[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Proposed Rules]
[Pages 12740-12791]
[FR Doc No: 2019-05787]

Vol. 84

Tuesday,

No. 63

April 2, 2019

Part III

Department of Health and Human Services

-----------------------------------------------------------------------

Food and Drug Administration

-----------------------------------------------------------------------

21 CFR Parts 16 and 1107

Content and Format of Substantial Equivalence Reports; Food and Drug
Administration Actions on Substantial Equivalence Reports; Proposed
Rule

Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 /
Proposed Rules

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 1107

[Docket No. FDA-2016-N-3818]
RIN 0910-AH89

Content and Format of Substantial Equivalence Reports; Food and
Drug Administration Actions on Substantial Equivalence Reports

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is issuing a proposed
rule to establish requirements for the content and format of reports
intended to establish the substantial equivalence of a tobacco product
(SE Reports). The proposed rule would establish the information an SE
Report must include so that FDA may make a substantial equivalence
determination. In addition, the proposed rule would establish the
general procedures FDA intends to follow when evaluating SE Reports,
including procedures that would address communications with the
applicant and the confidentiality of data in an SE Report. The proposed
rule is intended to provide more clarity to applicants and support
efficient and predictable reviews of SE Reports.

DATES: Submit either electronic or written comments on the proposed
rule by June 17, 2019. Submit comments on information collection issues
under the Paperwork Reduction Act of 1995 by May 2, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before June 17, 2019. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of June 17, 2019. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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-2016-N-3818 for ``Content and Format of Substantial Equivalence
Reports; Food and Drug Administration Actions on Substantial
Equivalence Reports.'' 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 protected]. All comments
should be identified with the title, ``Substantial Equivalence Reports
for Tobacco Products.''

FOR FURTHER INFORMATION CONTACT: Annette Marthaler or Daniel Gittleson,
Office of Regulations, Center for Tobacco Products, Food and Drug
Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary

I. Background
II. Legal Authority
III. Description of Proposed Regulations
    A. General (Proposed Subpart B)
    B. Substantial Equivalence Reports (Proposed Subpart C)
    C. FDA Review (Proposed Subpart D)
    D. Miscellaneous (Proposed Subpart E)
IV. Other Issues for Consideration
V. Paperwork Reduction Act of 1995
VI. Executive Order 13132: Federalism
VII. Consultation and Coordination with Indian Tribal Governments
VIII. Analysis of Environmental Impact

IX. Economic Analysis of Impacts
X. References
XI. Effective Datep

Executive Summary

Purpose of the Regulatory Action

    This proposed rule would establish requirements related to the
content and format of SE Reports, including the information that SE
Reports must contain. FDA is basing this proposed rule on the
experience the Agency has in reviewing thousands of SE Reports since
2010. The SE Reports that FDA has seen to date range widely in the
level of detail included. For example, some have very little
information on the comparison of the new tobacco product with a
predicate tobacco product while other SE Reports are much more detailed
in describing how the new tobacco product compares to the identified
predicate tobacco product and provide supporting information. This wide
variation in the depth of content may be due, at least in part, to
confusion about what information FDA needs from applicants to make a
substantial equivalence finding. FDA's experience reviewing this wide
range of SE Reports has been helpful in developing this proposed rule,
which describes in detail the information that an applicant would be
required to include in an SE Report.
    The proposed rule also addresses issues such as communications with
the applicant, the retention of records that support the SE Report,
confidentiality of SE Report information, and electronic submission of
the SE Report and amendments. The proposed rule is intended to provide
both applicants and FDA with more certainty about the content and
format of SE Reports and FDA's review of the SE Reports. The proposed
rule is also intended to provide more clarity to applicants and help
ensure that the SE pathway for premarket review of a new tobacco
product is used when appropriate, e.g., when there is a valid predicate
tobacco product to which the new product can be scientifically compared
and support efficient and predictable reviews.

Legal Authority

    This proposed rule is being issued based upon FDA's authority to
require premarket review of new tobacco products under sections 905(j)
and 910(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 387e(j) and 387j(a)), FDA's authority to require 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).

Summary of the Major Provisions

    This proposed rule would establish content and format requirements
for SE Reports. Under the proposed rule, an SE Report must provide
information comparing the new tobacco product to a predicate tobacco
product, including information that would enable FDA to uniquely
identify the new tobacco product and the predicate tobacco product. The
proposed requirements would help ensure that an SE Report provides
information necessary for FDA to determine whether the new tobacco
product is substantially equivalent to a tobacco product commercially
marketed in the United States as of February 15, 2007 (as required by
section 910(a)(2)(A) of the FD&C Act).
    In addition, the proposed rule would explain how an applicant can
amend or withdraw an SE Report, and explain how an applicant may
transfer ownership of an SE Report to a new applicant. The proposed
rule also would address FDA communications with applicants on SE
Reports, including when FDA would issue deficiency notifications;
explain FDA review cycles; and identify actions that FDA may take on SE
Reports. The proposed rule would address when FDA may rescind an SE
order and explain how long an applicant must maintain records related
to the SE Report. The proposed rule also would explain FDA's disclosure
provisions and provide for electronic submission of SE Reports, unless
the applicant requests a waiver. FDA is basing the proposed rule on our
experience reviewing SE Reports, and the proposed rule is intended to
provide both applicants and FDA with more certainty related to the
information needed to demonstrate substantial equivalence and FDA's
review processes with the goal of an efficient and predictable review
process for SE Reports.

Costs and Benefits

    This proposed rule would impose compliance costs on affected
entities to read and understand the rule, establish or revise internal
procedures, and fill out a form for SE Reports. We estimate that the
present value of industry compliance costs ranges from $0.60 million to
$2.64 million, with a primary estimate of $1.61 million at a 3 percent
discount rate, and from $0.56 million to $2.32 million, with a primary
estimate of $1.43 million at a 7 percent discount rate over 10 years.
Annualized industry compliance costs over 10 years range from $0.07
million to $0.31 million, with a primary estimate of $0.19 million at a
3 percent discount rate and from $0.08 million to $0.33 million, with a
primary estimate of $0.20 at a 7 percent discount rate.
    The benefits of this proposed rule are potential time-savings to
industry and cost-savings to government. This proposed rule clarifies
when applicants may certify that certain characteristics are identical
in the new tobacco product and the predicate tobacco product.
Certifying may save applicants time in preparing their SE Reports. In
this proposed rule, we intend to shorten review times for SE Reports.
In addition, based on our experience with prior SE Reports, we believe
this proposed rule would lead to better SE Reports, saving us time in
review and requiring fewer staff to review SE Reports, which would
result in cost-savings. We estimate that the present value of
government cost-savings ranges from $15 million to $198 million, with a
primary estimate of $62 million at a 3 percent discount rate, and from
$12 million to $163 million, with a primary estimate of $51 million at
a 7 percent discount rate over 10 years. Annualized government cost-
savings over 10 years range from $1.7 million to $23.2 million, with a
primary estimate of $7.2 million at both 3 and 7 percent discount
rates.
    The qualitative benefits of this proposed rule include additional
clarity to industry about the requirements for the content and format
of SE Reports. The proposed rule would also establish the general
procedures we intend to follow in reviewing and communicating with
applicants. In addition, this proposed rule would make the SE pathway
more predictable.

