any associated constituents. Instead, during PMTA
review, FDA evaluates how products are manufactured, and the controls
put in place during production. For the PMTA pathway, FDA reviews
whether each design parameter meets its specification through test
data, determining whether each parameter is adequately controlled via
documented processes, determining whether safeguards are in place
against hazards and foreseeable misuse, and assessing how the applicant
deals with nonconforming products. FDA believes it is necessary to
review sufficient information to ensure that products marketed under
the PMTA pathway have the necessary manufacturing and control processes
in place. Tables 1 through 22 in Sec. 1114.7(i)(2)(ii)(B) provide the
parameters that are required for different categories of tobacco
products. As part of the full description of the properties of the
tobacco product, the rule also requires, as included in the tables, a
quantitative description of the performance criteria, including test
protocols, test data, and a summary of the results, for each applicable
design parameter and manufacturing step. The test data is a required
part of the PMTA to demonstrate the product consistently meets the
nominal values or range of values as well as the design tolerance.
While test data is a required part of the PMTA, FDA does not require
test data for all the parameters for which it requires target and
range. For example, for parameters that are observational (e.g., number
of waterpipe holes), FDA would not seek test data on that parameter.
Also, some design parameters are machine settings (e.g., tobacco cut
size), calculated (e.g., denier per filament (DPF)), provided by
suppliers (e.g., certificate of analysis for base paper porosity), or
can be extrapolated from other design parameter test data (e.g., filter
pressure drop test data is more informative than filter length test
data). Test data would not be needed for such parameters. In addition,
in tables 1 through 22, FDA has clarified alternative terminology for
``porosity'' understanding that applicants may refer to this term as
``permeability'' for several design parameters as well as adding units
of measure for several design parameters. The design parameters, their
importance to understanding their impact on public health, and methods
for applicants to provide this information are described below.
One way an applicant can provide the information needed for a
product's required design parameters is with a Manufacturing Data Sheet
Specification (MDSS) document. The MDSS is a document typically
maintained by manufacturers, describing all the parameters that are
controlled by the manufacturer during manufacture of their tobacco
products. There will be cases where the design parameters on the MDSS
will not directly translate into one of the product-specific design
parameters in section 1114.7(i)(2)(ii). In these cases, additional
information would need to be submitted to provide the complete
characterization necessary. There may also be instances (e.g., for
novel tobacco products in one of the categories described in table 1 to
Sec. 1114.7(c)(3)(iii)) where one or more of the required design
parameters do not apply to the tobacco product described in the PMTA.
In these instances, an applicant must justify why the required design
parameter does not apply or how an alternative design parameter(s)
would satisfy one or more of the required design parameters. Similarly,
for test data, an applicant must justify why the required test data
does not apply or how alternative test data should be considered by FDA
in lieu of the required test data. Further, there may be instances
where the tobacco product may not fit into any of the categories
described in table 1 to Sec. 1114.7(c)(3)(iii). In these instances,
the applicant must provide design parameters that would fully
characterize their product. Additionally, if there are
[[Page 55337]]
design parameters beyond what FDA is requiring that would characterize
the tobacco product, applicants should provide those to aid in FDA's
scientific review. While failure to include additional design
parameters to fully characterize the tobacco product beyond what FDA is
requiring under this rule would not serve as the basis for FDA refusing
to accept or file an application under Sec. 1114.27(a)(1), it may slow
down the substantive review process.
Applicants should also state whether the ranges or tolerances
associated with each design parameter correspond to product or process
controls, and what actions the applicant takes when test data falls
outside of these specified ranges. As an example of product and process
controls, a smokeless tobacco product may have set design parameters
(also known as product specifications) for pH and oven volatiles (OV).
The applicant may establish process controls for the fermentation
process by setting lower and upper temperature and humidity limits for
specified time durations. At the end of the fermentation process, a
sample may be tested to verify that the tobacco product meets the
established pH and OV design parameter limits. For any design
parameters that are provided that are not included in the tables to
Sec. 1114.7(i)(2)(ii)(B), applicants must provide test data or process
information to demonstrate that these parameters or their associated
processes are adequately controlled.
Table 1 to Sec. 1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
contained in a PMTA for cigarettes. In this final rule we have revised
table 1 to Sec. 1114.7(i)(2)(ii)(B) to help ensure that FDA is able to
identify and evaluate each product more accurately and efficiently.
These changes include: (1) Removal of the proposed requirement for
applicants to provide cigarette draw resistance, as FDA determined that
requiring this parameter was unnecessary and not as informative as
pressure drop as draw resistance could be modified by the user by
puffing more or less intensely; (2) removal of cigarette paper base
paper basis weight and tipping paper basis weight, as they are not as
informative as other design parameters, such as cigarette paper base
paper porosity; (3) removal of plug wrap parameters, as the effects of
plug wrap are not as informative as cigarette paper parameters; (4)
removal of cigarette mass, paper width, filter diameter, tipping paper
width, and tobacco rod length, as these parameters can be either
calculated from other required design parameters or are not as
informative as other required parameters; (5) removal of filter mass
and filter tow crimp index, as these parameters have less of an impact
on the filter efficiency than other required design parameters that
will affect the smoke constituents that are exposed to users and
nonusers; (6) removal of filter ventilation position of holes, filter
ventilation number of holes, and filter ventilation number of rows as
filter ventilation, which is still required, is affected by these
parameters; (7) the inclusion of filter efficiency as an alternative to
DPF, total denier, or filter density, if available, as these parameter
have a direct effect on filter efficiency and vice versa; (8) the
option to provide cigarette diameter as an alternative to cigarette
circumference as FDA is able to calculate the necessary information
based on either one; and (9) the option for the applicant to provide
cigarette paper band diffusivity in lieu of cigarette paper band
porosity, if applicable (also described as permeability). FDA has
clarified terminology for cigarette paper band porosity, as applicants
may refer to this term as permeability, and also provided an
alternative to providing cigarette paper band porosity or
permeability--band diffusivity, while not preferred, is an acceptable
alternative if it is currently not part of an applicant's practice to
specify cigarette paper band porosity. While there are minor
differences (porosity is more relevant during active puffing, whereas
diffusivity is more relevant during smoldering), the addition of
diffusivity as an alternative parameter allows flexibility to
applicants who do not directly measure porosity or permeability (see
Ref. 46).
Additionally, FDA has revised certain proposed parameters for test
data, which includes: (1) Removal of puff count as this was duplicative
of information that an applicant would submit with smoke constituent
data since puff count is determined in a smoking machine using either
the ISO or HCI smoking regimen or other applicable regimen; (2) removal
of cigarette draw resistance, as explained above; (3) removal of
cigarette mass, cigarette paper base paper and tipping paper basis
weight, as explained above; (4) removal of plug wrap parameters, as
explained above; (5) removal of tipping paper width and tipping paper
perforation, as explained above; (6) removal of tipping paper length
and width, tobacco rod length, cigarette paper length and width,
cigarette length, cigarette diameter, cigarette paper band width,
cigarette paper band space, filter diameter and length as these are
measured parameters, that are not needed as test data; (7) removal of
filter tow crimping index and filter mass, as explained above. The
finalized parameters listed in table 1 to Sec. 1114.7(i)(2)(ii)(B) are
a necessary part of the application because they are needed to fully
characterize the product and changes in these parameters may affect the
cigarette's impact on the public health, as described below:
Cigarette length may alter tobacco biomarker levels (Ref.
