Proposed Rule2025-00397
Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products
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Published
January 16, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is proposing a tobacco product standard that would regulate nicotine yield by establishing a maximum nicotine level in cigarettes and certain other combusted tobacco products. FDA is proposing this action to reduce the addictiveness of these products, thus giving people who are addicted and wish to quit the ability to do so more easily. The proposed product standard is anticipated to benefit the population as a whole. For example, it would help to prevent people who experiment with cigarettes and cigars from developing addiction and using combusted tobacco products regularly.
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[Federal Register Volume 90, Number 10 (Thursday, January 16, 2025)]
[Proposed Rules]
[Pages 5032-5144]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-00397]
[[Page 5031]]
Vol. 90
Thursday,
No. 10
January 16, 2025
Part V
Department of Health and Human Services
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Food and Drug Administration
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21 CFR Part 1160
Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain
Other Combusted Tobacco Products; Proposed Rule
Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 /
Proposed Rules
[[Page 5032]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1160
[Docket No. FDA-2024-N-5471]
RIN 0910-AI76
Tobacco Product Standard for Nicotine Yield of Cigarettes and
Certain Other Combusted Tobacco Products
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
proposing a tobacco product standard that would regulate nicotine yield
by establishing a maximum nicotine level in cigarettes and certain
other combusted tobacco products. FDA is proposing this action to
reduce the addictiveness of these products, thus giving people who are
addicted and wish to quit the ability to do so more easily. The
proposed product standard is anticipated to benefit the population as a
whole. For example, it would help to prevent people who experiment with
cigarettes and cigars from developing addiction and using combusted
tobacco products regularly.
DATES: Either electronic or written comments on the proposed rule must
be submitted by September 15, 2025. Submit comments (including
recommendations) on the collection of information under the Paperwork
Reduction Act of 1995 (PRA) by September 15, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 15, 2025. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2024-N-5471 for ``Tobacco Product Standard for Nicotine Yield of
Cigarettes and Certain Other Combusted Tobacco Products.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
Go to the Federal eRulemaking Portal at <a href="https://www.regulations.gov">https://www.regulations.gov</a>
for access to the rulemaking docket, including any background documents
and the plain-language summary of the proposed rule of not more than
100 words in length required by the Providing Accountability Through
Transparency Act of 2023.
Submit comments on the information collection under the Paperwork
Reduction Act of 1995 to the Office of Management and Budget (OMB) at
<a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under Review--Open for
Public Comments'' or by using the search function. The title of this
proposed collection is ``Tobacco Product Standard for Nicotine Yield of
Cigarettes and Certain Other Combusted Tobacco Products.''
FOR FURTHER INFORMATION CONTACT: With regard to the proposed rule: Nate
Mease or Dhanya John, Center for Tobacco Products, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
877-287-1373, <a href="/cdn-cgi/l/email-protection#6b283f3b390e0c1e070a1f020405182b0d0f0a45030318450c041d"><span class="__cf_email__" data-cfemail="65263135370002100904110c0a0b16250301044b0d0d164b020a13">[email protected]</span></a>.
With regard to the information collection: JonnaLynn Capezzuto,
Office of Operations, Food and Drug Administration, Three White Flint
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
3794, <a href="/cdn-cgi/l/email-protection#48181a091b3c292e2e082e2c296620203b662f273e"><span class="__cf_email__" data-cfemail="b4e4e6f5e7c0d5d2d2f4d2d0d59adcdcc79ad3dbc2">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
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Table of Contents
I. Executive Summary
A. Purpose of the Proposed Rule
B. Summary of the Major Provisions of the Proposed Rule
C. Legal Authority
D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
A. Need for the Regulation
B. Relevant Regulatory History
C. Legal Authority
IV. Nicotine in Cigarettes and Other Combusted Tobacco Products:
Addiction, Initiation, Dependence, Cessation, Relapse, Health
Effects, and Consumer Perceptions
A. Nicotine Is Addictive
B. The Developing Brain's Vulnerability to the Effects of
Nicotine Leads to Progression to Regular Cigarette Use Among Youth
and Young Adults Who Experiment
C. Youth and Adult Cigarette Smoking Cessation and Relapse
D. Smoking Cigarettes and Other Combusted Tobacco Products
Causes Serious Negative Health Effects
E. Tobacco Product Marketing Has Contributed to Disparities in
Use and Health Outcomes
F. Consumer Knowledge, Attitudes, Beliefs, and Perceptions About
Nicotine
