Rule2021-21011
Premarket Tobacco Product Applications and Recordkeeping Requirements
Primary source
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Published
October 5, 2021
Effective
November 4, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 190 (Tuesday, October 5, 2021)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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, <a href="/cdn-cgi/l/email-protection#52132139110602123436337c3a3a217c353d24"><span class="__cf_email__" data-cfemail="a2e3d1c9e1f6f2e2c4c6c38ccacad18cc5cdd4">[email protected]</span></a>.
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 <a href="https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance">https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance</a>.
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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
------------------------------------------------------------------------
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:
<bullet> Submission of a PMTA under section 910(b);
<bullet> 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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<bullet> 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:
<bullet> That the continued marketing of such tobacco product no
longer is appropriate for the protection of the public health;
<bullet> that the application contained or was accompanied by an
untrue statement of a material fact;
<bullet> 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;
<bullet> 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;
<bullet> 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
<bullet> 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
<a href="https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance">https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance</a>.
---------------------------------------------------------------------------
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:
<bullet> A copy of the abbreviated report and, if applicable, the
exemption request and all amendments thereto;
<bullet> 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;
<bullet> 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.;
<bullet> 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.;
<bullet> documents related to product packing and storage
conditions;
<bullet> analytical test method records, including:
[cir] Performance criteria;
[cir] validation or verification documentation; and
[cir] reports/results from these test methods; and
<bullet> 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.).
---------------------------------------------------------------------------
<bullet> Is wrapped in whole tobacco leaf;
<bullet> contains a 100 percent leaf tobacco binder;
<bullet> 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);
<bullet> 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.
---------------------------------------------------------------------------
<bullet> has no filter, nontobacco tip, or nontobacco mouthpiece;
<bullet> does not have a characterizing flavor other than tobacco;
<bullet> contains only tobacco, water, and vegetable gum with no
other ingredients or additives; and
<bullet> 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:
<bullet> Is not intended or reasonably expected to affect or alter
the performance, composition, constituents, or characteristics of a
tobacco product or
<bullet> 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
<a href="https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance">https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance</a>.
---------------------------------------------------------------------------
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
<a href="https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/harmful-and-potentially-harmful-constituents-tobacco-products-and-tobacco-smoke-established-list">https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/harmful-and-potentially-harmful-constituents-tobacco-products-and-tobacco-smoke-established-list</a> (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:
<bullet> The reaction of sugars with amines to form families of
compounds with new carbon-nitrogen bonds, including Maillard reaction
products and Amadori compounds;
<bullet> the reaction of sodium hydroxide with citric acid to form
sodium citrate;
<bullet> the production of ethyl alcohol, a residual solvent, from
ethyl acetate during production of tipping paper adhesive;
<bullet> products of thermolytic reactions, such as the production
of carboxylic acids from sugar esters;
<bullet> products of enzymatically or nonenzymatically catalyzed
reactions, such as the hydrolytic production of flavor or aroma
precursors from nonvolatile glucosides; and
<bullet> 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:
<bullet> General information (as described in Sec. 1114.7(c));
<bullet> descriptive information (as described in Sec. 1114.7(d));
<bullet> product samples (as described in Sec. 1114.7(e));
<bullet> labeling (as described in Sec. 1114.7(f));
<bullet> statement of compliance with part 25 (21 CFR part 25) (as
described in Sec. 1114.7(g));
<bullet> summary (as described in Sec. 1114.7(h));
<bullet> product formulation (as described in Sec. 1114.7(i));
<bullet> manufacturing (as described in Sec. 1114.7(j));
<bullet> health risk investigations (as described in Sec.
1114.7(k));
<bullet> the effect on the population as a whole (as described in
Sec. 1114.7(l)); and
<bullet> 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 <a href="https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance">https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance</a>
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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: <a href="https://www.fda.gov/industry/fda-esubmitter/using-esubmitter-prepare-tobacco-product-submissions">https://www.fda.gov/industry/fda-esubmitter/using-esubmitter-prepare-tobacco-product-submissions</a>. 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, <a href="https://www.archives.gov/records-mgmt/bulletins/2014/2014-04.html">https://www.archives.gov/records-mgmt/bulletins/2014/2014-04.html</a>), 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: <a href="https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance">https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance</a>.
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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.
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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:
<bullet> Applicant name, address, and contact information;
<bullet> 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
<bullet> 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:
<bullet> 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);
<bullet> 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;
<bullet> 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;
<bullet> dates and purpose of any prior meetings with FDA regarding
the new tobacco product;
<bullet> 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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<bullet> 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;
<bullet> 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;
<bullet> 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
<bullet> 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:
<bullet> 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);
<bullet> 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;
<bullet> the product name(s) as designated on the product's label;
<bullet> 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
<bullet> 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 <a href="https://www.fda.gov/tobacco-products/products-guidance-regulations/labeling-and-warning-statements-tobacco-products">https://www.fda.gov/tobacco-products/products-guidance-regulations/labeling-and-warning-statements-tobacco-products</a>.
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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 gener
[…truncated; see source link]Indexed from Federal Register on October 5, 2021.
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