[Federal Register Volume 86, Number 190 (Tuesday, October 5, 2021)]
[Rules and Regulations]
[Pages 55224-55300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21009]
[[Page 55223]]
Vol. 86
Tuesday,
No. 190
October 5, 2021
Part III
Department of Health and Human Services
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Food and Drug Administration
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21 CFR Parts 16, 1100, 1107, et al.
Content and Format of Substantial Equivalence Reports; Food and Drug
Administration Actions on Substantial Equivalence Reports, and
Premarket Tobacco Product Applications and Recordkeeping Requirements;
Final Rules
Applications for Premarket Review of New Tobacco Products; Draft
Guidance for Industry; Withdrawal; Notice
Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 /
Rules and Regulations
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 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: Final rule.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
issuing this final rule to provide additional information on the
content and format of reports intended to demonstrate the substantial
equivalence of a tobacco product (SE Reports). The final rule also
establishes the general procedures FDA intends to follow when
evaluating SE Reports, including procedures that address communications
with the applicant and the confidentiality of data in an SE Report. The
final rule will provide applicants with more certainty and clarity
related to preparing and submitting SE Reports.
DATES: This rule is effective November 4, 2021.
ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-5700.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson or Nathan Mease,
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
I. Executive Summary
A. Purpose of the Final Rule
B. Summary of the Major Provisions of the Final Rule
C. Legal Authority
D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
IV. Legal Authority
V. Description of the Final Regulation and Comments and Responses
A. Introduction
B. Description of General Comments and FDA Responses
C. Comments on Subpart B--General and FDA Responses
D. Comments on Subpart C--Substantial Equivalence Reports and
FDA Responses
E. Comments on Subpart D--FDA Review and FDA Responses
F. Comments on Subpart E--Miscellaneous Provisions and FDA
Responses
G. Comments on Other Issues for Consideration and FDA Responses
VI. Effective Date
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Congressional Review Act
XII. Consultation and Coordination With Indian Tribal Governments
XIII. References
I. Executive Summary
A. Purpose of the Final Rule
This final rule provides further information on the content and
format of SE Reports, including the information that SE Reports must
contain. FDA is finalizing this rule after reviewing comments to the
proposed rule (84 FR 12740, April 2, 2019), as well as the SE review
experience the Agency has gained since enactment of the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31). As explained in the proposed rule, the SE Reports that FDA has
seen to date range widely in the level of detail included, with some
reports including very little information on the comparison of the new
tobacco product with a predicate tobacco product and some including
much more. This final rule will provide applicants with a better
understanding of the level of detail that an SE Report must contain.
The final rule also addresses issues such as FDA communications with
the applicant, the retention of records that support the SE Report,
confidentiality of SE Reports, and electronic submission of the SE
Report and amendments.
B. Summary of the Major Provisions of the Final Rule
Under the final rule, an SE Report must provide information
comparing the new tobacco product to a predicate tobacco product,
including information that will enable FDA to uniquely identify the new
tobacco product and the predicate tobacco product, as well as
comparison information. The requirements will 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 (other than for test marketing) 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 rule explains how an applicant can amend or
withdraw an SE Report, and explains how an applicant may transfer
ownership of an SE Report to a new applicant. The rule also addresses
FDA communications with applicants on SE Reports and explains FDA
review cycles and FDA actions, including the issuance of orders and the
rescission of orders. The rule also establishes the length of time
records related to the SE Report must be maintained, describes FDA's
disclosure provisions, and requires electronic submission of SE
Reports, unless the applicant requests and is granted a waiver.
C. Legal Authority
This 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).
D. Costs and Benefits
This final rule would impose incremental 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 $0.4
million to $3.4 million, with a primary estimate of $1.9 million at a 3
percent discount rate, and from $0.4 million to $2.9 million, with a
primary estimate of $1.6 million at a 7 percent discount rate over 10
years. Annualized industry compliance costs over 10 years range from
$0.05 million to $0.39 million, with a primary estimate of $0.22
million at a 3 percent discount rate and from $0.06 million to $0.42
million, with a primary estimate of $0.23 million at a 7 percent
discount rate.
The incremental benefits of this final rule are potential time-
savings to industry and cost-savings to government. The final rule
clarifies when applicants may certify that certain
[[Page 55225]]
characteristics are identical in the new tobacco product and the
predicate tobacco product. Certifying may save applicants time in
preparing their SE Reports. We anticipate shorter review times for SE
Reports as a result of this final rule. In addition, based on our
experience with prior SE Reports, we believe this final rule will lead
to higher quality SE Reports, saving us time in review and requiring
fewer staff to review SE Reports, which will result in cost-savings. We
estimate that the present value of government cost-savings ranges from
$15.1 million to $150.6 million, with a primary estimate of $50.2
million at a 3 percent discount rate, and from $12.4 million to $124
million, with a primary estimate of $41.3 million at a 7 percent
discount rate over 10 years. Annualized government cost-savings over 10
years range from $1.8 million to $17.7 million, with a primary estimate
of $5.9 million at both 3 and 7 percent discount rates.
The qualitative benefits of this final rule include additional
clarity to industry about the requirements for the content and format
of SE Reports. The final rule would also establish the general
procedures we will follow in reviewing and communicating with
applicants. In addition, this final rule would make the SE pathway more
predictable.
II. Table of Abbreviations/Commonly Used Acronyms in This Document
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Abbreviation What it means
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ANPRM............................... Advance Notice of Proposed
Rulemaking
CCS................................. Container Closure System
CORESTA............................. Cooperation Centre for Scientific
Research Relative to Tobacco
CTP................................. Center for Tobacco Products
DQPH................................ Different Questions of Public
Health
ENDS................................ Electronic Nicotine Delivery
System
EA.................................. Environmental Assessment
E.O................................. Executive Order
FDA................................. Food and Drug Administration
FD&C Act............................ Federal Food, Drug, and Cosmetic
Act
FSC................................. Fire Standard Compliant
FOIA................................ Freedom of Information Act
GRAS................................ Generally Recognized as Safe
HPHC................................ Harmful and Potentially Harmful
Constituents
HTP................................. Heated Tobacco Products
MDSS................................ Manufacturing Data Sheet
Specification
NEPA................................ National Environmental Policy Act
of 1969
NSE................................. Not Substantially Equivalent
PDU................................. Power Delivery Unit
PM.................................. Particulate Matter
PMTA................................ Premarket Tobacco Application
PRA................................. Paperwork Reduction Act of 1995
QRA................................. Quantitative Risk Assessment
RIA................................. Regulatory Impact Analysis
RYO................................. Roll-Your-Own
SE.................................. Substantial Equivalence
TPMF................................ Tobacco Product Master File
TSNA................................ Tobacco-Specific Nitrosamines
VOC................................. Volatile Organic Compound
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III. Background
The FD&C Act, as amended by the Tobacco Control Act, generally
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 (``provisional'' tobacco products). For any
new tobacco product introduced or delivered for introduction into
interstate commerce for commercial distribution on or after March 22,
2011, or for which a substantial equivalence report was not submitted
prior to March 23, 2011, a manufacturer must first submit a premarket
application 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 rule, FDA refers to ``SE applications'' as ``SE
Reports,'' but the terms both refer to a premarket submissions under
section 905(j)(1)(A) of the FD&C Act.
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Since the enactment of the Tobacco Control Act, FDA has received
thousands of SE Reports, many of which lacked the information necessary
for FDA to make a substantial equivalence determination. To assist
applicants in better preparing an SE Report, on April 2, 2019, FDA
issued a proposed rule to provide additional information regarding the
content and format of reports intended to establish the substantial
equivalence of a tobacco product. FDA received about 100 comments to
the docket for the proposed rule, including comments from tobacco
product manufacturers and trade organizations, retailers,
representatives of tribes/tribal organizations, public health groups,
individual consumers, and other submitters. We summarize and respond to
these comments in section V of this rule. After considering these
comments, FDA developed this final rule, which includes changes made in
response to the comments.
IV. Legal Authority
As described in the following paragraphs, FDA is issuing this rule
to address the content, form, and manner of reports intended to
demonstrate the substantial equivalence of a new tobacco product to a
predicate tobacco product. The rule also addresses record keeping,
reports, and the 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 established by this rule are severable
and that the invalidation of any provision of this rule would not
affect the validity of any other part of this rule.
Section 910(a)(2) of the FD&C Act requires a new tobacco product to
be the subject of a premarket tobacco product application (PMTA)
marketing 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
[[Page 55226]]
equivalence of a new tobacco product to a predicate tobacco product
under section 905(j) of the FD&C Act. Section 905(j) provides that FDA
may prescribe the form and manner of the substantial equivalence
report, and section 910(a)(4) of the FD&C Act 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 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.
V. Description of the Final Regulation and Comments and Responses
A. Introduction
We received about 100 comments to the docket for the proposed rule.
In addition to the comments specific to this rulemaking that we address
in this section, we received many general comments expressing support
or opposition to the rule. These comments express broad policy views
and do not address specific points related to this rulemaking.
Therefore, these general comments do not require a response. In this
section, we have grouped similar comments together by the topics
discussed or the particular portions of the proposed rule or codified
language to which they refer. To make it easier to identify comments
and FDA's responses, the word ``Comment,'' in parenthesis, appears
before the comment's description, and the word, ``Response,'' in
parenthesis appears before FDA's response. Each comment is numbered to
help distinguish among different comments, and the number assigned is
purely for organizational purposes and does not signify value or
importance. Similar comments are grouped together under the same
comment number. In this section we also describe changes we made to the
final rule following our consideration of the comments and other
information.
As described in more detail in this section, following our
consideration of these comments, we have made changes to proposed
Sec. Sec. 1107.10, 1107.12, 1107.18, 1107.19, 1107.22, 1107.40,
1107.44, 1107.46, 1107.48, and 1107.50. The changes are largely
intended to clarify areas of confusion or address concerns raised by
the comments, and we describe in detail the changes made to each of
these provisions in the following paragraphs. Following our review of
the comments, we are not making changes to other sections included in
the proposed rule and are finalizing those sections without change. In
addition, we received no comments on the proposed change to add
language to Sec. 16.1(b)(2) (21 CFR 16.1(b)(2)) regarding rescission
(as included in the proposed rule), and we are finalizing Sec.
16.1(b)(2) without change.
B. Description of General Comments and FDA Responses
(Comment 1) Some comments object to the proposed rule, stating that
the rule violates the statute because the rule would not create a
viable pathway to market products that qualify for the SE pathway that
is more streamlined than the PMTA pathway. For example, one comment
objects to the proposed rule and states that FDA has ``exceeded
Congressional intent by over-complicating the [premarket] pathways,
ignoring the first prong of the SE standard and making the second prong
nearly as burdensome as the PMTA pathway.'' Another comment states that
regardless of whether an SE Report cites the first or second prong for
determining substantial equivalence, ``the SE pathway is intended to be
significantly less burdensome than the PMTA pathway,'' and the SE
pathway should ``require the least information and be the simplest to
implement while the PMTA pathway, with its focus on the `protection of
public health' would require the more extensive information and data.''
Other comments also object to the rule and state the SE pathway should
be much more like a ``notification'' process than the PMTA pathway.
(Response 1) We disagree with these comments. We have received
thousands of premarket applications, including SE Reports, and we
developed this rule based on our experience with those SE Reports and
the framework for substantial equivalence under sections 905(j) and 910
of the FD&C Act. The statutory requirements related to substantial
equivalence differ from the statutory framework and requirements for a
PMTA, and each pathway has different standards for authorization. The
rule will provide applicants with additional clarity and understanding
of the information needed in an SE Report for FDA to make a
determination under the statutory requirements related to substantial
equivalence (sections 905(j) and 910(a) of the FD&C Act). Notably,
under the SE pathway, the applicant must receive an order prior to
marketing the new tobacco product (unless it has received authorization
through a different premarket pathway or it is a provisional tobacco
product); the FD&C Act does not authorize a ``notification process'' as
an alternative to receiving an SE order. As appropriate, however, we
have developed mechanisms to lessen the burden for submitting data that
are more streamlined by allowing for certifications when the data
between the new and predicate tobacco products are identical (see,
e.g., Sec. 1107.18(l)).
(Comment 2) Some comments suggest FDA adopt an approach similar to
the substantial equivalence process FDA applies to devices under
sections 510(k) and 513(i) of the FD&C Act (21 U.S.C. 360(k) and
360c(i)), for example, by permitting a notification process. Other
comments reference guidance documents related to the 510(k) process for
devices as examples of how to
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implement the SE pathway for tobacco products.
(Response 2) We disagree with these comments. FDA's interpretation
of SE with respect to medical devices is based on different statutory
sections from those applicable to tobacco products and, due to the
differences in the statutory provisions underlying the 510(k) premarket
pathway, it has limited utility as a model in considering SE for
tobacco products. As described in the preceding response and also in
section IV below, sections 905(j) and 910(a) of the FD&C Act set out
the substantial equivalence provisions that are specifically applicable
to tobacco products, and reflect the differences in these regulated
products. For example, the medical device provisions involve
considerations related to the safety and effectiveness of medical
devices. In comparison, the statutory provisions relating to SE for
tobacco products focus on the characteristics of the new tobacco
product, and where there are differences, whether such differences
cause the new tobacco product to raise different questions of public
health.
(Comment 3) Some comments object that the proposed rule would
require behavioral information in an SE Report that the FD&C Act
requires only for a new product subject to a PMTA. One comment notes
that because the ``SE process is an exception to PMTA requirements,
designed to determine whether the product should have to undergo the
full PMTA process, [r]equiring manufacturers to submit PMTA-level
evidence . . . is illogical.''
(Response 3) We disagree with the suggestion that behavioral
information, such as initiation and cessation information, can never be
relevant in the evaluation of an SE report. Congress broadly delegated
to FDA the authority to specify what should be included in an SE Report
and imposed no constraints of the type the comments suggest. (See
section 905 (j)(1) of the FD&C Act (``report to the Secretary [of
Health and Human Services] (in such form and manner as the Secretary
shall prescribe)'')). As many comments point out, where the new tobacco
product has different characteristics than the predicate tobacco
product, the information submitted in the SE application must ``contain
information, including clinical data if deemed necessary by [FDA], that
demonstrates . . . [that] the product does not raise different
questions of public health.'' (Section 910(a)(3)(A)(ii) of the FD&C
Act.) Congress included findings in the Tobacco Control Act that make
clear that one of the public health purposes of the legislation was to
reduce dependence on tobacco. For example, Congress stated that the
Tobacco Control Act's ``purposes'' include ensuring that FDA has the
authority to address issues of particular concern to public health
officials, especially the use of tobacco by young people and dependence
on tobacco and promoting cessation to reduce disease risk and the
social-costs associated with tobacco-related diseases. (see Tobacco
Control Act sections 3(2) and (9)). In addition, Congress defined
substantial equivalence to mean that the information submitted contains
information, including clinical data if deemed necessary by the
Secretary, that demonstrates that it is not appropriate to regulate the
product under this section because the product does not raise different
questions of public health. (See FD&C Act 910(a)(3)(A)(ii).) The
reference to ``this section'' is a reference to the PMTA pathway.
Because one of the bases for FDA finding that a product is appropriate
for the protection of public health (i.e., the PMTA ``standard'')
includes the increased or decreased likelihood that existing users will
stop using and new users will initiate use of such products, it is
reasonable to examine those same considerations under the SE standard
to determine whether the differences between the predicate and the new
product show that the product should be reviewed under the PMTA
pathway.
As a result, in determining whether a new tobacco product raises
different questions of public health, FDA considers potential impacts
on initiation and cessation of tobacco use. If the SE Report lacks this
information, then we may be unable to determine that the product is
substantially equivalent.
(Comment 4) A number of comments assert that the proposed
regulation does not provide enough specificity to adequately guide
industry. For example, one comment states that the proposed rule lacked
clarity regarding the scope, type, and amount of testing and other
information needed in SE Reports for smokeless tobacco products and the
comment requests that FDA include more specific requirements regarding
the content of SE Reports for smokeless tobacco products. Other
comments suggest the rule requires too much information or the wrong
information.
(Response 4) We disagree with these comments. The rule provides
content and format information that will be applicable across a range
of categories and subcategories of tobacco products, including
smokeless tobacco products (see, e.g., Sec. 1107.19). In addition,
after reviewing the comments received in response to our invitation to
comment on design parameters for cigars, Electronic Nicotine Delivery
Systems (ENDS), and other tobacco products, the final rule now includes
design parameter information for these products. Based on our
experience, we believe that the requirements in this rule are necessary
for FDA to determine whether a product is substantially equivalent.
(Comment 5) One comment suggests that FDA should apply the rule to
currently pending SE Reports.
(Response 5) As the proposed rule explained, the requirements
included in the rule apply only after the effective date of this rule.
Accordingly, the requirements do not apply to an SE Report for a
provisional tobacco product or to any SE Report submitted before the
effective date of this rule. This does not prevent applicants with
pending SE Reports or those preparing SE Reports from referring to this
rule for guidance on how to submit amendments to pending SE reports or
prepare their SE Report prior to the effective date of this rule.
Please note that we will continue to evaluate currently pending SE
Reports and those submitted prior to the effective date as we have
evaluated those thousands of SE Reports in the years since the Tobacco
Control Act was enacted. Importantly, our previous SE evaluation
experience helped aid in the development of this final rule. In
practical effect, this means that an applicant submitting an SE report
before this rule goes into effect has an opportunity to benefit from
its contents but FDA will not refuse to accept an application for
lacking information first required in this rule (i.e., information not
already required by regulation or statute). For example, for an
application received before this rule is in effect, FDA would not
retroactively refuse to accept an application that lacks information
required for acceptance under this rule that was not already required
by regulation or statute. Likewise, if an application submitted before
the effective date of this rule lacks information necessary to enable
FDA to determine whether or not the product meets the statutory
standard as articulated in this rule (e.g., lack of data to show that
the new product is SE), FDA would not rely on this rule to deny the
application--instead FDA generally intends to evaluate SE reports and
communicate with applicants consistent with its review process to date.
(Comment 6) At least one comment suggests that FDA revise or
withdraw SE-related guidance documents when the Agency issues the final
SE regulation to reduce confusion and because the guidance documents
would
[[Page 55228]]
no longer be warranted. Other comments suggest that FDA issue new
guidance, including guidance documents with decision trees (e.g.,
similar to 510(k) process for devices).
(Response 6) FDA agrees that revision or withdrawal of guidance
documents is appropriate if the recommendations are no longer relevant
or could be confusing. Following issuance of this final rule, we intend
to review SE-related guidance documents to determine whether to revise
or withdraw any guidance documents. More specifically, we intend to
consider whether the recommendations or information included in those
guidance documents are outdated due to this final rule, and we will
update or withdraw those guidance documents as appropriate. Similarly,
we will consider whether new guidance documents should be developed or
whether updates should be made to existing guidance documents. FDA will
make any changes or withdrawals or issue new guidance documents
promptly pursuant to the procedures in 21 CFR 10.115.
C. Comments on Subpart B--General and FDA Responses
1. Scope (Sec. 1107.10)
This part establishes the procedures and provides information 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. We are finalizing Sec. 1107.10 (Scope) with one change from
the proposed rule to reflect that this part applies to new tobacco
products ``other than `premium' cigars as defined in Sec. 1107.12.''
In the following paragraphs, we discuss the comments related to this
section, including comments on the scope of products covered.
(Comment 7) Several comments on the proposed rule discuss
``premium'' cigars. These comments included requests that FDA exempt
``premium'' cigars from premarket requirements, create a different
premarket pathway for ``premium'' cigars, or delay the effective date
for submitting premarket applications for ``premium'' cigars. Other
comments flag concerns with specific requirements included in the
proposed rule, such as concerns related to co-packaging requirements
(the comments state that ``premium'' cigar packaging does not have the
potential to alter or affect the performance, composition, constituent,
or other physical characteristics of the product); concerns related to
the applicability of ``product quantity'' change for ``premium'' cigars
as these are sold individually; and concerns related to the
``significant natural and inherent variability'' in handmade
``premium'' cigar products (the comments state these products cannot be
manufactured by hand consistently enough to permit manufacturers to
``fully characterize'' them in any meaningful way to permit a
traditional SE comparison). Other comments raise issues related to the
applicability of proposed requirements in Sec. 1107.19 to ``premium''
cigars, such as the proposed requirement that information on ``[t]he
type of tobacco, including grade and variety'' be submitted in an SE
Report, that harmful and potentially harmful constituents (HPHC) data
be submitted, given the variety of cigars and lack of smoke testing
methodologies for ``premium'' cigars, costs of HPHC testing, and
insufficient lab capacity, or that stability information be provided
given the characteristics of the product. Many of these comments
describe differences between ``premium'' cigars and other cigars, e.g.,
mechanized versus handmade processes, and state that these differences
make it more difficult for ``premium'' cigars to comply with SE
requirements.
(Response 7) FDA received a range of comments related to
``premium'' cigars.\2\ A recent court decision, Cigar Ass'n of Am., et
al. v. Food and Drug Admin., et al., ``remand[ed] the [deeming final
rule] to the FDA to consider developing a streamlined substantial
equivalence process for premium cigars'' and ``enjoin[ed] the FDA from
enforcing the premarket review requirements against premium cigars . .
. until the agency has completed its review.'' \3\ Under the terms of
the court's order, a ``premium'' cigar is defined as a cigar that meets
all of the following eight criteria:
---------------------------------------------------------------------------
\2\ Cigars are subject to Chapter IX of the FD&C Act as a result
of regulations enacted by FDA (Deeming Tobacco Products To Be
Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by
the Family Smoking Prevention and Tobacco Control Act; Restrictions
on the Sale and Distribution of Tobacco Products and Required
Warning Statements for Tobacco Products, 81 FR 28974, May 10, 2016
(``deeming final rule'')). The deeming final rule extended FDA's
regulatory authority to all tobacco products (excluding accessories
of such products). These products include all cigars, pipe tobacco,
waterpipe tobacco, electronic nicotine delivery systems (ENDS), and
other novel tobacco products.
\3\ Cigar Ass'n of Am., et al. v. Food and Drug Admin., et al.,
Case No. 1:16-cv-01460 (APM), (D.D.C. Aug. 19, 2020), Dkt. No. 214
(Cigar Ass'n of Am.).
---------------------------------------------------------------------------
1. Is wrapped in whole tobacco leaf;
2. contains a 100 percent leaf tobacco binder;
3. contains at least 50 percent (of the filler by weight) long
filler tobacco (i.e., whole tobacco leaves that run the length of the
cigar);
4. is handmade or hand rolled; \4\
---------------------------------------------------------------------------
\4\ A product is ``handmade or hand rolled'' if no machinery was
used apart from simple tools, such as a scissors to cut the tobacco
prior to rolling.
---------------------------------------------------------------------------
5. has no filter, nontobacco tip, or nontobacco mouthpiece;
6. does not have a characterizing flavor other than tobacco;
7. contains only tobacco, water, and vegetable gum with no other
ingredients or additives; and
8. weighs more than 6 pounds per 1,000 units.
As directed by the court in the Cigar Ass'n of Am. decision, FDA is
further considering the comments submitted to the deeming rule docket
that requested FDA create a streamlined SE process for ``premium''
cigars. Additionally, FDA notes that a Committee of the National
Academies of Science, Engineering, and Medicine is conducting a study
on such products. FDA intends to review the findings of that Committee
as well as any additional research specific to ``premium'' cigars (as
defined in the preceding paragraph) and their health effects, patterns
of use (such as frequency of use and usage patterns among underage
persons), and other factors. All such information will inform the
Agency's regulatory policy with respect to premarket review of
``premium'' cigars.
Because these are ongoing efforts, at this time, FDA is not
finalizing the proposed SE rule with respect to ``premium'' cigars.
Rather, FDA will take appropriate action once it has further considered
the comments submitted to the deeming rule docket that suggested FDA
create a streamlined SE process for ``premium'' cigars, as well as the
results from additional research. As such, the codified language has
been revised to exclude ``premium'' cigars from the scope of this final
rule, and the Cigar Ass'n of Am. court's definition of ``premium''
cigars has been added to Sec. 1107.12.
(Comment 8) One comment suggests that FDA add a definition for pipe
tobacco and create a different SE premarket pathway for pipe tobacco,
for example, more aligned with the 510(k) process for medical devices.
(Response 8) We interpret this comment to be a request that FDA
consider streamlined options within the three premarket pathways
available to pipe tobacco seeking authorization: PMTA, SE, and
exemption from SE, as provided in sections 905 and 910 of the FD&C Act.
Generally speaking, within the construct of the SE premarket pathway,
there are options for more
[[Page 55229]]
streamlined submissions, that will still provide the agency with the
information we need to determine whether the new tobacco product is SE,
which this final rule reflects. For example, where appropriate, certain
requirements (e.g., design parameters) are tailored by type of product.
In addition, the rule generally provides options to certify that
certain characteristics are identical in lieu of providing data for
each characteristic of the new and predicate tobacco product (Sec.
1107.18(l)). This option may be helpful to applicants as a means of
minimizing the content to be submitted, when appropriate. Finally,
because we are still considering how best to define ``pipe'' tobacco,
we are not including a definition of the term, but intend to undertake
further actions to define the term, if needed, at a future time.
However, we do not think a formal definition of ``pipe'' tobacco is
needed to continue regulating the product or to conduct an SE review.
(Comment 9) Some comments request that FDA clarify which changes
may proceed through the SE exemption pathway and those which may not.
The comment requests that FDA define the term ``minor modification'' to
help manufacturers understand which changes would qualify for the SE
exemption pathway. For example, the comments request that changes to
maintain product consistency or changes made by suppliers to components
be considered as changes eligible for the SE exemption pathway.
(Response 9) Requests for information on which changes would
qualify under the SE exemption pathway or for further information on
the term ``minor modification,'' relate to 21 CFR 1107.1 (see https://www.federalregister.gov/documents/2011/07/05/2011-16766/tobacco-products-exemptions-from-substantial-equivalence-requirements). Please
note that additional information related to exemption requests may be
found at https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/exemption-substantial-equivalence; FDA also maintains
information on exemption requests that FDA has granted at: https://www.fda.gov/tobacco-products/exemption-substantial-equivalence/marketing-orders-exemption-se.
2. Definitions (Sec. 1107.12)
Proposed Sec. 1107.12 listed terms and definitions used in the
proposed rule. In this final rule, we have added a definition of
``premium'' cigars, as well as updated several definitions on our own
initiative to clarify the meaning or to reflect current premarket
review processes or to help the definitions apply across product
categories.
As discussed in section V.C.1 of this final rule, we are adding the
Cigar Ass'n of Am. court's definition of ``premium'' cigars to Sec.
1107.12. That definition is:
``Premium'' cigars means a type of cigar that: (1) Is
wrapped in whole tobacco leaf; (2) contains a 100 percent leaf tobacco
binder; (3) contains at least 50 percent (of the filler by weight) long
filler tobacco (i.e., whole tobacco leaves that run the length of the
cigar); (4) is handmade or hand rolled (i.e., no machinery was used
apart from simple tools, such as scissors to cut the tobacco prior to
rolling); (5) has no filter, nontobacco tip, or nontobacco mouthpiece;
(6) does not have a characterizing flavor other than tobacco; (7)
contains only tobacco, water, and vegetable gum with no other
ingredients or additives; and (8) weighs more than 6 pounds per 1,000
units.
The updates to Sec. 1107.12 are to the following terms:
Brand to add an ``s'' following ``brand name'' in the
definition;
Constituent to add ``(e.g., smoke, aerosol, droplets),''
to delete ``or any chemical or chemical compound in mainstream or
sidestream tobacco smoke,'' to add ``or part'' following component, and
to replace ``smoke'' with ``emission'';
Finished tobacco product to move ``separately'' to follow
``consumers'' and to add ``or in the final form in which it is intended
to be sold to consumers'' to better clarify what is meant by finished;
Harmful and potentially harmful constituent to add the
phrase ``including as an aerosol or any other emission'' in paragraph
(1);
Heating source to change ``a'' to ``the'';
Other features to delete ``and are necessary for review'';
and
Submission tracking number to add ``voluntary'' and to
more closely track the statutory language by substituting ``that a
tobacco product was commercially marketed in the United States as of
February 15, 2007'' for ``grandfathered.''
We also received comments on several definitions included in the
proposed rule, and we describe and respond to those comments in the
following paragraphs. Following consideration of these comments, we
have added a definition of ``commercially marketed.'' In addition, we
have made changes to the definition of commercial distribution and
predicate tobacco product, as well as removing the definition
``grandfathered tobacco product,'' as discussed in the following
paragraphs related to those terms. Please note that if there were no
comments on a definition included in the proposed rule, there is no
discussion related to that definition. We are finalizing all other
definitions without change from the proposed rule.
Accessory
(Comment 10) One comment supports the definition of accessory,
noting that it reflects the definition included in the deeming final
rule.
(Response 10) We agree and note the final rule includes this
definition without change from the proposed rule.
Commercial Distribution
We proposed to define commercial distribution as: To mean 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.
In the following paragraphs, we discuss comments we received on the
proposed definition of commercial distribution. After considering the
comments related to this proposed definition, we have made several
changes to this definition that are included in the final rule.
Specifically, we are: (1) Adding ``whether domestic or imported'' to
clarify the distribution, (2) changing ``another,'' to ``any,'' (3)
deleting ``through sale or otherwise'' as unnecessary; (4) deleting
``registered'' as a modifier to ``establishment,'' (5) adding
``personal'' as a modifier to ``consumption,'' and (6) striking some of
the language related to what commercial distribution does not include
as other changes to the definition now clarify this point.
(Comment 11) One comment states that the definition of commercial
distribution included in the proposed rule is overly broad and
unworkable. This comment notes that including the phrase ``any
distribution of a tobacco product to consumers or to another person
through sale or otherwise'' (emphasis in comment) renders the
definition open-ended and potentially
[[Page 55230]]
includes any movement of a finished product that does not fit within
one of the enumerated exclusions, even if the product is not available
for consumption or resale. The comment notes that if FDA is concerned
with distribution of tobacco products that may be used for sampling
purposes, then FDA should tailor the definition to specify sampling (or
to an activity that either is a sale or promotes the sale of a
product).
(Response 11) FDA agrees that the definition of commercial
distribution included in the proposed rule required additional
refinement. We have thus removed ``through sale or otherwise'' from the
definition to clarify that commercial distribution is not limited to
the sale of tobacco products to the consumer. However, ``any person''
is necessary to capture movement such as that between a manufacturer,
importer, and distributor. As described in the preceding paragraph,
however, FDA has made minor revisions to the definition for
clarification to help in understanding the scope of this term.
(Comment 12) At least one comment objects to the use of
``registered'' establishments in the definition of commercial
distribution, stating that FDA should not require that interplant
transfers be between registered establishments to be excluded from the
scope of commercial distribution. This comment also notes that because
only domestic establishments are currently required to register,
interplant transfers with a company's foreign manufacturing facilities
(that are not registered) would be considered commercial distribution
under the proposed definition.
(Response 12) We agree that ``registered'' should be deleted, and
we have updated the definition in this final rule to reflect this
deletion. Furthermore, as we previously noted in the proposed rule, the
term commercial distribution excludes the providing of a tobacco
product for product testing where such products are not made available
for personal consumption or resale. Additionally, FDA does not intend
this term to include the handing or transfer of a tobacco product from
one consumer to another for personal consumption (consumer to consumer
transfers).
(Comment 13) One comment requests that FDA use the same definition
for commercial distribution and commercial marketing and proposes that
the definition be revised to recognize that commercial marketing and
commercial distribution may occur from the time of sale from a foreign
manufacturer to a U.S. distributor. The comment suggests that this
approach would better reflect that many pipe tobaccos are sold as
private label items to a specific retailer with a limited geographical
footprint.
(Response 13) We decline to make a change to combine these
definitions because, although the terms have some overlap, they are
also distinct, as reflected in the statute. Thus, it would not be
appropriate to combine the terms. As we discuss in the paragraphs
related to the definition of ``new tobacco product,'' following our
review of comments, we have decided to include a definition of
commercially marketed in this final rule. In response to the comment
related to pipe tobacco sales, we note that with respect to the sale
from a foreign manufacturer to a U.S. distributor, the final rule's
definitions of commercially marketed and commercial distribution
include a sale from a foreign manufacturer to a U.S. distributor and
sale of tobacco products to a specific retailer with a limited
geographical footprint. Applicants or others who have questions as to
whether a specific activity falls within these terms should contact
FDA.
Component or Part
We proposed 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.'' In the following paragraphs, we
summarize the comments we received on this proposed definition of
component and part, which we are finalizing without change. We also
received comments on the inclusion of ``container closure system'' as a
subset of component or part, and we address those comments in the
paragraphs related to the definition of container closure system.
(Comment 14) Some comments express concern about the definition of
component and part noting, for example, that using the terms
interchangeably can be confusing and that FDA should either define each
separately or settle on one term and use that term. Another comment
supports the definition of component and part noting that the term and
definition are consistent with language in the deeming final rule.
(Response 14) We agree that it is appropriate in this context to
remain consistent in defining terms across tobacco product regulations.
Thus, this final rule maintains the definition that was included in the
proposed rule and which reflects the definition included in the deeming
final rule (see, e.g., 21 CFR 1100.3). We disagree with comments
suggesting the definition is too broad or that we should break
``component or part'' into two definitions at this time. Although we
appreciate the concern about confusion, the rule makes clear that both
component and part share the same definition, and applicants can apply
the terms accordingly. Should FDA determine at some future point that a
distinction between the terms is necessary, we would undertake notice
and comment rulemaking on the issue before we would apply any changes.
(Comment 15) One comment requests that FDA exercise enforcement
discretion for the submission of SE Reports for smoking pipes. The
comment acknowledges that the deeming final rule states that smoking
pipes are components and parts of tobacco products (81 FR 28974 at
29042) but notes that FDA has exercised enforcement discretion for the
submission of ingredient reports for smoking pipes and suggests FDA do
the same for SE requirements.
(Response 15) As the comment states, FDA has established compliance
policies related to other FD&C Act requirements for smoking pipes. We
decline to extend or establish such a premarket compliance policy for
smoking pipes because pipes can impact the risk profile of the tobacco
product with which the pipe is used, e.g., by increasing HPHC exposure.
We note that the rule includes options to certify that certain
characteristics are identical in lieu of providing data for each
characteristic of the new and predicate tobacco product (Sec.
1107.18(l)). This option may be helpful to applicants as a means of
minimizing the content to be submitted, when appropriate. We also
encourage potential applicants to reach out to FDA to discuss questions
related to preparing an SE Report.
Container Closure System (CCS)
We proposed to define ``container closure system'' as ``any
packaging materials that are a component or part of a tobacco
product.'' As described in the following paragraphs, we received
several comments related to the definition of container closure system
included in the proposed rule, as well as comments on the discussion of
co-packaging that was included in the proposed rule. After considering
the comments, we are finalizing this definition without change from the
proposed rule.
(Comment 16) Some comments object to the definition of container
closure
[[Page 55231]]
system as ``any packaging materials that are a component or part of a
tobacco product,'' stating it is inconsistent with the FD&C Act (as
amended by the Tobacco Control Act) and ``an impermissible back door
effort'' to subject packaging changes to SE review. One comment adds
that the definition transforms packaging into a ``component or part''
of a tobacco product contrary to a D.C. District Court decision (Philip
Morris USA Inc. v. FDA, 202 F. Supp 3d 31 (D.D.C. 2016)) (Philip Morris
decision). These comments also state that although the FD&C Act
provides FDA with authority to regulate packaging under sections 903(a)
and 905(i) of the FD&C Act, that authority does not provide FDA with
the ability to include packaging under the definition of component or
part and thereby subject packaging to premarket review.
(Response 16) FDA is not requiring that an applicant include
information on all aspects of the packaging, but the requirements of
the final rule do require information on the CCS as a component or part
of the tobacco product. As explained in the proposed rule, 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. We are
including this requirement in the final rule because, as discussed in
the proposed rule, treating this distinct subset of packaging as a
component or part furthers the fundamental purpose of the Tobacco
Control Act to protect the public health. Some examples include CCS
where substances in the CCS are intended or reasonably expected to
affect product moisture, or when menthol is applied to inner foil to
become incorporated into the consumed product (Ref. 1). FDA can 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 where such information is needed to
demonstrate substantial equivalence.
(Comment 17) Other comments assert that the definition of container
closure system and the preamble discussion in the proposed rule
improperly provide that a container closure system ``is'' considered a
component or part ``categorically, without regard to whether the
container closure system somehow changes the tobacco product in any
way.'' The comments contend this approach is also contrary to the
Philip Morris decision and that the plain meaning of component and part
``pertains to something that is or can be expected to become
incorporated into the tobacco product itself, meaning a piece or
portion of a larger whole tobacco product.'' The comments state that
container closure systems are not components or parts because the
package is external to the tobacco product. The comments disagree with
the examples that FDA included in the preamble to the proposed rule,
such as the soft pack for cigarettes, stating these are examples of
packaging that are outside the scope of components and parts.
(Response 17) As described in detail in the proposed rule, FDA
defines ``component or part'' as any software or assembly of materials
intended or reasonably expected: (1) To alter or affect the tobacco
product's performance, composition, constituents, or characteristics or
(2) to be used with or for the human consumption of a tobacco product.
Packaging that constitutes the container closure system is intended or
reasonably expected to affect or alter the performance, composition,
constituents, or characteristics of the tobacco product (e.g., leaching
substances that are then incorporated into a tobacco product), and is
thus a component or part of a tobacco product. Where 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.
Packaging that is not the container closure system is not intended
or reasonably expected to affect or alter the performance, composition,
constituents, or characteristics of the tobacco product and is
therefore not a component or part of a tobacco product. As such,
packaging that is, for example, the box around a blister pack, is not a
CCS if it is not intended or reasonably expected to alter or affect the
performance, composition, constituents, or characteristics of the
tobacco product within the blister pack.
For example, packaging materials constitute a container closure
system if substances within that packaging are intended or reasonably
expected to affect product moisture, e.g., when the manufacturer
changes the package of a moist snuff from plastic to fiberboard, which
can affect microbial stability and tobacco-specific nitrosamine (TSNA)
formation during storage. Another example of this is when menthol or
other ingredients are applied to the inner foil to become incorporated
into the consumed product (Ref. 1). Packaging materials may also be
intended or reasonably expected to affect the characteristics of a
tobacco product by impacting the rate of leaching into, and ultimately,
the amount of substances found in, the consumable tobacco product. In
fact, it has been demonstrated that compounds in packaging materials
may 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. 3).
Considering a distinct subset of packaging (i.e., container closure
system) to be a component or part is consistent with the FD&C Act and
furthers the fundamental purpose of the Tobacco Control Act to protect
the public health. For example, section 900(1) of the FD&C Act (21
U.S.C. 387(1)) 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. Congress
specifically included a broad definition of additive that encompasses
not just substances that do in fact have such effects but also may
reasonably be expected to. Similarly, 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. 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.
Contrary to one of the comments, the court's decision in Philip
Morris does
[[Page 55232]]
not necessitate a different interpretation than the one FDA has adopted
and described above. First, the court was presented with a challenge
relating to FDA's regulation of product labels and changes in product
quantities. It was not asked to decide on--and the Agency did not
brief--the validity of FDA's interpretation of container closure
system. Second, FDA is not seeking to incorporate into the SE
evaluation any packaging that is not intended nor reasonably expected
to affect or alter the performance, composition, constituents, or
characteristics of the product itself. As noted above, for example, the
packaging around a blister pack is not part of the SE review process if
it is not intended or reasonably expected to alter or affect the
performance, composition, constituents, or characteristics of the
tobacco product within the blister pack. The court's opinion in Philip
Morris emphasizes the importance of looking to whether the ``physical
attributes of the product itself'' have changed in determining whether
a tobacco product is new. Philip Morris, 202 F. Supp. 3d at 51. By
limiting our review to changes to the CCS, we are only looking at
packaging that is intended or reasonably expected to affect or alter
the performance composition, constituents, or characteristics of the
tobacco product--in other words, we are looking at changes that could
affect the ``physical attributes'' of the product. Such an
interpretation is consistent with the Philip Morris decision, and, as
explained above, consistent with the Tobacco Control Act's purpose and
treatment of other definitions within the FD&C Act.
