[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Proposed Rules]
[Pages 12740-12791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05787]
[[Page 12739]]
Vol. 84
Tuesday,
No. 63
April 2, 2019
Part III
Department of Health and Human Services
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Food and Drug Administration
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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
[[Page 12740]]
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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.
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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, 877-287-1373,
[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
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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.
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Table 1--Summary of Annualized Costs and Benefits of the Proposed Rule
[$2016 over 10 years]
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Low (3%) Medium (3%) High (3%) Low (7%) Medium (7%) High (7%)
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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
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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.
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\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.
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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.
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\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.
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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
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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.,
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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
[[Page 12745]]
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
[[Page 12746]]
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
[[Page 12747]]
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
[[Page 12748]]
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
[[Page 12749]]
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
[[Page 12750]]
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).
[[Page 12751]]
--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).
[[Page 12752]]
--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).
[[Page 12753]]
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).
[[Page 12754]]
--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
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.
Pipe Tobacco Products......... Pipe............. --Package type (e.g.,
box, none).
--Product quantity
(e.g., 1 pipe).
--Length (e.g., 200
mm, 300 mm).
--Diameter (e.g., 25
mm).
--Characterizing
flavor(s) (e.g.,
none, menthol).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
Pipe Tobacco --Package type (e.g.,
Filler. bag, pouch).
--Product quantity
(e.g., 20 g, 16
ounces).
--Characterizing
flavor(s) (e.g.,
none, menthol,
Cavendish, cherry).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
Pipe Component... --Package type (e.g.,
bowl, shank, stem,
screen, filter).
--Product quantity
(e.g., 1 bowl, 1
stem, 100 filters).
--Characterizing
flavor(s) (e.g.,
none, menthol).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
Pipe Co-Package.. --For a new co-
packaged tobacco
product composed of
multiple pipe
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.
Waterpipe Tobacco Products.... Waterpipe........ --Package type (e.g.,
box, none).
--Product quantity
(e.g., 1 waterpipe).
--Length (e.g., 200
mm, 500 mm).
--Width (e.g., 100
mm, 300 mm).
--Number of hoses
(e.g., 1, 2, 4).
--Characterizing
flavor(s) (e.g.,
none, menthol).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
Waterpipe Tobacco --Package type (e.g.,
Filler. bag, pouch).
--Product quantity
(e.g., 20 g, 16
ounces).
--Characterizing
flavor(s) (e.g.,
none, tobacco,
menthol, apple).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
Waterpipe Heat --Package type (e.g.,
Source. box, film sleeve,
bag, none).
--Product quantity
(e.g., 150 g, 680
g).
--Characterizing
flavor(s) (e.g.,
none, menthol,
apple).
--Portion count
(e.g., 20 fingers,
10 discs, 1 base).
--Portion mass (e.g.,
15 g/finger).
--Portion length
(e.g., 40 mm, 100
mm).
--Portion width
(e.g., 10 mm, 40
mm).
--Portion thickness
(e.g., 10 mm, 40
mm).
--Source of energy
(e.g., charcoal,
battery,
electrical).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
[[Page 12755]]
Waterpipe --Package type (e.g.,
Component. bag, box, none).
--Product quantity
(e.g., 1 base, 1
bowl, 1 hose, 10
mouthpieces).
--Characterizing
flavor(s) (e.g.,
none, menthol,
apple).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
Waterpipe Co- --For a new co-
Package. packaged tobacco
product composed of
multiple waterpipe
tobacco products,
include, as
applicable, all
properties for each
individual tobacco
product as
identified above.
Waterpipe 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
(if applicable).
Other......................... 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
(if applicable).
------------------------------------------------------------------------
\7\ Characterizing flavors may include those added to certain components
or parts (e.g., paper) of the tobacco product. If there is no
characterizing flavor, the application must state ``none.''
The applicant would be required to include any additional
properties needed to uniquely identify the tobacco product, if
applicable (e.g., use of product descriptors such as ``premium'' would
be required to be identified). Proposed Sec. 1107.18(c)(8) would also
require the address of the facilities involved in the manufacture of
the tobacco products and any Facility Establishment Identifier number.
This information would assist the Agency in making environmental impact
considerations and determinations under part 25 by helping FDA
understand the scale of products that would be manufactured.
d. Summary. Proposed Sec. 1107.18(d) would require a summary at
the beginning of the SE Report. This summary portion of the SE Report
would act as an abstract designed to orient reviewers to the contents
of the SE Report. Under proposed Sec. 1107.18(d), the summary would be
required to include three elements. First, the summary would be
required to include a concise description of the characteristics of the
new tobacco product. As stated in section 910(a)(3)(B) of the FD&C Act,
characteristics means ``the materials, ingredients, design,
composition, heating source, or other features of a tobacco product,''
all of which are defined in proposed Sec. 1107.12. Second, the summary
would also be required to include the applicant's basis for whether the
new tobacco product has the same characteristics as the predicate
tobacco product or has different characteristics from the predicate
tobacco product which the applicant believes do not cause the new
tobacco product to raise different questions of public health. Third,
with respect to those characteristics, the summary would be required to
include a description of the similarities and differences between the
new tobacco product and the predicate tobacco product.
e. New tobacco product description. Proposed Sec. 1107.18(e) sets
forth the information that would be required in the description of the
new tobacco product. Based on our experience reviewing SE Reports, FDA
has found that, to have a meaningful scientific comparison, a new
tobacco product should be compared to a single predicate product (this
is discussed in more detail at proposed Sec. 1107.18(f), the section
of this document describing the predicate tobacco description).
Accordingly, proposed Sec. 1107.18(e) would require the applicant to
identify the new tobacco product in the SE Report for comparison to one
predicate tobacco product. As is currently the practice, applicants may
continue to bundle groups of SE Reports submitted under proposed Sec.
1107.18 that have the same proposed modifications (e.g., a change in
ingredient supplier that results in a new tobacco product). As
discussed previously, co-packaging two or more tobacco products may
result in a new tobacco product.
Proposed Sec. 1107.18(e) would require that the SE Report describe
the new tobacco product in sufficient detail to enable FDA to
understand and evaluate the characteristics of the new tobacco product
in comparison to the predicate. Specifically, the Agency proposes that
this section of the SE Report include the following information:
A narrative description of the new tobacco product, as
well as detailed drawings or schematics. The drawings would be required
to identify the container closure system and illustrate all of the
product's components. As defined in proposed Sec. 1107.12, a
``component or part'' of a tobacco product is 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. The definition excludes anything that is an
accessory of a tobacco product. For example, an applicant submitting an
SE Report for a pouched snus product would illustrate all the
components and parts of the product, including the pouch material and
tobacco filler. The narrative description would identify all the
components, e.g., for a cigarette, the applicant would identify the
rod, and the rod's paper and filler, and so on.
A description of and the function for each component or
part of the new tobacco product as well as an explanation of how each
component or part is integrated into the product design.
If the manufacturing process for the new tobacco product
could affect the characteristics of the new product, an applicant would
be required to provide an overview of the manufacturing process. This
overview would not need to be an exhaustive discussion but enough
information to enable FDA to fully understand and compare the
characteristics that can be affected by the manufacturing process of
the new
[[Page 12756]]
tobacco product and the predicate tobacco product. FDA has found during
reviews of SE Reports that changes in manufacturing, including
fermentation, may impact the characteristics of the tobacco product,
e.g., the quantities of nicotine (total and free), as well as HPHCs
such as tobacco-specific N-nitrosamines (TSNAs). Such changes could
cause the new product to raise different questions of public health,
e.g., fermentation can increase the levels of nicotine, which impacts
dependence and cessation (Refs. 36 and 37), and an increase in TSNAs
may increase the risk for certain types of cancer (Ref. 38). Thus, if
fermentation is used in the manufacturing process for the new tobacco
product, then the SE Report would be required to describe the process,
including the type and quantity of the microbial inoculum and/or
fermentation solutions (fermentation is typically used in smokeless
tobacco products, and the hot and sticky environment associated with
fermentation may contribute to bacteria and growth of contaminants,
which is a major health and safety concern). If the manufacturing
process for the new tobacco product does not affect the characteristics
of the new product beyond what is described elsewhere in the SE Report,
an applicant would be required to state that to satisfy this provision.
f. Description of the predicate tobacco product. Under proposed
Sec. 1107.18(f), the SE Report would be required to include a section
describing the predicate tobacco product. Under proposed Sec.
1107.18(f)(1), the applicant would be required to identify one
predicate tobacco product that is either a grandfathered tobacco
product or a tobacco product that FDA previously found to be
substantially equivalent to a predicate tobacco product. The applicant
may reference the STN if FDA has already made a grandfathered
determination, or provide specific information sufficient to support a
grandfathered determination (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)). If the SE Report includes information to demonstrate the
grandfathered status of the predicate product, FDA intends to make the
grandfathered determination on that predicate tobacco product before
beginning substantive scientific review of the SE Report.
As with any new tobacco product, applicants who wish to use the SE
pathway to obtain marketing authorization for new co-packaged products
would have to identify a single predicate tobacco product for each new
tobacco product. An applicant could use a co-packaged product as a
predicate so long as it is a valid predicate; however, an applicant
would not be required to use a co-packaged product as its predicate
tobacco product.
FDA invites comments on this approach or any recommended
alternative approaches for co-packaged products.
Proposed Sec. 1107.18(f)(2)(i) would require that the predicate
tobacco product chosen by the applicant be in the same category (e.g.,
cigarette, smokeless) and subcategory (e.g., filtered, non-filtered) as
the new tobacco product to provide a meaningful starting point for our
substantial equivalence review. This proposed requirement reflects
FDA's experience, which has been that if the predicate and new tobacco
products differ on these points, it is highly unlikely that we would be
able to find that the SE Report demonstrates the substantial
equivalence of the new tobacco product to the predicate tobacco
product. For example, when an SE Report includes a predicate and new
tobacco product that are in different categories (e.g., a comparison of
a combusted tobacco product to a smokeless product), the considerable
differences between the products in almost every characteristic will
raise different questions of public health (e.g., an applicant
attempting to compare a smokeless moist snuff predicate to a new
combusted filtered cigarette would likely not be able to demonstrate
that the cigarette does not raise different questions of public health
as compared to the smokeless moist snuff, as the properties and
characteristics of the two products are so vastly different. For
example, an applicant would not be able to show that a ventilation of
25 percent would not cause the cigarette to raise different questions
of public health given that the smokeless moist snuff has no
ventilation characteristic with which to compare). These drastic
differences in characteristics make it very hard for applicants to
provide the evidence necessary to show that these differences do not
cause the new product to raise different questions of public health
because addressing the uncertainty in the influence on adverse health
impact on the user, product use, initiation, and cessation would often
require complex clinical studies.
In addition, under proposed Sec. 1107.18(f)(2)(ii), the predicate
must have been either commercially marketed (not exclusively in a test
market) in the United States as of February 15, 2007 (a grandfathered
predicate tobacco product), or have been previously determined to be
substantially equivalent by FDA. If the SE Report is using a
grandfathered predicate tobacco product, the SE Report must include a
statement that ``I, (name of responsible official), confirm that the
predicate tobacco product, (insert name of predicate tobacco product),
was commercially marketed other than for test marketing as of February
15, 2007'' or reference the STN for a previous determination by FDA
that the predicate tobacco product is grandfathered. The statement
would be a means of ensuring that the applicant understands that the
product must have been commercially marketed on February 15, 2007, to
be considered grandfathered, and supports the information provided in
proposed Sec. 1107.18(f)(1).
Under proposed Sec. 1107.18(f)(2)(iii), the applicant would be
required to identify a predicate tobacco product that is an individual
product. As previously discussed, an applicant could use a co-packaged
product as a predicate so long as it is a valid predicate (e.g., on the
market as of February 15, 2007, or one that was previously found SE).
However, a predicate could not be a fictional product made up by
combining characteristics of two or more products that are
grandfathered or have been found SE. In addition, under proposed Sec.
1107.18(f)(2)(iv) and (v), the predicate tobacco product could not be
the subject of a rescission order by FDA as described in proposed Sec.
1107.50 and could not have been removed from the market at the
initiative of FDA or have been determined by judicial order to be
adulterated or misbranded. These proposed requirements are intended to
minimize some of the problems with predicate tobacco products that FDA
has identified during SE Report reviews which prevent us from
proceeding with an SE review.
g. Comparison information. Proposed Sec. 1107.18(g) states that
the SE Report would be required to include a comparison of the
characteristics of the new tobacco product and the predicate tobacco
product, as described in proposed Sec. 1107.19. FDA expects this
comparison to be a significant part of an SE Report as it would be
expected to describe in detail how the product characteristics of the
new tobacco product compare to the product characteristics of the
predicate tobacco product.\8\ If the new tobacco product
[[Page 12757]]
has some characteristics that are not identical to the predicate, but
some characteristics that are identical, the applicant must provide
comparison information related to the characteristics that are not
identical, but may certify that the other characteristics are identical
under proposed Sec. 1107.18(l)(2).
---------------------------------------------------------------------------
\8\ FDA notes that some applications may use surrogate tobacco
products for discrete parts of an SE application. A surrogate is a
tobacco product for which an applicant provides data it would like
to extrapolate to the new, predicate tobacco product or both new and
predicate tobacco products. However, the surrogate tobacco product
is neither the new or predicate tobacco product (a grandfathered
determination is not necessary for surrogate tobacco products as it
is not a predicate tobacco product). Data for a surrogate tobacco
product is provided in place of data or to provide a bridge between
data for the new or predicate tobacco product. A surrogate tobacco
product is used when there is inadequate data available for the new
or predicate tobacco product; data for a surrogate tobacco product
supplement the data for a new or predicate tobacco product. Unlike
predicate tobacco products, surrogate tobacco product data may be in
place at the start of substantive scientific review or may be
provided in response to a deficiency letter. FDA invites comments on
the use of surrogate tobacco products.
---------------------------------------------------------------------------
For example, if the modification between the new and predicate
product is a change to fire standard compliant (FSC) paper, the SE
Report would state and provide comparison information on the difference
of the non-FSC to FSC paper, the change in filtration (e.g., if there
is a change in filtration due to the change made to the paper), and the
change in tobacco blend (e.g., if there is a change in blend made with
the change to the paper), but the SE Report could then include a
certification that all other characteristics of the new and predicate
product, other than the modified paper, filtration, and blend, are
identical. Another example is a change in product quantity (e.g., an
increase from 20 grams to 35 grams of loose moist snuff). In this
scenario, if the per weight composition has not changed, the applicant
could provide comparison information on only the characteristics that
differ between the new and predicate product, and include a
certification under proposed Sec. 1107.18(l)(2) that all other
characteristics are identical. A third example would be a container
closure system (CCS) substitution of a bag for a box. In this case, the
SE Report would provide comparison information on the change in CCS and
the SE Report could then include a certification under proposed Sec.
1107.18(l)(2) that the characteristics of all non-CCS items have not
changed (e.g., rolling papers are identical between the new and
predicate product). The applicant would be required to maintain records
supporting the certification consistent with proposed Sec. 1107.58.
h. Comparative testing information. Other than for characteristics
that are identical (and for which the applicant has certified that the
characteristics are identical under paragraph (l)(2)), proposed Sec.
1107.18(h) would require the SE Report to include testing information
on the characteristics of the new and predicate tobacco products as
described in section Sec. 1107.19, except where the applicant
adequately justifies that such comparative testing information is not
necessary to demonstrate that the new product: (1) Has the same
characteristics as the predicate or (2) does not raise different
questions of public health. For example, it may not always be necessary
to provide comparative testing information on the heating source.
Comparative testing supports the SE Report by showing the
information contained in the SE Report is meaningful and accurate and,
where applicable, helps demonstrate that the different
characteristic(s) in a new tobacco product does not raise different
questions of public health. FDA's experience has been that the summary
data provided in some SE Reports has been miscalculated, and thus, a
substantial equivalence determination was not supportable. To ensure
the accuracy of the data provided, FDA has needed to review the
experimental data.
Accordingly, proposed Sec. 1107.18(h)(1) would require that the SE
Report include test protocols, quantitative acceptance criteria, and
test results (including means and variances, data sets, and a summary
of the results). Under proposed Sec. 1107.18(h)(2), the testing would
be required to be conducted on a sufficient sample size and on samples
that reflect the final tobacco product composition and design. Proposed
Sec. 1107.18(h)(3) would require the SE Report to state whether the
testing method for the new and predicate products are the same and, if
they differ, to explain how the results of the different test methods
can be compared. Under proposed Sec. 1107.18(h)(4), the SE Report also
must identify any national and international standards used to test the
new and predicate tobacco products and explain any deviations.\9\ If no
standards were used for testing, the SE Report would be required to
state so. There are multiple ways to satisfy this comparative testing
requirement that may not require comparative testing on the specific
characteristic that is different between the new and predicate tobacco
product. For example, if an applicant is proposing to modify the
container closure system of a smokeless tobacco product for loose moist
snuff, rather than supply testing information on the container closure
system, the applicant could demonstrate that the ingredients,
constituents, moisture, and stability of the loose tobacco within the
container closure system are not affected by the change in container
closure system in a way that would cause the new product to raise
different questions of public health. As testing information on the
ingredients, constituents, moisture, and stability information would
already be required for the smokeless tobacco product, additional
comparative testing information on differences in the container closure
system would not be required. Instead the applicant would state that
this information is already covered by the submission of the
ingredients, constituents, moisture, and stability information within
the SE Report.
---------------------------------------------------------------------------
\9\ In the guidance document entitled, ``Section 905(j) Reports:
Demonstrating Substantial Equivalence for Tobacco Products''
(January 2011), FDA provided some examples of standards that might
be used to support an SE application.
---------------------------------------------------------------------------
i. Statement of compliance with applicable tobacco product
standards. As required by section 905(j)(1)(B) of the FD&C Act, under
proposed Sec. 1107.18(i), the SE Report must list and describe the
action(s) that the applicant has taken to comply with the requirements
under section 907 of the FD&C Act (tobacco product standards) that are
applicable to the tobacco product. In the alternative, the SE Report
must state that there are no requirements under section 907 that are
applicable to the new tobacco product. For SE Reports that are
submitted after the finalization of this rule, but still pending after
issuance of any future tobacco product standards, FDA invites public
comments on how such pending SE Reports should be considered or handled
in relation to the satisfaction of the requirement for a statement of
compliance with applicable tobacco product standards.
j. Health information summary or statement regarding availability
of such information. As required by section 910(a)(4) of the FD&C Act,
the SE Report must include either an adequate summary of any health
information related to the new tobacco product or a statement that such
information would be made available upon request by any person.
Proposed Sec. 1107.18(j) would codify this statutory requirement and
ensure that applicants provide adequate information as required by
section 910(a)(4). Under proposed Sec. 1107.18(j)(1), if the applicant
chooses to provide a health information summary, the applicant would be
required to provide a redacted version of the full SE Report that
excludes research subject identifiers and trade secret and confidential
commercial information as defined in Sec. Sec. 20.61 and
[[Page 12758]]
20.63 (21 CFR 20.61 and 20.63). FDA believes that an SE Report redacted
in the manner described would generally provide an adequate summary of
any health information related to the new tobacco product, as well as
detailed information regarding data concerning adverse health effects
of the new tobacco product. The redacted SE Report would be required to
be submitted with the original submission, and a redacted copy of an
amendment would be required with the submission of any amendment to the
SE Report.
In addition, to the extent that there is additional health
information about the new tobacco product, including any information,
research (e.g., published or unpublished research, internal reports or
analyses), or data about adverse health effects, that the applicant has
or knows about and that is not contained in the SE Report, the
applicant would be required to provide such accurate and complete, and
not false or misleading, information in the health information summary.
If there is no such additional health information, the SE Report would
be required to include a statement that the company does not have and
does not know of any such additional health information. FDA would post
the health information summary, including the redacted SE Report, and
any additional health information provided by the applicant on FDA's
website.
Under proposed Sec. 1107.18(j)(2), if the applicant chooses to
make the health information available upon request, the SE Report would
be required to include a certification statement made by an authorized
representative of the applicant that an adequate summary of any health
information related to the new tobacco product, including detailed
information regarding data concerning adverse health effects of the new
tobacco product, would be made available to a requestor within 30
calendar days of a request. The certification is intended to ensure
that applicants understand that they are responsible for providing this
information upon request.
Under proposed Sec. 1107.18(j)(3), the health information the
applicant would need to make available would be a copy of the full SE
Report (which includes any amendments), excluding research subject
identifiers and trade secret and confidential commercial information as
defined in Sec. Sec. 20.61 and 20.63. To the extent that the applicant
has or knows of any additional health information, including any
information, research, or data regarding adverse health effects that is
not contained in the SE Report, the applicant would also provide the
requester such accurate and complete, and not false or misleading,
information. If there is no such additional health information, the
applicant would provide the requester with a statement that the company
does not have and does not know of any such additional health
information.
Proposed Sec. 1107.18(j)(4) would provide that requests for health
information be made to the authorized representative of the applicant,
whose contact information the applicant would provide to FDA. FDA
intends to make this contact information available on FDA's website.
The applicant would be required to update this contact information with
FDA whenever necessary (e.g., the identified authorized representative
is no longer with the company or the address or telephone information
changes). If an applicant elects to include the statement in their SE
Report, the applicant would be required to provide the information to
persons who request it. Applicants would not be permitted to later
amend SE Reports on which FDA has issued a marketing order to choose
instead to submit a health information summary. Therefore, applicants
that provide the statement instead of providing the summary to FDA as
part of the SE Report must be prepared to provide the information
required under section 910(a)(4) of the FD&C Act, as implemented
through proposed Sec. 1107.18(j).