47);
cigarette circumference or diameter may affect filter
efficiency and, in turn, smoke constituent yields (Ref. 48); puff count
can directly affect smoke constituent yields (Ref. 49);
tobacco filler mass may affect smoke constituent yields
(Ref. 50);
tobacco rod density may modify burn properties and smoke
constituent yields (Refs. 51 and 52);
tobacco cut size alters the size of the tobacco pieces,
which may result in more particulate matter (Ref. 53);
tobacco moisture may affect puff count (Ref. 54);
cigarette paper base paper basis weight may affect puff
count and smoke constituent yields (Ref. 55);
cigarette paper base paper porosity or permeability may
affect smoke constituent yields (Ref. 55);
cigarette paper band porosity or permeability may affect
smoke constituent yields because band porosity allows for the overall
assessment of the weighted change in air flow through the cigarette
paper during active puffing (Ref. 56);
cigarette paper band diffusivity may affect smoke
constituent yields because it mimics air flow during smoldering (Ref.
57);
cigarette paper band width may affect ventilation and, in
turn, smoke constituent yields (Ref. 58);
cigarette paper band space may affect ignition propensity
and, in turn, puff count (Ref. 59);
filter efficiency may affect smoke constituent yields
(Ref. 58);
filter DPF, total denier, filter density, and filter
length may affect filter efficiency and, in turn, smoke constituent
yields (Ref. 60);
filter pressure drop may affect smoke constituent yields
(Ref. 61);
tipping paper, including length, may affect smoke
constituent yields (Ref. 62); and
filter ventilation may affect smoke constituent yields
(Ref. 48).
Table 2 to Sec. 1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
contained in a PMTA for
[[Page 55338]]
portioned and nonportioned smokeless tobacco products. We have revised
table 2 to Sec. 1114.7(i)(2)(ii)(B) to help ensure that FDA is able to
identify and evaluate each product more accurately and efficiently.
These changes include: (1) Removal of portion thickness, as it is an
unnecessary parameter because it is the pouch effective area that may
result in an increase of the release level of nicotine, unprotonated
nicotine, and could affect TSNA levels, and the pouch effective area
can be calculated from other required design parameters, i.e., pouch
length and pouch width; (2) removal of pouch material nicotine
dissolution extent, as nicotine dissolution rate provides the nicotine
exposure to the user over time, and therefore was considered redundant
and unnecessary; (3) addition of pouch material thickness as this
parameter influences the release level of nicotine and can affect TSNA
levels; \22\ (4) option to provide tobacco particle size in lieu of
tobacco cut size, as tobacco particle size can impact the use profile
of the product and thereby affect the rate and total delivery of HPHCs
similar to tobacco cut size. FDA has revised certain proposed
parameters for test data, which includes the removal the portion
length, width, portion thickness, and material thickness, as these are
measured design parameters that can be obtained from the supplier of
the portion or pouch, and (5) clarification of requiring certain
parameters ``if applicable'' for portioned product properties. While
these parameters are needed for all portioned smokeless products, not
all portioned products are pouched, so the pouch-specific properties
should only be reported if applicable, and thus FDA has added ``if
applicable'' to pouch material porosity or permeability and pouch
material basis weight.
---------------------------------------------------------------------------
\22\ See, e.g., Gale, N., G. Errington, and K. McAdam, Group
Research & Development, British American Tobacco, ``Effects of
Product Format on Nicotine and TSNA Extraction from Snus Pouches,''
Presentation at the 67th Tobacco Science Research Conference,
Williamsburg, VA, September 15-18, 2013. Available at: https://www.researchgate.net/publication/299854728_Effects_of_Product_Format_on_Nicotine_and_TSNA_Extraction_from_Snus_Pouches.
---------------------------------------------------------------------------
The finalized parameters in table 2 to Sec. 1114.7(i)(2)(ii)(B)
are a necessary part of the applications because they are needed to
fully characterize the product and changes in these parameters may
affect the smokeless tobacco product's impact on public health, as
described below:
Tobacco cut size may alter the particle surface area and
accessibility of saliva to get to the surfaces of the tobacco, thereby
affecting the amount and rate of constituents released from the product
(Ref. 63);
tobacco moisture may affect microbial growth in the
product, extraction efficiency, and total exposure to nicotine, NNN,
and NNK (Refs. 3 and 64);
portion mass may affect user exposure to a tobacco product
and, in turn, HPHCs contained in each portion (Ref. 65);
portion length may affect the constituents in each portion
(Ref. 65);
portion width may result in a surface area difference,
which is proportional to the amount and rate of constituents released
from the product (Ref. 66);
pouch material basis weight, pouch material air
permeability, and pouch material thickness influences the interactions
between the tobacco and oral cavity, thereby potentially affecting the
amount and rate of constituents released from the product (Refs. 67,
141, and 142; \23\) and
---------------------------------------------------------------------------
\23\ See response 45 for additional information.
---------------------------------------------------------------------------
nicotine dissolution rate is a function of tobacco cut
size and pouch materials, thereby potentially affecting the amount and
rate of constituents released from the product (Ref. 68).
Table 3 to Sec. 1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
contained in a PMTA for RYO tobacco rolling paper products. In this
final rule, we have revised table 3 to Sec. 1114.7(i)(2)(ii)(B) to
help ensure that FDA is able to identify and evaluate each product more
accurately and efficiently. These changes include the option to provide
RYO paper band diffusivity in lieu of RYO paper band porosity (also
described as permeability). FDA has clarified terminology for RYO paper
band porosity, as applicants may refer to this term as permeability,
and also provided an alternative to providing cigarette paper band
porosity or permeability--band diffusivity, while not preferred, is an
acceptable alternative if it is currently not part of an applicant's
practice to specify cigarette paper band porosity. While there are
minor differences (porosity is more relevant during active puffing,
whereas diffusivity is more relevant during smoldering), the addition
of diffusivity as an alternative parameter allows flexibility to
applicants who do not directly measure porosity or permeability (see
Ref. 46). Additionally, FDA has revised certain proposed parameters for
test data, which includes the removal the paper length, width, band
space, and band width as these are measured design parameters that are
not needed as test data.
The finalized parameters listed in table 3 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes in these
parameters may affect the rolling paper's impact on public health, as
described below:
RYO paper length and RYO paper width may alter the surface
area that is available for tobacco packing, thereby affecting the smoke
constituent yields (Ref. 61);
RYO mass per paper may be a result of a surface area or
basis weight difference and, in turn, may affect puff count and smoke
constituent yields (Refs. 55 and 61);
RYO paper base paper basis weight may affect puff count
and smoke constituent yields (Ref. 55);
RYO paper base paper porosity may affect smoke constituent
yields (Ref. 55);
RYO paper band porosity may affect smoke constituent
yields because band porosity allows for the overall assessment of the
weighted change in air flow through the cigarette paper during active
puffing (Ref. 56);
RYO paper band diffusivity may affect smoke constituent
yields because it mimics air flow during smoldering (Ref. 57);
RYO paper band width may affect ventilation and, in turn,
smoke constituent yields (Ref. 58); and
RYO paper band space may affect ignition propensity and,
in turn, puff count (Ref. 59).
Table 4 to Sec. 1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
contained in a PMTA for RYO tobacco tubes. We have revised table 4 to
Sec. 1114.7(i)(2)(ii)(B) to help ensure that FDA is able to identify
and evaluate each product more accurately and efficiently. These
changes include the addition of: (1) The option to provide tube
diameter as an alternative to tube circumference, as FDA is able to
calculate the information necessary based on either one and (2) the
option for the applicant to provide tube paper band diffusivity in lieu
of tube paper band porosity or permeability, if applicable. FDA has
clarified terminology for RYO paper band porosity, as applicants may
refer to this term as permeability, and also provided an alternative to
providing cigarette paper band porosity or permeability--band
diffusivity, while not preferred, is an acceptable alternative if it is
currently not part of an applicant's practice to specify cigarette
paper band porosity. While there are minor
[[Page 55339]]
differences (porosity is more relevant during active puffing, whereas
diffusivity is more relevant during smoldering), the addition of
diffusivity as an alternative parameter allows flexibility to
applicants who do not directly measure porosity or permeability (see
Ref. 46). FDA has revised certain proposed parameters for test data,
which includes the removal of tube length, tube paper width, tube
circumference, tube paper band width, and tube paper band space, as
these are measured design parameters.