(Comment 18) One comment states that a container closure system
should only qualify as a component or part of the product when it is
designed or reasonably expected to change the characteristics of the
tobacco product, and not when it is designed to maintain or preserve
the characteristics of the product. Other comments state that FDA
should not require an SE Report for a change to a CCS because a
product's packaging does not impact its characteristics.
(Response 18) If aspects of packaging of a tobacco product are
intended or reasonably expected to affect or alter the performance,
composition, constituents, or characteristics of the tobacco product,
we consider that packaging to be a CCS that is a component or part of
the product. A change to the CCS would require a premarket submission.
Packaging that is intended or reasonably expected to maintain or
preserve the characteristics of the product could be reasonably
expected to affect or alter the performance, composition, constituents,
or characteristics of the product. For example, as described in the
preceding response, packaging material that affects the characteristics
of a tobacco product, including cigars, 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) (Refs. 1-3).
(Comment 19) Some comments object to the discussion in the proposed
rule that stated that ``co-packaging two or more tobacco products
within the same container closure system results in a new tobacco
product.'' The comments assert that this ``new category of packaging''
created by the proposed rule has no basis in the FD&C Act and that it
is improper to regulate co-packaged tobacco products as part of SE
review. Accordingly, the comments request FDA to exclude co-packaged
tobacco products from the scope of new tobacco products. The comment
argues that as long as each separate product is legally marketed, co-
packaging of the products does not create a new tobacco product
requiring SE review. Other comments state that changes to the container
closure system of co-packaged products should only result in a new
product when they intend or reasonably expect to change the physical
characteristics of the product.
(Response 19) We agree that changing the packaging of co-packaged
tobacco products only results in a new tobacco product where such
packaging is intended or reasonably expected to affect or alter the
performance, composition, constituents, or characteristics of the
tobacco product. Under section 910(a)(1)(B) of the FD&C Act, new
tobacco products include those that are new because they have been
rendered new through any modification (including a change in design,
any component, any part, or any constituent, including a smoke
constituent, or in the content, delivery or form of nicotine, or any
other additive or ingredient) of a tobacco product where the modified
product was commercially marketed in the United States after February
15, 2007. Therefore, if two or more products are proposed to be co-
packaged together within a single container closure system, that
results in a new tobacco product requiring premarket authorization.
However, as explained in the proposed rule, 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.
``Grandfathered'' Tobacco Product
We proposed to include a definition of ``grandfathered tobacco
product'' as ``a tobacco product that was commercially marketed in the
United States as of February 15, 2007, and does not include a tobacco
product exclusively in test markets as of that date.'' Such a product
would not be subject to the premarket requirements of section 910 of
the FD&C Act. We received several comments on this definition, as well
as related comments on the definition of new tobacco product, and we
respond to those comments in the following paragraphs and in the
paragraphs related to ``new tobacco product.'' We are removing this
definition because the term is no longer used in the codified text. In
this preamble, we have changed the term from ``grandfathered tobacco
product'' to ``Pre-Existing tobacco product'' because it more
appropriately describes these products, by using the more precise
``Pre-Existing'' in place of ``grandfathered.'' FDA received several
comments regarding the definition of ``Pre-Existing tobacco product,''
\5\ which are discussed as follows.
---------------------------------------------------------------------------
\5\ While comments were submitted regarding the term
``grandfathered tobacco product,'' we describe them using the new
term, ``Pre-Existing tobacco product,'' throughout this document for
the sake of clarity.
---------------------------------------------------------------------------
(Comment 20) Several comments suggest that we consider alternative
dates to February 15, 2007, as the date after which premarket review
would be required for deemed tobacco products, such as the effective
date of the deeming final rule (i.e., August 8, 2016).
(Response 20) As indicated in the deeming final rule, FDA lacks the
authority to change the February 15, 2007, date for any tobacco
products, including deemed tobacco products.\6\ This date is explicitly
prescribed in the statute. Section 910(a)(1)(A) of the FD&C Act states,
in pertinent part, that the term ``new tobacco product'' means, in
part, any tobacco product (including those products in test markets)
that was not commercially marketed in the United States as of February
15, 2007. For purposes of the SE pathway, the statute also clearly
states that a predicate product must be commercially marketed (other
than for test marketing) in the United States on February 15, 2007, in
both section 910(a)(2)(A) and section 905(j)(1) of the FD&C Act.
---------------------------------------------------------------------------
\6\ Note that for the purposes of this final rule, ``deemed
tobacco products'' are those tobacco products subject to the deeming
final rule.
---------------------------------------------------------------------------
[[Page 55233]]
Harmful and Potentially Harmful Constituent (HPHC)
We proposed to define ``harmful and potentially harmful
constituent'' as any chemical or chemical compound in a tobacco product
or tobacco smoke or emission that: (1) Is or potentially is inhaled,
ingested, or absorbed into the body and (2) causes or has the potential
to cause direct or indirect harm to users or nonusers of tobacco
products. We received comment on this definition, which we respond to
in the following paragraphs. We are finalizing this definition to
clarify that HPHCs include chemicals or chemical compounds that are
potentially inhaled, ingested, or absorbed into the body ``as an
aerosol or any other emission'' as described in the preamble to the
proposed rule.
(Comment 21) At least one comment supports the proposed definition,
noting it is consistent with the criteria applied in formulating the
HPHC list and includes both substances that are or potentially could be
inhaled, ingested, or absorbed into the body (77 FR 20034, April 3,
2012).
(Response 21) We agree with the comment and note the definition is
included in the final rule, with the change as noted, which we made to
ensure consistency with other regulatory documents.
Ingredient
We proposed to define ``ingredient'' as 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. We
received a comment on this definition, which we respond to in the
following paragraph. We are finalizing this definition without change.
(Comment 22) One comment disagrees with the proposed definition of
``ingredient,'' stating that ``compounds reasonably expected to be
formed through a chemical reaction during manufacturing are not
properly identified as ingredients'' and that the proposed definition
``is imprecise'' and will ``inevitably be subject to varying
interpretations.''
(Response 22) We disagree that this definition should not include
``compounds reasonably expected to be formed through a chemical
reaction'' as information on these ingredients is needed to aid FDA in
making an SE determination. However, we note that the phrase
``compounds reasonably expected to be formed through a chemical
reaction during tobacco product manufacturing'' should be interpreted
as compounds formed through well-known chemical reactions, for example,
reactions of sugars which could lead to the formation of related
alcohols, ketones, aldehydes, and esters (Refs. 4 and 5) and reactions
of nicotine which could lead to the formation of related N-nitrosamines
(Ref. 6).
New Tobacco Product
In the proposed rule, we included the statutory definition of ``new
tobacco product,'' which is defined 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. (See section 910(a)(1) of
the FD&C Act.) The final rule continues to include this statutory
definition. In the following paragraphs, we respond to comments related
to the definition of ``new tobacco product'' generally.
In addition, FDA received many comments related to our invitation
to comment on the terms ``test marketing'' and ``commercially
marketed,'' which are terms included in the statutory definition of new
tobacco product. In subsequent paragraphs, we describe and respond to
these comments on test marketing and commercially marketed. Following
our consideration of these comments, we are adding a definition of
``commercially marketed,'' to the final rule, which states
``commercially marketed means selling or offering for sale a tobacco
product in the United States to consumers or to any person for the
eventual purchase by consumers in the United States.'' We also describe
this definition below.
(Comment 23) One comment requests that FDA clarify that, under the
definition of new tobacco product, a modification to an existing
product's label does not require an SE Report. This comment cites the
Philip Morris decision.
(Response 23) A modification to an existing product's label
standing alone does not require an SE Report.
(Comment 24) Some comments address FDA's interpretation that a
tobacco product exclusively test marketed as of February 15, 2007, is
considered a new tobacco product under section 910 of the FD&C Act.
Other comments indicate FDA's interpretation is correct, and one of
these comments also notes that a tobacco product that was test marketed
as of February 15, 2007, cannot serve as a predicate tobacco product
under section 905(j) of the FD&C Act.
(Response 24) Following our consideration of these comments, we
agree with the comment indicating that a tobacco product test marketed
in the United States as of February 15, 2007, is not a new tobacco
product. Section 910(a)(1)(A) defines a ``new tobacco product'' to
include ``any tobacco product (including those in test markets) that
was not commercially marketed in the United States as of February 15,
2007.'' The parenthetical ``including those in test markets'' in
section 910(a)(1)(A) of the FD&C Act modifies the phrase directly
before it--``any tobacco product''--and is intended to clarify that
tobacco products commercially marketed in test markets in the United
States as of February 15, 2007, should be treated the same way as any
other tobacco product that was commercially marketed as of February 15,
2007, i.e., they are not ``new tobacco products.'' We also agree with
the comment that states that under section 905(j) of the FD&C Act, a
tobacco product that was solely in a test market as of February 15,
2007, despite being a Pre-Existing tobacco product, cannot serve as a
predicate tobacco product, which is consistent with the position taken
in the proposed rule. Section 905(j)(1)(A)(i) describes products that
can serve as valid predicate tobacco products: A tobacco product
commercially marketed (other than for test marketing) in the United
States as of February 15, 2007, or a tobacco product that the Secretary
by delegation to FDA has previously determined, pursuant to subsection
(a)(3) of section 910, is substantially equivalent. Here, the
parenthetical ``other than for test marketing'' explains a product
solely sold in test markets as of February 15, 2007, cannot serve as a
valid predicate tobacco product. Therefore, a product cannot serve as a
predicate if it was exclusively sold in a test market as of February
15, 2007.
(Comment 25) Another comment disagrees with FDA's interpretation
that the phrase ``as of'' means ``on'' arguing that ``[i]f Congress has
intended that [Pre-Existing tobacco] products must have been
commercially marketed on the singular date of February 15, 2007, it
would have used the word `on' in the statute,'' but, instead,
``Congress used the phrase `as of,' which, in this context, plainly
communicates marketing on or before February 15, 2007'' (emphases
[[Page 55234]]
omitted). This comment references a dictionary definition of ``as of
now'' as meaning up to the present time and also notes that Congress
used the term ``on'' in other places in the Tobacco Control Act (e.g.,
section 904(c)(1) use of ``on June 22, 2009''). The comment argues that
``as of'' should be interpreted as ``on or before.''
(Response 25) As discussed in the proposed rule, FDA's longstanding
interpretation is that ``as of'' means that the tobacco product was
commercially marketed in the United States ``on February 15, 2007''
(see the final guidance entitled ``Establishing That a Tobacco Product
Was Commercially Marketed in the United States as of February 15,
2007'' (79 FR 58358, September 29, 2014)). Contrary to the comment, the
term ``as of'' does not have a plain meaning. The dictionary
definitions of ``as of'' include: ``on; at'' (Webster's II New
Riverside University Dictionary, 1988); ``beginning on; on and after''
(Webster's Unabridged Dictionary Random House 1997); ``from, at, or
until a given time'' (The American Heritage Dictionary of Idioms 2003);
``on, at, from--used to indicate a time or date at which something
begins or ends'' (Merriam Webster's Online Dictionary). As evidenced
from these varying definitions, the term is ambiguous. ``[A]s of''
could be interpreted either as ``at any time prior to and not
necessarily including on the particular date'' (in short referred to as
the ``on or before'' interpretation) or as ``at any time up to and
necessarily including on the particular date'' (in short referred to as
the ``on'' interpretation). Interpreting ``as of'' to mean ``on'' gives
a firm line of demarcation that provides clarity. Additionally, reading
``as of'' to mean ``on or before'' would mean that obsolete, abandoned,
or discontinued tobacco products could return to the market without any
premarket review and could serve as predicates under the substantial
equivalence provision. It is reasonable to conclude that Congress did
not intend to allow an immeasurable number of obsolete, abandoned, or
discontinued tobacco products that were marketed before February 15,
2007, to return to the market without any premarket review or serve as
predicates under the substantial equivalence provision, but rather
intended to confine this number to those tobacco products that were
commercially marketed in the United States on February 15, 2007. Thus,
we decline to change to the interpretation the comment suggests.
Test Marketing and Commercially Marketed
In the preamble to the proposed rule, we explained that FDA was
considering whether to add the following definition of test marketing:
``test marketing'' means distributing or offering for sale (which may
be shown by advertisements, etc.) a tobacco product in the United
States for the purpose of determining consumer response or other
consumer reaction to the tobacco product, with or without the user
knowing it is a test product, in which any of the following criteria
apply: (1) Offered in a limited number of regions; (2) offered for a
limited time; or (3) offered to a chosen set of the population or
specific demographic group. In addition, the proposed rule stated we
were considering whether to add a definition of commercially marketed,
such as ``offering a tobacco product for sale to consumers in all or in
parts of the United States.''
After reviewing the comments we received in response to the
invitation to comment, we have determined that further discussion of
the scope of ``test marketing'' is needed before we issue a definition
of this term; however, following our consideration of comments, we have
decided to codify a definition of ``commercially marketed.'' The
proposed rule stated we were considering whether to add a definition of
commercially marketed, such as ``offering a tobacco product for sale to
consumers in all or in parts of the United States.'' The final rule now
includes a definition of ``commercially marketed'' as selling or
offering for sale a tobacco product in the United States to consumers
or to any person for the eventual purchase by consumers in the United
States. This addition clarifies that tobacco products that are not sold
or offered for sale in order to reach consumers within the United
States, such as tobacco products sold solely for export fall outside of
the definition of commercial marketing.
We describe the comments and our responses on these terms in the
following paragraphs.
(Comment 26) Several comments provide suggestions on how to define
commercially marketed and test marketed, and some comments request that
FDA not define these at all, finding the discussion in the proposed
rule confusing. One comment suggests that FDA define ``commercially
marketed'' and ``test marketing'' as meaning the same thing. Those
comments addressing test marketing indicate that manufacturers may
distribute and market tobacco product in limited regions for a set
period of time without test marketing the products. Some comments
suggest that ``test marketing'' should not be based on time or
geographical region, but rather should be based on manufacturer intent.
One comment suggests that consumer response is an inherent part of
marketing any product, for testing purposes or otherwise.
Comments addressing the term ``commercially marketed'' as discussed
in the proposed rule, suggest that if defined, it should be defined as
``offered for sale in the United States to any individual or entity by
advertising or by any other manner used to communicate that the tobacco
product is available for purchase.'' One comment states FDA has never
required firms to demonstrate that a product was offered for sale to
consumers, and, in fact, many manufacturers do not market or sell
directly to consumers, to establish that their tobacco product is a
Pre-Existing tobacco product. Other comments suggest either that a
product sold wholly within one state would be commercially marketed or
that anything other than a nationwide product launch could constitute
test marketing.
(Response 26) Following our consideration of the responses to the
proposed rule's invitation to comment on these terms, we agree that
further discussion and experience on the term test marking is needed in
order to more accurately capture the scope of this term. As we stated
previously, we are accordingly not including a definition of test
marketing in the final rule. However, after reviewing the comments
related to commercially marketed, we have added a definition of this
term to the final rule, which reflects the input we received.
Specifically, we added a definition stating that ``commercially
marketed'' means selling or offering for sale a tobacco product in the
United States to consumers or to any person for the eventual purchase
by consumers in the United States. Examples of products that may not be
covered by the definition of commercially marketed include
investigational tobacco products and free samples. Examples of
documentation of commercial marketing may include dated bills of
lading, dated freight bills, dated waybills, dated invoices, dated
purchase orders, dated advertisements, dated catalog pages, dated
promotional material, dated trade publications, dated manufacturing
documents, inventory lists, or any other document demonstrating that
the product was commercially marketed in the United States as of
February 15, 2007.
[[Page 55235]]
Importantly, as we explain in a preceding response, we also note
that although a ``solely'' test marketed product may not be considered
``new'' under section 910 of the FD&C Act, it cannot serve as a
predicate product under section 905(j) of the FD&C Act. Test marketed
products may include, for example, products that were sold or offered
for sale to consumers to determine the commercial viability of a
product through the collection of consumer reaction data.
(Comment 27) One comment requests that any definition of a test
marketed product include an alternative pathway for the test marketed
product to come to the market without having to file an SE Report. This
comment proposes a ``less cumbersome process by which products may be
test marketed, in order that companies may develop data on shelf-life,
HPHC changes, if any, over time, changes in nicotine content, etc.''
This comment proposes allowing the filing of a report advising FDA of a
manufacturer's desire to test market a product without the manufacturer
having to submit a premarket application.
(Response 27) This comment appears to provide suggestions more
closely concerned with research or investigational tobacco products.
Such products are outside of the scope of this rulemaking. In general,
any tobacco product (including products in test markets) that was not
commercially marketed in the United States as of February 15, 2007, is
considered a ``new tobacco product'' under section 910(a)(1) of the
FD&C Act. As such, manufacturers of test marketed products that were
not commercially marketed in the United States as of February 15, 2007,
are required to first submit to FDA a PMTA under section 910 for the
new tobacco product, and FDA must issue an order authorizing the
commercial distribution of the new tobacco product; or submit an SE
Report under section 905(j) of the FD&C Act, and FDA must issue an
order finding the product substantially equivalent to a predicate
tobacco product (section 910(a)(2)(A) of the FD&C Act); or FDA must
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 any new
tobacco product, including a test marketed product, enters into
interstate commerce for commercial distribution 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.
Package or Packaging
We proposed to define ``package or packaging'' as 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. Although there
were no comments to the definition included in the proposed rule, there
were comments that discussed packaging in the context of CCS. We
address those comments in the discussion of the definition of CCS. We
are finalizing the definition of package or packaging without change.
Predicate Tobacco Product
We proposed to define ``predicate tobacco product'' as a tobacco
product that is a Pre-existing Tobacco Product or a tobacco product
that FDA has previously found substantially equivalent under section
910(a)(2)(A)(i) of the FD&C Act. We received some comments related to
this term, which we discuss in the following paragraphs (see also
comments to Sec. 1107.18(f) for related discussion). We are finalizing
this definition with changes to more closely mirror the statutory
language. Thus, the definition in the final rule states that
``predicate tobacco product'' means a tobacco product that was
commercially marketed (other than for test marketing) in the United
States as of February 15, 2007, or a tobacco product that FDA has
previously found substantially equivalent under section 910(a)(2)(A)(i)
of the FD&C Act.
(Comment 28) Some comments request that FDA expand the definition
of predicate tobacco product to allow a product for which FDA issues a
marketing order under the PMTA pathway to serve as a predicate tobacco
product. Other comments suggest that tobacco products authorized
through the SE exemption pathway could serve as valid predicates.
(Response 28) The FD&C Act establishes which tobacco products may
serve as eligible predicate tobacco products for the SE premarket
pathway. These products are limited to tobacco products that were
commercially marketed (other than for test marketing) in the United
States as of February 15, 2007, and products that were previously found
SE by FDA. (See section 905(j)(1)(A) of the FD&C Act.)
Substantial Equivalence
In the proposed rule, we proposed to include the statutory
definition of substantial equivalence, which states:
Substantially equivalent or substantial equivalence 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 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.
(See section 910(a)(3) of the FD&C Act.)
In the proposed rule, we did not propose definitions of ``same
characteristics'' and ``different characteristics'' under section
910(a)(3)(A) of the FD&C Act. Rather, the proposed rule explained that
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. The proposed rule included four examples of changes between the
new and predicate products that might be appropriate to proceed through
the ``same characteristics'' prong, either individually or in
combination, and several examples where a new product would have
``different characteristics'' because the new product was dissimilar
enough from the predicate that FDA could not determine without
scientific information whether the new tobacco product raised different
questions of public health. We noted these examples were based on our
current thinking, relying on the current state of science and the
available evidence. We noted that, if evidence arises in a particular
case that requires more information from an applicant, we would
communicate to the applicant what information is needed to demonstrate
that the new tobacco product is substantially equivalent. The proposed
rule also included several factors that FDA might consider when
determining if a new product raised different questions of public
health. We invited comments on this discussion.
FDA received a number of comments related to this discussion.
Following our consideration of these comments, we have further refined
our thinking on these terms, particularly on changes that might be
appropriate to proceed through the same characteristics prong. This
includes adding other examples to this list. We describe our thinking
on these updates in the following paragraphs.
[[Page 55236]]
The final rule continues to include the statutory definition of
substantial equivalence, and does not include codified definitions of
``same characteristics'' or ``different characteristics.'' FDA intends
to further consider the scope of these terms and will undertake further
notice and comment rulemaking before moving to further define any of
these terms by regulation.
Following are examples of changes that are likely to be appropriate
to proceed as same characteristics at this time:
[cir] A change in product quantity between the new and predicate
tobacco products;
[cir] a change in container closure system between the new and
predicate non-moist tobacco products (e.g., soft pack to hard pack of
cigarettes);
[cir] a change in container closure system between the new and
predicate non-moist tobacco products where the same material is being
used (e.g., change from one plastic container to another plastic
container, change from one metal container to another metal container)
and there is no difference in flavors being added to the container
closure systems that would change the characterizing flavor;
[cir] for moist tobacco products, a change in container closure
system between the new and predicate tobacco products from one type of
plastic to another similar type of plastic where there is no difference
in flavors being added to the container closure systems that would
change the characterizing flavor and no difference in size of the
container closure system;
[cir] a change to a lower amount of total tobacco in the new
tobacco product without any corresponding changes in other ingredients
or characteristics in the new tobacco product;
[cir] a change in tipping paper color from plain to cork where the
target specifications of the tipping paper are identical;
[cir] a change in adhesive in the non-combusted portion of a
cigarette;
[cir] the replacement of one filter tow with an alternate filter
tow with identical target specifications (e.g., vendor specifications,
measured values for denier per filament, total denier); \7\
---------------------------------------------------------------------------
\7\ Note that the addition or removal of a filter between the
new and predicate tobacco products would not likely succeed through
the same characteristics prong because the addition or deletion of a
filter could impact product performance or HPHC yields and result in
different exposures to the consumer and population.
---------------------------------------------------------------------------
[cir] the removal of a dye or ink from the non-combusted portion of
a tobacco product or removal of printed monogram ink from the barrel of
a cigarette;
[cir] a change to replace a lower grade version of an ingredient
with an equal quantity of a higher grade version of the same ingredient
(e.g., replacing nicotine with USP grade nicotine);
[cir] a change to remove a single flavor ingredient, including a
complex ingredient, in the new tobacco product compared to the
predicate or removing an ingredient in the predicate tobacco product
and replacing that ingredient with an equal quantity of water in the
new tobacco product;
[cir] for combusted tobacco products, a change in the pattern of
non-ink watermark on papers or wrappers, provided the papers or
wrappers have identical target specifications and the change does not
alter or affect the design parameters of the paper/wrapper;
[cir] for combusted tobacco products, a change from one paper or
wrapper to a similar paper or wrapper from an alternate supplier that
do not impact HPHC yields;
[cir] a change between a new and predicate tobacco product that
results in a removal of characterizing flavor (e.g., removal of menthol
from cigarettes, or removal of cherry flavor in smokeless tobacco), as
well as removal of a flavor from a component of a finished tobacco
product (e.g., removal of vanilla flavored adhesive in cigars and
replacement with a non-flavored adhesive);
[cir] a change in inert tip material (e.g., replacing a wood tip
with a plastic tip on a cigar);
[cir] a change from non-Fire Standard Compliant (FSC) paper to FSC
paper (also known as low ignition propensity paper);
[cir] a change from one FSC paper to an alternate FSC paper; and
[cir] an absolute increase or decrease in ventilation of 11 percent
or less between the new and predicate tobacco product (Ref. 7).
(Comment 29) Some comments note that the Philip Morris decision is
instructive on the meaning of the term ``same characteristics.'' One
comment discussing the district court decision in the Philip Morris
(Philip Morris, 202 F.Supp. 3d at 54) case stated that ``same
characteristics means the product has more than minor modifications to
a predicate product, but less than significant modifications''. The
comments state that the district court rejected FDA's interpretation
that same characteristics meant that the new and predicate products had
identical characteristics. Other comments note the language in the
decision stating that ``the `same characteristics' prong may encompass
similar, but not necessarily identical, products, while the `different
characteristics' prong may cover significantly different products.''
(Response 29) We agree that the district court rejected FDA's
interpretation that same characteristics meant that the new and
predicate products had identical characteristics. As explained in the
proposed rule, we view the same characteristics prong to encompass new
tobacco products that are so similar to the predicate product that FDA
would not need scientific information beyond identification of the
changes to determine whether the new product raises different questions
of public health. The examples provided in the preceding paragraphs are
intended to further illustrate the changes that might be appropriate to
proceed through the same characteristics prong.
(Comment 30) One comment states that FDA should limit any finding
that a new tobacco product has the ``same characteristics'' as a
predicate product where the characteristics are not identical and an
applicant ``demonstrate[s] that the differences, both individually and
collectively, cannot plausibly have an effect on individual health or
population-level health.'' This comment states that at a minimum the
applicant should explain all the differences in characteristics and
demonstrate that the differences cannot plausibly increase the
potential harm to an individual or to the population as a whole. Other
comments view as inappropriate FDA's statement that the same
characteristics prong would be appropriate for new tobacco products
that are ``so similar'' to the predicate that FDA would not need
scientific information to determine whether the new product raises
different questions of public health. The comments maintain that a
public health analysis should not be part of the same characteristics
analysis.
(Response 30) Under the same characteristics prong, an applicant
need not demonstrate that any modifications to the new product do not
cause the new product to raise different questions of public health.
The ``different questions of public health'' analysis arises under the
different characteristics prong. An SE review is structured as a
tobacco product to tobacco product comparison, which does not account
for population standards. We agree, and the rule requires, that the
applicant provide information on the similarities and differences in
characteristics between the new and predicate tobacco products (see,
e.g., Sec. Sec. 1107.18(d) and 1107.19). However, we disagree with the
[[Page 55237]]
comments that suggest that public health considerations generally
should not be considered as part of an SE review under either prong.
Rather, under the SE pathway, FDA protects the public health by
authorizing only new tobacco products that are substantially equivalent
to a predicate tobacco product.
(Comment 31) Some comments request additional clarity on the same
characteristics prong and suggest that the lack of distinct definitions
for ``same characteristic'' and ``different characteristic'' creates
unclear pathways for manufacturers to follow. For example, one comment
finds circular FDA's suggestion that ``the `same characteristics'
analysis might be appropriate for new tobacco products that are so
similar to the predicate product that FDA would not need scientific
information to determine different questions of public health'' while
``different characteristics' [is] 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.'' This comment notes that FDA should
determine whether two products have the ``same characteristics,'' and,
if so, find the new product substantially equivalent, and, if not, then
move to the second prong to determine ``whether the new product as a
whole raises different questions of public health relative to products
in the same category that were on the market as of February 15, 2007.''
Similarly, another comment suggests that the ``function of the
`same characteristics' prong is to determine whether any difference in
characteristics between a new product and its predicate are materially
different,'' stating that materiality is determined by whether such
differences raise questions of public health. The comment further
argues that if the differences are not material, then the products have
the same characteristics. This comment suggests that under the
different characteristics prong, a product should be substantially
equivalent if requiring authorization under the more demanding PMTA
pathway is not appropriate because the product does not raise different
questions of public health.
Other comments suggest FDA define ``same characteristics'' to mean
the products being compared have similar, but not identical, materials,
ingredients, design, composition, heating source or other features, and
the differences are not material to a public health assessment of the
new product. The comment proposes FDA might define ``different
characteristics'' to mean the products being compared have material
differences in materials, ingredients, design, composition, heating
source or other features, such that there is a potential to raise
different questions of public health.
(Response 31) The initial decision of whether to submit a change
under the same characteristics or different characteristics prong in an
SE Report rests with the applicant who is best positioned to understand
their new tobacco product, as well as how it compares with the
predicate tobacco product. However, it is possible that FDA may
determine that an SE Report submitted under the different
characteristics prong has the same characteristics, or that FDA may
determine that an SE Report submitted under the same characteristics
prong has different characteristics. Note that an applicant's failure
to properly identify the type of report will not prevent further review
of the SE Report. In addition, although we agree that characteristics
that have material differences are likely to fall under the different
characteristics prong, we do not agree that a determination as to
whether any differences are ``materially different'' is necessarily a
function of the same characteristics prong or that using that term adds
much clarity. As noted, we view the same characteristics prong to
encompass new tobacco products that are so similar to the predicate
product that FDA would not need scientific information beyond
identification of the changes to determine whether the new product
raises different questions of public health.
The range and scope of comments received on this topic illustrate
that codifying definitions that will appropriately address the spectrum
of tobacco product and changes that an SE Report might include could be
premature and result in inflexibility. Thus, as we discussed earlier in
this section, although this final rule continues to include examples of
changes that might proceed as same characteristics, we have determined
at this time not to proceed with codifying definitions of same
characteristics and different characteristics.
(Comment 32) Several comments address whether there are some
classes of changes that would not require scientific information to
determine whether the new product raises different questions of public
health. Some comments note that several examples included in the
proposed rule as examples of changes that could proceed as same
characteristics in an SE Report should be eligible for the SE Exemption
pathway. For example, some comments state that product quantity changes
should be exempt from premarket review, although one comment states FDA
should not allow a product quantity change to fall under the same
characteristics prong of SE. Other comments request that we include
additional examples of changes that might proceed as same
characteristics in an SE Report, such as changes to low ignition
propensity cigarette paper, tipping paper, and tipping paper adhesives,
or that we provide a decision-tree.
(Response 32) FDA agrees that certain changes could proceed through
either the same characteristics prong or through the SE exemptions
pathway, and we disagree with the comment that suggests that product
quantity changes are not appropriate for a ``same characteristics'' SE
Report. At this time, based on the currently available evidence
regarding consumer perception and use, changes in product quantity
between a new and predicate tobacco product do not cause new tobacco
products to raise different questions of public health. As explained
earlier in this section of the final rule, we have added examples of
changes that are likely to be able to proceed as same characteristics
in an SE Report, including a change in tipping paper color from plain
to cork where the tipping paper target specifications are identical, a
change in adhesive, the removal of a dye or ink, or replacing filter
tow with an alternate filter tow with identical target specifications.
In addition, as we note above, with more review experience we intend to
provide further information and clarification about the Agency's
thinking about what kinds of modifications could proceed through the
same characteristics prong, different characteristics prong, and/or an
exemption request under section 905(j)(3) of the FD&C Act (as
implemented at Sec. 1107.1).
(Comment 33) One comment suggests that a change submitted as a same
characteristics SE Report could contain all the general information
outlined in proposed Sec. 1107.18(c), a certification that all
characteristics are identical between the predicate and new tobacco
product except for listed changes, a side-by-side design and ingredient
comparison, a health information summary statement, and a statement of
compliance with any applicable product standards. The comment notes
that a same characteristics SE Report should not contain comparative
testing data, HPHC testing, or stability testing.
[[Page 55238]]
(Response 33) FDA expects that SE Reports submitted under the same
characteristics prong will be 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. An SE Report submitted under the same
characteristics prong must contain the applicable required information
set out in Sec. 1107.18 but would not need to include the comparison
information as set out in Sec. 1107.19. If an applicant submitting an
SE Report under the same characteristics prong is not able to show that
the new tobacco product is eligible for the same characteristics prong,
the applicant should proceed under the different characteristics prong
which requires the submission of further information, such as
comparison of HPHCs data.
(Comment 34) Several comments also state that requiring SE
submissions for product quantity changes conflicts with an FDA
memorandum that the comments suggest show that FDA has no scientific or
other basis to require SE Reports for product quantity changes (this
comment references the FDA memorandum, ``Product Quantity Changes in
Substantial Equivalence Reports (SE Reports) for Statutorily Regulated
Tobacco Products.'' December 2017, available at: https://www.fda.gov/media/124674/download).
(Response 34) We disagree that product quantity changes for tobacco
products do not require premarket review. 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. As explained in Philip
Morris v. FDA, a change in product quantity results in a new tobacco
product requiring premarket authorization. Philip Morris, 202 F.Supp.
3d at 55-56.
We also disagree that product quantity changes can proceed through
the exemption pathway under section 905(j)(3) of the FD&C Act. The FD&C
Act establishes when a modification might be exempt from substantial
equivalence, stating that FDA may exempt from the requirements of
section 905(j) relating to the demonstration that a tobacco product is
substantially equivalent within the meaning of section 910 of the FD&C
Act, tobacco products that are modified by adding or deleting a tobacco
additive, or increasing or decreasing the quantity of an existing
tobacco additive (section 905(j)(3) of the FD&C Act; see also Sec.
1107.1). The statute limits the eligible modifications to changes to
additives. Therefore, a change in product quantity is not eligible to
use the exemption premarket pathway because a change in product
quantity, even if combined with a change in additives, is not only a
change in additives.
(Comment 35) Another comment requests that FDA extend the product
quantity change ``streamlined approach'' to other modifications and
suggests as examples ingredient changes within 5 percent of the target
and the replacement of non-Generally Recognized as Safe (GRAS) to GRAS
ingredients in smokeless tobacco.
(Response 35) FDA agrees in part with this comment. We agree that
other types of modifications can be submitted as a ``streamlined'' SE
Report. FDA has received numerous successful applications where the
manufacturer described any modification(s) between the new and
predicate tobacco product, and provided a certification statement that
all other characteristics are identical. For these SE Reports, FDA
expects the applicant to provide adequate data to support that the new
tobacco product is substantially equivalent to the predicate (which,
for a different characteristics report, would include data to support
that the proposed modification between the new and predicate tobacco
product does not cause the new tobacco product to raise different
questions of public health). A change in ingredient amount within 5
percent of the target specifications of the predicate tobacco product
may be found substantially equivalent. This is a case-by-case
determination. For example, a change of 5 percent could raise different
questions of public health if there is toxicity associated with that
ingredient; therefore, scientific data would be needed to ensure that
any increase in toxicity does not cause the new tobacco product to
raise different questions of public health. Also, if there are
ingredient changes within 5 percent of the target specifications for a
large number of ingredients (e.g., 30 ingredients), the totality of all
modifications may raise different questions of public health.
As with any ingredient change between a new and predicate tobacco
product, the applicant must provide adequate information to demonstrate
the new tobacco product meets the standard for authorization through
the SE pathway.
FDA has received SE Reports that have included a change from non-
GRAS to GRAS ingredients. Any ingredient change where the ingredients
involved are (1) chemically identical; (2) have the same or nearly the
same specifications; and (3) are present in identical or lower
quantities, are not expected to raise HPHC quantities. Ingredient
changes from non-GRAS to GRAS meet this type of change and therefore
are not expected to raise HPHC quantities. In this scenario, FDA agrees
no data would be needed beyond that required to identify this change
under Sec. 1107.18(g). FDA notes that GRAS designation pertains to
foods and is not determinative with respect to the substantial
equivalence standard, although in some cases, a GRAS determination and
data underlying that determination may be appropriately bridged to
tobacco products. As indicated above, changes from one ingredient to a
higher grade of that ingredient can qualify as a same characteristics
SE Report (e.g., a change from non-USP to USP grade nicotine).
(Comment 36) Several comments generally object to FDA's approach to
the ``different'' characteristics prong stating, for example, that FDA
treats every SE Report as a different characteristics SE Report. One
comment states that FDA is requiring the same or similar information
for both prongs, and that all SE reports in essence would have to
submit under the ``different'' characteristics prong to show the new
tobacco product has the same characteristics. The comments state that
the approach in the proposed rule is in conflict with Congressional
intent.
(Response 36) We disagree with this comment. Both the proposed rule
and this final rule illustrate modifications that are likely to be able
to fall under the same characteristics prong and thus would not require
submission of the information required under Sec. 1107.19, unlike
modifications that fall under the different characteristics prong,
which do require submission of the information in Sec. 1107.19.
(Comment 37) Some comments state that the different characteristics
prong does not make reference to a predicate tobacco product at all and
suggest that the different questions of public health determination
should be without reference to a predicate and instead be determined by
a comparison to all tobacco products in the marketplace. For example,
one comment suggests that FDA ``look only to the risks to the public
that are of a different type or
[[Page 55239]]
magnitude from the risks present in the market for the particular
category of tobacco product at issue as of the baseline date of
February 15, 2007.'' Similarly, some comments state that because the
FD&C Act does not include ``predicate product'' in the ``different
characteristics'' prong, FDA must evaluate products by comparing the
attributes of the product to a broader range of other marketed products
(beyond the referenced predicate). These comments generally state that
the different questions of public health language included in the
second prong is intended to route to the PMTA process those new tobacco
products that raise different questions of public health beyond those
already recognized, i.e., to identify products that have risks distinct
in type or magnitude from the existing, known risks prevalent in the
market as of February 15, 2007, and that this should be a ``heavy
lift'' before FDA can conclude that a new product raises different
questions of public health.
(Response 37) We disagree with the comment's assertion that the
analysis of different characteristics should include consideration of
all tobacco products in the marketplace as of February 15, 2007. Both
the same characteristics and different characteristics prongs are
specific to the comparison between a new tobacco product and its
predicate. A marketplace range of products, or multiple predicates, as
suggested by the commenter, would be inconsistent with the statutory
framework Congress provided for authorization through the SE pathway.
Nowhere in section 910(a)(3)(A) or 905(j) of the FD&C Act does the
statute state--either explicitly or implicitly--that the SE comparison
should be made to the market as a whole as of February 15, 2007. On the
contrary, there are numerous references to a single predicate product
throughout the sections of the FD&C Act which discuss SE. See, e.g.,
section 905(j)(1)(A)(i) of the FD&C Act (person seeking to introduce
new tobacco product via SE pathway must provide its basis for
determination that the new tobacco product is substantially equivalent,
within the meaning of section 910, to a tobacco product commercially
marketed as of February 15, 2007); section 910(a)(2)(A) of the FD&C Act
(a PMTA order is required unless FDA has issued an order that the new
tobacco product--is substantially equivalent to a tobacco product
commercially marketed as of February 15, 2007); section 910(a)(3)(A)
(``substantial equivalence'' means, with respect to the tobacco product
being compared to the predicate tobacco product); section 910(a)(3)(C)
(a new tobacco product may not be found to be substantially equivalent
to a predicate tobacco product that has been removed from the market or
that has been determined by a judicial order to be misbranded or
adulterated). There are no references in the FD&C Act that discuss any
SE finding in connection with the marketplace or a marketplace range of
products. In addition to being inconsistent with the FD&C Act, a
comparison to all tobacco products in the ``marketplace'' would make it
difficult and impractical to compare each characteristic between the
new and predicate tobacco products. This approach also raises questions
as to what should be considered the ``marketplace,'' such as which
tobacco products should be used in determining the marketplace and
whether the understanding of marketplace shifts over time.
This is in contrast to the evaluation FDA must make to authorize a
product through the PMTA pathway. In order to receive authorization
through the PMTA pathway, FDA must find that permitting the new tobacco
product to be marketed would be ``appropriate for the protection of the
public health.'' (See section 910(c)(2) of the FD&C Act.) In making
this determination, FDA must evaluate the risks and benefits to the
population as a whole, including users and nonusers of the tobacco
product, and taking into account the increased or decreased likelihood
that existing users of tobacco products will stop using such products;
and the increased or decreased likelihood that those who do not use
tobacco products will start using such products. (See section 910(a)(4)
of the FD&C Act.) This is a much different standard and inquiry than
that which is undertaken under the different questions of public health
analysis under SE.