Under proposed Sec. 1107.18(j)(5), to the extent information is
included in the health information summary or the health information
provided upon request under paragraphs (j)(1) and (2) of this section
that is not required by section 910(a)(4) of the Federal Food, Drug,
and Cosmetic Act or paragraph (j) of this section, that information
cannot contain a statement that would cause the proposed new tobacco
product to be in violation of section 911 of the FD&C Act (21 U.S.C.
387k) upon the introduction or delivery for introduction of the
proposed new product into interstate commerce. If an applicant includes
such a statement in its health information summary or in the health
information the applicant provides upon request, the review of the
applicant's SE Report may be delayed.
FDA would generally not consider a statement of relative risk to be
required by section 910(a)(4) of the FD&C Act or paragraph (j) of this
section if the risk being conveyed is unrelated to the applicant's
demonstration that the new product is substantially equivalent and
FDA's review of the SE Report. For example, if an applicant submitted
an SE Report for a new smokeless tobacco product and identified a
smokeless tobacco product as the predicate product, a statement
comparing the tar in the new smokeless tobacco product to the tar in a
cigarette would generally be unrelated to the applicant's demonstration
that the new product is substantially equivalent and FDA's review of
the SE Report.
For the purposes of Sec. 1107.18(j), any statement an applicant is
required to include in a health information summary or the health
information provided in response to a request--including statements
made in an SE Report (e.g., comparisons of HPHCs between the new and
predicate tobacco products)--typically would not cause the proposed new
tobacco product to be in violation of section 911 of the FD&C Act upon
introduction or delivery for introduction of the proposed new product
into interstate commerce. Congress required applicants to submit health
information summaries with their SE Reports or to provide such
information upon request. Nothing in section 911 of the FD&C Act
suggests that Congress intended for that provision to impede an
applicant's ability to fulfill its obligations under section 910(a)(4)
of the FD&C Act.
k. Compliance with part 25. An applicant must include an
environmental assessment (EA) prepared in accordance with Sec. 25.40
or a valid claim of a categorical exclusion, if applicable. (Under
Sec. 25.15(a), all submissions requesting FDA action require the
submission of either a claim of categorical exclusion or an EA.) In
accordance with Sec. 25.40(a), an environmental assessment must
include, at a minimum, brief discussions of the need for the proposed
action, of alternatives as required by section 102(2)(E) of the
National Environmental Policy Act (NEPA), of the environmental impacts
of the proposed action and alternatives, a listing of the agencies and
persons consulted, and the relevant environmental issues relating to
the use and disposal from use. Although applicants may wish to review
the categorical exclusions specific to tobacco product applications at
Sec. 25.35, the only categorical exclusion currently available for an
order authorizing the marketing of a new tobacco product is found at
Sec. 25.35(a), and applies only to orders finding provisional products
substantially equivalent. If the applicant believes the action would
qualify for an available categorical exclusion, the applicant would be
required to state under Sec. 25.15(a) and (d) that the action
qualifies for a categorical exclusion, cite to the claimed exclusion,
and state that to the applicant's knowledge no
[[Page 12759]]
extraordinary circumstances exist under Sec. 25.21.
To evaluate the environmental impact (as described in Sec.
25.40(a)), information that addresses the status of the new tobacco
product relative to the predicate tobacco product would be required.
Accordingly, the environmental assessment would be required to include
a statement indicating whether the new tobacco product is intended to:
(1) Replace the predicate tobacco product once the new tobacco product
receives market authorization and is commercially marketed; (2) be a
line extension of the predicate tobacco product; (3) be marketed along
with the predicate product by the same manufacturer; and/or (4) be
marketed along with the predicate tobacco product by a different
manufacturer (e.g., by a manufacturer other than the manufacturer of
the predicate tobacco product). This statement would be included in the
section on the need for the proposed action and would help FDA
understand the environmental impact of an SE order by understanding the
marketing intention for the new and predicate tobacco products. The
marketing authorization of a new tobacco product may have a different
impact if the new tobacco product is intended to be marketed along with
the predicate tobacco product than if the new tobacco product is
intended to replace a predicate tobacco product.
l. Certification statement. Proposed Sec. 1107.18(l)(1) would
require that an applicant include in the SE Report a specific statement
certifying that the applicant would maintain all records to
substantiate the accuracy of the report consistent with the record
retention requirements in proposed Sec. 1107.58, that, to the best of
their knowledge, the information and accompanying submission are true
and correct, no material fact has been omitted, the signer is
authorized to submit the information on the applicant's behalf, and
that the signer understands that anyone who knowingly and willfully
makes a materially false, fictitious, or fraudulent statement or
representation in any matter within the jurisdiction of the executive,
legislative, or judicial branch of the Government of the United States
is subject to criminal penalties (under 18 U.S.C. 1001). The
certification is intended to provide FDA with additional assurance that
the applicant has fully considered the SE Report and its contents, that
the applicant believes there is a basis for making the findings
required by section 910(a)(2) of the FD&C Act, and that the applicant
understands the potential consequences of submitting false information
to the U.S. Government.
In addition, under proposed Sec. 1107.18(l)(2), if an SE Report
states that the new tobacco product has certain characteristics that
are identical to the predicate tobacco product (though not all
characteristics, such that the product would not be ``new''), an
applicant can choose to submit a certification in lieu of providing
information for each characteristic of the new and predicate tobacco
products. FDA would permit the applicant to certify that the other
characteristics are identical as long as the applicant maintains
supporting documentation, including the records demonstrating the
comparison information detailed in proposed Sec. 1107.19. The records
would be required to be maintained consistent with proposed Sec.
1107.58. The certification must be signed by an authorized
representative of the applicant.
3. Comparison Information (Proposed Sec. 1107.19)
This proposed section describes the comparison information that
would be required in the SE Report. Comparative testing supports the SE
Report by showing the information contained in the SE Report is
meaningful and accurate; where applicable, the testing also helps
demonstrate that the different characteristic(s) in a new tobacco
product does not raise different questions of public health. FDA
requests public comments on the quantitative and qualitative
differences in each of the design parameters for each of the tobacco
product categories identified below as well as data to support such
values or characteristics.
a. Product design. Proposed Sec. 1107.19(a) would require the SE
Report to include descriptions of the product designs of the new and
predicate tobacco products and identify any differences. This proposed
section would require that the information be in a tabular format with
a side-by-side comparison of each design parameter of the new and
predicate tobacco products. The SE report would also be required to
include for each design parameter a target value and range of
acceptable values, actual measured value (if applicable), and ranges of
measured values (if applicable) with units of measure. The report would
also be required to include test data for each applicable design
parameter. Proposed Sec. 1107.19(a)(1)-(6) would establish the
required design parameter information for the tobacco product category,
as follows:
For cigarettes, the required design parameter information to be
provided for each predicate and new tobacco product would be:
Table 3--Required Design Parameter Information for Cigarettes
------------------------------------------------------------------------
Provide test data (include
test protocols, quantitative
Provide target specification with upper acceptance criteria, data
and lower range limits for: sets, and a summary of the
results) for:
------------------------------------------------------------------------
--Cigarette length (mm) --Puff count.
--Cigarette circumference (mm) --Cigarette draw resistance
(mm H2O).
--Cigarette draw resistance (mm H2O) --Tobacco filler mass (mg).
--Tobacco filler mass (mg) --Tobacco moisture (%).
--Tobacco rod density (g/cubic centimeter --Filter ventilation (%).
(cm3))
--Tobacco moisture (%) --Cigarette paper base paper
basis weight (g/m2).
--Filter ventilation (%) --Cigarette paper base paper
porosity (CU).
--Tipping paper length (mm) --Cigarette paper band
porosity (CU).
--Cigarette paper base paper basis weight --Filter efficiency (%) [If
(g/meter squared(m2)) no filter efficiency data
is available for the
products, include
information sufficient to
show that the cigarette
filter is unchanged (e.g.,
denier per filament, total
denier, and filter
density)].
--Filter pressure drop (mm
H2O).
--Cigarette paper base paper porosity (CU)
--Cigarette paper band porosity (CU)
--Cigarette paper band width (mm)
--Cigarette paper band space (mm)
[[Page 12760]]
--Filter efficiency (%) (If no filter
efficiency data is available for the
products, include information sufficient
to show that the cigarette filter is
unchanged (e.g., denier per filament,
total denier, and filter density))
--Filter length (mm)
--Filter pressure drop (mm H2O)
------------------------------------------------------------------------
FDA is proposing to require that these parameters be included for
cigarettes because variations in these parameters may cause the new
tobacco product to raise different questions of public health, as
described below:
A difference in cigarette length may alter tobacco
biomarker levels (Ref. 5).
A difference in cigarette circumference may affect filter
efficiency and, in turn, smoke constituent yields (Ref. 6).
A difference in puff count can directly affect smoke
constituent yields (Ref. 7).
A difference in cigarette draw resistance may result in
differences in the difficulty of pulling air through the tobacco rod
and, in turn, affect smoke constituent yields (Ref. 8).
A difference in tobacco filler mass may affect smoke
constituent yields (Refs. 9 and 10).
A difference in tobacco rod density may modify burn
properties and smoke constituent yields (Refs. 11 and 12).
A difference in tobacco moisture may affect puff count
(Refs. 13-15).
A difference in cigarette paper base paper basis weight
may affect puff count and smoke constituent yields (Ref. 16).
A difference in cigarette paper base paper porosity may
affect smoke constituent yields (Ref. 16).
A difference in cigarette paper band porosity may affect
smoke constituent yields since band porosity allows for the overall
assessment of the weighted change in air flow through the cigarette
paper during active puffing (Refs. 18, 19, and 38).
A difference in cigarette paper band width may affect
ventilation and, in turn, smoke constituent yields (Ref. 20).
A difference in cigarette paper band space may affect
ignition propensity and, in turn, puff count (Ref. 21).
A difference in filter efficiency may affect smoke
constituent yields (Refs. 18 and 20).
A difference in denier per filament may affect filter
efficiency and, in turn, smoke constituent yields (Ref. 22).
A difference in total denier may affect filter efficiency
and, in turn, smoke constituent yields (Ref. 22).
A difference in filter density may affect filter
efficiency and, in turn, smoke constituent yields (Ref. 22).
A difference in filter pressure drop may affect smoke
constituent yields (Ref. 23, slide 40).
A difference in filter length may affect filter efficiency
and, in turn, smoke constituent yields (Ref. 22).
A difference in filter ventilation may affect smoke
constituent yields (Ref. 6).
A difference in tipping paper length may affect smoke
constituent yields (Ref. 24).
For portioned and non-portioned smokeless tobacco products, the
required design parameter information to be provided for each predicate
and new tobacco product would be:
Table 4--Required Design Parameter Information for Portioned and Non-
Portioned Smokeless Tobacco Products
------------------------------------------------------------------------
Provide test data (include
test protocols, quantitative
Provide target specification with upper acceptance criteria, data
and lower range limits for: sets, and a summary of the
results) for:
------------------------------------------------------------------------
Portioned Smokeless Tobacco Products
------------------------------------------------------------------------
--Tobacco cut size (mm) --Tobacco cut size (mm).
--Tobacco moisture (%) --Tobacco moisture (%).
--Portion length (mm) (if applicable) --Portion mass (mg) (if
applicable).
--Portion width (mm) (if applicable) --Pouch paper porosity (CU).
--Portion mass (mg) (if applicable) --Pouch paper basis weight
(g/m2).
--Portion thickness (mm) (if applicable).
--Pouch paper wicking.
--Pouch paper porosity (CU).
--Pouch paper basis weight (g/m2).
------------------------------------------------------------------------
Non-portioned Smokeless Tobacco Products
------------------------------------------------------------------------
--Tobacco cut size (mm). --Tobacco cut size (mm).
--Tobacco moisture (%). --Tobacco moisture (%).
------------------------------------------------------------------------
FDA is proposing to require that these parameters be included for
smokeless tobacco products because variations in these parameters may
cause the new tobacco product to raise different questions of public
health, as described below:
A difference in tobacco cut size may alter the surface
area and accessibility of saliva to get to the surfaces of the tobacco,
thereby affecting the amount and rate of constituents released from the
product (Ref. 25).
A difference in tobacco moisture may affect microbial
growth in the product, extraction efficiency, and total exposure to
nicotine, NNN, and NNK (Ref. 26).
[[Page 12761]]
A difference in portion mass may affect user exposure to
the tobacco product and, in turn, exposure to the HPHCs contained in
each portion (Ref. 27).
A difference in portion length as it relates to portion
size may affect the amount of constituents in each portion (Ref. 27).
A difference in portion width may result in a surface area
difference, which is proportional to the amount and rate of
constituents released from the product (Ref. 28).
A difference in portion thickness may result in a surface
area difference, which is directly proportional to the amount and rate
of constituents released from the product (Ref. 28).
A difference in pouch paper basis weight may alter the
interactions between the tobacco and oral cavity, thereby affecting the
amount and rate of constituents released from the product (Ref. 29).
A difference in pouch paper porosity may alter the
interactions between the tobacco and oral cavity, thereby affecting the
amount and rate of constituents released from the product (Ref. 29).
For RYO tobacco rolling papers, the required design parameter
information to be provided for each predicate and new tobacco product
would be:
Table 5--Required Design Parameter Information for RYO Tobacco Rolling
Papers
------------------------------------------------------------------------
Provide test data (include
test protocols, quantitative
Provide target specification with upper acceptance criteria, data
and lower range limits for: sets, and a summary of the
results) for:
------------------------------------------------------------------------
--Paper length (mm). --Mass per paper (mg).
--Paper width (mm). --Cigarette paper base paper
basis weight (g/m2).
--Mass per paper (mg). --Cigarette paper base paper
porosity (CU).
--Cigarette paper base paper basis weight --Cigarette paper band
(g/m)2. porosity (CU) (if
applicable).
--Cigarette paper base paper porosity
(CU).
--Cigarette paper band porosity (CU) (if
applicable).
--Cigarette paper band width (mm) (if
applicable).
--Cigarette paper band space (mm)
(applicable).
------------------------------------------------------------------------
FDA is proposing to require that these parameters be included for
rolling papers because variations in these parameters may cause the new
tobacco product to raise different questions of public health, as
described below:
A difference in overall length may alter the surface area
that is available for tobacco packing, thereby affecting the smoke
constituent yields (Ref. 23, slide 46).
A difference in overall width may alter the surface area
that is available for tobacco packing, thereby affecting the smoke
constituent yields (Ref. 23, slide 46).
A difference in total mass per pack may be a result of a
surface area or basis weight difference and, in turn, may affect puff
count and smoke constituent yields (Refs. 16 and 23 (slide 46)).
A difference in RYO paper base paper basis weight may
affect puff count and smoke constituent yields (Ref. 16).
A difference in RYO paper base paper porosity may affect
smoke constituent yields (Ref. 16).
A difference in RYO paper band porosity may affect smoke
constituent yields because band porosity allows for the overall
assessment of the weighted change in air flow through the cigarette
paper during active puffing (Refs. 17 and 37).
A difference in RYO paper band width may affect
ventilation and, in turn, smoke constituent yields (Ref. 20).
A difference in RYO paper band space may affect ignition
propensity and, in turn, puff count (Ref. 21).
For RYO tobacco tubes, the required design parameter information to
be provided for each predicate and new tobacco product is as follows:
Table 6--Required Design Parameter Information for RYO Tobacco Tubes
------------------------------------------------------------------------
Provide test data (include
test protocols, quantitative
Provide target specification with upper acceptance criteria, data
and lower range limits for: sets, and a summary of the
results) for:
------------------------------------------------------------------------
--Tube length (mm). --Total mass (mg).
--Tube circumference (mm). --Cigarette paper base paper
basis weight (g/m2).
--Total mass (mg). --Cigarette paper base paper
porosity (CU).
--Cigarette paper base paper basis weight --Cigarette paper band
(g/m2). porosity (CU).
--Cigarette paper base paper porosity
(CU).
--Cigarette paper band porosity (CU).
--Cigarette paper band width (mm).
--Cigarette paper band space (mm).
------------------------------------------------------------------------
For RYO tobacco filtered tubes, the required design parameter
information to be provided for each new predicate and new tobacco
product would be:
Table 7--Required Design Parameter Information for RYO Tobacco Filtered
Tubes
------------------------------------------------------------------------
Provide test data (include
test protocols, quantitative
Provide target specification with upper acceptance criteria, data
and lower range limits for: sets, and a summary of the
results) for:
------------------------------------------------------------------------
--Tube length (mm). --Total mass (mg).
--Tube circumference (mm). --Filter ventilation (%).
--Total mass (mg). --Cigarette paper base paper
basis weight (g/m2).
--Tipping paper length (mm). --Cigarette paper base paper
porosity (CU).
[[Page 12762]]
--Filter ventilation (%). --Cigarette paper band
porosity (CU).
--Cigarette paper base paper basis weight --Filter denier per filament
(g/m2). (DPF).
--Cigarette paper base paper porosity --Filter total denier (g/
(CU). 9000m).
--Cigarette paper band porosity (CU). --Filter density (g/cm3).
--Cigarette paper band width (mm). --Filter pressure drop (mm
H2O).
--Cigarette paper band space (mm).
--Filter length (mm).
--Filter denier per filament (DPF).
--Filter total denier (g/9000m).
--Filter density (g/cm3).
--Filter pressure drop (mm H2O).
------------------------------------------------------------------------
FDA is proposing to require that these parameters be included for
RYO tobacco tubes because variations in these parameters may cause the
new tobacco product to raise different questions of public health, as
described below:
A difference in tube length may alter tobacco biomarker
levels (Ref. 5).
A difference in tube circumference may affect filter
efficiency and, in turn, smoke constituent yields (Ref. 6).
A difference in total mass per pack may be a result of a
surface area or basis weight difference and, in turn, may affect puff
count and smoke constituent yields (Refs. 16 and 23 (slide 46)).
A difference in tube paper base paper basis weight may
affect puff count and smoke constituent yields (Ref. 16).
A difference in tube paper base paper porosity may affect
smoke constituent yields (Ref. 16).
A difference in tube paper band porosity may affect smoke
constituent yields since band porosity allows for the overall
assessment of the weighted change in air flow through the cigarette
paper during active puffing (Refs. 17 and 37).
A difference in tube paper band width may affect
ventilation and, in turn, smoke constituent yields (Ref. 20).
A difference in tube paper band space may affect ignition
propensity and, in turn, puff count (Ref. 21).
A difference in filter efficiency may affect smoke
constituent yields (Ref. 13).
A difference in denier per filament may affect filter
efficiency and, in turn, smoke constituent yields (Ref. 22).
A difference in total denier may affect filter efficiency
and, in turn, smoke constituent yields (Ref. 33).
A difference in filter density may affect filter
efficiency and, in turn, smoke constituent yields (Ref. 32).
A difference in filter pressure drop may affect smoke
constituent yields (Ref. 23, slide 40).
A difference in filter length may affect filter efficiency
and, in turn, smoke constituent yields (Ref. 32).
A difference in ventilation may affect smoke constituent
yields (Ref. 24).
A difference in tipping paper length may affect smoke
constituent yields (Ref. 24).
For RYO tobacco, the required design parameter information to be
provided for each predicate and new tobacco product would be:
Table 8--Required Design Parameter Information for RYO Tobacco
------------------------------------------------------------------------
Provide test data (include
test protocols, quantitative
Provide target specification with upper acceptance criteria, data
and lower range limits for: sets, and a summary of the
results) for:
------------------------------------------------------------------------
--Tobacco filler mass (mg). --Tobacco filler mass (mg).
--Tobacco cut size (mm). --Tobacco cut size (mm).
--Tobacco moisture (%). --Tobacco moisture (%).
------------------------------------------------------------------------
FDA is proposing to require that these RYO tobacco parameters be
included for RYO tobacco because variations in these parameters may
cause the new tobacco products to raise different questions of public
health, as described below:
A difference in tobacco filler mass may affect smoke
constituent yields when used with rolling paper (Ref. 9).
A difference in tobacco cut width alters the size of the
tobacco pieces, which may result in more particulate matter (Ref. 30).
A difference in moisture may affect smoke composition
(Ref. 13).
For tobacco products not specifically identified (e.g., ENDS,
cigars) FDA invites comments and information on the parameters that may
be needed to support an SE Report.
b. Heating source. Proposed Sec. 1107.19(b) would require that the
SE Report include a description of any heating source for both the new
and predicate tobacco products (e.g., burning coal, electric, chemical
reaction, carbon tip) and identify any differences. If there is no
heating source for the new and predicate tobacco products, the SE
Report would be required to state that.
c. Product composition. Proposed Sec. 1107.19(c) would require
that the SE Report include descriptions of the product composition of
the new and predicate tobacco products and identify any differences.
The information would be required to be in tabular format with a side-
by-side comparison of the materials and ingredients for each component
or part of the new and predicate tobacco products. Under the proposed
rule, the SE Report would be required to provide for each material and
ingredient the following information: The quantity, the target value
and range of acceptable values, actual measured value (where
applicable), and range of measured values (where applicable) reported
as mass per component or part.
