[Federal Register Volume 84, Number 186 (Wednesday, September 25, 2019)]
[Proposed Rules]
[Pages 50566-50658]
[FR Doc No: 2019-20315]

Vol. 84

Wednesday,

No. 186

September 25, 2019

Part II

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Parts 1100, 1107 and 1114

Premarket Tobacco Product Applications and Recordkeeping Requirements;
Proposed Rule

Federal Register / Vol. 84 , No. 186 / Wednesday, September 25, 2019
/ Proposed Rules

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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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a proposed
rule that would set forth requirements for premarket tobacco product
applications (PMTAs) and would require manufacturers to maintain
records establishing that their tobacco products are legally marketed.
The proposed rule would help to ensure that PMTAs contain sufficient
information for FDA to determine whether a marketing order should be
issued for a new tobacco product, including detailed information
regarding the physical aspects of a tobacco product, as well as full
reports of information to demonstrate the scope of, and details
regarding, investigations that may show the potential health risks of
the product. The proposed rule would codify the general procedures FDA
would follow when evaluating PMTAs, including application acceptance,
application filing, and inspections, and would also create postmarket
reporting requirements for applicants that receive marketing orders.
The proposed rule would allow for the submission of PMTAs in
alternative formats in certain instances to reduce the burden of
submitting a PMTA for modifications to a product that previously
received a PMTA marketing order or resubmitting a PMTA to address
deficiencies specified in a no marketing order. The proposed rule would
also require tobacco product manufacturers to keep records regarding
the legal marketing of certain tobacco products without a PMTA, such as
documents showing that a tobacco product is not required to undergo
premarket review or has received premarket authorization.

DATES: Submit either electronic or written comments on the proposed
rule by November 25, 2019.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-2854 for ``Premarket Tobacco Product Applications and
Recordkeeping Requirements.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatory-information/dockets-management.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    Submit comments on information collection issues to the Office of
Management and Budget in the following ways: Fax to the Office of
Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax:
202-395-7285, or email to<EMAIL_ADDRESS>All comments
should be identified with the title, ``Premarket Tobacco Product
Applications and Recordkeeping Requirements.''

FOR FURTHER INFORMATION CONTACT: Paul Hart or Samantha Loh Collado at
the 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,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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. Proposed Regulations for the Maintenance of Records
Demonstrating That a Tobacco Product Was Commercially Marketed in
the United States as of February 15, 2007 (Part 1100, Proposed
Subpart C)
    A. Purpose and Scope (Proposed Sec.  1100.200)
    B. Definitions (Proposed Sec.  1100.202)
    C. Recordkeeping Requirements (Proposed Sec.  1100.204)
IV. Proposed Regulations for the Maintenance of Records Relating to
Exemptions From the Requirements of Demonstrating Substantial
Equivalence (Proposed Sec.  1107.3)
    A. Definition
    B. Record Maintenance
    C. Record Quality
    D. Record Retention
V. Proposed Regulations for Premarket Tobacco Product Applications
(Proposed Part 1114)
VI. General (Proposed Part 1114, Subpart A)
    A. Scope (Proposed Sec.  1114.1)
    B. Definitions (Proposed Sec.  1114.3)
VII. Premarket Tobacco Product Applications (Proposed Part 1114,
Subpart B)
    A. Application Submission (Proposed Sec.  1114.5)
    B. Required Content and Format (Proposed Sec.  1114.7)
    C. Amendments (Proposed Sec.  1114.9)
    D. Withdrawal by Applicant (Proposed Sec.  1114.11)
    E. Change in Ownership of an Application (Proposed Sec.
1114.13)
    F. Supplemental Application Submission (Proposed Sec.  1114.15)
    G. Resubmissions (Proposed Sec.  1114.17)
VIII. FDA Review (Proposed Part 1114, Subpart C)
    A. Communications Between FDA and Applicants (Proposed Sec.
1114.25)
    B. Review Procedure (Proposed Sec.  1114.27)
    C. FDA Action on an Application (Proposed Sec.  1114.29)
    D. Issuance of a Marketing Order (Proposed Sec.  1114.31)
    E. Issuance of a No Marketing Order (Proposed Sec.  1114.33)
    F. Withdrawal of a Marketing Order (Proposed Sec.  1114.35)
    G. Temporary Suspension of a Marketing Order (Proposed Sec.
1114.37)
IX. Postmarket Requirements (Proposed Part 1114, Subpart D)
    A. Postmarket Changes (Proposed Sec.  1114.39)
    B. Reporting Requirements (Proposed Sec.  1114.41)
X. Miscellaneous (Proposed Part 1114, Subpart E)
    A. Record Retention (Proposed Sec.  1114.45)
    B. Confidentiality (Proposed Sec.  1114.47)
    C. Electronic Submission (Proposed Sec.  1114.49)
XI. Paperwork Reduction Act of 1995
XII. Executive Order 13132: Federalism
XIII. Consultation and Coordination With Indian Tribal Governments
XIV. Analysis of Environmental Impact
XV. Preliminary Economic Analysis of Impacts
XVI. Proposed Effective Date
XVII. References

Executive Summary

A. Purpose of the Regulatory Action

    This proposed rule would interpret and set forth requirements
related to the content and format of PMTAs, the procedure by which FDA
would review PMTAs, and the maintenance of records regarding the legal
marketing of certain tobacco products without PMTAs. The proposed
content and format requirements for PMTAs would assist FDA in
completing initial, procedural reviews of applications, which include a
determination of whether an application has sufficient information for
FDA to initiate a substantive review of the PMTA. These content
requirements would require 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
proposing to require 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.
    FDA is basing this proposed rule on the experience the Agency has
gained 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. FDA has received thousands of
premarket applications that range widely in the level of detail they
contain. For example, some have very little of the information that is
necessary for FDA to complete its statutorily required review, while
other applications are more detailed and provide the necessary
sufficient supporting information. This experience has been helpful in
developing the proposed rule, which describes the information FDA is
proposing that an applicant must include in a PMTA for FDA to be able
to complete a substantive review of an application.
    Although FDA has conducted acceptance and filing reviews of
hundreds of PMTAs, it is still gaining experience in applying the
statutory authorization standard to PMTAs because few have contained
sufficient information to reach substantive review. The main focus of
the proposed rule's content requirements is the threshold amount of
information necessary for application filing, rather than every piece
of information necessary to receive a marketing order both because FDA
is still gaining experience in applying the authorization standard to
PMTAs and because at this time, FDA believes applicants have some
flexibility in the types of scientific information they can submit in
order to provide sufficient health risk information to meet the
standard.
    The proposed rule also addresses issues such as the procedures by
which FDA will review a PMTA, the retention of records related to the
PMTA, confidentiality of application information, electronic submission
of the PMTA and amendments, and postmarket reporting requirements. The
proposed rule would also create requirements for the maintenance of
records demonstrating the legal marketing status of grandfathered
tobacco products and products that are exempt from the requirements of
demonstrating substantial equivalence.

B. Legal Authority

    This proposed 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

    The proposed rule would create requirements for tobacco product
manufacturers to maintain records regarding the legal marketing of
grandfathered tobacco products and products that are exempt from the
requirements of demonstrating substantial equivalence. This proposed
rule would also set forth content and format requirements for PMTAs.
Under the proposed rule, a PMTA must contain information necessary for
FDA to determine whether it should issue a marketing 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: There is a
showing that marketing of the new tobacco product would be appropriate
for the protection of the public health; 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)); the product
labeling is not false or misleading in any particular; and 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 proposed rule would also
allow applicants to submit a supplemental PMTA or a resubmission, which
would reduce the burden of submitting and reviewing an application. A
supplemental PMTA could 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
PMTA marketing order. A resubmission could be submitted to address
application deficiencies following the issuance of a no marketing
order. The proposed rule would also require the submission of
postmarket reports by applicants that receive a PMTA marketing order.
    In addition, the proposed rule would explain how an applicant could
amend or withdraw a PMTA and how an applicant may transfer ownership of
a PMTA to a new owner. The proposed rule also addresses FDA
communications with applicants and identifies the actions that FDA may
take after receipt of a PMTA. The proposed rule addresses when FDA may
withdraw a PMTA marketing order and explains how long an applicant
would be required to maintain the records related to the PMTA and
postmarket reports. The proposed rule would also set forth FDA's
disclosure procedures regarding PMTAs and require the electronic
submission of PMTAs, unless the applicant requests and obtains a
waiver.