(Comment 38) One comment states that FDA's intent to judge
differences in characteristics individually and in the aggregate under
the different characteristics prong ``place[s] undue and unreasonable
importance on every individual change to a specific ingredient,
material, or characteristic, no matter how minor or unrelated to public
health, and without any explanation of how FDA will weigh the
differences.'' This comment argues that if true, FDA will be unlikely
to determine that any new product is substantially equivalent.
(Response 38) We disagree with the assertion that we will be unable
to determine that any new tobacco product is substantially equivalent.
FDA has issued a high number of SE orders and a large ratio of such
orders relative to not substantially equivalent (NSE) orders. As of
December 31, 2019, of the orders issued for regular SE Reports, 80
percent were for an SE finding (a total of 1,009 SE orders versus a
total of 209 NSE orders) (information on marketing orders related to
substantial equivalence for tobacco products can be found at https://www.fda.gov/tobacco-products/substantial-equivalence/marketing-orders-se). Additionally, as of December 31, 2019, FDA had closed 96% of all
regular SE Reports accepted. FDA evaluates SE Reports on a case-by-case
basis based on the content of the SE Report. Certain changes between
the new and predicate tobacco product may affect additional
characteristics or impact HPHCs in a way that would cause a new tobacco
product to raise different questions of public health. For example,
certain changes in design parameters can lead to an increase HPHCs. We
also want to note, in response to the concern that FDA's approach
places ``unreasonable importance on every individual change'', ``no
matter how minor'' the change, that for changes that are minor
modification to tobacco additives, the exemption from substantial
equivalence pathway is available. SE Reports that include changes that
FDA believes limited or no information is needed may be eligible to
proceed as a ``same characteristics'' SE Report, as explained in the
examples above, or via a streamlined SE Report containing limited
information sufficient to demonstrate the changes subject of that SE
Report do not cause the new tobacco product to raise different
questions of public health.
(Comment 39) At least one comment states that the considerations
included in the proposed rule related to different characteristics and
different questions of public health exceed the physical
characteristics of the product itself (e.g., that FDA is requiring that
applicants examine the potential to increase initiation, increase abuse
liability, or decrease cessation). The comment further argues that, if
FDA is requiring applicants to address whether every change has the
potential to affect any of these outcomes, it is requiring
manufacturers to meet a subjective, unmeasurable standard contrary to
law, i.e., FDA appears to want manufacturers to prove a negative.
(Response 39) We disagree that these considerations do not relate
to the physical characteristics of a tobacco product. Rather, a
modification to a tobacco product may cause the new tobacco product to
have different characteristics from the predicate
[[Page 55240]]
tobacco product. When a new product has different characteristics, FDA
evaluates whether the totality of difference(s) in characteristics do
not cause the new product to raise different question of public health.
Congress stated that the Tobacco Control Act's ``purposes'' include
ensuring that the FDA has the authority to address issues of particular
concern to public health officials, especially the use of tobacco by
young people and dependence on tobacco and promoting cessation to
reduce disease risk and the social-costs associated with tobacco-
related diseases (Tobacco Control Act sections 3(2) and (9)). In
addition, as explained above, Congress defined substantial equivalence
to mean that the information submitted contains information, including
clinical data if deemed necessary by the Secretary, that demonstrates
that it is not appropriate to regulate the product under this section
because the product does not raise different questions of public
health. (See section 910(a)(3)(A)(ii) of the FD&C Act.) The reference
to ``this section'' is a reference to the PMTA pathway. Because one of
the bases for FDA finding that a product is appropriate for the
protection of public health (i.e., the PMTA ``standard'') includes the
increased or decreased likelihood that existing users will stop using
and new users will initiate use of such products, it is reasonable to
examine those same considerations under the SE standard to determine
whether the differences between the predicate and the new product show
that the product should be reviewed under the PMTA pathway. Thus, as
part of making the ``different questions of public health''
determination, FDA typically considers whether the new product has
potentially higher HPHC yields, toxicity, initiation, abuse liability,
or dependence relative to the predicate product.
(Comment 40) Some comments disagree with the proposed rule's
discussion of the phrase ``different questions of public health''
(DQPH) and state that FDA's thinking is incorrect. Other comments note
that the six identified factors included in the proposed rule for
determining if a new tobacco product raises different questions of
public health seem optional, non-exhaustive, and vague.
(Response 40) We agree that additional information may assist
applicants in understanding DQPH. Thus, in the following paragraphs FDA
is providing further information on our thinking related to this
phrase. Specifically, in evaluating whether an applicant has
demonstrated that a difference in characteristic does not cause the new
product to raise different questions of public health, FDA may
consider, among other public health considerations, whether:
[cir] The new tobacco product has higher HPHC yields compared to
the predicate tobacco product, and the difference in HPHC yields is
greater than the analytical variability of the method used to detect
it.\8\
---------------------------------------------------------------------------
\8\ In determining whether an applicant has demonstrated that
any differences in characteristics do not cause the new product to
raise different questions of public health, FDA will consider
whether increases in certain HPHCs are offset by decreases of other
HPHCs.
---------------------------------------------------------------------------
[cir] The new tobacco product has potentially higher toxicity due
to an appreciable increase in an ingredient associated with adverse
health effects, compared to the predicate tobacco product. For example,
the evaluation of the available toxicology information may show that an
increase in an ingredient between the new and predicate tobacco
products demonstrates an increase in cancer risk or non-cancer hazard
for users of the new tobacco product compared to those of the predicate
tobacco product, and thus causes the new tobacco product to raise
different questions of public health.
[cir] The new tobacco product compared to the predicate has the
potential to affect use behavior such as an increase in initiation of
the product, especially among youth or other vulnerable populations; a
decrease in cessation; or use by different tobacco-use status groups.
[cir] The new tobacco product compared to the predicate has
potentially higher abuse liability.
[cir] The new tobacco product has the potential to increase
dependence.
Based on these considerations, as well as other public health
considerations, FDA will determine whether the applicant has
demonstrated that any differences do not cause the new tobacco product
to raise different questions of public health.
(Comment 41) Other comments request that FDA include a definition
of the phrase ``different questions of public health'' in the final
regulation. The comments assert that industry needs this information to
determine the appropriate pathway for its SE submission. Some comments
propose definitions of the phrase; for example, one comment proposes to
define the phase ``different questions of public health'' to mean when
``the new product as a whole raises questions of public health that are
significantly different in type and magnitude from those presented by
[Pre-Existing tobacco products] or other legally marketed tobacco
products.'' The comments contend that the analysis should look at
``different questions of public health'' as a whole rather than the
implications of the particular product as compared to another product.
One comment suggests that an applicant could satisfy the public health
analysis by providing HPHC data for both the new and predicate
products, and if none of the HPHCs for the new product are
statistically higher than the predicate product, then the new product
should pass the public health analysis. The comment suggests that
applicants could submit a quantitative risk assessment (QRA) (defined
by the comment as a magnitude of individual disease risk tool), and if
the new product is of no greater risk than the predicate product then
the new product should pass the public health analysis. This comment
also suggests that FDA should establish a QRA framework and ``identify
the number of product runs or batches necessary to generate HPHC
data,'' as well as publish this data so that manufacturers can generate
QRA category curves.
(Response 41) We agree that changes in characteristics could cause
the new tobacco product to raise ``different questions of public
health'' where ``the new product as a whole raises questions of public
health that are significantly different in type and magnitude from
those presented by [Pre-Existing] or other legally marketed tobacco
products.'' However, instead of adopting a definition, we include
additional details in the preceding paragraphs on what we may consider
when determining if a new tobacco product raises different questions of
public health. The public health analysis of an SE Report involves the
evaluation of all toxicologically relevant changes, including HPHCs,
but also non-tobacco ingredient changes that may cause the new tobacco
product to raise different questions of public health. At this time, we
are not recommending the inclusion of QRA with SE Reports, as they are
not needed for the comparison of HPHCs from the new and corresponding
predicate tobacco products. If an applicant has scientific evidence
that a QRA would be supportive in evaluating the overall toxicological
comparison between a new and predicate tobacco product, we strongly
encourage the applicant to contact FDA and to justify the methodology
and applicability of a potential QRA before an applicant voluntarily
develops or submits a risk assessment, as the assessment may not
[[Page 55241]]
be needed or appropriate to support the SE Report.
(Comment 42) Another comment asserts that a definition of different
questions of public health should include information that indicates a
product with a low usage rate will not impact public health.
(Response 42) We disagree with the assertion that new tobacco
products with low usage rates would necessarily not impact public
health. Under section 905(j)(1)(A)(i) of the FD&C Act, the basis for
determining substantial equivalence is through the comparison of the
new tobacco product to the predicate tobacco product. Therefore,
providing prevalence of use (even if it indicates low usage) of the new
tobacco product without comparison to prevalence of use to a predicate
tobacco product is insufficient to determine if the new tobacco product
raises different questions of public health. In addition, differences
in the composition of users of the new and predicate tobacco products
may still raise DQPH even with low overall prevalence of use.
Furthermore, FDA's assessment of the product's impact on public health
goes beyond usage rate. For example, a new tobacco product that has a
low usage rate, but is found to be more toxic than the predicate
tobacco product (e.g., a tobacco product with higher HPHCs than the
predicate tobacco product) could raise different questions of public
health and be found not substantially equivalent. Moreover, prevalence
can change over time, and it can be difficult to predict the prevalence
of a new product before it is marketed.
Tobacco Product
We proposed to include the statutory definition of tobacco product
(section 201(rr) of the FD&C Act (21 U.S.C. 321(rr))). In the FD&C Act,
tobacco product is defined as 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 FD&C Act is a drug (section 201(g)(1)), a device
(section 201(h)), or a combination product (section 503(g) (21 U.S.C.
353(g))). We discuss the comment related to this definition in the
following paragraphs, and we are including this definition in the final
rule without change.
(Comment 43) At least one comment disagrees with FDA's
interpretation of tobacco product (i.e., as encompassing the whole
product and not limited to a single unit or portion) and argues that
FDA's interpretation is too broad, misinterprets the FD&C Act, and is
unnecessary.
(Response 43) We disagree with these objections related to the
language included in the proposed rule's discussion of new tobacco
product and tobacco product. Rather, as noted in the proposed rule, and
supported by the Philip Morris decision, for purposes of determining
whether a tobacco product is new under section 910 of the FD&C Act, and
therefore requires premarket authorization prior to marketing, a
``tobacco product'' encompasses the whole product (e.g., a pack of
cigarettes or a tin of loose tobacco), and is not limited to a single
unit or portion of the whole product (e.g., a single cigarette or a
single snus pouch). (See Philip Morris, 202 F. Supp. 3d at 55-57.) If
an SE Report includes information on only a portion of a new tobacco
product, FDA would have an incomplete understanding of the tobacco
product (e.g., FDA may not get information on the container closure
system, which could impact the consumable product) and would not be
able to determine, for example, potential impacts on initiation and
cessation of tobacco use (information which may be needed for
determining whether there are DQPH).
Tobacco Product Manufacturer
We proposed to include the statutory definition of tobacco product
manufacturer in the rule (section 900(20) of the FD&C Act). The statute
defines tobacco product manufacturer as 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. In the
following paragraphs, we discuss the comments related to this
definition. We are including this definition without change in the
final rule.
(Comment 44) One comment requests that FDA clarify that ``an entity
that contracts with another domestic entity to manufacture a tobacco
product'' is included in this definition.
(Response 44) The rule includes the definition of tobacco product
manufacturer from the FD&C Act, stating that ``tobacco product
manufacturer'' includes any repacker or relabeler and any person who
manufactures, fabricates, assembles, processes, or labels a tobacco
product; or imports a finished tobacco product for sale or distribution
in the United States (this term and definition are included in the
final rule). Under this definition, contract entities engaged in the
activities described in the definition of a tobacco product
manufacturer would fall within the scope of the definition of tobacco
product manufacturer.
D. Comments on Subpart C--Substantial Equivalence Reports and FDA
Responses
1. Submission of an SE Report (Sec. 1107.16)
Proposed Sec. 1107.16 would establish when an applicant should
submit an SE Report. We received no comments on this proposed section,
and we are finalizing this section without change.
2. Content and Format of an SE Report (Sec. 1107.18)
Proposed Sec. 1107.18 set out the required content and format of
SE Reports. This proposed section included requirements related to: (a)
Overview; (b) format; (c) general information; (d) summary; (e) new
tobacco product description; (f) description of predicate tobacco
product; (g) comparison information; (h) comparative testing
information; (i) statement of compliance with applicable tobacco
product standards; (j) health information summary or statement
regarding availability of such information; (k) compliance with part 25
(21 CFR part 25); and (l) certification statement. Proposed Sec.
1107.18(b) and (c) also included requirements for the use of Form FDA
3964 (Tobacco Amendment and General Correspondence Report) and Form FDA
3965 (Tobacco Substantial Equivalence Report Submission) (Refs. 8 and
9).
After considering the comments, we are revising Sec. 1107.18 in
several places for consistency with other changes to the rule and to
add clarity. Specifically, in Sec. 1107.18(a), we have revised
language that previously referred to ``grandfathered'' to reflect the
statutory language related to what types of tobacco product can serve
as predicate tobacco products. We also added in paragraph (a) a cross-
reference to Sec. 1105.10 to clarify that FDA generally intends to
refuse to accept an SE Report for review if it does not comply with
both Sec. Sec. 1105.10 and 1107.18 to help ensure applicants are aware
that the requirements of both sections must be satisfied. As we explain
further below, we have made modifications to Sec. 1107.18(g) and (h)
to clarify what information is needed for acceptance for further
review.
We are also revising Sec. 1107.18(c)(4) to add ``voluntary'' as a
modifier to ``request'' to further emphasize that
[[Page 55242]]
seeking an FDA determination relating to a potential predicate tobacco
product is a voluntary process. We revised Sec. 1107.18(c)(5) and (6)
to add ``including email address'' as information the SE Report must
include to help ensure we have complete contact information.
We revised Sec. 1107.18(c)(7)(iii) (product category, product
subcategory, and product properties table) to help ensure that we are
able to identify and evaluate each product more accurately and
efficiently for purposes of SE review. Under this revised taxonomy,
some tobacco products may fit under more than one category. For
example, the cigarette product category no longer lists noncombusted
cigarettes as a subcategory. Instead, for purposes of SE review, a
``heated tobacco product'' category has been added to the
identification tables. This SE review category should be used for
(among others) tobacco products that meet the definition of a cigarette
but are not combusted (products that do not exceed 350[deg]C). Heated
tobacco products (HTP) can be used with e-liquids, other types of
tobacco filler, or consumable (e.g., wax, oils). If, however, a tobacco
product can be used only with e-liquids, it should be captured under
ENDS and not the HTP category. To ensure we have all the information we
need to efficiently and effectively review your application, if the
product that is the subject of your application is a heated tobacco
product and is not an ENDS product, you should submit information under
Sec. Sec. 1107.18(c)(7)(iii) and 1107.19(a)(21) under the heated
tobacco product category.\9\ FDA believes these product categorizations
will help ensure that applications include the most relevant
information for their product, which in turn will speed up FDA's review
and ability to reach an authorization decision.
---------------------------------------------------------------------------
\9\ The categorization of HTPs as a separate category from
cigarettes in this rule, as demonstrated in Sec. Sec.
1107.18(c)(7)(iii) and 1107.19(a)(21), does not extend to other
legal requirements beyond those associated with the SE review
process.
---------------------------------------------------------------------------
Other changes to Sec. 1107.18(c)(7)(iii) include FDA's
clarification under the ``cigar'' category to designate ``leaf-
wrapped'' cigars as unfiltered to more accurately describe the product
category, as ``leaf-wrapped'' cigars typically do not include filters;
and under the ``waterpipe'' category, waterpipe ``diameter'' has been
added to distinguish between waterpipes of different sizes (width/
diameter and height) where all other uniquely identifying information
is the same; under the ``pipe tobacco filler'' category, ``tobacco cut
style'' has been added to distinguish between different cut pipe
tobacco filler e.g., standard cut, such as shag cut, bugler cut, loose
cut, etc., or a pressed cut, such as flake, cube cut, roll cake, etc.
or a mixture. Additionally, FDA has removed the requirement to provide
tobacco cut size from the unique identification requirements for
smokeless tobacco and cigar tobacco filler. A specific numerical value
for this field is not necessary to uniquely identify the specific
product to which the SE Report pertains, as it can be described further
through identification of additional properties (e.g., fine cut, long
cut). However, for the purposes of determining whether characteristics
related to tobacco cut size cause the new tobacco product to raise
different questions of public health, information to determine tobacco
cut size is required under Sec. 1107.19 for the product categories
specified in that section.
Across all product categories, the subcategory of ``co-package''
has been removed from Sec. 1107.18(c)(7)(iii). If an applicant submits
an SE Report for a co-packaged tobacco product, the unique
identification of this co-packaged product would include the specific
items needed to identify each product within the co-package. For
example, if the co-package is a pouch of roll-your-own (RYO) tobacco
filler that contains rolling papers inside the pouch, the applicant
would identify the tobacco product as a co-packaged product and provide
the unique identification for both RYO tobacco filler and rolling
papers.
In Sec. 1107.18(d)(2), we have added ``any differences in
characteristics do not cause the new tobacco product to'' instead of
``does not'' to clarify that this part of the sentence refers to
differences in characteristics.
In Sec. 1107.18(e), we are deleting ``including the fermentation
process, where applicable, with information on the type and quantity of
the microbial inoculum and/or fermentation solutions'' as the SE Report
does not need to include this as part of a concise overview of the
process used to manufacture the new tobacco product. The information
that would have been submitted under this proposed requirement would
also be duplicative of the fermentation information that will be
submitted as part of the SE Report under Sec. 1107.19.
In Sec. 1107.18(f), for the reasons explained earlier in this
preamble, we have removed references to ``grandfathered'' and instead
use language that reflects the statutory definition of predicate
tobacco product. We are also deleting from Sec. 1107.18 proposed
paragraph (f)(2)(i), which would have required the predicate tobacco
product to be in the same product category and subcategory as the new
tobacco product and making corresponding renumbering edits to this
subsection. As we discuss in later paragraphs, we are removing this
requirement because although it will likely be difficult for an
applicant to demonstrate substantial equivalence in this situation
(where the new product is in a different category or subcategory as its
selected predicate), it may, in rare cases, be possible for an
applicant to make a showing of substantial equivalence. In Sec.
1107.18(f)(2)(iii) (formerly (f)(2)(iv)), we have changed ``rescission
order'' to ``rescission action,'' which is a more accurate description.
In Sec. 1107.18(g), we have made some minor clarifying edits, and
in Sec. 1107.18(h) we have added ``that has been demonstrated to be
fully validated'' following comparative testing, which is needed to
ensure the method is fit for purpose and the measured values can be
accurately compared between a new and predicate tobacco product. FDA
considers full validation of a quantitative analytical procedure to
include: (1) Accuracy; precision (repeatability, intermediate
precision, and robustness); (2) selectivity; (3) sensitivity (limit of
detection and limit of quantification); (4) linearity; and (5) range.
The performance criteria typically include information such as the
target analyte, an approximation of the range of concentrations of the
analyte in the sample, the intended purpose of the procedure (e.g.,
qualitative, quantitative, major component, minor component, etc.), and
the number of samples to be analyzed.
We have also corrected minor typographical errors in proposed Sec.
1107.18(g) and (k)(2). We have also removed the phrase ``as described
in Sec. 1107.19'' from Sec. 1107.18(g) and (h) to better reflect that
FDA's determination of acceptability for review is not intended to be
an exhaustive review of the SE Report but rather is intended to serve
as a check that the SE Report generally includes required information
before FDA accepts an SE Report and proceeds to substantive review. For
the same reason, we also moved the detailed requirements related to
comparative testing from proposed Sec. 1107.18(h) to Sec. 1107.19.
Both ``same characteristics'' and ``different characteristics'' SE
Reports must provide the information required by Sec. 1107.18(g). As
explained in Sec. 1107.18(g), if the new tobacco product
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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 any characteristic(s) that have
changed, but may certify that the other characteristics are identical
under Sec. 1107.18(l)(2).
Where the new tobacco product has the same characteristics as the
predicate tobacco products, applicants need only explain that their SE
Report is a ``same characteristics'' report to satisfy the requirement
of Sec. 1107.18(h). Furthermore, as explained in Sec. 1107.18(h), an
applicant need not provide comparative testing information for any
characteristics that are identical between the new tobacco product and
the predicate tobacco product, and for which the applicant has
certified that the characteristics are identical under Sec.
1107.18(l)(2).
The following paragraphs describe the comments we received on
proposed Sec. 1107.18 and our responses to those comments.
Forms (Sec. 1107.18(b)-(c))
Proposed Sec. 1107.18(b) and (c) included requirements that the
applicant use the forms that FDA provides when submitting an SE Report.
Following our consideration of the comments related to the forms, we
are finalizing these requirements without change. We describe the
comments to these subsections and our responses next.
(Comment 45) At least one comment states that use of the FDA forms
should be optional rather than mandatory.
(Response 45) We disagree. As explained in the proposed rule, the
requirements in this rule, including use of these forms, are intended
to provide clarity to applicants with respect to what they must submit
in an SE Report and to 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 (other than for test marketing) in the United States as of
February 15, 2007. Additionally, use of a standardized form allows FDA
to receive information in a way that allows for faster processing and
uploading of the SE Report and its contents, thereby increasing
efficiency of the review process.
(Comment 46) One comment believes FDA has underestimated the time
needed to complete the forms and did not explain how it arrived at
these estimates.
(Response 46) FDA conducted a thorough analysis of the current
paperwork burden associated with the SE program and other similar
forms. After a further review of similar forms, we have adjusted Form
3965 to 45 minutes per response and Form 3964 to 10 minutes per
response. Using our knowledge of elements in an SE report FDA believe
we have applied the most accurate burden to the forms. Beyond entering
data into the form, we conclude that the burden for searching existing
data sources and gathering and maintaining the data needed, is
accounted for in the burden charts. FDA notes that the commenter did
not provide a recommendation for alternative estimates (see also
section IX of this final rule).
(Comment 47) Another comment notes that although FDA appears to
recognize that the evidence required in an SE Report depends on whether
the new tobacco product has the ``same'' characteristics as the
predicate product or if the new tobacco product has ``different''
characteristics than the predicate product, this distinction is not
reflected in either the draft of Form FDA 3965 or the rule itself.
(Response 47) The form has been revised to include a section where
the applicant would distinguish whether they are submitting a ``same
characteristics'' SE Report, or a ``different characteristics'' SE
Report. A ``same characteristics'' SE Report must describe the
modification(s) and include all of the other information required in
Sec. 1107.18. As described in previous paragraphs, however, an SE
Report submitted under the same characteristics prong would not be
required to provide the information described in Sec. 1107.19.
General Information (Sec. 1107.18(c))
Proposed Sec. 1107.18(c) listed the information that the SE Report
would be required to include. This information included general
administrative information specifying the type of submission (e.g., SE
Report or amendment to a report); unique identification of both the new
and the predicate tobacco products, as well as contact information.
Following our consideration of comments, we are finalizing Sec.
1107.18(c) with changes to reflect updates to Sec. 1107.18(c)(7)(iii)
(related to product category, product subcategory, and product
properties).
(Comment 48) Several comments request clarity regarding the
proposed requirement that an SE Report include information about the
product's characterizing flavor. Specifically, the comments request FDA
to clarify the requirement or include a definition of the term, or seek
to understand if the purpose of the requirement is simply to see how
the applicant identifies the product (e.g., ``no characterizing
flavor'' or a ``particular flavor''). Some comments note that the only
information available is in an FDA memorandum, and they disagree with
how the memorandum explains that characterizing flavor should be
indicated by factors including chemical composition or olfactory
response (the comment cites an FDA document, entitled, ``Unique
Identification of Tobacco Products,'' November 2016, which is available
at: https://www.fda.gov/media/124658/download). Other comments request
that FDA consider only the toxicological effects rather than the effect
on user behavior, when considering the differences in characterizing
flavor between the new and predicate tobacco products.
(Response 48) This final rule does not define characterizing
flavor. As part of uniquely identifying a new and predicate tobacco
product, the SE Report must include product property information on
whether the products have a characterizing flavor or not. The SE Report
may state, for example, that a new cigarette has ``none'' for the
product property of characterizing flavor. In addition, this
information is needed as part of fully characterizing a new tobacco
product to aid FDA during the review process and in making an SE
determination. When considering the differences in characterizing
flavor between the new and predicate tobacco products, FDA considers
both the toxicological effects and the effects on user behavior.
(Comment 49) At least one comment indicates general disagreement
that a change in characterizing flavor should require submission of an
SE Report. The comment states that, if a new product includes a
different flavoring from the predicate, FDA should not require that an
SE Report be submitted for that new or different flavor but that, if an
SE Report is required, the product should not ``fail'' SE review
``unless the addition of flavor alters the chemistry of the product
such that it increases the inherent risks of tobacco-related diseases
in an individual user either through the introduction of new or greater
HPHCs.'' A comment also states FDA has not explained why a change in
characterizing flavor would require submission of an SE Report for a
product with different characteristics.
(Response 49) We disagree that an SE Report should not be required
for a change in characterizing flavor. Section 910(a)(1) of the FD&C
Act establishes that any modification results in a new tobacco product.
A change to or
[[Page 55244]]
addition or deletion of ingredients that make up a characterizing
flavor renders a tobacco product ``new.'' For FDA to make an SE
finding, the SE Report must demonstrate that the new tobacco product is
substantially equivalent to the predicate tobacco product. As we
explain in previous paragraphs related to the definition of substantial
equivalence, at this time, an SE Report for the removal of a
characterizing flavor is likely to be able to come in as a same
characteristic SE Report as FDA has found such a change does not
require scientific data to show that the change does not cause the new
tobacco product to raise different questions of public health.
New Tobacco Product Description (Sec. 1107.18(e))
(Comment 50) Several comments object to requiring any manufacturing
information, such as the ``concise overview of the process used to
manufacture the tobacco product'' as provided in this subsection as
unnecessary in an SE review. These comments note that FDA should
address manufacturing procedures through manufacturing practice
regulations issued under section 906(e) of the FD&C Act (21 U.S.C.
387f). Another comment disagrees with these comments, stating that
information on manufacturing practices is important to ensure that
products are consistently produced.
(Response 50) We agree with the comment suggesting that information
on manufacturing practices can be relevant to an SE determination.
Note, however, that a concise overview of the process used to
manufacture the new tobacco product is only needed where the
manufacturing process for the new tobacco product could affect the
characteristics of the new tobacco product beyond what is described
elsewhere in the SE Report. 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 Sec. 1107.18(e)(3).
As explained in the proposed rule, 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 tobacco product and the
predicate tobacco product. FDA has found during reviews of SE Reports
that changes in manufacturing may impact the characteristics of the
tobacco product, e.g., the quantities of nicotine (total and free), as
well as HPHCs such as TSNAs. Such changes could cause the new product
to raise different questions of public health, e.g., an increase in
TSNAs may increase the risk for certain types of cancer (Ref. 10).
We disagree with the comments that suggest this information would
be more appropriately required through manufacturing practices
regulations issued under section 906 of the FD&C Act. Section 906
authorizes FDA to issue regulations requiring that the methods used in,
and the facilities and controls used for, the manufacture,
preproduction design validation (including a process to assess the
performance of a tobacco product), packing, and storage of a tobacco
product conform to current good manufacturing practice. Such
regulations could include comprehensive requirements on purchasing
controls, production and process controls, and requirements related to
acceptance activities and nonconforming products (see, e.g., 21 CFR
part 820). In comparison, Sec. 1107.18(e)(3) requires only a ``concise
overview'' of the process used to manufacture the new tobacco product''
to aid FDA in understanding in how the manufacturing process might
affect the characteristics (or, if the manufacturing process does not
affect the characteristics of the new tobacco product beyond what is
described elsewhere in an SE Report, an applicant may simply state
that). The requirement for a concise overview is vastly different from
the manufacturing information that may be required under a tobacco
products manufacturing practices regulation under section 906 of the
FD&C Act. Moreover, the purpose of the requirement in Sec.
1107.18(e)(3) is not for the purposes described in section 906 of the
FD&C Act but, rather, is to help ensure enough information to enable
FDA to fully understand and compare the characteristics that can be
affected by the manufacturing process of the new tobacco product and
the predicate tobacco product.
Description of the Predicate Product (Sec. 1107.18(f))
As described in an earlier paragraph in this section, we have made
changes to this subsection for consistency with changes that we made to
the definition of predicate tobacco product and other clarifying edits.
We also removed the requirement that a tobacco product to which a new
tobacco product is compared be in the same category and subcategory of
product as the new tobacco product. In the following paragraphs, we
describe the comments we received on this subsection and our responses.
(Comment 51) Some comments object to the proposed requirement that
the new and predicate products be in the same category and subcategory.
The comments state, ``there is nothing in the statute to prohibit the
attempted use of cross-category comparisons in an SE submission'' and
also refer to the deeming final rule as suggesting such a comparison is
appropriate. The comments state that while cross-category comparisons
may be more burdensome or require more information, the comparison may
be appropriate and, therefore, applicants should be permitted to
attempt it.
(Response 51) After careful review of the comments submitted and
our own experience, we agree and are no longer requiring that the new
and predicate products be in the same category and subcategory. We note
that it would likely be difficult for an applicant to demonstrate
substantial equivalence where the new product is in a different
category or subcategory as its selected predicate, but it may, in rare
cases, be possible for an applicant to make a showing of substantial
equivalence. For example, an applicant may be able to compare a new
snus tobacco product to a pouched moist snuff predicate tobacco
product.
It continues to be critical, however, that an applicant select an
appropriate predicate tobacco product and provide the scientific
evidence demonstrating the new tobacco product is substantially
equivalent to that predicate. Even where there are differences in the
category or subcategory between the new and predicate tobacco products,
FDA could issue an SE order if the applicant provides scientific
evidence that demonstrates to FDA that differences between the new
product and the predicate product do not cause the new tobacco product
to raise different questions of public health. Comparison of a new and
predicate tobacco product is much easier, and more likely to result in
a finding of SE, if the new and predicate tobacco products are of the
same category and subcategory, as the basic characteristics of the
predicate and new products are likely to be more similar. For example,
manufacturers of ENDS may find it difficult to show that their product
is substantially equivalent to a combusted cigarette or a smokeless
tobacco product because of the differences in product properties.
If an applicant chooses to compare a new and predicate tobacco
product that are not in the same category or subcategory, for FDA to be
able to conduct a review of the SE Report, the
[[Page 55245]]
applicant should provide a strong scientific justification for why a
product that may differ from the new tobacco product in even the most
basic of characteristics and parameters is an appropriate predicate and
how any differences in characteristics do not cause the new tobacco
product to raise different questions of public health. For example,
where the new and predicate tobacco products are not in the same
category or subcategory, an applicant could provide information to
demonstrate that users or likely users of the new product display very
similar tobacco product use behaviors (e.g., likelihood of initiation,
experimentation, switching, dual-use/polyuse, or cessation, as well as
actual use patterns, frequency and amount of use) in addition to
information on comparison of HPHCs exposure.
(Comment 52) One comment agrees with the proposed requirement of
Sec. 1107.18(f) that an applicant include a single predicate product
for comparison and that a composite predicate tobacco product would be
inconsistent with the FD&C Act. Other comments disagree with FDA's
proposal to require manufacturers to identify a single predicate
product to compare to the new product. Several of these comments
contend that manufacturers should be able to use multiple predicates in
a single SE report, stating that permitting the use of multiple
predicates would be more consistent with statutory design and also
align with the substantial equivalence requirements for devices in
sections 510(k) and 513(g) of the FD&C Act. The comments state that we
have been inconsistent in our position regarding the use of predicate
products and contend that the one predicate approach described in the
proposed regulation would create problems for manufacturers because it
does not allow for product innovation. In support of this, some
comments refer to FDA webinars that suggest that use of two predicates
would be appropriate, an FDA decision to permit two predicates to be
used for a smokeless product, and an FDA policy memorandum that
acknowledges ``multiple predicate tobacco products are identified in an
SE Report'' (this comment referenced the FDA memorandum FDA, ``Use of
Surrogate Tobacco Products in SE Reports,'' September 2016. Available
at: https://www.fda.gov/media/124665/download). Some comments ask that,
if the final rule maintains the single predicate approach, applicants
be permitted to amend currently pending SE Reports to designate the
most appropriate predicate product.
(Response 52) We disagree that the final rule should permit the use
of multiple predicate tobacco products in an SE Report. There is
nothing in the statutory language to support the assertion that the SE
comparison can be made to a range of predicate products, and doing so
would be inconsistent with the premise of SE review. Creating a new
tobacco product from a range of predicate tobacco products can raise
different questions of public health beyond those questions raised by
the individual predicates because of the way the various additives and
other features of a tobacco product interact to impact how chemicals
are handled by the body. Some of the ways chemicals can interact is to
alter how they are absorbed into the body, metabolized by the body, or
how they bind to receptors in the body.
For example, acetaldehyde when present at a level that is below its
independent reinforcing effect could boost the reinforcing effect of
nicotine, the primary addictive substance in tobacco, beyond what it
would be without acetaldehyde present or the sum of the two independent
effects (Refs. 11 and 12). If a component from one predicate that
contains nicotine is mixed with a component from another predicate that
contains acetaldehyde, the synergistic effect of this mixture could
raise different questions of public health beyond the separate
predicates, because the addictiveness of the product could be greater
than either independently or the sum of the two predicate products
alone and may reduce cessation and increase initiation, thereby
impacting public health.
Finally, the comments also cite instances where it appears that FDA
has suggested or permitted reference to two predicate tobacco products.
However, in the past, if an SE Report referenced multiple predicate
tobacco products, we generally have either broken this down into
multiple reports or have used a single predicate tobacco product for
comparison. This approach can result in delays in processing or
reviewing an SE Report, which the final rule seeks to prevent by
requiring use of single predicate tobacco product. With respect to the
comment that requests that FDA permit this for pending SE Reports, as
explained in previous paragraphs, this rule does not apply to pending
submissions.
(Comment 53) Some comments suggest that requiring that predicate
tobacco products be ``fully characterized'' would be too restrictive
and have an anticompetitive impact. These comments state that the level
of detail required to fully characterize a predicate tobacco product
would necessarily limit each manufacturer to using its own products as
predicates and would become too difficult with the passage of time. The
comments also suggest there is no public health purpose to requiring
these data on predicates.
(Response 53) We disagree. Demonstrating substantial equivalence
necessitates a comparison of physical characteristics between a new and
predicate tobacco product. In the absence of predicate product
characteristics, FDA is unable to conduct scientific review and fulfill
its statutory obligation. If an applicant does not have access to a
predicate product or wishes to use a predicate product they do not own,
one option is the use of a Tobacco Product Master File (TPMF) (see,
e.g., the guidance entitled ``Tobacco Product Master Files, which can
be accessed at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tobacco-product-master-files). A TPMF is a file that
is voluntarily submitted to the Center for Tobacco Products (CTP) that
contains trade secret and/or confidential commercial information about
a tobacco product or component that the owner does not want to share
with other persons. TPMFs are a beneficial tool for manufacturers,
component suppliers, and ingredient suppliers, and can assist the
tobacco product submission process. Also, as discussed in the following
paragraph, if an applicant no longer manufacturers a predicate product,
it can be remanufactured and tested for the purposes of SE review, or a
surrogate may be appropriate for use in place of the actual predicate
tobacco product.
Comparison Information (Sec. 1107.18(g)) (Surrogates)
In the proposed rule, in the description of Sec. 1107.18(g), FDA
requested comment on the use of information from surrogate tobacco
products where there is inadequate data available for the new or
predicate tobacco product. FDA received several comments on the use of
information from surrogate tobacco products.
(Comment 54) One comment states that manufacturers should not be
able to use a surrogate tobacco product in the place of a predicate
tobacco product. The comment argues that there is no statutory basis
for allowing this, and requests FDA to remove this from the final
regulation.
(Response 54) Under the statute, applicants must submit an SE
Report that provides information to support that a new tobacco product
is
[[Page 55246]]
substantially equivalent to a predicate tobacco product. The use of
surrogate tobacco products in certain situations does not change those
statutory requirements. Although permitting use of a surrogate tobacco
product may provide an opportunity for applicants to provide stand-in
information in lieu of the precise predicate product itself, it is the
applicant's responsibility to provide FDA with adequate bridging
information for FDA to determine that it is appropriate to extrapolate
the data provided on the surrogate tobacco product to the actual
predicate product. Ultimately, FDA makes a determination as to whether
or not the new product is substantially equivalent to the selected,
valid predicate product.
(Comment 55) Several comments request that FDA provide more
information regarding the use of surrogate tobacco products, including
whether these may be used for SE Reports for cigars. Some comments
request that FDA define a surrogate product in the final regulation or
that FDA clarify when and how surrogate data may be used, to ensure
that its use is applied consistently across applicants and FDA
reviewers. The comments on this topic request more clarity on the use
of surrogates to assist applicants in providing sufficient information
about the surrogate in their submissions.
(Response 55) Although we are not adding a definition of
``surrogate tobacco product'' to this final rule, for the purposes of
an SE review, FDA considers a surrogate tobacco product to be a tobacco
product, other than the predicate or new tobacco product that is the
subject of the SE Report, for which data are available (or can be
generated) and may be scientifically bridged or extrapolated to the
predicate or new tobacco product. A surrogate tobacco product is not a
fictional tobacco product, but an actual product for which there are
empirical data.\10\ FDA believes that, when appropriate, applicants,
regardless of category of tobacco product, may use a surrogate tobacco
product but should clearly designate the specific parts of the SE
Report for which the surrogate tobacco product is to be used.\11\ Such
a surrogate tobacco product may be used, where appropriate, by an
applicant looking to demonstrate the substantial equivalence of a new
cigar product as compared to a valid predicate.
---------------------------------------------------------------------------
\10\ Note that a predicate tobacco product that is no longer
being manufactured may be reproduced using the design parameters,
tobacco blend, structural materials, and ingredients that are
identical to those of the predicate tobacco previously produced,
and, in this case, FDA would consider the reproduced predicate
product to be the predicate product. But if the reproduced predicate
product differs from the predicate product in any characteristic,
FDA would consider the product to be a surrogate and the applicant
would have to supply appropriate bridging information to the
selected predicate product. For example, if the reproduced predicate
product has the same tobacco blend (percentage of tobacco type) and
tobacco curing process as the predicate product, FDA would consider
the reproduced predicate product to be the predicate product, even
if the crop years are different. If, however, there is any change in
the amount of ingredients, including grade and purity or in
materials or design parameters, including any change to a
manufacturing process that would affect design parameters, FDA would
consider the reproduced product to be a surrogate tobacco product.
\11\ Surrogate products are not predicate tobacco products.
Evidence of commercial marketing for surrogate products is not
appropriate to determine whether the predicate tobacco product is a
tobacco product commercially marketed (other than for test
marketing) as of February 15, 2007.