Proposed Sec. 1107.19(c)(1) would require that the SE Report
include the following information for each material in the product:
The material name and common name (if applicable);
The component or part where it is located;
[[Page 12763]]
The subcomponent or subpart where it is located (if
applicable);
The function of the material;
Quantities (including ranges or means and acceptance
limits) with identification of any specification variation between the
new tobacco product and predicate tobacco product;
Specifications (including quality, grades, and suppliers)
used for the new tobacco product and the predicate (including any
specification variations, if applicable); and
Any other material properties necessary to characterize
the new and predicate tobacco products.
Proposed Sec. 1107.19(c)(2) would require that the SE Report
include information on ingredients other than tobacco (information on
tobacco ingredients is addressed in proposed Sec. 1107.19(c)(3)).
Required information would include:
International Union of Pure and Applied Chemistry chemical
name and common name (if applicable);
Chemical Abstracts Service (CAS) number(s) or FDA Unique
Ingredients Identifier;
The function of the ingredient;
The quantity with the unit of measure (including ranges or
means, and acceptance limits) of the materials in the new tobacco
product and predicate tobacco product (with any specification
variation, if applicable);
The specifications (including purity or grade and
supplier);
For complex purchased ingredients, each single chemical
substance reported separately; and
Any other ingredient information necessary to characterize
the new and predicate tobacco products.
Proposed Sec. 1107.19(c)(3) would require information on tobacco
ingredients. This information would include the following:
The type of tobacco, including grade and variety. This
impacts the characteristics of the products because different grades
have different constituent profiles (the SE Report would need to
include information on the applicant's grading system so that FDA
understands the grade);
The quantity, with the unit of measure (including ranges
or means, and acceptance limits), of tobacco in the new and predicate
tobacco products (with a specification variation, if applicable);
The specification of tobacco used for the new tobacco
product and predicate tobacco product (with any specific variation, if
applicable);
A description of any genetic engineering that impacts
characteristics, because genetic engineering affects the constituent
profile; and
Any other information about tobacco ingredients necessary
to characterize the new and predicate tobacco products.
If the new tobacco product does not contain tobacco (e.g., rolling
paper or tipping paper), this section of the report would be required
to state that.
FDA is proposing that ingredient quantities under proposed Sec.
1107.19(c)(2) and (3) be reported as mass per gram of tobacco for non-
portioned tobacco products and as mass per portion for portioned
tobacco products. These specific measurements provide consistent,
complete information that would allow FDA to understand the ingredient
quantities. In contrast, if ingredient quantities were reported as
percentages, FDA would have to make assumptions about the denominator
used to calculate the percentage. For example, if xylitol were reported
as 10 percent of a portioned moist snuff, FDA would not able to
determine if xylitol was 10 percent of the mass of the tobacco filler
or of the entire product (containing filler, paper, etc.).
Proposed Sec. 1107.19(c)(4) would require that the SE Report
include a description of the container closure system for the new and
predicate tobacco products, including a side-by-side quantitative
comparison of the subcomponents or subparts and materials and annotated
illustrations.
d. Other features. Proposed Sec. 1107.19(d) would require that the
SE Report include descriptions of any other applicable features of the
new and predicate tobacco products and identify any differences that
exist. If a specific feature described in proposed Sec. 1107.19(d) is
not applicable to the new tobacco product, the SE Report would be
required to state as such. In response, FDA may request a scientific
explanation for why a particular feature is not applicable, and under
proposed Sec. 1107.19(d) the applicant would be required to provide
that information to FDA. The SE Report must also address any other
product characteristics that relate to the chemical, physical or
biological properties of the tobacco product and are necessary for SE
Report review.
Specifically, proposed Sec. 1107.19(d)(1) would require that the
SE Report include HPHC and other constituent information as appropriate
to demonstrate that: (1) The new tobacco product has the same
characteristics as the predicate tobacco product or (2) any differences
in characteristics between the new and predicate tobacco product do not
cause the new tobacco product to raise different questions of public
health, as follows:
Constituent names in alphabetical order,
Common names,
CAS number,
Mean quantity and variance with unit of measure,
Number of samples and measurement replicates for each
sample,
Analytical methods used, description and associated
reference(s),
Testing laboratory(ies) and accreditation information,
Length of time between dates of manufacture and dates of
testing,
Storage conditions of the tobacco product before it was
tested, and
Full test data (including test protocols, any deviations
from the test protocols, quantitative acceptance (pass/fail) criteria,
and complete data sets) for all testing performed.
For combusted tobacco products, constituent smoke yields from the
new and predicate products would need to be determined using intense
and non-intense smoking regimens.\10\ Two smoking regimens are required
in order to understand the way that constituent yields delivered by a
tobacco product can change over a range of different smoking
conditions. If constituent yields were only reported from a single
smoking regimen, FDA would have limited and potentially misleading
information about constituent yields produced by a given tobacco
product. Many studies demonstrate that different smoking regimens
result in different constituent yields from the same product (Refs. 31
and 32). By requiring both an intense and a non-intense smoking
regimen, FDA would have a better understanding of quantities of each
constituent that may be produced by the tobacco product when smoked
under different conditions. If an alternative to these smoking regimens
is used, the applicant would be required to provide an explanation of
why the alternative provides comparable results to the intense and non-
intense smoking regimens.
---------------------------------------------------------------------------
\10\ These refer to regimens by the International Organization
for Standardization and Health Canada.
---------------------------------------------------------------------------
FDA is proposing that the HPHC information in an SE Report for a
new cigarette include, at a minimum, a comparison of the quantities of
nicotine-dry particulate matter, total particulate matter, carbon
monoxide, and nicotine (total) in the mainstream smoke of the new
tobacco product with that of the predicate tobacco product, using both
intense and non-intense smoking regimens. Further, additional HPHC
[[Page 12764]]
yields may need to be reported in order to demonstrate that: (1) The
new tobacco product has the same characteristics as the predicate
tobacco product or (2) any differences in characteristics do not cause
the new tobacco product to raise different questions of public health.
For example, blend differences may require reporting of HPHC yields
specific to the differences in tobacco blends. Studies show that the
mainstream smoke of burley and reconstituted tobaccos contains much
higher TSNA levels than the mainstream smoke of bright and oriental
tobacco, whereas the mainstream smoke of bright tobacco contains higher
benzo[a]pyrene levels than other tobacco types (Refs. 33 and 34).
Reconstituted tobacco can produce high levels of carbon monoxide,
nitrogen oxides, and TSNAs during combustion (Ref. 8). Smoke from
cigarettes made from expanded stems is higher in carbon monoxide,
nitrous oxides, formaldehyde, tar, benzo[a]anthracene, and
benzo[a]pyrene than smoke from cigarettes made of puffed tobacco,
expanded tobacco, or freeze-dried tobacco (Ref. 30). Similarly,
addition of sugar or corn syrup to a tobacco product may increase HPHCs
such as formaldehyde and may therefore require additional HPHC
measurements (Ref. 35). Or, if the new tobacco product contains
significantly more guar gum (a binder in rod paper and tobacco blends)
than the predicate product, additional HPHC yields may be required to
be reported because pyrolysis of guar gum may form formaldehyde,
acetaldehyde, acetone, benzene, cresol, and toluene (Refs. 39-41).
Based on its experience reviewing new tobacco products, FDA has
found significant increases in HPHCs (e.g., TSNAs and polycyclic
aromatic hydrocarbons (PAHs)) in cigarettes due to changes in types of
tobacco when compared to a predicate tobacco product. For all new
cigarettes that have a substantial increase in other types of tobacco,
to support a finding of SE the applicant should include a comparison of
TSNAs and PAHs in the mainstream smoke of the new tobacco product with
that of the predicate tobacco product using both intense and non-
intense smoking regimens. Depending on the specific differences between
the new and predicate products, quantities of additional HPHCs in
mainstream smoke may be required to be reported.
For a smokeless tobacco product, the HPHC information in an SE
Report would need to include a comparison of the quantities of total
and free nicotine, total TSNAs, NNN, and NNK in the tobacco of the
products. Depending on the specific differences between the new and
predicate products, the applicant may be required to report quantities
of additional HPHCs in the product.
Proposed Sec. 1107.19(d)(2) would require that the SE Report
include a description and comparison of any other features of the new
and predicate tobacco products.
Proposed Sec. 1107.19(e) would require stability information for
smokeless tobacco products and any tobacco product that contains
fermented tobacco. As described in more detail in the following
paragraphs, stability information is a particular concern with
smokeless tobacco products and other tobacco products that contain
fermented tobacco because the characteristics of these products can be
affected by the manufacturing process, storage conditions, and length
of time on a shelf. Accordingly, proposed Sec. 1107.19(e) would
require stability information for the new and predicate tobacco
products, including:
A description of how stability is indicated and whether
stability testing is identical for the predicate and new tobacco
products (proposed Sec. 1107.19(e)(i));
Any known or expected impacts on product stability due to
differences between the new and predicate products (if there are none,
the SE Report would state that) (proposed Sec. 1107.19(e)(ii)). For
example, for products that contain fermented tobacco, the SE Report
would be required to provide information on the fermentation processing
steps, including the following:
[cir] Composition of the inoculum including species name(s) and
concentration(s)
[cir] pH
[cir] Temperature
[cir] Moisture content
[cir] Water activity
[cir] Duration
[cir] Ingredients added.
FDA is proposing to require that this information be submitted in
the SE Report because these parameters of the fermentation process can
result in different degrees of change in the chemical constituents of
the tobacco (Refs. 42 and 43) and affect the type and amount of
microorganisms in the final product (Ref. 44), thereby affecting the
stability of the product, which could change the characteristics of the
tobacco product, which may cause the new tobacco product to raise
different questions of public health. In addition, the type and amount
of the fermentation inoculum can be used to control or affect the
fermentation process and thus, can change the product as a result of
directed fermentation, which could cause the new tobacco product to
raise different questions of public health (Ref. 45).
Detailed stability testing information, including test
protocols, quantitative acceptance criteria, data sets, and a summary
of the results for all stability testing performed (proposed Sec.
1107.19(e)(iii)). Stability testing would be required to be performed
at the beginning (zero time), middle, and end of the expected storage
time for the following chemical and microbial endpoints:
[cir] Microbial content data, including total aerobic microbial count
and total yeast and mold count, along with identification of detected
microbiological organisms by genus and species names (if applicable)
[cir] pH
[cir] Moisture content
[cir] Water activity
[cir] Tobacco-specific nitrosamines (TSNAs, including total, NNN, and
NNK)
[cir] Nitrate and nitrite levels
[cir] Preservatives and microbial metabolic inhibitors, if any
[cir] Method of heat treatment or pasteurization used to reduce
microbial loads.
The proposed rule would require this information because product
stability is affected by factors such as the fermentation and
stabilization processes (if applicable), addition of chemical additives
to control microbial activity (e.g., preservatives, metabolic
inhibitors, humectants), and water activity (aw) of the
product (Refs. 42, 46-48). Additionally, factors such as nitrate/
nitrite concentrations, moisture content, microbial content, storage
temperature, and pH are reported to influence the microbial stability
and TSNA formation during storage of tobacco products (Refs. 49-53).
Storage conditions for samples retained for testing,
identifying the test methods used, along with testing of the tobacco
product in the same container closure system as that in which the
tobacco product is intended to be marketed, and testing supporting the
expiration date (proposed Sec. 1107.19(e)(iv)). Accelerated studies,
combined with basic stability information, could be used to support
tentative expiration dates provided full shelf life studies are not yet
available but are being conducted. Where data from accelerated studies
are used to project a tentative expiration date that is beyond a date
supported by actual shelf-life studies, stability studies would need to
be conducted to support the SE
[[Page 12765]]
Report, including tobacco product testing at appropriate intervals,
until the tentative expiration date could be verified or the
appropriate expiration date could be determined.
Proposed Sec. 1107.19(e)(v) and (vi) would require information on
the stability testing laboratory and identification of the
microbiological organisms by genus and species names, where applicable,
along with the culture collection number either used during the
manufacturing process and/or detected through stability testing.
Proposed Sec. 1107.19(f) would require applicants to state that
the new tobacco product has either: (1) The same characteristics as the
predicate tobacco product and the basis for this determination or (2)
different characteristics than the predicate tobacco product. Where an
applicant states that its new tobacco product has different
characteristics than the predicate tobacco product, the applicant must
also include an explanation as to why a difference in any of the
following characteristics do not cause the new product to raise
different questions of public health: Product design (see Sec.
1107.19(a)); heating source (see Sec. 1107.19(b)); materials and
ingredients (see Sec. 1107.19(c)); and other features (see Sec.
1107.19(d)). In addition, in order to demonstrate that a new tobacco
product with different characteristics is substantially equivalent, an
applicant must also explain why any differences in the manufacturing
process that could affect the characteristics of the new product do not
cause the new product to raise different questions of public health
(see Sec. 1107.18(e)). Similarly, for smokeless tobacco products, an
applicant must explain why any difference in stability between the new
tobacco product and the predicate tobacco product does not raise
different questions of public health (see Sec. 1107.19(e)).
Proposed Sec. 1107.19(g) would explain that, if the applicant is
comparing the new tobacco product to a predicate product that FDA has
previously found to be substantially equivalent to another product, FDA
may request that the applicant include information related to the
original grandfathered tobacco product. Although an applicant can
support a showing of SE by comparing the new tobacco product to a
tobacco product that is grandfathered or that FDA has previously found
SE, in order to issue an SE order, FDA must find that the new tobacco
product is substantially equivalent to a tobacco product commercially
marketed in the United States as of February 15, 2007 (see section
910(a)(2)(A)(i)(I) of the FD&C Act). This statutory provision helps FDA
ensure that new tobacco products using the substantial equivalence
pathway and relying on predicate tobacco products previously found SE
do not vary so much from the original grandfathered tobacco product
that the new product would actually raise different questions of public
health compared to the originally grandfathered tobacco product. New
products with differences that may appear only incremental when a new
tobacco product is compared to a predicate product previously found SE
may actually have had significant changes when compared to the
grandfathered tobacco product.
Because the statute permits applicants to compare to either a
grandfathered tobacco product or one that FDA has previously found SE
(section 905(j)(1)(A)(i)) but also requires FDA to make an SE
determination by comparing the new tobacco product to the grandfathered
tobacco product (section 910(a)(2)(A)(i)(I)), FDA is proposing the
approach in Sec. 1107.19(g). To meet its statutory obligation, FDA may
need to look back to previously submitted SE Reports in the SE chain
that rely on the original grandfathered product in order to issue an SE
order. Manufacturers have been on notice since the passage of the
Tobacco Control Act that FDA must make the comparison between the new
tobacco product and the original grandfathered tobacco product, and in
doing so, may need to rely on previously submitted SE Reports, even if
submitted by a different manufacturer than the applicant at hand.
Accordingly, for SE Reports that compare the new tobacco product to
a predicate tobacco product that FDA previously found substantially
equivalent, proposed Sec. 1107.19(g) states that, if requested by FDA,
the applicant would be required to provide information related to the
original grandfathered tobacco product, even if the grandfathered
tobacco product is several tobacco products removed from the predicate
identified by the applicant. FDA would request this information when
necessary to ensure that any order issued by the Agency complies with
section 910(a)(2)(A)(i)(I) of the FD&C Act. Before requesting this
information from the applicant, FDA would review other relevant SE
Reports in the chain, for example, the first SE Report that received an
SE order using the grandfathered product as a predicate product to make
this finding. If FDA is unable to look back to data provided to the
Agency regarding the grandfathered product and the applicant does not
provide the information, FDA would be unable to make the finding
required by section 910(a)(2)(A)(i)(I) of the FD&C Act. FDA encourages
applicants to provide this information with the initial SE Report to
support an efficient review of the SE Report, although FDA acknowledges
this may be more difficult if the applicant is not the manufacturer or
owner of the predicate tobacco product. FDA requests specific public
comment on this proposed provision and any challenges it may present.
4. Amendments (Proposed Sec. 1107.20)
Proposed Sec. 1107.20(a) would permit an applicant to submit an
amendment to an SE Report. Proposed Sec. 1107.20(a) would require any
applicant who chose to submit a health information summary with its SE
Report under proposed Sec. 1107.18(j)(1) to submit with the amendment
a redacted copy of the amendment that excludes research subject
identifiers and trade secret and confidential and commercial
information as defined in Sec. Sec. 20.61 and 20.63 (21 CFR 20.61 and
20.63).
An applicant may not amend an SE Report to change the predicate
tobacco product (proposed Sec. 1107.20(b)). Because the comparison
between the new and predicate tobacco products is the crux of the
substantial equivalence determination, changing the predicate product
changes the fundamental basis of the analysis. An applicant that
determines that a predicate change is necessary should withdraw the
initial SE Report and resubmit the SE Report with the information
related to the new predicate tobacco product as described in proposed
Sec. 1107.18.
In addition, under proposed Sec. 1107.20(c), an applicant may not
amend a closed SE Report, e.g., one that FDA has refused to accept,
closed, canceled, or issued an order for under proposed Sec. 1107.44,
or one that has been withdrawn under proposed Sec. 1107.22. Proposed
Sec. 1107.20(d) also explains that FDA would review the additional
information in the next review cycle (proposed Sec. 1107.42 discusses
review cycles). As explained in proposed Sec. 1107.62, SE Reports,
including amendments, would be submitted to CTP's Document Control
Center. Phone calls and emails to FDA staff would not be considered
amendments to an SE Report.
5. Withdrawal by Applicant (Proposed Sec. 1107.22)
Proposed Sec. 1107.22 would permit an applicant to make a request
to withdraw an SE Report unless FDA has closed the SE Report through an
action in proposed Sec. 1107.44 (all FDA actions in proposed Sec.
1107.44 would close the SE
[[Page 12766]]
Report except for a request for additional information in proposed
Sec. 1107.44(b)). FDA has determined that withdrawal of an SE Report
would benefit both the Agency and the applicant by potentially saving
time and resources if the original SE Report might otherwise be
insufficient or marketing authorization is no longer desired. The
withdrawal request would state: (1) If the withdrawal is due to a
health or safety concern related to the tobacco product; (2) the STN;
and (3) the name of the new tobacco product that is the subject of the
SE Report. This information would assist FDA in correctly identifying
the SE Report to be withdrawn and also help inform FDA as to whether
there were any concerns under section 909 of the FD&C Act (e.g.,
relating to serious unexpected adverse experiences). Under proposed
Sec. 1107.22(b), an SE Report would be considered withdrawn when FDA
issues a notice stating the SE Report has been withdrawn (see also
proposed Sec. 1107.40(e)).
The SE Report is an Agency record even if withdrawn. Thus, under
proposed Sec. 1107.22(c), FDA would retain the withdrawn SE Report
consistent with Agency record retention schedules and policies and,
under the Agency's public information regulations in part 20, would
provide a copy to the applicant upon request subject to Sec. 20.45. If
the withdrawal request is made at the final review stage and FDA has
identified unresolved deficiencies in the SE Report, FDA may provide a
list of deficiencies in the communication that the Agency sends to the
applicant acknowledging withdrawal. Under proposed Sec. 1107.40(e), an
SE Report would be considered withdrawn when FDA issues a notice
stating that it is withdrawn.
6. Change in Ownership of an SE Report (Proposed Sec. 1107.24)
Proposed Sec. 1107.24 would reflect that transfers in ownership of
SE Reports occur. This proposed section is intended to facilitate
transfers of ownership and help ensure that FDA has current information
regarding the ownership of an SE Report. Proposed Sec. 1107.24 applies
to both pending SE Reports and SE Reports that are the subject of an SE
order. Under proposed Sec. 1107.24, at the time of the transfer, the
new and former applicants (or owners) of the SE Report would be
required to submit certain information to the Agency. First, the former
applicant would be required to submit a notice to FDA identifying the
new applicant and stating that all of the former applicant's rights and
responsibilities relating to the SE Report have been transferred to the
new applicant. Second, the new applicant would be required to submit a
signed notice to FDA containing the following information:
To the extent applicable, the new applicant's commitment
to agreements, promises, and conditions made by the former applicant
and contained in the SE Report (e.g., this could be an agreement by the
new applicant to conduct studies the former applicant had agreed to
conduct in support of a request for an extension of time to respond to
a deficiency);
The date that the change in ownership is effective;
Either a statement that the new applicant has a complete
copy of the SE Report that FDA determined was substantially equivalent
(including any amendments, or any records required to be kept under
proposed Sec. 1107.58); or a statement of intent to request a copy of
the SE Report under the Freedom of Information Act (FDA's implementing
regulations are in part 20); and
A certification that no modifications have been made to
the new tobacco product since the SE Report was submitted to FDA.
Although FDA expects that the new applicant would have a copy of
the SE Report from the former applicant, if the new applicant requests
a copy of the SE Report from FDA, FDA would provide a copy to the new
applicant, subject to the Freedom of Information Act requirements as
implemented by FDA at part 20 and under the fee schedule in Sec.
20.45.
The new applicant also would be required to make available all
required records upon inspection by FDA (proposed Sec. 1107.58 would
impose a recordkeeping requirement). The information required to be
made available for inspection would include raw data and other
information necessary to substantiate the SE Report.
C. FDA Review (Proposed Subpart D)
1. Communications Between FDA and Applicants (Proposed Sec. 1107.40)
Proposed Sec. 1107.40 would establish general principles and
provide clarity regarding communications between FDA and applicants
during review of an SE Report. Proposed Sec. 1107.40(a) explains that,
during the course of FDA's review of an SE Report, FDA may seek to
communicate with applicants about relevant matters, including
scientific and procedural issues that arise during the review process.
