Document ID: FDA-2016-N-3818-0176
Agency: fda
Document Type: Rule
Title: Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports
Posted Date: 2021-10-05T04:00Z

[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Applications for Premarket Review of New Tobacco Products; Draft 
Guidance for Industry; Withdrawal; Notice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  

[[Page 55224]]

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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, 
AskCTP@fda.hhs.gov.

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

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

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

[[Page 55227]]

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.

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[[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\
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    \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.
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    [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

[[Page 55243]]

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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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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