D. Costs and Benefits

    If finalized, the proposed rule would create cost savings for firms
and for FDA by reducing the number of follow-on submissions for PMTAs
(i.e., additional PMTAs submitted for the same product(s) after FDA
refuses to accept or file, or issues a no marketing order in response
to, an initial PMTA). The proposed rule would also create cost savings
for FDA by reducing the cost of review, reducing the number of
deficiency letters we would issue during substantive scientific review,
and eliminating the need to process unnecessary data. We estimate that
average annualized benefits over 20 years would equal $5.54 million at
a 7 percent discount rate and $5.44 million at a 3 percent discount
rate.
    If finalized, the proposed rule would create costs for firms and
for FDA by increasing the number of complete PMTA submissions for
deemed and originally regulated tobacco products. Moreover, because
this is the first regulation to account for the costs of the PMTA
requirements for originally regulated products, we also include the
costs to submit and review PMTAs for these tobacco products; we already
included the costs to submit and review PMTAs for deemed tobacco
products in the final regulatory impact analysis for the final rule
entitled ``Deeming Tobacco Products To Be Subject to the Food, Drug,
and Cosmetic Act, as Amended by the Family Smoking Prevention and
Tobacco Control Act; Regulations Restricting the Sale and Distribution
of Tobacco Products and Required Warning Statements for Tobacco Product
Packages and Advertisements'' (Deeming Rule), which was published in
the Federal Register of May 10, 2016 (81 FR 28973). Firms would incur
costs to maintain and submit postmarket reports, and we would incur
costs to review postmarket reports. Finally, firms would incur costs to
read and understand the rule and costs to maintain records for some
grandfathered products. We estimate that average annualized costs over
20 years would equal $7.05 million at a 7 percent discount rate and
$6.76 million at a 3 percent discount rate.

Table of Abbreviations/Commonly Used Acronyms

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        Abbreviation/ acronym                    What it means
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FDA.................................  Food and Drug Administration.
CTP.................................  Center for Tobacco Products.
FD&C Act............................  Federal Food, Drug, and Cosmetic
                                       Act.
EA..................................  Environmental assessment.
ENDS................................  Electronic nicotine delivery
                                       systems.
FEI.................................  Facility Establishment Identifier.
APPH................................  Appropriate for the protection of
                                       public health.
CAS.................................  Chemical Abstracts Service.
FOIA................................  Freedom of Information Act.
GLP.................................  Good laboratory practice.
HPHC................................  Harmful and potentially harmful
                                       constituent.
IUPAC...............................  International Union of Pure and
                                       Applied Chemistry.
ICH.................................  International Council for
                                       Harmonization.
IRB.................................  Institutional Review Board.
ISO.................................  International Organization for
                                       Standardization.
MRTPA...............................  Modified risk tobacco product
                                       application.
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.
PDU.................................  Power delivery unit.
PG/VG...............................  Propylene glycol/vegetable
                                       glycerin.
PMTA................................  Premarket tobacco product
                                       application.
PRIA................................  Preliminary regulatory impact
                                       analysis.
RYO.................................  Roll-your-own.
SE..................................  Substantial equivalence.
The Secretary.......................  The Secretary of Health and Human
                                       Services.
STN.................................  Submission tracking number.
TPMF................................  Tobacco product master file.
TSNA................................  Tobacco specific nitrosamine.
TPSAC...............................  Tobacco products scientific
                                       advisory committee.
UNII................................  Unique Ingredients Identifier.
------------------------------------------------------------------------

I. Background

    The Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) 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 before a new tobacco product may
be introduced or delivered for introduction into interstate commerce,
it must undergo premarket review by FDA. 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 \1\ for a
new tobacco product:
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    \1\ As described in the Preliminary Economic Analysis of Impacts
(Ref. 118), we expect that manufacturers will submit PMTAs primarily
for ENDS and will generally submit SE Reports or exemption requests
for cigars and other deemed products. We also expect that a number
of cigars and pipe tobacco products are grandfathered tobacco
products (see section III of this document) not subject to premarket
review. This is consistent with FDA's experience so far in issuing
SE marketing orders for cigars and determining cigars to be
grandfathered tobacco products, and is also consistent with the
regulatory impact analysis for the Deeming Rule (``Deeming Tobacco
Products To Be Subject to the Food, Drug, and Cosmetic Act, as
Amended by the Family Smoking Prevention and Tobacco Control Act;
Regulations Restricting the Sale and Distribution of Tobacco
Products and Required Warning Statements for Tobacco Product
Packages and Advertisements,'' (81 FR 28973) (May 10, 2016)).
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     Submission of a PMTA under section 910(b);

     Submission of an application 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); \2\ and
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    \2\ 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 an applicant submitted an SE Report prior
to March 23, 2011 (``provisional tobacco products''), unless FDA
issues an order that the tobacco product is not substantially
equivalent.
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     Submission of a request for an exemption under section
905(j)(3) (implemented at 21 CFR 1107.1) (exemption request).
    Generally, if a new tobacco product is marketed without either a
PMTA or SE marketing order or a finding of exemption from substantial
equivalence, 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 thousands of premarket applications
for tobacco products, hundreds of which have been PMTAs. Of these
PMTAs, FDA has completed its full substantive review on two sets of
bundled PMTAs, which are single submissions containing PMTAs for a
number of similar or related tobacco products (totaling 12
applications), all of which received marketing orders. To assist
manufacturers in preparing PMTAs, FDA has issued guidance, conducted
webinars, met with manufacturers, hosted a public meeting regarding
premarket submissions, and posted the technical project lead reviews
(which describe the reviews completed on specific PMTAs) and marketing
orders issued to date. If finalized, the proposed rule would interpret
and set forth requirements related to the PMTA premarket pathway and
outline the information needed for FDA to determine whether it will
issue a marketing order under the pathway.
    FDA has also processed hundreds of exemption requests and thousands
of voluntarily-submitted grandfathered status reviews. The proposed
rule would state the records that a company would be required to keep
regarding the legal marketing of its tobacco product.

II. Legal Authority

    As described in the following paragraphs, FDA is proposing
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 proposing
recordkeeping requirements regarding the legal marketing of
grandfathered 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 would be established by this proposed rule be
severable and that the invalidation of any provision of this proposed
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 PMTA marketing 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.\3\ 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)-(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 marketing the 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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    \3\ 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 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 order if FDA finds:
     That the continued marketing of such tobacco product no
longer is appropriate for the protection of the public health;
     that the application contained or was accompanied by an
untrue statement of a material fact;
     that the applicant:
    [cir] Has failed to establish a system for maintaining records, or
has repeatedly or deliberately failed to maintain records or to make
reports, required by an applicable regulation under section 909 of the
FD&C Act;
    [cir] has refused to permit access to, or copying or verification
of, such records as required by section 704 of the FD&C Act; or
    [cir] has not complied with the requirements of section 905 of the
FD&C Act;
     on the basis of new information before the Secretary of
Health and Human Services (the Secretary) with respect to such tobacco
product, evaluated together with the evidence before the Secretary when
the application was reviewed, that the methods used in, or the
facilities and controls used for, the manufacture, processing, packing,
or installation of such tobacco product do not conform with the
requirements of section 906(e) of the FD&C Act and were not brought
into conformity with such requirements within a reasonable time after
receipt of written notice from the Secretary of nonconformity;
     on the basis of new information before the Secretary,
evaluated together with the evidence before the Secretary when the
application was reviewed, that the labeling of such tobacco product,
based on a fair evaluation of all material facts, is false or
misleading in any particular and was not corrected within a reasonable
time after receipt of written notice from the Secretary of such fact;
or
     on the basis of new information before the Secretary,
evaluated together with the evidence before the Secretary when such
order was issued, that such tobacco product is not shown to conform in
all respects to a tobacco product standard which is in effect under
section 907 of the FD&C Act, compliance with which was a condition to
the issuance of an order relating to the application, and that there is
a lack of adequate information to justify the deviation from such
standard, if applicable.