Communications regarding medical issues may arise if adverse events
reports exist for the tobacco product. FDA may use a variety of methods
to communicate with applicants, such as telephone conversations,
letters, or emails, depending on the circumstances and issues. FDA
would document any communications regarding an SE Report in accordance
with 21 CFR 10.65.
Proposed Sec. 1107.40(b) would provide that applicants and
representatives of the Agency may have meetings to discuss scientific
and other issues. Applicants interested in requesting meetings would
direct their requests to the Office of Science through the Document
Control Center. For further information, applicants may review the
guidance entitled ``Meetings with Industry and Investigators on the
Research and Development of Tobacco Products'' (May 25, 2012, 77 FR
31368; revised guidance issued July 2016). As discussed in this
guidance, FDA does not intend to grant meetings in most circumstances
to discuss an applicant's questions related to a pending SE Report
because the timing is frequently inappropriate (e.g., premature or
late, depending on stage of review) and such meetings are generally an
inefficient or duplicative use of resources. For example, the applicant
may be seeking substantive information while FDA's review is underway
but before FDA has issued a deficiency letter or other response. Please
note that each SE Report has a specific CTP contact to whom an
applicant may ask clarifying questions, which helps ensure faster and
more direct responses. FDA specifically requests public comment on the
proposed decision to not grant meetings to discuss an applicant's
questions related to a pending SE Report. Specifically, FDA seeks to
understand if there are reasons why such meetings may be necessary for
an applicant to respond to a deficiency letter or if the absence of
such meetings present obstacles to the applicant in responding to
deficiency letters.
Proposed Sec. 1107.40(c) would provide that, upon receipt of an SE
Report under proposed Sec. 1107.18, FDA would either refuse to accept
the SE Report or issue an acknowledgement letter. FDA requests comment
on what a reasonable period of time would be within which such refusal
to accept or acknowledgement of receipt letters should be issued.
Proposed Sec. 1107.40(d) addresses FDA's notification of
deficiencies in an SE Report submitted under proposed Sec. 1107.18.
FDA reviewers would make reasonable efforts to communicate to
applicants the procedural, administrative, or scientific deficiencies
found in an SE Report and, if appropriate, the data needed to enable
[[Page 12767]]
the Agency's review. For example, a reviewer might inform the applicant
that a signature is needed for a certification, that provided test
results have last values cutoff or appear to have a typographical
error, or that the SE Report is missing a reference for support. This
communication is intended to give applicants an opportunity to correct
deficiencies in the SE Report and to submit an amendment if needed.
Proposed Sec. 1107.40(e) explains that an SE Report would be
considered withdrawn when FDA issues a notice stating that it is
withdrawn, which would ensure that FDA has received the withdrawal
notification and that both FDA and the applicant now consider the SE
Report as withdrawn.
FDA invites public comments on the following topics related to
reasonable time periods to respond to a deficiency letter:
Appropriate timelines for responding to a deficiency
letter identifying missing information that is described in the final
rule;
Appropriate timelines for responding to a deficiency
letter identifying missing information that requests additional
information not described in the final rule;
When requests for extensions of time to respond to a
deficiency letter should be granted, and
Whether or not deadlines to respond to deficiency letters
should be tailored to the relative burden of the request.
2. Review Cycles (Proposed Sec. 1107.42)
Proposed Sec. 1107.42(a) would set forth the timeframe for FDA's
initial review cycle. The ``initial review cycle'' would consist of the
90 calendar days following: (1) FDA's receipt of the SE Report and
determination that a predicate product is grandfathered (for SE Reports
that claim the predicate product was commercially marketed in the
United States as of February 15, 2007, and FDA has not already
determined the tobacco product is grandfathered) or (2) FDA's receipt
of an SE Report (for SE Reports that contain a predicate product that
was previously found substantially equivalent or for which FDA has
previously determined that the predicate product is grandfathered). As
described in more detail in proposed Sec. 1107.44, FDA intends to
review the SE Report and communicate with the applicant or take an
action on an SE Report during this time period. At any time before FDA
issues an order on the SE Report, the applicant would be allowed to
withdraw it under proposed Sec. 1107.22.
Proposed Sec. 1107.42(b) would provide for the use of additional
review cycles to complete FDA's review of an SE Report. If FDA issues a
deficiency letter for an SE Report under proposed Sec. 1107.40(d), FDA
would stop reviewing the SE Report until it received a response to the
notification of deficiencies (or deficiency letter) or the timeframe
specified in the letter has elapsed. If the applicant fails to provide
a response within the time period provided, FDA would issue an order
denying marketing authorization for the new tobacco product under the
criteria set forth in Sec. 1107.48. If the applicant provides a
response within the allotted timeframe, but FDA identifies the need for
additional information as a result of this response, FDA could issue an
additional deficiency notification. Each response would begin a new 90
calendar day review cycle for FDA to review the response.
FDA's intent is to complete review of an SE Report submitted under
proposed Sec. 1107.18 within a maximum of 270 review days (i.e., three
90-day review cycles). Based on FDA's review experience, an SE Report
should be resolved within three review cycles. If fewer review cycles
are needed, FDA intends to decide in a shorter time period. Section
1107.40 would not obligate FDA to notify applicants of deficiencies in
all circumstances before taking an action on an SE Report per proposed
Sec. 1107.44 or proposed Sec. 1107.48. In any case where the SE
Report has significant deficiencies, FDA might issue an order denying
marketing authorization without providing additional opportunities to
provide the missing information. Examples of significant deficiencies
include when an SE Report provides no scientific evidence to
substantiate a statement from the applicant that the new tobacco
product does not raise different questions of public health or when an
SE Report has multiple deficiencies but the applicant does not provide
responses to all of the deficiencies. FDA requests public comment on
whether FDA should provide specific timeframes within which applicants
would need to respond to deficiency letters, along with an explanation
as to why the proposed timeframes may be suitable for addressing the
concerns commonly cited in the letters and why.
Proposed Sec. 1107.42(c) states that, in the event that an
applicant's response to FDA's deficiency notification(s) does not
provide adequate information or the applicant provides information but
the SE Report remains deficient, FDA intends to issue an order denying
market authorization under the criteria set forth in proposed Sec.
1107.48. The applicant also could make a written request to withdraw
the SE Report under proposed Sec. 1107.22 at any time before FDA
issues an order regarding the SE Report.
3. FDA Action on an SE Report (Proposed Sec. 1107.44)
Proposed Sec. 1107.44 lists six actions FDA may take after
completing review of an SE Report:
First, FDA could refuse to accept the SE Report and not
begin substantive scientific review if the SE Report does not comply
with the requirements of proposed Sec. 1107.18 (this action would stop
the review clock and end the review cycle). For example, FDA could
refuse to accept an SE Report that was not written in English as
required under Sec. 1107.18(b), or did not provide the information on
product composition as required under Sec. 1107.19(c)(1). Or, FDA
could advise the applicant that the SE Report is not appropriate under
chapter IX of the FD&C Act because the product does not meet the
definition of a tobacco product under section 201(rr) of the FD&C Act.
Second, FDA could request additional information as
provided in proposed Sec. 1107.40(d).
Third, FDA could issue a letter closing the SE Report if
it not possible to make a determination on an SE Report (sometimes
referred to as an administrative closure, for example, which we might
do when there is no way to determine if a new product is SE or NSE and
additional information is unavailable);
Fourth, FDA could issue a letter canceling the SE Report
if FDA finds it mistakenly acknowledged the SE Report, e.g., the SE
Report does not pertain to a new tobacco product;
Fifth, FDA could issue an order finding the new tobacco
product to be substantially equivalent and in compliance with the
requirements of the FD&C Act under proposed Sec. 1107.46.
Sixth, FDA could issue an order denying marketing
authorization under proposed Sec. 1107.48 (NSE order) because:
[cir] The applicant has failed to provide the information needed
for FDA to find that the new tobacco product is substantially
equivalent to a tobacco product that was commercially marketed in the
United States on February 15, 2007;
[cir] The new tobacco product is not substantially equivalent to a
tobacco product that was commercially marketed in the United States on
February 15, 2007; or
[[Page 12768]]
[cir] The new tobacco product is not in compliance with the
requirements of the FD&C Act. For example, a new tobacco product is not
in compliance with the requirements of the FD&C Act if the manufacturer
of such product is in arrears with respect to its user fees; therefore,
FDA would issue an NSE order.
4. Issuance of an Order Finding a New Tobacco Product Substantially
Equivalent (Proposed Sec. 1107.46)
Proposed Sec. 1107.46 would explain that if, after review, FDA
determines that the new tobacco product is substantially equivalent to
a predicate tobacco product that was commercially marketed in the
United States on February 15, 2007, and in compliance with the FD&C
Act, the Agency would send the applicant an order authorizing the
marketing of the product. The marketing authorization would be
effective on the date the order is issued, which would typically be
noted on the first page of the order.
5. Issuance of an Order Denying Marketing Authorization (Proposed Sec.
1107.48)
Proposed Sec. 1107.48(a) would provide that, in general, if FDA:
(1) Is unable to determine that the new tobacco product is
substantially equivalent to a predicate tobacco product that was
commercially marketed in the United States on February 15, 2007, or (2)
determines that the new tobacco product is not in compliance with the
FD&C Act, the Agency would issue an NSE order indicating that the
manufacturer cannot market the new tobacco product. FDA would
communicate this decision to the applicant in writing. Proposed Sec.
1107.48(b) provides that the NSE order would describe the basis for
denying marketing authorization. FDA intends to describe any
deficiencies that FDA has identified in an SE Report.
6. Rescission of Order (Proposed Sec. 1107.50)
Proposed Sec. 1107.50 would provide the procedural mechanism for
FDA to rescind an SE order and describes the grounds for when an SE
order may be rescinded. FDA intends to exercise this authority in a
judicious and timely way in specific circumstances. FDA is proposing
this provision based on our authority to issue an order only when it
can make the findings provided in section 910(a)(2)(A)(i) of the FD&C
Act and our authority to promulgate regulations for the efficient
enforcement of the FD&C Act (section 701 of the FD&C Act). FDA's
inherent authority to timely revisit and reconsider prior decisions is
also supported by case law, with the inherent authority for timely
administrative reconsideration premised on the notion that the ``
`power to reconsider is inherent in the power to decide.' '' See Ivy
Sports Med. LLC, v. Burwell, 767 F.3d 81, 86 (D.C. Cir. 2014) (quoting
Albertson v. FCC, 182 F.2d 397, 399 (D.C. Cir. 1950)). Where, as here,
nothing in the Tobacco Control Act suggests that Congress intended to
displace this inherent authority in the context of SE determinations,
FDA may rescind an SE order based on its inherent authority. If, after
issuing an SE order, FDA later determines, for example, that the order
was based on false information or there was an error in information
upon which the SE order is based, FDA would rescind the SE order. This
proposed section would provide that--
First, FDA may rescind an SE order if, after an order has
issued, FDA becomes aware that the tobacco product for which the order
has been issued:
[cir] Does not have the same characteristics as the predicate
tobacco product or
[cir] has different characteristics and there is insufficient
information demonstrating that it was not appropriate to require a
premarket tobacco product application under section 910(b) of the FD&C
Act because the product does not raise different questions of public
health.
Second, FDA may rescind an SE order if, after an order has
issued, FDA becomes aware that the SE Report (including any submitted
amendments) contains an untrue statement of material fact.
Third, FDA may rescind an SE order if the SE Report
compared the new tobacco product to a tobacco product that FDA
previously found substantially equivalent, and the predicate tobacco
product relied on in the SE Report has been found ineligible because
its SE Report (including any submitted amendments) contains an untrue
statement of material fact, and/or a predicate product on which any of
the previous substantial equivalence determinations was based, going
back to the original grandfathered product, has been found ineligible
because its SE Report (including any amendments) contained an untrue
statement of material fact.
Fourth, FDA may rescind an SE order if FDA or the
applicant has removed from the market due to a health or safety concern
related to the tobacco product:
[cir] The predicate product on which the substantial equivalence
determination is based and/or
[cir] a predicate product on which any of the previous substantial
equivalence determinations is based, going back to the original
grandfathered product, if the SE Report compared the new tobacco
product to a tobacco product that FDA previously found substantially
equivalent. FDA may rescind in this scenario because the new tobacco
product is SE to, or is in the same generational line as a predicate
tobacco product with safety issues, and, therefore, may present similar
safety concerns.
Proposed Sec. 1107.50(b) states that, generally, FDA would rescind
an SE order only after it has provided notice to the applicant and an
opportunity for a hearing under part 16. FDA is proposing to amend
Sec. 16.1 to add a reference Sec. 1107.50. FDA encourages applicants
to bring errors to the Agency's attention that may necessitate
rescission, and FDA intends to work with applicants in such scenarios.
In addition, FDA may need to rescind an order without providing
notice and a prior opportunity for a hearing if FDA finds that the
continued marketing of the tobacco product presents a serious risk to
public health, e.g., if the applicant represented that the new tobacco
product conformed to a tobacco product standard, but FDA later
determined that the new tobacco product did not conform to a tobacco
product standard in a way that presents a serious risk to public
health. Another example would be if FDA identifies data integrity
issues during an inspection that would lead FDA to believe that the
tobacco product presents a serious risk to public health. In these
cases, FDA would provide the applicant an opportunity for a hearing as
soon as possible after the rescission.
D. Miscellaneous (Proposed Subpart E)
Subpart E describes other procedures and requirements related to SE
Reports, including record retention, electronic submission
requirements, foreign data, and confidentiality considerations.
1. Record Retention (Proposed Sec. 1107.58)
Consistent with the authority to require recordkeeping under
section 909 of the FD&C Act, proposed Sec. 1107.58, would require
applicants receiving an order under proposed Sec. 1107.46 authorizing
the marketing of a new tobacco product to maintain all records
supporting that SE Report for at least 4 years from the date of the
order even if such product is discontinued. FDA has selected 4 years as
a means to help ensure that the records would be available for at least
one biennial FDA
[[Page 12769]]
inspection under section 704 and 905(g) of the FD&C Act. The records
would be required to be legible, written in English or an English
translation provided, and available for inspection and copying by
officers or employees designated by the Secretary of Health and Human
Services. Applicants that have stopped marketing a tobacco product may
want to retain the records for a longer period, if the product might be
reintroduced in order to avoid the time and expense of having to
generate the information again.
2. Confidentiality (Proposed Sec. 1107.60)
Proposed Sec. 1107.60(a) states that FDA would determine the
public availability of any part of any SE Report and other content
related to an SE Report as provided under this proposed section and
part 20 (Public Information). The Freedom of Information Act (FOIA) (5
U.S.C. 552), as well as certain provisions of the FD&C Act, e.g.,
section 301(j) (21 U.S.C. 331(j)) and section 906(c) (21 U.S.C.
387f(c)), govern the disclosure of the existence of a pending SE Report
and the information contained in such an SE Report. Under FOIA, the
public has broad access to government documents. However, FOIA provides
certain exemptions from mandatory public disclosure. One such
provision, 5 U.S.C. 552(b)(4), exempts records that are ``trade secrets
and commercial or financial information obtained from a person and
privileged or confidential'' from the requirement of mandatory
disclosure. Part 20 of FDA's regulations sets forth FDA's general
regulations concerning public availability of FDA records.
Like with drugs and devices, the intent to market a tobacco product
is often considered confidential commercial information, as premature
disclosure could result in a competitive advantage to competitors.
Therefore, FDA is proposing Sec. 1107.60(b)(1), which would address
the confidentiality of an SE Report prior to the issuance of an order
under either proposed Sec. 1107.46 or proposed Sec. 1107.48. Under
the proposed regulation and consistent with part 20, FDA would not
publicly disclose the existence of an SE Report unless the applicant
has publicly disclosed or acknowledged the existence (as such
disclosure is defined in Sec. 20.81), or has authorized FDA in writing
to publicly disclose or acknowledge, that the applicant has submitted
the SE Report to FDA.
Proposed Sec. 1107.60(b)(2) provides that FDA would not disclose
the existence or contents of an FDA communication with an applicant
regarding its SE Report except to the extent that the applicant has
publicly disclosed or acknowledged, or authorized FDA in writing to
publicly disclose or acknowledge, the existence of or contents of that
particular FDA communication. Proposed Sec. 1107.60(b)(3) provides
that FDA would not disclose information contained in an SE Report
unless the applicant has publicly disclosed or acknowledged, or
authorized FDA in writing to publicly disclose or acknowledge, that
particular information. If the applicant has publicly disclosed or
acknowledged, or authorized FDA in writing to publicly disclose or
acknowledge, that particular information contained in an SE Report, FDA
may disclose that particular information.
Proposed Sec. 1107.60(c) would address the disclosure of data and
information after an order is issued under proposed Sec. 1107.46. This
proposed section would provide that, after an order under Sec. 1107.46
(finding a new tobacco product substantially equivalent), FDA would
make the following information related to the SE Report and order
available for public disclosure upon request or at FDA's own
initiative, including information from amendments to the SE Report and
FDA's reviews of the SE Report: (1) All data previously disclosed to
the public, as such disclosure is defined in Sec. 20.81; (2) any
protocol for a test or study, except to the extent it is shown to fall
within the exemption established for trade secrets and confidential
commercial information in Sec. 20.61; (3) information and data
submitted to demonstrate that the new tobacco product does not raise
different questions of public health, except to the extent it is shown
to fall within the exemptions established in Sec. 20.61 for trade
secrets and confidential commercial information, or in Sec. 20.63 for
personal privacy; (4) correspondence between FDA and the applicant,
including any requests FDA made for additional information and
responses to such requests, and all written summaries of oral
discussions between FDA and the applicant, except to the extent it is
shown to fall within the exemptions in Sec. 20.61 for trade secrets
and confidential commercial information, or in Sec. 20.63 for personal
privacy; and (5) the environmental assessment or, if applicable, the
claim of categorical exclusion from the requirement to submit an
environmental assessment under part 25 of this chapter.
Even after issuance of an order under Sec. 1107.48 (Denying
marketing authorization), the applicant's intent to market may still
constitute confidential commercial information, as the applicant may
still be planning to market the new tobacco product that is the subject
of the SE Report (e.g., by submitting a new SE Report, a PMTA, or a
request for exemption from substantial equivalence, or by seeking
further review of the denial). Therefore, proposed Sec. 1107.60(d)
addresses the disclosure of data and information after FDA issues an
order under Sec. 1107.48 (Denying marketing authorization). Under this
proposed subsection, FDA may make certain information related to the SE
Report and the order available for public disclosure upon request or at
FDA's own initiative except to the extent the information is otherwise
exempt from disclosure under part 20. Information FDA may disclose
includes the tobacco product category (e.g., cigarette), tobacco
product subcategory (e.g., filtered), package size, and the basis for
the order denying marketing authorization.
Proposed Sec. 1107.60(e) addresses disclosure of the health
information summary or statement and would provide that health
information required by section 910(a)(4) of the FD&C Act, if submitted
as part of the SE Report (which includes any amendments), would be
disclosed within 30 calendar days of issuing a substantially equivalent
order. If the applicant has instead submitted a 910(a)(4) statement as
provided in Sec. 1107.18(j)(2), FDA would make publicly available on
FDA's website the responsible official to whom a request for health
information may be made. FDA intends to include this information on our
website to ensure that the information is easily accessible to
requestors.
3. Electronic Submission (Proposed Sec. 1107.62)
Based on our authority in section 905 of the FD&C Act to prescribe
the format of SE Reports, proposed Sec. 1107.62(a) and (b) would
require the applicant to submit the SE Report and supporting and other
related documents in an electronic format that FDA can process, read,
review, and archive unless a waiver from this requirement is requested
by the applicant and FDA grants the waiver. Reasons that an applicant
might request a waiver would include that the applicant has no access
to email or a computer. Under proposed Sec. 1107.62(c), an applicant
that has a waiver would submit a paper submission to the address that
FDA provides in the letter granting the waiver. FDA is proposing Sec.
1107.62 based on FDA's general experiences with electronic submission,
which FDA
[[Page 12770]]
has found helps facilitate premarket reviews because electronic
submission typically has enabled FDA to receive, open, and read a
submission more quickly than a submission submitted on paper through
postal mail. If this rule is finalized, FDA intends to provide
information on submitting information in an electronic format that FDA
can process, read, review and archive (e.g., method of transmission,
media, file formats, preparation, organization of files, accompanying
metadata) (https://www.fda.gov/TobaccoProducts/default.htm). FDA
intends to update this information as needed (e.g., to accommodate
changes in technology).
IV. Other Issues for Consideration
In addition to comments and information on the proposed
requirements described in section III, FDA is also seeking comments and
information on whether some modifications to tobacco products that
result in a new tobacco product, beyond those eligible for an exemption
from substantial equivalence, might be handled through a
``categorical'' approach to substantial equivalence. Under such an
approach, FDA would establish categories of modifications, and if a
modification is within a category, the applicant could then submit a
streamlined SE Report that identifies the modification and demonstrates
substantial equivalence. FDA is soliciting concerns or benefits of this
type of approach, along with information on the types of modifications
or categories that might be handled in this way, or should not be
handled this way.
V. Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). A
description of these provisions is given in the Description section of
this document with an estimate of the annual reporting and
recordkeeping. Included in the estimate is the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
FDA invites comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Title: Substantial Equivalence Reports for Tobacco Products.