The finalized parameters listed in table 4 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes in these
parameters may affect the RYO tube's impact on public health, as
described below:
Tube mass may affect smoke constituent yields (Ref. 50);
tube length may alter tobacco biomarker levels (Ref. 47);
tube circumference or diameter may affect filter
efficiency and, in turn, smoke constituent yields (Ref. 48);
tube paper width may affect smoke constituent yields (Ref.
50);
tube paper base paper basis weight may affect puff count
and smoke constituent yields (Ref. 55);
tube paper base paper porosity may affect smoke
constituent yields (Ref. 55);
tube paper band porosity may affect smoke constituent
yields since band porosity allows for the overall assessment of the
weighted change in air flow through the cigarette paper during active
puffing (Ref. 56);
tube paper band diffusivity may affect smoke constituent
yields because it mimics air flow during smoldering (Ref. 57);
tube paper band width may affect ventilation and, in turn,
smoke constituent yields (Ref. 58); and
tube paper band space may affect ignition propensity and,
in turn, puff count (Ref. 59).
Table 5 to Sec. 1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
contained in a PMTA for RYO tobacco filtered tubes. In this final rule
we have revised table 5 to Sec. 1114.7(i)(2)(ii)(B) to help ensure
that FDA is able to identify and evaluate each product more accurately
and efficiently. These changes include: (1) The option to provide tube
diameter as an alternative to tube circumference, as FDA is able to
obtain the information necessary from calculations based on what the
applicant submits; (2) the option for the applicant to provide filter
efficiency as an alternative to DPF, total denier, or filter density
(Ref. 60); (3) the option for the applicant to provide diffusivity in
lieu of paper band porosity or permeability, as described in previous
design parameter sections, is an acceptable alternative if it is
currently not part of an applicant's practice to specify paper band
porosity; (4) removal of filter mass, filter diameter, and filter tow
crimping index as these parameters are considered as not as important
as other parameters such as DPF and total denier, and therefore deemed
unnecessary; (5) removal of plug wrap length, width, basis weight, and
porosity as plug wrap parameters contribute to ventilation; however,
filter ventilation and paper porosity have more of an effect on
ventilation and therefore, plug wrap parameters were considered
unnecessary; (6) removal of tipping paper width, basis weight, and
perforation are considered unnecessary because they have little effect
on the airflow and are not combusted during use; and (7) removal of
filter ventilation position of holes, filter ventilation number of
holes, and filter ventilation number of rows as these parameters are
considered redundant because the filter ventilation is affected by
these parameters. The alternatives (filter efficiency and diffusivity)
are also provided under test data for this product category. Further,
FDA has revised certain parameters for test data that were previously
proposed in the PMTA rule, which include: (1) Removal of the tube mass,
tube length, tube diameter, tube paper length, nonfilter tube length,
tube width, tube paper band width and space, filter length, filter
mass, and filter diameter as these are measured design parameters and
(2) removal of filter tow index, plug wrap length, plug wrap width, and
tipping paper basis weight for reasons described above.
The finalized parameters listed in table 5 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes in these
parameters may affect the filtered tube's impact on public health, as
described below:
Tube mass may affect smoke constituent yields (Ref. 50);
tube length may alter tobacco biomarker levels (Ref. 47);
tube circumference or diameter may affect filter
efficiency and, in turn, smoke constituent yields (Ref. 48);
tube paper length directly correlates to non-filter tube
length, which may affect smoke constituent yields (Ref. 50);
tube paper width may affect smoke constituent yields (Ref.
50);
tube paper base paper basis weight may affect puff count
and smoke constituent yields (Ref. 55);
tube paper base paper porosity may affect smoke
constituent yields (Ref. 55);
tube paper band porosity may affect smoke constituent
yields since band porosity allows for the overall assessment of the
weighted change in air flow through the cigarette paper during active
puffing (Ref. 56);
tube paper band diffusivity may affect smoke constituent
yields because it mimics air flow during smoldering (Ref. 57);
tube paper band width may affect ventilation and, in turn,
smoke constituent yields (Ref. 58);
tube paper band space may affect ignition propensity and,
in turn, puff count (Ref. 59);
filter efficiency may affect smoke constituent yields
(Ref. 58);
filter DPF may affect filter efficiency and, in turn,
smoke constituent yields (Ref. 60);
total denier, filter density, and filter length may affect
filter efficiency and, in turn, smoke constituent yields (Ref. 43);
filter pressure drop may affect smoke constituent yields
(Ref. 61);
tipping paper length may affect smoke constituent yields
(Ref. 62); and
filter ventilation may affect smoke constituent yields
(Ref. 48).
Table 6 to Sec. 1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
contained in a PMTA for RYO tobacco. In this final rule, we have
revised table 6 to Sec. 1114.7(i)(2)(ii)(B) to help ensure that FDA is
able to identify and evaluate each product more accurately and
efficiently. This change includes the removal of the requirement for
the applicant to provide filler mass as this is provided as part of
unique identification of the tobacco product under Sec. 1114.7(c).
The finalized parameters listed in table 6 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes in these
parameters may affect the RYO tobacco's impact on public health, as
described below:
Tobacco cut size alters the size of the tobacco pieces,
which may result in more particulate matter (Ref. 53) and
tobacco moisture may affect puff count when used with
rolling paper (Ref. 54).
Table 7 to Sec. 1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
contained in a PMTA for RYO tobacco paper tips. In this final rule, we
have revised table 7 to
[[Page 55340]]
Sec. 1114.7(i)(2)(ii)(B) to help ensure that FDA is able to identify
and evaluate each product more accurately and efficiently. This
includes the replacement of the requirement for the applicant to
provide RYO paper base paper perforation, and instead provide RYO paper
porosity. RYO porosity was found to directly convey the smoke
constituent exposure to users, while paper perforation was less
indicative of the exposure of smoke constituents when accounting for
additional design parameters. FDA has also revised certain parameters
for test data that were proposed previously in the PMTA rule, which
include: (1) Removal of the tip length and width and tip mass as these
are measured design parameters; and (2) replacement of paper
perforation to paper porosity, as described above.
The finalized parameters listed in table 7 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes may
affect the paper tip's impact on public health, as described below:
RYO paper tip length and RYO paper tip width may alter the
surface area that is available for tobacco packing, thereby affecting
the smoke constituent yields (Ref. 61);
RYO paper tip mass may be a result of a surface area or
basis weight difference and, in turn, may affect puff count and smoke
constituent yields (Refs. 55 and 61);
RYO paper base paper basis weight may affect puff count
and smoke constituent yields (Ref. 55);
RYO paper base paper porosity may affect smoke constituent
yields (Ref. 55); and
RYO paper tip ventilation may affect smoke constituent
yields (Ref. 48).