                                         Table 1--Summary of Annualized Costs and Benefits of the Proposed Rule
                                                                  [$2016 over 10 years]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Low (3%)       Medium (3%)      High (3%)       Low (7%)       Medium (7%)      High (7%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs...................................................           $0.07           $0.19           $0.31           $0.08           $0.20           $0.33
Benefits................................................             1.7             7.2            23.2             1.7             7.2            23.2
Net Benefits (rounded)..................................             1.7             7.1            22.9             1.7             7.0            22.9
--------------------------------------------------------------------------------------------------------------------------------------------------------

I. Background

    The Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111-31) was enacted June 22, 2009, and provided
FDA the authority to regulate tobacco products under the FD&C Act. The
FD&C Act, as amended by the Tobacco Control Act, requires that before a
new tobacco product may be introduced into interstate commerce for
commercial distribution in the United States, the new tobacco product
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.
    The FD&C Act establishes three premarket review pathways for a new
tobacco product:
     Submission of a premarket tobacco application under
section 910(b);
     Submission of a report intended to demonstrate that the
new tobacco product is substantially equivalent to a predicate tobacco
product under section 905(j)(1)(A) (``SE Report''); and
     Submission of a request for an exemption under section
905(j)(3) (implemented at Sec.  1107.1 (21 CFR 1107.1)).
    Under section 910(a)(2)(B) of the FD&C Act, a manufacturer of a
tobacco product that was first introduced or delivered for introduction
into interstate commerce for commercial distribution after February 15,
2007, and prior to March 22, 2011, that submitted an SE Report \1\
prior to March 23, 2011, may continue to market the tobacco product
unless FDA issues an order that the tobacco product is not
substantially equivalent. For any new tobacco product introduced into
commercial distribution on or after March 22, 2011, or for which a
substantial equivalence report was not submitted by March 23, 2011, a
manufacturer must first submit a premarket application under section
910 for the new tobacco product to FDA, and FDA must issue an order
authorizing the commercial distribution of the new tobacco product or
find the product exempt from the requirements of substantial
equivalence under section 910(a)(2)(A) of the FD&C Act, before the
product may be introduced into commercial distribution. If a new
tobacco product is marketed without an 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.
---------------------------------------------------------------------------

    \1\ In this proposed rule, FDA refers to ``SE applications'' as
``SE Reports,'' but the terms both refer to a premarket submission
under section 905(j)(1)(A) of the FD&C Act.
---------------------------------------------------------------------------

    Since 2010, FDA has received more than 5,000 premarket
applications. Almost all of the premarket applications have been SE
Reports. To assist manufacturers in preparing SE Reports, FDA has
issued guidance documents; \2\ conducted Webinars; met with
manufacturers; posted technical project lead reviews (which describe
the administrative, compliance, and substantive scientific reviews
completed on a specific SE Report), general information about not
substantially equivalent (NSE) determinations, and orders (FDA posts
the NSE orders for provisional tobacco products,\3\ and SE orders for
all tobacco products); and issued letters outlining deficiencies in
individual tobacco product SE Reports. Manufacturers are now more
informed about what an SE Report should contain, and FDA is more
informed about the range of tobacco products and changes made to these
products and the data needed to demonstrate substantial equivalence.
The proposed rule is based on this experience and would establish
requirements related to the substantial equivalence premarket pathway
and provide both manufacturers and FDA with more certainty related to
the information needed to demonstrate substantial equivalence and FDA's
review processes.
---------------------------------------------------------------------------

    \2\ The guidance documents include: ``Section 905(j) Reports:
Demonstrating Substantial Equivalence for Tobacco Products''
(January 2011); ``Establishing That a Tobacco Product Was
Commercially Marketed in the United States as of February 15, 2007''
(September 2014); ``Demonstrating the Substantial Equivalence of a
New Tobacco Product: Responses to Frequently Asked Questions''
(December 2016); and ``Meetings with Industry and Investigators on
the Research and Development of Tobacco Products'' (July 2016).
These guidance documents may be accessed at https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.
    \3\ ``Provisional'' tobacco products refer to those tobacco
products that were first introduced or delivered for introduction
into interstate commerce for commercial distribution in the United
States after February 15, 2007, and prior to March 22, 2011, and for
which a 905(j) (Substantial Equivalence) Report was submitted no
later than March 22, 2011.
---------------------------------------------------------------------------

II. Legal Authority

    As described in the following paragraphs, FDA is proposing this
rule to prescribe the content, form, and manner of reports intended to
demonstrate the substantial equivalence of a new tobacco product to a
predicate tobacco product, as well as to establish other requirements
related to SE Reports including requirements for keeping records,
making reports, and providing information essential to FDA's
implementation of the FD&C Act. 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 a new tobacco product to
be the subject of a premarket tobacco application (PMTA) order unless
FDA has issued an SE order authorizing its commercial distribution or
the tobacco product is exempt from substantial equivalence. To satisfy
the requirement of premarket review, a manufacturer may submit a report
intended to demonstrate the substantial equivalence of a new tobacco
product to a predicate tobacco product under section 905(j) of the FD&C
Act. Section 905(j) provides that FDA may prescribe the form and

manner of the substantial equivalence report, and section 910(a)(4)
requires that as part of the 905(j) report, the manufacturer provide an
adequate summary of any health information related to the new tobacco
product or state that such information will be made available upon
request.
    Based on the information provided by the applicant, section
910(a)(3)(A) of the FD&C Act authorizes FDA to issue an order finding
substantial equivalence when FDA finds that the new tobacco product is
in compliance with the requirements of the FD&C Act and either: (1) Has
the same characteristics as the predicate tobacco product or (2) has
different characteristics and the information submitted contains
information, including clinical data if deemed necessary by FDA, that
demonstrates that it is not appropriate to regulate the product under
(the premarket tobacco application or ``PMTA'' provisions) because the
product does not raise different questions of public health.
    Section 909(a) of the FD&C Act authorizes FDA to issue regulations
requiring tobacco product manufacturers or importers to maintain such
records, make such reports, and provide such information as may be
reasonably required to assure that their tobacco products are not
adulterated or misbranded and to otherwise protect public health.
    Under section 902(6)(A) 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) of the FD&C Act.
Under section 903(a)(6) of the FD&C Act, a tobacco product is
misbranded if a notice or other information respecting it was not
provided as required by section 905(j) of the FD&C Act. In addition, a
tobacco product is misbranded if there is a failure or refusal to
furnish any material or information required under section 909 (section
903(a)(10)(B) of the FD&C Act).
    Section 701(a) of the FD&C Act 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. Description of Proposed Regulations

    The proposed rule would add subparts B through E to current part
1107 of Title 21. The requirements set out in this proposed rule would
not apply to provisional SE Reports or to any SE Report submitted
before the effective date of any final rule associated with this
proposed rulemaking. FDA has published a final rule extending the
Agency's ``tobacco product'' authorities in the FD&C Act to all
categories of products that meet the statutory definition of ``tobacco
product'' in the FD&C Act, except accessories of such newly deemed
tobacco products (``Deeming Tobacco Products To Be Subject to the
Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking
Prevention and Tobacco Control Act; Restrictions on the Sale and
Distribution of Tobacco Products and Required Warning Statements for
Tobacco Products'' (81 FR 28974, May 10, 2016) (the Deeming final
rule)). This proposed rule would apply to SE Reports for all tobacco
products submitted after the final rule is effective, including the
newly deemed tobacco products, that FDA regulates under Chapter IX of
the FD&C Act. Proposed subparts D and E set out FDA's review processes
and would be applicable to FDA's review of SE Reports after the
effective date of any final rule. The proposed rule also would amend
Sec.  16.1 (21 CFR 16.1) to add a reference to proposed Sec.  1107.50
(this proposed section would address rescission of an SE order).