Description: Tobacco Products, Substantial Equivalence Reports,
Requirements for Submitting Information Needed to Determine Substantial
Equivalence and Maintaining Records to Support a Substantial
Equivalence Report.
This proposed rule would establish requirements for the content and
format of substantial equivalence (SE) Reports (proposed Sec. Sec.
1107.18 and 1107.19). Most of the proposed requirements would mirror
current practices and recommendations related to the submission of SE
Reports, including information related to part 25 (environmental
considerations), but the rule would provide both applicants and FDA
more certainty regarding the content and format the SE Reports. A
health information summary or statement would continue to be required
(section 910(a)(4) of the FD&C Act) and the health summary or response
to a request would be required to be in the format of a redacted SE
Report, along with any additional health information about the new
tobacco product, including any information, research, or data about
adverse health effects, that the applicant has or knows about and that
is not contained in the SE Report.
As is currently the practice, the proposed rule would continue to
permit amendments for SE Reports submitted under proposed Sec.
1107.18, e.g., to address deficiencies (proposed Sec. 1107.20). Also
in accordance with current practice, the proposed rule would continue
to permit withdrawals (proposed Sec. 1107.22) of pending SE Reports.
The proposed rule would also propose requirements for when the
ownership of an SE Report changes to ensure that FDA has information
related to the current applicant (proposed Sec. 1107.24).
The proposed rule would establish a recordkeeping requirement,
under which applicants would be required to maintain records supporting
the SE Report for an authorized new tobacco product for 4 years from
the date of an order finding substantial equivalence, even if such
product is discontinued (proposed Sec. 1107.58).
The proposed rule would require that respondents submit an SE
Report in an electronic format, unless a waiver from this requirement
is requested by the applicant and granted by FDA (proposed Sec.
1107.62). FDA created two new forms for submission; Form FDA 3964,
Tobacco Amendment and General Correspondence; and Form FDA 3965,
Tobacco Substantial Equivalence Report Submission.
Description of Respondents: Manufacturers of tobacco products who
submit SE Reports.
Existing Burden OMB Control Number 0910-0673
Table 9--Estimated Annual Reporting Burden 1 2
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Full SE 905(j)(1)(A)(i) and 410 1 410 300 123,000
910(a).........................
Full SE 905(j)(1)(A)(i) and 250 1 250 90 22,500
910(a) Bundled.................
Product Quantity Change SE 264 1 264 87 22,968
Report.........................
Product Quantity Change Bundled 55 1 55 62 3,410
SE Report......................
-------------------------------------------------------------------------------
Totals...................... .............. .............. .............. .............. 171,878
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ This chart represents the currently OMB approved burden for the SE program.
Reporting Burden Updated Estimates
[[Page 12771]]
Table 10--Estimated Annual Reporting Burden 1 2
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Full SE 905(j)(1)(A)(i) and 683 1 683 300 204,900
910(a).........................
Full SE 905(j)(1)(A)(i) and 456 1 456 90 41,040
910(a) Bundled.................
Product Quantity Change SE 239 1 239 87 20,793
Report.........................
Product Quantity Change Bundled 192 1 192 62 11,904
SE Report......................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 278,637
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Draft burden not yet OMB approved.
In the Federal Register of September 6, 2018 (83 FR 45251), FDA
published a notice soliciting comments on the extension of the current
SE program. The numbers above in table 10 represent the tentative
revisions which have not yet been approved by OMB. These estimates
revise the number of reports under OMB control number 0910-0673 and
take into account updated registration and listing data. The previous
estimate for reports was 979 and total burden hours were 171,878. This
chart accounts for the tentative increase in burden due to the expected
rise in submissions other than any increases in burden due to the
proposed rule, if finalized.
New Reporting Per Rule
Table 11--Estimated Annual Reporting Burden 1 2
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR part Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
FDA 3965 Tobacco Substantial 1,570 1 1,570 .5 785
Equivalence Report Submission..
FDA 3964 Tobacco Amendment and 628 1 628 .083 52
General Correspondence.........
Waiver from Electronic 240 1 240 .25 60
submission 1107.62(b)..........
-------------------------------------------------------------------------------
Totals...................... .............. .............. .............. .............. 897
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Draft burden not yet OMB approved.
Final Combined Reporting Burden (Tables 10 +11)
Table 12--Estimated Annual Reporting Burden 1 2
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR part Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
SE Report 1107.18............... 683 1 683 300 204,900
Bundled SE 1107.18.............. 456 1 456 90 41,040
SE Report where applicant 239 1 239 87 20,793
provides certification for
identical characteristics
1107.18(g) and 1107.18(1)(2)...
SE Report where applicant 192 1 192 62 11,904
provides certification for some
identical characteristics
(bundled) 1107.18(g) and
1107.18(1)(2)..................
FDA 3965 Tobacco Substantial 1,570 1 1,570 .5 785
Equivalence Report Submission..
FDA 3964 Tobacco Amendment and 628 1 628 .083 52
General Correspondence Report..
Waiver from Electronic 240 1 240 .25 60
submission 1107.62(b)..........
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Totals...................... .............. .............. .............. .............. 279,534
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Draft burden not yet OMB approved.
New Final Recordkeeping Burden
[[Page 12772]]
Table 13--Estimated Annual Recordkeeping Burden 1 2
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR part Number of records per Total annual Average burden Total hours
recordkeepers recordkeeper records per recordkeeping
----------------------------------------------------------------------------------------------------------------
Recordkeeping SE Report 471 1 471 2.5 1,178
under 1107.18 1107.58......
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Draft burden not yet OMB approved.
FDA's estimates are based on experience with SE Reports,
registration and listing data, interactions with the industry, and
information related to other regulated products. As explained above,
taking into account the updated registration and listing data for
deemed tobacco products, the estimated annual number of SE Reports is
expected to be 1,570. That estimate is not expected to change as a
result of the proposed rule, if finalized.
When groups of full SE Reports or SE Reports that each contain a
certification that some characteristics are identical have identical
content, they may be bundled; when a group of similar reports are
bundled, the subsequent bundled reports are expected to take less time
to prepare than the initial report.
FDA has based these estimates on information it now has available
from interactions with the industry, information related to other
regulated products, and FDA expectations regarding the tobacco
industry's use of the substantial equivalence pathway to market their
products. Table 9 describes the annual reporting burden for compliance
with the requirements to demonstrate substantial equivalence under the
FD&C Act. We do not expect a large burden increase for this program,
as, without the proposed rule, manufacturers would routinely submit SE
Reports for new tobacco products, and the Agency believes most
respondents are currently practicing most of the proposed requirements.
FDA will revise this collection with the new burden. FDA requests
public comments on the estimated burden associated with the
requirements associated with this rule and whether there is any
evidence, information, or data to support alternate burden estimates.
Table 11 describes the annual reporting burden as a result of the
requirements proposed in Sec. Sec. 1107.18 and 1107.19, implementing
the substantial equivalence requirements of section 905(j)(1)(A)(i) and
910(a) of the FD&C Act. This proposed rule would require manufacturers
to submit SE Reports electronically (proposed Sec. 1107.62). We
estimate that it would initially take about 30 minutes per product to
fill out the Form FDA 3965. However, for amendments we estimate that
filling out the Form FDA 3964 will take 5 minutes as applicants can
copy and paste from the first submission. Proposed 1107.62(b) also
allows for waivers from the electronic format requirement. FDA
estimates that 240 respondents or 15 percent of SE Reports (1,570) will
submit a waiver.
Based on updated information, FDA estimates that it will receive
683 full initial SE Reports for a new tobacco product each year under
proposed Sec. 1107.18 that take a manufacturer approximately 300 hours
to prepare. Additionally, manufacturers may bundle groups of SE Reports
for their new products in the same product category and subcategory
where the proposed modifications are the same; when a group of similar
SE Reports are bundled, the reporting burden for the initial SE Report
is expected to take the same amount of time as a stand-alone SE Report.
However, the reporting burden for subsequent bundled SE Reports is
expected to be lower than the initial SE Report. We expect to receive
456 bundled SE Reports under proposed Sec. 1107.18 (other than the
initial SE Report in the bundle) at approximately 90 hours per response
for a total of 41,040 hours.
In the absence of more specific information concerning SE Reports
where applicants provide a certification for some identical
characteristics under proposed Sec. 1107.18(g) and 1107.18(l)(2), FDA
estimates receiving 239 such SE Reports at 87 hours per response for a
total of 20,973 hours. We also estimate receiving 192 bundled SE
Reports where applicants provide a certification for some identical
characteristics under proposed Sec. Sec. 1107.18(g) and 1107.18(l)(2)
(other than the initial SE Report in the bundle) at 62 hours per
response for a total of 11,904 hours. Although we believe that the
number of SE Reports that include a certification will increase because
the proposed rule clarifies when applicants may certify that certain
characteristics are identical in the new tobacco product and the
predicate tobacco product, in the absence of specific information on
how many more applicants might choose to certify, we are maintaining
our previous estimates at this time. We request comment on these
estimates.
FDA has based these estimates on the full analysis of economic
impacts and experience with the recently-revised existing information
collection that applies to tobacco products. In addition, anyone
submitting an SE Report is required to submit an environmental
assessment prepared in accordance with Sec. 25.40 under proposed Sec.
1107.18(k). The burden for environmental reports has been included in
the burden per response for each type of SE Report.
Based on FDA's experience with EAs for currently regulated tobacco
products, we expect industry to spend 80 hours preparing an
environmental assessment for a full SE Report under proposed Sec.
1107.18.
Generally, an applicant may withdraw its SE Report after submission
(proposed Sec. 1107.22), change the ownership of its SE Report
(proposed Sec. 1107.24), and amend its SE Report (proposed Sec.
1107.20). The information required to grant these requests is already
being collected, so we do not expect a change in burden.
FDA estimates that 30 percent of SE Reports or 471 respondents will
maintain required records related to their SE Reports at 2.5 hours per
record for a total of 1,178 recordkeeping hours.
FDA estimates that the burden for new requirements will increase
this collection by 108,834 (107,656 + 1,178 recordkeeping). The burden
for the submission of substantial equivalence information is estimated
to total 280,712 hours (279,534 reporting and 1,178 recordkeeping).
This proposed rule also refers to previously approved collections of
information found in FDA regulations. Proposed Sec. 1107.40 references
meetings that may be held with applicants who want to meet with FDA to
discuss scientific and other issues. Additional information about how
to request meetings with FDA's CTP can be found in FDA's guidance
entitled ``Meetings with Industry and Investigators on the Research and
Development of Tobacco Products.'' The collections of information in
the guidance referenced have been approved under OMB control number
[[Page 12773]]
0910-0731. In addition to the premarket application under section
910(b) and a report under 905(j)(1)(A)(i), certain new tobacco products
may use the exemption premarket pathway, see 21 CFR 1107.1. The
collections of information found in 21 CFR 1107.1 have been approved
under OMB control number 0910-0684.
To ensure that comments on information collection are received, OMB
recommends that written comments be faxed to the Office of Information
and Regulatory Affairs, OMB (see ADDRESSES). All comments should be
identified with the title of the information collection.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3407(d)), the Agency has submitted the information collection
provisions of this proposed rule to OMB for review. These requirements
will not be effective until FDA obtains OMB approval. FDA will publish
a notice concerning OMB approval of these requirements in the Federal
Register.
VI. Executive Order 13132: Federalism
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. Section 4(a) of the
Executive Order requires Agencies to ``construe . . . a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.''
Section 916(a)(2) of the FD&C Act (21 U.S.C. 387p) is an express
preemption provision. Section 916(a)(2) provides that ``no State or
political subdivision of a State may establish or continue in effect
with respect to a tobacco product any requirement which is different
from, or in addition to, any requirement under the provisions of this
chapter relating to . . . premarket review.'' Thus, if this proposed
rule is made final, the final rule would create requirements that fall
within the scope of section 916(a)(2) of the FD&C Act.
VII. Consultation and Coordination With Indian Tribal Governments
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175. We have tentatively
determined that the rule does not contain policies that would have a
substantial direct effect on one or more Indian Tribes, on the
relationship between the Federal Government and Indian Tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian Tribes. The Agency solicits comments from tribal
officials on any potential impact on Indian Tribes from this proposed
action.
VIII. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. No extraordinary circumstances exist
to indicate that the specific proposed action may significantly affect
the quality of the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
IX. Economic Analysis of Impacts
We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, Executive Order 13771, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and
13563 direct us to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). We believe that this
proposed rule is not an economically significant regulatory action as
defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because we have determined that the compliance costs are less
than 0.1 percent of revenues, we propose to certify that the rule would
not have a significant economic impact on a substantial number of small
entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $150 million, using the most current (2017) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.
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 million 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 at a 3
percent discount rate, and from $12 million to $163 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 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.
The proposed rule's costs and benefits are summarized in Table 14
entitled ``Economic Data: Costs and Benefits Statement.''
[[Page 12774]]
Table 14--Economic Data: Costs and Benefits Statement
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
------------------------------------
Category Low Primary High Period Notes
estimate estimate estimate Year Discount covered
dollars rate (%) (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized $millions/year....... 1.7 7.2 23.2 2016 7 10 Cost-savings to government.
1.7 7.2 23.2 2016 3 10 Cost-savings to government.
Annualized................................ .......... .......... .......... 2016 7 10 ................................
Quantified................................ .......... .......... .......... 2016 3 10 ................................
Qualitative............................... .......... .......... .......... .......... .......... .......... Greater certainty for SE
applicants.
Costs:
Annualized Monetized $millions/year....... 0.08 0.20 0.33 2016 7 10 ................................
0.07 0.19 0.31 2016 3 10
Annualized................................ .......... .......... .......... 2016 7 10 ................................
Quantified................................ .......... .......... .......... 2016 3 10 ................................
Qualitative. .......... .......... .......... .......... .......... .......... ................................
Transfers:
Federal Annualized Monetized $millions/ .......... .......... .......... 2016 7 10 ................................
year. 2016 3 10
------------------------------------------------------------------------
From:
To: ..........
------------------------------------------------------------------------
Other Annualized Monetized $millions/year. .......... .......... .......... 2016 7 10 ................................
2016 3 10
------------------------------------------------------------------------
From:
To: ..........
---------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government: No effect
Small Business: No effect
Wages: No effect
Growth: No effect
--------------------------------------------------------------------------------------------------------------------------------------------------------
In line with Executive Order 13771, in Table 15 we estimate present
and annualized values of costs and cost-savings over an infinite time
horizon. Our primary estimate of the present value over an infinite
time horizon of net costs due to this proposed rule is -$101.4 million
at a 7 percent discount rate, and -$237.7 million at a 3 percent
discount rate. Our primary estimate of the annualized net costs is -
$7.1 million at a 7 percent discount rate and -$7.1 million at a 3
percent discount rate. Table 15 summarizes the costs, cost-savings and
net costs of this proposed rule. Based on these cost-savings this
proposed rule, if finalized, would be considered a deregulatory action
under E.O. 13771.
Table 15--E.O. 13771 Summary Table
[In $ Millions 2016 dollars, over infinite time horizon]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Lower bound Upper bound Lower bound Upper bound
Primary (7%) (7%) (7%) Primary (3%) (3%) (3%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Costs.................................. $2.05 $0.57 $3.56 $3.75 $0.69 $6.92
Present Value of Cost Savings........................... 103.49 24.84 331.18 241.48 57.96 772.75
Present Value of Net Costs.............................. (101.4) (24.3) (327.6) (237.7) (57.3) (765.8)
Annualized Costs........................................ 0.14 0.04 0.25 0.11 0.02 0.21
Annualized Cost Savings................................. 7.24 1.74 23.18 7.24 1.74 23.18
Annualized Net Costs.................................... (7.1) (1.7) (22.9) (7.1) (1.7) (23.0)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Values in parentheses denote net negative costs (i.e., cost-savings).
We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the proposed rule. The full analysis of
economic impacts is available in the docket for this proposed rule
(Ref. 54) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
X. References
The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.
1. Wayne, G. F. and G. N. Connolly, ``Application, Function, and
Effects of Menthol in Cigarettes: A Survey of Tobacco Industry
Documents,'' Nicotine & Tobacco Research, 6(Suppl. 1):S43-S54, 2004.
2. Brunnemann, K. D., J. C. Scott, and D. Hoffmann, ``N-
Nitrosomorpholine and
[[Page 12775]]
Other Volatile N-nitrosamines in Snuff Tobacco,'' Carcinogenesis,
3(6):693-696, 1982.
3. Draft Form FDA 3965 (Substantial Equivalence Submission).
4. Draft Form FDA 3964 (Amendment).
5. Agaku, I. T., C. I. Vardavas, and G. N. Connolly, ``Cigarette Rod
Length and Its Impact on Serum Cotinine and Urinary Total NNAL
Levels, NHANES 2007-2010,'' Nicotine & Tobacco Research, 16(1):100-
107, 2014.
6. Eaker, D. W., ``Dynamic Behavior and Filtration of Mainstream
Smoke in the Tobacco Column and Filter,'' Recent Advances in Tobacco
Science, 16:103-187, 1990.
7. Connolly, G. N., H. R. Alpert, G. F. Wayne, et al., ``Trends in
Nicotine Yield in Smoke and its Relationship with Design
Characteristics Among Popular US Cigarette Brands, 1997-2005,''
Tobacco Control, 16(5):e5, 2007, doi: 10.1136/tc.2006.019695.
8. American Tobacco, ``Cigarette Pressure Drop,'' Bates Numbers
991508327-991508331, 1990.
9. U.S. Department of Health and Human Services, ``The Health
Consequences of Smoking: The Changing Cigarette,'' A Report of the
Surgeon General; 1981.
10. Torikaiu, K., Y. Uwano, T. Nakamore, et al., ``Study on Tobacco
Components Involved in Pyrolytic Generation of Selected Smoke
Constituents,'' Food and Chemical Toxicology, 43: 559-568, 2005.
11. Spears, A. W., ``Effect of Manufacturing Variables on Cigarette
Smoke Composition,'' CORESTA Information Bulletin, Special Issue:
65-78, 1974.
12. Geiss, O. and D. Kotzias, ``Tobacco, Cigarettes and Cigarette
Smoke: An Overview,'' Institute for Health and Consumer Protection,
European Commission, Directorate-General, Joint Research Centre,
2007, available at http://publications.jrc.ec.europa.eu/repository/bitstream/111111111/8885/1/7472%20-%20EUR22783EN_Geiss_Kotzias.pdf.
13. DeBardeleben, M. Z., W. E. Claflin, and W. F. Gannon, ``Role of
Cigarette Physical Characteristics on Smoke Composition,'' Recent
Advances in Tobacco Science, 4:85-111, 1978.
14. Bourlas, M. C., D. F. Magin, R. A., Kornfeld, et al., ``The
Generation of Water in the Tobacco Oven Volatile Test, Beitr[auml]ge
zur Tabakfoschung International, 10(3), 149-154, 1980.
15. Coleman, W. M., ``Tobacco Volatiles: Gas Chromatography,'' R. J.
Reynolds Tobacco Company, 4380-4388, Academic Press, 2000.
16. Owens, W. F., ``Effect of Cigarette Paper on Smoke Yield and
Composition,'' Recent Advances in Tobacco Science, 4:3-24, 1978.
17. British American Tobacco, Research & Development, ``Lower
Ignition Propensity.''
18. Adam, T., J. McAughey, C. Mocker, et al., ``Influence of Filter
Ventilation on the Chemical Composition of Cigarette Mainstream
Smoke,'' Analytica Chimica Acta, 657(1): 36-44, 2010.
19. Hammond, D., N. Collishaw, and C. Callard, ``Secret Science:
Tobacco Industry Research on Smoking Behaviour and Cigarette
Toxicity,'' The Lancet, 367 (9512) 781-787, 2006.
20. Browne, C. L., The Design of Cigarettes. Charlotte, NC: Hoechst
Celanese, 1990.
21. World Health Organization, ``The Scientific Basis of Tobacco
Product Regulation,'' Second Report of a WHO Study Group, WHO
Technical Report Series 951, 2008.
22. Taylor, M. J., Scientific Services Manager, Filtrona Technology
Centre, ``The Role of Filter Technology in Reduced Yield
Cigarettes,'' Text of Presentation for World Tobacco Symposium
Kunming, Nov. 17, 2004.
23. Podraza K., Director, Product Integrity, Philip Morris USA,
``Basic Principles of Cigarette Design and Function,'' Presentation
to LSRO, Oct. 29-30, 2001 (Slides 40 & 46).
24. O'Connor, R. J., D. Hammond, A. McNeill, et al., ``How Do
Different Cigarette Design Features Influence the Standard Tar
Yields of Popular Cigarette Brands Sold in Different Countries?,''
Tobacco Control, 17(Suppl. 1):i1-i5, 2008, doi:10.1136/
tc.2006.019166.
25. Dash, S., P. N. Murthy, L. Nath, et al., ``Kinetic Modeling on
Drug Release from Controlled Drug Delivery Systems,'' Acta Poloniae
Pharmaceutica--Drug Research, 67(3):217-223, 2010.
26. Gale, N., G. Errington, and K. McAdam, Group Research &
Development, British American Tobacco, ``Effects of Product Format
on Nicotine and TSNA Extraction from Snus Pouches,'' Presentation at
the 67th Tobacco Science Research Conference, Williamsburg, VA,
September 15-18, 2013.