    Under section 902(6) of the FD&C Act, a tobacco product is
adulterated if it is required to have premarket review and does not
have an order in effect under 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. In
addition, section 701(a) of the FD&C Act 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. Proposed Regulations for the Maintenance of Records Demonstrating
That a Tobacco Product Was Commercially Marketed in the United States
as of February 15, 2007 (Part 1100, Proposed Subpart C)

    The proposed rule would add subpart C regarding records to Part
1100 of subchapter K of title 21.

A. Purpose and Scope (Proposed Sec.  1100.200)

    Proposed Sec.  1100.200 states that subpart C of part 1100 would
establish requirements for the maintenance of records by tobacco
product manufacturers who introduce a grandfathered tobacco product, or
deliver it for introduction, into interstate commerce. FDA is proposing
requirements for tobacco product manufacturers to maintain records
regarding the legal marketing of their tobacco products under the
authority of section 909 of the FD&C Act. 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). The records that would be
required under this subpart would demonstrate that a tobacco product is
grandfathered and therefore not required by section 910(a) to have
premarket review and are not adulterated if marketed without an FDA
order. FDA is basing these requirements on its experience gained by
performing thousands of grandfathered status reviews conducted during
its review of substantial equivalence reports and at manufacturers'
voluntary requests. In the absence of these required records,
manufacturers do not always maintain sufficient documentation to
demonstrate whether their tobacco product is grandfathered. The records
that would be required under this rule would allow FDA to more quickly
and efficiently determine whether a tobacco product is grandfathered.

B. Definitions (Proposed Sec.  1100.202)

    Proposed Sec.  1100.202 sets forth the meaning of terms as they
apply to proposed part 1100 and includes the following definitions from
the FD&C Act:
1. Tobacco Product
    As defined in section 201(rr)(1) of the FD&C Act (21 U.S.C.
321(rr)(1)), the term ``tobacco product'' means any product 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 the tobacco used in manufacturing a component,
part, or accessory of a tobacco product). The term ``tobacco product''
does not mean an article that under the FD&C Act is a drug (section
201(g)(1)), a device (section 201(h)), or a combination product
(section 503(g) (21 U.S.C. 353(g))).
2. Tobacco Product Manufacturer
    As defined in section 900(20) of the FD&C Act (21 U.S.C. 387(20)),
the term ``tobacco product manufacturer'' means any person, including a
repacker or relabeler, who: (1) Manufacturers, 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. Manufacturing activities typically
do not include the activities of de-stemming, drying, or packaging
tobacco leaves; mechanically removing foreign material from tobacco
leaves; and humidifying tobacco leaves with nothing other than potable
water in the form of steam or mist. For the purposes of this definition
``finished tobacco product'' would mean a tobacco product, including
all components and parts, sealed in final packaging (e.g., filters or
filter tubes sold separately to consumers or as part of kits).
    In addition, FDA proposes the following definitions:
3. Commercially Marketed
    FDA proposes to define ``commercially marketed'' to mean the
offering of a tobacco product for sale to consumers in all or parts of
the United States. Factors FDA may consider include advertising or
other means used to communicate that the tobacco product is available
for purchase. Tobacco products that are exclusively in a test market
are not commercially marketed.
4. Grandfathered Tobacco Product
    FDA proposes to define a ``grandfathered tobacco product'' to mean
a tobacco product that was commercially marketed in the United States
on February 15, 2007. This term does not include tobacco products
exclusively marketed in a test market as of that date. FDA interprets
the statutory phrase ``as of February 15, 2007,'' as meaning that the
tobacco product was commercially marketed in the United States ``on
February 15, 2007,'' and this interpretation is based on a plain
language reading of the term ``as of.'' The proposed definition
reflects this interpretation, which has been included as part of
previously issued regulations and guidance.\4\ This definition is also
in the proposed rule, ``Content and Format of Substantial Equivalence
Reports; Food and Drug Administration Actions on Substantial
Equivalence Reports'' (SE Proposed Rule), which was published in the
Federal Register of April 2, 2019 (84 FR 12740).\5\ A grandfathered
tobacco product is not subject to the premarket requirements of section
910 of the FD&C Act.
    A tobacco product that the applicant test marketed after February
15, 2007, is not a grandfathered tobacco product because it was not
commercially marketed in the United States as of February 15, 2007 and,
therefore, it is a new tobacco product subject to premarket review
under section 910(a) of the FD&C Act.
---------------------------------------------------------------------------

    \4\ See the final rule ``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 ``Establishing That a Tobacco Product Was
Commercially Marketed in the United States as of February 15, 2007''
(Grandfathered Tobacco Product Guidance) (79 FR 58358, September 29,
2014), available at https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance.
    \5\ FDA intends the PMTA provisions in this proposed rule to be
consistent with the SE Proposed Rule wherever it is appropriate. FDA
intends to harmonize any differences between definitions in these
proposed rules when issuing final rules.
---------------------------------------------------------------------------

    As described in the SE Proposed Rule and in the definition of ``new
tobacco product'' proposed in 21 CFR part 1114 below, FDA is
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:
     Offered in a limited number of regions;
     Offered for a limited time; or
     Offered to a chosen set of the population or specific
demographic group.

C. Recordkeeping Requirements (Proposed Sec.  1100.204)

1. Required Records
    Consistent with the authority to require recordkeeping under
section 909 of the FD&C Act, proposed Sec.  1100.204(a) would require
any tobacco product manufacturer that introduces a grandfathered
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 proposed requirement would
ensure that records are available to FDA during an inspection. The
proposed rule would 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. These records
may include items such as:
    (1) Dated copies of advertisements;
    (2) Dated catalog pages;
    (3) Dated promotional material;
    (4) Dated trade publications;
    (5) Dated bills of lading;
    (6) Dated freight bills;
    (7) Dated waybills;
    (8) Dated invoices;
    (9) Dated purchase orders;
    (10) Dated customer receipts;
    (11) Dated manufacturing documents;
    (12) Dated distributor or retailer inventory lists; or
    (13) Any other dated document that demonstrates that the tobacco
product was commercially marketed (not exclusively in test markets) in
the United States as of February 15, 2007. For additional information
on records related to grandfathered tobacco products, see the
Grandfathered Tobacco Product Guidance.
2. Record Maintenance
    Proposed Sec.  1100.204(b) would require that all records required
to be 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. FDA is also proposing 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.
3. Record Retention
    Proposed Sec.  1100.204(c) would require that the records and
documents demonstrating that the tobacco product was commercially
marketed be retained for a period of 4 years from the date that either
FDA makes a grandfather 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 as a means to help ensure that
the records would be available for at least one biennial FDA inspection
under section 704 and 905(g) of the FD&C Act. FDA's biennial
inspections under section 905(g) 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 would allow FDA to verify the
grandfathered 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 would still need to retain the records
to allow FDA to verify the grandfathered status of the product when
they resume marketing the product. Additionally, manufacturers might
also want to retain records for longer than 4 years to help establish
their product is grandfathered for use as a predicate product in an SE
Report.