A. General (Proposed Subpart B)

1. Scope (Proposed Sec.  1107.10)
    According to proposed Sec.  1107.10, subparts B through E would
establish the procedures and requirements for the submission of an SE
Report under sections 905 and 910 of the FD&C Act, the basic criteria
for establishing substantial equivalence, and the general procedures
FDA intends to follow when evaluating SE Reports.
2. Definitions (Proposed Sec.  1107.12)
    Proposed Sec.  1107.12 sets forth the meaning of terms as they
apply to proposed subparts B through E of part 1107. Proposed Sec.
1107.12 includes the following definitions from the FD&C Act:
     Additive. As defined in section 900(1) of the FD&C Act (21
U.S.C. 387), ``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.
     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.
     Characteristic. As defined in section 910(a)(3)(B) of the
FD&C Act, ``characteristic'' means the materials, ingredients, design,
composition, heating source, or other features of a tobacco product.
All of the terms used in the definition of characteristic (materials,
ingredients, design, etc.) are defined in proposed Sec.  1107.12.
     Distributor. As defined in section 900(7) of the FD&C Act,
``distributor'' means any person who furthers the distribution of a
tobacco product, whether domestic or imported, at any point from the
original place of manufacture to the person who sells or distributes
the product to individuals for personal consumption. Common carriers
are not considered distributors for the purposes of this part.
     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 SE Reports, 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). 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 considers a tobacco product marketed exclusively in test
markets on February 15, 2007, to be a new tobacco product that is
subject to premarket review by FDA. In addition, such test marketed
products cannot serve as valid predicate products in an SE Report. A
tobacco product that the applicant intends to test market 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 further expand on or define the terms
``test marketing'' and ``commercially marketed.'' Specifically, 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.
    FDA is considering whether to define ``commercially marketed'' as
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.
     Package or packaging. As defined in section 900(13) of the
FD&C Act, ``package'' or ``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 tobacco product), but packaging that is
not the container closure system is not intended or reasonably expected
to affect or alter the performance, composition, constituents, or
characteristics of the tobacco product.
     Substantial equivalence or substantially equivalent. As
defined in section 910(a)(3)(A) of the FD&C Act, the term ``substantial
equivalence'' or ``substantially equivalent'' means, with respect to
the tobacco product being compared to the predicate tobacco product,
that FDA, by order, has found that the tobacco product:
    [cir] Has the same characteristics as the predicate tobacco product
or
    [cir] Has different characteristics and the information submitted
contains information, including clinical data if deemed necessary by
FDA that demonstrates that it is not appropriate to require premarket
review under section 910(a), (b) and (c) of the FD&C Act because the
product does not raise different questions of public health.
    FDA notes that this proposed rule does not include a proposed
interpretation of ``same characteristics'' and ``different
characteristics'' under section 910(a)(3)(A) of the FD&C Act.\4\
However, FDA recognizes that stakeholders have requested additional
clarity on these terms. FDA continues to consider the appropriate
implementation of these terms, as well as public feedback the Agency
has received on the terms during workshops

and in response to other Federal Register notices (e.g., most recently,
in response to a notice related to the Paperwork Reduction Act, 83 FR
45251, September 6, 2018). For example, FDA is considering whether the
``same characteristics'' prong might be appropriate for new tobacco
products that are so similar to the predicate product that FDA would
not need scientific information to determine whether the new product
raises different questions of public health. Examples of changes
between the new and predicate products that might be appropriate to
proceed through ``same characteristics,'' either individually or in
combination, include, non-exhaustively: (1) A change in product
quantity between the new and predicate tobacco products; (2) a change
in container closure system for non-moist tobacco products; (3)
decreases in the total amount of tobacco in the new tobacco product
without any corresponding changes in other ingredients or
characteristics of the new tobacco product; and (4) changes in the non-
combusted portion of a cigarette, for example, a change in tipping
paper color from plain to cork, or a change in adhesive, or the removal
of a dye or ink.
---------------------------------------------------------------------------

    \4\ FDA notes that products with identical characteristics are
not new products, and thus are not required to undergo premarket
review.
---------------------------------------------------------------------------