27. Stepanov, I., J. Jensen, L. Biener, et al., ``Increased Pouch
Sizes and Resulting Changes in the Amounts of Nicotine and Tobacco-
Specific N-Nitrosamines in Single Pouches of Camel Snus and Marlboro
Snus,'' Nicotine & Tobacco Research, 14(10):1241-1245, 2012.
28. Zhang, H., J. Zhang, and J. B. Streisand, ``Oral Mucosal Drug
Delivery: Clinical Pharmacokinetics and Therapeutic Applications,''
Drug Delivery Systems, 41(9):661-680, 2002.
29. Lewis, S., G. Subramanian, S. Pandey, et al., ``Design,
Evaluation and Pharmacokinetic Study of Mucoadhesive Buccal Tablets
of Nicotine for Smoking Cessation,'' Indian Journal of
Pharmaceutical Sciences, 68:829-831, 2006.
30. Hoffmann, D. and I. Hoffmann, ``The Changing Cigarette: Chemical
Studies and Bioassays,'' Chapter 5 in Risks Associated with Smoking
Cigarettes with Low Machine-Measured Yields of Tar and Nicotine,
Smoking and Tobacco Control Monograph No. 13:159-191, Bethesda, MD:
U.S. Department of Health and Human Services, National Institutes of
Health, National Cancer Institute, 2001, available at https://cancercontrol.cancer.gov/brp/tcrb/Monographs/13/m13_5.pdf.
31. Hammond, D., G. T. Fong, K. M. Cummings, et al., ``Cigarette
Yields and Human Exposure: A Comparison of Alternative Testing
Regimens,'' Cancer Epidemiology, Biomarkers & Prevention,
15(8):1495-1501, 2006.
32. Rees, V. W., G. F. Wayne, B. F. Thomas, et al., ``Physical
Design Analysis and Mainstream Smoke Constituent Yields of the New
Potential Reduced Exposure Product, Marlboro UltraSmooth,'' Nicotine
& Tobacco Research, 9(11):1197-1206, 2007.
33. Ding, Y. S., J. S. Trommel, X. J. Yan, et al., ``Determination
of 14 Polycyclic Aromatic Hydrocarbons in Mainstream Smoke from
Domestic Cigarettes, Environmental Science & Technology, 39(2):471-
478, 2005.
34. Ding, Y. S., L. Zhang, R. B. Jain, et al., ``Levels of Tobacco-
Specific Nitrosamines and Polycyclic Aromatic Hydrocarbons in
Mainstream Smoke from Different Tobacco Varieties,'' Cancer
Epidemiology, Biomarkers & Prevention, 17(12):3366-3371, 2008.
35. Baker, R. R., ``The Generation of Formaldehyde in Cigarettes--
Overview and Recent Experiments,'' Food and Chemical Toxicology,
44:1799-1822, 2006.
36. U.S. Department of Health and Human Services, ``Preventing
Tobacco Use Among Young People,'' A Report of the Surgeon General;
1994.
37. U.S. Department of Health and Human Services, ``How Tobacco
Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-
Attributable Disease,'' A Report of the Surgeon General; 2010,
available at https://www.ncbi.nlm.nih.gov/books/NBK53017.
38. National Cancer Institute, Centers for Disease Control and
Prevention, U.S. Department of Health and Human Services,
``Smokeless Tobacco and Public Health: A Global Perspective, 91-106,
2014, available at https://cancercontrol.cancer.gov/brp/tcrb/global-perspective/SmokelessTobaccoAndPublicHealth.pdf.
39. German Cancer Research Center (DKFZ), ``Additives in Tobacco
Products. Contribution of Carob Bean Extract, Cellulose Fibre, Guar
Gum, Liquorice, Menthol, Prune Juice Concentrate and Vanillin to
Attractiveness, Addictiveness and Toxicity of Tobacco Smoking,''
Report, 2012.
40. Naworal, J. D., ``Pyrolysis GC/MS analysis of Guar Gum and
Hydroxypropyl Guar at 300 Degrees C and 600 Degrees C,'' Philip
Morris, Inter-Office Correspondence, Mar. 26, 1990, available at
https://industrydocuments.library.ucsf.edu/tobacco/docs/ptnn0108.
41. Baker, R. R. and L. J. Bishop, ``The Pyrolysis of Non-Volatile
Tobacco Ingredients Using a System that Simulates Cigarette
Combustion Conditions,'' Journal of Analytical and Applied
Pyrolysis, 74:145-170, 2005.
42. Smith, T. E., ``A Literature Review of Aging and Fermentation of
Tobacco,'' Brown and Williamson Tobacco Corporation, 1964.
43. Cornell, A., W. F. Cartwright, and T. A. Bertinuson, ``Influence
of
[[Page 12776]]
Microorganisms (Fermentation) on the Chemistry of Tobacco,'' Recent
Advances in Tobacco Science, 5:27-62, 1979.
44. Schulthess, D., Philip Morris International, ``Project Clover,
Marlboro-Roll Your Own, Report on the Microbial Analysis,'' January
26, 1984.
45. Geiss, V. L., Brown and Williamson Tobacco Corporation,
``Control and Use of Microbes in Tobacco Product Manufacturing,''
1989.
46. Andersen, R. A., P. D. Fleming, T. R. Hamilton-Kemp, et al.,
``pH Changes in Smokeless Tobaccos Undergoing Nitrosation During
Prolonged Storage: Effects of Moisture, Temperature, and Duration,''
Journal of Agricultural and Food Chemistry, 41:968-972, 1993.
47. Mutasa, E. S., K. J. Seal, and N. Magan, ``The Water Content/
Water Activity Relationship of Cured Tobacco and Water Relations of
Associated Spoilage Fungi,'' International Biodeterioration, 26:
381-896, 1990.
48. St. Charles, F. K., ``Reduction of the Water Activity of Wet
Snuff/259,'' Brown and Williamson Tobacco Corporation, Research &
Development, File Note, December 20, 1989.
49. Andersen, R. A., H. R. Burton, P. D. Fleming, et al., ``Effect
of Storage Conditions on Nitrosated, Acylated, and Oxidized Pyridine
Alkaloid Derivatives in Smokeless Tobacco Products,'' Cancer
Research, 49:5895-5900, 1989.
50. Rutqvist, L.E., M. Curvall, T. Hassler, et al., ``Swedish Snus
and the GothiaTek[supreg] Standard,'' Harm Reduction Journal, 8:11,
2011.
51. Brunnemann, K. D., B. Prokopczyk, M. V. Djordjevic, et al.,
``Formation and Analysis of Tobacco-Specific N-Nitrosamines,''
Critical Reviews in Toxicology 26(2):121-137, 1996.
52. Fisher, M. T., C. B. Bennett, A. Hayes, et al., ``Sources of and
Technical Approaches for the Abatement of Tobacco Specific
Nitrosamine Formation in Moist Smokeless Tobacco Products,'' Food
and Chemical Toxicology, 50:942-948, 2012.
53. Djordjevic, M. V., J. Fan, L. P. Bush, et al., ``Effects of
Storage Conditions on Levels of Tobacco-Specific N-Nitrosamines and
N-Nitrosamino Acids in U.S. Moist Snuff,'' Journal of Agricultural
and Food Chemistry, 41:1790-1794, 1993.
54. Preliminary Regulatory Impact Analysis; Initial Regulatory
Flexibility Analysis; Unfunded Mandates Reform Act Analysis, Content
and Format of Substantial Equivalence Reports; Proposed Rule.
XI. Effective Date
FDA proposes that any final rule that issues based on this proposal
become effective 30 days after the final rule publishes in the Federal
Register.
List of Subjects
21 CFR Part 16
Administrative practice and procedure.
21 CFR Part 1107
Administrative practice and procedure, Smoke, Smoking, Tobacco,
Tobacco products.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, it is
proposed that chapter I of title 21 of the Code of Federal Regulations
be amended as follows:
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
0
1. The authority citation for part 16 continues to read as follows:
Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394,
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.
0
2. In Sec. 16.1(b)(2) add in numerical sequence an entry for ``Sec.
1107.50'' to read as follows:
Sec. 16.1 Scope.
* * * * *
(b) * * *
(2) * * *
Sec. 1107.50, relating to rescission of an order finding a tobacco
product substantially equivalent.
* * * * *
PART 1107--EXEMPTIONS AND SUBSTANTIAL EQUIVALENCE REPORTS
0
3. The authority citation for part 1107 is revised to read as follows:
Authority: 21 U.S.C. 371, 374, 387b, 387c, 387e(j), 387i, and
387j.
0
4. The heading of part 1107 is revised to read as set forth above.
0
5. Add subparts B through E to read as follows:
Subpart B--General
Sec.
1107.10 Scope.
1107.12 Definitions.
Subpart C--Substantial Equivalence Reports
1107.16 Submission of a substantial equivalence report.
1107.18 Required content and format of a report.
1107.19 Comparison information.
1107.20 Amendments.
1107.22 Withdrawal by applicant.
1107.24 Change in ownership of an SE report.
Subpart D--FDA Review
1107.40 Communications between FDA and applicants.
1107.42 Review cycles.
1107.44 FDA action on an SE report.
1107.46 Issuance of an order finding a new tobacco product
substantially equivalent.
1107.48 Issuance of an order denying marketing authorization.
1107.50 Rescission of order.
Subpart E--Miscellaneous
1107.58 Record retention.
1107.60 Confidentiality.
1107.62 Electronic submission.
Subpart B--General
Sec. 1107.10 Scope.
(a) Subparts B through E of this part apply to a substantial
equivalence report (or SE Report) for a new tobacco product that has:
(1) Characteristics different from a predicate tobacco product and
for which information is submitted to demonstrate it is not appropriate
to regulate the product under section 910(b) and (c) of the Federal
Food, Drug, and Cosmetic Act because the new tobacco product does not
raise different questions of public health; or
(2) The same characteristics as a predicate tobacco product.
(b) These subparts set forth procedures and requirements for the
submission to FDA of an SE Report under sections 905 and 910 of the
Federal, Food, Drug, and Cosmetic Act; the basic criteria for
establishing substantial equivalence; and the general procedures FDA
will follow when evaluating submissions.
Sec. 1107.12 Definitions.
For purposes of this part:
Accessory means any product that is intended or reasonably expected
to be used with or for the human consumption of a tobacco product; does
not contain tobacco and is not made or derived from tobacco; and meets
either of the following:
(1) Is not intended or reasonably expected to affect or alter the
performance, composition, constituents, or characteristics of a tobacco
product; or
(2) Is intended or reasonably expected to affect or maintain the
performance, composition, constituents, or characteristics of a tobacco
product; but
(i) Solely controls moisture and/or temperature of a stored
product; or
(ii) Solely provides an external heat source to initiate but not
maintain combustion of a tobacco product.
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,
[[Page 12777]]
packaging, transporting, or holding), except that the term does not
include tobacco or a pesticide chemical residue in or on raw tobacco,
or a pesticide chemical.
Applicant means any manufacturer of tobacco products who is subject
to chapter IX of the Federal Food, Drug, and Cosmetic Act that submits
a premarket application to receive marketing authorization for a new
tobacco product.
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 means the materials, ingredients, design,
composition, heating source, or other features of a tobacco product.
Commercial distribution means any distribution of a tobacco product
to consumers or to another person through sale or otherwise, but does
not include interplant 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 product is not made available for
consumption or resale. ``Commercial distribution'' does not include 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 that it does
not include distribution of a tobacco product that is neither imported
nor offered for import into the United States.
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.
Composition means the materials in a tobacco product, including
ingredients, additives, and biological organisms. The term includes the
manner in which the materials, for example, ingredients, additives, and
biological organisms, are arranged and integrated to produce a tobacco
product.
Constituent means 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.
Container closure system means any packaging materials that are a
component or part of a tobacco product.
Design means the form and structure concerning, and the manner in
which, components or parts, ingredients, software, and materials are
integrated to produce a tobacco product.
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.
Finished tobacco product means 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 means a tobacco product that was
commercially marketed in the United States as of February 15, 2007, and
does not include a tobacco product exclusively in test markets as of
that date. A grandfathered tobacco product is not subject to the
premarket requirements of section 910 of the Federal Food, Drug, and
Cosmetic Act.
Harmful or potentially harmful constituent (HPHC) means any
chemical or chemical compound in a tobacco product or tobacco smoke or
emission that:
(1) Is or potentially is inhaled, ingested, or absorbed into the
body; and
(2) Causes or has the potential to cause direct or indirect harm to
users or nonusers of tobacco products.
Health information statement means a statement, made under section
910(a)(4) of the Federal Food, Drug, and Cosmetic Act, that the health
information related to a new tobacco product will be made available
upon request by any person.
Health information summary means a summary, submitted under section
910(a)(4) of the Federal Food, Drug, and Cosmetic Act, of any health
information related to a new tobacco product.
Heating source means the source of energy used to burn or heat a
tobacco product.
Ingredient means tobacco, substances, compounds, or additives
contained within or 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.
Material means an assembly of ingredients. Materials are assembled
to form a tobacco product or components or parts of tobacco products.
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.
Other features means any distinguishing qualities of a tobacco
product similar to those specifically enumerated in section
910(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act. Such other
features include harmful and potentially harmful constituents and any
other product characteristics that relate to the chemical, biological,
and physical properties of the tobacco product and are necessary for
review.
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.
Predicate tobacco product means a tobacco product that is a
grandfathered tobacco product or a tobacco product that FDA has
previously found substantially equivalent under section 910(a)(2)(A)(i)
of the Federal Food, Drug, and Cosmetic 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 or substantially equivalent means, with
respect to a new tobacco product being compared to a predicate tobacco
product, that FDA by order has found that the new tobacco product:
(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
[[Page 12778]]
to require premarket review under section 910(b) and (c) of the Federal
Food, Drug, and Cosmetic Act because the new tobacco product does not
raise different questions of public health.
Substantial equivalence report or SE Report means a submission
under section 905(j)(1)(A)(i) of the Federal Food, Drug, and Cosmetic
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 substantial equivalence report
and all subsequent amendments.
Tobacco product means any product made or derived from tobacco that
is intended for human consumption, including any component, part, or
accessory of a tobacco product (except for raw materials other than
tobacco used in manufacturing a component, part, or accessory of a
tobacco product). The term ``tobacco product'' does not mean an article
that under the Federal Food, Drug, and Cosmetic Act is a drug (section
201(g)(1)), a device (section 201(h)), or a combination product
(section 503(g)).
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.
Subpart C--Substantial Equivalence Reports
Sec. 1107.16 Submission of a substantial equivalence report.
An applicant may submit a SE Report intended to demonstrate that a
new tobacco product is substantially equivalent to a predicate tobacco
product. The applicant must submit the SE Report at least 90 calendar
days prior to the date the applicant intends to introduce or deliver
for introduction a new tobacco product into interstate commerce for
commercial distribution. The applicant cannot begin commercial
distribution of the new tobacco product until FDA has provided the
applicant 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.
Sec. 1107.18 Required content and format of a SE report.
(a) Overview. The SE Report must provide information uniquely
identifying the new tobacco product and the predicate tobacco product,
and compare the new tobacco product to either a grandfathered tobacco
product or a tobacco product that FDA previously found to be
substantially equivalent. The SE Report must provide sufficient
information as described in this section to enable FDA to determine
whether the new tobacco product is substantially equivalent to a
tobacco product that was commercially marketed in the United States as
of February 15, 2007. If FDA cites deficiencies and requests
information to support a statement in the SE Report, the applicant must
provide that information for review to continue, or FDA may issue an
order under Sec. 1107.48. FDA will refuse to accept an SE Report if it
does not comply with this section. The SE Report must contain the
following information:
(1) General information (as described in paragraph (c) of this
section);
(2) Summary (as described in paragraph (d) of this section);
(3) New tobacco product description (as described in paragraph (e)
of this section);
(4) Predicate tobacco product description (as described in
paragraph (f) of this section), including 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 submission tracking number of the SE
order finding the predicate product SE, or the submission tracking
number of, or information to support, a grandfathered determination of
the predicate tobacco product;
(5) Comparison information (as described in paragraph (g) of this
section);
(6) Comparative testing information (as described in paragraph (h)
of this section);
(7) Statement of compliance with applicable tobacco product
standards (as described in paragraph (i) of this section);
(8) Health information summary or statement that such information
will be made available upon request (as described in paragraph (j) of
this section);
(9) Compliance with 21 CFR part 25 (as described in paragraph (k)
of this section); and
(10) Certification statement (as described in paragraph (l) of this
section).
(b) Format. The applicant must submit the SE Report using the
form(s) that FDA provides. The SE Report must contain a comprehensive
index and table of contents, be well-organized and legible, and be
written in English. As described in Sec. 1107.62, the applicant must
submit the SE Report and all information supporting the SE Report in an
electronic format that FDA can process, read, review, and archive,
unless FDA has provided a waiver.
(c) General information. The SE Report must include the following
information, using the form FDA provides:
(1) The date the SE Report is submitted;
(2) Type of submission (e.g., the SE Report or amendment to a
report);
(3) FDA STN if previously assigned;
(4) Any other relevant FDA STN, such as a request for grandfathered
determination or SE Report previously found substantially equivalent
(if applicable), and cross-references to meetings with FDA regarding
the new tobacco product;
(5) Applicant name, address, and contact information;
(6) Authorized representative or U.S. agent (for a foreign
applicant), including the name, address, and contact information;
(7) For both the new and predicate tobacco products, the following
information to uniquely identify the products:
(i) Manufacturer;
(ii) Product name, including the brand and sub brand (or other
commercial name used in commercial distribution); and
(iii) Product category, product 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) as provided in the following table:
------------------------------------------------------------------------
Tobacco product
Tobacco product category: subcategory: Product properties:
------------------------------------------------------------------------
(A)Cigarettes................. (1) Combusted, --Package type (e.g.,
Filtered. hard pack, soft
pack, clam shell).
--Product quantity
(e.g., 20
cigarettes, 25
cigarettes).
--Length (e.g., 89
millimeters (mm),
100 mm).
--Diameter (e.g., 6
mm, 8.1 mm).
[[Page 12779]]
--Ventilation (e.g.,
none, 10%, 25%).
--Characterizing
Flavor(s) (e.g.,
none, menthol).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(2) Combusted, --Package type (e.g.,
Non-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).
(3) Combusted, --Package type (e.g.,
Other. 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).
(4) Non-Combusted --Package type (e.g.,
(e.g., a hard pack, soft
cigarette where pack, clam shell).
the tobacco is --Product quantity
heated not (e.g., 20
burned). 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).
(5) Cigarette, Co- For a new co-packaged
Package. tobacco product
composed of multiple
cigarette tobacco
products, include,
as applicable, all
properties for each
individual tobacco
product, as
identified in this
section.
(B) Roll-Your-Own Tobacco (1) Roll-Your-Own --Package type (e.g.,
Products. Tobacco 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).
(2) 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).
(3) 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).
(4) 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).
(5) 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).
(6) 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).
[[Page 12780]]
(7) Roll-Your-Own --For a new co-
Co-Package. packaged tobacco
product composed of
multiple RYO tobacco
products, include,
as applicable, all
properties for each
individual tobacco
product (e.g., roll-
your own tobacco,
rolling paper,
filtered cigarette
tube, non-filtered
cigarette tube,
filter, paper tip)
as identified in
this section.
(8) 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.
(C) Smokeless Tobacco Products (1) Loose Moist --Package type (e.g.,
Snuff. 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).
(2) Portioned --Package type (e.g.,
Moist. plastic can with
(3) Snuff........ 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).
(4) Loose 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., 5 mm, 7 mm).
--Characterizing
flavor(s) (e.g.,
none, menthol,
cherry,
wintergreen).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(5) Portioned --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).
(6) Loose Dry --Package type (e.g.,
Snuff. 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).
(7) 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 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).
(8) 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).
[[Page 12781]]
(9) Portioned --Package type (e.g.,
Chewing 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).
(10) 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 in this
section.
(11) 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.
(D) ENDS (Electronic Nicotine (1) Open E-Liquid --Package type (e.g.,
Delivery System). bottle, box).
--Product quantity
(e.g., 1 bottle, 5
bottles).
--Characterizing
flavor(s) (e.g.,
none, tobacco,
menthol, cherry,
wintergreen).
--E-liquid volume
(e.g., 10
milliliters (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).
(2) Closed E- --Package type (e.g.,
Liquid. cartridge).
--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).
(3) Closed E- --Package type (e.g.,
Cigarette. box, none, plastic
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.
(4) Open E- --Package type (e.g.,
Cigarette. box, none, plastic
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
Watts (W), 200 W).
--Battery capacity
(e.g., 100 mAh, 200
mAh).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(5) ENDS --Package type (e.g.,
Component. 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).
(6) ENDS Co- --For a new co-
Package. packaged tobacco
product composed of
multiple ENDS
tobacco products,
include, as
applicable, all
properties for each
individual tobacco
product as
identified in this
section.
(7) ENDS Other... --Package type (e.g.,
bag, box).
--Product quantity.
--Characterizing
flavor(s) (e.g.,
none, tobacco,
menthol, cherry).
[[Page 12782]]
--Additional
properties needed to
uniquely identify
the tobacco product.
(E) Cigars.................... (1) Filtered, --Package type (e.g.,
Sheet-Wrapped hard pack, soft
Cigar. 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).
(2) Unfiltered, --Package type (e.g.,
Sheet-Wrapped box, film sleeve).
Cigar. --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).
(3) 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).
(4) Cigar --Package type (e.g.,
Component. 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).
(5) 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).