Tables 8 through 12 to Sec. 1114.7(i)(2)(ii)(B) describe the
design parameters and information on performance criteria that must be
contained in a PMTA for products categorized as cigars. Cigarettes
(outside the category of heated tobacco products) and cigars are
similar, as they are both cylinders filled with a blend of processed
tobacco that is generally smoked. Both are generally lit with a fire
source, which burns the tobacco as the user inhales at one end; thus,
they are consumed and deliver nicotine in a similar manner. A main
difference between cigarettes and cigars is that cigars are either
wrapped in a tobacco leaf (wrapper and binder) or a material containing
tobacco, whereas non-HTP cigarettes are wrapped in paper (cigarette
paper) or a material that does not contain tobacco. Additionally,
cigars come in a wider variety of sizes and some types of cigars may be
thicker in diameter and contain more tobacco filler than cigarettes.
Despite these differences, for both types of tobacco products, no
matter the size, air is pulled through the tobacco column, which aids
in tobacco combustion and nicotine delivery. Cigarette paper commonly
has an established porosity (permeability), that is set during
manufacturing, while cigar wrapper properties are based on the tobacco
used as the wrapper. Although cigars and cigarettes are wrapped in
different materials, both cigar wrappers and binders, as well as
cigarette papers, have inherent permeabilities/porosities, which may
affect smoke constituent yields. Cigars may be filtered (containing
filter tow or other materials), unfiltered, or unfiltered with tips
made of wood or plastic, while most cigarettes have filters (containing
filter tow) and do not contain tips. If a cigar does contain a filter,
it will be similar to cigarette filters and contain tow. Based on FDA's
experience with cigarettes under the SE pathway, as well as the
similarities between the two products, FDA has used established design
parameter information from cigarettes to develop some of the design
parameter requirements for cigars. Tables 8 through 12 to Sec.
1114.7(i)(2)(ii)(B) describe in more detail the parameters for each
subcategory of cigars.
Table 8 to Sec. 1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
contained in a PMTA for filtered, sheet-wrapped cigars. In this final
rule we have revised table 8 to Sec. 1114.7(i)(2)(ii)(B) to help
ensure that FDA is able to identify and evaluate each product more
accurately and efficiently. These changes include (1) the addition of
cigar wrapper and binder band space, as these parameters affect smoke
constituents; (2) the addition of cigar minimum and maximum diameter
(mm), as the shape of cigars can differ, with the tips being narrower
than the center of the cigar, affecting the rod density, which in turn
modifies the burn properties and smoke yields; (3) providing applicants
the option to provide oven volatiles as an alternative to tobacco
moisture, as well as the option to provide oven volatiles instead of
moisture, as this provides similar information to FDA \24\ and allows
the applicant flexibility to provide either parameter based on the
specific manufacturing processes they employ; and (4) removing cigar
length, cigar diameter, filter diameter, filter length as requirements
for test data as these are measured design parameters that are not
needed as test data.
---------------------------------------------------------------------------
\24\ Please note that the term ``moisture,'' has widely varying
and conflicting definitions and terminology in use within the
tobacco industry. It is common for ``moisture'' or ``moisture
content'' to be used to refer to water content of a material but in
relation to the tobacco industry it is necessary to differentiate
between ``moisture'' as water content and ``moisture'' as oven
volatiles. https://www.coresta.org/sites/default/files/technical_documents/main/PTM-CTR_MoistureWaterOvenVolatiles_July2014%282%29.pdf.
---------------------------------------------------------------------------
Additionally, based on FDA's understanding of machine-made cigars
and their similarity to cigarettes, we have also included design
requirements previously recommended in the proposed PMTA rule. These
design parameters include (1) cigar mass, wrapper and binder basis
weight, cigar binder and wrapper length and width, cigar wrapper and
binder band porosity, and cigar wrapper and binder width, as these
design parameters may affect smoke constituent yields and (2) the
option for the applicant to provide filter efficiency, if available, as
an alternative to DPF, total denier, or filter density. We have also
included test data requirements for cigar mass, puff count, wrapper and
binder basis weight, and cigar minimum and maximum diameter for reasons
previously discussed.
The finalized parameters listed in table 8 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes may
affect the cigar's impact on public health, as described below:
Cigar mass reflects the amount of tobacco in a cigar,
which may affect smoke constituent yields (Ref. 69);
cigar puff count can directly affect smoke constituent
yields (Ref. 69);
cigar length and diameter can directly affect the amount
of tobacco that is burned and, in turn, affect smoke constituent yields
(Ref. 70);
tobacco filler mass may affect smoke constituent yields
(Ref. 71);
for cigarettes, the cigarette paper basis weight may
affect puff count and smoke constituents (Ref. 71). Similarly, for
cigars, the cigar wrapper and binder basis weight may affect puff count
and smoke constituent yields;
for cigarettes, the paper length and width may affect puff
count and smoke constituents (Ref. 71). Similarly, for cigars, the
cigar wrapper and binder length and width may directly influence the
area through which air is permitted to enter the tobacco column, which,
in turn, may affect puff count and smoke constituent yields;
cigar wrapper porosity may affect smoke constituent yields
(Refs. 72 and 73);
[[Page 55341]]
for cigarettes, tobacco rod density may modify burn
properties and smoke constituent yields (Refs. 51 and 52). Similarly,
for cigars, tobacco rod density may modify burn properties and smoke
constituent yields;
for cigarettes, the tobacco moisture or oven volatiles may
affect puff count (Ref. 54). Similarly, for cigars, the tobacco
moisture may affect puff count (Ref. 54);
for cigarettes, the tobacco cut size may result in more
particulate matter (Ref. 53). Similarly, for cigars, the tobacco cut
size alters the size of the tobacco pieces, which may result in more
particulate matter;
for cigarettes, the band porosity may affect smoke
constituent yields (Ref. 56). Similarly, for cigars, the band porosity
or permeability may affect smoke constituent yields because band
porosity allows for the overall assessment of the weighted change in
air flow through the cigarette paper during active puffing;
for cigarettes, the band width may affect smoke yields
(Ref. 58). Similarly, for cigars, the wrapper band width and binder
band width may affect ventilation and, in turn, smoke constituent
yield;
for cigarettes, the band space may affect puff count (Ref.
59). Similarly, for cigars, the wrapper band space and binder space may
affect ignition propensity and, in turn, puff count;
for cigarettes, the filter parameters can impact smoke
yields (Ref. 60). Similarly, for cigars, the filter diameter, filter
mass, filter tow crimping index, DPF, total denier, filter density, and
filter length may affect filter efficiency and, in turn, smoke
constituent yields;
For cigarettes, the filter pressure drop affects smoke
yields (Ref. 61). Similarly, for cigars, the filter pressure drop may
affect smoke constituent yields.
for cigarettes, tipping paper length may affect smoke
constituent yields (Ref. 62). Similarly, for cigars, the tipping paper,
including width, and basis weight, may affect smoke constituent yields;
and
ventilation may affect smoke constituent yields (Ref. 69).
Table 9 to Sec. 1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for unfiltered, sheet-wrapped cigars. In this final rule, we
have revised table 9 to Sec. 1114.7(i)(2)(ii)(B) to help ensure that
FDA is able to identify and evaluate each product more accurately and
efficiently. These changes include: (1) The addition of overall
diameter because cigar diameter can directly affect the amount of
tobacco that is burned and, in turn, affect smoke constituent yields;
(2) the removal of cigar tip width (mm); (3) the option for applicants
to provide oven volatiles in lieu of tobacco moisture, as this provides
similar information to FDA \25\ and allows the applicant flexibility to
provide either parameter based on the specific manufacturing processes
they employ. In addition, as compared to the proposed PMTA rule, FDA
has removed certain parameters for test data, including the removal of
cigar length, cigar tip length, cigar tip diameter, and cigar tip
width, as FDA has determined that these parameters are not necessary as
test data. Additionally, based on FDA's understanding of cigars and
their similarity to cigarettes, we have also included all the design
requirements previously recommended in the proposed PMTA rule except
cigar burn rate and cigar draw resistance. We have also included the
following test data: Puff count, tobacco rod density, tobacco cut size,
cigar wrapper and binder basis weight, binder porosity, and cigar tip
mass.