---------------------------------------------------------------------------
FDA believes it would only be appropriate to use a surrogate
tobacco product when the relevant data are not available for the new or
predicate tobacco product and the surrogate tobacco product data can be
scientifically bridged to the new or predicate product. Data for a
surrogate tobacco product may be provided in place of data for the new
or predicate tobacco products, but applicants should provide a
scientific justification for why it is reasonable to use the surrogate
data and then bridge between the surrogate data and the new or
predicate tobacco product. For example, if stability data for a
smokeless predicate product are not available, but there is a smokeless
surrogate product for which there is stability testing data that can be
bridged to the predicate (e.g., through data on the water content and
activity, tobacco (blend and format), ingredients, and container
closure), these data could be used for the missing predicate stability
data. Similarly, if smoking regimen data (intense and non-intense) for
the predicate tobacco product are not available, test data from a
surrogate tobacco product could be appropriate if the predicate and
surrogate tobacco products can be bridged through data (e.g.,
ventilation, paper, tobacco blend, filtration). However, surrogate
products should not be used for the purpose of extrapolating target
specifications and range limits from a surrogate product to a new
product (emphasis added). This is because target specifications and
range limits should be specified by the manufacturer for the new
tobacco product. If an applicant chooses to use a surrogate tobacco
product, we recommend an SE Report include the following information
related to the surrogate product:
[cir] The tobacco product to which data on the surrogate product is
to be bridged (e.g., predicate product);
[cir] A detailed description of the ingredients in the surrogate
product, noting any difference(s) in ingredients from the bridged
tobacco product (i.e., the new tobacco product or predicate tobacco
product);
[cir] Design parameters of the surrogate product (e.g., cigarette
paper base paper porosity, ventilation, tobacco cut or particle size);
\12\
---------------------------------------------------------------------------
\12\ For example, if an applicant submits HPHC data from a
surrogate combusted filtered cigarette in lieu of HPHC data from a
predicate combusted filtered cigarette, the applicant could explain
that the surrogate data are appropriate for FDA to consider because
the surrogate and predicate tobacco products are identical with the
exception of tobacco blend differences. The SE Report also should
include data that show those differences are not expected to cause
the surrogate tobacco product to yield significant differences in
HPHC when compared to the predicate product. Please note that this
is just one approach, and FDA expects that the scientific
justification for use of the surrogate tobacco product may vary from
case to case and depend on the type of differences (e.g., in tobacco
blend, design features) between the surrogate tobacco product and
the new or predicate tobacco product.
---------------------------------------------------------------------------
[cir] An identification in a side-by-side list of the
specifications for ingredients and additives, and materials and design
parameters, that differ between the surrogate and the tobacco product
to which data (e.g., HPHC or stability) on the surrogate product is to
be bridged, including tobacco blend or other ingredients, design
parameters, and materials such as pouch, filter tow, or paper. To
facilitate review and reduce FDA requests for clarification, FDA
recommends that side-by-side comparisons of the surrogate and
corresponding predicate or new product be provided in tabular format.
Where any difference in the characteristics of the products has the
potential to impact the use of test data between the surrogate and
predicate or new tobacco product, a scientific justification that
explains how the surrogate data may be bridged to the predicate or new
product will help FDA evaluate whether the surrogate is appropriate. We
recommend that the SE Report include supporting information, e.g.,
publications to show that bridging is appropriate (this may be provided
in an appendix);
[cir] Testing procedures used to measure and obtain data on the
surrogate tobacco product that may be used in lieu of data on the
predicate product;
[cir] Surrogate tobacco HPHC yields or quantities (these would not
be needed when the new or predicate tobacco product is available for
testing);
[cir] Method validation reports of analytical testing (e.g.,
accuracy,
[[Page 55247]]
repeatability, limit of detection, limit of quantification).
(Comment 56) One comment asks whether one product could be a
surrogate for another product if the products contain an identical
blend, but one product is wrapped in cellophane and the other is not.
(Response 56) While it may be possible to use a surrogate product
in this instance, because the answer to this comment depends on more
specific information than is provided, we recommend that for this or
any other specific question related to the use of surrogates, the
applicant contact the Agency.
(Comment 57) A few comments reference the comparison requirements
(in Sec. 1107.19) stating these unreasonably restrict the use of
surrogate products and do not promote clarity and efficiency.
(Response 57) As we discuss in detail in preceding paragraphs, FDA
is allowing the use of surrogate tobacco product data in specific
scenarios and has provided a more robust description on how a surrogate
can be utilized in an SE Report. Section 1107.19 does not place
limitations on the type of scientific data an applicant may provide
surrogate information for in lieu of the actual new or predicate
tobacco product.
Statement of Compliance With Applicable Tobacco Product
Standards (Sec. 1107.18(i))
In the proposed rule, we invited comment on how we should handle SE
Reports that are pending at the time a final product standard issues
with respect to the requirement that the SE Report include a statement
of compliance with any applicable standard. We received some comments
in response, which we discuss and respond to in the following
paragraphs.
(Comment 58) One comment suggested that FDA should continue its
review of the SE Report through final determination, and, if the
product is determined to be substantially equivalent, FDA could
condition the marketing of that product on the manufacturer
establishing compliance with the product standard that went into effect
while the SE Report was under review. The comment also states that, as
part of issuing a standard, FDA should establish the process for
bringing legally marketed products into compliance with the standard.
Another comment suggests that applicants be permitted to modify their
prior statements regarding compliance, and that compliance with the
standard be considered during review of the pending SE Report.
(Response 58) We appreciate the information provided in response to
our invitation to comment. FDA agrees with the comments that suggest
that this issue should be considered as part of issuing a standard
under section 907 of the FD&C Act (21 U.S.C. 387g). Additionally, the
regulatory process that FDA must follow to issue a product standard
under section 907 of the FD&C Act is lengthy and would provide
applicants with notice of proposed requirements well in advance of any
change becoming effective.
Compliance With Part 25 (Sec. 1107.18(k))
(Comment 59) Some comments urge FDA to either remove the
requirement that manufacturers include an environmental assessment (EA)
in their SE Reports or establish categorical exclusions for SE reports.
The comments find the EA process unnecessarily burdensome without
legitimate purpose. One comment objects that requiring EAs for deemed
tobacco products that are still on the market is inconsistent with
FDA's categorical exclusion for provisional SE Reports (those products
on the market as of February 15, 2007) (see 80 FR 57531, September 24,
2015). The comment asserts FDA's different treatment of these
categories of products is arbitrary and capricious. Other comments
state that EAs are burdensome, with some noting greater difficulty for
cigar manufacturers, and that FDA could alleviate some of these costs
by allowing multiple products to be addressed in one EA or allowing the
use of EA-specific master files for all products manufactured at the
same facility.
(Response 59) We disagree with the assertion that the requirement
of EAs is unnecessarily burdensome. FDA is required to examine the
environmental impacts of issuing marketing orders under the National
Environmental Policy Act of 1969 (NEPA) (FDA's implementing regulations
are at title 21 CFR, part 25). Part 25 requires EAs as a means of
assessing the potential environmental impacts from tobacco products,
which may present environmental issues during manufacturing (e.g.,
release of chemicals), use (e.g., smoke and aerosol may impact air
quality), and disposal (e.g., litter, which persists in the environment
and is toxic to different organisms). Per Sec. 25.20, an EA is
normally required for the issuance of an SE order, except that
provisional SE reports that receive an SE order are categorially
excluded under Sec. 25.35(a). SE Reports for which an NSE is issued
are also categorically excluded from having an EA under Sec. 25.35;
however, that outcome is not known until review of an SE Report is
complete.
FDA also disagrees with the assertion that the requirement of EAs
for deemed tobacco products still on the market is inconsistent,
arbitrary, or capricious in comparison to the requirements for
provisional products. In issuing the categorical exclusion for
provisional products, FDA provided an estimate of the environmental
impacts of all FDA-regulated tobacco products on the market, including
products marketed after February 15, 2007, and before March 22, 2011,
and pre-Existing tobacco products (tobacco products that were
commercially marketed in the United States as of February 15, 2007) (79
FR 3742 at 3746). FDA currently lacks the information to conduct such
an analysis for deemed tobacco products still on the market. Unlike
provisional products, deemed tobacco products include products whose
environmental impacts are largely unknown, with the potential to result
in greater or different impacts on the environment compared to other
tobacco products. Because there is no basis for such a categorical
exclusion at this time, NEPA and its implementing regulations require
FDA to examine the potential environmental impacts from the issuance of
an SE order; therefore, EAs are required for deemed tobacco products to
comply with NEPA.
We disagree with the suggestions that a single EA be submitted for
multiple products or that an EA-specific master file be permitted.
Additionally, FDA is required by regulation to evaluate the
environmental impact individually from one proposed action (Sec.
25.40(a)). An aggregated impact from multiple products is not
sufficient under NEPA to determine whether the individual proposed
action has a significant impact on the human environment.
Certification Statement (Sec. 1107.18(l))
(Comment 60) Some comments assert that FDA has no authority to
impose the certification requirement or that it invites imprecision and
falsification particularly when certifying that characteristics are
identical without supporting test data. Other comments suggest there is
no need for this ``additional assurance.'' Two comments suggest that an
applicant should be permitted to submit a certification stating that
all characteristics of the new and predicate tobacco products are
identical except for those identified. Alternatively, other comments
support
[[Page 55248]]
the certification approach and request that we permit applicants of
currently pending SE Reports to submit such a certification without
waiting for the final rule to become effective. One comment states that
any certification that some or all characteristics are identical must
be fully supported by actual test data.
(Response 60) We disagree that FDA does not have the authority to
impose the certification requirement, that it invites imprecision or
falsification, or is unnecessary. Section 905(j)(1) of the FD&C Act
authorizes FDA to issue regulations prescribing the form and manner of
SE Reports, and we have included this requirement based on that
authority. Notably, as some comments indicate, these certifications can
help minimize the burden on applicants by providing an opportunity to
certify when characteristics are identical (Sec. 1107.18(l)(2)). With
respect to the concern related to ensuring there is underlying support
for a certification, the certification is intended in part to ensure
that an applicant is prepared to support their SE Report with further
information, if needed (for example, the certification in Sec.
1107.18(l)(2) provides that the company ``will maintain records to
support the comparison information in Sec. 1107.19 that substantiate
the accuracy of this statement''). Moreover, after careful
consideration of this concern, we also have included in Sec.
1107.18(l)(2) a requirement that a justification for the certification
be included. Such a justification could include, for example, the type
of test data that was compared between the new and predicate tobacco
products and/or a description of the quality control checks that were
conducted, which demonstrate the characteristics being certified are
identical. The certification also is intended to provide FDA with
assurance that the applicant has fully considered the SE Report and its
contents, believes there is a basis for making the findings required by
section 910(a)(2) of the FD&C Act, and understands the potential
consequences of submitting false information to the U.S. Government.
Thus, contrary to what some of the comments suggest, the
certification is an important, but also simple, means of helping ensure
that the authorized representative is aware of and understands the
recordkeeping requirements, that the submission is truthful and
accurate, and the representative is authorized to submit the SE Report
on behalf of the applicant. For a certification under Sec.
1107.18(l)(2), the certification also helps ensure that the authorized
representative is aware of and understands that, in lieu of providing
data for each characteristic of the new and predicate tobacco products,
the applicant is choosing to certify that the characteristics of the
products are identical and that records will be maintained to support
this determination. With respect to the comment that requests FDA
permit this for pending SE Reports, as explained in preceding
paragraphs, this rule does not apply to pending submissions.
3. Comparison Information (Sec. 1107.19)
Proposed Sec. 1107.19 set out the comparison information that
would be required in an SE Report. It also set forth the manner in
which the comparison section of the SE Report would be required to be
organized, and explained that applicants who make a comparison of a new
product to a predicate product may also need to provide information to
demonstrate that the new tobacco product is substantially equivalent to
the original predicate tobacco product. Following our consideration of
the comments, which we describe and respond to in detail in this
section, we are clarifying in this preamble and in changes to the
codified that Sec. 1107.19 applies to ``different characteristics'' SE
Reports. ``Same characteristics'' SE Reports do not need to include the
information in this section. In reviewing an SE Report, FDA may request
additional information if needed to make an SE determination.
On our own initiative, we have revised the introductory text in
Sec. 1107.19 so that it no longer states ``The comparison section of
the SE Report must be organized in the following manner'' as not all of
the subsections require information to be submitted in an SE Report,
and instead added ``as described in this section.'' Following our
consideration of comments and based on our increased experience
reviewing SE Reports, we are finalizing with changes Sec. 1107.19(a)
(comparison of product design). These changes include the addition of
design parameters for cigars, pipes, waterpipes, ENDS, and heated
tobacco products, as described in detail in the product design
paragraphs that follow.
In addition, we have made clarifications in Sec. 1107.19(c)
(product composition), including replacing ``material'' with
``ingredient'' in paragraph (c)(2)(iv) due to a typographical error;
adding examples of the type of tobacco to be identified and striking
``grade and variety'' in paragraph (c)(3)(i) because tobacco grading is
not uniform throughout the industry, which reduces the utility of this
information in application review, and FDA does not need to
characterize the tobacco type to the level of detail of tobacco variety
for the purposes of an SE evaluation; adding a requirement that
information on the type of curing method be submitted as paragraph
(c)(3)(ii) because the curing method is known to influence the
formation of TSNAs and other select HPHCs and this information will
allow FDA to fully characterize the tobacco (Refs. 13 and 14); adding
``of each type'' following quantity in paragraph (c)(3)(iii), and
striking proposed paragraph (c)(3)(iii) to clarify we need this for
each type of tobacco since many tobacco products are made from blends
of different tobacco types.
To Sec. 1107.19(d)(1)(ii)(F) we have added a requirement that full
validation reports for each analytical method be included because, as
noted in the earlier discussion in this rule, this information is
needed to ensure the method is fit for purpose and the measured values
can be accurately compared between a new and predicate tobacco product.
In addition, we added that reference product datasets be included
(if applicable) in Sec. 1107.19(d)(1)(ii)(J). A reference product is a
product of known physical and chemical composition and is typically
accompanied by a Certificate of Analysis that states the attributes of
the reference product. A suitable reference product is one that is
compositionally and functionally representative of the test samples in
the study, and laboratories may use a reference product for proficiency
testing to demonstrate that the laboratory is capable of accurately
measuring tobacco chemicals of interest and as a control sample during
instrument calibration, method validation, and sample analysis. Thus,
reference product datasets are used to demonstrate that the test
results obtained from testing of tobacco products are reliable. Because
of the addition of reference product datasets to the final rule, we
have renumbered proposed Sec. 1107.19(d)(1)(ii)(J) to Sec.
1107.19(d)(1)(ii)(K). In the final rule, we also are adding to Sec.
1107.19(d)(1)(ii)(K) ``Test data for combusted or heated tobacco
products must reflect testing conducted using both intense and
nonintense smoking or aerosol-generating regimens, where established''
(Refs. 15 and 16). The proposed rule explained that for combusted
tobacco products constituent smoke yields from the new and predicate
tobacco products would need to be determined using intense and
nonintense smoking regimens, but the proposed codified did not
specifically reference these regimens (see 84 FR
[[Page 55249]]
12740 at 12763). Following our consideration of comments on this issue
(see later paragraphs in this section for a discussion of comments), we
added codified text to ensure the understanding that this is required
for these products. Because heated tobacco products present issues
similar to combusted tobacco products, the final rule also specifies
that test data for heated tobacco products reflect testing conducted
using both intense and nonintense smoking or aerosol-generating
regimens, where established. The final rule also now includes a Sec.
1107.19(d)(1)(ii)(L) that clarifies that the applicant must include in
the SE Report a complete description of any smoking or aerosol-
generating regimens used for analytical testing that are not
standardized or widely accepted by the scientific community, if
applicable.
In addition, we have reorganized and modified proposed Sec.
1107.19(e) for clarity. We also added a requirement for information on
the heat treatment process (if applicable), which is a tobacco
processing method that could potentially reduce the microbial load of
the tobacco product and result in lower levels of carcinogenic TSNAs,
thereby altering product composition (i.e., product characteristics) in
Sec. 1107.19(e)(2) (Refs. 17 and 18). For better organization, we
moved the stability information in proposed Sec. 1107.19(e) to Sec.
1107.19(f); moved the testing information from proposed Sec.
1107.18(h) to Sec. 1107.19; and renumbered proposed Sec. 1107.19(f)
to Sec. 1107.19(g) and proposed Sec. 1107.19(g) to Sec. 1107.19(h)
in this final rule.
Following our consideration of comments, we are finalizing the
stability testing in Sec. 1107.19(f) with some changes. First, we are
expanding the types of tobacco products that will need to submit
information on stability and shelf life. The proposed rule would only
have required stability testing information for smokeless tobacco
products and tobacco products that contained fermented tobacco,
including naturally fermented tobacco. As explained in the proposed
rule, 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.
Upon further consideration, the final rule will require information
on stability and shelf life for all tobacco products, except RYO
tobacco products and cigarettes that are not HTPs.\13\ Information
obtained through stability testing and shelf life is important for FDA
to consider during its review to ensure that the tobacco products are
microbiologically and chemically stable during storage and do not
result in different questions of public health. Fermentation of tobacco
(including natural fermentation) affects the microbial content, which
could potentially affect TSNA content and product stability (Refs. 19-
24). In addition, based on our experience, HTPs can contain high levels
of humectants, which can affect product stability; therefore shelf life
and stability information is required to support an SE report for HTPs.
Humectants function to keep a product moist, thereby impacting the
moisture content and water activity of the product, which in turn may
impact microbial growth and product stability (Ref. 25).
---------------------------------------------------------------------------
\13\ See the discussion in section V.D.2, about how products
should be categorized for purposes of SE review.
---------------------------------------------------------------------------
Based on FDA's experience with cigarettes and RYO tobacco products
under the SE pathway and because the vast majority of cigarettes and
RYO tobacco products do not contain fermented tobacco, these products
do not have the same stability concerns. However, we lack similar
experience with more novel tobacco products, such as ENDS and HTPs, and
thus need stability information for these types of products to
determine whether there is a difference in microbial factors or HPHC
quantities over time. The proposed rule did not specify that this
information was needed for novel tobacco products because we did not
expect many substantial equivalence reports to be submitted for novel
tobacco products. In reviewing the PMTA rule and its stability
requirements, though, we recognized the possibility that a novel
product manufacturer may pursue authorization through the SE pathway
and we wanted to make sure that both the PMTA and SE regulations would
require applicants to provide the Agency with the necessary stability
information. FDA believes information regarding these products' shelf
life and stability over time is needed to ensure FDA fully understands
the microbial and chemical stability of the new and predicate tobacco
products throughout their stated shelf life, and will thus have the
needed information to make the SE determination.
Second, stability testing requirements have been updated to remove
identification of microbiological organisms by genus and species and
remove testing for pH, moisture content, nitrate and nitrite levels,
and preservatives and microbial metabolic inhibitors. In addition, if a
tobacco product does not have a defined shelf life, stability data will
need to be provided over a specified amount of time with a
justification for why that time period is appropriate.
Section 1107.19(f)(2) of the proposed rule (now Sec.
1107.19(g)(2)) stated that, when 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 difference 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)). In the final rule, we
have updated this subsection to remove repetitive language (i.e.,
``with different characteristics''), add clarifying language (``would
not change the characteristics of the new tobacco product such that the
new tobacco product could'' and ``cause the new tobacco product to''),
and after ``smokeless tobacco'' add ``and tobacco products that contain
fermented tobacco as these tobacco products have similar stability
considerations.''
We have also updated Sec. 1107.19(i) to reflect the updated
definition of predicate tobacco product, as described in the
definitions section of this final rule.
Product Design (Sec. 1107.19(a))
In the following paragraphs, we describe in more detail the changes
to Sec. 1107.19(a)and we describe the comments submitted on Sec.
1107.19(a) and our responses to those comments.
We have revised Sec. 1107.19(a) so that it does not require test
data, target specifications and range limits be submitted in all
instances, as the proposed rule would have required.
[[Page 55250]]
Instead, Sec. 1107.19(a) requires that SE Reports include test data
(including test protocols, quantitative acceptance criteria, data sets
(i.e., measured values), and a summary of the results) only when the
target specification or range limits of the new tobacco product differ
from the predicate tobacco product. We have also clarified that test
data would need to be submitted for both the new and predicate tobacco
products. Additionally, FDA has clarified that for tobacco cut size or
particle size, when target specifications and range limits are not
available, the following alternative information may be submitted in
place of this information: A description of the tobacco cutting process
(including a complete description of the milling, cutting, and sifting
process; the control parameters of the miller or cutter; and any sift
specifications) or the measured particle size distribution for the new
and predicate tobacco products. This alternative may be used, for
example, if an applicant does not set target specifications or range
limits for tobacco cut size. In this case, they could submit
information about the tobacco cutting process of the new and predicate
tobacco products to demonstrate that the products are substantially
equivalent.
Applicants may also choose to submit the necessary design parameter
information using a Manufacturing Data Sheet Specification (MDSS)
document. The MDSS is a document typically maintained by manufacturers,
describing all the parameters that are controlled by the manufacturer
during manufacture of their tobacco products. However, there will be
cases where the design parameters on the MDSS will not directly
translate into one of the product-specific design parameters required
in Sec. 1107.19. In these cases, additional information would need to
be submitted to provide the complete characterization necessary.
Additionally, FDA will not require test data for all parameters for
which target and range are required. For example, for parameters that
are observational (e.g., number of waterpipe holes), FDA would not seek
test data on that parameter. Also, some design parameters are machine
settings (e.g., tobacco cut size), calculated (e.g., denier per
filament), provided by suppliers (e.g., Certificate of Analysis for
base paper porosity), or can be extrapolated from other design
parameter test data (e.g., filter pressure drop test data is more
informative than filter length test data). FDA has clarified
alternative terminology for ``porosity'' understanding that applicants
may refer to this term as ``permeability'' for several design
parameters, as well as adding units of measure for several design
parameters.
Following our review of comments, we have revised the tables of
design parameters required for certain product categories as described
here:
Cigarettes: As discussed in section V.D.2 above, tobacco products
that meet the definition of cigarette but are heated tobacco products
should be categorized as heated tobacco products (HTPs) for purposes of
SE review. Accordingly, this section discusses cigarettes that are not
HTPs. Section 1107.19(a) has changed certain proposed requirements
under target specification and range. These changes include: (1)
Removal of the proposed requirement for applicants to provide cigarette
draw resistance as FDA determined that requiring this as distinct
parameter was unnecessary and not as informative as filter pressure
drop because draw resistance could be modified by the user by puffing
more or less intensely; (2) removal of cigarette paper base paper basis
weight as it provides duplicative information that is already captured
by the submission of ingredient levels (e.g., a higher basis weight
might be due to the inclusion of more cellulose and more calcium
carbonate); (3) addition of tobacco cut size as this parameter has an
influence on the chemical concentration in the combusted portion of the
cigarette, combustion temperature, and affects the particle size and
distribution of particles; (4) FDA has clarified terminology for
cigarette paper band porosity, as applicants may refer to this term as
permeability, and also provide an alternative to providing cigarette
paper band porosity or permeability. Band diffusivity, while not
preferred, is an acceptable alternative if it is currently not part of
an applicant's practice to specify cigarette paper band porosity.
Regardless of whether porosity or diffusivity is specified, the same
parameter must be provided for both the new and predicate tobacco
products to conduct a meaningful comparison. While there are minor
differences (porosity is more relevant during active puffing, whereas
diffusivity is more relevant during smoldering), the addition of
diffusivity as an alternative parameter allows flexibility to
applicants who do not directly measure porosity or permeability while
still providing FDA with the information it needs to make the
substantial equivalence finding (Ref. 26).
FDA has revised certain proposed parameters for test data which
include: (1) Removal of puff count as this was duplicative of
information that an applicant would submit with smoke constituent data
because puff count is determined in a smoking machine using either the
International Organization for Standardization or Health Canada Intense
smoking regimen or other applicable regimen (Refs. 27 and 28); (2)
removal of cigarette draw resistance as explained above; (3) removal of
cigarette paper base paper basis weight as explained above; (4)
addition of tobacco filler mass as this has a direct influence on smoke
constituents (Ref. 29); and (5) the option to provide oven volatiles
instead of moisture as this provides similar information to FDA (Ref.
30) \14\ and allows the applicant flexibility to provide either
parameter based on the specific manufacturing processes they employ.
---------------------------------------------------------------------------
\14\ Please note that the term ``moisture,'' has widely varying
and conflicting definitions and terminology in use within the
tobacco industry. It is common for ``moisture'' or ``moisture
content'' to be used to refer to water content of a material but in
relation to the tobacco industry it is necessary to differentiate
between ``moisture'' as water content and ``moisture'' as oven
volatiles. https://www.coresta.org/sites/default/files/technical_documents/main/PTM-CTR_MoistureWaterOvenVolatiles_July2014%282%29.pdf.
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Smokeless Tobacco: Section 1107.19(a) has changed certain proposed
requirements under target specification and range. These changes
include: (1) Removal of portion thickness as it is an unnecessary
parameter because it is the pouch effective area that may result in an
increase of the release level of nicotine, unprotonated nicotine, and
could affect TSNA levels and the pouch effective area can be calculated
from other required design parameters, i.e., pouch length and pouch
width; (2) addition of pouch material thickness as this parameter
influences the release level of nicotine and can affect TSNA levels;
\15\ (3) addition of nicotine dissolution rate because it is a measure
of how much free nicotine a user could be exposed to and differences in
nicotine dissolution can have an impact on addiction and nicotine
uptake (Refs. 31, 32, 85); and (4) clarification of requiring certain
parameters ``if applicable'' for portioned product properties (i.e.,
portion length, portion width, and portion mass, ``if applicable'' has
been removed) because these parameters are needed for all portioned
smokeless products. However, not all portioned products are pouched, so
the pouch-specific
[[Page 55251]]
properties should only be reported if applicable, and thus FDA has
added ``if applicable'' to pouch material porosity or permeability and
pouch material basis weight.
---------------------------------------------------------------------------
\15\ See, e.g., Gale, N., G. Errington, and K. McAdam, Group
Research & Development, British American Tobacco, ``Effects of
Product Format on Nicotine and TSNA Extraction from Snus Pouches,''
Presentation at the 67th Tobacco Science Research Conference,
Williamsburg, VA, September 15-18, 2013. Available at: https://www.researchgate.net/publication/299854728_Effects_of_Product_Format_on_Nicotine_and_TSNA_Extraction_from_Snus_Pouches.
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Roll-your-own tobacco, rolling papers: Section 1107.19(a) has
changed a proposed requirement under target specification, range, and
test data. This change includes the option to provide diffusivity in
lieu of cigarette paper band porosity (also described as permeability)
for the reasons explained above under Cigarettes.
Roll-your-own tobacco, non-filtered tubes: Section 1107.19(a) has
changed certain proposed requirements under target specification and
range. These changes include the addition of: (1) Clarification of
terminology changing ``total mass (mg)'' to ``tube mass (mg);'' (2) the
option to provide tube diameter as an alternative to tube circumference
as FDA is able to obtain the information necessary from other required
design parameters; and (3) the option for the applicant to provide
diffusivity in lieu of cigarette paper band porosity or permeability as
described above. This alternative is also provided under test data for
this product category.
Roll-your-own tobacco, filtered tubes: Section 1107.19(a) has
changed certain proposed requirements under target specification and
range. These changes include the addition of: (1) Clarification of
terminology changing ``total mass (mg)'' to ``tube mass (mg);'' (2) the
option to provide tube diameter as an alternative to tube circumference
as FDA is able to obtain the information necessary from other required
design parameters; (3) the option for the applicant to provide filter
efficiency as an alternative to denier per filament, total denier, or
filter density (Ref. 33); and (4) the option for the applicant to
provide diffusivity in lieu of cigarette paper band porosity or
permeability as described above. These alternatives (filter efficiency
and diffusivity) are also provided under test data for this product
category.
Roll-your-own tobacco: Section 1107.19(a) has changed certain
proposed requirements under target specification, range, and test data.
This change includes the removal of the requirement for the applicant
to provide filler mass as this is provided as part of unique
identification of the tobacco product under Sec. 1107.18.
In addition, in the proposed rule, we invited comments and
information on the parameters that may be needed to support an SE
Report for tobacco products that were not specifically included in the
proposed rule, such as cigars and ENDS. Based on the comments and
information we received, we have added design parameters to Sec.
1107.19(a) for cigar tobacco products, pipe tobacco products, waterpipe
tobacco products, ENDS tobacco products, and heated tobacco products,
as described in the following paragraphs.
Cigars. Cigarettes (outside the category of heated tobacco
products) and cigars are generally similar in design and principles of
operation as they are both cylinders filled with a blend of processed
tobacco that is generally smoked. Both are generally lit with a fire
source, which burns the tobacco as the user inhales at one end; thus,
they are consumed and deliver nicotine in a similar manner. A main
difference between cigarettes and cigars is that cigars are either
wrapped in a tobacco leaf (wrapper and binder) or a material containing
tobacco, whereas non-HTP cigarettes are wrapped in paper (cigarette
paper) or a material that does not contain tobacco. Additionally,
cigars come in a wider variety of sizes and may be thicker in diameter
and contain more tobacco filler than cigarettes. Despite these
differences, for both types of tobacco products, no matter the size,
air is pulled through the tobacco column, which aids in tobacco
combustion and nicotine delivery. Cigarette paper commonly has an
established porosity or permeability, that is set during manufacturing,
while cigar wrapper properties are based on the tobacco used as the
wrapper. Although cigars and cigarettes may be wrapped in different
materials, both cigar wrappers and binders, as well as cigarette
papers, have inherent permeabilities/porosities, which may affect smoke
constituent yields. Cigars may be filtered (containing filter tow or
other materials), unfiltered, or unfiltered with tips made of wood or
plastic, while most cigarettes have filters (containing filter tow) and
do not contain tips. If a cigar does contain a filter, it will be
similar to cigarette filters and contain tow. Based on FDA's experience
with cigarettes, many design parameters required to assess public
health impacts for cigarettes will also be needed to assess public
health impacts for cigars. The following paragraphs describe in more
detail the required parameters for each subcategory of cigars.
Filtered, sheet-wrapped cigars: Section 1107.19(a) includes the
design parameters that must be contained in an SE Report to fully
characterize filtered, sheet-wrapped cigars and how changes to these
parameters may impact public health, as described next:
[cir] Cigar mass reflects the amount of tobacco in a cigar, which
may affect smoke constituent yields (Ref. 34).
[cir] Cigar puff count can directly affect smoke constituent yields
(Ref. 34).
[cir] Cigar length and diameter can directly affect the amount of
tobacco that is burned and, in turn, affect smoke constituent yields
(Ref. 35).
[cir] Tobacco filler mass may affect smoke constituent yields (Ref.
34).
[cir] For cigarettes, the cigarette paper basis weight may affect
puff count and smoke constituents (Ref. 36). Similarly for cigars, the
cigar wrapper and binder basis weight may affect puff count and smoke
constituent yields (Refs. 36 and 37).
[cir] For cigarettes, the paper length and width may affect puff
count and smoke constituents (Ref. 36). Similarly for cigars, the cigar
wrapper and binder width and wrapper length may directly influence the
area through which air is permitted to enter the tobacco column, which,
in turn, may affect puff count and smoke constituent yields.
[cir] Cigar wrapper porosity may affect smoke constituent yields
(Refs. 37 and 38).
[cir] For cigarettes, tobacco rod density may modify burn
properties and smoke constituent yields (Refs. 39 and 40). Similarly
for cigars, the tobacco rod density may modify burn properties and
smoke constituent yields.
[cir] For cigarettes, the tobacco moisture or oven volatiles may
affect puff count (Ref. 41). Similarly for cigars, the tobacco moisture
or oven volatiles may affect puff count.
[cir] For cigarettes, the tobacco cut size may result in more
particulate matter (Ref. 42). Similarly for cigars, the tobacco cut
size alters the size of the tobacco pieces, which may result in more
particulate matter.
[cir] For cigarettes, the band porosity may affect smoke
constituent yields (Ref. 43). Similarly for cigars, the wrapper or
binder band porosity or permeability may affect smoke constituent
yields because band porosity allows for the overall assessment of the
weighted change in air flow through the paper during active puffing.
[cir] For cigarettes, the band width may affect smoke yields (Ref.
44). Similarly for cigars, the wrapper band width and binder band width
may affect ventilation and, in turn, smoke constituent yields.
[cir] For cigarettes, the band space may affect puff count (Ref.
45). Similarly for cigars, the wrapper band space and binder band space
may affect ignition propensity and, in turn, puff count.
[[Page 55252]]
[cir] For cigarettes, the filter parameters can impact smoke yields
(Ref. 33). Similarly for cigars, the filter diameter, filter mass, and
filter tow crimping index, denier per filament, total denier, filter
density, and filter length may affect filter efficiency and, in turn,
smoke constituent yields.
[cir] For cigarettes, the filter pressure drop affects smoke yields
(Ref. 46). Similarly for cigars, the filter pressure drop may affect
smoke constituent yields.
[cir] For cigarettes, tipping paper length may affect smoke
constituent yields (Ref. 47). Similarly for cigars, the tipping paper
length may affect smoke constituent yields.
[cir] Ventilation may affect smoke constituent yields (Ref. 34).
[cir] For cigarettes, the diameter can affect the smoke yields
(Ref. 46). Similarly for cigars, the cigar maximum and minimum diameter
may affect rod density, which modifies the burn properties and smoke
yields; FDA needs this information to characterize the diameters as
shapes of cigars can differ with the tips being narrower than the
center of the cigar. This may result in multiple rod densities used to
test the smoke and influence smoke yields depending on what part of the
cigar is tested.
[cir] For cigarettes, the paper porosity may affect smoke
constituents (Ref. 43). Similarly for cigars, the binder porosity may
affect or may further limit air flow into and out of the cigar which
may affect smoke yields.
Unfiltered, sheet-wrapped cigars: Section 1107.19(a) includes the
design parameters that must be contained in an SE Report to fully
characterize unfiltered, sheet-wrapped cigars and how changes to these
parameters may impact public health, as described next:
[cir] Cigar mass reflects the amount of tobacco in a cigar, which
may affect smoke constituent yields (Ref. 34).
[cir] Cigar puff count can directly affect smoke constituent yields
(Ref. 34).
[cir] Cigar length and diameter can directly affect the amount of
tobacco that is burned and, in turn, affect smoke constituent yields
(Ref. 35).
[cir] Tobacco filler mass may affect smoke constituent yields (Ref.
34).
[cir] For cigarettes, the cigarette paper basis weight may affect
puff count and smoke constituents (Ref. 36). Similarly for cigars, the
cigar wrapper and binder basis weight may affect puff count and smoke
constituent yields (Refs. 36 and 37).
[cir] For cigarettes, the paper length and width may affect puff
count and smoke constituents (Ref. 36). Similarly for cigars, the cigar
wrapper and binder width and wrapper length may directly influence the
area through which air is permitted to enter the tobacco column, which,
in turn, may affect puff count and smoke constituent yields.
[cir] Cigar wrapper porosity may affect smoke constituent yields
(Refs. 37 and 38).
[cir] For cigarettes, tobacco rod density may modify burn
properties and smoke constituent yields (Refs. 39 and 40). Similarly
for cigars, the tobacco rod density may modify burn properties and
smoke constituent yields.
[cir] For cigarettes, the tobacco moisture or oven volatiles may
affect puff count (Ref. 41). Similarly for cigars, the tobacco moisture
or oven volatiles may affect puff count.
[cir] For cigarettes, the tobacco cut size may result in more
particulate matter (Ref. 42). Similarly for cigars, the tobacco cut
size alters the size of the tobacco pieces, which may result in more
particulate matter.
[cir] For cigarettes, the band porosity may affect smoke
constituent yields (Ref. 43). Similarly for cigars, the wrapper or
binder band porosity or permeability may affect smoke constituent
yields because band porosity allows for the overall assessment of the
weighted change in air flow through the paper during active puffing.
[cir] For cigarettes, the band width may affect smoke yields (Ref.
44). Similarly for cigars, the wrapper and binder band width may affect
ventilation and, in turn, smoke constituent yields.
[cir] For cigarettes, the band space may affect puff count (Ref.
45). Similarly for cigars, the wrapper and binder band space may affect
ignition propensity and, in turn, puff count.
[cir] Cigar tip mass, length, and inner diameter dimensions
directly influence the overall cigar draw resistance and in turn, puff
count (Ref. 48).
[cir] For cigarettes, the diameter can affect the smoke yields
(Ref. 46). Similarly for cigars, the cigar maximum and minimum diameter
may affect rod density, which modifies the burn properties and smoke
yields; FDA needs this information to characterize the diameters as
shapes of cigars can differ with the tips being narrower than the
center of the cigar. This may result in multiple rod densities used to
test the smoke and influence smoke yields depending on what part of the
cigar is tested.
[cir] For cigarettes, the paper porosity may affect smoke
constituents (Ref. 43). Similarly for cigars, the binder porosity may
affect or may further limit air flow into and out of the cigar which
may affect smoke yields.
Unfiltered, leaf-wrapped cigars: Section 1107.19(a) includes the
design parameters that must be contained in an SE Report to fully
characterize unfiltered, leaf-wrapped cigars and how changes to these
parameters may impact public health, as described next:
[cir] Cigar mass reflects the amount of tobacco in a cigar, which
may affect smoke constituent yields (Ref. 34).
[cir] Cigar puff count can directly affect smoke constituent yields
(Ref. 34).
[cir] For cigarettes, the paper length and width may affect puff
count and smoke constituents (Ref. 36). Similarly for cigars, the cigar
binder and wrapper length and wrapper width may directly influence the
area through which air is permitted to enter the tobacco column, which,
in turn, may affect puff count and smoke constituent yields.
[cir] Cigar length and diameter can directly affect the amount of
tobacco that is burned and, in turn, affect smoke constituent yields
(Ref. 35).
[cir] For cigarettes, the tobacco moisture or oven volatiles may
affect puff count (Ref. 41). Similarly for cigars, the tobacco moisture
or oven volatiles may affect puff count.
[cir] For cigarettes, the cigarette paper basis weight may affect
puff count and smoke constituents (Ref. 36). Similarly for cigars, the
cigar wrapper and binder basis weight may affect puff count and smoke
constituent yields (Refs. 36 and 37).
[cir] For cigarettes, tobacco rod density may modify burn
properties and smoke constituent yields (Refs. 39 and 40). Similarly
for cigars, the tobacco rod density may modify burn properties and
smoke constituent yields.
[cir] For cigarettes, the tobacco cut size may result in more
particulate matter (Ref. 42). Similarly for cigars, the tobacco cut
size alters the size of the tobacco pieces, which may result in more
particulate matter.
[cir] Tobacco filler mass may affect smoke constituent yields (Ref.
34).
[cir] For cigarettes, the diameter can affect the smoke yields
(Ref. 46). Similarly for cigars, the cigar maximum and minimum diameter
may affect rod density, which modifies the burn properties and smoke
yields; FDA needs this information to characterize the diameters as
shapes of cigars can differ with the tips being narrower than the
center of the cigar. This may result in multiple rod densities used to
test the smoke and influence smoke yields depending on what part of the
cigar is tested.
Cigar filler: \16\ Section 1107.19(a) describes the design
parameters that
[[Page 55253]]
must be contained in an SE Report to fully characterize cigar filler
and how changes to these parameters may impact public health, as
described next:
---------------------------------------------------------------------------
\16\ These design parameters are for an SE Report where ``cigar
filler'' is the new tobacco product (not when cigar filler is a
component or part of a cigar or other tobacco product).
---------------------------------------------------------------------------
[cir] For cigarettes, the tobacco cut size may result in more
particulate matter (Ref. 42). Similarly for cigars, the tobacco cut
size alters the size of the tobacco pieces, which may result in more
particulate matter.
[cir] For cigarettes, the tobacco moisture or oven volatiles may
affect puff count (Ref. 41). Similarly for cigars, the tobacco moisture
or oven volatiles may affect puff count.
Cigar component: \17\ Section 1107.19(a) includes the design
parameters that must be contained in an SE Report to fully characterize
a cigar component and how changes to these parameters may impact public
health, as described next:
---------------------------------------------------------------------------
\17\ These design parameters are for an SE Report where a
``cigar component'' is the new tobacco product (not when the cigar
component is a component or part of a cigar or other tobacco
product).
---------------------------------------------------------------------------
[cir] For cigarettes, the paper length and width may affect puff
count and smoke constituents (Ref. 36). Similarly for cigars, the cigar
wrapper length and width may directly influence the area through which
air is permitted to enter the tobacco column, which, in turn, may
affect puff count and smoke constituent yields.