(6) Cigar Co- --For a new co-
Package. packaged tobacco
product composed of
multiple cigar
tobacco products,
include, as
applicable, all
properties for each
individual tobacco
product as
identified
previously.
(7) 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.
(F) Pipe Tobacco Products..... (1) Pipe......... --Package type (e.g.,
box, none).
--Product quantity
(e.g., 1 pipe).
--Length (e.g., 200
mm, 300 mm).
--Diameter (e.g., 25
mm).
--Characterizing
flavor(s) (e.g.,
none, menthol).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(2) Pipe Tobacco --Package type (e.g.,
Filler. bag, pouch).
--Product quantity
(e.g., 20 g, 16
ounces).
--Characterizing
flavor(s) (e.g.,
none, menthol,
cavendish, cherry).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(3) Pipe --Package type (e.g.,
Component. bowl, shank, stem,
screen, filter).
--Product quantity
(e.g., 1 bowl, 1
stem, 100 filters).
--Characterizing
flavor(s) (e.g.,
none, menthol).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(4) Pipe Co- --For a new co-
Package. packaged tobacco
product composed of
multiple pipe
tobacco products,
include, as
applicable, all
properties for each
individual tobacco
product as
identified
previously.
(5) 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.
(G) Waterpipe Tobacco Products (1) Waterpipe.... --Package type (e.g.,
box, none).
--Product quantity
(e.g., 1 waterpipe).
--Length (e.g., 200
mm, 500 mm).
[[Page 12783]]
--Width (e.g., 100
mm, 300 mm).
--Number of hoses
(e.g., 1, 2, 4).
--Characterizing
flavor(s) (e.g.,
none, menthol).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(2) Waterpipe --Package type (e.g.,
Tobacco Filler. bag, pouch).
--Product quantity
(e.g., 20 g, 16
ounces).
--Characterizing
flavor(s) (e.g.,
none, tobacco,
menthol, apple).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(3) Waterpipe --Package type (e.g.,
Heat Source. box, film sleeve,
bag, none).
--Product quantity
(e.g., 150 g, 680
g).
--Characterizing
flavor(s) (e.g.,
none, menthol,
apple).
--Portion count(e.g.,
20 fingers, 10
discs, 1 base).
--Portion mass (e.g.,
15 g/finger).
--Portion length
(e.g., 40 mm, 100
mm).
--Portion width
(e.g., 10 mm, 40
mm).
--Portion thickness
(e.g., 10 mm, 40
mm).
--Source of energy
(e.g., charcoal,
battery,
electrical).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(4) Waterpipe --Package type (e.g.,
Component. bag, box, none).
--Product quantity
(e.g., 1 base, 1
bowl, 1 hose, 10
mouthpieces).
--Characterizing
flavor(s) (e.g.,
none, menthol,
apple).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(5) Waterpipe Co- --For a new co-
Package. packaged tobacco
product composed of
multiple waterpipe
tobacco products,
include, as
applicable, all
properties for each
individual tobacco
product as
identified in this
section.
(6) Waterpipe --Package type (e.g.,
Other. bag, box).
--Product quantity.
--Characterizing
flavor(s) (e.g.,
none, tobacco,
menthol).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
Other......................... 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
(if applicable).
------------------------------------------------------------------------
(8) Address and the FDA Establishment Identifier (FEI) number(s) of
the establishments involved in the manufacture and/or importation of
the new and predicate tobacco products.
(d) Summary. The SE Report must include a summary at the beginning
of the SE Report that includes the following:
(1) A concise description of the characteristics of the new tobacco
product;
(2) A statement as to whether the applicant believes the new
tobacco product has the same characteristics as the predicate tobacco
product or has different characteristics but does not raise different
questions of public health; and
(3) A concise description of the similarities and differences
between the new tobacco product and the predicate tobacco product with
respect to their characteristics (materials, ingredients, design,
composition, heating source, or other features).
(e) New tobacco product description. The applicant must identify
one new tobacco product in the SE Report for comparison to one
predicate tobacco product. The SE Report must describe the new tobacco
product in sufficient detail to enable FDA to evaluate its
characteristics. This part of the SE Report must include:
(1) A narrative description of the new tobacco product and detailed
drawings or schematics of the new tobacco product, including its
container closure system, illustrating all components or parts of the
product. For a portioned tobacco product, the SE Report must also
include a diagram illustrating all components or parts of the
individual unit of use;
(2) A description and the function of each component or part of the
new tobacco product, and an explanation of how each component or part
is integrated into the design of the new tobacco product; and
(3) A concise overview of the process used to manufacture the new
tobacco product, including the fermentation process, where applicable,
with information on the type and quantity of the microbial inoculum
and/or fermentation solutions. If the manufacturing process for the new
tobacco product does not affect the characteristics of the new tobacco
product beyond what is described elsewhere in the SE Report, an
applicant must state that to satisfy this provision.
(f) Description of predicate tobacco product. (1) The applicant
must identify a predicate tobacco product that is either a
grandfathered tobacco product or a tobacco product that FDA previously
found to be substantially equivalent.
(2) A tobacco product to which a new tobacco product is compared
must:
(i) Be in the same category and subcategory of product as the new
tobacco product;
(ii) Have been either:
(A) Commercially marketed (not exclusively in a test market) in the
United States as of February 15, 2007, as shown by either specific
information sufficient to support this in the SE Report, including a
statement that ``I, (name of responsible official), confirm that the
predicate tobacco product, (insert name of predicate tobacco product),
was commercially marketed
[[Page 12784]]
other than for test marketing as of February 15, 2007'', or reference
to an STN for a previous determination by FDA that the predicate
product is grandfathered; or
(B) Previously determined to be substantially equivalent by FDA;
(iii) Be an individual product and not a composite of multiple
products;
(iv) Not be the subject of a rescission order by FDA, as described
in Sec. 1107.50; and
(v) Not have been removed from the market at the initiative of FDA
and not have been determined by judicial order to be adulterated or
misbranded.
(g) Comparison information. The SE Report must include a comparison
of the characteristics of the new tobacco product and the predicate
tobacco product, as described in Sec. 1107.19. If the new tobacco
product has limited changes to a characteristic(s) when compared to the
predicate tobacco product, and all other characteristics are identical
(e.g., a change to product quantity), the applicant must provide
comparison information related to such characteristic(s), but may
certify that the other characteristics identical under paragraph (1)(2)
of this section. The applicant must maintain records supporting the
certification consistent with Sec. 1107.58.
(h) Comparative testing information. Other than for characteristics
that are identical, and for which the applicant has certified that the
characteristics are identical under paragraph (1)(2) of this section,
the SE Report must provide comparative testing information on the
characteristics of the new and predicate tobacco products, as described
in Sec. 1107.19, except where the applicant adequately justifies that
such comparative testing information is not necessary to demonstrate
that the new product has the same characteristics as the predicate or
does not raise different questions of public health. The testing
information must:
(1) Include the test protocols, quantitative acceptance criteria,
and test results (including means and variances, data sets, and a
summary of the results);
(2) Be conducted on a sufficient sample size and on test samples
that reflect the finished tobacco product composition and design;
(3) State whether the same test methods were used for the new
tobacco product and the predicate product, and if the methods differed,
an explanation as to how the results of the different test methods can
be compared; and
(4) Identify national and international standards used to test the
new and predicate tobacco products and explain any deviations from the
standard, or state that no standards were used for the testing.
(i) Statement of compliance with applicable tobacco product
standards. The SE Report must either:
(1) List and describe the action(s) taken by the applicant to
comply with applicable requirements under section 907 of the Federal
Food, Drug, and Cosmetic Act; or
(2) State there are no applicable requirements under section 907 of
the Federal Food, Drug, and Cosmetic Act.
(j) Health information summary or statement regarding availability
of such information. The SE Report must include either a health
information summary or a statement that such information will be made
available upon request, as provided in section 910(a)(4) of the Federal
Food, Drug, and Cosmetic Act, in accord with the following:
(1) Health information summary. If including a health information
summary with the SE Report, the applicant must provide a copy of the
full SE Report that excludes research subject identifiers and trade
secret and confidential commercial information as defined in Sec. Sec.
20.61 and 20.63 of this chapter (21 CFR 20.61 and 20.63); and either
(i) Provide accurate, complete, and not false or misleading,
additional health information, including information, research, or data
about adverse health effects, that the applicant has or knows about
concerning the new tobacco product that is not contained in the SE
Report; or
(ii) Provide the following statement, if true, about the new
tobacco product: ``Applicant does not have or know of any additional
health information, including information, research or data regarding
adverse health effects, about the new tobacco product that is the
subject of this SE Report.''
(2) Statement regarding availability of health information. If the
applicant chooses to make the health information available upon
request, the SE Report must include the following statement, with the
appropriate applicant information inserted as indicated by
parenthetical text, signed by an authorized representative of the
applicant, made on a separate page of the SE Report, and clearly
identified as ``910(a)(4) health information statement''. ``I certify
that, in my capacity as (the position held in company by person
required to submit the SE Report, preferably the responsible official
of the applicant) of (company name), I will make available, upon
request, the information identified in 21 CFR 1107.18(j)(3) within 30
calendar days of a request.''
(3) Content of health information. The health information the
applicant agrees to make available in paragraph (j)(2) of this section
must be a copy of the full SE Report, excluding all research subject
identifiers, trade secrets, and confidential commercial information, as
defined in 21 CFR 20.61 and 21 CFR 20.63; and either.
(i) Accurate, complete, and not false or misleading, additional
health information, including information, research, or data about
adverse health effects, that the applicant has or knows about
concerning the new tobacco product and that is not contained in the SE
Report; or
(ii) The following statement, if true, about the new tobacco
product. ``(Company name) does not have or know of any additional
health information, including information, research or data regarding
adverse health effects about the new tobacco product that is the
subject of the provided SE Report.''
(4) Requests for information. All requests for information under
paragraph (j)(2) of this section must be made in writing to the
authorized representative of the applicant, whose contact information
will be posted on the FDA website listing substantial equivalence
determinations. The applicant must provide FDA any updated information
if the contact information changes.
(5) No modified risk violations. To the extent information is
included in the health information summary or health information
provided upon request under paragraphs (j)(1) and (2) of this section
that is not required by section 910(a)(4) of the Federal Food, Drug,
and Cosmetic Act or paragraph (j) of this section, that information
must not contain a statement that would cause the tobacco product to be
in violation of section 911 of the Federal Food, Drug, and Cosmetic Act
upon the introduction or delivery for introduction of the proposed new
product into interstate commerce.
(k) Compliance with 21 CFR part 25. (1) The SE Report must include
an environmental assessment prepared in accordance with Sec. 25.40 of
this chapter, or a valid claim of categorical exclusion. If the
applicant believes that the action qualifies for an available
categorical exclusion, the applicant must state under Sec. 25.15(a)
and (d) of this chapter that the action requested qualifies for a
categorical exclusion, citing the particular exclusion that is claimed,
and that to the applicant's knowledge, no extraordinary circumstances
exist under Sec. 25.21.
[[Page 12785]]
(2) The environmental assessment must include a statement
explaining whether the new tobacco product is intended to replace the
predicate tobacco product once the new tobacco product receives market
authorization, is intended to be a line extension of the predicate
tobacco product, is intended to be introduced as an additional product
by the same manufacturer, or if the new tobacco product will be
introduced as an additional product but by a different manufacturer.
(l) Certification Statement. (1) The SE Report must contain the
following certification, with the appropriate information inserted (as
indicated by parenthetical text), and be signed by an authorized
representative of the applicant. ``I (name of responsible official) on
behalf of (applicant), hereby certify that (applicant) will maintain
all records to substantiate the accuracy of this SE Report for the
period of time required in Sec. 1107.58 and ensure that such records
remain readily available to the FDA upon request. I certify that this
information and the accompanying submission are true and correct, that
no material fact has been omitted, and that I am authorized to submit
this on the applicant's behalf. I understand that under section 1001 of
title 18 of the United States Code anyone who knowingly and willfully
makes a materially false, fictitious, or fraudulent statement or
representation in any matter within the jurisdiction of the executive,
legislative, or judicial branch of the Government of the United States
is subject to criminal penalties.''
(2) The SE Report must include the following certification if an
applicant chooses to certify that certain characteristics are identical
in lieu of providing data for each characteristic of the new and
predicate tobacco products. This certification must include the
appropriate information inserted (as indicated by parenthetical text)
and be signed by an authorized representative of the applicant. ``I,
(name of responsible official), on behalf of (name of company), certify
that (new tobacco product name) has the following modification(s) as
compared to (name of predicate tobacco product): (describe
modification(s), e.g., change in product quantity or change in
container closure system). Aside from these modifications, the
characteristics of (new tobacco product name) and (name of predicate
tobacco product) are identical. I certify that (name of company)
understands this means there is no other modification to the materials,
ingredients, design features, heating source, or any other feature. I
also certify that (name of company) will maintain records to support
the comparison information in 21 CFR 1107.19 that substantiate the
accuracy of this statement for the period of time required in 21 CFR
1107.58, and ensure that such records remain readily available to FDA
upon request.''
Sec. 1107.19 Comparison information.
The SE Report must include a comparison of the characteristics of
the new tobacco product to the predicate tobacco product. The
comparison section of the SE Report must be organized in the following
manner:
(a) Comparison of product design. The SE Report must include
descriptions of the product designs of the new and predicate tobacco
products and identify any differences. The SE Report must include, in a
tabular format, a side-by-side comparison of each design parameter of
the new and predicate tobacco products. For each design parameter, the
target value and range of acceptable values, actual measured value
(where applicable), and range of measured values (where applicable)
with units of measure must be provided. In addition, for each
applicable design parameter, test data must be provided.
(1) Cigarettes. For cigarettes, the required design parameter
information to be provided for each predicate and new tobacco product
is as follows:
Table 1 to Sec. 1107.19(a)(1)
------------------------------------------------------------------------
Provide test data (include
test protocols, quantitative
Provide target specification with upper acceptance criteria, data
and lower range limits for: sets, and a summary of the
results) for:
------------------------------------------------------------------------
--Cigarette length (mm) --Puff count
--Cigarette circumference (mm) --Cigarette draw resistance
(mm H2O)
--Cigarette draw resistance (mm H2O) --Tobacco filler mass (mg)
--Tobacco filler mass (mg) --Tobacco moisture (%)
--Tobacco rod density (g/cubic centimeter --Filter ventilation (%)
(cm3))
--Tobacco moisture (%) --Cigarette paper base paper
basis weight (g/m2))
--Filter ventilation (%) --Cigarette paper base paper
porosity (CU)
--Tipping paper length (mm) --Filter efficiency (%) (If
no filter efficiency data
is available for the
products, include
information sufficient to
show that the cigarette
filter is unchanged (e.g.,
denier per filament, total
denier, and filter
density))
--Cigarette paper base paper basis weight --Filter pressure drop (mm
(g/m2) H2O)
--Cigarette paper base paper porosity (CU)
--Cigarette paper band width (mm)
--Cigarette paper band space (mm)
--Filter efficiency (%) (If no filter
efficiency data is available for the
products, include information sufficient
to show that the cigarette filter is
unchanged (e.g., denier per filament,
total denier, and filter density))
--Filter length (mm)
--Filter pressure drop (mm H2O)
------------------------------------------------------------------------
(2) Smokeless tobacco. For portioned and non-portioned smokeless
tobacco products, the required design parameter information to be
provided for each predicate and new tobacco product is as follows:
[[Page 12786]]
Table 2 to Sec. 1107.19(a)(2)
------------------------------------------------------------------------
Provide test data (include
test protocols, quantitative
Provide target specification with upper acceptance criteria, data
and lower range limits for: sets, and a summary of the
results) for:
------------------------------------------------------------------------
Portioned Smokeless Tobacco Products
------------------------------------------------------------------------
--Tobacco cut size (mm) --Tobacco cut size (mm).
--Tobacco moisture (%) --Tobacco moisture (%).
--Portion length (mm) (if applicable) --Portion mass (mg) (if
applicable).
--Portion width (mm) (if applicable) --Pouch paper porosity (CU).
--Portion mass (mg) (if applicable) --Pouch paper basis weight
(g/m2).
Portion thickness (mm) (if applicable)
Pouch paper wicking
Pouch paper porosity (CU)
Pouch paper basis weight (g/m2)
------------------------------------------------------------------------
Nonportioned Smokeless Tobacco Products
------------------------------------------------------------------------
--Tobacco cut size (mm) --Tobacco cut size (mm).
--Tobacco moisture (%) --Tobacco moisture (%).
------------------------------------------------------------------------
(3) Roll-your-own tobacco, rolling papers. For roll-your-own
tobacco rolling papers, the required design parameter information to be
provided for each predicate and new tobacco product is as follows:
Table 3 to Sec. 1107.19(a)(3)
------------------------------------------------------------------------
Provide test data
(include test protocols,
Provide target specification with upper and quantitative acceptance
lower range limits for: criteria, data sets, and
a summary of the results)
for:
------------------------------------------------------------------------
--Paper length(mm) --Mass per paper (mg).
--Paper width (mm) --Cigarette paper base
--Mass per paper (mg) paper basis weight (g/
--Cigarette paper base paper basis weight (g/ m2).
m2) --Cigarette paper base
paper porosity (CU).
--Cigarette paper band
porosity (CU) (if
applicable).
--Cigarette paper base paper porosity (CU)
--Cigarette paper band porosity (CU) (if
applicable)
--Cigarette paper band width (mm) (if
applicable)
--Cigarette paper band space (mm)
(applicable)
------------------------------------------------------------------------
(4) Roll-your-own tobacco, tubes. For roll-your-own tobacco tubes,
the required design parameter information to be provided for each
predicate and new tobacco product is as follows:
Table 4 to Sec. 1107.19(a)(4)
------------------------------------------------------------------------
Provide test data (include
test protocols, quantitative
Provide target specification with upper acceptance criteria, data
and lower range limits for: sets, and a summary of the
results) for:
------------------------------------------------------------------------
--Tube length (mm) --Total mass (mg).
--Tube circumference (mm) --Cigarette paper base paper
--Total mass (mg) basis weight (g/m2).
--Cigarette paper base paper basis weight --Cigarette paper base paper
(g/m2) porosity (CU).
--Cigarette paper band
porosity (CU).
--Cigarette paper base paper porosity (CU)
--Cigarette paper band porosity (CU)
--Cigarette paper band width (mm)
--Cigarette paper band space (mm)
------------------------------------------------------------------------
(5) Roll-your-own tobacco, filtered tubes. For roll-your-own
tobacco filtered tubes, the required design parameter information to be
provided for each new predicate and new tobacco product is as follows:
Table 5 to Sec. 1107.19(a)(5)
------------------------------------------------------------------------
Provide test data (include
test protocols, quantitative
Provide target specification with upper acceptance criteria, data
and lower range limits for: sets, and a summary of the
results) for:
------------------------------------------------------------------------
--Tube length (mm) --Total mass (mg).
--Tube circumference (mm) --Filter ventilation (%).
--Total mass (mg) --Cigarette paper base paper
--Tipping paper length (mm) basis weight (g/m2).
--Cigarette paper base paper
porosity (CU).
[[Page 12787]]
--Filter ventilation (%) --Cigarette paper band
--Cigarette paper base paper basis weight porosity (CU).
(g/m2) --Filter denier per filament
--Cigarette paper base paper porosity (CU) (DPF).
--Cigarette paper band porosity (CU) --Filter total denier (g/
9000m).
--Filter density (g/cm3).
--Cigarette paper band width (mm) --Filter pressure drop (mm
H2O).
--Cigarette paper band space (mm)
--Filter length (mm)
--Filter denier per filament (DPF)
--Filter total denier (g/9000m)
--Filter density (g/cm3)
--Filter pressure drop (mm H2O)
------------------------------------------------------------------------
(6) Roll-your-own tobacco. For roll-your-own tobacco, the required
design parameter information to be provided for each predicate and new
tobacco product is as follows:
Table 6 to Sec. 1107.19(a)(6)
------------------------------------------------------------------------
Provide test data (include
test protocols, quantitative
Provide target specification with upper acceptance criteria, data
and lower range limits for: sets, and a summary of the
results) for:
------------------------------------------------------------------------
--Tobacco filler mass (mg) --Tobacco filler mass (mg).
--Tobacco size (mm) --Tobacco size (mm).
--Tobacco moisture (%) --Tobacco moisture (%).
------------------------------------------------------------------------
(b) Comparison of heating sources. The SE Report must include a
description of the heating source for the new and predicate tobacco
products and identify any differences, or state that there is no
heating source.
(c) Comparison of product composition. The SE Report must include
descriptions of the product composition of the new and predicate
tobacco products and identify any differences. The SE Report must
include, in a tabular format, a side-by-side comparison of the
materials and ingredients for each component or part of the new and
predicate tobacco products. For each material and ingredient quantity,
the target value and range of acceptable values, actual measured value
(where applicable), and range of measured values (where applicable)
reported as mass per component or part, must be provided.
(1) Materials. For each material in the products include:
(i) The material name and common name(s), if applicable;
(ii) The component or part of the tobacco product where the
material is located;
(iii) The subcomponent or subpart where the material is located, if
applicable;
(iv) The function of the material;
(v) The quantities (including ranges or means, acceptance limits)
of the material(s) in each new tobacco product and predicate tobacco
product (with any specification variation, if applicable);
(vi) The specification(s) (including quality/grades, suppliers)
used for the new tobacco product and predicate tobacco product (with
any specification variations, if applicable); and
(vii) Any other material properties necessary to characterize the
new and predicate tobacco products.