---------------------------------------------------------------------------
\25\ See footnote 21.
---------------------------------------------------------------------------
The finalized parameters listed in table 9 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes may
affect the cigar's impact on public health, as described below:
Cigar mass reflects the amount of tobacco in a cigar,
which may affect smoke constituent yields (Ref. 69);
cigar puff count can directly affect smoke constituent
yields (Ref. 69);
cigar length and diameter can directly affect the amount
of tobacco that is burned and, in turn, affect smoke constituent yields
(Ref. 70);
tobacco filler mass may affect smoke constituent yields
(Ref. 69);
for cigarettes, the cigarette paper basis weight may
affect puff count and smoke constituents (Ref. 71). Similarly, for
cigars, the cigar wrapper and binder basis weight may affect puff count
and smoke constituent yields;
for cigarettes, the paper length and width may affect puff
count and smoke constituents (Ref. 71). Similarly, for cigars, the
cigar wrapper length and width and binder width may directly influence
the area through which air is permitted to enter the tobacco column,
which, in turn, may affect puff count and smoke constituent yields;
cigar wrapper porosity may affect smoke constituent yields
(Refs. 72 and 73).
for cigarettes, tobacco rod density may modify burn
properties and smoke constituent yields (Refs. 51 and 52). Similarly,
for cigars, the tobacco rod density may modify burn properties and
smoke constituent yields;
for cigarettes, the tobacco moisture or oven volatiles may
affect puff count (Ref. 54). Similarly, for cigars, the tobacco
moisture may affect puff count;
for cigarettes, the tobacco cut size may result in more
particulate matter (Ref. 53). Similarly, for cigars, the tobacco cut
size alters the size of the tobacco pieces, which may result in more
particulate matter;
for cigarettes, the band porosity may affect smoke
constituent yields (Ref. 56). Similarly, for cigars, the wrapper and
binder band porosity or permeability may affect smoke constituent
yields because band porosity allows for the overall assessment of the
weighted change in air flow through the cigarette paper during active
puffing;
for cigarettes, the band width may affect smoke yields
(Ref. 58). Similarly, for cigars, the wrapper and binder band width may
affect ventilation and, in turn, smoke constituent yields;
for cigarettes, the band space may affect puff count (Ref.
59). Similarly, for cigars, the wrapper and binder band space may
affect ignition propensity and, in turn, puff count; and
cigar tip dimensions directly influence the overall cigar
draw resistance and in turn, puff count (Ref. 74).
Table 10 to Sec. 1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for leaf-wrapped cigars. In this final rule, we have revised
table 10 to Sec. 1114.7(i)(2)(ii)(B) to help ensure that FDA is able
to identify and evaluate each product more accurately and efficiently.
These changes include the option to provide oven volatiles instead of
moisture, as this provides similar information to FDA \26\ and allows
the applicant flexibility to provide either parameter based on the
specific manufacturing processes they employ. FDA has also revised
certain parameters for test data previously discussed in the proposed
PMTA rule. Specifically, FDA has removed cigar length as this is a
measured design parameter for which we do not need test data.
Additionally, based on FDA's understanding of leaf-wrapped cigars and
their similarity to cigarettes, we have included the design
requirements that were previously recommended in the proposed PMTA rule
except cigar draw resistance, wrapper and binder porosity, and cigar
burn rate. We have
[[Page 55342]]
also included the following parameters for test data that were
previously recommended in the proposed PMTA rule: Puff count, tobacco
rod density, tobacco filler mass, tobacco cut size, and wrapper and
binder basis weight.
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\26\ See footnote 21.
---------------------------------------------------------------------------
FDA has also included: (1) The overall diameter as a design
parameter because cigar diameter can directly affect the amount of
tobacco that is burned and, in turn, affect smoke constituent yields
and (2) tobacco cut size as a design parameter as it can alter the size
of tobacco pieces, which may result in more particulate matter.
The finalized parameters listed in table 10 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes may
affect the cigar's impact on public health, as described below:
Cigar mass reflects the amount of tobacco in a cigar,
which may affect smoke constituent yields (Ref. 69);
cigar puff count can directly affect smoke constituent
yields (Ref. 69);
for cigarettes, the paper length and width may affect puff
count and smoke constituents (Ref. 71). Similarly, for cigars, the
cigar wrapper length and width and binder width may directly influence
the area through which air is permitted to enter the tobacco column,
which, in turn, may affect puff count and smoke constituent yields;
cigar length and diameter can directly affect the amount
of tobacco that is burned and, in turn, affect smoke constituent yields
(Ref. 70);
for cigarettes, the tobacco moisture or oven volatiles may
affect puff count (Ref. 54). Similarly, for cigars, the tobacco
moisture may affect puff count;
for cigarettes, the cigarette paper basis weight may
affect puff count and smoke constituents (Ref. 71). Similarly, for
cigars, the cigar wrapper and binder basis weight may affect puff count
and smoke constituent yields;
for cigarettes, tobacco rod density may modify burn
properties and smoke constituent yields (Refs. 51 and 52). Similarly,
for cigars the tobacco rod density may modify burn properties and smoke
constituent yields; and
for cigarettes, the tobacco cut size may result in more
particulate matter (Ref. 53). Similarly, for cigars, the tobacco cut
size alters the size of the tobacco pieces, which may result in more
particulate matter.
Table 11 to Sec. 1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for cigar tobacco. In this final rule, we have revised table
11 to Sec. 1114.7(i)(2)(ii)(B) to help ensure that FDA is able to
identify and evaluate each product more accurately and efficiently.
These changes include the option to provide oven volatiles instead of
moisture, as this provides similar information to FDA \27\ and allows
the applicant flexibility to provide either parameter based on the
specific manufacturing processes they employ. FDA has also revised
certain proposed parameters for test data, which includes the option to
provide oven volatiles instead of moisture, as described above. In the
proposed rule, we proposed a recommended design parameter for cigar
tobacco, filler mass. Based on FDA's understanding of cigar tobacco, we
have decided not to include filler mass (mg) as a required design
parameter. FDA has concluded that the amount of tobacco added to a
cigar is generally user-dependent and so, the filler mass of the cigar
tobacco as packaged does not have a direct effect on the smoke
constituents.
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\27\ See footnote 21.
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The finalized parameters listed in table 11 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes may
affect its impact on public health, as described below:
For cigarettes, the tobacco cut size may result in more
particulate matter (Ref. 53). Similarly, for cigars, the tobacco cut
size alters the size of the tobacco pieces, which may result in more
particulate matter and
for cigarettes, the tobacco moisture or oven volatiles may
affect puff count (Ref. 54). Similarly, for cigars, the tobacco
moisture may affect puff count.
Table 12 to Sec. 1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for a cigar wrapper. In this final rule, we have revised table
12 to Sec. 1114.7(i)(2)(ii)(B) to help ensure that FDA is able to
identify and evaluate each product more accurately and efficiently.
These changes include, for both target specification and test data, the
replacement of cigar maximum and minimum width with wrapper width, as
not all cigar wrappers have a maximum and minimum width; additionally,
in the proposed rule, we discussed recommended design parameters for
cigar wrappers. Based on FDA's understanding of cigar wrappers, and
because cigar wrapper basis weight affects smoke constituents as well
as puff count, we have included cigar wrapper basis weight in the final
rule. For test data that was previously recommended in the proposed
rule, FDA has included cigar wrapper basis weight as a requirement and
replaced cigar minimum and maximum wrapper width with wrapper width for
the reasons discussed previously.