[cir] For cigarettes, the cigarette paper basis weight may affect
puff count and smoke constituents (Ref. 36). Similarly for cigars, the
cigar wrapper basis weight may affect puff count and smoke constituent
yields (Refs. 36 and 37).
[cir] Cigar wrapper porosity may affect smoke constituent yields
(Refs. 37 and 38).
Pipe. Cigarette tobacco and pipe tobacco are similar, as they are
both processed tobacco that is cut, milled, and sifted before
ingredients are added to control for tobacco moisture and taste.
Therefore, tobacco parameters for a cigarette can be extrapolated to
tobacco parameters for a pipe. Additionally, the filter in a pipe is
similar to a filter in a cigarette, as they both contain tow and the
length of the filter can determine the amount of suction a smoker needs
to apply to the tobacco product to draw smoke through (filter pressure
drop). Furthermore, the filter in a pipe can affect the filter
efficiency just as a cigarette filter would. Therefore, filter pressure
drop and filter parameters for a cigarette can be extrapolated to the
filter parameters for a pipe. Based on FDA's experience with
cigarettes, many design parameters required to assess public health
impacts for cigarettes will also be needed to assess public health
impacts for pipes. The following paragraphs describe in more detail the
required parameters for each subcategory of pipes.
Section 1107.19(a) includes the design parameters that must be
contained in an SE Report to fully characterize a pipe and how changes
to these parameters impact public health, as described next:
[cir] The bowl chamber inner and outer diameters allow FDA to
calculate the chamber wall thickness. A thicker wall will lead to a
cooler smoke and makes it less likely the user will burn themselves
when holding the chamber. Additionally, the chamber inner diameter will
affect temperature and tobacco capacity, meaning the greater the pipe
surface area, the more leaf can be burned at once, and with increased
temperature, as we have learned from our experience with other types of
tobacco products (e.g., cigarettes), this will affect smoke
constituents.
[cir] The bowl chamber hole shape is important to characterize the
pipe as this may affect the airflow and tobacco temperatures, which, as
we have learned from our experience with other types of tobacco
products (e.g., cigarettes), affects the burn rate and smoke
constituents delivered.
[cir] The bowl chamber volume affects the burn rate and
temperature, which, as we have learned from our experience with other
types of tobacco products (e.g., cigarettes), dictates the smoke
constituents delivered to users.
[cir] The draught hole allows the user to pull air through the
tobacco to their mouth. The diameter of the draught hole affects the
resistance to draw which, as we have learned from our experience with
other types of tobacco products (e.g., cigarettes), can impact nicotine
and other toxicant delivery to the user.
[cir] The draught hole dimensions and geometry may affect the
airflow and oxygen available at the burning tobacco for the chemical
reaction and, as we have learned from our experience with other types
of tobacco products (e.g., cigarettes), can affect smoke constituent
yields.
[cir] The location of the draught hole can affect airflow and
tobacco temperatures, which, as we have learned from our experience
with other types of tobacco products (e.g., cigarettes), affects the
burn rate and smoke constituents delivered.
[cir] The stem of a pipe delivers smoke from the bowl to the user's
mouth. The length of the stem may affect the smoke temperature, which
may affect how the product is consumed, while the width of the stem may
affect resistance to draw which, as we have learned from our experience
with other types of tobacco products (e.g., cigarettes), can impact
toxicant delivery to the user.
[cir] The shank of a pipe similarly may affect the smoke
temperature (length) and resistance to draw (diameter), which, as we
have learned from our experience with other types of tobacco products
(e.g., cigarettes), can impact nicotine and other toxicant delivery to
the user.
[cir] For cigarettes, the filter pressure drop affects smoke yields
(Ref. 46). Similarly for pipes, the pressure drop through the air valve
can affect nicotine and other toxicant delivery to the user. Air flow
through an air valve can affect tobacco burn rate and tobacco
temperatures which in turn, may affect smoke constituent delivery to
the user.
[cir] Some pipes may come with a filter. For cigarettes, filter
diameter, denier per filament, total denier, filter density, and filter
length may affect filter efficiency and, in turn, smoke constituent
yields (Ref. 33). Similarly for pipes, the filter efficiency, filter
pressure drop, and filter length may affect smoke constituent yields.
Pipe tobacco. Section 1107.19(a) includes the design parameters
that must be contained in an SE Report to fully characterize pipe
tobacco and how changes to these parameters may impact public health:
[cir] For cigarettes, the tobacco cut size may result in more
particulate matter (Ref. 42). Similarly for pipes, the tobacco cut size
alters the size of the tobacco pieces, which may result in more
particulate matter.
[cir] For cigarettes, the tobacco moisture or oven volatiles may
affect puff count (Ref. 41). Similarly for pipes, the tobacco moisture
or oven volatiles may affect puff count.
Waterpipes: Cigarette tobacco and waterpipe tobacco are similar, as
they are both processed tobacco that is cut, milled, and sifted before
ingredients are added to control for tobacco moisture and taste.
Therefore, tobacco parameters for a cigarette can be extrapolated to
tobacco parameters for a waterpipe. Additionally, the length of the
waterpipe stem affects the pressure drop in the waterpipe in a similar
way as the length of the filter and filter tow causes a filter pressure
drop in a cigarette: Both determine the amount of suction a smoker
needs to apply to the tobacco product to draw smoke through. Therefore,
filter pressure drop for a cigarette can be extrapolated to the
pressure drop of a waterpipe. Based on FDA's experience with
cigarettes, many design parameters required to assess
[[Page 55254]]
public health impacts for cigarettes will also be needed to assess
public health impacts for waterpipes. The following paragraphs describe
in more detail the required parameters for each subcategory of
waterpipes.
Section 1107.19(a) includes the design parameters that must be
contained in an SE Report to fully characterize waterpipes and how
changes to these parameters may impact public health, as described
next:
[cir] Hose dimensions (length and diameter) are directly
proportional to air infiltration and affects toxicant yields (Ref. 49).
[cir] Hose material may affect hose permeability, which may affect
smoke constituent yields (Ref. 49).
[cir] Water filtering efficiency is directly proportional to
mainstream smoke and can increase exposure to HPHCs (Ref. 50).
[cir] For cigarettes, the filter pressure drop affects smoke yields
(Ref. 46). Similarly for waterpipes, the pressure drop may result in
differences in the difficulty of pulling air through the waterpipe and,
in turn, affect smoke constituent yields.
[cir] Waterpipe components or parts, including stem, bowl,
windscreen (foil), and purge valve, impact puffing behavior and
toxicant exposure; therefore, the foil dimensions and ventilation may
affect smoke constituent yields (Ref. 51).
[cir] The shape and size (diameter and volume) of the base can
affect the pressure drop or difficulty of pulling air through the
waterpipe hose (Ref. 51).
[cir] The head dimensions (height, top diameter, bottom diameter,
volume, and number of holes) affect how long a smoke session lasts by
controlling how much tobacco can be used during a session. Head
dimensions can also affect airflow beneath and through the tobacco to
make heat transfer more effective, prolonging smoking sessions (Ref.
51).
[cir] The head materials could aid in heat transfer, prolonging the
heating of the tobacco and causing the tobacco to reach temperatures
that affect smoke yields (Ref. 52).
Waterpipe heating source: Section 1107.19(a) includes the design
parameters that must be contained in an SE Report to fully characterize
a waterpipe heating source and how changes to these parameters may
impact public health, as described next:
[cir] When combusted, heating sources such as charcoal or wood
cinders expose the user to high yields of toxicants such as carbon
monoxide and polycyclic aromatic hydrocarbons. Therefore, the heating
source mass, density, and temperature may affect smoke constituent
yields (Ref. 53).
Waterpipe filler: Section 1107.19(a) includes the design parameters
that must be contained in an SE Report to fully characterize waterpipe
filler and how changes to these parameters may impact public health, as
described next:
[cir] For cigarettes, the tobacco cut size may result in more
particulate matter (Refs. 41 and 42). Similarly for waterpipe filler,
the tobacco cut size alters the size of the tobacco pieces, which may
result in more particulate matter. Finer tobacco cut size may result in
a decrease in filling power and in turn, a larger amount of tobacco in
the bowl.
[cir] For cigarettes, the tobacco moisture or oven volatiles may
affect puff count (Ref. 41). Similarly for waterpipe filler, the
tobacco moisture or oven volatiles may affect puff count. Moisture
contributes to packing density, thus decreasing void volume.
Waterpipe foil: Section 1107.19(a) includes the design parameters
that must be contained in an SE Report to fully characterize waterpipe
foil and changes to these parameters may impact public health, as
described next:
[cir] Waterpipe components or parts, including the windscreen
(foil) impact smoke's puffing behavior and toxicant exposure.
Therefore, the foil dimensions such as length, width, diameter, and
foil thickness may affect smoke constituent yields (Ref. 51).
[cir] The aluminum foil perforation pattern (diameter and number of
holes) impacts the path of hot gases through the tobacco mixture, which
may affect smoke constituent yields (Ref. 51).
Waterpipe head: Section 1107.19(a) includes the design parameters
that must be contained in an SE Report to fully characterize a
waterpipe head and how changes to these parameters may impact public
health, as described next:
[cir] Waterpipe components or parts, including stem, bowl,
windscreen (foil), and purge valve, impact puffing behavior and
toxicant exposure; therefore, the foil dimensions and ventilation may
affect smoke constituent yields (Ref. 51).
ENDS: Section 1107.19(a) includes the design parameters that must
be contained in an SE Report to fully characterize ENDS and how changes
to these parameters may impact public health, as described next:
[cir] The air flow rate of the ENDS can affect the coil/heating
element temperature, e-liquid consumption, and aerosol characteristics
such as particle number concentration, count median diameter, and
particulate matter (PM)2.5, which impact aerosol exposure (Ref. 54).
[cir] Coil/heating element resistance may affect overall heating
element resistance, thereby influencing heating element temperature.
The coil/heating element's resistance, material and the voltage \18\
determine the current flow and heating element temperature. Because the
coil/heating element temperature is not constant, coil/heating element
resistance can be used to characterize the coil temperature over time.
The heating element temperature and temperature duration may affect
toxicant emissions and nicotine delivery (Refs. 55-59).
---------------------------------------------------------------------------
\18\ Voltage, current, and resistance are used to ensure the
battery and the ENDS are operating within the ``normal operating
range.'' The battery manufacturer sets the normal range of the
voltage and current. Understanding the resistance allows FDA to
assess whether the coil is drawing more current than the battery is
designed for.
---------------------------------------------------------------------------
[cir] Coil/heating element resistance and battery output voltage
determine power delivery unit (PDU) wattage. PDU wattage determines the
amount of heat produced by the atomizer. PDU wattage or wattage
operating range may affect the heating element temperature, thereby
affecting toxicant emissions (Refs. 57 and 59).
[cir] An increase in battery capacity (mAh rating) can increase the
number of puffs the e-cigarette can deliver per vaping session. Longer
vaping sessions may lead to greater exposure to toxicant emissions
(Ref. 58).
[cir] The temperature of the coil/heating element can affect the
chemical and physical characteristics of the aerosol delivered to the
user. An increase in coil/heating element temperature can increase HPHC
levels in the aerosol, therefore, maximum coil/heating element
temperature and temperature control deviation from this maximum coil/
heating element temperature can affect toxicant emissions and nicotine
delivery (Refs. 56-59).
[cir] Number of coils/heating element present can affect overall
atomizer resistance and distribution of heat dissipation (Ref. 60).
[cir] The position of the coil/heating element can increase the
possibility of dry puff conditions and subsequent increased toxicant
emissions (Ref. 57).
[cir] Atomizer and cartridge components of e-cigarettes may be
heated repeatedly and aerosolized and can contribute to increased
toxicant emissions (Ref. 55).
[cir] Puff count can differ depending on other puff topography
(e.g., puff duration and puff flow rate), e-cigarette and atomizer
design, and e-liquid parameters. Puff count can also affect total puff
volume, which in turn can
[[Page 55255]]
affect total toxicant emissions (Ref. 61). In addition, information on
the puff count of ENDS helps FDA assess how the product compares with
other products.
[cir] E-liquid capacity of the atomizer tank/cartridge can affect
total puff volume, which in turn can affect total toxicant emissions
(Refs. 61 and 62).
[cir] Battery/PDU voltage or voltage operating range may affect the
heating element temperature, thereby affecting toxicant emissions and
nicotine delivery (Refs. 56-59).
[cir] Battery wattage or wattage operating range may affect the
heating element temperature, thereby affecting toxicant emissions
(Refs. 57 and 59).
[cir] Coil/heating element resistance and battery output voltage
determine PDU wattage. PDU wattage determines the amount of heat
produced by the atomizer. PDU wattage or wattage operating range may
affect the heating element temperature, thereby affecting toxicant
emissions (Refs. 57 and 59).
[cir] PDU wattage operating range may affect the heating element
temperature, thereby affecting toxicant emissions (Refs. 57 and 59).
[cir] The temperature of the coil/heating element can affect the
chemical and physical characteristics of the aerosol delivered to the
user. An increase in coil/heating element temperature can increase HPHC
levels in the aerosol, therefore, maximum coil/heating element
temperature and temperature control deviation from this maximum coil/
heating element temperature can affect toxicant emissions and nicotine
delivery (Refs. 56-59).
[cir] Coil/heating element resistance, number of coils/heating
element, coil/heating element gauge, and coil/heating element
configuration may affect overall heating element resistance, thereby
influencing heating element temperature. The heating element
temperature may affect toxicant emissions and nicotine delivery (Refs.
55-59).
[cir] Battery type, battery current operating range, battery
failure safety features, battery conformance to standards, and PDU
current operating range are necessary for evaluating battery and PDU
safety. Risks of e-cigarette battery explosion, leakage, fire, or
overheating are a safety concern (Refs. 55 and 63).
[cir] Battery power impacts the delivery of nicotine and the total
emissions of volatile aldehydes (Refs. 64 and 65).
[cir] Battery and PDU voltage impacts the amount of e-liquid
consumed, the vapor temperature, and the total emissions of volatile
aldehydes (Ref. 65).
[cir] The draw resistance of the ENDS impacts the ease of drawing
air into the ENDS to produce aerosol, which can affect nicotine and
other toxicant delivery to the user (Ref. 66). For cigarettes, we
evaluate filter pressure drop since it is more informative than draw
resistance; however, for ENDS, there is no filter pressure drop or
other similar parameter that could be used in place of draw resistance.
[cir] PDU current cutoff is an electrical cutoff and a safety
feature, that interrupts electric current when a specific condition is
met (temperature, current, etc.) to protect the user. (Refs. 55 and
63).
[cir] Inhaled aerosol temperatures can be damaging or uncomfortable
to users who inhale aerosol above a certain temperature (Ref. 67).
E-liquid. Section 1107.19(a) includes the design parameters that
must be contained in an SE Report to fully characterize e-liquids and
how changes to these parameters may impact public health, as described
next:
[cir] The e-liquid volume can affect the delivery of nicotine and
other toxicants to the user (Refs. 61 and 62).
[cir] Aerosol parameters such as particle number concentration,
count median diameter, and PM2.5 are used to characterize
the amount and size of particles to which the user is exposed.
Epidemiological and clinical studies have shown that exposure to large
amounts of small particles can impair lung function and is correlated
with cardiovascular disease (Refs. 68 and 69).
[cir] E-liquid viscosity and boiling point impact the proportion of
nicotine that is aerosolized (Ref. 70). E-liquid viscosity can also
affect the e-liquid absorbency through the wick and wicking rate,
possibly leading to dry puff conditions and increased toxicant
emissions. Also, the e-liquid viscosity can affect the electronic
cigarette nicotine and other toxicant delivery to the user (Refs. 60
and 61).
[cir] The e-liquid volume can affect the delivery of nicotine and
other toxicants to the user (Refs. 61 and 62).
Heated tobacco products (HTP): HTPs currently sold in global
markets can function in ways that are similar to products in other
product categories. For example, some HTPs can function like ENDS
products by aerosolizing e-liquids or using a battery and PDU to power
the product. Other HTPs can contain tobacco filler, like a non-HTP
cigarette or cigar, but are heated instead of combusted. For these
reasons, the properties of HTPs vary widely but are comparable to the
properties of other tobacco product categories. Based on FDA's
experience with other similarly characterized tobacco products, many
design parameters required to assess public health impacts for those
products will also be needed to assess public health impacts for HTPs.
The following paragraphs describe in more detail the required
parameters for each subcategory of HTPs.
Section 1107.19(a) includes the design parameters that must be
contained in an SE Report to fully characterize HTPs and changes to how
these parameters may impact public health, as described next.
[cir] For cigars, the length, diameter, and mass can affect smoke
constituent yields (Ref. 35). Similarly for HTPs, dimensions (mass,
length, width, height, and diameter) can directly affect the amount of
tobacco that is heated and, in turn, affect smoke constituent yields.
[cir] For ENDS products, the draw resistance can affect nicotine
and other toxicant delivery to the user (Ref. 66). Similarly for HTPs,
the draw resistance can impact the ease of drawing air into the product
to produce aerosol, which can affect smoke constituent yields.
[cir] For ENDS, puff count can affect total toxicants emissions
(Ref. 61). Similarly for HTPs, the puff count can affect puff volume,
which in turn can affect total toxicant emissions.
[cir] For ENDS, e-liquid capacity of the atomizer tank/cartridge
can affect total toxicant emissions (Refs. 61 and 62). Similarly for
HTPs, the product volume (capacity of the cartridge) can affect total
puff volume, which, in turn, can affect total toxicant emissions.
[cir] For ENDS, airflow rate can impact aerosol exposure (Ref. 54).
Similarly for HTPs, the airflow rate allows air to flow from the
heating element to the user's mouth; some products allow the user to
manually change the airflow while others have a minimum airflow that
activates the product. Overall, airflow rate will impact aerosol
exposure.
[cir] For cigars, ventilation may affect smoke constituents yields
(Ref. 34). Similarly for HTPs, ventilation may affect smoke constituent
yields.
[cir] For ENDS, the battery and PDU voltage can impact volatile
aldehydes emission (Ref. 65). Similarly for HTPs, the battery and PDU
voltage impact the amount of e-liquid consumed, the vapor temperature,
and the total emissions of volatile aldehydes.
[cir] For ENDS, the battery type, failure safety features, and
battery conformance to standards are necessary for evaluating battery
and PDU safety. Risks of e-cigarette battery explosion, leakage, fire,
or overheating are a safety concern (Refs. 55 and 63). Similarly for
HTPs the temperature sensor is a safety feature that allows the product
power to be cut
[[Page 55256]]
off to ensure the product does not get too hot, causing the battery to
vent or harm the user.
[cir] For cigarettes, the paper length and width may affect puff
count and smoke constituents (Ref. 36). Similarly for HTPs, the
material wrapper length and width may directly influence the area
through which the air is permitted to enter the tobacco column, which,
in turn, may affect puff count and smoke constituent yields.
[cir] For cigarettes, the cigarette paper basis weight may affect
puff count and smoke constituents (Ref. 36). Similarly for HTPs, the
material wrapper basis weight may affect puff count and smoke
constituent yields.
[cir] For cigars, the cigar wrapper porosity may affect smoke
constituent yields (Refs. 37 and 38). Similarly for HTPs, the material
porosity may affect smoke constituent yields.
[cir] For ENDS, the heating element configuration and the
temperature it reaches based on the type of heating element and its
configuration, can affect the chemical and physical characteristics of
the aerosol delivered to the user (Refs. 56-59). Similarly, for HTPs,
different heating element sources, such as coils, can reach different
temperatures, which affects the chemical and physical characteristics
of the aerosol delivered to the user.
[cir] For ENDS, the temperature of the heating element can affect
the chemical and physical characteristics of the aerosol delivered to
the user (Refs. 56-59). Similarly for HTPs, the temperature of the
heating element (heating element temperature range, operational
temperature, maximum temperature) can affect the chemical and physical
characteristics of the aerosol delivered to the user. An increase in
heating element temperature can increase HPHC levels in the aerosol;
therefore, maximum heating element temperature and temperature control
deviation from this maximum heating element temperature can affect
toxicant emissions and nicotine delivery.
[cir] For ENDS, the heating element temperature may affect toxicant
emissions and nicotine delivery (Ref. 59). Similarly for HTPs, the
heating element can have a direct effect on the heat transfer to the e-
liquid or tobacco, and in turn, affect the smoke constituent yields.
[cir] For ENDS, the heating element configuration may affect
toxicant emissions and nicotine delivery (Refs. 55-59). Similarly for
HTPs, the heating element configuration may affect overall heating
element resistance, thereby influencing heating element temperature.
The heating element temperature may affect toxicant emissions and
nicotine delivery.
[cir] For ENDS, the heating element dimensions may affect toxicant
emissions and nicotine delivery (Refs. 55-59). Similarly for HTPs, the
heating element dimensions, such as length, influence the overall
surface area, which affects heating element resistance, which
influences the heating element temperature.
[cir] For ENDS, the heating element mass may affect toxicant
emissions and nicotine delivery (Refs. 55-59). Similarly for HTPs, the
heating element mass influences the power delivery of the battery, and
in turn, the heat applied to the e-liquid or tobacco, which affects the
smoke constituent yields and in turn, affects the smoke constituent
yields.
[cir] For ENDS, the heating element location may affect toxicant
emissions and nicotine delivery (Refs. 55-59). Similarly for HTPs, the
heating element location can affect nicotine emissions.
[cir] For ENDS, the number of heating elements may influence the
heating element temperature thereby affecting toxicant exposure and
nicotine delivery (Ref. 60). Similarly for HTPs, the number of coils/
heating elements present can affect overall resistance and distribution
of heat dissipation.
[cir] For ENDS, the heating element diameter or gauge may affect
toxicant emissions and nicotine delivery (Refs. 55-59). Similarly for
HTPs, the larger the diameter of the heating element, the lower its
resistance, and vice versa. Heating element resistance may influence
heating element temperature. The heating element temperature may affect
toxicant emissions and nicotine delivery.
[cir] For ENDS, the heating element resistance may affect toxicant
emissions and nicotine delivery (Refs. 55-59). Similarly for HTPs, the
heating element resistance may affect overall heating element
resistance, thereby influencing heating element temperature. The
heating element temperature may affect toxicant emissions and nicotine
delivery.
[cir] For cigars, tobacco filler mass may affect smoke constituent
yields (Ref. 34). Similarly for HTPs, the tobacco filler mass may
affect smoke constituent yields.
[cir] For cigarettes, tobacco rod density may modify burn
properties and smoke constituent yields (Refs. 39 and 40). Similarly
for HTPs, the tobacco rod density may modify burn properties and smoke
constituent yields.
[cir] For cigarettes, the tobacco moisture or oven volatiles may
affect puff count (Ref. 41). Similarly for HTPs, tobacco moisture or
oven volatiles may affect puff count.
[cir] For cigarettes, tobacco cut size alters the size of the
tobacco pieces, which may result in more particulate matter (Ref. 42).
Similarly for HTPs, tobacco filler manufacturing and processing as well
as tobacco cut size alters the size of the tobacco pieces, which may
result in more particulate matter.
[cir] For e-liquids, the e-liquid volume can affect the delivery of
nicotine and other toxicants to the user (Refs. 61 and 62). Similarly
for HTPs, the e-liquid volume can affect the delivery of nicotine and
other toxicants to the user.
[cir] For e-liquids, the e-liquid viscosity can affect the
electronic cigarette nicotine and other toxicant delivery to the user
(Refs. 60, 61, and 70). Similarly for HTPs, the e-liquid viscosity and
boiling point impact the proportion of nicotine that is aerosolized
(Ref. 70). The e-liquid viscosity can affect the nicotine and other
toxicant delivery to the user.
[cir] For ENDS, an increase in battery capacity (mAh rating) can
increase the number of puffs the e-cigarette can deliver per vaping
session. Longer vaping sessions may lead to greater exposure to
toxicant emissions (Ref. 58). Similarly for HTPs the battery capacity
is a measure of the charge stored by the battery. The higher the mAh
rating, the higher the capacity of the battery and the longer it will
last between charges. The longer the battery lasts, the more the user
can inhale smoke constituents.
[cir] For ENDS the battery and PDU voltage operating range and
wattage effects volatile aldehydes emission (Ref. 65). Similarly for
HTPs, the battery and PDU voltage operating range or wattage impact the
amount of e-liquid consumed, the vapor temperature, and the total
emissions of volatile aldehydes.
[cir] For ENDS, the battery type, battery current operating range,
battery failure safety features, battery conformance to standards, and
PDU current operating range are necessary for evaluating battery and
PDU safety. Risks of e-cigarette battery explosion, leakage, fire, or
overheating are a safety concern (Refs. 55 and 63). Similarly for HTPs
the battery current range gives an indication of the safe zone for the
battery to charge and what is considered its normal operating region;
if the battery levels go beyond the safe zone while charging, the
battery could be damaged, which could cause harm to the user.
[cir] For ENDS, the battery and PDU voltage impacts the amount of
e-liquid consumed, the vapor temperature, and the total emissions of
volatile aldehydes
[[Page 55257]]
(Ref. 65) Similarly for HTPs, the battery voltage indicates how much
current the battery can send out to the heating element. For the same
resistance, a higher voltage will send more current (and more watts) to
the heating element and it will produce more vapor. There is a link
between voltage and capacity because vaping at a higher wattage will
produce a higher current and that will reduce the amount of time you
can vape between charges. In addition, the voltage will influence the
vapor temperature, and in, turn smoke yields.
[cir] For ENDS, an increase in battery capacity (mAh rating) can
increase the number of puffs the e-cigarette can deliver per vaping
session. Longer vaping sessions may lead to greater exposure to
toxicant emissions (Ref. 58). Similarly for HTPs, the battery capacity
rating is a measure of the average amount of current the battery
releases over time under normal use. Current may influence the heating
element temperature, which in turn affects toxicant emissions and
nicotine delivery. In addition, battery mAh rating provides an
understanding of how long a battery will last and thus the product
stability.
[cir] For ENDS, the battery type, battery current operating range,
battery failure safety features, battery conformance to standards, and
PDU current operating range are necessary for evaluating battery and
PDU safety. Risks of e-cigarette battery explosion, leakage, fire, or
overheating are a safety concern (Refs. 55 and 63). Similarly for HTPs,
the battery charging temperature limits give insight on the safe range
for battery charging temperatures and testing will show if the software
of the battery can keep the battery in the safe zone.
[cir] For ENDS, the battery type, battery current operating range,
battery failure safety features, battery conformance to standards, and
PDU current operating range are necessary for evaluating battery and
PDU safety. Risks of e-cigarette battery explosion, leakage, fire, or
overheating are a safety concern (Refs. 55 and 63). Similarly for HTPs,
the battery discharge temperature limits give insight on the safe range
for battery discharging temperatures and testing will show if the
software of the battery can keep the battery in the safe zone.
[cir] For ENDS, the battery type, battery current operating range,
battery failure safety features, battery conformance to standards, and
PDU and battery current operating range are necessary for evaluating
battery and PDU safety. Risks of e-cigarette battery explosion,
leakage, fire, or overheating are a safety concern (Refs. 55 and 63).
Similarly for HTPs, the end of discharge voltage is the level to which
the battery voltage or cell voltage can fall before affecting the load.
This helps to establish the life cycle of the battery.
[cir] For ENDS, the battery type, battery current operating range,
battery failure safety features, battery conformance to standards, and
PDU and battery current operating range are necessary for evaluating
battery and PDU safety. Risks of e-cigarette battery explosion,
leakage, fire, or overheating are a safety concern (Refs. 55 and 63).
Similarly for HTPs, the maximum current at which the battery can be
charged continuously is usually defined by the battery manufacturer in
order to prevent excessive charge rates that would damage the battery
or reduce its capacity. Damage to batteries is a hazard to users.
[cir] For ENDS, the battery type, battery current operating range,
battery failure safety features, battery conformance to standards, and
PDU and battery current operating range are necessary for evaluating
battery and PDU safety. Risks of e-cigarette battery explosion,
leakage, fire, or overheating are a safety concern (Refs. 55 and 63).
Similarly for HTPs, the maximum current at which the battery can be
discharged continuously is usually defined by the battery manufacturer
in order to prevent excessive discharge rates that would damage the
battery or reduce its capacity. Damage to batteries is a hazard to
users.
[cir] For ENDS, the battery type, battery current operating range,
battery failure safety features, battery conformance to standards, and
PDU current operating range are necessary for evaluating battery and
PDU safety. Risks of e-cigarette battery explosion, leakage, fire, or
overheating are a safety concern (Refs. 55 and 63). Similarly for HTPs,
the battery upper limit charging voltage is important to limit the
maximum battery voltage during charging to prevent damage to the
battery, which is a hazard to users.
[cir] For ENDS, the battery and PDU voltage range may influence
volatile aldehydes emissions (Ref. 65). Similarly for HTPs, the battery
and PDU voltage impact the amount of e-liquid consumed, the vapor
temperature, and the total emissions of volatile aldehydes.
[cir] For ENDS, the Battery and PDU current operating range and
wattage range may influence the toxicant emissions (Refs. 57 and 59).
Similarly for HTPs, the PDU current operating range and wattage
operating range may influence the heating element temperature thereby
affecting toxicant emissions.
[cir] For ENDS, the battery type, failure safety features, and
battery conformance to standards are necessary for evaluating battery
and PDU safety. Risks of e-cigarette battery explosion, leakage, fire,
or overheating are a safety concern (Refs. 55 and 63). Similarly for
HTPs, the PDU temperature cutoff is an electrical safety product that
interrupts electric current when heated to a specific temperature to
protect the user.
[cir] For ENDS, the battery type, failure safety features, and
battery conformance to standards are necessary for evaluating battery
and PDU safety. Risks of e-cigarette battery explosion, leakage, fire,
or overheating are a safety concern (Refs. 55 and 63). Similarly for
HTPs, the current cutoff is an electrical cutoff, which is an
electrical safety product that interrupts electric current when a
specific condition is met (temperature, current, etc.) to protect the
user.
[cir] For ENDS, the battery and PDU current operating range may
influence the toxicant emissions (Refs. 57 and 59). Similarly for HTPs,
the batteries should have a normal operating current range so as to not
overheat the product and cause it to become a hazard to the user. In
addition, this current range has a direct impact on the heating
element, which in turn affects the smoke constituent yields.
[cir] Inhaled aerosol temperatures can be damaging or uncomfortable
to users who inhale aerosol above a certain temperature (Ref. 67).
[cir] For e-liquids, aerosol parameters such as particle number
concentration, count median diameter, and PM2.5 are used to
characterize the amount and size of particles to which the user is
exposed (Refs. 68 and 69). Similarly for HTPs, the aerosol parameters
such as particle number concentration, count median diameter, and
PM2.5 are used to characterize the amount and size of
particles to which the user is exposed. Clinical studies have shown
that exposure to large amounts of small particles can impair lung
function and is correlated with cardiovascular disease.
[cir] For cigarettes, filter pressure drop may affect smoke
constituent yields (Ref. 46). Similarly for HTPs, the filter pressure
drop may affect smoke constituent yields.
[cir] For cigarettes, filter diameter, denier per filament, total
denier, filter density, and filter length may affect filter efficiency
and, in turn, smoke constituent yields (Ref. 33). Similarly for the
HTPs, the filter diameter, denier per filament, total denier, filter
density, and filter length may affect filter efficiency and, in turn,
smoke constituent yields.
[[Page 55258]]
(Comment 61). Some comments provide information in response to the
proposed rule's request for comment on the appropriate design
parameters for cigars and pipe tobacco. These comments suggest the
following list as appropriate design parameters to be addressed for
cigars: Cigar length; ring gauge; total tobacco mass (including wrapper
mass, binder mass, and filler mass); and filter ventilation (if
applicable). One comment provided this list of appropriate design
parameters for pipe tobacco: Tobacco filler mass (mg); tobacco cut size
(mm); and tobacco moisture (%). One comment suggests that without
design parameters or testing information related to cigar, hookah, pipe
tobacco and other comments, the rule is deficient and further states
that the final rule must include content requirements for each product
category and subcategory.
(Response 61) As discussed earlier in this section, following
consideration of these comments, FDA has added design parameters for
cigars, pipes, waterpipes, and other tobacco products to this section.
Note that FDA does not consider a tobacco product to be ``new'' if
there are variations that fall within the product's specifications. So
long as the product is manufactured within specified parameters, FDA
would not consider variations within these parameters to be a design
change that would result in a new tobacco product. It is also important
to note that at this time, FDA does not intend to enforce the premarket
requirements of sections 910 and 905(j) for tobacco blending changes
required to address the natural variation of tobacco (e.g., blending
changes due to variation in growing conditions) in order to maintain a
consistent product. FDA agrees with the commenter's suggested list of
appropriate design parameters for pipe tobacco.
Comparison of Heating Sources (Sec. 1107.19(b))
In the following paragraphs, we describe the comments and our
responses on Sec. 1107.19(b). We are finalizing this subsection
without change.
(Comment 62) One comment states that the information required by
proposed Sec. 1107.19(b), which states that the SE Report must include
a description of the heating source for the new and predicate tobacco
products and identify any differences, or the report must state that
there is no heating source in the product, is similar to the previously
submitted ingredient listing information. The comment asserts that
requiring manufacturers to submit this information a second time is
unnecessary and would lengthen FDA's review of the SE Report.
(Response 62) Section 910(a)(3)(B) of the FD&C Act specifically
identifies the heating source as one of the characteristics of a
tobacco product that FDA must consider in determining whether a new
tobacco product is substantially equivalent to a predicate tobacco
product. We disagree that information describing the heat source of the
products being compared in an SE Report is similar to or duplicative of
previously submitted ingredient listing information. Although there
will likely be some overlap, the ingredient listing requirement under
section 904 of the FD&C Act (21 U.S.C. 387d) is a separate requirement
from the requirement to submit ingredient information in a premarket
application. It is necessary to receive ingredient information in an SE
Report because a finding of substantial equivalence is based on a side-
by-side listing of quantitative and qualitative comparisons of all
product characteristics that differ between a new and predicate tobacco
product.
Comparison of Product Composition (Sec. 1107.19(c))
In the following paragraphs, we describe the comments and our
responses on Sec. 1107.19(c). As discussed in the introductory
paragraphs to Sec. 1107.19, we are finalizing this subsection with
minor clarifying changes.
(Comment 63) Two comments took issue with the requirement in Sec.
1107.19(c) that information on ``[t]he type of tobacco, including grade
and variety'' be submitted in an SE Report. These comments assert that
the Department of Agriculture grading system would not be useful
because they claim that it is not uniformly used by farmers and
manufacturers. Instead, they noted that each farmer and manufacturer
has its own unique grading system and that a written record may not
exist for such system.
(Response 63) FDA has decided to remove the requirement in Sec.
1107.19(c) that applicants provide information regarding the grade and
variety of tobacco type in their SE Reports. FDA agrees with the
comments that tobacco grading is not uniform throughout the industry,
which reduces the utility of this information in application review. In
addition, FDA does not need to characterize the tobacco type to the
level of detail of tobacco variety for the purposes of an SE
evaluation. Instead, information regarding the tobacco curing process
is more useful to FDA to characterize and analyze the tobacco used in
the tobacco products and tobacco products in general. FDA is still
requiring that the tobacco type (e.g., Bright, Burley, Oriental) and
curing process (e.g., fire-cured, flue-cured, air-cured) be provided in
SE Reports. As described in the proposed rule, the tobacco type impacts
the characteristics of the products as different types have different
smoke constituent profiles, including potentially different HPHC
profiles (Refs. 71 and 72). The curing process also can impact HPHC
profiles (Ref. 73).
Comparison of Other Features (Sec. 1107.19(d))
In the following paragraphs, we describe the comments and our
responses Sec. 1107.19(d). We are finalizing this subsection with the
minor clarifying changes as described in the introductory paragraphs to
Sec. 1107.19.
(Comment 64) Section 1107.19(d) lists the other features that must
be included in an SE Report. One such other feature listed in Sec.
1107.19(d) are HPHCs. Several comments express concern with the
proposed requirement that data from two smoking regimens be submitted
for combusted tobacco products. They state that this requirement would
lead to an unnecessary and significant increase in testing burden with
no corresponding benefit. However, one comment contends that, if
constituent yields were reported from a single smoking regimen only,
FDA would have limited and potentially misleading information about
constituent yields produced by a given product.
(Response 64) We disagree that mainstream smoke data from two
smoking regimens (non-intense and intense) should not be required. Each
of these regimens provides unique information on the HPHCs generated by
the tobacco product under different pyrolysis conditions (i.e., varying
amounts of oxygen due to smoker use). Studies have shown identical
tobacco products smoked using a non-intense smoking regimen differ in
the formation of volatile organic compounds (VOCs) and aldehydes than
when smoked using an intense smoking regimen. A non-intense smoking
regimen can provide the upper range of aldehydes generated from smoking
while an intense smoking regimen can provide the upper range of VOCs
generated from smoking. Exposure to VOCs and aldehydes results in an
increased risk of cancer and respiratory disease, and for some of these
VOCs and aldehydes tobacco smoke is the primary source of non-
occupational exposure in the U.S. population (Ref. 74). Aldehydes, such
as
[[Page 55259]]
formaldehyde, have been classified as class 1 carcinogens by the
International Agency for Research on Cancer. A 2018 study (Ref. 75)
shows aldehyde (formaldehyde, acrolein, acetaldehyde, and
crotonaldehyde) formation may increase nonlinearly, up to six times
more in a non-intense smoking regimen than in an intense smoking
regimen. Another study showed there is a disproportionate increase in
monoaromatic VOCs under a smoking regimen where the filter ventilation
is blocked (i.e., intense smoking regimen) compared to a non-intense
smoking regimen (Ref. 76). Thus, the current state of science
indicates: (1) There is a nonlinear correlation between the smoke data
obtained by a non-intense compared to an intense smoking regimen and
(2) due to variations in the oxygen environment during pyrolysis,
different VOCs and aldehydes are formed in a non-intense smoking
regimen than those formed in an intense smoking regimen.
Finally, considering smoke data from only one smoking regimen would
result in an incomplete assessment of smoker exposure. A non-intense
and intense smoking regimen provides an upper and lower range of HPHCs
that are generated during the use of a combusted tobacco product;
consequently, it is necessary that FDA evaluate smoke data obtained by
both intense and non-intense smoking regimens.
(Comment 65) Several comments expressed concern regarding the
requirement in proposed Sec. 1107.19(d) that HPHC data be submitted,
particularly as it relates to cigars, given the variety of cigars and
the variability of several smoke HPHCs in filler HPHC data, the lack of
smoke testing methodologies, for example, for pipes and cigars, costs
of HPHC testing, and insufficient laboratory capacity. One comment also
notes that FDA has not clarified which HPHCs will be required to be
reported for any cigars. A few comments also maintain that FDA has not
provided substantial evidence that the testing will yield meaningful
results. In addition, one comment claims that FDA should not require
that HPHC testing be included in an SE Report because the FD&C Act does
not require it be included. One comment encourages FDA to ensure that
analytical methods are appropriately validated.
(Response 65) We disagree that HPHC data should not be required in
an SE Report. In determining whether a new tobacco product is
substantially equivalent, it is important for FDA to understand what is
placed into the product (e.g., ingredients), as well as what comes out
of the product and what is, or potentially is, inhaled, ingested, or
absorbed in the body (e.g., HPHCs). HPHCs are of particular importance,
as they may be carcinogens and/or respiratory, cardiovascular, and/or
reproductive or developmental toxicants.