    Under this approach, a new product would have ``different
characteristics'' if a product were dissimilar enough from the
predicate product that FDA could not determine without scientific
information whether the new product raised different questions of
public health. Examples of changes between the new and predicate
products that might be appropriate to proceed through ``different
characteristics,'' either individually or in the aggregate, include,
non-exhaustively:
     A change in filter or ventilation of a combusted tobacco
product, because such a change has the potential to affect the public
health analysis required to assess substantial equivalence, such that
FDA would need scientific information to determine whether the new
product raises different questions of public health. For example, in
some circumstances, a change in filter could result in an increase in
ventilation and a change in harmful or potentially harmful constituent
(HPHC) exposure levels to the user, with effects on the public health
impact of the product. It is possible that in some other circumstances,
a change in filter would not have results that would affect the public
health impact of the product.
     A change in container closure system for a moist smokeless
tobacco product, because FDA would need scientific information to
determine, for example, whether or not such differences could result in
a change in tobacco product stability that would increase HPHC levels
and exposures to the user.
     A change in characterizing flavor in the new product
because FDA would need scientific information to determine, for
example, whether or not such differences could affect use behaviors.
    FDA notes that these examples are illustrative only and are not
intended to convey that any differences specific to an individual case
would or would not be appropriate to proceed through the ``different
characteristics'' approach or result in a determination of SE.
    When a new product has different characteristics, FDA would
evaluate whether the difference(s) in characteristics, individually and
in the aggregate, do not cause the new product to raise different
questions of public health. In determining if a new product raises
different questions of public health, FDA may consider, among other
things, whether one or more of the following is the case, as compared
to the predicate product, (1) the new product has the potential to
increase HPHC yields, and, if so, the degree of such an increase; (2)
the new product has the potential to increase toxicity; (3) the new
product has the potential to increase initiation; (4) the new product
has the potential to increase abuse liability; (5) the new product has
the potential to increase dependence; or (6) the new product has the
potential to decrease cessation. Based on this analysis, FDA will
determine whether the applicant has demonstrated that any differences
do not cause the new product to raise different questions of public
health.
    Please note that FDA is including these examples based on the
Agency's experience to date in reviewing SE reports, and for purposes
of soliciting comments on this approach, and FDA will continue to
review each SE Report and make an SE determination on the basis of the
information included in that SE Report. FDA invites comment on the
terms ``same characteristics'' and ``different characteristics,'' the
potential approach discussed above, and any alternative approaches to
interpretation of these terms, including examples of new tobacco
products that would have the ``same characteristics'' as the predicate,
as well as new tobacco products that would have ``different
characteristics'' from the predicate. While the rule proposes that
certain information would be required for reports submitted under
either the same characteristics or different characteristics prong, we
welcome comments on what information would need to be included under
either or both prongs if the approach described above, or an
alternative approach, is implemented. FDA also invites comment on how
we might evaluate different questions of public health. In your
comment, please include your reasoning for how you would distinguish
the scope of the same characteristics prong from the different
characteristics prong, i.e., when an applicant might claim that a
proposed new tobacco product is substantially equivalent to a predicate
tobacco product because it has the ``same'' characteristics. FDA will
consider all comments and will seek to provide additional clarity in
the final rule, if possible.
     Tobacco product. As defined in section 201(rr) of the FD&C
Act (21 U.S.C. 321(rr)), the term ``tobacco product'' means any product
that is made or derived from tobacco that is intended for human
consumption, including any component, part, or accessory of a tobacco
product (except for raw materials other than tobacco used in
manufacturing a component, part, or accessory of a tobacco product).
The term ``tobacco product'' does not mean an article that is a drug
under section 201(g)(1), a device under section 201(h), or a
combination product described in section 503(g) of the FD&C Act (21
U.S.C. 353(g)). As explained in the definition of ``new tobacco
product,'' FDA 's interpretation is that the tobacco product
encompasses the whole product and is not limited to a single unit or
portion of the whole product.
     Tobacco product manufacturer. As defined in section
900(20) of the FD&C Act, the term ``tobacco product manufacturer''
means any person, including a 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: (a) Repackaging or otherwise changing the container,
wrapper, or labeling of any tobacco product package; (b) reconstituting
tobacco leaves; or (c) 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:
     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:
    [cir] Is not intended or reasonably expected to affect or alter the
performance, composition, constituents, or characteristics of a tobacco
product; or
    [cir] Is intended or reasonably expected to affect or maintain the
performance, composition, constituents, or characteristics of a tobacco
product but solely controls moisture and/or temperature of a stored
product; or solely provides an external heat source to initiate but not
maintain combustion of a tobacco product.
    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. This proposed definition is also in accord with
the definition included in the Deeming final rule.
     Applicant. FDA proposes to define ``applicant'' as any
manufacturer of tobacco products who is subject to chapter IX of the
FD&C Act that submits a premarket application to receive marketing
authorization for a new tobacco product. For the purposes of part 1107,
a premarket application refers to an SE Report or an exemption request.
     Commercial distribution. FDA proposes to define
``commercial distribution'' as any distribution of a tobacco product to
consumers or to another person through sale or otherwise. This term
does not include transfers of a tobacco product between registered
establishments within the same parent, subsidiary, and/or affiliate
company, nor does it include providing a tobacco product for product
testing where such products are not made available for consumption or
resale. This term would exclude the handing or transfer of a tobacco
product from one consumer to another for personal consumption. For
foreign establishments, the term ``commercial distribution'' has the
same meaning except the term does not include distribution of any
tobacco products that are neither imported nor offered for import into
the United States. This term is intended to include a tobacco product
that is test marketed after February 15, 2007, and this term would
encompass distribution of free samples (e.g., smokeless products). FDA
intends to limit our enforcement of the requirements of section 910 and
905(j) to finished tobacco products (see the Guidance for Industry and
FDA Staff entitled ``Section 905(j) Reports: Demonstrating Substantial
Equivalence for Tobacco Products'' (76 FR 789, January 6, 2011); see
also Deeming final rule, 81 FR at 29019).
     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 would also be 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 and approach are in
accord with the Deeming final rule. FDA invites comments on this
approach.
     Composition. FDA proposes to define ``composition'' as all
of the materials in a tobacco product, including ingredients,
additives, and biological organisms. The term also includes the manner
in which these ingredients, additives, biological organisms, etc., 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.
     Constituent. FDA proposes to define ``constituent'' as any
chemical or chemical compound in a tobacco product that is or
potentially is inhaled, ingested, or absorbed into the body, any
chemical or chemical compound in an emission from a tobacco product, or
any chemical or chemical compound in mainstream or sidestream tobacco
smoke that either transfers from any component of the tobacco product
to the smoke or that is formed by the combustion or heating of tobacco,
additives, or other component of the tobacco product. 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.
     Container closure system. FDA proposes to define
``container closure system'' as any packaging materials that are a
component or part of a tobacco product.
    Examples of 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. In the context of determining whether a product
is substantially equivalent as defined in section 910(a)(3)(A) of the
FD&C Act, 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. For example, if a change in the
container closure system could affect the chemistry of the product, FDA
could require the applicant to demonstrate that the change in the
container closure system does not cause the new tobacco product to
raise different questions of public health. Although the FD&C Act does
not itself define ``component'' or ``part,'' FDA recently promulgated
definitions for these terms in the Deeming final rule. According to 21
CFR 1100.3, ``component or part'' means 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.\5\ The same definitions are also reflected in
this rule's proposed Sec.  1107.12.
---------------------------------------------------------------------------

    \5\ ``Accessory'' is defined 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 solely controls moisture and/or temperature of a
stored tobacco product or solely provides an external heat source to
initiate but not maintain combustion of a tobacco product (Sec.
1100.3).
---------------------------------------------------------------------------

    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 900(1) of the FD&C Act defines an
``additive'' as any substance the intended use of which results or may
reasonably be expected to result, directly or indirectly, in its
becoming a component or otherwise affecting the characteristic of any
tobacco product (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. This definition
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 a
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 a container closure system if substances within
that packaging are intended or reasonably expected to affect product
moisture, e.g., when the manufacturer changes the package of a moist
snuff from plastic to fiberboard, which can affect microbial stability
and TSNA formation during storage. Another example of this is when
menthol or other ingredients are applied to the inner foil to become
incorporated into the consumed product (Ref. 1). Packaging materials
may also be intended or reasonably expected to affect the
characteristics of a tobacco product by impacting the rate of leaching
into, and ultimately, the amount of substances found in, the consumable
tobacco product. In fact, it has been demonstrated that compounds in
packaging materials may also diffuse into snuff and affect its
characteristics (Ref. 2). Thus, for example, packaging material that
affects the characteristics of a tobacco product by impacting the
moisture level or shelf life of a tobacco product is a container
closure system (e.g., a plastic versus a metal container of smokeless
tobacco). A difference in tobacco moisture is reasonably expected to
affect microbial growth in the product, extraction efficiency, and
total exposure to nicotine or the carcinogens N-nitrosonornicotine
(NNN) or 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) (Ref.
26).
    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 any substance that may be reasonably
expected to result, directly or indirectly, in its 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 a 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, the Agency's ability to evaluate
whether the differences between the new and predicate tobacco product
cause the new tobacco product to raise different questions of public
health would be impeded, thereby leaving the Agency unable to fully
execute its mission to protect the public health.
     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. Examples of design features include tip ventilation,
paper porosity, tobacco cut width, and filter efficiency.
     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).
     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 phrase ``as of February 15,
2007,'' as meaning that the tobacco product was commercially marketed
in the United States ``on February 15, 2007,'' and the proposed
definition reflects this interpretation (see the final guidance
entitled ``Establishing That a Tobacco Product Was Commercially
Marketed in the United States as of February 15, 2007'' (79 FR 58358,
September 29, 2014)). A grandfathered tobacco product is not subject to
the premarket requirements of section 910 of the FD&C Act.
     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 that potentially could be inhaled,
ingested, or absorbed into the body, including as an aerosol (vapor) or
any other emission and (2) causes or has the potential to cause direct
or indirect harm to users or nonusers of tobacco products.
    FDA has previously discussed HPHCs in FDA guidance documents (see
the final guidance entitled ``Harmful and Potentially Harmful
Constituents' in Tobacco Products as Used in Section 904(e) of the
Federal Food, Drug, and Cosmetic Act'' (76 FR 5387, January 31, 2011;
revised guidance issued August 2016)). The current established list of
HPHCs can be found on FDA's website at https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm297786.htm (77 FR
20034, April 3, 2012). In addition, since the inception of the SE
program for tobacco products, HPHCs have been considered ``other
features,'' and the proposed definition of ``other features'' in this
rule would include HPHCs (see the final guidance entitled ``Section
905(j) Reports: Demonstrating Substantial Equivalence for Tobacco
Products,'' (January 5, 2011)).
     Health information summary. FDA proposes to define
``health information summary'' to mean a summary, submitted by the
applicant under section 910(a)(4) of the FD&C Act, of any health
information related to the new tobacco product. This would