The finalized parameters listed in table 12 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes may
affect its impact on public health, as described below:
For cigarettes, the paper length and width may affect puff
count and smoke constituents (Ref. 71). Similarly, for cigars, the
cigar wrapper length and width may directly influence the area through
which air is permitted to enter the tobacco column, which, in turn, may
affect puff count and smoke constituent yields and
for cigarettes, the cigarette paper basis weight may
affect puff count and smoke constituents (Refs. 71 and 72). Similarly,
for cigars, the cigar wrapper and binder basis weight may affect puff
count and smoke constituent yields.
Table 13 to Sec. 1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for a waterpipe. Cigarette tobacco and waterpipe tobacco are
similar, as they are both processed tobacco that is cut, milled, and
sifted before ingredients are added to control for tobacco moisture and
taste. Therefore, tobacco parameters for a cigarette can be
extrapolated to tobacco parameters for a waterpipe. Additionally, the
waterpipe length of the waterpipe stem causes affects the pressure drop
in the waterpipe in a similar way as to the length of the cigarette
filter and filter tow causes a filter pressure drop in a cigarette:
Both determines the amount of suction a smoker needs to apply to the
tobacco product to draw smoke through. Therefore, filter pressure drop
for a cigarette can be extrapolated to the pressure drop of a
waterpipe. The parameters included in table 13 apply to waterpipes
generally. For products that contain a heating source or waterpipe
tobacco, applications should specify information regarding the heating
source and waterpipe tobacco as described in tables 14 and 15.
In this final rule, we have revised table 13 to Sec.
1114.7(i)(2)(ii)(B) to help ensure that FDA is able to identify and
evaluate each product more accurately and efficiently. These changes
include: (1) The removal of number of hoses as the number of hoses can
vary during smoking session and (2) the change in terminology from
``bowl'' to ``base.'' Additionally, in the proposed rule, we
recommended design parameters for waterpipes. Based on FDA's
understanding of waterpipes, we have
[[Page 55343]]
required the following design parameters: (1) Hose length, hose
material, and hose internal diameter, which are directly proportional
to air infiltration and affects toxicant yields; (2) stem length and
stem internal diameter, which impacts puffing behavior and toxicant
exposure; (3) pressure drop, which affects smoke constituent yields;
(4) water filter efficiency, which is directly proportional to
mainstream smoke and can increase exposure to HPHCs; and (5) hose air
permeability and heating source type, as theses parameters have a
direct correlation with toxicants and smoke constituents exposed to
users and nonusers. For test data that was previously recommended in
the proposed rule, FDA is requiring all the parameters except foil
length, foil width, and ventilation.
Further, based on FDA's understanding of waterpipes, we have also
included the following required design parameters: Base diameter, base
volume, base shape, head height, head top diameter, head bottom
diameter, number of holes, head volume, and head material. The shape
and size of the base can affect the pressure drop or difficulty of
pulling air through the waterpipe hose, while the head dimensions
affect how long a smoke session lasts by controlling how much tobacco
can be used during a session. Head dimensions can also affect airflow
beneath and through the tobacco to make heat transfer more effective,
prolonging smoking sessions. FDA has also included the following
required parameter for test data: Head height, head top diameter, head
bottom diameter, and head volume.
The finalized parameters listed in table 13 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes may
affect its impact on public health, as described below:
Hose dimensions (length and diameter) are directly
proportional to air infiltration and affects toxicant yields (Ref. 75);
hose material may affect hose permeability, which may
affect smoke constituent yields (Ref. 75);
stem length influences draw resistance, which can in turn
impact nicotine and other toxicant delivery to the user (Ref. 76);
stem internal diameter can impact puffing behavior and
toxicant exposure, and in turn, smoke constituent yields (Ref. 76);
for cigarettes, the pressure drop effect smoke constituent
yields (Ref. 71). For waterpipes the base diameter and base volume
impact how much water the base can hold and how much water the user can
add to the base and the volume of water impacts the pressure drop or
the difficulty of pulling air through the waterpipe hose. Similarly,
for waterpipes, the pressure drop may result in differences in the
difficulty of pulling air through the waterpipe and, in turn, affect
smoke constituent yields (Ref. 71);
head dimensions affect how long a smoke session lasts by
controlling how much tobacco can be used during a session. Head
dimensions can also affect airflow beneath and through the tobacco to
make heat transfer more effective, prolonging smoking sessions. With a
wider surface area, there is more room for the head to more evenly
distribute heat to the tobacco. A shallower bowl makes tobacco at the
bottom of the head more accessible to heat and allows for heat to be
more evenly distributed to the tobacco. The more holes in the head, the
more airflow, which affects the tobacco temperature. All of this causes
the tobacco to reach different temperatures that affects smoke yields
(Ref. 75);
water filtering efficiency is directly proportional to
mainstream smoke and can increase exposure to HPHCs (Ref. 77);
for cigarettes, the filter pressure drop affects smoke
yields (Ref. 71). Similarly, for waterpipes, the pressure drop may
result in differences in the difficulty of pulling air through the
waterpipe and, in turn, affect smoke constituent yields;
heating source type affects tobacco temperature, which in
turn, may affect smoke constituent yields (Ref. 78); and
head material could aid in heat transfer, prolonging the
heating of the tobacco and causing the tobacco to reach temperatures
that affect smoke yields.
Table 14 in Sec. 1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for waterpipe tobacco. In this final rule, we have revised
table 14 to Sec. 1114.7(i)(2)(ii)(B) to help ensure that FDA is able
to identify and evaluate each product more accurately and efficiently.
These changes include the option for the applicant to provide oven
volatiles as an alternative to tobacco filler moisture. We have
provided this alternative because it will allow the applicant to
provide information needed to evaluate the product without conducting
additional testing as this alternative may satisfy these requirements.
Additionally, in the proposed rule, we recommended a design parameter
for waterpipe tobacco, filler mass. Based on FDA's understanding of
waterpipe tobacco, we have decided not to include filler mass as a
required design parameter for waterpipe tobacco. FDA concluded that the
amount of tobacco added during a given smoking session is user-
dependent and so, filler mass of the waterpipe tobacco as packaged does
not have a direct impact on smoke constituents.
The finalized parameters listed in table 14 to Sec.
1114.7(i)(2)(ii)(B) are necessary to fully characterize the product and
changes may affect its impact on public health as follows:
For cigarettes, the tobacco cut size may result in more
particulate matter (Refs. 53 and 54). Similarly, for waterpipe tobacco,
the tobacco cut size alters the size of the tobacco pieces, which may
result in more particulate matter. Finer tobacco cut size may result in
a decrease in filling power and in turn, a larger amount of tobacco in
the bowl (Refs. 53 and 54) and
for cigarettes, the tobacco moisture or oven volatiles may
affect puff count (Ref. 54). Similarly, for waterpipe tobacco, the
tobacco moisture may affect puff count. Moisture contributes to packing
density, thus decreasing void volume (Ref. 54).
Table 15 to Sec. 1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for a waterpipe heating source. In this final rule, we have
revised table 15 to Sec. 1114.7(i)(2)(ii)(B) to help ensure that FDA
is able to identify and evaluate each product more accurately and
efficiently. These changes include: (1) The removal of heating source
type. As there are multiple types of heating source for waterpipe,
instead of asking for the source type, FDA has changed the terminology
and considered all heating sources as the heating element and (2) the
removal of charcoal temperature and coil temperature range, as
described above, FDA considers all heating sources the heating element;
therefore, the charcoal and coil temperature have been removed and
replaced with ``heating element temperature.'' FDA has also revised the
test data and removed test data for charcoal temperature range and coil
temperature range, for reasons previously described.