IV. Proposed Regulations for the Maintenance of Records Relating to
Exemptions From the Requirements of Demonstrating Substantial
Equivalence (Proposed Sec.  1107.3)

    The proposed rule would add Sec.  1107.3 to part 1107 of subchapter
K of title 21. Proposed Sec.  1107.3 would establish recordkeeping
requirements related to tobacco products that are exempt from the
requirements of demonstrating substantial equivalence 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, proposed Sec.
1107.3 would require applicants that submitted an abbreviated report
under section 905(j)(1)(A)(ii) of the FD&C Act, and received a letter
from FDA 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 proposed rule would require 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

    Proposed Sec.  1107.3(a) would define ``grandfathered tobacco
product'' as a tobacco product that was commercially marketed in the
United States on February 15, 2007. The term would not include a
tobacco product exclusively in test markets as of that date. 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,'' this interpretation is based on a plain language
reading of the term ``as of.'' \6\
---------------------------------------------------------------------------

    \6\ Id.
---------------------------------------------------------------------------

B. Record Maintenance

    The proposed rule would require applicants to maintain all
documents that support their abbreviated report, which includes the
documents listed in proposed Sec.  1107.3(b)(1). The proposed rule
would not require an applicant to create new or additional records;
rather, it would require 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 an applicant would be required to create by other regulatory
or statutory sections such as the submission of exemption requests
under Sec.  1107.1, PMTAs under section 910(b) of the FD&C Act (or
proposed part 1114 when finalized), SE Reports under section 905(j)
FD&C Act, and tobacco product manufacturing requirements issued under
section 906(e) of the FD&C Act. The records an applicant would be
required to maintain include, but are not limited to:
     A copy of the abbreviated report and, if applicable, the
exemption request and all amendments thereto;
     A copy of the acknowledgement letter issued in response to
an abbreviated report and, if applicable, a copy of the exemption order
issued by FDA;
     Documents related to formulation of product, product
specifications, packaging, and related items. Product formulation would
include, for example, items such as the types of information described
in proposed Sec.  1114.7(i) as described in section VII.B.;
     Documents showing that design specifications are
consistently met. This could include, for example, information about
testing procedures that are carried out before the product is released
to market, such as the information described in proposed Sec.
1114.7(j) as described in section VII.B.;
     Product labeling. As defined in section 201(m) of the FD&C
Act, ``labeling'' means all labels and other written, printed, or
graphic matter upon any article or any of its containers or wrappers,
or accompanying such article. This would include, for example,
specimens of all labeling for the new tobacco product, including
labels, inserts, onserts, instructions, and other accompanying
information. The specimens of labeling would include all panels,
reflect the actual size and color proposed to be used for the tobacco
product, and include any warning label statements and other information
required by regulation or statute, as applicable;
     Documents related to product packing and storage
conditions;
     Analytical test method records, including:
    [cir] Performance criteria;
    [cir] Validation or verification documentation; and
    [cir] Reports/results from these test methods; and
     Source data and related summaries.
    In addition to the documents specified in proposed Sec.
1107.3(b)(1), proposed Sec.  1107.3(b)(2) through (b)(4) would 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 would need to maintain records
demonstrating that the modification is being made to either a
grandfathered 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
grandfathered tobacco product, proposed Sec.  1107.3(b)(2) would
require 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 marketing order
from FDA (i.e., an order from FDA authorizing the marketing of the new
tobacco product after review of an SE Report or PMTA), proposed Sec.
1107.3(b)(3) would require applicants to maintain a copy of the
exemption or marketing 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 consistent with section
910(a)(2)(B) of the FD&C Act for which FDA has not issued an SE
marketing order, an applicant would be required to 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

    Proposed Sec.  1107.3(c) would require 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 is also
proposing that documents that have been translated from another
language into English must 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 would help FDA ensure that the
English language translations of documents are complete and accurately
reflect the content of the original documents.

D. Record Retention

    Proposed Sec.  1107.3(d) would require the records described in
Sec.  1107.3 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 would be available for at least one biennial
FDA inspection under section 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.

V. Proposed Regulations for Premarket Tobacco Product Applications
(Proposed Part 1114)

    The proposed rule would add part 1114 to subchapter K of Title 21.
The requirements set forth in this proposed part would apply to PMTAs
for new tobacco products. Proposed subpart A sets out the scope and
definitions that apply to this proposed part. Proposed subpart B sets
out the proposed 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 PMTA. Proposed subpart C describes how FDA
proposes to review and act on applications, including provisions for
withdrawal and temporary suspension of orders. Proposed subpart D
describes proposed postmarket restrictions, reporting requirements, and
inactivation and reactivation of a marketing order. Proposed subpart E
sets out proposed miscellaneous requirements such as record retention,
confidentiality, and electronic submissions.

VI. General (Proposed Part 1114, Subpart A)

A. Scope (Proposed Sec.  1114.1)

    Proposed Sec.  1114.1 describes the scope of proposed part 1114 and
its application to the submission, review, and postmarket requirements
related to PMTAs. Proposed Sec.  1114.1 provides that proposed part
1114 would not apply to MRTPAs, except instances where a single
application is submitted under section 911(l)(4) of the FD&C Act
instead of a separate PMTA and MRTPA

for the product. Under the proposed rule, an applicant that submits a
single application seeking both a PMTA marketing order and a modified
risk order under section 911(g) would need to meet the requirements of
both part 1114 and section 911 of the FD&C Act. This section also notes
that references in the proposed rule to regulatory sections of the Code
of Federal Regulations (CFR) are to chapter I of title 21, unless
otherwise noted. This means that any CFR reference that begins with
``part'' 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).

B. Definitions (Proposed Sec.  1114.3)

    Proposed Sec.  1114.3 sets forth the meaning of terms as they apply
to proposed part 1114. Proposed Sec.  1114.3 includes the following
definitions from the FD&C Act:
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, 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 proposed Sec.  1114.3.
4. Label
    As defined in section 201(k) of the FD&C Act (21 U.S.C. 321(k)),
``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 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.
    Under the FD&C Act, and as reflected in the proposed 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, specifications that change characteristics (e.g., a
modification to a different tobacco cut size) would render a tobacco
product new.
    Manufacturers sometimes co-package tobacco products. 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. Examples include a carton of
cigarette packs and a variety pack of three smokeless tins shrink-
wrapped together where the cigarette packs and smokeless tins,
respectively, could be legally marketed separately. However, if a
manufacturer wishes to co-package two or more tobacco products
(including their respective container closure systems), premarket
review is required for any new tobacco product that the manufacturer
intends to include in the co-package. An example includes shrink-
wrapping grandfathered tobacco filler (in its unmodified container
closure system) with new rolling papers; here premarket authorization
would be required for the rolling papers. In addition, co-packaging two
or more tobacco products within the same container closure system
results in a new tobacco product, unless such co-packaged product is
grandfathered. Examples include an RYO kit where rolling papers are
placed inside the tin of tobacco filler, and shrink-wrapping together
two soft-packs of cigarettes, neither of which had been individually
shrink-wrapped prior to being co-packaged. FDA invites comment on
approaches to its review of these types of PMTAs, including, where
relevant, how co-packaging products impacts consumer use and behavior.
    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'' can
be considered to encompass 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) (finding that a change
in product quantity results in a new tobacco product under the Tobacco
Control Act). Consequently, a change in product quantity (e.g.,
decreasing the weight of a smokeless package from 24 grams to 15 grams)
results in a new tobacco product subject to premarket review since such
a modification ``necessarily entails a change in the amount of the
constituent ingredients and additives within the tobacco product,
including nicotine'' (id. at 56).
    FDA also interprets section 910(a)(1)(A) of the FD&C Act to mean