include detailed information concerning adverse health effects of the
new tobacco product. For example, information concerning adverse health
effects includes specific adverse events that have been reported to the
applicant and also includes any research or data concerning adverse
health effects of which the applicant is aware.
     Health information statement. FDA proposes to define
``health information statement'' to mean a statement, made under
section 910(a)(4) of the FD&C Act that health information related to
the new tobacco product would be made available upon request by any
person. Like the health information summary, the health information
provided to a person requesting it would be required to include any
health information related to the new tobacco product, including
detailed information regarding data concerning adverse health effects
of the new tobacco product.
     Heating source. FDA proposes to define ``heating source''
as the source of energy that is used to burn or heat a tobacco product.
An example of a heating source is a flame.
     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. 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:
    [cir] The reaction of sugars with amines to form families of
compounds with new carbon-nitrogen bonds, including Maillard reaction
products and Amadori compounds.
    [cir] The reaction of sodium hydroxide with citric acid to form
sodium citrate.
    [cir] The production of ethyl alcohol, a residual solvent, from
ethyl acetate during production of tipping paper adhesive.
    [cir] Products of thermolytic reactions, such as the production of
carboxylic acids from sugar esters.
    [cir] Products of enzymatically or nonenzymatically catalyzed
reactions, such as the hydrolytic production of flavor or aroma
precursors from nonvolatile glucosides.
    [cir] Products of acid-base reactions, such as removal of a proton
from protonated nicotine to generate the basic form of nicotine
(``free'' nicotine).
     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 products. 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).
     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.
The definition would include: (1) HPHCs (note that the definition of
new tobacco product includes any modification to any constituents,
including smoke constituents, section 910(a)(1)(B) of the FD&C Act) and
(2) any other product characteristics that relate to the chemical,
biological, and physical properties of the tobacco product that are
necessary for SE Report review. As described in the proposed definition
of HPHC, HPHC information is necessary to provide a complete comparison
between the new and predicate tobacco products: HPHCs are a subset of
the chemical and chemical compounds in a tobacco product or tobacco
smoke or emission. As such, HPHC information for the new and predicate
tobacco products is necessary for FDA to determine whether the new
tobacco product raises different questions of public health. Other
features also would encompass other product characteristics that relate
to the chemical, biological, and physical properties that would not be
addressed as a material, ingredient, design, composition, or heating
source.
     Predicate tobacco product. FDA proposes to define
``predicate tobacco product'' to mean a tobacco product that is a
grandfathered tobacco product or a tobacco product that FDA has
previously found to be substantially equivalent under section
910(a)(2)(A)(i) of the FD&C Act. This proposed definition is also based
on language in section 905(j)(1)(A)(i) of the FD&C Act.
     Submission tracking number or STN means the number that
FDA assigns to submissions that are received from a manufacturer of
tobacco products, such as SE Reports and requests for grandfather
determinations.
     Substantial equivalence report or SE Report. FDA proposes
to define ``substantial equivalence report'' (also known as a 905(j)
report) or SE Report to mean a submission under section 905(j)(1)(A)(i)
of the FD&C Act that includes the basis for the applicant's
determination that a new tobacco product is substantially equivalent to
a predicate tobacco product. This term includes the initial SE Report
and all subsequent amendments (e.g., amendments include information an
applicant submits in response to a deficiency letter).

B. Substantial Equivalence Reports (Proposed Subpart C)

1. Submission of a Substantial Equivalence Report (Proposed Sec.
1107.16)
    Proposed Sec.  1107.16 explains the basic timeframes that would be
required for submitting an SE Report to FDA before commencing
commercial distribution of a new tobacco product. An applicant may
submit an SE Report to demonstrate that a new tobacco product is
substantially equivalent to a predicate tobacco product (an applicant
could also consider whether the exemption under Sec.  1107.1 or an
application under section 910(b) of the FD&C Act is a more appropriate
premarket pathway for the applicant's new tobacco product). If an
applicant chooses to submit an SE Report for a new tobacco product, it
must do so at least 90 calendar days before the date the applicant
intends to begin commercial distribution of the product (see section
905(j)(1) of the FD&C Act). The proposed rule also provides that an
applicant may not begin commercial distribution of the new tobacco
product that is the subject of the SE Report until FDA has issued an
order stating that the Agency has determined that the new tobacco
product is substantially equivalent to a predicate tobacco product
(unless the new tobacco product has received authorization to be
marketed through another premarket pathway, i.e., PMTA or exemption
from substantial equivalence). Otherwise, the new tobacco product is
both adulterated and misbranded (sections 902(6)(A) and 903(a)(6) of
the FD&C Act) and subject to enforcement action.
2. Required Content and Format of an SE Report (Proposed Sec.  1107.18)
    Since March 22, 2011 (the date that SE Reports for provisional
tobacco products were required to be submitted), FDA has gained
considerable experience in reviewing more than 3,000 SE Reports
submitted under sections 905(j) and 910(a) of the FD&C Act. As a
result, FDA has identified information essential to the review of SE
Reports, which is reflected

in the content and format requirements of proposed Sec.  1107.18.
    a. Overview. Proposed Sec.  1107.18(a) provides an overview of the
requirements for the content and format of an SE Report. Proposed Sec.
1107.18(a) would provide that the SE Report include information that
would enable FDA to uniquely identify the new tobacco product and the
predicate tobacco product and compare the new tobacco product to a
predicate tobacco product. This information is necessary for FDA both
in reviewing the SE Report so that we can understand the comparison and
also to issue an order that appropriately identifies the tobacco
product that is subject to the order. Providing sufficient information
as described in proposed Sec.  1107.18 would help enable FDA to
determine whether the new tobacco product is substantially equivalent
to a tobacco product commercially marketed in the United States as of
February 15, 2007 (as required by section 910(a)(2)(A) of the FD&C
Act).
    The proposed provision would require that the SE Report contain the
following elements:
     General information (described in proposed Sec.
1107.18(c));
     Summary (described in proposed Sec.  1107.18(d));
     New tobacco product description (described in proposed
Sec.  1107.18(e));
     Predicate tobacco product description (described in
proposed Sec.  1107.18(f)). This would include a statement that the
predicate tobacco product has not been removed from the market at the
initiative of FDA and has not been determined by judicial order to be
adulterated or misbranded, and the STN of the SE order finding the
predicate tobacco product SE, or the STN of, or specific information
sufficient to support, a grandfathered determination of the predicate
tobacco product. If the SE Report includes information on the
grandfathered status of the predicate tobacco product (but FDA has not
yet made a grandfathered determination \6\), FDA would make the
grandfathered determination before beginning substantive scientific
review of the SE Report to ensure that the predicate tobacco product is
valid;
---------------------------------------------------------------------------