V. History and Perceptions of VLNC Cigarettes
A. History of LNC and VLNC Cigarettes
B. Consumer Knowledge, Attitudes, Beliefs, and Perceptions
Regarding VLNC Cigarettes and Regulation of Levels of Nicotine in
Tobacco
VI. Rationale for Products Covered by the Proposed Product Standard
A. Prevalence and Abuse Potential of Cigarettes and Other
Combusted Tobacco Products
B. Potential for Tobacco Product Switching
VII. Discussion of Nicotine-Related Topics
A. Approach To Limiting User Exposure to Nicotine
B. Scientific Evidence Supports the Target Level of Nicotine
C. An Immediate Nicotine Reduction Approach Is Strongly
Supported by Scientific Evidence
D. Scientific Evidence Supports the Use of an Analytical Test
Method To Determine Nicotine Level
E. Scientific Evidence Supports the Technical Achievability of
the Proposed Maximum Nicotine Level Target
F. Proposal Does Not Seek To Limit Nicotine to Zero
VIII. Determination That the Standard Is Appropriate for the
Protection of the Public Health
A. Approach To Estimating Impacts to the Population as a Whole
B. The Likelihood That Nonusers Would Start Using Cigarettes or
Other Combusted Tobacco Products
C. The Likelihood That Existing Users Would Reduce Cigarette and
Other Combusted Tobacco Product Consumption or Stop Smoking
D. Benefits and Risks to the Population as a Whole
E. Approach Concerning Adjustments to Inputs to the Model
Accounting for Other Tobacco Product Standards
F. Benefits and Risks to the Population as a Whole Accounting
for Other Tobacco Product Standards
G. Conclusion
IX. Additional Considerations and Requests for Comment
A. Section 907 of the FD&C Act
B. Pathways to Market
C. Considerations and Request for Comments on Scope of Products
D. Considerations and Request for Comments on the Potential for
Illicit Trade
X. Description of Proposed Regulation
A. General Provisions (Proposed Subpart A)
B. Product Requirements (Proposed Subpart B)
C. Manufacturing Code and Recordkeeping Requirements (Proposed
Subpart C)
XI. Proposed Effective Date
XII. Preliminary Economic Analysis of Impacts
A. Introduction
B. Summary of Costs and Benefits
XIII. Analysis of Environmental Impact
XIV. Paperwork Reduction Act of 1995
XV. Federalism
XVI. Severability
XVII. Consultation and Coordination With Indian Tribal Governments
XVIII. References
I. Executive Summary
A. Purpose of the Proposed Rule
Each year, 480,000 people die prematurely from a smoking-
attributable disease, making tobacco use the leading cause of
preventable disease and death in the United States (Ref. 1). Nearly all
these adverse health effects are ultimately the result of addiction to
the nicotine in combusted tobacco products, leading to repeated
exposure to toxicants from those products. Nicotine, the primary
addictive constituent in tobacco products, can be delivered through a
variety of products along a continuum of risk. To protect youth and
reduce tobacco-related disease and death, the Agency utilizes a
comprehensive approach to tobacco and nicotine regulation (<a href="https://www.fda.gov/media/174911/download">https://www.fda.gov/media/174911/download</a>). As part of this comprehensive
approach, FDA is proposing a tobacco product standard that would
regulate nicotine yield by establishing a maximum nicotine level in
cigarettes \1\ and certain other combusted tobacco products (proposed
product standard).
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\1\ Throughout this document, FDA generally uses the term
``cigarettes'' to refer to combusted cigarettes, unless specifically
stated or context indicates that noncombusted cigarettes are
referenced. In general, the term is not meant to include any
noncombusted tobacco products that meet the definition of cigarette
in section 900(3) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 387(3)).
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As the U.S. District Court for the District of Columbia recognized
in United States v. Philip Morris USA, Inc. et al., 449 F.Supp.2d 1
(D.D.C. 2006), aff'd in relevant part, 566 F.3d 1095 (D.C. Cir. 2009),
the tobacco industry has long known that nicotine creates and sustains
addiction, and the industry is dependent on maintaining this addiction.
Id. at 307. The court noted how cigarette companies have engaged in
extensive research to understand how nicotine operates within the human
body and then designed their cigarettes to precisely control nicotine
delivery and provide nicotine doses to create and sustain addiction.
Id. at 307-309. Moreover, the court confirmed that industry documents
supported the conclusion that these companies ``knew early on in their
research that if a cigarette did not deliver a certain amount of
nicotine, new smokers would not become addicted, and `confirmed'
smokers would be able to quit.'' Id. at 219. In fact, the tobacco
industry has had programs in place since the 1960s to obtain ``any
level of nicotine desired'' (Ref. 2). These companies sought to
identify the ``optimum'' dose needed to ``satisfy'' people who smoke
cigarettes and, thereby, assure their continued smoking. Philip Morris,
449 F.Supp.2d at 309-10. This proposed product standard would seek to
set a maximum nicotine level such that cigarettes and certain other
combusted tobacco products could no longer create and sustain this
addiction among people who smoke cigarettes and certain other combusted
tobacco products.