that a tobacco product marketed exclusively in test markets on February
15, 2007, is a new tobacco product that is subject to premarket review
by FDA. A tobacco product that the applicant test marketed after
February 15, 2007, is also a new tobacco product subject to premarket
review under section 910(a) of the FD&C Act because it was not
commercially marketed in the United States as of February 15, 2007.
    Because the terms ``test marketing'' and ``commercially marketed''
are not interchangeable, FDA is considering whether it would be useful
to applicants for the rule to expand on or further define the terms
``test marketing'' and ``commercially marketed.'' Specifically, as set
forth in the description of proposed part 1100 and described in the SE
Proposed Rule, FDA is 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:
     Offered in a limited number of regions;
     Offered for a limited time; or
     Offered to a chosen set of the population or specific
demographic group.
    As set forth in the description of proposed part 1100, FDA is
considering whether to define ``commercially marketed'' to mean
offering a tobacco product for sale to consumers in all or in parts of
the United States. Factors FDA may consider include advertising or
other means used to communicate that the tobacco product was available
for purchase, including dated advertisements, dated catalog pages,
dated promotional material, dated trade publications, dated bills of
lading, dated freight bills, dated waybills, dated invoices, dated
purchase orders, dated manufacturing documents, inventory lists, or any
other document that demonstrates that the product was commercially
marketed (other than exclusively in test markets) in the United States
as of February 15, 2007. FDA invites comment on what evidence would be
sufficient to demonstrate that a product was commercially marketed
(other than in test markets) as of February 15, 2007.
    FDA is inviting comments on: (1) Whether the rule should further
expand on the interpretation or include definitions of these terms, (2)
the substance of the definitions, if included, and (3) whether or not
the approach described is adequate to protect the public health.
7. Package or Packaging
    As defined in section 900(13) of the FD&C Act, the term
``package,'' also referred to in the proposed 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 proposed rule). For example, the carton holding
multiple soft packs of cigarettes is considered the package, and each
soft 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
characteristics of the 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.
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. Manufacturing activities typically
do not include the activities of de-stemming, drying, or packaging
tobacco leaves; mechanically removing foreign material from tobacco
leaves; and humidifying tobacco leaves with nothing other than potable
water in the form of steam or mist. A proposed definition for the term
``finished tobacco product'' is also included in the proposed rule.
    In addition, FDA proposes the following definitions:
10. Accessory
    FDA proposes to define ``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:
    (1) Is not intended or reasonably expected to affect or alter the
performance, composition, constituents, or characteristics of a tobacco
product or
    (2) is intended or reasonably expected to affect or maintain the
performance, composition, constituents, or characteristics of a tobacco
product, but:
    (i) Solely controls moisture and/or temperature of a stored product
or
    (ii) 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
and contained in the SE Proposed Rule. 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 proposes to define ``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.

12. Applicant
    FDA proposes to define ``applicant'' as any person that submits a
premarket tobacco product application to receive a marketing order for
a new tobacco product.
13. Component or Part
    FDA proposes to define ``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 proposed 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 proposed 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
proposed definition matches the definition in Sec.  1100.3 and that was
published in the SE Proposed Rule and FDA invites comments on this
approach in the PMTA context.
14. Composition
    FDA proposes to define ``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. This proposed
definition matches the definition published in the SE Proposed Rule.
15. Constituent
    FDA proposes to define ``constituent'' as any chemical or chemical
compound in a tobacco product or in tobacco smoke or emission that is
or potentially is inhaled, ingested, or absorbed into the body.
Examples of constituents include harmful or potentially harmful
constituents, total particulate matter, nicotine-free dry particulate
matter, and water. A constituent also could include any other chemical
or chemical compound contained in or produced by a tobacco product
under conditions of use. This proposed definition matches the
definition that was published in the SE Proposed Rule.
16. Container Closure System
    FDA proposes to define ``container closure system'' as any
packaging materials that are a component or part of the tobacco
product. This proposed definition matches the definition published in
the SE Proposed Rule.
    Examples of what is typically a container closure system include
the blister pack around a dissolvable tablet (in this example, if there
is a box around a blister pack, the box is not considered a container
closure system if it is not intended or reasonably expected to alter or
affect the dissolvable tablet), the can that contains and protects a
moist snuff product, and the plastic-wrapped hard pack or soft pack
used to contain and protect cigarettes. A container closure system is a
component or part of a tobacco product because of its potential to
alter or affect the performance, composition, constituents, or other
physical characteristics of the product.
    In addition, considering a distinct subset of packaging (i.e.,
container closure system) to be a component or part is consistent with
the FD&C Act. For example, section 903(a)(2) of the FD&C Act describes
when, under certain conditions, a tobacco product ``in package form''
is misbranded, thereby recognizing that at least some portion of the
package is subsumed within the ``tobacco product'' (and the components
and parts thereof). Similarly, the definition of ``additive'' in
section 900(1) of the FD&C Act 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 (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, further
evinces Congress's understanding that packaging is not entirely
separable from the tobacco product. Finally, 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.
    According to the proposed definition above, packaging constitutes
the container closure system if it is intended or reasonably expected
to affect or alter the performance, composition, constituents, or
characteristics of a tobacco product, even if it is also used to
protect or contain the tobacco product. For example, packaging
materials constitute the 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 (Ref.
1). Another example of this is when menthol or other ingredients are
applied to the inner foil to become incorporated into the consumed
product (Ref. 2). 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 also
diffuse into snuff and affect its characteristics (Ref. 3). Thus, for
example, packaging material that affects the characteristics of a
tobacco product by impacting the moisture level or shelf life of a
tobacco product is a container closure system (e.g., a plastic 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) (Refs. 4 and 5).
    Treating a distinct subset of packaging as a component or part thus
furthers the fundamental purpose of the Tobacco Control Act to protect
the public health. This interpretation is also consistent with the
broad definition of ``tobacco product,'' as well the definition of
``additive,'' which includes substances that may be reasonably expected
to result, directly or indirectly, in it becoming a component or
otherwise affecting the characteristics of any tobacco product--and not
just substances that do in fact have such effects. This shows that
Congress did not intend for FDA to be required to show that the
container closure system did in fact alter or affect the tobacco
product's performance, composition, constituents, or other
characteristics. Indeed, if FDA were to adopt a narrow

construction of ``tobacco product'' to exclude these materials, it
would impede the Agency's ability to evaluate whether authorizing the
marketing of the tobacco product would be appropriate for the
protection of the public health, thereby leaving the Agency unable to
fully execute its mission to protect the public health.
17. Design
    FDA proposes to define ``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 and
matches the definition published in the SE Proposed Rule. Examples of
design parameters include ventilation, paper porosity, filter
efficiency, battery voltage and current operating range, and electrical
heater coil resistance.
18. Finished Tobacco Product
    FDA proposes to define ``finished tobacco product'' to mean a
tobacco product, including all components and parts, sealed in final
packaging (e.g., filters or filter tubes sold separately to consumers
or as part of kits, e-liquids sold separately or packaged with an e-
cigarette). This proposed definition matches the definition published
in the SE Proposed Rule.
19. Harmful or Potentially Harmful Constituent (HPHC)
    FDA proposes to define ``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 proposed
definition matches the definition published in the SE Proposed Rule.
    The established list of HPHCs can be found on FDA's website at
https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/harmful-and-potentially-harmful-constituents-tobacco-products-and-tobacco-smoke-established-list (77 FR 20034, April 3, 2012). FDA issued
a notice in the Federal Register of August 5, 2019 (84 FR 38032),
seeking public comment on the proposed addition of 19 constituents to
the established list of HPHCs. FDA is proposing these additions to
reflect the range of tobacco products now subject to FDA's tobacco
product authorities, including deemed products such as ENDS. FDA will
finalize the addition of these HPHCs to the established list, as
appropriate, after reviewing public comment and general intends to make
any future updates to the established list of HPHCs through a similar
notice and comment process.
20. Heating Source
    FDA proposes to define ``heating source'' as the source of energy
used to burn or heat the tobacco product. This proposed definition
matches the definition published in the SE Proposed Rule. Examples of a
heating source include a flame or a rechargeable battery.
21. Ingredient
    FDA proposes to define ``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. This proposed definition matches
the definition published in the SE Proposed Rule. For example, an
ingredient may be a single chemical substance, leaf tobacco, or the
product of a reaction, such as a chemical reaction, in manufacturing.
Examples of substances and compounds (ingredients) reasonably expected
to be formed through a chemical reaction during tobacco product
manufacturing include the following:
     The reaction of sugars with amines to form families of
compounds with new carbon-nitrogen bonds, including Maillard reaction
products and Amadori compounds.
     The reaction of sodium hydroxide with citric acid to form
sodium citrate.
     The production of ethyl alcohol, a residual solvent, from
ethyl acetate during production of tipping paper adhesive.
     Products of thermolytic reactions, such as the production
of carboxylic acids from sugar esters.
     Products of enzymatically or nonenzymatically catalyzed
reactions, such as the hydrolytic production of flavor or aroma
precursors from nonvolatile glucosides.
     Products of acid-base reactions, such as removal of a
proton from protonated nicotine to generate the basic form of nicotine
(``free'' nicotine).
22. Line Data
    FDA proposes to define ``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
proposing to require that an applicant submit line data rather than
source data to allow for a more efficient review process. As described
in proposed Sec.  1114.45, applicants would be required to retain all
source data in the event that FDA needs to inspect the data as part of
its application review.
23. Material
    FDA proposes to define ``material'' to mean an assembly of
ingredients. Materials are assembled to form the tobacco product, or
components or parts of tobacco product. This proposed definition
matches the definition published in the SE Proposed Rule. For example,
material would include 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.
24. Marketing Order
    FDA proposes to define ``marketing 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.
25. No Marketing Order
    FDA proposes to define ``no marketing 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.
26. Other Features
    FDA proposes to define ``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. This
proposed definition matches the definition published in the SE Proposed
Rule. The definition would include: (a) 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 (b) any other product characteristics that relate to the chemical,
biological, or physical properties of the tobacco product. Other
features also would encompass 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.
27. Premarket Tobacco Product Application or PMTA
    FDA proposes to define ``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.
28. Serious Adverse Experience
    FDA proposes to define ``serious adverse experience'' to mean an
adverse experience that results in any of the following outcomes:
    (a) Death;
    (b) a life-threatening condition or illness;
    (c) inpatient hospitalization or prolongation of existing
hospitalization;
    (d) a persistent or significant incapacity or substantial
disruption of the ability to conduct normal life functions (e.g.,
seizures not that do not result in hospitalization, burns that result
in damage to a limb or nerve damage);
    (e) a congenital anomaly/birth defect; or
    (f) 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.
29. Unexpected Adverse Experience
    FDA proposes to define ``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:
    (a) 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;
    (b) 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
    (c) the results of nonclinical investigations.