    \6\ FDA discusses the information the Agency will consider,
along with Agency's general thinking on grandfathered
determinations, in the guidance document, ``Establishing That a
Tobacco Product Was Commercially Marketed in the United States as of
February 15, 2007'' (79 FR 58358, September 29, 2014).
---------------------------------------------------------------------------

     Comparison information (described in proposed Sec.
1107.18(g));
     Comparative testing information (described in proposed
Sec.  1107.18(h))
     Statement of compliance with applicable tobacco product
standards under section 907 of the FD&C Act (21 U.S.C. 387g) (described
in proposed Sec.  1107.18(i));
     Health summary or statement regarding the availability of
such information as required by section 910(a)(4) of the FD&C Act
(described in proposed Sec.  1107.18(j));
     Compliance with part 25 (21 CFR part 25) (environmental
impact considerations) (described in proposed Sec.  1107.18(k)); and
     Certification statement (described in proposed Sec.
1107.18(l)).
    If the SE Report were missing any of these items, the Agency would,
under proposed Sec.  1107.44(a), refuse to accept the SE Report for
review.
    b. General Format. Proposed Sec.  1107.18(b) provides the general
requirements for the format of the SE Report and would require the
applicant to submit the SE Report with the appropriate FDA form (Refs.
3 and 4). Proposed Sec.  1107.18(b) would require the SE Report and any
amendments to contain a comprehensive index and table of contents and
be well organized, legible, and written in the English language. For
any foreign language documents, the original foreign language document
must be accompanied by the English translation and a certification by
the applicant or responsible official authorized to represent the
applicant that the translation into English is accurate. The
comprehensive index would include the listing of files and data
associated with those files (e.g., for an SE Report that is
electronically submitted, the comprehensive index would include the
listing of files and associated metadata).
    As described in proposed Sec.  1107.62, FDA is proposing that, for
an SE Report and supporting documents to be accepted by FDA, the SE
Report and documents must be submitted to FDA in an electronic format
that the Agency can process, read, review, and archive, unless the
Agency has previously granted a waiver from these requirements. FDA
will not act on an SE Report until the Center for Tobacco Product's
(CTP's) Document Control Center has received an SE Report that the
Agency can process, read, review, and archive. Applicants that are
unable to submit their reports in electronic format would be advised to
consult proposed Sec.  1107.62, which explains how the applicant may
obtain a waiver from the electronic filing requirement. FDA intends to
provide information on our website about technical specifications
related to submission, including the electronic formats, which would
allow FDA to process, read, review, and archive the SE Report.
Providing technical specifications information on our website enables
FDA to periodically update the electronic formats that we are capable
of accepting so that we can accommodate quickly evolving technology.
    The requirements in proposed Sec.  1107.18(b) and 1107.62 are
intended to address some of the problems we have seen with SE Reports.
For example, some SE Reports have been submitted to FDA in a
proprietary format or password protected 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, re-bullet, or re-date each time
the document is accessed. Receiving SE Reports with these issues
affects our ability to cross-reference, share, 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 Record Administration Bulletin
2014-04, https://www.archives.gov/records-mgmt/bulletins/2014/2014-04.html), proposed Sec.  1107.18(b) would ensure that these files can
be managed, opened, and read by the Agency for the duration of the
retention period.
    c. General information. Proposed Sec.  1107.18(c) lists the
information that the SE Report would be required to include. This
information includes general administrative information that must
specify the type of submission (e.g., SE Report); the new tobacco
product with unique identification and the predicate tobacco product
with unique identification (to enable us to identify the new tobacco
product as well as identify the predicate product), as well as contact
information. The SE Report must include the following information using
the FDA-provided forms, as appropriate:
     The date the SE Report is submitted (using the applicant-
generated submittal date, i.e., the date the applicant assigns to it,
which for a paper submission is the date typically located at the top
of a cover letter, and for an electronic submission is the date when
the document is uploaded to FDA's electronic submission system);
     Type of submission (e.g., SE Report or amendment to an SE
Report);
     Previously assigned FDA STN, where applicable (e.g., in
cases where

the applicant is submitting an amendment to an SE Report, the Agency
has assigned a number in advance, or the applicant is referencing a
previously denied SE Report);
     Any other relevant FDA STN, such as a request for a
grandfathered determination, and cross-references to meetings regarding
the new tobacco product (e.g., if FDA issues an order denying marketing
authorization for a tobacco product and meets with the applicant about
it before the applicant submits a new SE Report, the meeting should be
referenced in the new SE Report);
     The name, address, and contact information for the
applicant and the authorized representative or authorized U.S. agent
(for a foreign applicant). FDA would require identification of an
authorized representative or, for foreign applicants, authorized U.S.
agent to help FDA ensure adequate notice is provided to applicants of
official Agency communications. In particular, FDA may be unable to
confirm that adequate notice of Agency action or correspondence
concerning premarket submissions is provided to foreign applicants as
FDA cannot necessarily confirm receipt of correspondence sent
internationally. Accordingly, the designation of a U.S. agent provides
an official contact to the Agency who can receive the information or
documentation on behalf of the applicant. Providing notice regarding
that SE Report to the U.S. agent would constitute notice to the foreign
applicant. FDA requires identification of a U.S. agent to assist FDA in
communicating with the foreign applicant and help permit the Agency to
efficiently process SE Reports and avoid delays. In many instances
during the SE Report review process, FDA has reached out numerous times
to a foreign applicant and has either been unable to speak with the
applicant or was unable to directly communicate questions and/or
concerns. This impediment has resulted in delays or terminations in the
review of specific SE Reports and a slowdown of the premarket
application process as a whole. A U.S. agent would act as a
communications link between FDA and the applicant and would facilitate
timely correspondence between FDA and foreign applicants, including
responding to questions concerning pending applications and, if needed,
assisting FDA in scheduling meetings with the foreign applicants to
resolve outstanding issues before agency action is taken. In addition,
the authorized representative or U.S. agent would be authorized to act
on behalf of the applicant for that specific SE Report.
     For both the new and predicate tobacco product,
information needed to uniquely identify the products, including:
    [cir] The manufacturer;
    [cir] Product name, including the brand and sub brand;
    [cir] Product category; product subcategory; and product
properties, as provided in table 2. The applicant would select and
provide for both the new and predicate tobacco products the appropriate
category, subcategory, and product properties (if the product does not
have a listed product property, e.g., ventilation or characterizing
flavor, the report must state ``none'' for that property):