Additionally, in the proposed rule, we recommended design
parameters for waterpipe heating source. Based on FDA's understanding
of waterpipe heating sources, we have included some of these design
parameters, including those related to batteries and power delivery
units (PDU). The finalized parameters listed in table 15 to
[[Page 55344]]
Sec. 1114.7(i)(2)(ii)(B) are necessary to fully characterize the
product and changes may affect its impact on public health as follows:
When combusted, heating sources such as charcoal or wood
cinders expose the user to high yields of toxicants such as carbon
monoxide and polycyclic aromatic hydrocarbons. Therefore, the heating
source mass, density, and temperature may affect smoke constituent
yields (Ref. 78);
for ENDS, the number of elements affects resistance and
distribution of heat dissipation (Ref. 79). Similarly, for waterpipe
heating source, the number of heating elements can affect resistance
and distribution of heat dissipation;
for ENDS, the heating element configuration effect affect
toxicant emissions and nicotine delivery (Refs. 80-84). Similarly, for
waterpipe heating source, the eating element configuration may affect
overall heating element resistance, thereby influencing heating element
temperature. The heating element temperature may affect toxicant
emissions and nicotine delivery;
for ENDS, the heating element diameter may affect toxicant
emissions and nicotine delivery (Refs. 80-84). Similarly, for waterpipe
heating source, the diameter of the heating element affects its
resistance. Heating element resistance may influence heating element
temperature, which in turn affects toxicant emissions and nicotine
delivery;
for ENDS, an increase in battery capacity (mAh rating) can
increase the number of puffs the e-cigarette can deliver per vaping
session. Longer vaping sessions may lead to greater exposure to
toxicant emissions (Ref. 83). Similarly, for waterpipe heating source
the battery mAh ratings is a measure of the average amount of current
the battery releases over time under normal. Current may influence the
heating element temperature, which in turn affects toxicant emissions
and nicotine delivery. In addition, provides understanding how long a
battery will last and thus the product stability;
for ENDS, the battery and PDU voltage impacts the amount
of e-liquid consumed, the vapor temperature, and the total emissions of
volatile aldehydes (Ref. 85). Similarly for waterpipe heating sources,
the battery voltage operating range and PDU voltage operating range
(volts) impact the amount of e-liquid consumed, the vapor temperature,
and the total emissions of volatile aldehydes;
for ENDS, the battery type, battery current operating
range, battery failure safety features, battery conformance to
standards, and PDU current operating range are necessary for evaluating
battery and PDU safety. Risks of e-cigarette battery explosion,
leakage, fire, or overheating are a safety concern (Refs. 58 and 86).
Similarly, for waterpipe heating source, the battery current operating
range is a measure of the current batteries put out to heat the heating
element of the product. The battery should have a normal operating
range as to not overheat the product and cause it to become a hazard to
the user. In addition, this current range has a direct impact on the
heating element, which in turn affects the smoke constituent yields;
for ENDS, the battery and PDU voltage impacts the amount
of e-liquid consumed, the vapor temperature, and the total emissions of
volatile aldehydes (Ref. 85). Similarly for waterpipe heating source
the PDU voltage operating range impacts the amount of e-liquid
consumed, the vapor temperature, and the total emissions of volatile
aldehydes;
for ENDS, the battery type, battery current operating
range, battery failure safety features, battery conformance to
standards, and PDU current operating range are necessary for evaluating
battery and PDU safety. Risks of e-cigarette battery explosion,
leakage, fire, or overheating are a safety concern (Refs. 58 and 86).
Similarly for waterpipe heating source, the PDU current operating range
is a measure of the current output to heat the heating element of the
product, which, if not adequately controlled can lead to overheating
the product subsequently may harm the user. In addition, this current
range has a direct impact on the heating element, which in turn affects
the smoke constituent yields; and
for ENDS, PDU current operating range and wattage range
are necessary for evaluating battery and PDU safety. Risks of e-
cigarette battery explosion, leakage, fire, or overheating are a safety
concern (Refs. 80 and 86). Similarly, for waterpipe heating source the
PDU wattage operating range determines the amount of heat produced. PDU
wattage or wattage operating range may affect the heating element
temperature, thereby affecting toxicant emissions.
Table 16 to Sec. 1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for waterpipe foil. In this final rule, we have revised table
16 to Sec. 1114.7(i)(2)(ii)(B) to help ensure that FDA is able to
identify and evaluate each product more accurately and efficiently.
Specifically, in the proposed rule, we recommended design parameters
for waterpipe foil. Based on FDA's understanding of waterpipe foil, we
have included the following design parameter requirements: Foil
diameter, foil thickness, number of holes, and diameter of holes. We
have added these parameters because foil parameters affect smoke
constituent yields, and ultimately, the user's exposure to toxicants
and HPHCs. FDA has also revised the required test data to include the
following parameters for the reasons detailed previously: Foil
diameter, foil thickness, and diameter of the holes. Waterpipe foil
length and width were erroneously listed both as required parameters
(in table 16) and as recommended parameters in table 16a. FDA notes
that waterpipe foil length and width are included in the final rule
required parameters.
The finalized parameters listed in table 16 to Sec.
1114.7(i)(2)(ii)(B) are necessary to fully characterize the product and
changes may affect its impact on public health as follows.
Waterpipe foil length, diameter, and width are necessary
because they impact the user's puffing behavior and toxicant exposure.
Therefore, the foil dimensions may affect smoke constituent yields
(Ref. 76);
waterpipe foil thickness influences the distribution of
heat to the tobacco, affecting tobacco temperatures and therefore smoke
constituent yields (Ref. 76); and
the number and diameter of holes impacts the path of hot
gases through the tobacco mixture, which may affect smoke constituent
yields (Ref. 76).
Table 17 to Sec. 1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for a waterpipe head. These parameters are a necessary part of
the application because they are needed to fully characterize the
product and changes may affect the waterpipe head's impact on public
health, as described below:
Head dimensions (height, top diameter, bottom diameter),
including number of holes, and head volume, affect how long a smoke
session lasts, as well as how much tobacco is used. Head dimensions can
also affect airflow beneath and through the tobacco in the head,
affecting heat transfer to the tobacco. The temperatures reached during
smoking affect smoke yields, and user exposure to these smoke yields
and
the head material could aid in heat transfer, prolonging
the heating of the tobacco and causing the tobacco to reach
temperatures that affect smoke yields.
Table 18 to Sec. 1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for a pipe. The design
[[Page 55345]]
parameters described in table 18 to Sec. 1114.7(i)(2)(ii)(B) are a
necessary part of the application because they are needed to fully
characterize the product and changes that may affect the pipe's impact
on public health. In this final rule, we have revised the design
parameters related to pipes to help ensure that FDA is able to identify
and evaluate each product more accurately and efficiently. These
changes include the removal of: Bore minimum diameter, bore maximum
diameter, bit length, and bit diameter. We have removed these
parameters because they were found to be equal to the stem and shank
diameter should be equal to the bore diameter, and in addition, the
length of the bit can vary and have little effect on the user's
exposure to toxicants. FDA has also revised the parameters for test
data to include the removal of: Bore minimum diameter, bore maximum
diameter, bit length, and bit diameter for the reasons described
previously. Additionally, in the proposed rule, we recommended design
parameters for pipes. Based on FDA's understanding of pipes, we have
added design parameters related to the bowl chamber (bowl chamber cover
outer diameter, bowl chamber cover inner diameter, bowl chamber hole
shape, and bowl chamber volume), shank (length and diameter), draught
hole (draught hole diameter, draught hole shape, draught hole location,
and draught hole dimension), screen, airway and pressure drop, and
filter (filter efficiency, pressure drop, and length). These parameters
are a necessary part of the application because they are needed to
fully characterize the product and changes may affect the pipe's impact
on public health, as described below:
Pipe screens are used in pipes to filter and stop hot
embers and tobacco from traveling up the pipe to the user;
the bowl chamber inner and outer diameters allow FDA to
calculate the chamber wall thickness. A thicker wall will lead to a
cooler smoke and makes it less likely the user will burn themselves
when holding the chamber. Additionally, the chamber inner diameter will
affect temperature and tobacco capacity, meaning the greater the pipe
surface area, the more leaf can be burned at once, and with increased
temperature, this will affect smoke constituents;
the bowl chamber hole shape is important to characterize
the pipe as this may affect the airflow and tobacco temperatures, which
in turn affects the burn rate and smoke constituents delivered;
the bowl chamber volume affects the burn rate and
temperature, which in turn, dictates the smoke constituents delivered
to users.