VII. Premarket Tobacco Product Applications (Proposed Part 1114,
Subpart B)

A. Application Submission (Proposed Sec.  1114.5)

    Proposed Sec.  1114.5 explains that if an applicant seeks a
marketing order under the PMTA pathway for its new tobacco product, it
would be required to submit a PMTA to FDA and receive a marketing 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 proposed
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 of proposed 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 proposed Sec.  1114.27 in
section VIII.B, FDA may refuse to accept or file an incomplete
application for review.

B. Required Content and Format (Proposed Sec.  1114.7)

1. General
    Proposed Sec.  1114.7(a) would require each PMTA to contain
sufficient information necessary for FDA to determine whether the
grounds for denial of an application listed in section 910(c)(2) of the
FD&C Act apply to the PMTA, which includes the following sections:
     General information (as described in Sec.  1114.7(c));
     Descriptive information (as described in Sec.  1114.7(d));
     Product samples (as described in Sec.  1114.7(e));
     Labeling (as described in Sec.  1114.7(f));
     Statement of compliance with part 25 (21 CFR part 25) (as
described in Sec.  1114.7(g));
     Summary (as described in Sec.  1114.7(h));
     Product formulation (as described in Sec.  1114.7(i));
     Manufacturing (as described in Sec.  1114.7(j));
     Health risk investigations (as described in Sec.
1114.7(k)); and
     Certification statement (as described in Sec.  1114.7(l)).
    As described in the discussion of proposed Sec.  1114.27(a)(1) 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.
As described in section VIII.B on proposed Sec.  1114.27(b)(1), 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.
2. Format
    Proposed Sec.  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 (Ref. 6). Proposed 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 proposing 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 proposed Sec.  1114.49, FDA is proposing that the
PMTA and all supporting documents must 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 would be permitted to
obtain a waiver from the electronic filing requirement, in accordance
with Sec.  1114.49. FDA has provided information on our website about
technical specifications, including electronic formats that would allow
FDA to process, review, and archive the

application.\7\ FDA intends to update this information as needed to
accommodate changes in technology.
---------------------------------------------------------------------------

    \7\ For more information on electronic submission, including
electronic submission file formats and specification, please visit
FDA's web page at: https://www.fda.gov/industry/fda-esubmitter/using-esubmitter-prepare-tobacco-product-submissions.
---------------------------------------------------------------------------

    FDA is proposing 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 proposed 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 submissions have
not been in a static format, and thus, the pages reformat, renumber,
rebullet, or re-date each time the document is accessed. Receiving
applications with these issues affects our ability to cross-reference,
share (internally), and efficiently evaluate information. Lastly,
because FDA is required under regulations governing Federal records to
maintain many files long term, and in a ``sustainable'' format (for
more information on sustainable formats, please refer to National
Archives and Records Administration Bulletin 2014-04, https://www.archives.gov/records-mgmt/bulletins/2014/2014-04.html), proposed
Sec.  1114.7(b) would ensure that these files can be managed, opened,
and read by the Agency for the duration of the retention period.
    Finally, proposed Sec.  1114.7(b)(2) would 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 (21 U.S.C. 387k). 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 master files, please consult the guidance for industry ``Tobacco
Product Master Files.'' \8\
---------------------------------------------------------------------------

    \8\ Available at: https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance.
---------------------------------------------------------------------------

    Applicants may also include content in a PMTA by cross-reference to
a pending MRTPA for the same tobacco product.\9\ FDA recommends that
applicants seeking to market a new tobacco product that has not
previously received marketing authorization as a modified risk tobacco
product submit a single application under section 911(l)(4) of the FD&C
Act (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 only one application
and include it in the other by cross-reference. This approach would
prevent any transcription errors and would also 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.
---------------------------------------------------------------------------

    \9\ 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 an
order 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.
Such an approach would 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.
---------------------------------------------------------------------------

    Under the proposed rule, except as described in subpart B, FDA
would 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 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 would be
required to include the full text of such information in its PMTA. FDA
is proposing 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. 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.
3. General Information
    Proposed Sec.  1114.7(c) lists the information that would be
required to 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. The table, as set forth in
proposed Sec.  1114.7(c), would include requirements to submit general
information related to electronic nicotine delivery systems (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 guidance
``Premarket Tobacco Product Applications for Electronic Nicotine
Delivery Systems.''
    The PMTA would be required to include the following information
using the FDA-provided form (Ref. 6), as appropriate:
     Applicant name, address, and contact information;
     The name, address, and contact information for the
authorized