 Table 2--Tobacco Product Category, Subcategory, and Product Properties
                               Information
------------------------------------------------------------------------
                                 Tobacco product
   Tobacco product category        subcategory       Product properties
------------------------------------------------------------------------
Cigarettes....................  Combusted,         --Package type (e.g.,
                                 Filtered.          hard pack, soft
                                                    pack, clam shell).
                                                   --Product quantity
                                                    (e.g., 20
                                                    cigarettes, 25
                                                    cigarettes).
                                                   --Length (e.g., 89
                                                    millimeter (mm), 100
                                                    mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Ventilation (e.g.,
                                                    none, 10%, 25%).
                                                   --Characterizing
                                                    Flavor(s) \7\ (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Combusted, non-    --Package type (e.g.,
                                 filtered.          hard pack, soft
                                                    pack, clam shell).
                                                   --Product quantity
                                                    (e.g., 20
                                                    cigarettes, 25
                                                    cigarettes).
                                                   --Length (e.g., 89
                                                    mm, 100 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Characterizing
                                                    Flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Combusted, Other.  --Package type (e.g.,
                                                    hard pack, soft
                                                    pack, clam shell).
                                                   --Product quantity
                                                    (e.g., 20
                                                    cigarettes, 25
                                                    cigarettes).
                                                   --Length (e.g., 89
                                                    mm, 100 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Ventilation (e.g.,
                                                    none, 10%, 25%).
                                                   --Characterizing
                                                    Flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Non-Combusted      --Package type (e.g.,
                                 (e.g., a           hard pack, soft
                                 cigarette where    pack, clam shell).
                                 the tobacco is
                                 only heated not
                                 burned).
                                                   --Product quantity
                                                    (e.g., 20
                                                    cigarettes, 25
                                                    cigarettes).
                                                   --Length (e.g., 89
                                                    mm, 100 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Ventilation (e.g.,
                                                    none, 10%, 25%).
                                                   --Characterizing
                                                    Flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Source of energy
                                                    (e.g., charcoal,
                                                    electrical heater).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Cigarette, Co-     --For a new co-
                                 Package.           packaged tobacco
                                                    product composed of
                                                    multiple cigarette
                                                    tobacco products,
                                                    include, as
                                                    applicable, all
                                                    properties for each
                                                    individual tobacco
                                                    product, as
                                                    identified above.
Roll-Your-Own (RYO) Tobacco     RYO Tobacco        --Package type (e.g.,
 Products.                       Filler.            bag, pouch).

                                                   --Product quantity
                                                    (e.g., 20 g, 40 g).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Rolling Paper....  --Package type (e.g.,
                                                    bag, box, booklet).
                                                   --Product quantity
                                                    (e.g., 50 sheets,
                                                    200 papers).
                                                   --Length (e.g., 79
                                                    mm, 100 mm, 110 mm).
                                                   --Width (e.g., 28 mm,
                                                    33 mm, 45 mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Filtered           --Package type (e.g.,
                                 Cigarette Tube.    bag, box).
                                                   --Product quantity
                                                    (e.g., 100 tubes,
                                                    200 tubes).
                                                   --Length (e.g., 89
                                                    mm, 100 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Ventilation (e.g.,
                                                    none, 10%, 25%).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Non-Filtered       --Package type (e.g.,
                                 Cigarette Tube.    bag, box).
                                                   --Product quantity
                                                    (e.g., 100 tubes,
                                                    200 tubes).
                                                   --Length (e.g., 89
                                                    mm, 100 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Filter...........  --Package type (e.g.,
                                                    bag, box).
                                                   --Product quantity
                                                    (e.g., 100 filters,
                                                    200 filters).
                                                   --Length (e.g., 8 mm,
                                                    12 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Ventilation (e.g.,
                                                    none, 10%, 25%).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Paper Tip........  --Package type (e.g.,
                                                    bag, box).
                                                   --Product quantity
                                                    (e.g., 200 tips, 275
                                                    tips).
                                                   --Length (e.g., 12
                                                    mm, 15 mm).
                                                   --Width (e.g., 27
                                                    mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                RYO Co-Package...  --For a new co-
                                                    packaged tobacco
                                                    product composed of
                                                    multiple RYO tobacco
                                                    products, include,
                                                    as applicable, all
                                                    properties for each
                                                    individual tobacco
                                                    product (e.g., RYO
                                                    tobacco, rolling
                                                    paper, filtered
                                                    cigarette tube, non-
                                                    filtered cigarette
                                                    tube, filter, paper
                                                    tip) as identified
                                                    above.
                                Other............  --Package type (e.g.,
                                                    bag, box).
                                                   --Product quantity.
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product.
Smokeless Tobacco Products....  Loose Moist Snuff  --Package type (e.g.,
                                                    plastic can with
                                                    metal lid, plastic
                                                    can with plastic
                                                    lid).
                                                   --Product quantity
                                                    (e.g., 20 grams (g),
                                                    2 ounces).
                                                   --Tobacco cut size
                                                    (e.g., 5 mm, 7 mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cherry,
                                                    wintergreen).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Portioned Moist    --Package type (e.g.,
                                 Snuff.             plastic can with
                                                    metal lid, plastic
                                                    can with plastic
                                                    lid).
                                                   ----Product quantity
                                                    (e.g., 22.5 g, 20
                                                    g).
                                                   --Portion count
                                                    (e.g., 15 pouches,
                                                    20 pieces).
                                                   --Portion mass (e.g.,
                                                    1.5 g/pouch, 2 g/
                                                    piece).
                                                   --Portion length
                                                    (e.g., 15 mm, 20
                                                    mm).
                                                   --Portion width
                                                    (e.g., 10 mm, 15
                                                    mm).
                                                   --Portion thickness
                                                    (e.g., 5 mm, 7 mm).
                                                   --Tobacco cut size
                                                    (e.g., 5 mm, 7 mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cherry,
                                                    wintergreen).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Loose Snus.......  --Package type (e.g.,
                                                    plastic can with
                                                    metal lid, plastic
                                                    can with plastic
                                                    lid).

                                                   --Product quantity
                                                    (e.g., 20 g, 2
                                                    ounces).
                                                   --Tobacco cut size
                                                    (e.g., 5 mm, 7 mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cherry,
                                                    wintergreen).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Portioned Snus...  --Package type (e.g.,
                                                    plastic can with
                                                    metal lid, plastic
                                                    can with plastic
                                                    lid).
                                                   --Product quantity
                                                    (e.g., 22.5 g, 20
                                                    g).
                                                   --Portion count
                                                    (e.g., 15 pouches,
                                                    20 pieces).
                                                   --Portion mass (e.g.,
                                                    1.5 g/pouch, 2 g/
                                                    piece).
                                                   --Portion length
                                                    (e.g., 15 mm, 20
                                                    mm).
                                                   --Portion width
                                                    (e.g., 10 mm, 15
                                                    mm).
                                                   --Portion thickness
                                                    (e.g., 5 mm, 7 mm).
                                                   --Tobacco cut size
                                                    (e.g., 5 mm, 7 mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cherry,
                                                    wintergreen).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Loose Dry Snuff..  --Package type (e.g.,
                                                    plastic can with
                                                    metal lid, plastic
                                                    can with plastic
                                                    lid).
                                                   --Product quantity
                                                    (e.g., 20 g, 2
                                                    ounces).
                                                   --Tobacco cut size
                                                    (e.g., 0.05 mm, 0.07
                                                    mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cherry,
                                                    wintergreen).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Dissolvable......  --Package type (e.g.,
                                                    plastic can with
                                                    metal lid, plastic
                                                    can with plastic
                                                    lid).
                                                   --Product quantity
                                                    (e.g., 22.5 g, 20
                                                    g).
                                                   --Portion count
                                                    (e.g., 15 sticks, 20
                                                    tablets).
                                                   --Portion mass (e.g.,
                                                    1.5 g/strip, 1.0 g/
                                                    piece).
                                                   --Portion length
                                                    (e.g., 10 mm, 15
                                                    mm).
                                                   --Portion width
                                                    (e.g., 5 mm, 8 mm).
                                                   --Portion thickness
                                                    (e.g., 3 mm, 4 mm).
                                                   --Tobacco cut size
                                                    (e.g., 0.05 mm, 0.07
                                                    mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cherry,
                                                    wintergreen).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Loose Chewing      --Package type (e.g.,
                                 Tobacco.           bag, pouch,
                                                    wrapped).
                                                   --Product quantity
                                                    (e.g., 20 g, 3
                                                    ounces).
                                                   --Tobacco cut size
                                                    (e.g., 0.05 mm, 0.07
                                                    mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cherry,
                                                    wintergreen).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Portioned Chewing  --Package type (e.g.,
                                 Tobacco.           plastic can with
                                                    metal lid, plastic
                                                    can with plastic
                                                    lid).
                                                   --Product quantity
                                                    (e.g., 20 g).
                                                   --Portion count
                                                    (e.g., 10 bits).
                                                   --Portion mass (e.g.,
                                                    2 g/bit).
                                                   --Portion length
                                                    (e.g., 8 mm, 10 mm).
                                                   --Portion width
                                                    (e.g., 6 mm, 8 mm).
                                                   --Portion thickness
                                                    (e.g., 5 mm, 7 mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cherry,
                                                    wintergreen).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Smokeless Co-      --For a new co-
                                 Package.           packaged tobacco
                                                    product composed of
                                                    multiple smokeless
                                                    tobacco products,
                                                    include, as
                                                    applicable, all
                                                    properties for each
                                                    individual tobacco
                                                    product as
                                                    identified above.
                                Other............  --Package type (e.g.,
                                                    bag, box).
                                                   --Product quantity.
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product.
ENDS (Electronic Nicotine       Open E-Liquid      --Package type (e.g.,
 Delivery System).               (e.g., an e-       bottle, box).
                                 liquid in a
                                 bottle with a
                                 removable cap).
                                                   --Product quantity
                                                    (e.g., 1 bottle, 5
                                                    bottles).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol, cherry,
                                                    wintergreen).
                                                   --E-liquid volume
                                                    (e.g., 10 ml).
                                                   --Nicotine
                                                    concentration (e.g.,
                                                    0, 0.2 mg/ml).
                                                   --PG/VG ratio (e.g.,
                                                    N/A, 0/100, 50/50).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).