With respect to the comments on the lack of smoke testing
methodologies, we note that there are some cigar smoking methods that
are applicable to many commercially available products, including
larger cigars.\19\ The cost of testing will be dependent upon a variety
of factors related to the new tobacco product, including the product
characteristics and proposed modifications (e.g., minor changes to
ingredients may need no or limited testing information while more
significant changes to tobacco blend or ingredient changes in higher
quantities may require a higher number of HPHCs tested or more
voluminous data). In general, the cost of testing information necessary
to submit with an SE Report to determine substantial equivalence is not
disproportionate for any product category. FDA acknowledges that
applicants may rely on third party laboratories, the SE program has
been in existence for many years, and FDA has received thousands of SE
Reports, including SE reports containing information obtained from
third party laboratories. Additionally, we anticipate laboratory
capability and capacity will continue to expand over time to meet the
needs of future applicants.
---------------------------------------------------------------------------
\19\ See, e.g., the following CORESTA standards: CORESTA
Reference Method (CRM) 65: Determination of Total and Nicotine-Free
Dry Particulate Matter using a Routine Analytical Cigar-Smoking
Machine--Determination of Total Particulate Matter and Preparation
for Water and Nicotine Measurements; CRM 66: Determination of
Nicotine in the Mainstream Smoke of Cigars by Gas Chromatographic
Analysis; CRM 67: Determination of Water in the Mainstream Smoke of
Cigars by Gas Chromatographic Analysis; CRM 68: Determination of
Carbon Monoxide in the Mainstream Smoke of Cigars by Non-Dispersive
Infrared Analysis.
---------------------------------------------------------------------------
Shelf Life and Stability Information (Sec. 1107.19(f))
In the following paragraphs, we describe the comments and our
responses on Sec. 1107.19(f) (in the proposed rule, this was proposed
as Sec. 1107.19(e), stability information). We are finalizing
subsection (f) with the changes described in the introductory
paragraphs to Sec. 1107.19.
(Comment 66) Proposed Sec. 1107.19(e) (now subsection (f))
requires the submission of stability information for smokeless tobacco
products and any other tobacco product that contains fermented tobacco.
Several comments dispute that stability information is a relevant
testing parameter. The comments also claim that FDA cannot require
stability testing without substantial evidence regarding its necessity,
and that FDA has not met this requirement.
(Response 66) We disagree. TSNAs are carcinogenic compounds that
are present at very low levels in freshly harvested tobacco leaves but
can increase dramatically during tobacco processing and storage (Refs.
10, 19-21, 77, 78). TSNA production is critically influenced by the
microbial communities associated with the tobacco. Microbial-mediated
reduction of nitrate results in production of nitrite, which further
reacts with alkaloids present in tobacco to produce the carcinogenic
TSNAs (Refs. 17, 18, 20, 79-82). Therefore, TSNA content in the
finished tobacco products is greatly affected by a variety of factors
such as tobacco processing method(s) (e.g., curing, aging, sweating,
fermentation, heat treatment), product composition (e.g., humectants,
preservatives), container closure system, and product storage
conditions (e.g., temperature, humidity), all of which could
potentially alter microbial activity and, in turn, affect the stability
of the tobacco product over the shelf life. Since bacterial communities
and constituents in tobacco products can potentially change over the
shelf life (Refs. 17, 83, 84), information obtained through stability
testing is important for FDA to consider during its review to ensure
that the tobacco products are microbiologically and chemically stable
during storage and do not result in an increased risk to public health
as the product sits in storage as compared to the predicate tobacco
product.
Comparison to Original Predicate Tobacco Product (Sec.
1107.19(h))
In the following paragraphs, we describe the comments and our
responses on Sec. 1107.19(h) (proposed Sec. 1107.19(g)). We are
finalizing this subsection with the changes described in the
introductory paragraphs to Sec. 1107.19, including changes for
consistency with the updated definition of predicate tobacco product.
We received several comments related to this proposed subsection.
In the proposed rule, we explained that FDA may request that the
applicant include information related to the ``original'' predicate
tobacco product (a tobacco product that was commercially marketed
(other than for test marketing) in the United States as of February 15,
2007), even if the original predicate tobacco product is back several
[[Page 55260]]
predicate tobacco products. Due to the removal of the definition of
``grandfathered,'' we are no longer using the term grandfathered
tobacco product in this section. We describe the comments and responses
on this subsection in the following paragraphs.
(Comment 67) One comment states that FDA has underestimated the
burden that would be imposed by the proposed requirement that a new
tobacco product be compared to the original predicate tobacco product.
Other comments object to the proposed requirement arguing that it could
foster anti-competitive competition and create an imbalance in the
industry in favor of large manufacturers that can afford to maintain a
large pool of tobacco products. In addition, they assert that smaller
companies will risk non-compliance given the costs associated with
complying with the rule and that the cost of compliance may cause
companies to raise prices on their goods. Instead of requiring this
information, the comments suggest FDA should instead rely on data the
Agency currently has including data from previously submitted SE
Reports. Another comment suggests that this interpretation also is
inconsistent with FDA's position that only a single predicate can be
used as the basis for an SE determination because the interpretation
suggests that applicants that use as a predicate a tobacco product that
was previously found SE ``must demonstrate multiple levels of
substantial equivalence and support multiple comparisons in a single
application.''
(Response 67) We disagree that this requirement should or even
could be deleted. This is because, as explained in the proposed rule,
although an applicant can support a showing of SE by comparing the new
tobacco product to a predicate tobacco product that was commercially
marketed (other than for test marketing) in the United States as of
February 15, 2007, 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
(other than for test marketing) 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
predicate tobacco product that the new product would actually raise
different questions of public health compared to the original predicate
tobacco product. New products with differences that may appear only
incremental when a new tobacco product is compared to a predicate
tobacco product previously found SE can lead to product ``creep,''
which could result in the new tobacco product actually having
significant changes when compared to the original predicate tobacco
product. Issuance of an order under section 910(a)(2)(A)(i)(I) of the
FD&C Act would undermine the public health purposes of the Tobacco
Control Act (section 3) by permitting significant product evolution
over time that raises different questions of public health. Such
products should be submitted for premarket authorization through the
PMTA pathway, which requires an applicant to demonstrate that their
product is ``appropriate for the protection of the public health.'' FDA
would only request the information described in Sec. 1107.19(h) 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 original predicate tobacco product as a predicate
product, to make this finding. If FDA is unable to make the finding
required by section 910(a)(2)(A)(i)(I) of the FD&C Act based on the
information in its files, and the applicant does not provide the needed
information when requested, FDA would not be able to issue an order
authorizing the new tobacco product. We disagree with the comments
suggesting this requirement favors large companies or would lead to
anti-competitive behavior as we expect that companies, regardless of
size, maintain records such as these as part of their business
practices. We note that FDA expects to be able to make the finding
required by section 910(a)(2)(A)(i)(I) of the FD&C Act based on the
information in its files in the vast majority of circumstances, and
thus only expects applicants to need to provide additional information
in unusual circumstances. In response to the comment that suggests that
FDA's ``look-back'' approach effectively implements an SE process
relying on multiple predicates, we note that where FDA must compare the
new product to the original predicate tobacco product in addition to
the selected predicate, each of those comparisons involves an
evaluation comparing a singular new product to a singular predicate.
(Comment 68) One comment states that FDA's proposed requirement
means that specifications and measurements for the original predicate
tobacco products be submitted, and because those data were not required
at the time the original predicate tobacco product was originally
manufactured, would essentially be requiring the manufacturer to
retroactively adopt certain design and manufacturing requirements for
products. Other comments state that applicants would have to
manufacture the original predicate tobacco products in order to comply
with the proposed requirements. One comment added that the requirement
would decrease clarity, efficiency, and predictability during the SE
review process. Some comments state that while it is appropriate to
``compare key design parameters'' to determine whether a new product
has the same or different characteristics as a predicate tobacco
product, the FD&C Act does not give FDA the authority to retroactively
impose design requirements on tobacco products, especially for
provisional tobacco products that were designed, manufactured, and
marketed before the Act required submission of SE Reports. Instead, the
comments assert that FDA must issue a regulation under section 906(e)
to impose design criteria and that such regulation must be independent
of the SE framework. One comment instead proposes a framework that
would require the manufacturer to provide the specifications employed
in designing the new and predicate product, confirm that those
specifications were met in manufacturing the product for HPHC testing,
and then compare the output to determine whether there is a difference
in disease risk posed.
(Response 68) We disagree that this section requires applicants to
retroactively adopt or impose certain design and manufacturing
requirements for original predicate tobacco products. FDA is not
imposing design parameters on original predicate tobacco products and
section 906(e) of the FD&C Act does not apply here. Rather, this
section is intended to make applicants aware that in certain cases FDA
may need to request information related to the original predicate
tobacco product 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. As
explained in a preceding response, before requesting this information
from the applicant, FDA would review its own files for other relevant
SE Reports in the chain, for example, the first SE Report that received
an SE order using the original
[[Page 55261]]
predicate tobacco product as a predicate product to make this finding.
(Comment 69) Some comments object to the proposed requirement that,
if an applicant is using as a predicate a tobacco product found SE by
FDA, and not one that is considered the original predicate tobacco
product, FDA may request information related to the original predicate
tobacco product. The comments dispute that applicants should have to
comply with FDA's ``look back'' approach because under section 905(j)
of the FD&C Act, an applicant may compare a new tobacco product to
either a tobacco product commercially marketed (other than for test
marketing) in the United States as of February 15, 2007, or a product
previously found to be substantially equivalent. The comments also
claim that the proposed requirement allowing FDA to request this
information is in conflict with Congressional intent, and presents
other issues, including preventing tobacco products from evolving by
locking products into their 2007 composition, difficulty for applicants
in obtaining data on the 2007 product, and inconsistency with FDA's
proposed requirement that applicants maintain records for four years
since this provision would require records in perpetuity if FDA could
reach back to the 2007 product.
(Response 69) We disagree with these objections as manufacturers
have been on notice since the passage of the Tobacco Control Act that
FDA is required to make the comparison between the new tobacco product
and the original predicate tobacco product, and, in doing so, may need
to rely on previously submitted SE Reports, including those submitted
by a different manufacturer. As discussed in the proposed rule, the
statute permits an applicant to compare its new tobacco product to
either a tobacco product commercially marketed (other than for test
marketing) in the United States as of February 15, 2007, or one that
FDA has previously found SE (section 905(j)(1)(A)(i) of the FD&C Act).
However, the statute also requires FDA to make an SE determination by
comparing the new tobacco product to a tobacco product commercially
marketed (other than for test marketing) in the United States as of
February 15, 2007 (section 910(a)(2)(A)(i)(I) of the FD&C Act).
Therefore, to meet its statutory obligation, FDA may need to look back
to previously submitted SE Reports in the SE chain that relied on the
original predicate tobacco product in order to issue an SE order. 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
predicate tobacco product that the new product would actually raise
different questions of public health compared to the original predicate
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 original predicate tobacco product. Should this be
the case, such that FDA cannot issue the determination required under
section 910(a)(2)(A)(i)(I), the statute also provides alternative
premarket pathways.
(Comment 70) Another comment supports the proposed requirement to
include the information regarding the original predicate tobacco
product in the SE Report. The comment states that successive iterations
of SE Reports, each referencing a predicate product that is not itself
the original predicate tobacco product, would attenuate the
relationship between the new tobacco product and the original predicate
tobacco product, thereby introducing products that are not
substantially equivalent to any product actually commercially marketed
(other than for test marketing) on February 15, 2007.
(Response 70) We agree with this comment and have maintained this
requirement without change from the proposed rule.
Other Comments on Comparison Information
(Comment 71) A few comments request that we provide further clarity
on the comparison information required to be submitted for cigars and
ENDS, and particularly more clarity with respect to required HPHC
information. Some comments suggest specific cigar design parameter
information that should be included, such as cigar length,
circumference, wrapper mass, binder mass and filter ventilation.
Another comment states that is inappropriate for FDA to require cigar
manufacturers to include wrapper material as part of the product
properties information to be submitted since whole leaf tobacco is the
wrapper material.
(Response 71) FDA is providing additional clarity related to
comparison information for deemed tobacco products in this final rule.
Following our consideration of the comments and based on our
experience, FDA has added information to Sec. 1107.19 to address these
concerns, including as suggested by at least one comment, cigar
parameter information (cigar length, circumference, wrapper mass,
binder mass, and filter ventilation) as well as additional product
parameters that vary based on cigar construction (e.g., unfiltered,
hand rolled). We disagree that it is inappropriate to require
information on wrapper material as part of the reported cigar product
properties, as the composition of the wrapper will contribute to
changes in smoke constituent delivery to the user.
With respect to HPHC information, as defined in this rule and
discussed in the proposed rule, HPHCs are a subset of the chemical and
chemical compounds in the tobacco product, including cigars, or its
tobacco smoke or emission and, accordingly, the SE Report for a cigar
must include the HPHC information necessary to provide a complete
comparison between the new and predicate tobacco products. CORESTA \20\
has established and published methods on how to generate cigar smoke in
order to quantitatively compare HPHCs found in cigar smoke. We also
recommend that applicants that wish to submit a premarket application
for a new ENDS, cigar, or other tobacco product consider 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, see https://www.fda.gov/media/80109/download),
which FDA intends to update in the future. Although this guidance
document does not break out the information for those specific tobacco
product categories, this guidance document may still provide useful
information for these products; additionally, applicants may request a
meeting to discuss these and other issues and, as noted in the proposed
rule, FDA will make every attempt to grant requests for meetings to
resolve important issues (see, e.g., the guidance entitled ``Meetings
with Industry and
[[Page 55262]]
Investigators on the Research and Development of Tobacco Products''
(May 25, 2012, 77 FR 31368; revised guidance issued July 2016, see
https://www.fda.gov/media/83420/download)).
---------------------------------------------------------------------------
\20\ CORESTA standards that applicants might consider include
CORESTA Reference Method (CRM) 46: Atmosphere for Conditioning and
Testing Cigars of all Sizes and Shapes; CRM 47: Cigars--Sampling;
CRM 64: Routine Analytical Cigar-Smoking Machine--Specifications,
Definitions and Standard Conditions; CRM 65: Determination of Total
and Nicotine-Free Dry Particulate Matter using a Routine Analytical
Cigar-Smoking Machine--Determination of Total Particulate Matter and
Preparation for Water and Nicotine Measurements; CRM 66:
Determination of Nicotine in the Mainstream Smoke of Cigars by Gas
Chromatographic Analysis; CRM 67: Determination of Water in the
Mainstream Smoke of Cigars by Gas Chromatographic Analysis; CRM 68:
Determination of Carbon Monoxide in the Mainstream Smoke of Cigars
by Non-Dispersive Infrared Analysis.
---------------------------------------------------------------------------
4. Amendments (Sec. 1107.20)
We proposed in Sec. 1107.20 to establish how and when applicants
may submit amendments to an SE Report, including information on when a
redacted copy of the amendment might need to be submitted. The proposed
section provided that an applicant could not amend an SE Report to
change the predicate tobacco product and that an applicant could not
amend an SE Report after FDA closed the report under proposed Sec.
1107.44 or the report was withdrawn under proposed Sec. 1107.22. The
proposed provision also stated that amendments would generally be
reviewed in the next review cycle as described in proposed Sec.
1107.42. Following our review of comments on this section, we are
finalizing the section without change. We describe the comments on this
section in the following paragraphs.
(Comment 72) One comment disagrees with the proposed requirement
that an applicant could not amend an SE Report to change the predicate
after the report is accepted for review. This comment states that
permitting applicants to change a predicate prior to the initiation of
scientific review is important for products covered by FDA's current
compliance policy for deemed new tobacco products that were on the
market on August 8, 2016, as withdrawal of a timely submitted SE Report
would impact the marketing status of the product.
(Response 72) We disagree that applicants should be permitted to
change the predicate tobacco product identified in an SE Report that
FDA has accepted for review. As stated in the proposed rule, changing
the predicate product changes the fundamental basis of the analysis, as
the comparison between the new and predicate tobacco products is the
crux of the SE determination. Unless FDA refuses to accept the SE
Report (Sec. 1107.40), FDA intends to issue an acceptance for review
letter and then begin to review the SE Report . Therefore, there is no
time to change the predicate tobacco product between FDA's acceptance
of an SE Report for review and FDA's initiation of the review. If an
applicant determines that a predicate change is necessary, they should
withdraw the initial SE Report and resubmit it as a new SE Report with
the information related to the new predicate tobacco product.
5. Withdrawal by Applicant (Sec. 1107.22) and Change in Ownership of
an SE Report (Sec. 1107.24)
Proposed Sec. 1107.22 would establish when and how an applicant
may withdraw an SE Report. We received no comments on this proposed
section, and we are finalizing the section with one substitute of
``part 20'' for Sec. 20.45. Proposed Sec. 1107.24 would establish the
procedures for transferring ownership of an SE Report. We received no
comments on this proposed section, and we are finalizing the section
without change.
E. Comments on Subpart D--FDA Review and FDA Responses
In this subpart, FDA proposed requirements related to FDA review of
an SE Report, including how FDA would communicate with an applicant,
review cycles, and FDA's actions on an SE Report, including issuance of
orders and rescission of orders. Following our review of the comments,
we are finalizing Sec. 1107.40 with a minor change to reflect that,
after receiving an SE Report, FDA will either refuse to accept the
report for review or issue an ``acceptance for review'' letter rather
than an ``acknowledgement'' letter, as proposed. We revised Sec.
1107.44(a) to add a reference to Sec. 1105.10 (refuse to accept). We
revised Sec. Sec. 1107.42, 1107.44, 1107.46, and 1107.48 for
consistency with the updates to the definition of predicate tobacco
product. We also revised Sec. 1107.42(c) to replace a ``will'' with
``generally intends to'' to provide the Agency with some discretion
following receipt of a deficient SE Report. We also revised Sec.
1107.50 pertaining to the opportunity for a hearing in a rescission
action, and we describe those revisions in more detail in the
paragraphs related to that section.
We note that in addition to the general comments we received on
this subpart, in the proposed rule, FDA invited comment on two issues:
The appropriate amount of time to allow applicants to respond to a
deficiency letter and when extensions of time should be granted. In
response, some comments discuss FDA's review process generally, and
many of these comments recommend that FDA change the timeframes for
review and response.
In the following paragraphs, we describe the comments we received
on this proposed subpart and our responses.
1. Comments on Communications Between FDA and Applicants (Sec.
1107.40)
Proposed Sec. 1107.40(a) provided for general principles regarding
communications between applicants and FDA and the form of these
communications, e.g., phone conversations, letters, email. Proposed
Sec. 1107.40(b) addressed the purpose of meetings and that FDA would
make every attempt to grant meeting requests for important issues.
Proposed Sec. 1107.40(c) described how FDA would acknowledge an SE
Report, and proposed Sec. 1107.40(d) stated that FDA would make
reasonable efforts to communicate to applicants the deficiencies found
in an SE report and any additional information needed for FDA's review.
This section also stated that applicants must provide additional
comparison information under proposed Sec. 1107.19 if requested by
FDA. Following our review of comments to this proposed section, we are
finalizing the section by replacing ``acknowledgement'' with
``acceptance for review'' in paragraph (c).
(Comment 73) Some comments state that FDA should grant meetings
with industry while an SE Report is pending and when FDA requests
scientific information or testing in the pending SE Report. The
comments reason that meetings during the review process serve to
clarify and improve the quality of information required, and improve
the timelines for future actions. Another comment notes that a phone
conversation could help advance the review process for a request for a
determination that a product was commercially marketed in the United
States as of February 15, 2007 (Pre-Existing tobacco product).
(Response 73) FDA agrees that opportunities can be helpful to
clarify the information being requested, e.g., in a deficiency letter
with an applicant. In addition, FDA intends to use a variety of methods
to communicate with applicants depending on the circumstances and
issues, including but not limited to, telephone conversations, letters,
and/or emails, and, therefore, in many cases a formal meeting may not
be necessary. If there are complex scientific issues that require
discussion, an applicant may request a meeting to discuss these and
other issues and, as noted in the proposed rule, FDA will make every
attempt to grant requests for meetings to resolve important issues.
However, fundamental scientific issues should be the subject of meeting
requests prior to submitting an SE Report (see, e.g., the guidance
entitled
[[Page 55263]]
``Meetings with Industry and Investigators on the Research and
Development of Tobacco Products'').
(Comment 74) One comment argues that FDA should communicate
deficiencies in SE Reports to applicants prior to issuing an NSE order.
A comment requests that FDA establish dispute resolution procedures
that include a mechanism for stay of an NSE order for a provisional
tobacco product, and that during this period of time, FDA should be
barred from making it known that the product was found to be NSE given
the potentially serious business consequences of such a disclosure.
(Response 74) We note that Sec. 1107.42(b) provides for the use of
multiple review cycles allowing FDA to communicate procedural,
administrative, or scientific deficiencies found during a review,
rather than issuing an NSE order. There may be cases where it is in
FDA's and/or the applicant's interest to not issue deficiency letters
but rather issue an NSE order, and, as customary, FDA generally intends
to outline the deficiencies that are the basis for the decision. This
will allow applicants to consider the deficiencies and consider the
best course to address the deficiencies identified in their NSE order
letter. An applicant has the option to request a meeting with FDA, if
they choose, and FDA intends to make every effort to grant pre-
submission meetings with applicants to discuss the scientific
principles in their NSE determination and how best to prepare a
subsequent premarket application. In addition, the scope of this rule
is SE Reports for new, non-provisional products, which should not be on
the market during FDA's review. FDA intends to comply with the
requirements related to disclosure of information in 21 CFR part 20 and
Sec. 1107.60. If an applicant wishes to dispute the issuance of an NSE
order, they may request supervisory review of FDA decisions under Sec.
10.75 (21 CFR 10.75).
2. Comments on Review Cycles (Sec. 1107.42)
Proposed Sec. 1107.42 addressed review cycles and explained what
an initial review cycle is, as well as when additional review cycles
would occur and what would happen if FDA issued a deficiency
notification. Following our review of comments, we are finalizing this
section with a minor change to add ``(other than for test marketing)''
following commercially marketed in paragraph (a).
(Comment 75) Several comments state that FDA should set clear
deadlines for the review process. One comment suggests that FDA's rule
should establish a 90-day review timeline noting that Congress directed
that FDA review ``the more rigorous PMTA applications for new and novel
products'' ``no later than 180 days after receiving the application.''
(Response 75) FDA agrees that review timeframes are important for
both FDA and industry. Thus, in general, FDA intends to review SE
Reports and either issue a deficiency letter or make a final
determination within 90 calendar days of receipt of the SE Report or
amendment as proposed in Sec. 1107.42(a).
(Comment 76) One comment disagrees with the review cycles set out
in the proposed rule (initial review, at least one scientific Advice/
Information request, and one preliminary finding letter), which could
mean that review could take 270 days. Some comments support the
proposed review process of three review-cycles, noting it provides
appropriate time and resources for industry and FDA.
(Response 76) We agree with those comments that support the three
review-cycle process as providing appropriate timeframes. Although the
FD&C Act does not require FDA to provide multiple review cycles, FDA
has provided this framework to help applicants. This final rule
provides additional predictability to this review process by
establishing timeframes for both FDA's review and the applicant's
response. As the proposed rule explained, FDA's intent is to complete
review of an SE Report submitted under 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, sometimes fewer. If fewer review cycles are needed, FDA intends
to decide in a shorter time period, and we expect that this rule will
result in a decrease in the average number of review cycles needed to
issue an order. As the tobacco industry and we continue to gain
experience with submitting and reviewing, respectively, our goal would
be to complete SE reviews in shorter timeframes.
It is ultimately the applicant's responsibility to provide a
complete SE Report that supports a scientific finding of substantial
equivalence. If the applicant receives a deficiency letter and cannot
respond within the specified timeframe, they have the option to
withdraw and resubmit the SE Report with the required content.
(Comment 77) Some comments propose that FDA issue a notice of
refusal to accept an SE Report for review within five business days of
receipt of the report. Other comments propose that an acknowledgement
or refusal to accept letter should be issued within 10 business days,
and that applicants have a reasonable period of time to respond, such
as 30 or 60 days, with a request that for the first five deficiencies,
FDA provide 60 days to respond. The comments also assert that the time
permitted to respond to a deficiency letter should be based on factors
such as the size of the company submitting the SE report and the type
or number of deficiencies identified by FDA. Some comments state that
FDA should provide 180 days for applicants to respond to deficiency
letters without regard to the type or number of deficiencies. The
comments propose a similar approach to extension requests, noting that
the extensions should be given on a case-by-case basis, with
consideration given to the nature of the request.
(Response 77) The rule will provide predictability to the review
process with timeframes for both FDA review and applicant response. As
already stated, it is the applicant's responsibility to provide a
complete SE Report that supports a scientific finding of substantial
equivalence. With respect to issuance of a refuse to accept letter, FDA
has established performance goals of 21 calendar days. This action
closes the SE Report; therefore, an applicant would need to submit a
new SE Report in order to obtain premarket authorization through the SE
pathway. For an SE Report that is accepted for review, and for which
the applicant receives a deficiency letter to which it cannot respond
within the specified timeframe, the applicant has the option to
withdraw and resubmit the SE Report with the required information. With
respect to deficiency timeframes being based on the size of the
manufacturer or the number of deficiencies involved, FDA is committed
to following a consistent and transparent process for all submitters of
SE Reports. As an SE Report should be complete upon submission to the
Agency, if an applicant is unable to respond to the number of
deficiencies in the timeframe provided in the letter, the applicant has
the option to withdraw and resubmit the SE Report with the required
information. FDA will review all subsequent applications without
prejudice.
3. FDA Action on an SE Report (Sec. 1107.44) and Issuance of an Order
Finding a New Tobacco Product Substantially Equivalent
Proposed Sec. 1107.44 listed the actions FDA could take after
receipt of an SE
[[Page 55264]]
Report. We received no comments on this proposed section, and we are
finalizing the section with a minor change to add ``for review'' and a
reference to Sec. 1105.10 (to ensure applicants are aware of that
provision). Proposed Sec. 1107.46 explained when FDA would issue an
order finding a new tobacco product substantially equivalent. We
received no comments on this proposed section, and we are finalizing
the section without change.
4. Issuance of an Order Denying Marketing Authorization (Sec. 1107.48)
Proposed Sec. 1107.48 explained when FDA would issue an order that
the new tobacco product cannot be marketed. After considering the
comment on this proposed section, we are finalizing the section without
change. We describe the comment and our response in the following
paragraphs.
(Comment 78) One comment requests that FDA include a dispute
resolution mechanism for those applicants that seek to challenge an
adverse decision by FDA. The comment asserts that manufacturers whose
products are removed from the market while NSE orders are pending
appeal are harmed when the Agency does not have a formal mechanism to
challenge the decision beyond 21 CFR part 10.
(Response 78) As discussed in previous paragraphs, this rule
applies to new, non-provisional SE Reports, not provisional SE Reports.
In general, tobacco products that are the subject of non-provisional SE
reports should not be on the market prior to FDA making an SE or NSE
determination. Therefore, no products would need to be removed from the
market during supervisory review of an NSE determination. Applicants
who wish to dispute an NSE finding can use Sec. 10.75.
5. Rescission of an Order and FDA Response (Sec. 1107.50)
Proposed Sec. 1107.50 set out the grounds for rescinding an SE
order and providing notice of the opportunity for a hearing related to
the Agency's intention to rescind. We are finalizing this section with
some clarifications to reflect the updated definition of predicate
tobacco product, as well as additions related to when notice of an
opportunity for a hearing will be offered. As described in the proposed
rule, FDA will generally rescind an order only after notice of an
opportunity for a hearing under 21 CFR part 16 (hereinafter a Part 16
hearing). However, also as described in the proposed rule, FDA may
rescind an order prior to notice of an opportunity for a hearing 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 a notice of an opportunity
for a hearing as soon as possible after the rescission. In addition,
FDA has revised Sec. 1107.50(b) to add paragraphs (i)-(iii) as a means
of more clearly explaining that FDA may rescind an order without notice
of an opportunity for a Part 16 hearing where an entity that has, on
its own initiative, identified a mistake, notified the Agency of the
mistake, and agreed to a rescission of the marketing order of the
tobacco product without the need for a Part 16 hearing. In this narrow
circumstance, providing notice of an opportunity for a hearing is an
unnecessary procedural step as the applicant has already informed the
Agency that they would not request a Part 16 hearing. Other than these
two circumstances, FDA will offer notice of an opportunity for a Part
16 hearing prior to rescission, as described in Sec. 1107.50(b). We
received comments on this proposed section, and we respond to those in
the following paragraphs.
(Comment 79) Some comments object to Sec. 1107.50 of the proposed
regulation which provides the grounds for rescinding an SE order. The
comments state that FDA was not granted authority to rescind an SE
order, in contrast to FDA's express authority to withdraw a PMTA or
modified risk tobacco product order. One comment objects to FDA's
reliance in the proposed rule on Ivy Sports Med. LLC v. Burwell, 767
F.3d 81, 86 (D.C. Cir. 2014) (hereinafter Ivy Sports) as misplaced
because Congress did not confer rescission authority for SE orders.
This comment notes that Congress ``plainly intended to displace any
[rescission] authority here'' as it provided misbranding, adulteration,
and recall authorities to address SE orders based on false information
or unanticipated safety issues. Other comments state that if the
rescission provision is maintained, FDA should include clear
definitions and specific time limits.
(Response 79) We disagree with the comments that suggest FDA cannot
or should not rescind SE orders when the grounds set out in Sec.
1107.50 exist. As explained in the proposed rule, this provision is
based on our authority to issue an order when we can make the findings
in section 910(a)(2)(A)(i) of the FD&C Act, as well as our authority in
section 701 (related to issuing regulations for the efficient
enforcement of the FD&C Act). Moreover, as explained in the proposed
rule, this section is also based on FDA's inherent authority to timely
revisit and reconsider prior decisions, as discussed in Ivy Sports.
Although misbranding, adulteration, and recall authorities are
important authorities that can be used to address safety and other
issues related to a tobacco product, Sec. 1107.50 will work in tandem
with those authorities to protect the public health. For example, under
Sec. 1107.50, FDA may rescind a substantially equivalent order if the
applicant has removed the new tobacco product from the market for a
safety concern. If the applicant continued to market such a product
without premarket authorization, that product would then be adulterated
under section 902 of the FD&C Act and misbranded under section 903 of
the FD&C Act. However, without rescission of an SE order, there is no
adulteration, misbranding, or other provision in the statute to address
products found SE based on false information.
As discussed in the proposed rule, FDA's initiation of rescission
will occur only when the grounds described in Sec. 1107.50 exist. We
agree with comments that suggest FDA should exercise this authority in
a timely and judicious way; while we are declining to set specific time
limits, FDA intends to initiate a rescission action within a reasonable
period of time, which will depend on the circumstances of each order.
For example, we note that, in the absence of applicant malfeasance, 10
months has been held to be ``comfortably within the reasonableness
standard'' in light of the particular facts. Ivy Sports Medicine, LLC
v. Sebelius, 938 F. Supp. 2d 47, 63 (D.D.C. 2013) (upholding FDA
rescission of medical device clearance), rev'd on other grounds 767 F.
3d 81 (D.C. Cir. 2014). In the presence of applicant malfeasance, more
than six years has been held to be reasonable. Ranbaxy Labs., Ltd. v.
Burwell, 82 F. Supp. 3d 159, 196 (D.D.C. 2015) (upholding FDA
rescission of tentative approval of abbreviated new drug applications).
F. Comments on Subpart E--Miscellaneous Provisions and FDA Responses
1. Record Retention (Sec. 1107.58)
Proposed Sec. 1107.58 described record retention requirements. The
proposed provision would require that records supporting an SE order be
maintained for a period of not less than 4 years from the date of an SE
order. After considering comments on this proposed section, we are
finalizing the section without change. We describe the comments to this
section and our responses in the following paragraphs.
[[Page 55265]]
(Comment 80) A few comments state that by requiring manufacturers
to trace their products back to the original predicate product (Sec.
1107.19(h)), a record retention requirement of 4 years has no effect
since they would have to maintain records in ``perpetuity'' if the
manufacturer wanted to use the original predicate tobacco product at a
later date.
(Response 80) Section 1107.58 states that 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 records 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. If an applicant believes that they will want
to rely on the data in the future, they may choose to retain records
longer than this time period. For example, manufacturers who elect to
use a predicate that is a product that has been previously found SE may
need to be able to produce records relating to the original predicate
tobacco product where FDA is unable to make the finding required by
section 910(a)(2)(A)(i)(I) of the FD&C Act based on the information in
its files.
2. Confidentiality (Sec. 1107.60)
Proposed Sec. 1107.60 described how FDA would determine the public
availability of any part of an SE Report and other content related to
such an SE Report under this proposed section and part 20 of this
chapter. After considering comments on this proposed section, we are
finalizing the section without change. We describe the comments to this
section and our responses in the following paragraphs.
(Comment 81) One comment objects to the level of confidentiality
afforded to SE Reports noting that this has ``prevented the public from
having any significant information about FDA's review of such
applications or the standards FDA is applying.'' The comment states
that to obtain information about SE Reports, Freedom of Information Act
(FOIA) requests must be submitted and the Agency's responses to those
FOIA requests are too slow. This comment also notes that because FDA
does not disclose the existence of SE Reports the public cannot
participate in the consideration of such reports. Another comment
disagrees with limiting disclosure of information to only the summary
review or the final cycle primary discipline reviews for SE Reports
found NSE (without the need for FOIA requests). This comment urges FDA
to release reviewer notes from each cycle of review to the manufacturer
(or applicant), as well as information related to the measures FDA
takes to ensure consistency among reviewers.
(Response 81) We decline to make any changes to the codified
provisions. Although we agree with the goals of transparency, the
confidentiality provisions in this section align with the requirements
of FOIA, other statutory provisions governing disclosure of pending SE
Reports and the information contained in such SE Reports, and 21 CFR
part 20. As FDA explained in the proposed rule, the intent to market a
tobacco product that is not currently marketed is often considered
confidential commercial information. Consistent with this rule, FDA
will continue to make available to the public information related to
tobacco product premarket review and marketing orders at https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/tobacco-product-marketing-orders.
3. Electronic Submissions (Sec. 1107.62)
Proposed Sec. 1107.62 describes the requirement for the electronic
submission of an SE Report, unless the applicant requested and FDA
granted a waiver request. After considering comments on this proposed
section, we are finalizing this section with one minor change that the
applicant include their email address to help ensure we have complete
contact information. We note that we intend to periodically issue
specifications and guidance pertaining to electronic submission format
and organization to provide updated information related to electronic
submission, e.g., as technology evolves. We describe the comments to
this section and our responses in the following paragraphs.
(Comment 82) One comment believes submitting the SE Report
electronically should be optional and the applicant should be permitted
to submit paper reports without requesting a waiver.
(Response 82) As stated in Sec. 1107.62, FDA requires the SE
Report and supporting information to be submitted electronically,
unless the applicant requested and FDA granted a waiver request. In
addition, Sec. 1107.18 requires applicants to submit the SE Report
using the forms that FDA provides (i.e., Forms FDA 3964 and 3965) (FDA
forms may be found at https://www.fda.gov/about-fda/reports-manuals-forms/forms). This approach is consistent with Sec. 1105.10, which
states that FDA generally intends to refuse to accept for review an SE
Report if required forms are not included with the SE Report. Also,
requiring electronic submission is consistent with the requirements for
other FDA regulated products, e.g., new drug applications (NDAs) and
investigational new drug applications (INDs). FDA provides tools, such
as eSubmitter, to facilitate the creation of an electronic submission.
This is available for voluntary use by sponsors, manufacturers, and
importers to create a variety of submission types within the drug,
device, radiological health, tobacco, animal drug and animal food
regulated industries.
Without the mandatory information from the forms and electronic
submission, the processing and review of each submission would be
slower and more burdensome. The use of a form also helps avoid the
submission of incomplete information, which can hinder decision-making
and prolong the review process. Electronic data and electronic
submission enable automation in the review process, which in turn
increases data quality by eliminating human error from manual data
entry.
G. Comments on Other Issues for Consideration and FDA Response
FDA requested comment 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. For example,
under such an approach, FDA could 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. We solicited
comment on 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.
(Comment 83) Several comments support consideration of categories
of modifications that could be subject to streamlined SE reviews or
excluded from review, and provided specific examples. For example, one
comment presents suggestions for categories of modifications for which
no SE Report should be required, such as changes based on operation of
law (e.g., change made to comply with a product standard); supplier/
commodity changes, modifications to ensure tobacco product consistency
(e.g., blending changes and
[[Page 55266]]
similar changes to maintain consistency); packaging changes, including
changes to CCS; product quantity changes.
(Response 83) After considering these comments, FDA has determined
that further consideration is needed on whether and, if so, what,
categories should be created for a ``categorical'' approach to
substantial equivalence, particularly once FDA has gained more
experience and is able to identify potential categories. We note that
some of the changes included as suggestions for exclusion may not
require a premarket submission, i.e., a change in supplier that does
not result in a new product (there is no modification to the product as
a result in the change in supplier).
(Comment 84) Some comments note that there are categories of minor
changes which would not raise different questions of public health. One
such comment includes several modifications that the commenter states
does not raise different questions of public health. The comment notes
that modifications that: (1) Reduce HPHC yield; (2) change quantity;
(3) change product design; (4) change from loose to portioned tobacco;
(5) change the packaging or container; (6) reduce ingredients; (7)
change an ingredient supplier; (8) change a manufacturing process; or
(9) respond to other FDA requirements should not require SE Reports
because they do not raise different questions of public health.
(Response 84) We disagree that changes that result in a
modification of the tobacco product should not require premarket
authorization. The FD&C Act generally 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. However, depending on the
modification, an applicant could proceed through the same
characteristics SE pathway (which does not require a showing that any
changes do not cause the product to raise different questions of public
health) or the SE exemption pathway. In addition, as with some of the
previous examples, some of the changes highlighted in this comment may
not result in a new tobacco product, and therefore would not require
premarket review (e.g., changes to packaging that are not part of a
container closure system, a change in supplier that does not result in
a modification of the tobacco product, or a change in manufacturing
process that does not affect the characteristics of the tobacco
product).
(Comment 85) Similarly, a comment requests FDA to remove
``aesthetic'' changes, supplier changes, changes performed to ensure
consistency of the product, and packaging changes from those
modifications that would require applicants to submit an SE submission.
This comment expresses concern that the rule as proposed would require
a manufacturer to submit a report on a change that it may not even know
took place.
(Response 85) An application is only required if the change renders
a product a new tobacco product. ``Aesthetic'' changes that alter the
name or labeling, changes to packaging that are not part of a container
closure system, or other modifications that do not impact the
characteristics of a tobacco product do not require submission of an SE
Report. However, any modifications that create a new tobacco product
must receive authorization through the submission of an application
(e.g., PMTA, SE Report, or Exemption Request). Otherwise, if the new
tobacco product enters into interstate commerce for commercial
distribution, it would be adulterated under section 902 of the FD&C Act
and misbranded under section 903 of the FD&C Act and subject to
enforcement action.
(Comment 86) One comment opposes the creation of categories of
products eligible for a streamlined substantial equivalence process
stating that the FD&C Act contemplates product-by-product review. This
comment refers to FDA's experience with SE reviews and notes that the
majority of SE Reports do not result in SE orders and that this shows
``that manufacturers, if not required to produce specific evidence in
support of substantial equivalence, will make claims of substantial
equivalence that cannot be supported.'' Other comments request further
clarification on the issue. The comments request that if FDA were to
adopt a categorical approach, FDA publish the list of categorical
modifications appropriate under the approach.
(Response 86) Given the wide range of suggested categories and
other feedback on this topic, FDA agrees with the comments that
indicate further consideration is needed on whether and, if so, what,
categories should be created. FDA intends to continue to consider this
issue and how we might best proceed in providing additional clarity and
recommendations on the premarket approach that may work best for any
``category'' of change.