representative or U.S. agent (for a foreign applicant). As required by
Sec.  1105.10(a)(5) for application acceptance, a foreign applicant
must identify a U.S. agent (i.e., an individual located in the United
States who is authorized to act on behalf of the applicant for the
submission) to help FDA ensure adequate notice is provided to
applicants for official Agency communications, assist FDA in
communicating with the foreign applicant, and help the Agency to
efficiently process applications and avoid delays.
     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 would include:
    [cir] The manufacturer;
    [cir] Product name(s), including the brand and subbrand (or other
commercial name(s) used in commercial distribution);
    [cir] Product category; product subcategory; and product
properties, as provided by the tables in proposed Sec.  1114.7(c). The
applicant would select and provide the appropriate category,
subcategory, and product properties for the new tobacco product. This
product-specific information is required under sections 910(b)(1)(B)
and (G) of the FD&C Act and the proposed rule would require its
inclusion in the general information section 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 would be a
required part of an application, see the discussion of proposed Sec.
1114.7(i)(1) in section VII.B.9. It is important to note that for the
characterizing flavor product property, the applicant would be required
to state ``none'' if it does not consider the product to have a
characterizing flavor. Applicants that have questions regarding how to
describe their product's characterizing flavor are encouraged 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
proposed Sec.  1114.27(a)(1), it would likely slow down the substantive
review process.
     The type of PMTA. The applicant would be required to state
the type of PMTA the applicant is submitting (i.e., PMTA, supplemental
PMTA, or resubmission);
     Whether the applicant requests that FDA refer the PMTA to
the Tobacco Products Scientific Advisory Committee (TPSAC). An
applicant should briefly describe its justification for a request to
refer the PMTA to TPSAC. FDA retains the discretion to refer an
application to TPSAC, but will consider an applicant's request as part
of its determination.
     Identifying information regarding any prior submissions
relating to the new tobacco product, including submission tracking
numbers (STNs), where applicable. The types of prior submissions may
include premarket applications, such as PMTAs, SE Reports, and
exemption requests, as well as other submissions to FDA including
MRTPAs and submissions related to investigational tobacco products. The
regulatory history of a tobacco product can provide useful context for
FDA's review of a submission;
     Dates and purpose of any prior meetings with FDA regarding
the new tobacco product;
     Address and the Facility Establishment Identifier (FEI)
number(s) of the establishment(s) involved in the manufacturer of the
new tobacco product. This information would assist the Agency with
environmental impact considerations and determinations under part 25 by
helping FDA understand the location of manufacturing and scale of
products that would be manufactured. Additionally, it helps FDA
schedule and conduct facility inspections;
     A brief statement regarding how the PMTA satisfies the
content requirements of section 910(b)(1) of the FD&C Act. This could
consist of a table reproducing the section 910(b)(1) requirements and
listing the sections or page numbers of the PMTA that satisfy the
requirements. FDA is requiring this brief statement under authority of
sections 701(a) and 910(b)(1)(G) of the FD&C Act, which would allow FDA
to more quickly locate application content necessary to determine
whether a PMTA should be accepted and filed for further review under
proposed Sec.  1114.27;
     A brief description of how permitting the marketing of the
new tobacco product is expected to be appropriate for the protection of
the public health (APPH). This description should be no more than a
sentence or two that highlights the key product characteristics and
study results the applicant believes would make the marketing of the
product APPH (e.g., the product delivers significantly lower levels of
a specific HPHCs to users than the tobacco products they are currently
consuming, which studies indicate may result in decreased morbidity and
mortality); and
     A list identifying all enclosures, labels, and labeling
being submitted with the application. This list will help FDA identify
application content and ensure a PMTA contains all the information the
applicant intended to submit.
4. Descriptive Information
    Proposed Sec.  1114.7(d) would require applicants to provide
descriptive information in this section that outlines the major aspects
of the new tobacco product, which is required to be submitted under
sections 910(b)(1)(A), (D), and (G) of the FD&C Act. This information
would include:
     A concise description of the new tobacco product (e.g.,
the product is a portioned smokeless tobacco product made using a blend
of burley and bright tobacco);
     A statement identifying all tobacco product standards
issued under section 907 of the FD&C Act that are applicable to the new
tobacco product and a brief description of how the new tobacco product
fully meets the identified tobacco product standard(s). If the new
tobacco product deviates from such standard(s), if applicable, the
proposed rule would require the application to include adequate
information to identify and justify those deviations;
     The product name(s) as designated on the product's label;
     A description of problems identified in prototypes that
are the subject of studies contained in the application, or previous or
similar versions of the new tobacco product that were marketed, if any.
If there are previous or similar versions that are the subject of
studies in the application or were marketed, the proposed rule would
require the applicant to include a bibliography of all reports
regarding the previous or similar version of the product, whether
adverse or supportive. FDA would require 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;
     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 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 would be required to explicitly state that
it proposes no restrictions. As described in proposed Sec.  1114.31,
FDA will consider these proposed restrictions during its review of the
PMTA and, where appropriate, include the restrictions in the marketing
order for the product together with any additional restrictions FDA may
require.
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. Proposed Sec.  1114.7(e) would require 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
no marketing 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 is proposing to have applicants submit samples as required by
FDA after acceptance of an application rather than as part of an
initial submission. This would allow FDA to determine the need for
samples, allow the samples to be tracked and identified as part of the
correct application, and submitted to testing facilities that are
adequately prepared to accept the samples (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. As described in proposed
Sec.  1114.27, if required by FDA, product samples would 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.
6. Labeling and Marketing Plans
    Proposed Sec.  1114.7(f) of the FD&C Act would require that a PMTA
contain specimens of labeling and 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. Proposed Sec.  1114.7(f)(1) would elaborate on this
requirement and require the application to contain specimens of all
proposed labeling for the new tobacco product, including labels,
inserts, onserts, instructions, and other accompanying information. The
specimens of labeling would be 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.
    As described in proposed 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 proposed Sec.  1114.7(k)(1)(iv).
    b. Marketing Plan. Proposed Sec.  1114.7(f)(2) would require a PMTA
to contain a description of the applicant's marketing plans for the
tobacco product that an applicant has developed by the time of
submission and concerning at least the first year of marketing after an
applicant receives a marketing order, including information relating to
labeling, advertising, marketing, promotion, and sales and distribution
of its new tobacco product. FDA is proposing to require the submission
of marketing plans as part of a PMTA under its authority in section
910(b)(1)(G) of the FD&C Act to require other information relevant to
the subject matter of the application because marketing plans can
provide important information regarding whether permitting the
marketing of the new tobacco product would be APPH. Specifically,
marketing plans can inform FDA's consideration under section 910(c)(4)
of the FD&C Act of the potential risks and benefits of the tobacco
product to the population as a whole, including whether the marketing
of the product would increase or decrease the likelihood that those who
do not use tobacco products, including youth and young adults, will
start using them.
    FDA is proposing to require the submission of marketing plans to
help it understand and prevent or minimize the potential harm that
could be caused by the marketing of a new tobacco product. Consistent
with its mission to protect the public health, FDA seeks to limit youth
exposure to the labeling, advertising, marketing, or promotion of a new
tobacco product in order to limit uptake of the new tobacco product by
nonusers of tobacco products, especially youth. FDA must also assess
potential uptake of the new tobacco product by current tobacco product
users who