(2) Ingredients other than tobacco. For ingredients other than
tobacco in each material and/or component or part of the product
include:
(i) The International Union of Pure and Applied Chemistry (IUPAC)
chemical name and common name, if applicable;
(ii) The Chemical Abstracts Service (CAS) number(s) or FDA Unique
Ingredient Identifier (UNII);
(iii) The function of the ingredient;
(iv) The quantity with the unit of measure (including ranges or
means, acceptance limits) of the material(s) in the new tobacco product
and predicate tobacco product reported as mass per gram of tobacco for
non-portioned tobacco products and as mass per portion for portioned
tobacco products (with any specification variation, if applicable);
(v) The specification(s) (including purity or grade and supplier);
(vi) For complex purchased ingredients, each single chemical
substance reported separately; and
(vii) Any other ingredient information necessary to characterize
the new and predicate tobacco products.
(3) Tobacco ingredients. For tobacco include:
(i) The type, including grade and variety;
(ii) The quantity with the unit of measure (including ranges or
means, acceptance limits) of tobacco in the new tobacco product and
predicate tobacco product reported as mass per gram of tobacco for non-
portioned tobacco products and as mass per portion for portioned
tobacco products (with any specification variation, if applicable);
(iii) The specification of tobacco used for the new tobacco product
and the predicate tobacco product (with any specification variation, if
applicable);
(iv) A description of any genetic engineering of the tobacco; and
(v) Any other information necessary to characterize the new and
predicate tobacco products.
(vi) If the new tobacco product does not contain tobacco, then
include a statement that the new tobacco product does not contain
tobacco.
(4) Container closure system. A description of the container
closure system for the new and predicate tobacco products, including a
side-by-side quantitative comparison of the components and materials
and annotated illustrations.
(d) Comparison of other features. The SE Report must include
descriptions of any other features of the new and
[[Page 12788]]
predicate tobacco products, such as those described in this section,
and identify any differences. If a specific feature specified in this
section is not applicable to the product design, this must be stated
clearly. If FDA requests a scientific justification explaining why a
feature is not applicable, the applicant must provide the justification
to FDA. The comparison of other features must include information on:
(1) Constituents. HPHCs and other constituents, as appropriate, to
demonstrate that:
(i) The new tobacco product has the same characteristics as the
predicate tobacco product, or
(ii) Any differences in characteristics between the new and
predicate product do not cause the new tobacco product to raise
different questions of public health, including:
(A) The constituent names in alphabetical order;
(B) The common name(s);
(C) The Chemical Abstract Services number(s);
(D) The mean quantity and variance with unit of measure;
(E) The number of samples and measurement replicates for each
sample;
(F) The analytical methods used and associated reference(s);
(G) The testing laboratory or laboratories and documentation
showing that the laboratory or laboratories is (or are) accredited by a
nationally or internationally recognized external accreditation
organization;
(H) Length of time between dates of manufacture and date(s) of
testing;
(I) Storage conditions of the tobacco product before it was tested;
and
(J) Full test data (including test protocols, any deviation(s) from
the test protocols, quantitative acceptance (pass/fail) criteria and
complete data sets) for all testing performed.
(2) Any other features. A description and comparison of any other
features of the new tobacco product and the predicate tobacco product.
(e) Stability information. For smokeless tobacco products and
tobacco products that contain fermented tobacco, the SE Report must
contain information on the stability of the new and predicate tobacco
products, including the following information:
(1) A description of how the stability is indicated on the tobacco
product, and an explanation as to whether the stability testing is
identical for the predicate and the new tobacco product;
(2) Any known or expected impacts of the differences between the
new and predicate products on the product stability. If no impact is
known or expected, state that. For those products that contain
fermented tobacco, the SE Report must provide information on the
fermentation processing steps, including the composition of the
inoculum, with species name(s) and concentration(s); pH; temperature;
moisture content; water activity; duration; and added ingredients;
(3) Detailed stability testing, including test protocols,
quantitative acceptance criteria, data sets, and a summary of the
results for all stability testing performed. Stability testing must be
performed at the beginning (zero time), middle, and end of the expected
storage time for the chemical and microbial endpoints as follows:
Microbial content data including total aerobic microbial count and
total yeast and mold count along with identification of detected
microbiological organisms by genus and species names (if applicable);
pH; moisture content; water activity; tobacco-specific nitrosamines
(total, N-nitrosonornicotine (NNN), 4-methylnitrosamino)-1-(3-
pydridyl)-1-butanone) (NNK)); nitrate and nitrite levels; preservatives
and microbial metabolic inhibitors (if any); and method of heat
treatment or pasteurization used to reduce microbial loads;
(4) Testing information, including the storage conditions for
samples retained for testing; identification of the test methods used;
a statement that the testing was performed on a tobacco product in the
same container closure system in which the tobacco product is intended
to be marketed; and support for the expiration date (e.g., by showing
that an adequate number of batches was tested);
(5) Stability testing laboratory or laboratories used and
documentation showing that the laboratory or laboratories is (or are)
accredited by a nationally or internationally recognized external
accreditation organization; and
(6) Identification of microbiological organisms by genus and
species names, where applicable, and culture collection number either
used during the manufacturing process and/or detected through stability
testing.
(f) Applicant's basis for substantial equivalence determination.
The applicant must state that the new tobacco product has either:
(1) The same characteristics as the predicate tobacco product and
the basis for this determination, or
(2) Different characteristics than the predicate tobacco product.
Where an applicant states that its new tobacco product has different
characteristics than the predicate tobacco product, the applicant must
also include an explanation as to why a difference in any of the
following characteristics do not cause the new product to raise
different questions of public health: Product design (Sec.
1107.19(a)); heating source (Sec. 1107.19(b)); materials and
ingredients (Sec. 1107.19(c)); and other features (Sec. 1107.19(d)).
In addition, to demonstrate that a new tobacco product with different
characteristics is substantially equivalent, an applicant must also
explain why any differences in the manufacturing process between the
new tobacco product and the predicate tobacco product does not raise
different questions of public health (Sec. 1107.18(e)). Similarly, for
smokeless tobacco products, an applicant must explain why any
difference in stability between the new tobacco product and the
predicate tobacco product does not raise different questions of public
health (Sec. 1107.19(e)).
(g) Comparison to grandfathered product. If the applicant is
comparing the new tobacco product to a predicate tobacco product that
FDA has previously found to be substantially equivalent, FDA may
request that the applicant include information related to the original
grandfathered tobacco product for that predicate, even if the
grandfathered tobacco product is back several predicate tobacco
products. FDA will request this information when necessary to ensure
that any order the Agency may issue finding the new tobacco product
substantially equivalent complies with section 910(a)(2)(A)(i)(I) of
the Federal Food, Drug, and Cosmetic Act. FDA may need to review the
first SE Report that received a finding of substantial equivalence
using the grandfathered product as a predicate tobacco product in order
to make this finding.
Sec. 1107.20 Amendments.
(a) Except as provided in paragraphs (b) and (c) of this section,
the applicant may submit an amendment to an SE Report in accordance
with subpart C of this part. If an applicant chose to submit a health
information summary with its SE Report under Sec. 1107.18(j)(1), the
applicant must submit with the amendment a redacted copy of the
amendment that excludes research subject identifiers and trade secret
and confidential commercial information as defined in 21 CFR 20.61 and
20.63.
(b) An applicant may not amend an SE Report to change the predicate
tobacco product.
(c) An applicant may not amend an SE Report after FDA has closed
the SE Report under Sec. 1107.44 or it has been withdrawn under Sec.
1107.22.
[[Page 12789]]
(d) In general, amendments will be reviewed in the next review
cycle as described in Sec. 1107.42.
Sec. 1107.22 Withdrawal by applicant.
(a) An applicant may at any time make a written request to withdraw
an SE Report for which FDA has not issued an order. The withdrawal
request must state:
(1) Whether the withdrawal is due to a health or safety concern
related to the tobacco product;
(2) The submission tracking number; and
(3) The name of the new tobacco product that is the subject of the
SE Report.
(b) An SE Report will be considered withdrawn when FDA issues a
notice stating the SE Report has been withdrawn.
(c) The SE Report is an agency record, even if withdrawn. FDA will
retain the withdrawn SE Report under Federal Agency records schedules.
The availability of the withdrawn SE Report will be subject to FDA's
public information regulations in Sec. 20.45 of this chapter.
Sec. 1107.24 Change in ownership of an SE Report.
An applicant may transfer ownership of its SE Report. On or before
the time of transfer, the new and former applicants are required to
submit information to FDA as follows:
(a) The former applicant must sign and submit a notice to FDA that
states that all of the former applicant's rights and responsibilities
relating to the SE Report have been transferred to the new applicant.
This notice must identify the name and address of the new applicant and
the SE Report transferred.
(b) The new applicant must sign and submit a notice to FDA
containing the following:
(1) The new applicant's commitment to agreements, promises, and
conditions made by the former applicant and contained in the SE Report;
(2) The date that the change in ownership is effective;
(3) Either a statement that the new applicant has a complete copy
of the SE Report and order (if applicable), including amendments and
records that are required to be kept under Sec. 1107.58, or a request
for a copy of the SE Report from FDA's files by submitting a request in
accordance with 21 CFR part 20. In accordance with the Freedom of
Information Act, FDA will provide a copy of the SE Report to the new
applicant under the fee schedule in FDA's public information
regulations in Sec. 20.45 of this chapter; and
(4) A certification that no modifications have been made to the new
tobacco product since the SE Report was submitted to FDA.
Subpart D--FDA Review
Sec. 1107.40 Communications between FDA and applicants.
(a) General principles. During the course of reviewing an SE
Report, FDA may communicate with applicants about relevant matters,
including scientific, medical, and procedural issues that arise during
the review process. These communications may take the form of telephone
conversations, letters, or emails, and will be documented in the SE
Report in accordance with Sec. 10.65 of this chapter.
(b) Meeting. Meetings between FDA and applicants may be held to
discuss scientific and other issues. Requests for meetings will be
directed to the Office of Science, and FDA will make every attempt to
grant requests for meetings that involve important issues.
(c) Acknowledgement of an SE Report. After receiving an SE Report
under Sec. 1107.18, FDA will either refuse to accept the SE Report or
issue an acknowledgement letter.
(d) Notification of deficiencies in a SE Report submitted under
Sec. 1107.18. FDA will make reasonable efforts to communicate to
applicants the procedural, administrative, or scientific deficiencies
found in an SE Report and any additional information and data needed
for the Agency's review. The applicant must also provide additional
comparison information under Sec. 1107.19 if requested by FDA.
(e) Withdrawal of SE Report. An SE Report will be considered
withdrawn when FDA issues a notice stating that the SE Report has been
withdrawn.
Sec. 1107.42 Review cycles.
(a) Initial review cycle. FDA intends to review the SE Report and
either communicate with the applicant as described in Sec. 1107.40 or
take an action under Sec. 1107.44 within 90 calendar days of FDA's
receipt of the SE Report, or within 90 days of determining that the
predicate was found to be commercially marketed in the United States as
of February 15, 2007 (if applicable), whichever is later. This 90-day
period is called the ``initial review cycle.''
(b) Additional review cycles. If FDA issues a deficiency
notification under Sec. 1107.40(d) during the initial review cycle,
FDA will stop reviewing the SE Report until it receives a response from
the applicant or the timeframe specified in the notification of
deficiencies for response has elapsed. If the applicant fails to
respond within the time period provided in the notification of
deficiency, FDA will issue an order denying marketing authorization
under the criteria set forth in Sec. 1107.48. If the applicant's
response to the notification of deficiencies provides the information
FDA requested, but FDA identifies additional deficiencies, FDA may
issue an additional deficiency notification. Each response will begin a
new 90-day review cycle.
(c) Inadequate response. If the applicant's response to FDA's
deficiency notification(s) does not provide the information FDA
requested, or the applicant provides information but the SE Report is
still deficient, FDA will issue an order denying market authorization
under the criteria set forth in Sec. 1107.48. At any time before FDA
issues an order, an applicant may make a written request to withdraw a
SE Report under Sec. 1107.22.
Sec. 1107.44 FDA action on an SE Report.
After receipt of an SE Report, FDA will:
(a) Refuse to accept the SE Report if it does not comply with Sec.
1107.18;
(b) Request additional information as provided in Sec. 1107.40(d);
(c) Issue a letter administratively closing the SE Report if it is
not possible to make a determination on an SE Report;
(d) Issue a letter canceling the SE Report if FDA finds the SE
Report was created in error;
(e) Issue an order as described in Sec. 1107.46 finding the new
tobacco product to be substantially equivalent and in compliance with
the requirements of the Federal Food, Drug, and Cosmetic Act; or
(f) Issue an order as described in Sec. 1107.48 denying marketing
authorization because the new tobacco product is:
(1) Not substantially equivalent to a tobacco product commercially
marketed in the United States on February 15, 2007, or
(2) Not in compliance with the requirements of the Federal Food,
Drug, and Cosmetic Act.
Sec. 1107.46 Issuance of an order finding a new tobacco product
substantially equivalent.
If FDA finds that the information submitted in the SE Report
establishes that the new tobacco product is substantially equivalent to
a predicate tobacco product that was commercially marketed in the
United States on February 15, 2007, and finds that the new tobacco
product is in compliance with the requirements of the Federal
[[Page 12790]]
Food, Drug, and Cosmetic Act, FDA will send the applicant an order
authorizing marketing of the product. A marketing authorization order
becomes effective on the date the order is issued.
Sec. 1107.48 Issuance of an order denying marketing authorization.
(a) General. FDA will issue an order that the new tobacco product
cannot be marketed if FDA finds that:
(1) The information submitted in the SE Report does not establish
that the new tobacco product is substantially equivalent to a predicate
tobacco product that was commercially marketed in the United States on
February 15, 2007; or
(2) The new tobacco product is not in compliance with the Federal
Food, Drug, and Cosmetic Act.
(b) Basis for order. The order will describe the basis for denying
marketing authorization.
Sec. 1107.50 Rescission of order.
(a) Grounds for rescinding a substantially equivalent order. FDA
may rescind a substantial equivalence order allowing a new tobacco
product to be marketed if FDA determines that:
(1) The tobacco product for which the order has been issued:
(i) Does not have the same characteristics as the predicate tobacco
product; or
(ii) Has different characteristics and there is insufficient
information demonstrating that it is not appropriate to require a
premarket tobacco product application under section 910(b) of the
Federal Food, Drug, and Cosmetic Act because the product does not raise
different questions of public health; or
(2) The SE Report (including any submitted amendments) contains an
untrue statement of material fact; or
(3) Concerning a SE Report that compared the new tobacco product to
a tobacco product that FDA previously found substantially equivalent:
(i) The predicate tobacco product relied on in the SE Report has
been found ineligible because its substantial equivalence SE Report
(including any amendments) contains an untrue statement of material
fact; or
(ii) A predicate tobacco product on which any of the previous
substantial equivalence determinations was based, going back to the
original grandfathered product, has been found ineligible because its
substantial equivalence SE Report (including any amendments) contains
an untrue statement of material fact; or
(4) FDA or the applicant has removed from the market, due to a
health or safety concern related to the tobacco product:
(i) The predicate tobacco product on which the substantial
equivalence determination is based; or
(ii) A predicate tobacco product on which any of the previous
substantial equivalence determinations is based, going back to the
original grandfathered product, if the substantial equivalence SE
Report compared the new tobacco product to a tobacco product that FDA
previously found substantially equivalent.
(b) Opportunity for a hearing. In general, FDA will rescind an
order only after notice and opportunity for a hearing under part 16 of
this chapter. However, FDA may rescind a substantially equivalent order
prior to notice and opportunity for a hearing under part 16 of this
chapter if it finds that there is a reasonable probability that
continued marketing of the tobacco product presents a serious risk to
public health. In that case, FDA will provide the manufacturer an
opportunity for a hearing as soon as possible after the rescission.
Subpart E--Miscellaneous
Sec. 1107.58 Record retention.
Each applicant that receives an order under Sec. 1107.46
authorizing the marketing of a new tobacco product must maintain all
records required by this subpart and that support the SE Report for a
substantial equivalence order. These records must be legible, in the
English language, and available for inspection and copying by officers
or employees duly designated by the Secretary. All records must be
retained for a period of not less than 4 years from the date of the
order even if such product is discontinued.
Sec. 1107.60 Confidentiality.
(a) General. FDA will determine the public availability of any part
of an SE Report and other content related to such an SE Report under
this section and part 20 of this chapter.
(b) Confidentiality of data and information prior to an order.
Prior to issuing an order under this section:
(1) FDA will not publicly disclose the existence of an SE Report
unless:
(i) The tobacco product has been introduced or delivered for
introduction into interstate commerce for commercial distribution; or
(ii) The applicant has publicly disclosed or acknowledged the
existence of the SE Report (as such disclosure is defined in Sec.
20.81 of this chapter), or has authorized FDA in writing to publicly
disclose or acknowledge, that the applicant has submitted the SE Report
to FDA;
(2) FDA will not disclose the existence of or contents of an FDA
communication with an applicant regarding its SE Report except to the
extent that the applicant has publicly disclosed or acknowledged, or
authorized FDA in writing to publicly disclose or acknowledge, the
existence of or contents of that particular FDA communication.
(3) FDA will not disclose information contained in an SE Report
unless the applicant has publicly disclosed or acknowledged, or
authorized FDA in writing to publicly disclose or acknowledge, that
particular information. If the applicant has publicly disclosed or
acknowledged, or authorized FDA in writing to publicly disclose or
acknowledge, that particular information contained in an SE Report, FDA
may disclose that particular information.
(c) Disclosure of data and information after an order under Sec.
1107.46. After FDA issues an order under Sec. 1107.46 finding a new
tobacco product substantially equivalent, it will make the following
information related to the SE Report and order available for public
disclosure upon request or at FDA's own initiative, including
information from amendments to the SE Report and FDA's reviews of the
SE Report:
(1) All data previously disclosed to the public, as such disclosure
is defined in Sec. 20.81 of this chapter;
(2) Any protocol for a test or study, except to the extent it is
shown to fall within the exemption established for trade secrets and
confidential commercial information in Sec. 20.61 of this chapter;
(3) Information and data submitted to demonstrate that the new
tobacco product does not raise different questions of public health,
except to the extent it is shown to fall within the exemptions
established in Sec. 20.61 of this chapter for trade secrets and
confidential commercial information, or in Sec. 20.63 of this chapter
for personal privacy;
(4) Correspondence between FDA and the applicant, including any
requests FDA made for additional information and responses to such
requests, and all written summaries of oral discussions between FDA and
the applicant, except to the extent it is shown to fall within the
exemptions in Sec. 20.61 of this chapter for trade secrets and
confidential commercial information, or in Sec. 20.63 of this chapter
for personal privacy; and
(5) In accordance with Sec. 25.51 of the chapter (21 CFR 25.51),
the environmental assessment or, if applicable, the claim of
categorical exclusion from the requirement to
[[Page 12791]]
submit an environmental assessment under part 25 of this chapter.
(d) Disclosure of data and information after an order under Sec.
1107.48. After FDA issues an order under Sec. 1107.48 (denying
marketing authorization), FDA may make certain information related to
the SE Report and the order available for public disclosure upon
request or at FDA's own initiative except to the extent the information
is otherwise exempt from disclosure under part 20 of this chapter.
Information FDA may disclose includes the tobacco product category
(e.g., cigarette), tobacco product subcategory (e.g., filtered),
package size, and the basis for the order denying marketing
authorization.
(e) Health information summary or statement. Health information
required by section 910(a)(4) of the Federal Food, Drug, and Cosmetic
Act, if submitted as part of the SE Report (which includes any
amendments), will be disclosed within 30 calendar days of issuing a
substantially equivalent order. If the applicant has instead submitted
a 910(a)(4) statement as provided in Sec. 1107.18(j)(2), FDA will make
publicly available on FDA's website the responsible official to whom a
request for health information may be made.
Sec. 1107.62 Electronic submission.
(a) Electronic format requirement. Applicants submitting any
documents to the Agency under this part must provide all required
information to FDA using the Agency's electronic system, except as
provided in paragraph (b) of this section. The SE Report and all
supporting information must be in an electronic format that FDA can
process, read, review, and archive.
(b) Waivers from electronic format requirement. An applicant may
submit a written request that is legible and written in English, to the
Center for Tobacco Products asking that FDA waive the requirement for
electronic format and content. Waivers will be granted if use of
electronic means is not reasonable for the person requesting the
waiver. To request a waiver, applicants can send the written request to
the address included on our website (www.fda.gov/tobaccoproducts). The
request must include the following information:
(1) The name and address of the applicant, list of individuals
authorized for the applicant to serve as the contact person, and
contact information. If the applicant has submitted a SE Report
previously, the regulatory correspondence must also include any
identifying information for the previous submission; and
(2) A statement that creation and/or submission of information in
electronic format is not reasonable for the person requesting the
waiver, and an explanation of why creation and/or submission in
electronic format is not reasonable. This statement must be signed by
the applicant or by an employee of the applicant who is authorized to
make the declaration on behalf of the applicant.
(c) Paper submission. An applicant who has obtained a waiver from
filing electronically must send a written SE Report through the
Document Control Center to the address provided in the FDA
documentation granting the waiver.
Dated: March 21, 2019.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2019-05787 Filed 3-28-19; 11:15 am]
BILLING CODE 4164-01-P