VI. Effective Date
As stated in the proposed rule, this final rule will become
effective 30 days after the final rule publishes in the Federal
Register. FDA responds to the comments on the effective date in the
following paragraphs.
(Comment 87) More than one comment requests that FDA delay or
stagger the effective date of the final regulation or the submission
dates for premarket applications.
(Response 87) We decline to change the effective date for the rule,
or add compliance dates at this time. We note that premarket
requirements already apply to new tobacco products as described in the
statute and the deeming final rule (sections 905 and 910 of the FD&C
Act and 81 FR 28974, May 10, 2016, see https://www.govinfo.gov/content/pkg/FR-2016-05-10/pdf/2016-10685.pdf, codified at 21 CFR 1101.) This
rule supports those existing requirements by, among other things,
providing content and format requirements related to SE Reports for new
tobacco products that will help applicants prepare SE Reports and
enable FDA to make SE determinations for new tobacco products.
VII. Economic Analysis of Impacts
We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, 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).
This final rule is a 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 0.2 percent of revenues, we certify that the rule will 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
[[Page 55267]]
adjustment for inflation is $158 million, using the most current (2020)
Implicit Price Deflator for the Gross Domestic Product. This final rule
would not result in an expenditure in any year that meets or exceeds
this amount.
This analysis uses the state of the world where manufacturers
routinely submit SE Reports as the baseline. This final rule will
impose compliance costs on affected entities to read and understand the
rule, establish or revise internal procedures, keep records, and fill
out a form for SE Reports. We estimate that the present value of
industry compliance costs ranges from $0.4 million to $3.4 million,
with a primary estimate of $1.9 million at a 3 percent discount rate,
and from $0.4 million to $2.9 million, with a primary estimate of $1.6
million at a 7 percent discount rate over 10 years. Annualized industry
compliance costs over 10 years range from $0.05 million to $0.39
million, with a primary estimate of $0.22 million at a 3 percent
discount rate and from $0.06 million to $0.42 million, with a primary
estimate of $0.23 million at a 7 percent discount rate. The costs to
industry range from around $200 to around $1,400 per affected entity
per year, with a primary estimate of around $800 per entity per year.
The incremental benefits of this final rule are potential time-
savings to industry and cost-savings to FDA. The final 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. We
anticipate shorter review times for SE Reports as a result of this
final rule. In addition, based on our experience with prior SE Reports,
we believe this final rule will lead to higher quality SE Reports,
saving us time in review and requiring fewer staff to review SE
Reports, which will result in cost-savings. We estimate that the
present value of government cost-savings ranges from $15.1 million to
$150.6 million, with a primary estimate of $50.2 million at a 3 percent
discount rate, and from $12.4 million to $124 million, with a primary
estimate of $41.3 million at a 7 percent discount rate over 10 years.
Annualized government cost-savings over 10 years range from $1.8
million to $17.7 million, with a primary estimate of $5.9 million at
both 3 and 7 percent discount rates. The FDA cost-savings per report
ranges from around $17,700 to around $58,800, with our best estimate at
around $29,400.
The qualitative benefits of this final rule include additional
clarity to industry about the requirements for the content and format
of SE Reports. The final rule establishes the general procedures we
intend to follow in reviewing and communicating with applicants. In
addition, this final rule will make the SE pathway more predictable.
Table 1 summarizes the benefits and costs of the final rule.
Table 1--Summary of Benefits, Costs and Distributional Effects of Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
Low Primary High ------------------------------------
Category estimate estimate estimate Period Notes
(million) (million) (million) Year Discount covered
dollars rate (%) (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized $millions/ $1.8 $5.9 $17.7 2018 7 10 Cost-savings to government.
year. 1.8 5.9 17.7 2018 3 10 Cost-savings to government.
Annualized Quantified............. .......... .......... .......... 2018 7 10
.......... .......... .......... 2018 3 10
Qualitative....................... .......... .......... .......... .......... .......... .......... Greater certainty for SE applicants.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
Annualized Monetized $millions/ 0.06 0.23 0.42 2018 7 10
year. 0.05 0.22 0.39 2018 3 10
Annualized Quantified............. .......... .......... .......... 2018 7 10
.......... .......... .......... 2018 3 10
-----------------------------------------------------------------------------------------------------------------
Qualitative
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
Federal Annualized Monetized .......... .......... .......... 2018 7 10
$millions/year. .......... .......... .......... 2018 3 10
-----------------------------------------------------------------------------------------------------------------
From:
To:
-----------------------------------------------------------------------------------------------------------------
Other Annualized Monetized .......... .......... .......... 2018 7 10
$millions/year. .......... .......... .......... 2018 3 10
-----------------------------------------------------------------------------------------------------------------
From:
To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government: No
effect.
Small Business: No effect.........
Wages: No effect..................
Growth: No effect.................
--------------------------------------------------------------------------------------------------------------------------------------------------------
We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. The full analysis of economic
impacts is available in the docket for this final rule (Ref. 86) and at
https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.
VIII. Analysis of Environmental Impact
The Agency has determined under Sec. 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 action may significantly affect the
quality of the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
IX. Paperwork Reduction Act of 1995
This final rule contains information collection provisions that are
subject
[[Page 55268]]
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The title,
description, and respondent description of the information collection
provisions are shown in the following paragraphs with an estimate of
the annual reporting and recordkeeping burden. 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.
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.
As required by section 3506(c)(2)(B) of the Paperwork Reduction Act
of 1995 (PRA), FDA provided an opportunity for public comment on the
information collection requirements of the proposed rule that published
in the Federal Register of April 2, 2019. In response to this rule FDA
received the following PRA related comments:
(Comment 88) Some comments state that FDA underestimated the burden
associated with collecting the information and suggest the proposed
collection of information would have better utility and value if FDA
went by product category. Specifically, the comments take issue with
estimates of 683 SE reports filed and state that FDA failed to consider
foreign manufacturers filing when the Agency used the registration and
listing data to estimate the associated burden with the requirements.
The comments also state that FDA has underestimated the burden of the
proposed collection of information on FDA and does not reflect the
level of agency resources needed to review the thousands of SE reports.
(Response 88) We disagree. The rule reflects estimates of the
burden for the submission and review of SE Reports beginning when the
rule becomes effective, which will be 30 days after the final rule
publishes. These estimates reflect what we expect will be the level of
submissions and burden at that time, based on our experience with SE
Reports since the inception of the program. We disagree that we did not
account for foreign firms. For SE purposes foreign firms are handled
the same way as domestic firms. Although foreign firms are currently
not required to register and list, they must still provide a U.S. agent
to export a tobacco product.
(Comment 89) Several comments stated that our estimate of 87 to 300
hours to prepare and submit an SE Report is too low and that this must
not account for the burden associated with HPHC testing. Several
comments suggest that, based on the commenters' experience, it will
take approximately 900-1,000 hours to prepare an SE Report for one
product, and other comments estimate that it may take 15-28 months to
prepare an SE Report depending on the scientific testing required. One
comment asserts that this estimate is too low because the Agency is
assuming a single submission, when the commenter's experience is that
multiple submissions may be made with an SE Report including the
original report. In addition, the comment states that this estimate
does not include the time associated with amending the SE Report or an
environmental assessment. The comment states that FDA may need multiple
years to review and process SE Reports for tobacco products subject to
the deeming final rule (``deemed tobacco products''), such as cigars,
and that FDA will likely make multiple requests to applicants for
additional information. One comment states that SE Reports require
extensive data that could take thousands of hours per application to
prepare and submit.
(Response 89) Because the estimates are based on our experience
with SE Reports, we are maintaining the estimates as proposed. The SE
program was originally approved by OMB in 2010. Since then, FDA has
reassessed the program burden each time the collection was up for
extension and other related programmatic changes in between.
Additionally, we have further analysis on our reporting and
recordkeeping requirements that was provided in the preamble to the
proposed rule and the proposed regulatory impact analysis. We note that
the final rule provides more clarity on both design parameters for
cigars, pipes, and other deemed tobacco products, and also when
scientific testing may be needed. This information will assist
applicants in understanding the content and format of an SE report
which will accelerate the process of submitting a report.
(Comment 90) A comment states that our estimated burden of
``bundled'' SE Reports is significantly lower than our estimate for a
single product. The comments believe that this is wrong because the
bundled applications cover multiple products and should therefore be
greater than the burden associated with preparing a report for a single
product.
(Response 90) We agree that the total time to submit a bundled SE
Report is greater than the time to submit a report for a single
product. Our estimates for ``bundled'' SE Reports were the time
associated with submitting for each additional product in the bundle.
Therefore, the total cost for submitting a bundle of 3 products would
be the full SE burden for the first product, plus two times the burden
to submit a bundled report. We have clarified this in the final
analysis.
(Comment 91) Several commenters provided estimates for the hours
needed for preparing and submitting SE Reports of between 900 hours and
28 months. Based on these hours, the commenters estimate that the cost
per SE Report could be between $250,000 and $2,000,000, although they
state there may be some economies of scale in submitting multiple
reports.
(Response 91) We believe some commenters have confused cost
estimates from the regulatory impact analysis (RIA) and burden hours
from the PRA. Although these concepts are similar and account for some
corresponding items, they ultimately serve different purposes and
separate functions. The PRA estimates burden in hours on an annual
basis generally for three years; while the regulatory impact analysis
uses these estimated burden hours on an annual basis, along with an
estimate of wage per hour, to estimate a cost in terms of dollars over
a long-term horizon. See comment 4 of the RIA and comment 1 in the
appendix of the RIA for a further discussion regarding costs and see
comments 2 and 3 of the RIA for discussion on burden hours.
(Comment 92) A comment states that they believe our estimated
burden for an environmental assessment is too high as a proportion of
the time to prepare and submit an SE Report. They state that our
estimate of 52 to 80 hours for an EA is potentially more than our
estimated burden for an SE Report at 35 to 220 hours. Other comments
suggest that the burden associated with EAs is too low.
(Response 92) FDA has estimated 80 hours for an environmental
assessment for the SE program for many years. Based on experience with
SE Reports,
[[Page 55269]]
interactions with the industry, and information related to other
regulated products we do not have evidence suggesting a different
estimate and note that the range given for EAs is intended to reflect
the variation that might exist depending on the specific tobacco
product.
(Comment 93) Several comments believe that FDA has substantially
underestimated the number of SE Reports it will receive annually. The
comments state that FDA should expect tens of thousands of SE Reports--
much higher than the proposed rule estimate of 683 standalone SE
Reports and 456 bundled SE Reports each year. Additionally, the
commenter also notes that it expects to submit well over 100 reports
per year as opposed to the FDA estimate of one application per year.
(Response 93) FDA believes our PRA estimates are accurate as we
have had years of experience with the SE pathway. The SE program was
originally approved by OMB in 2010. Since then FDA has reassessed the
program burden each time the collection was up for extension and other
related programmatic changes in between. Additionally, we have further
analysis that was provided in the preamble to the proposed rule and the
proposed regulatory impact analysis. As referenced in the proposed
rule, many of our estimates were based on submissions being bundled. As
is currently the practice, applicants may continue to bundle groups of
SE Reports submitted under Sec. [thinsp]1107.18 that have the same
proposed modifications (e.g., a change in ingredient supplier that
results in a new tobacco product). Co-packaging two or more tobacco
products may result in a new tobacco product. When groups of full or
product quantity change SE Reports have identical content, they may be
submitted together (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. 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.
Section 1107.18, paragraphs (b) and (c) include requirements that
the applicant use the forms that FDA provides when submitting an SE
Report. Following our consideration of the comments related to the
forms, we are finalizing these requirements without change. We describe
the comments to these sections and our responses next.
(Comment 94) At least one comment states that use of the FDA forms
should be optional rather than mandatory.
(Response 94) We disagree. As explained in the proposed rule, the
requirements in this rule, including use of these forms, are intended
to provide clarity to applicants with respect to what they should
submit in an SE Report and to 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 (other than for test marketing) in the United States as of
February 15, 2007. Additionally, use of a standardized form allows FDA
to receive information in a way that allows for faster processing and
uploading of the SE Report and its contents, thereby increasing
efficiency of the review process.
(Comment 95) Another comment notes that although FDA appears to
recognize that the evidence required in an SE Report depends on whether
new tobacco product has ``same'' characteristics as the predicate
product or if the new tobacco product has ``different'' characteristics
than the predicate product, this distinction is not reflected in either
the draft of Form FDA 3965 or the rule itself.
(Response 95) We disagree. The form and the rule are structured to
clarify both the common elements (``same'' characteristics) and
distinct elements (``different'' characteristics) of SE Reports for
both new tobacco products with the ``same'' characteristics as the
predicate product and for new tobacco products with ``different''
characteristics than the predicate product. This includes reference to
and discussion of these elements in the forms and throughout the rule.
Applicants should indicate that their report is a ``same
characteristics'' report where no data is necessary to demonstrate that
the new tobacco product is substantially equivalent to its predicate.
The form has been revised to include a section where the applicant
would distinguish whether they are submitting a ``same
characteristics'' SE Report, or a ``different characteristics'' SE
Report. For a ``same characteristics'' SE Report, an applicant must
describe the modification and certify that is the only change between
the new and predicate tobacco product.
(Comment 96) One comment believes FDA has underestimated the time
needed to complete the forms and did not explain how it arrived at
these estimates.
(Response 96) FDA conducted a thorough analysis of the current
paperwork burden associated with the SE program and other similar forms
and applied the most accurate burden to the forms; however, upon
consideration of this comment and certain updates made to the form
based on comments received and product categorization changes FDA is
revising the burden associated with entering the data into the form
(which includes searching existing data sources and gathering and
maintaining the data needed) to be 45 minutes per individual product
(rather than 30 minutes per product) on Form FDA 3965. For Form FDA
3964, FDA is revising the burden for this form to 10 minutes (from 5
minutes). This form serves several purposes from changing a point of
contact (minimal burden) to providing additional substantive
information for the purpose of the review of the SE Report (more
burdensome). FDA notes that the comment did not provide a
recommendation for the alternative estimates FDA might consider.
Description of Respondents: Manufacturers of tobacco products who
submit SE Reports.
The information collection provisions in this final rule have been
submitted to OMB for review as required by section 3507(d) of the
Paperwork Reduction Act of 1995.
This establishes requirements for the content and format of SE
Reports (Sec. Sec. 1107.18 and 1107.19). Most of the requirements
mirror current practices and recommendations related to the submission
of SE Reports, including information related to part 25 (environmental
considerations), but the rule provides both applicants and FDA more
certainty regarding the content and format for 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 rule continues to permit
amendments for SE Reports submitted under Sec. 1107.18, e.g., to
address deficiencies (Sec. 1107.20). Also, in accordance with current
practice, the rule continues to permit withdrawals (Sec. 1107.22) of
pending SE Reports. The rule also describes requirements for
[[Page 55270]]
when the ownership of an SE Report changes to ensure that FDA has
information related to the current applicant (Sec. 1107.24).
The rule establishes a recordkeeping requirement, under which
applicants are 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 (Sec. 1107.58).
The rule requires 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 (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.
FDA estimates the burden as the following:
Table 2--Existing Burden for OMB Control Number 0910-0673, Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity; 21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per 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\ This chart represents the currently OMB approved burden for the SE program.
Table 3--New Burden per the Final Rule, Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity; FDA form; 21 CFR section Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA 3965--Tobacco Substantial Equivalence 1,570 1 1,570 .75 (45 minutes)......................... 1,178
Report Submission.
FDA 3964--Tobacco Amendment and General 628 1 628 .16 (10 minutes)......................... 100
Correspondence.
Waiver from Electronic submission 1107.62(b). 240 1 240 .25 (15 minutes)......................... 60
----------------------------------------------------------------------------------------------------------
Totals................................... .............. .............. .............. ......................................... 1,338
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 4--Final Reporting Table 2 + 3 Reporting Burden, Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity; FDA form; 21 CFR section Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
SE Report--1107.18........................... 683 1 683 300...................................... 204,900
Bundled SE--1107.18.......................... 456 1 456 90....................................... 41,040
SE Report where applicant provides 239 1 239 87....................................... 20,793
certification for identical characteristics--
1107.18(g) and 1107.18(l)(2).
SE Report where applicant provides 192 1 192 62....................................... 11,904
certification for some identical
characteristics (bundled)--1107.18(g) and
1107.18(l)(2).
FDA 3965--Tobacco Substantial Equivalence 1,570 1 1,570 .75 (45 minutes)......................... 1,178
Report Submission.
FDA 3964--Tobacco Amendment and General 628 1 628 .16 (10 minutes)......................... 100
Correspondence Report.
Waiver from Electronic submission--1107.62(b) 240 1 240 .25 (15 minutes)......................... 60
----------------------------------------------------------------------------------------------------------
Totals................................... .............. .............. .............. ......................................... 279,975
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 5--New Recordkeeping Burden per the Final Rule, Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity; 21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping SE Report under 1107.18-1107.58................... 471 1 471 5 2,355
--------------------------------------------------------------------------------------------------------------------------------------------------------
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. Utilizing registration
and listing data for deemed
[[Page 55271]]
tobacco products, the estimated annual number of SE Reports is expected
to be 1,570. The expected number of reports has not changed since the
proposed rule. As discussed earlier in this rule, FDA is not finalizing
the proposed SE rule with respect to ``premium'' cigars. As such, the
estimate of the number of reports expected is likely an overestimate as
it includes ``premium'' cigars, which are excluded from the scope of
this final rule.
When groups of full SE Reports or SE Reports that each contain a
certification that some characteristics 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 2 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 rule, manufacturers would routinely submit SE Reports
for new tobacco products, and the Agency believes most respondents are
currently practicing most of the requirements. FDA will revise this
collection with the new burden.
Table 3 describes the annual reporting burden as a result of the
requirements in Sec. Sec. 1107.18 and 1107.19, implementing the
substantial equivalence requirements of sections 905(j)(1)(A)(i) and
910(a) of the FD&C Act. This rule requires manufacturers to submit SE
Reports electronically (Sec. 1107.62). We estimate that it would
initially take about 45 minutes per product to fill out the Form FDA
3965. However, for amendments we estimate that filling out the Form FDA
3964 will take 10 minutes as applicants can copy and paste from the
first submission. Section 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
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 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 Sec. 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 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 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.
FDA has based these estimates on the full analysis of economic
impacts and experience with the recently-revised existing information
collection (OMB Control Number 0910-0673) 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 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 Sec. 1107.18.
Generally, an applicant may withdraw its SE Report after submission
(Sec. 1107.22), change the ownership of its SE Report (Sec. 1107.24),
and amend its SE Report (Sec. 1107.20). Currently, FDA has an OMB
approved information collection for SE. The information required to
grant these applications is already being collected under the OMB
approval, so we do not expect a change in burden to these sections.
FDA estimates that 30 percent of SE Reports or 471 respondents will
maintain required records related to their SE Reports at 5 hours per
record for a total of 2,355 recordkeeping hours. FDA has revised the
estimated burden for recordkeeping per hour from 2.5 hours per record
to 5 hours. As discussed in the RIA, the first SE Report in a chain
must use a tobacco product commercially marketed (other than for test
marketing) in the United States as of February 15, 2007, as a predicate
product for the SE Report. Therefore, we believe that manufacturers
will have records on those ``original'' predicate tobacco products from
their initial SE Reports. Based on this assumption, this requirement
could lead to manufacturers keeping records for a longer time. The
final regulatory impact analysis estimates zero to 10 hours per entity
each year for recordkeeping, and the PRA estimate has assumed a mid-
point of that estimate.
FDA estimates that the burden for new requirements will increase
this collection by 3,693 hours (1,338 reporting + 2,355 recordkeeping).
The burden for the submission of substantial equivalence information is
estimated to total 282,330 hours (279,975 reporting and 2,355
recordkeeping). This rule also refers to previously approved
collections of information found in FDA regulations.
Section 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 0910-0731. In addition to
the premarket application under section 910(b) and a report under
905(j)(1)(A)(i) of the FD&C Act, certain new tobacco products may use
the exemption premarket pathway (see Sec. 1107.1). The collections of
information found in Sec. 1107.1 have been approved under OMB control
number 0910-0684.
Before the effective date of this final rule, FDA will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in this
final rule. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.
[[Page 55272]]
X. Federalism
We have analyzed this 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 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, the final rule creates
requirements that fall within the scope of section 916(a)(2) of the
FD&C Act.
XI. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
the Office of Information and Regulatory Affairs designated this rule
as not a ``major rule,'' as defined by 5 U.S.C. 804(2).
XII. Consultation and Coordination With Indian Tribal Governments
We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that have substantial direct effects 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. Accordingly, we
conclude that the rule does not contain policies that have tribal
implications as defined in the Executive Order and, consequently, a
tribal summary impact statement is not required. We received one
comment related to tribal consultation and we respond to this comment
in the following paragraphs.
(Comment 97) A comment disagrees with the Agency's tentative
determination 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 comment notes that FDA's decisions
regarding substantial equivalence have had profound effects on the
tribe's ability to raise revenue for government services and have
required significant expenditures for compliance costs over the last 3
years.
The comment also states the tribe's representatives were unable to
participate in an All Tribes' Call on the proposed rule due to late
notice of the call. The tribe notes that, although FDA provided them
with another opportunity for a call on the proposed rule, late notice
of the All Tribes' Call may have caused other tribes to miss the
opportunity for consultation and recommends a second All Tribes' Call
with at least 30 days' notice, or an in-person consultation with a
phone-in option, prior to completing the next phase of rulemaking.
(Response 97) The impact and costs of the proposed rule on tribal
manufacturers were considered as part of the Preliminary Regulatory
Impact Statement. FDA agrees that collaboration and consultation with
Federally recognized tribal governments, per the FDA Tribal
Consultation Policy and Executive Order 13175, is important. FDA
engages with tribal stakeholders, including tribal government leaders,
tribal health leaders, and public health professionals, about the
implementation and enforcement of the Tobacco Control Act and related
regulations by various methods (e.g., ``Dear Tribal Leader'' letters,
All Tribes' Calls, formal and informal consultations as well as face-
to-face meetings). We also encourage tribes to stay informed about
developments related to tobacco products through our website (https://www.fda.gov/TobaccoProducts).
There were several opportunities for tribes to engage with FDA
about the proposed rule, including the impact and costs of the proposed
rule on tribal manufacturers, which was considered as part of the
Preliminary Regulatory Impact Statement (https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm). In a ``Dear
Tribal Leader'' letter dated April 4, 2019, FDA initiated consultation
with federally recognized Indian tribes on the proposed rule and
invited tribes to participate in an All Tribes' Call. The purpose of
the call was to provide an overview of the proposed rule, answer
questions, and hear tribal comments on the proposed rule. We provided
contact information in the letter and during the call to help ensure
that there was a mechanism to address any further questions. To help
ensure accessibility to the call, we recorded the call and made that
recording available on FDA's website for 30-days following the call,
and we added a transcript of the call to the docket for the rulemaking.
We also encouraged tribes to submit written comments on the proposed
rule and supporting documents such as the Preliminary Regulatory Impact
Statement. We note that no other tribe has requested additional
consultation on the proposed rule.
XIII. References
The following references marked with an asterisk (*) are on display
at 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 also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. 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.
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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,
chapter I of title 21 of the Code of Federal Regulations will 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 an SE 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 an SE Report) for a new tobacco product, other
than ``premium'' cigars as defined in Sec. 1107.12, 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
[[Page 55276]]
(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, 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(s),
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, whether domestic or imported, to consumers or to any person,
but does not include interplant transfers of a tobacco product between
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 personal
consumption or resale. ``Commercial distribution'' does not include the
handing or transfer of a tobacco product from one consumer to another
for personal consumption.
Commercially marketed means selling or offering for sale a tobacco
product in the United States to consumers or to any person for the
eventual purchase by consumers in the United States.
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 (e.g.,
smoke, aerosol, droplets) from a tobacco product, that either transfers
from any component or part of the tobacco product to the emission or
that is formed by the 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 to consumers separately or as part of kits) or in the
final form in which it is intended to be sold to consumers.
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, including as an aerosol or any other emission; and
(2) Causes or has the potential to cause direct or indirect harm to
users or nonusers of tobacco products.
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 the
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.
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 was
commercially marketed (other than for test marketing) in the United
States as of February 15, 2007, 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.
Premium cigars means a type of cigar that:
(1) Is wrapped in whole tobacco leaf;
(2) Contains a 100 percent leaf tobacco binder;
(3) Contains at least 50 percent (of the filler by weight) long
filler tobacco (i.e., whole tobacco leaves that run the length of the
cigar);
[[Page 55277]]
(4) Is handmade or hand rolled (i.e., no machinery was used apart
from simple tools, such as scissors to cut the tobacco prior to
rolling);
(5) Has no filter, nontobacco tip, or nontobacco mouthpiece;
(6) Does not have a characterizing flavor other than tobacco;
(7) Contains only tobacco, water, and vegetable gum with no other
ingredients or additives; and
(8) Weighs more than 6 pounds per 1,000 units.
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 voluntary requests for determinations
that a tobacco product was commercially marketed in the United States
as of February 15, 2007.
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 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 an 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 an 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 tobacco product
commercially marketed (other than for test marketing) in the United
States as of February 15, 2007, 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 (other
than for test marketing) 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 generally intends to refuse to accept an SE Report for review if it
does not comply with Sec. 1105.10 and 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, that the predicate tobacco
product was commercially marketed (other than for test marketing) in
the United States as of February 15, 2007;
(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 part 25 of this chapter (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 under Sec. 1107.62(b).
(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 voluntary request for a
determination that a tobacco product was commercially marketed in the
United States as of February 15, 2007, or SE Report previously found
substantially equivalent (if applicable),
[[Page 55278]]
and cross-references to meetings with FDA regarding the new tobacco
product;
(5) Applicant name, address, and contact information (including
email address);
(6) Authorized representative or U.S. agent (for a foreign
applicant), including the name, address, and contact information
(including email address);
(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:
Table 1 to Sec. 1107.18(c)(7)(iii)
------------------------------------------------------------------------
Tobacco product
Tobacco product category subcategory Product properties
------------------------------------------------------------------------
(A) Cigarettes................ (1) Filtered..... --Package type (e.g.,
hard pack, soft
pack, clam shell).
--Product quantity
(e.g., 20
cigarettes, 25
cigarettes).
--Length (e.g., 89.1
millimeters (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).
(2) Non-filtered. --Package type (e.g.,
hard pack, soft
pack, clam shell).
--Product quantity
(e.g., 20
cigarettes, 25
cigarettes).
--Length (e.g., 89.1
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) Other........ --Package type (e.g.,
hard pack, soft
pack, clam shell).
--Product quantity
(e.g., 20
cigarettes, 25
cigarettes).
--Length (e.g., 89.1
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).
(B) Roll-Your-Own Tobacco (1) Roll-Your-Own --Package type (e.g.,
Products. Tobacco Filler. bag, pouch).
--Product quantity
(e.g., 20.1 grams
(g), 16 ounces
(oz.)).
--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.,
box, booklet).
--Product quantity
(e.g., 50 sheets,
200 papers).
--Length (e.g., 79.1
mm, 100 mm, 110.2
mm).
--Width (e.g., 28.1
mm, 33 mm, 45.2 mm).
--Characterizing
flavor(s) (e.g.,
none, menthol,
tobacco).
--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., 89.1
mm, 100 mm).
--Diameter (e.g., 6
mm, 8.1 mm).
--Ventilation (e.g.,
none, 10%, 25%).
--Characterizing
flavor(s) (e.g.,
none, menthol,
tobacco).
--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., 89.1
mm, 100 mm).
--Diameter (e.g., 6
mm, 8.1 mm).
--Characterizing
flavor(s) (e.g.,
none, menthol,
tobacco).
--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,
12.1 mm).
--Diameter (e.g., 6
mm, 8.1 mm).
--Characterizing
flavor(s) (e.g.,
none, menthol,
tobacco).
--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, 15.1 mm).
[[Page 55279]]
--Width (e.g., 27.1
mm).
--Characterizing
flavor(s) (e.g.,
none, menthol,
tobacco).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(7) Other........ --Package type (e.g.,
bag, box, booklet).
--Product quantity
(e.g., 200 tips, 100
filters, 200 tubes).
--Characterizing
flavor(s) (e.g.,
none, menthol,
tobacco).
--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 g, 2.1
oz.).
--Characterizing
flavor(s) (e.g.,
none, menthol,
cherry,
wintergreen).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable,
e.g., fine cut, long
cut, straight cut).
(2) Portioned --Package type (e.g.,
Moist 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, 1 g/
piece).
--Portion length
(e.g., 15 mm, 20.1
mm).
--Portion width
(e.g., 10 mm, 15.1
mm).
--Portion thickness
(e.g., 5 mm, 7.1
mm).
--Characterizing
flavor(s) (e.g.,
none, menthol,
cherry,
wintergreen).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(3) Loose Snus... --Package type (e.g.,
plastic can with
metal lid, plastic
can with plastic
lid).
--Product quantity
(e.g., 20 g, 2.1
oz.).
--Characterizing
flavor(s) (e.g.,
none, menthol,
cherry,
wintergreen).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(4) Portioned --Package type (e.g.,
Snus. 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, 1 g/
piece).
--Portion length
(e.g., 15 mm, 20.1
mm).
--Portion width
(e.g., 10 mm, 15.1
mm).
--Portion thickness
(e.g., 5 mm, 7.1
mm).
--Characterizing
flavor(s) (e.g.,
none, menthol,
cherry,
wintergreen).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(5) Loose Dry --Package type (e.g.,
Snuff. plastic can with
metal lid, plastic
can with plastic
lid).
--Product quantity
(e.g., 20 g, 2.1
oz.).
--Characterizing
flavor(s) (e.g.,
none, menthol,
cherry,
wintergreen).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(6) 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
pieces).
--Portion mass (e.g.,
1.5 g/strip, 1 g/
piece).
--Portion length
(e.g., 10 mm, 15.1
mm).
--Portion width
(e.g., 5 mm, 8.1
mm).
--Portion thickness
(e.g., 3 mm, 4.1
mm).
--Characterizing
flavor(s) (e.g.,
none, menthol,
cherry,
wintergreen).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(7) Loose Chewing --Package type (e.g.,
Tobacco. bag, pouch,
wrapped).
--Product quantity
(e.g., 20 g, 3.1
oz.).
--Characterizing
flavor(s) (e.g.,
none, menthol,
cherry,
wintergreen).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(8) Portioned --Package type (e.g.,
Chewing Tobacco. plastic can with
metal lid, plastic
can with plastic
lid).
--Product quantity
(e.g., 22.5 g, 20
g).
--Portion count
(e.g., 10 bits).
--Portion mass (e.g.,
2.1 g/bit).
--Portion length
(e.g., 8 mm, 10.1
mm).
--Portion width
(e.g., 6 mm, 8.1
mm).
[[Page 55280]]
--Portion thickness
(e.g., 5.1 mm, 7
mm).
--Characterizing
flavor(s) (e.g.,
none, menthol,
cherry,
wintergreen).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(9) Other........ --Package type (e.g.,
box, bag, can).
--Product quantity
(e.g., 20.1 g, 22.5
g, 3 oz.).
--Characterizing
flavor(s) (e.g.,
none, menthol,
cherry, wintergreen,
tobacco).
--Additional
properties needed to
uniquely identify
the tobacco product.
(D) Electronic Nicotine (1) Open E-Liquid --Package type (e.g.,
Delivery Systems (ENDS) bottle, box, pod).
(Vapes).
--Product quantity
(e.g., 1 bottle, 5
bottles).
--E-liquid volume
(e.g., 0.5
milliliters (ml)), 2
ml, 5.1 ml).
--Nicotine
concentration (e.g.,
0 mg/ml), 0.2 mg/ml,
0.4 mg/ml, 1%, 0.2
mg/bottle).
--Propylene Glycol
(PG)/Vegetable
Glycerin (VG) ratio
(e.g., not
applicable (N/A), 0/
100, 50/50, 100/0).
--Characterizing
flavor(s) (e.g.,
none, tobacco,
menthol, cherry,
wintergreen).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(2) Closed E- --Package type (e.g.,
Liquid. cartridge, pod).
--Product quantity
(e.g., 1 cartridge,
5 cartridges).
--E-liquid volume
(e.g., 0.5 ml, 2 ml,
5.1 ml).
--Nicotine
concentration (e.g.,
0 mg/ml, 0.2 mg/ml,
0.4 mg/ml, 1%, 0.2
mg/bottle).
--PG/VG ratio (e.g.,
N/A, 0/100, 50/50,
100/0).
--Characterizing
flavor(s) (e.g.,
none, tobacco,
menthol, cherry,
wintergreen).
--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).
--Length (e.g., 100
mm, 120 mm)
--Diameter (e.g., 6
mm, 8 mm).
--Wattage (e.g., 100
watts (W), 200 W).
--Battery capacity
(e.g., 100
milliampere hours
(mAh), 200 mAh).
--E-liquid volume
(e.g., 0.5 ml, 2 ml,
5.1 ml).
--Nicotine
concentration (e.g.,
0 mg/ml, 0.2 mg/ml,
0.4 mg/ml, 1%, 0.2
mg/e-cigarette).
--PG/VG ratio (e.g.,
N/A, 0/100, 50/50,
100/0).
--Characterizing
flavor(s) (e.g.,
none, tobacco,
menthol, cherry,
wintergreen).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(4) Open E- --Package type (e.g.,
Cigarette. box, none, plastic
clamshell).
--Product quantity
(e.g., 1 e-
cigarette, 5 e-
cigarettes).
--Length (e.g., 100
mm, 120 mm)
--Diameter (e.g., 6
mm, 8 mm).
--Wattage (e.g., 100
W, 200 W).
--Battery capacity
(e.g., 100 mAh, 200
mAh).
--E-liquid volume
(e.g., 0.5 ml, 2 ml,
5.1 ml).
--Characterizing
flavor(s) (e.g.,
none, tobacco,
menthol, cherry,
wintergreen).
--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 coil).
--Characterizing
flavor(s) (e.g.,
none, menthol,
cherry, wintergreen,
tobacco).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(6) Other........ --Package type (e.g.,
box, none, plastic
clamshell).
--Product quantity
(e.g., 1 e-
cigarette, 5
bottles).
--Characterizing
flavor(s) (e.g.,
none, menthol,
cherry, wintergreen,
tobacco).
--Additional
properties needed to
uniquely identify
the tobacco product.
(E) Cigars.................... (1) Filtered, --Package type (e.g.,
Sheet-Wrapped. hard pack, soft
pack, clam shell).
--Product quantity
(e.g., 20 filtered
cigars, 25 filtered
cigars).
[[Page 55281]]
--Length (e.g., 89.1
mm, 100 mm).
--Diameter (e.g., 6
mm, 8.1 mm).
--Ventilation (e.g.,
none, 0%, 10%, 25%).
--Characterizing
flavor (e.g., none,
menthol).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(2) Unfiltered, --Package type (e.g.,
Sheet-Wrapped. box, film sleeve).
--Product quantity
(e.g., 1 cigar, 5
cigarillos).
--Length (e.g., 100.1
mm, 140 mm).
--Diameter (e.g., 8
mm, 10.1 mm).
--Tip (e.g., none,
wood tips, plastic
tips).
--Characterizing
flavor (e.g., none,
menthol, cherry).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(3) Unfiltered, --Package type (e.g.,
Leaf-Wrapped. box, film, sleeve,
none).
--Product quantity
(e.g., 1 cigar, 5
cigars).
--Length (e.g., 150.1
mm, 200 mm).
h;Diameter (e.g., 8
mm, 10.1 mm).
--Wrapper material
(e.g., burley
tobacco leaf,
Connecticut shade
grown tobacco leaf).
--Characterizing
flavor (e.g., none,
whiskey).
--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, 16.1
oz.).
--Characterizing
flavor (e.g., none,
tobacco, menthol,
cherry).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(6) Other........ --Package type (e.g.,
box, booklet).
--Product quantity
(e.g., 1 cigar, 5
cigars, 20 leaves,
16 g).
--Characterizing
flavor(s) (e.g.,
none, menthol,
cherry).
--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, 300.1 mm).
--Diameter (e.g.,
25.1 mm).
--Characterizing
flavor(s) (e.g.,
none, menthol,
cavendish, cherry).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(2) Pipe Tobacco --Package type (e.g.,
Filler. box, none).
--Product quantity
(e.g., 20 g, 16.1
oz.).
--Tobacco cut style
(e.g., standard cut,
such as shag cut,
bugler cut, loose
cut, etc., or a
pressed cut, such as
flake, cube cut,
roll cake, etc. or a
mixture).
--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. box, bag, none).
--Product quantity
(e.g., 1 bowl, 1
stem, 100 filters).
--Characterizing
flavor(s) (e.g.,
none, cherry).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(4) Other........ --Package type (e.g.,
box, bag, none).
--Product quantity
(e.g., 1 pipe, 1
bowl, 1 stem, 100
filters).
--Characterizing
flavor(s) (e.g.,
none, cherry).
--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).
--Height (e.g., 200
mm, 500.1 mm).
--Width (e.g., 100.1
mm, 300 mm).
--Diameter (e.g.,
100.1 mm, 300 mm).
--No. of hoses (e.g.,
1, 2, 4).
--Characterizing
flavor(s) (e.g.,
none).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
[[Page 55282]]
(2) Waterpipe --Package type (e.g.,
Tobacco Filler. bag, pouch).
--Product quantity
(e.g., 20 g, 16.1
oz.).
--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).
--Portion count
(e.g., 20 fingers,
10 discs, 1 base).
--Portion mass (e.g.,
15 g/finger, 10 g/
brick).
--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).
--Characterizing
flavor(s) (e.g.,
none, menthol,
apple).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(4) Waterpipe --Package type (e.g.,
Component. box, bag, none).
--Product quantity
(e.g., 1 base, 1
bowl, 1 hose, 10
mouthpieces).
--Characterizing
flavor(s) (e.g.,
none, cherry).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(5) Other........ --Package type (e.g.,
box, bag, none).
--Product quantity
(e.g., 1 base, 1
bowl, 1 hose, 10
mouthpieces).
--Characterizing
flavor(s) (e.g.,
none, cherry).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(H) Heated Tobacco Products (1) Closed HTP... --Package type (e.g.,
(HTP). box, none, plastic
clamshell).
--Product quantity
(e.g., 1 device, 1
HTP).
--Length (e.g., 100
mm, 120 mm).
--Diameter (e.g., 6
mm, 8.1 mm).
--Wattage (e.g., 100
W, 200 W).
--Battery capacity
(e.g., 100 mAh, 200
mAh).
--Characterizing
flavor(s) (e.g.,
none).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(2) Open HTP..... --Package type (e.g.,
box, none, plastic
clamshell).
--Product quantity
(e.g., 1 device, 1
HTP).
--Length (e.g., 100
mm, 120 mm)
--Diameter (e.g., 6
mm, 8.1 mm).
--Wattage (e.g., 100
W, 200 W).
--Battery capacity
(e.g., 100 mAh, 200
mAh).
--Characterizing
flavor(s) (e.g.,
none).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(3) HTP --Package type (e.g.,
Consumable. hard pack, soft
pack, plastic
clamshell).
--Product quantity
(e.g., 20 sticks, 25
cartridges).
--Length (e.g., 60
mm, 82 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) HTP Component --Package type (e.g.,
box, none, plastic
clamshell).
--Product quantity
(e.g., 1 mouthpiece,
1 spacer).
--Characterizing
flavor(s) (e.g.,
none, tobacco,
menthol).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
(5) Other........ --Package type (e.g.,
box, bag, plastic
clamshell, none).
--Product quantity
(e.g., 1 base, 5
capsules).
--Characterizing
flavor(s) (e.g.,
none, tobacco,
menthol, cherry).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
Other......................... Other............ --Package type (e.g.,
box, bag, plastic
clamshell, none).
--Product quantity
(e.g., 1 base, 5
capsules).