                                Closed E-Liquid    --Package type (e.g.,
                                 (e.g., a sealed    cartridge).
                                 cartridge for
                                 use in an e-
                                 cigarette).
                                                   --Product quantity
                                                    (e.g., 1 cartridge,
                                                    5 cartridges).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol, cherry,
                                                    wintergreen).
                                                   --E-liquid volume
                                                    (e.g., 10 ml).
                                                   --Nicotine
                                                    concentration (e.g.,
                                                    0, 0.2 mg/ml).
                                                   --PG/VG ratio (e.g.,
                                                    N/A, 0/100, 50/50).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Closed E-          --Package type (e.g.,
                                 Cigarette (e.g.,   box, none, plastic
                                 a cigalike).       clamshell).
                                                   --Product quantity
                                                    (e.g., 1 e-
                                                    cigarette, 5 e-
                                                    cigarettes).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol, cherry,
                                                    wintergreen).
                                                   --Length (e.g., 100
                                                    mm, 120 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8 mm).
                                                   --E-liquid volume
                                                    (e.g., 2 ml, 5 ml).
                                                   --Nicotine
                                                    concentration (e.g.,
                                                    0, 0.2 mg/ml).
                                                   --PG/VG ratio (e.g.,
                                                    N/A, 0/100, 50/50).
                                                   --Wattage (e.g., 100
                                                    W, 200 W).
                                                   --Battery capacity
                                                    (e.g., 100 mAh, 200
                                                    mAh).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product.
                                Open E-Cigarette   --Package type (e.g.,
                                 (e.g., a tank      box, none, plastic
                                 system).           clamshell).
                                                   --Product quantity
                                                    (e.g., 1 e-
                                                    cigarette, 5 e-
                                                    cigarettes).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol, cherry,
                                                    wintergreen).
                                                   --Length (e.g., 100
                                                    mm, 120 mm).
                                                   --Diameter (e.g., 8
                                                    mm, 14 mm).
                                                   --E-liquid volume
                                                    (e.g., 2 ml, 5 ml).
                                                   --Wattage (e.g., 100
                                                    W, 200 W).
                                                   --Battery capacity
                                                    (e.g., 100 mAh, 200
                                                    mAh).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                ENDS Component...  --Package type (e.g.,
                                                    box, none, plastic
                                                    clamshell).
                                                   --Product quantity
                                                    (e.g., 1 e-
                                                    cigarette, 5 e-
                                                    cigarettes).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol, cherry,
                                                    wintergreen).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                ENDS Co-Package..  --For a new co-
                                                    packaged tobacco
                                                    product composed of
                                                    multiple ENDS
                                                    tobacco products,
                                                    include, as
                                                    applicable, all
                                                    properties for each
                                                    individual tobacco
                                                    product as
                                                    identified above.
                                ENDS Other.......  --Package type (e.g.,
                                                    bag, box).
                                                   --Product quantity.
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol, cherry).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product.
Cigars........................  Filtered, Sheet-   --Package type (e.g.,
                                 Wrapped Cigar.     hard pack, soft
                                                    pack, clam shell).
                                                   --Product quantity
                                                    (e.g., 20 filtered
                                                    cigars, 25 filtered
                                                    cigars).
                                                   --Characterizing
                                                    flavor (e.g., none,
                                                    menthol).
                                                   --Length (e.g., 89
                                                    mm, 100 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Ventilation (e.g.,
                                                    none, 10%, 25%).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Unfiltered, Sheet- --Package type (e.g.,
                                 Wrapped Cigar.     box, film sleeve).
                                                   --Product quantity
                                                    (e.g., 1 cigar, 5
                                                    cigarillos).
                                                   --Characterizing
                                                    flavor (e.g., none,
                                                    menthol).
                                                   --Length (e.g., 100
                                                    mm, 140 mm).
                                                   --Diameter (e.g., 8
                                                    mm, 10 mm).
                                                   --Tip (e.g., none,
                                                    wood tips, plastic
                                                    tips).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Leaf-Wrapped       --Package type (e.g.,
                                 Cigar.             box, film, sleeve,
                                                    none).
                                                   --Product quantity
                                                    (e.g., 1 cigar, 5
                                                    cigars).
                                                   --Characterizing
                                                    flavor (e.g., none,
                                                    whiskey).
                                                   --Length (e.g., 150
                                                    mm, 200 mm).
                                                   --Diameter (e.g., 8
                                                    mm, 10 mm).

                                                   --Wrapper material
                                                    (e.g., burley
                                                    tobacco leaf,
                                                    Connecticut shade
                                                    grown tobacco leaf).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Cigar Component..  --Package type (e.g.,
                                                    box, booklet).
                                                   --Product quantity
                                                    (e.g., 10 wrappers,
                                                    20 leaves).
                                                   --Characterizing
                                                    flavor (e.g., none,
                                                    menthol, cherry).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Cigar Tobacco      --Package type (e.g.,
                                 Filler.            bag, pouch).
                                                   --Product quantity
                                                    (e.g., 20 g, 16
                                                    ounces).
                                                   --Characterizing
                                                    flavor (e.g., none,
                                                    tobacco, menthol,
                                                    cherry).
                                                   --Tobacco cut size
                                                    (e.g., 5 mm, 10 mm).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Cigar Co-Package.  --For a new co-
                                                    packaged tobacco
                                                    product composed of
                                                    multiple cigar
                                                    tobacco products,
                                                    include, as
                                                    applicable, all
                                                    properties for each
                                                    individual tobacco
                                                    product as