would have otherwise stopped using tobacco products and how use of the
new tobacco product may affect poly use behaviors and subsequent
tobacco use. Applicants may have information that allows them to
carefully target the marketing for a particular product to reach only
its intended consumers of legal age. In reviewing the marketing plans
contained in a PMTA, FDA intends to consider how an applicant will
target the marketing of its new tobacco product to reach its intended
consumers of legal age and to assess potential effect on nonusers. FDA
will also consider how the applicant intends to minimize the extent to
which youth can access the product and are exposed to its marketing.
Where FDA determines that restrictions on the sales and distribution of
the new tobacco product (including access to, and the advertising and
promotion of, the tobacco product) would be APPH, FDA can impose such
restrictions under the terms of a marketing order as described in
section VIII.D.
    The applicant's marketing plans will help FDA determine whether
permitting the marketing of the new tobacco product would be APPH
because they will provide input that is critical to FDA's determination
of the likelihood of changes in tobacco product use behavior,
especially when considered in conjunction with other information
contained in the application. FDA will review the marketing plan to
evaluate potential youth access to, and youth exposure to the labeling,
advertising, marketing, or promotion of, a new tobacco product. For
example, heavy use of online social media to promote a tobacco product
without access restrictions, as opposed to actions such as paper
mailings directed only to current smokers of legal age, indicates the
potential for youth to be exposed to the promotion of the product. This
information would help FDA make its APPH determination by showing
whether a PMTA fully or accurately accounts for the likelihood of
changes in tobacco product use behavior that may occur as a result of
marketing the new tobacco product. For example, if the PMTA does not
address youth access to the product, youth exposure to the product's
labeling, advertising, marketing, and promotion, and youth initiation,
such as describing how it proposes to restrict the sale or distribution
of its product to limit potential youth access to the product (e.g.,
selling the tobacco product in adult-only establishments) or exposure
to advertising (e.g., using age verification controls for digital
advertising), FDA may be unable to determine that the applicant has
made a showing that permitting the marketing of the new tobacco product
would be APPH. FDA expects that companies seeking authorization will
have prepared plans for potential marketing that they expect to
undertake during at least an initial period of marketing, such that
providing these plans as part of the application would not require
significant resources.
    Additionally, as set forth in proposed Sec.  1114.41, FDA would
require each applicant that receives a marketing order to continue to
report its marketing plans, along with items such as copies of the
product's labeling, advertising, marketing, and promotion, and the
results of the implementation of such plans. Continuing to monitor the
marketing plans for the new tobacco product once on the market is
important to help FDA evaluate both the potential for changes to
tobacco product use behavior and the implementation of any restrictions
in the marketing order. As described in section VIII.F., where FDA
finds that the continued marketing of a new tobacco product is no
longer APPH, such as where changes in the marketing of a new tobacco
product result or are likely to result in a significant increase in
youth initiation not foreseen in FDA's review of a PMTA, FDA would
withdraw the marketing order for a product.
    There is a well-established body of scientific evidence regarding
the effect of advertising and marketing on tobacco product initiation
(see e.g., Refs. 7-10), which FDA must consider as part of its basis
for determining whether permitting the marketing of a product would be
appropriate for the protection of the public health under section
910(c)(4) of the FD&C Act. The impact of tobacco advertising and
marketing on youth and young adult tobacco use behavior has been well
documented. The 2012 Surgeon General's report, Preventing Tobacco Use
Among Youth and Young Adults, synthesizes more than 30 years of
research on the topic and states that the strong empirical evidence,
along with the tobacco industry's own internal documents and trial
testimony, as well as widely accepted principles of advertising and
marketing, support the conclusion that tobacco manufacturers'
advertising, marketing, and promotions recruit new users as youth and
continue to reinforce use among young adults. (Ref. 12). The National
Cancer Institute made a similar conclusion it its monograph, The Role
of the Media in Promoting and Reducing Tobacco Use, that the total
weight of evidence--from multiple types of studies, conducted by
investigators from different disciplines, and using data from many
countries--demonstrates a causal relationship between tobacco
advertising and promotion and increased tobacco use. (Ref. 8). A
variety of research has found that exposure to advertising is
associated with susceptibility to use tobacco products and the actual
use of tobacco products (see e.g., Refs. 13-21). For example, research
has found that the use of certain kinds of imagery, such as logos and
cartoons, have an impact on youth tobacco initiation (see, e.g., Refs.
22-24) and that a key tactic of tobacco companies seeking to attract
and recruit youth users is to use advertising and marketing with
aspirational imagery and themes known to resonate with younger
audiences, such as independence, popularity, rebelliousness,
attractiveness, and being cool (Ref. 12).
    Marketing plans would provide information about the ways and
frequency with which consumers would be exposed to tobacco product
advertising, marketing, promotion, and other communication activities.
This information can provide valuable insight into the likelihood that
nonusers, particularly youth, would initiate tobacco product use. An
analysis of the 2011 National Youth Tobacco Survey (NYTS) found that
adolescents who reported frequent exposure to tobacco advertising at
the point of sale and on the internet had significantly higher odds of
ever using e-cigarettes and that there was a dose-response association
between the number of marketing channels to which they were exposed and
whether they used tobacco products. (Refs. 21 and 25). An analysis of
2014 NYTS data assessing exposure to e-cigarette advertising in
different channels (i.e., internet, print, television and movies,
retail stores) found that as the number of channels of e-cigarette
marketing exposure increased, the likelihood of use and susceptibility
also increased. (Refs. 25-27).
    Proposed Sec.  1114.7(f)(2) would require, as part of the
description of the marketing plans, that the PMTA specify information
such as the intended target audience(s), media and distribution
channels, specific tactics, total dollar amount(s) of media buys and
marketing and promotional activities, and timing for the activities,
including, but not limited to, information describing the items listed
below. As used in proposed Sec.  1114.7(f)(2), other consumer-directed
activities include any other types of action regarding the new tobacco
product that may reach consumers, such as communications that are
intended to

inform retailers' communications with consumers. If an applicant does
not intend to use any advertising, marketing, promotion, or other
communication activities directed at consumers regarding its new
tobacco product, or the applicants has not developed marketing plans by
the time of filing, the PMTA must contain a statement to that effect in
this section of the application. The types of information that the
marketing plan section would be required to contain include, but are
not limited to:
     Any plans to use competent and reliable data sources,
tools, technologies, and methodologies to establish, maintain, and
monitor highly targeted marketing plans and media buys. This could
include, for example, use of and sources of first and second-party age-
verified data, public records, industry-standard syndicated research
services, and embedded tracking pixels in digital advertising;
     A description of the target adult audiences by age-
range(s) (including young adult audiences ages 18-24) and other
demographic and psychographic characteristics. Examples of demographic
characteristics include, but are not limited to race, ethnicity, and
geographic location (e.g., urban, rural). Examples of types of
psychographic characteristics include, but are not limited to hobbies,
interests, risk-taking behaviors, tobacco use behaviors, purchase
behaviors, and online search behaviors;
     A description of the target audience insights (e.g.,
demographics, psychographics, findings from consumer research) the
applicant is using to inform its marketing plans, including its
strategic approach, key messages and themes, creative direction, and
potential tactics or marketing channels. FDA generally expects that
applicants will have conducted market or consumer research to
determine, and gain information regarding, its target audience. This
could include product-specific insights (e.g., target audience
impressions of one product being just as harmful as another, preference
of a certain brand), as well as other beliefs, interests, motivations,
or behaviors that can be used to tailor a manufacturers approach to
marketing the product. This could also include information regarding
where the target audience tends to consume marketing and advertising
(e.g., television programs the target audience watches, social media
influencers the target audience follows, websites and retail locations
the target audience frequents) that can be used to tailor its approach,
select relevant marketing tactics, and use relevant marketing channels.
The applicant should describe such insights in this section of the
application;
     Any means by which youth-access to the tobacco product or
youth-exposure to the tobacco product labeling, advertising, marketing,
and promotion would be limited. FDA expects that applications will
contain information regarding how the applicant intends to prevent
sales or distribution to individuals below the legal purchasing age.
Such information could include, for example, whether and how the
company intends to: utilize independent, third-party age and identity-
verification software on its website(s); distribute its product only to
age-restricted locations; and limit the quantity of its product that an
adult customer may purchase within a given period of time;
     Plans to use owned, earned, shared, or paid social media
to advertise or promote the tobacco product. While media categories
often overlap, owned media typically consists of a company's own media
properties they control, such as the company's product-branded website.
Earned media typically consists of unpaid media publicity, consumer
interest or pick up of advertising or promotion, such as a news article
about the product or a social media influencer talking about a
company's product or sharing's a company's social media post without
payment. Shared media typically consists of a company's social media
properties, such as a company's social media accounts and content. Paid
media consists of advertising and promotion that a company pays for,
such as advertising appearing on television and radio, in and around
retail stores, and in digital media, including content shared by a
social media influencer who a company pays to promote to the tobacco
product;
     Plans to use partners, sponsors, influencers (e.g.,
celebrities, cultural icons, individuals with substantial followers on
social media), bloggers, or brand ambassadors to create labeling for,
market, advertise or promote the tobacco product;
     Plans to conduct in-person consumer engagements, including
events at which the tobacco product will be demonstrated or sampled.
Applicants planning to conduct in-person engagements should include a
description of how access would be restricted to individuals at or
above the Federal minimum age of purchase; and
     Plans to use earned media, public relations, or other
communications outreach to promote the tobacco product. Earned media
could consist of actions such as plans to pitch stories about the new
tobacco product to newspapers without compensation. Public relations
could consist of actions such as using a public-relations firm to
promote the tobacco product. Other communications to promote the
product could consist of actions such as direct mail to consumers.
    FDA invites comment on the specific information in the proposed
marketing plans section, and whether FDA should require additional
information related to marketing plans and the basis for any such
additional provisions.
    At this time, FDA is not proposing to require the submission of
advertising for application filing, except where used as stimuli in
studies (e.g., stimuli in perception studies). Specifically, in
addition to the marketing plan requirements in this section, proposed
Sec.  1114.7(k)(1)(iv) would require a PMTA to contain full reports of
information concerning investigations that are published, known to, or
should be known to, the applicant regarding the impact of the tobacco
product's label, labeling, and advertising on perceptions of the
product and tobacco product use intentions.
7. Statement of Compliance With Part 25
    A PMTA must contain an environmental assessment (EA) prepared in
accordance with Sec.  25.40 or a valid claim of a categorical