--Characterizing
flavor(s) (e.g.,
none, tobacco,
menthol, cherry).
--Additional
properties needed to
uniquely identify
the tobacco product
(if applicable).
------------------------------------------------------------------------
[[Page 55283]]
(8) Address and the FDA Establishment Identifier 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 any differences in
characteristics do not cause the new tobacco product to 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. 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 tobacco
product commercially marketed (other than for test marketing) as of
February 15, 2007, 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) Have been either:
(A) Commercially marketed (other than for test marketing) 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, (insert name and position title of responsible
official), confirm that the predicate tobacco product associated with
this submission, (insert name of predicate tobacco product), was
commercially marketed (other than for test marketing) in the United
States as of February 15, 2007,'' and, if applicable, reference to an
STN for a previous determination by FDA that the predicate product was
commercially marketed (other than for test marketing) in the United
States as of February 15, 2007; or
(B) Previously determined to be substantially equivalent by FDA;
(ii) Be an individual product and not a composite of multiple
products;
(iii) Not be the subject of a rescission action by FDA, as
described in Sec. 1107.50; and
(iv) 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. 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
any characteristic(s) that have changed, but may certify that the other
characteristics are identical under paragraph (l)(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 (l)(2) of this section,
the SE Report must provide comparative testing information that has
been demonstrated to be fully validated on the characteristics of the
new and predicate tobacco products 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.
(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 accordance 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; 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
[[Page 55284]]
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
Sec. Sec. 20.61 and 20.63 of this chapter; 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 this paragraph (j), 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 part 25 of this chapter. (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.
(2) The environmental assessment must include a statement
explaining whether the new tobacco product is intended to replace the
predicate tobacco product after 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 21 CFR 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, as well
as a justification for the 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. Where test
data is submitted, the testing information must include the test
protocols, quantitative acceptance criteria, and test results
(including means and variances, data sets, and a summary of the
results). Comparison testing must be conducted on a sufficient sample
size and on test samples that reflect the finished tobacco product
composition and design. The SE report must 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. The SE report
must 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. The SE
report must include the following:
(a) Comparison of product design. The SE Report must include a
description of the product designs of the new and predicate tobacco
products and an identification of 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. The target
specification and upper and lower range limits must be provided for
each design parameter. Test data (including test protocols,
quantitative acceptance criteria, data sets (i.e., measured values),
and a summary of the results) must be provided for the new and
predicate tobacco products when the target specification or range
limits of the new tobacco product differ from the predicate tobacco
product. For tobacco cut size or particle size, when target
specifications and range limits are not available, the following
alternative information may be submitted in place of this information:
A description of the tobacco cutting process (including a complete
description of the milling, cutting, and sifting process; the control
parameters of the miller or cutter; and any sift specifications) or the
measured particle size distribution for the new and predicate tobacco
products.
(1) Cigarettes. For cigarettes, the required design parameter
information to be provided for each predicate and new tobacco product
is as follows:
[[Page 55285]]
Table 1 to Sec. 1107.19(a)(1)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Provide Target Specification With Upper and Lower Range Limits for:
--Cigarette length (mm).
--Cigarette circumference or diameter (mm).
--Tobacco filler mass (mg).
--Tobacco rod density (g/cm\3\).
--Tobacco moisture or oven volatiles (%).
--Tobacco cut size (mm or cuts per inch (CPI)).
--Filter ventilation (%).
--Tipping paper length (mm).
--Cigarette paper base paper porosity (CORESTA unit (CU)) or
permeability.
--Cigarette paper band porosity or permeability (CU) (alternately,
band diffusivity (cm\2\/s)) (if applicable).
--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 (DPF),
total denier (g/9000m), and filter density (g/cm\3\))).
--Filter length (mm).
--Filter pressure drop (mm H2O).
------------------------------------------------------------------------
Table 2 to Sec. 1107.19(a)(1)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
Section, Provide This Information for the Following Parameters:
--Tobacco filler mass (mg).
--Tobacco moisture (%) or oven volatiles (%).
--Filter ventilation (%).
--Tobacco cut size (mm or CPI).
--Cigarette paper base paper porosity (CU).
--Cigarette paper band porosity or permeability (CU) (alternately,
band diffusivity (cm\2\/s)).
--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., DPF, total denier (g/9000m),
and filter density (g/cm\3\))).
--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:
Table 3 to Sec. 1107.19(a)(2)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Provide Target Specification With Upper and Lower Range Limits for:
Portioned Smokeless Tobacco Products:
--Tobacco cut size (mm or CPI) or tobacco particle size (mm or
micron).
--Tobacco moisture (%).
--Portion length (mm).
--Portion width (mm).
--Portion mass (mg).
--Pouch material thickness (mm) (if applicable).
--Pouch material porosity or permeability (CU or L/m\2\/s) (if
applicable).
--Pouch material basis weight (g/m\2\). (if applicable).
--Nicotine dissolution rate (%/min) (if applicable).
Non-portioned Smokeless Tobacco Products:
--Tobacco cut size (mm or CPI) or tobacco particle size (mm or
micron).
--Tobacco moisture (%).
------------------------------------------------------------------------
Table 4 to Sec. 1107.19(a)(2)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
Section, Provide This Information for the Following Parameters:
Portioned Smokeless Tobacco Products:
--Tobacco cut size (mm or CPI) or tobacco particle size (mm or
micron).
--Tobacco moisture (%).
--Portion mass (mg).
--Pouch material porosity or permeability (CU or L/m\2\/s).
--Pouch material basis weight (g/m\2\).
--Nicotine dissolution rate (%/min) (if applicable).
Non-portioned Smokeless Tobacco Products:
--Tobacco cut size (mm or CPI) or tobacco particle size (mm or
micron).
--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:
[[Page 55286]]
Table 5 to Sec. 1107.19(a)(3)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
--Paper length (mm).
--Paper width (mm).
--Mass per paper (mg).
--Cigarette paper base paper basis weight (g/m\2\).
--Cigarette paper base paper porosity or permeability (CU).
--Cigarette paper band porosity or permeability (CU) (alternately,
band diffusivity (cm\2\/s)) (if applicable).
--Cigarette paper band width (mm) (if applicable).
--Cigarette paper band space (mm) (if applicable).
------------------------------------------------------------------------
Table 6 to Sec. 1107.19(a)(3)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
Section, Provide This Information for the Following Parameters:
--Mass per paper (mg).
--Cigarette paper base paper basis weight (g/m\2\).
--Cigarette paper base paper porosity or permeability (CU).
--Cigarette paper band porosity or permeability (CU) (alternately,
band diffusivity (cm\2\/s)) (if applicable).
------------------------------------------------------------------------
(4) Roll-your-own tobacco, non-filtered tubes. For roll-your-own
tobacco non-filtered tubes, the required design parameter information
to be provided for each predicate and new tobacco product is as
follows:
Table 7 to Sec. 1107.19(a)(4)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
--Tube length (mm).
--Tube circumference or diameter (mm).
--Tube mass (mg).
--Cigarette paper base paper basis weight (g/m\2\).
--Cigarette paper base paper porosity (CU).
--Cigarette paper band porosity or permeability (CU) (alternately,
band diffusivity (cm\2\/s)) (if applicable).
--Cigarette paper band width (mm) (if applicable).
--Cigarette paper band space (mm) (if applicable).
------------------------------------------------------------------------
Table 8 to Sec. 1107.19(a)(4)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
Section, Provide This Information for the Following Parameters:
--Tube mass (mg).
--Cigarette paper base paper basis weight (g/m\2\).
--Cigarette paper base paper porosity (CU).
--Cigarette paper band porosity or permeability (CU) (alternately,
band diffusivity (cm\2\/s)).
------------------------------------------------------------------------
(5) Roll-your-own tobacco, filtered tubes. For roll-your-own
tobacco filtered tubes, the required design parameter information to be
provided for each predicate and new tobacco product is as follows:
Table 9 to Sec. 1107.19(a)(5)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
--Tube length (mm).
--Tube circumference or diameter (mm).
--Tube mass (mg).
--Tipping paper length (mm).
--Filter ventilation (%).
--Cigarette paper base paper basis weight (g/m\2\).
--Cigarette paper base paper porosity or permeability (CU).
--Cigarette paper band porosity or permeability (CU) (alternately,
band diffusivity (cm\2\/s)) (if applicable).
--Cigarette paper band width (mm) (if applicable).
--Cigarette paper band space (mm) (if applicable).
--Filter 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., DPF, total denier (g/9000m),
and filter density (g/cm\3\))).
--Filter pressure drop (mm H2O).
------------------------------------------------------------------------
Table 10 to Sec. 1107.19(a)(5)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
Section, Provide This Information for the Following Parameters:
--Tube mass (mg).
[[Page 55287]]
--Filter ventilation (%).
--Cigarette paper base paper basis weight (g/m\2\).
--Cigarette paper base paper porosity or permeability (CU).
--Cigarette paper band porosity or permeability (CU) (alternately,
band diffusivity (cm\2\/s)) (if applicable).
--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., DPF, total denier (g/9000m),
and filter density (g/cm\3\))).
--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 11 to Sec. 1107.19(a)(6)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
--Tobacco cut size (mm or CPI).
--Tobacco moisture (%) or oven volatiles (%).
------------------------------------------------------------------------
Table 12 to Sec. 1107.19(a)(6)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
Section, Provide This Information for the Following Parameters:
--Tobacco cut size (mm or CPI).
--Tobacco moisture (%) or oven volatiles (%).
------------------------------------------------------------------------
(7) Filtered, sheet-wrapped cigars. For filtered, sheet-wrapped
cigars, the required design parameter information to be provided for
each predicate and new tobacco product is as follows:
Table 13 to Sec. 1107.19(a)(7)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
--Cigar mass (mg).
--Cigar wrapper basis weight (g/m\2\).
--Cigar binder length (mm).
--Cigar binder width (mm).
--Cigar binder basis weight (g/m\2\).
--Cigar length (mm).
--Cigar overall diameter (mm).
--Cigar minimum diameter (mm) (if applicable).
--Cigar maximum diameter (mm) (if applicable).
--Tobacco filler mass (mg).
--Tobacco rod density (g/cm\3\).
--Tobacco moisture or oven volatiles (%).
--Tobacco cut size (CPI or mm).
--Cigar wrapper porosity or permeability (CU).
--Cigar wrapper length (mm).
--Cigar wrapper width (mm).
--Cigar wrapper band porosity or permeability (CU) (alternately,
band diffusivity (cm\2\/s)) (if applicable).
--Cigar wrapper band width (mm) (if applicable).
--Cigar wrapper band space (mm) (if applicable).
--Tipping paper length (mm).
--Cigar binder porosity or permeability (CU).
--Cigar binder band porosity or permeability (CU) (alternately, band
diffusivity (cm\2\/s)) (if applicable).
--Cigar binder band width (mm) (if applicable).
--Cigar binder band space (mm) (if applicable).
--Filter efficiency (%) (If no filter efficiency data is available
for the products, include information sufficient to show that the
cigar filter is unchanged (e.g., DPF, total denier (g/9000m), and
filter density(g/cm\3\))).
--Filter pressure drop (mm H2O).
--Filter length (mm).
--Filter diameter (mm).
--Filter ventilation (%).
------------------------------------------------------------------------
Table 14 to Sec. 1107.19(a)(7)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
Section, Provide This Information for the Following Parameters:
--Cigar mass (mg).
--Puff count.
--Cigar wrapper basis weight (g/m\2\).
[[Page 55288]]
--Cigar wrapper porosity or permeability (CU).
--Cigar binder porosity or permeability (CU).
--Cigar binder basis weight (g/m\2\).
--Filter efficiency (%) (If no filter efficiency data is available
for the products, include information sufficient to show that the
filter is unchanged (e.g., DPF, total denier (g/9000m), and filter
density (g/cm\3\))).
--Tobacco filler mass (mg).
--Tobacco rod density (g/cm\3\).
--Tobacco cut size (CPI or mm).
--Tobacco moisture or oven volatiles (%).
--Cigar wrapper band porosity or permeability (CU) (alternately,
band diffusivity (cm\2\/s)) (if applicable).
--Cigar binder band porosity or permeability (CU) (alternately, band
diffusivity (cm\2\/s)) (if applicable).
--Cigar binder band width (mm) (if applicable).
--Cigar binder band space (mm) (if applicable).
--Cigar minimum diameter (mm) (if applicable).
--Cigar maximum diameter (mm) (if applicable).
--Filter ventilation (%).
--Filter pressure drop (mm H2O).
------------------------------------------------------------------------
(8) Unfiltered, sheet-wrapped cigars. For unfiltered, sheet-wrapped
cigars, the required design parameter information to be provided for
each predicate and new tobacco product is as follows:
Table 15 to Sec. 1107.19(a)(8)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
--Cigar length (mm).
--Cigar mass (mg).
--Cigar overall diameter (mm).
--Cigar minimum diameter (mm) (if applicable).
--Cigar maximum diameter (mm) (if applicable).
--Tobacco filler mass (mg).
--Tobacco rod density (g/cm\3\).
--Tobacco moisture or oven volatiles (%).
--Tobacco cut size (CPI or mm).
--Cigar wrapper porosity or permeability (CU).
--Cigar wrapper length (mm).
--Cigar wrapper width (mm).
--Cigar wrapper basis weight (g/m\2\).
--Cigar binder porosity or permeability (CU).
--Cigar binder width (mm) (if applicable).
--Cigar binder basis weight (g/m\2\).
--Cigar tip mass (mg) (if applicable).
--Tip length (mm) (if applicable).
--Tip inner diameter (mm) (if applicable).
--Cigar binder band porosity or permeability (CU) (alternately, band
diffusivity (cm\2\/s)) (if applicable).
--Cigar binder band width (mm) (if applicable).
--Cigar binder band space (mm) (if applicable).
--Cigar wrapper band porosity or permeability (CU) (alternately,
band diffusivity (cm\2\/s)) (if applicable).
--Cigar wrapper band width (mm) (if applicable).
--Cigar wrapper band space (mm) (if applicable).
------------------------------------------------------------------------
Table 16 to Sec. 1107.19(a)(8)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
Section, Provide This Information for the Following Parameters:
--Puff count.
--Cigar mass (mg).
--Tobacco rod density (g/cm\3\).
--Tobacco cut size (CPI or mm).
--Tobacco moisture or oven volatiles (%).
--Tobacco filler mass (mg).
--Cigar wrapper basis weight (g/m\2\).
--Cigar wrapper porosity or permeability (CU).
--Cigar binder width (mm) (if applicable).
--Cigar binder basis weight (g/m\2\).
--Cigar binder porosity or permeability (CU).
--Cigar wrapper band porosity or permeability (CU) (alternately,
band diffusivity (cm\2\/s)) (if applicable).
--Cigar binder band porosity or permeability (CU) (alternately, band
diffusivity (cm\2\/s)) (if applicable).
--Cigar tip mass (mg) (if applicable).
--Cigar minimum diameter (mm) (if applicable).
--Cigar maximum diameter (mm) (if applicable).
------------------------------------------------------------------------
[[Page 55289]]
(9) Unfiltered, leaf-wrapped cigars. For unfiltered, leaf-wrapped
cigars, the required design parameter information to be provided for
each predicate and new tobacco product is as follows:
Table 17 to Sec. 1107.19(a)(9)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
--Cigar length (mm).
--Cigar mass (mg).
--Overall diameter (mm).
--Cigar minimum diameter (mm) (if applicable).
--Cigar maximum diameter (mm) (if applicable).
--Tobacco filler mass (mg).
--Tobacco rod density (g/cm\3\).
--Tobacco moisture or oven volatiles (%).
--Tobacco cut size (CPI or mm).
--Cigar wrapper length (mm).
--Cigar wrapper width (mm).
--Cigar wrapper basis weight (g/m\2\).
--Cigar binder width (mm).
--Cigar binder basis weight (g/m\2\).
------------------------------------------------------------------------
Table 18 to Sec. 1107.19(a)(9)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
Section, Provide This Information for the Following Parameters:
--Puff count.
--Cigar mass (mg).
--Tobacco filler mass (mg).
--Tobacco rod density (g/cm\3\).
--Tobacco cut size (CPI or mm).
--Cigar wrapper basis weight (g/m\2\).
--Cigar binder basis weight (g/m\2\).
--Tobacco moisture or oven volatiles (%).
--Cigar minimum diameter (mm) (if applicable).
--Cigar maximum diameter (mm) (if applicable).
------------------------------------------------------------------------
(10) Cigar filler. For cigar filler, the required design parameter
information to be provided for each predicate and new tobacco product
is as follows:
Table 19 to Sec. 1107.19(a)(10)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
--Tobacco moisture or oven volatiles (%).
--Tobacco cut size (CPI or mm).
------------------------------------------------------------------------
Table 20 to Sec. 1107.19(a)(10)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
Section, Provide This Information for the Following Parameters:
--Tobacco moisture or oven volatiles (%).
--Tobacco cut size (CPI or mm).
------------------------------------------------------------------------
(11) Cigar component. For cigar components, the required design
parameter information to be provided for each predicate and new tobacco
product is as follows:
Table 21 to Sec. 1107.19(a)(11)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
--Cigar wrapper length (mm).
--Cigar wrapper width (mm).
--Cigar wrapper porosity (CU).
--Cigar wrapper basis weight (g/m\2\).
------------------------------------------------------------------------
Table 22 to Sec. 1107.19(a)(11)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
Section, Provide This Information for the Following Parameters:
--Cigar wrapper length (mm).
[[Page 55290]]
--Cigar wrapper width (mm).
--Cigar wrapper basis weight (g/m\2\).
------------------------------------------------------------------------
(12) Pipes. For pipes, the required design parameter information to
be provided for each predicate and new tobacco product is as follows:
Table 23 to Sec. 1107.19(a)(12)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
--Bowl chamber outer diameter (mm).
--Bowl chamber inner diameter (mm).
--Draught hole diameter (mm).
--Draught hole location.
--Draught hole shape.
--Bowl chamber hole shape.
--Bowl chamber volume (cm\3\).
--Stem length (mm).
--Stem diameter (mm).
--Shank length (mm).
--Shank diameter (mm).
--Draught hole area (mm\2\).
--Pressure drop through air valve (mm H2O).
--Air flow through air valve (cc/min).
--Filter efficiency (%) (If no filter efficiency data is available
for the products, include information sufficient to show that the
filter is unchanged (e.g., DPF, total denier (g/9000m), and filter
density (g/cm\3\))).
--Filter pressure drop (mm H2O).
--Filter length (mm).
------------------------------------------------------------------------
Table 24 to Sec. 1107.19(a)(12)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
Section, Provide This Information for the Following Parameters:
--Bowl chamber volume (cm\3\).
--Air flow through air valve (cc/min).
--Filter length (mm).
--Filter pressure drop (mm H2O).
--Filter efficiency (%) (If no filter efficiency data is available
for the products, include information sufficient to show that the
filter is unchanged (e.g., DPF, total denier (g/9000m), and filter
density (g/cm\3\))).
------------------------------------------------------------------------
(13) Pipe filler. For pipe filler, the required design parameter
information to be provided for each predicate and new tobacco product
is as follows:
Table 25 to Sec. 1107.19(a)(13)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
--Tobacco moisture or oven volatiles (%).
--Tobacco cut size (CPI or mm).
------------------------------------------------------------------------
Table 26 to Sec. 1107.19(a)(13)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
Section, Provide This Information for the Following Parameters:
--Tobacco moisture or oven volatiles (%).
--Tobacco cut size (CPI or mm).
------------------------------------------------------------------------
(14) Waterpipes. For waterpipes, the required design parameter
information to be provided for each predicate and new tobacco product
is as follows:
Table 27 to Sec. 1107.19(a)(14)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
--Hose length (mm).
--Hose internal diameter (mm).
--Hose materials.
--Stem length (mm).
--Stem internal diameter (mm).
--Base diameter (mm).
[[Page 55291]]
--Base volume (cm\3\).
--Base shape.
--Pressure drop (mm H2O).
--Water filter efficiency (%).
--Hose air permeability (CU).
--Head height (mm).
--Head top diameter (mm).
--Head bottom diameter (mm).
--No. of holes.
--Head volume (mm\3\).
--Heating source type.
--Head materials.
------------------------------------------------------------------------
Table 28 to Sec. 1107.19(a)(14)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
Section, Provide This Information for the Following Parameters:
--Hose length (mm).
--Hose internal diameter (mm).
--Stem length (mm).
--Stem internal diameter (mm).
--Base diameter (mm).
--Base volume (cm\3\).
--Pressure drop (mm H2O).
--Water filter efficiency (%).
--Head height (mm).
--Head top diameter (mm).
--Head bottom diameter (mm).
--Head volume (mm\3\).
------------------------------------------------------------------------
(15) Waterpipe, heating source. For waterpipe heating sources, the
required design parameter information to be provided for each predicate
and new tobacco product is as follows:
Table 29 to Sec. 1107.19(a)(15)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
--Heating element mass (mg).
--Heating element density (g/cm\3\).
--Heating element resistance (ohms) (if applicable).
--No. of heating elements.
--Heating element configuration.
--Heating element diameter (gauge).
--Battery current rating (mA) (if applicable).
--Battery capacity (mAh) (if applicable).
--Battery voltage operating range (volts) (if applicable).
--Battery current operating range (amps) (if applicable).
--Power delivery unit (PDU) voltage operating range (volts) (if
applicable).
--PDU current operating range (amps) (if applicable).
--PDU wattage operating range (watts) (if applicable).
--PDU temperature cut-off ([deg]C) (if applicable).
------------------------------------------------------------------------
Table 30 to Sec. 1107.19(a)(15)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
Section, Provide This Information for the Following Parameters:
--Heating element temperature range ([deg]C) (if applicable).
--Heating element mass (mg).
--Heating element density (g/cm\3\).
--Heating element resistance (ohms) (if applicable).
--Heating element diameter (gauge).
--Battery current rating (mA) (if applicable).
--Battery capacity (mAh) (if applicable).
--Battery voltage operating range (volts) (if applicable).
--Battery current operating range (amps) (if applicable).
--Power delivery unit (PDU) voltage operating range (volts) (if
applicable).
--PDU current operating range (amps) (if applicable).
--PDU wattage operating range (watts) (if applicable).
--PDU temperature cut-off ([deg]C) (if applicable).
------------------------------------------------------------------------
[[Page 55292]]
(16) Waterpipe component, head. For waterpipe heads, the required
design parameter information to be provided for each predicate and new
tobacco product is as follows:
Table 31 to Sec. 1107.19(a)(16)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
1--Head height (mm).
--Head top diameter (mm).
--Head bottom diameter (mm).
--No. of holes.
--Head volume (mm\3\).
--Head materials.
------------------------------------------------------------------------
Table 32 to Sec. 1107.19(a)(16)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
Section, Provide This Information for the Following Parameters:
--Head height (mm).
--Head top diameter (mm).
--Head bottom diameter (mm).
--Head volume (mm\3\).
------------------------------------------------------------------------
(17) Waterpipe component, foil. For waterpipe foil, the required
design parameter information to be provided for each predicate and new
tobacco product is as follows:
Table 33 to Sec. 1107.19(a)(17)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
--Length (mm) (for square or rectangular shape foil).
--Width (mm) (for square or rectangular shape foil).
--Diameter (mm) (for circular shape foil).
--Foil thickness (mm).
--No. of holes.
--Diameter of the holes (mm).
------------------------------------------------------------------------
Table 34 to Sec. 1107.19(a)(17)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
Section, Provide This Information for the Following Parameters:
--Length (mm) (for square or rectangular shape foil).
--Width (mm) (for square or rectangular shape foil).
--Diameter (mm) (for circular shape foil).
--Foil thickness (mm).
--Diameter of the holes (mm).
------------------------------------------------------------------------
(18) Waterpipe filler. For waterpipe filler, the required design
parameter information to be provided for each predicate and new tobacco
product is as follows:
Table 35 to Sec. 1107.19(a)(18)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
--Tobacco moisture or oven volatiles (%).
--Tobacco cut size (CPI or mm).
------------------------------------------------------------------------
Table 36 to Sec. 1107.19(a)(18)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
Section, Provide This Information for the Following Parameters:
--Tobacco moisture or oven volatiles (%).
--Tobacco cut size (CPI or mm).
------------------------------------------------------------------------
(19) Electronic Nicotine Delivery System (ENDS). For ENDS (vapes),
the required design parameter information to be provided for each
predicate and new tobacco product is as follows:
[[Page 55293]]
Table 37 to Sec. 1107.19(a)(19)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
--Draw resistance (mm H2O).
--Puff count (for full tank/cartridge).
--Atomizer tank/cartridge volume (mL).
--No. of heating elements (e.g., coil).
--Heating element diameter (gauge).
--Heating element length (mm).
--Heating element resistance (Ohms).
--Heating element temperature range ([deg]C).
--Heating element configuration (target only).
--Battery voltage operating range (V).
--Battery current operating range (mA).
--Battery capacity (mAh).
--Battery nominal voltage (V).
--Battery current rating (mA).
--Battery charging temperature limits ([deg]C).
--Battery discharge temperature limits ([deg]C).
--Battery end of discharge voltage (V).
--Battery maximum charging current (mA).
--Battery maximum discharging current (mA).
--Battery upper limits charging voltage (V).
--Power Delivery Unit (PDU) voltage operating range (V).
--PDU current operating range (mA).
--PDU wattage operating range (watts).
--PDU temperature cut-off ([deg]C) (if applicable).
--PDU current cut-off (mA) (if applicable).
--Airflow rate (L/min) (if applicable).
--Ventilation (%).
--Inhaled aerosol temperature ([deg]C).
------------------------------------------------------------------------
Table 38 to Sec. 1107.19(a)(19)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
Section, Provide This Information for the Following Parameters:
--Draw resistance (mm H2O).
--Puff count (for full tank/cartridge).
--Atomizer tank/cartridge volume (mL).
--Heating element diameter (gauge).
--Heating element resistance (Ohms).
--Heating element temperature range ([deg]C).
--Battery voltage operating range (V).
--Battery current operating range (mA).
--PDU voltage operating range (V).
--PDU current operating range (mA).
--PDU wattage operating range (watts).
--PDU current cut-off (mA) (if applicable).
--Inhaled aerosol temperature ([deg]C).
--PDU temperature cut-off ([deg]C) (if applicable).
--Battery capacity (mAh).
--Battery nominal voltage (V).
--Battery current rating (mA).
--Heating element length (mm).
--Battery charging temperature limits ([deg]C).
--Battery discharge temperature limits ([deg]C).
--Battery maximum charging current (mA).
--Battery maximum discharging current (mA).
--Battery upper limits charging voltage (V).
--Airflow rate (L/min) (if applicable).
--Ventilation (%).
------------------------------------------------------------------------
(20) E-liquids. For e-liquids, the required design parameter
information to be provided for each predicate and new tobacco product
is as follows:
Table 39 to Sec. 1107.19(a)(20)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
--E-liquid viscosity (at 20[deg]C).
--E-liquid volume (ml).
--Particle number concentration (#/cm\3\).
--Count median diameter (nm).
[[Page 55294]]
--PM2.5 ([micro]g/m\3\).
------------------------------------------------------------------------
Table 40 to Sec. 1107.19(a)(20)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
Section, Provide This Information for the Following Parameters:
--E-liquid viscosity (at 20[deg]C).
--E-liquid volume (ml).
--Particle number concentration (#/cm\3\).
--Count median diameter (nm).
--PM2.5 ([micro]g/m\3\).
------------------------------------------------------------------------
(21) Heated Tobacco Products (HTP). For HTPs, the required design
parameter information to be provided for each predicate and new tobacco
product is as follows:
Table 41 to Sec. 1107.19(a)(21)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
--Overall Device:
--Mass (mg).
--Length (mm).
--Width (mm).
--Height (mm).
--Diameter (mm).
--Draw resistance (mm H2O).
--Puff count (for full tank/cartridge).
--Puff volume (mL).
--Product volume (mL).
--Airflow rate (L/min) (if applicable).
--Ventilation (%).
--Operational temperature ([deg]C).
--Temperature sensor (if applicable).
--Material wrapper length (mm) (if applicable).
--Material wrapper width (mm) (if applicable).
--Material wrapper basis weight (g/m\2\) (if applicable).
--Material porosity or permeability (CU) (if applicable).
--Heating element:
--Heating element source/type/approach (electrical, carbon,
aerosol, etc.).
--Heating element temperature range ([deg]C).
--Heating element operational temperature ([deg]C).
--Heating element maximum temperature (boost temperature)
([deg]C).
--Heating element material.
--Heating element configuration.
--Heating element length (mm).
--Heating element mass (mg).
--Heating element location.
--No. of heating elements (e.g., coil).
--Heating element diameter (gauge) (if applicable).
--Heating element resistance (Ohms) (if applicable).
--Tobacco/E-liquid:
--Tobacco mass (mg) (if applicable).
--Tobacco density (g/cm\3\) (if applicable).
--Tobacco moisture or oven volatiles (%) (if applicable).
--Tobacco cut size (CPI or mm) (if applicable).
--E-liquid volume (mL) (if applicable).
--E-liquid viscosity (at 20[deg]C) (if applicable).
--Battery (if applicable):
--Battery capacity (mAh).
--Battery voltage operating range (V) or wattage (W).
--Battery current charging range (amps).
--Battery nominal voltage (V).
--Battery current rating (mA).
--Battery charging temperature limits ([deg]C).
--Battery discharge temperature limits ([deg]C).
--Battery end of discharge voltage (V).
--Battery maximum charging current (mA).
--Battery maximum discharging current (mA).
--Battery upper limits charging voltage (V).
--Power Delivery Unit (PDU) voltage operating range (V).
--PDU current operating range (mA).
--PDU wattage operating range (watts).
[[Page 55295]]
--PDU temperature cut-off ([deg]C) (if applicable).
--PDU current cut-off (mA) (if applicable).
--Aerosol:
--Inhaled aerosol temperature ([deg]C).
--Aerosol particle number concentration (#/cm\3\).
--Count median diameter (nm).
--PM2.5 ([micro]g/m\3\).
--Filter (if applicable):
--Filter efficiency (%) (If no filter efficiency data is
available for the products, include information sufficient to
show that the filter is unchanged (e.g., DPF, total denier (g/
9000m), and filter density(g/cm\3\))).
--Filter pressure drop (mm H2O).
--Filter length (mm).
--Filter diameter (mm).
--Filter ventilation (%).
------------------------------------------------------------------------
Table 42 to Sec. 1107.19(a)(21)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
Section, Provide This Information for the Following Parameters:
--Overall device:
--Draw resistance (mm H2O).
--Puff count (for full tank/cartridge) (dimensionless).
--Product volume (mL).
--Airflow rate (L/min) (if applicable).
--Ventilation (%).
--Operational temperature ([deg]C).
--Temperature sensor (if applicable).
--Material wrapper length (mm) (if applicable).
--Material wrapper width (mm) (if applicable).
--Material wrapper basis weight (g/m\2\) (if applicable).
--Material porosity or permeability (CU) (if applicable).
--Heating element:
--Heating element diameter (gauge) (if applicable).
--Heating element resistance (Ohms) (if applicable).
--Heating element temperature range ([deg]C).
--E-liquid:
--E-liquid viscosity (at 20[deg]C) (if applicable).
--E-liquid volume (ml) (if applicable).
--Tobacco:
--Tobacco moisture or oven volatiles (%) (if applicable).
--Tobacco cut size (CPI or mm) (if applicable).
--Tobacco density (g/cm\3\) (if applicable).
--Battery:
--Battery voltage operating range (V) or wattage (W).
--Battery current operating range (mA).
--PDU voltage operating range (V).
--PDU current operating range (mA).
--PDU wattage operating range (watts).
--PDU current cut-off (mA) (if applicable).
--PDU temperature cut-off ([deg]C) (if applicable).
--Battery capacity (mAh).
--Battery nominal voltage (V).
--Battery current rating (mA).
--Battery charging temperature limits ([deg]C).
--Battery discharge temperature limits ([deg]C).
--Battery maximum charging current (mA).
--Battery maximum discharging current (mA).
--Battery upper limits charging voltage (V).
--Aerosol:
--Inhaled aerosol temperature ([deg]C).
--Aerosol particle number concentration (#/cm\3\).
--Count median diameter (nm).
--PM2.5 ([micro]g/m\3\).
--Filter (if applicable):
--Filter efficiency (%) (If no filter efficiency data is
available for the products, include information sufficient to
show that the filter is unchanged (e.g., DPF, total denier (g/
9000m), and filter density(g/cm\3\))).
--Filter ventilation (%).
--Filter pressure drop (mm H2O).
------------------------------------------------------------------------
(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.
[[Page 55296]]
(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 specifications 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 each ingredient other than
tobacco in each material 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 ingredient 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 (e.g., Bright, Burley, reconstituted);
(ii) The curing method (e.g., flue cured, dark air cured);
(iii) The quantity of each type 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;
(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 predicate tobacco
products, such as those described in paragraphs (d)(1) and (2) of this
section, and identify any differences. If a specific feature specified
in paragraphs (d)(1) and (2) of 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, associated reference(s), and full
validation reports for each analytical method;
(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;
(J) Reference product datasets (if applicable);
(K) 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. Test data for combusted
or inhaled tobacco products must reflect testing conducted using both
intense and non-intense smoking or aerosol-generating regimens, where
established; and
(L) Complete descriptions of any smoking or aerosol-generating
regimens used for analytical testing that are not standardized or
widely accepted by the scientific community, if applicable.
(2) Any other features. A description and comparison of any other
features of the new tobacco product and the predicate tobacco product.
(e) Comparison of tobacco processing. The SE Report must include
information on the tobacco processes in paragraphs (e)(1) and (2) of
this section for the new and predicate tobacco products, if applicable,
and identify any differences.
(1) Fermentation process. For smokeless tobacco products and
tobacco products that contain fermented tobacco (including naturally
fermented tobacco), the SE Report must contain the following
information regarding the fermentation process of the new and predicate
tobacco products and identify any differences:
(i) Description of the fermentation process;
(ii) Composition of the inoculum (starter culture) with genus and
species name(s) and concentration(s) (if applicable);
(iii) Any step(s) taken to reduce microbes already present during
processing (e.g., cleaning of contact surfaces);
(iv) Specifications and test data for pH, temperature, and moisture
content or water activity;
(v) Frequency of aeration or turning (if applicable);
(vi) Duration of fermentation;
(vii) Added ingredients;
(viii) Method used to stabilize or stop fermentation ((e.g., heat
treatment), if
[[Page 55297]]
applicable), including parameters of the method (e.g., length of
treatment, temperature) and method validation data; and
(ix) Storage conditions of the fermented tobacco prior to further
processing or packaging and duration of storage (if applicable).
(2) Heat treatment process. For tobacco products that are heat
treated, the SE Report must contain the following information regarding
the heat treatment process of the new and predicate tobacco products
and identify any differences:
(i) Description of the heat treatment process;
(ii) Type of heat treatment;
(iii) Conditions of heat treatment, including time, temperature,
and moisture; and
(iv) Method validation data, including microbial loads (including
bacteria, spores, yeast and fungi) and tobacco-specific nitrosamines
(TSNAs) before and after heat treatment.
(f) Shelf life and stability information. With the exception of SE
Reports for roll-your-own tobacco products and cigarettes that are not
HTPs, SE Reports for all tobacco products must contain information on
the stability of the new and predicate tobacco products over the shelf
life, including the following information:
(1) The length of the shelf life, a description of how shelf life
is determined, and a description of how shelf life is indicated on the
tobacco product, if applicable. If a tobacco product does not have a
defined shelf life, state as such;
(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;
(3) Stability data assessed at the beginning (zero time), middle,
and end of the expected shelf life. If a tobacco product does not have
a defined shelf life, provide stability data over a specified amount of
time and a justification for why that time period is appropriate.
Stability testing must be performed for the microbial and chemical
endpoints as follows:
(i) Microbial content data including total aerobic microbial count
and total yeast and mold count;
(ii) Water activity; and
(iii) Tobacco-specific nitrosamine yields (total, N-
nitrosonornicotine (NNN), and 4-methylnitrosamino)-1-(3-pydridyl)-1-
butanone) (NNK)).
(4) Stability testing details for each microbial and chemical
endpoint, including:
(i) The mean quantity and variance with unit of measure;
(ii) The number of samples and measurement replicates for each
sample;
(iii) The methods used, associated reference(s), and full
validation reports for each method (as applicable);
(iv) 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;
(v) Length of time between dates of tobacco product manufacture and
date(s) of testing;
(vi) Storage conditions of the tobacco products before they were
tested;
(vii) 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
(viii) Full test data (including test protocols, any deviation(s)
from the test protocols, quantitative acceptance (pass/fail) criteria,
complete data sets, and a summary of the results) for all stability
testing performed.
(g) 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 (paragraph (a) of
this section); heating source (paragraph (b) of this section);
materials and ingredients (paragraph (c) of this section); and other
features (paragraph (d) of this section). In addition, to demonstrate
that a new tobacco product 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 would
not change the characteristics of the new tobacco product such that the
new tobacco product could raise different questions of public health
(Sec. 1107.18(e)). Similarly, for smokeless tobacco products and
tobacco products that contain fermented tobacco, an applicant must
explain why any difference in stability between the new tobacco product
and the predicate tobacco product does not cause the new tobacco
product to raise different questions of public health (paragraph (f) of
this section).
(h) Comparison to original predicate tobacco 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 predicate tobacco product that was commercially marketed
(other than for test marketing) in the United States as of February 15,
2007, even if that original predicate tobacco product is back several
predicate tobacco products. FDA will request this information when
necessary to ensure that any order the Agency issues 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 original predicate tobacco 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 Sec. Sec. 20.61
and 20.63 of this chapter.
(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.
(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.
[[Page 55298]]
(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 part 20 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 part 20 of this chapter. 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, Center for Tobacco Products, and FDA
will make every attempt to grant requests for meetings that involve
important issues.
(c) Acceptance of an SE Report for review. After receiving an SE
Report under Sec. 1107.18, FDA will either refuse to accept the SE
Report for review or issue an acceptance for review letter.
(d) Notification of deficiencies in an 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 calendar days of determining
that the predicate was found to be commercially marketed (other than
for test marketing) 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 generally intends to 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 an 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 for review if it does not comply
with Sec. 1107.18 and Sec. 1105.10 of this chapter;
(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 (other than for test marketing) 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 (other than
for test marketing) in the United States on February 15, 2007, and
finds that the new tobacco product is in compliance with the
requirements of the Federal Food, Drug, and Cosmetic Act, FDA will send
the applicant an order authorizing marketing of the new tobacco
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
[[Page 55299]]
equivalent to a predicate tobacco product that was commercially
marketed (other than for test marketing) 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 substantially equivalent 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 an 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 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 predicate tobacco product, has been found ineligible because
its 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 predicate tobacco 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. (1) Except as provided in paragraphs
(b)(2) and (3) of this section, FDA will rescind an order only after
notice and opportunity for a hearing under part 16 of this chapter.
(2) 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.
(3) FDA may rescind a substantially equivalent order without notice
and opportunity for a hearing under part 16 of this chapter if the
applicant has notified the Agency of a mistake in the application, FDA
has determined that the mistake is part of the underlying scientific
determination of the order which makes the order invalid, and the
applicant has agreed that FDA can rescind the order without providing
notice and opportunity for a hearing under part 16 of this chapter.
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 issuance of 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 this chapter, the
environmental assessment or, if applicable, the claim of categorical
exclusion from the requirement to
[[Page 55300]]
submit an environmental assessment under part 25 of this chapter.
(d) Disclosure of data and information after issuance of 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 including an email address. If the applicant has
submitted an SE Report previously, the regulatory correspondence must
also include any identifying information for the previous submission.
(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: September 21, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
[FR Doc. 2021-21009 Filed 10-4-21; 8:45 am]
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