the draught hole allows the user to pull air through the
tobacco to their mouth. The diameter of the draught holes affects the
resistance to draw, which can impact nicotine and other toxicant
delivery to the user;
the draught hole dimensions and geometry may affect the
airflow and oxygen available at the burning tobacco for the chemical
reaction and thus affect smoke constituent yields;
the draught hole location should enter the bowl directly
centered and at the very bottom of the bowl. The location can affect
airflow and tobacco temperatures, which in turn, affects the burn rate
and smoke constituents delivered;
the stem of a pipe delivers smoke from the bowl to the
user's mouth. The length of the stem may affect the smoke temperature,
which may affect how the product is consumed, while the diameter of the
stem may affect resistance to draw which can impact nicotine and other
toxicant delivery to the user;
the shank of a pipe may affect the smoke temperature
(length) and resistance to draw (diameter);
for cigarettes, the filter pressure drop affects smoke
yields (Ref. 62). Similarly, for pipes, the pressure drop through the
air valve can affect nicotine and other toxicant delivery to the user.
Air flow through an air valve can affect tobacco burn rate and tobacco
temperatures which in turn, may affect smoke constituent delivery to
the user. Some pipes may come with a filter; and
for cigarettes, filter diameter, DPF, total denier, filter
density, and filter length may affect filter efficiency and, in turn,
smoke constituent yields (Ref. 60). Similarly, for pipes, the filter
efficiency, filter pressure drop, and filter length may affect smoke
constituent yields.
Table 19 to Sec. 1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for pipe tobacco. In this final rule, we have revised table 19
(formerly table 18 in the proposed PMTA rule) to Sec.
1114.7(i)(2)(ii)(B) to help ensure that FDA is able to identify and
evaluate each product more accurately and efficiently. These changes
include allowing applicants to provide oven volatiles (%) as an
alternative for tobacco moisture. We have provided these alternatives
because it will allow the applicant to provide information needed to
evaluate the product without conducting additional testing as these
alternatives may satisfy the requirements. Additionally, in the
proposed rule, we recommended design parameters for pipe tobacco. Based
on FDA's understanding of pipe tobacco, we have decided not to include
filler mass (mg) as a design parameter.
The finalized parameters listed in table 19 to Sec.
1114.7(i)(2)(ii)(B) are required as part of the application because
they are necessary to fully characterize the product and changes may
affect its impact on public health:
for cigarettes, the tobacco cut size may result in more
particulate matter (Ref. 53). Similarly, for pipes, the tobacco cut
size alters the size of the tobacco pieces, which may result in more
particulate matter and
for cigarettes, the tobacco moisture or oven volatiles may
affect puff count (Ref. 54). Similarly, for pipes, the tobacco moisture
or oven volatiles may affect puff count.
While demonstrating compliance with voluntary standards can provide
information that is important to FDA's review, this alone would neither
fulfill the reporting requirements for battery design parameters under
Sec. 1114.7(i)(2)(ii) nor render further of the battery review
superfluous. As described elsewhere in this section, FDA needs a full
characterization of the tobacco product--including the battery, where
applicable--to complete its review. FDA provides information regarding
the health impacts for each design parameter for products categorized
as ENDS, as discussed elsewhere in this section.
Table 20 to Sec. 1114.7(i)(2)(ii)(B) describes the design
parameters and information on performance criteria that must be
provided for an ENDS. In this final rule, we have revised table 20
(formerly table 19 in the proposed PMTA rule) to Sec.
1114.7(i)(2)(ii)(B) to help ensure that FDA is able to identify and
evaluate each product more accurately and efficiently. These changes
include (1) the removal of overall atomizer resistance (ohms), wick
ignition temperature, coil temperature cut-off, and coil temperature
range. We have removed these parameters because, current cut-off and
heating element temperature range are now required; as such, the
inclusion of these parameters would be considered redundant. We have
removed wicking ignition because not all wicking materials have an
ignition temperature, nor do all ENDS products have an overall atomizer
resistance; (2) change in language instead of ``coil'' the phrase
``heating element'' is used to include all heating elements that may
not be considered a coil; and (3) the inclusion of ventilation.
Additionally, in the proposed rule, we recommended design parameters
for
[[Page 55346]]
ENDS. Based on FDA's evolving understanding of ENDS products, we have
included the following previously recommended design parameters, as
required: Draw resistance puff count, atomizer tank/cartridge volume,
number of heating elements, heating elements length and diameter,
heating element configuration, battery voltage operating range, battery
current operating range, battery nominal voltage, battery current
rating, battery charging temperature limits, battery discharge
temperature limits, battery end of discharge voltage, battery maximum
charging current, battery maximum discharging current, battery upper
limits charging voltage, PDU voltage operating range, and PDU current
operating range. FDA has also revised the test data to include these
parameters, as these parameters affect the heating element temperature
which in turn effects the smoke constituents exposed to the users and
nonusers.
The finalized parameters listed in table 20 to Sec.
1114.7(i)(2)(ii)(B) are a necessary part of the application because
they are needed to fully characterize the product and changes may
affect its impact on public health, as described below.
The air flow rate of the ENDS can affect the coil/heating
element temperature, e-liquid consumption, and aerosol characteristics
such as particle number concentration, count median diameter, and
PM2.5, which impact aerosol exposure (Ref. 87);
coil/heating element resistance may affect overall heating
element resistance, thereby influencing heating element temperature.
The coil/heating element's resistance, material and the voltage \28\
determine the current flow and heating element temperature. The heating
element temperature and temperature duration may affect toxicant
emissions and nicotine delivery (Refs. 80-84);
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\28\ Voltage, current, and resistance are used to ensure the
battery and the ENDS are operating within the ``normal operating
range.'' The battery manufacturer sets the normal range of the
voltage and current. Understanding the resistance allows FDA to
assess whether the coil is drawing more current than the battery is
designed for.
---------------------------------------------------------------------------
coil/heating element resistance and battery output voltage
determine PDU wattage. PDU wattage determines the amount of heat
produced by the atomizer. PDU wattage or wattage operating range may
affect the heating element temperature, thereby affecting toxicant
emissions and nicotine delivery (Refs. 82 and 84);
an increase in battery capacity (mAh rating) can increase
the number of puffs the e-cigarette can deliver per vaping session.
Longer vaping sessions may lead to greater exposure to toxicant
emissions (Ref. 83);
the temperature of the coil/heating element can affect the
chemical and physical characteristics of the aerosol delivered to the
user. An increase in coil/heating element temperature can increase HPHC
levels in the aerosol, therefore, maximum coil/heating element
temperature and temperature control deviation from this maximum coil/
heating element temperature can affect toxicant emissions and nicotine
delivery (Refs. 80-84);