The proposed product standard would limit the addictiveness of the
most toxic and widely used tobacco products, which would have
significant public health benefits for all age groups. The proposal
would have cessation benefits for adults who use cigarettes and certain
other combusted tobacco products, most of whom want to quit but are
repeatedly unsuccessful because of the highly addictive nature of these
products (see section IV.A of this document). Because these products
would not create and sustain addiction, users would be able to quit
when they would like, something many who use these products currently
do not have the ability to do. Additionally, combusted tobacco products
at minimally addictive or nonaddictive levels of nicotine would remain
on the market for those who currently smoke and would like to continue
to do so.
It would also help prevent people who experiment with cigarettes or
certain other combusted tobacco
[[Page 5034]]
products (mainly youth) from moving beyond experimentation, developing
an addiction to nicotine, and progressing to regular use of combusted
tobacco products as a result of that addiction (see section VIII.B of
this document). Reducing the number of people who experiment with
cigarettes or certain other combusted tobacco products who then
transition to regular use of these products would prevent severe
adverse health consequences of long-term smoking at the individual
level and result in public health benefits at the population level.
Based on FDA's population health model, by the year 2100, in the United
States, approximately 48 million youth and young adults who would have
otherwise initiated habitual cigarette smoking would not as a result of
the proposed product standard. The model also projects that more than
12.9 million additional people who smoke cigarettes would quit smoking
cigarettes \2\ 1 year after implementation of the proposed product
standard; this estimate increases to 19.5 million additional people
within 5 years of implementation (this includes people who exclusively
smoke cigarettes quitting all tobacco products or completely switching
to noncombusted tobacco product use, as well as people who engage in
dual use of cigarettes and noncombusted tobacco products quitting
cigarette use). In addition, the model estimates that, by the year
2060, in the United States, this proposed product standard would result
in 1.8 million tobacco-related deaths averted, rising to 4.3 million
deaths averted by the end of the century. The reduction in premature
deaths attributable to the proposed product standard would result in
19.6 million life years gained by 2060 and 76.4 million life years
gained by 2100. For the reasons discussed in the preamble, FDA finds
that the proposed product standard would be appropriate for the
protection of the public health.
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\2\ For the purposes of this proposed rule, where describing
expected transition behaviors, we also use the shorter phrase ``quit
smoking'' to refer to stopping use of combusted cigarettes.
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As explained in section VIII.A., the population health model uses
inputs derived from available empirical evidence and expert opinion to
estimate the impact of this proposed rule. To obtain expert opinion for
the model inputs, FDA conducted a formal expert elicitation process in
2015 and repeated it in 2018. FDA is conducting another expert
elicitation process and intends to publish the results of this update
for public review and additional comment on this proposed standard in
light of that update.
B. Summary of the Major Provisions of the Proposed Rule
There are currently no tobacco product standards regulating
nicotine in tobacco products. The proposed rule would establish a
maximum level of nicotine in cigarettes and certain other combusted
tobacco products. FDA issued an Advance Notice of Proposed Rulemaking
regarding a potential nicotine tobacco product standard (Nicotine
ANPRM), and the Agency reviewed and analyzed the comments to that ANPRM
(83 FR 11818 (March 16, 2018)). FDA also conducted an extensive and
robust review of the relevant scientific literature, as discussed
throughout this document. FDA is proposing the following provisions
based on the comments received and the Agency's analysis of relevant
scientific literature.
Proposed scope--Given that approximately 28 million adults and
380,000 youth in the United States currently smoke cigarettes and the
toxicity and addictiveness of these products, cigarettes are the
tobacco product category that causes the largest amount of harm to
public health in the United States (Refs. 3 and 4). However, if a
product standard were to cover only cigarettes, it is likely that a
significant number of addicted people who smoke cigarettes would
migrate to other similar combusted tobacco products after the standard
went into effect to maintain their nicotine exposure, thereby
undermining the public health benefits of the standard (Ref. 5) (see
also section VI.B of this document). Therefore, to increase the public
health benefits, we are proposing to cover the following products under
this proposed product standard: Cigarettes (other than noncombusted
cigarettes, such as heated tobacco products (HTPs \3\) that meet the
definition of a cigarette), cigarette tobacco, roll-your-own (RYO)
tobacco, cigars (including little cigars, cigarillos, and large cigars
but excluding premium cigars \4\), and pipe tobacco (other than
waterpipe tobacco \5\). FDA requests comments, data, and research
regarding this proposed scope.
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\3\ Tobacco products that meet the statutory or regulatory
definition of a cigarette but are not combusted (do not exceed 350
[deg]C) are categorized as ``heated tobacco products'' (HTPs) for
purposes of FDA's premarket review. HTPs that meet the definition of
a cigarette must be in compliance with the applicable statutory and
regulatory requirements for cigarettes, unless otherwise noted in a
marketing authorization order (Ref. 6).
\4\ See section III.B.3 of this document.
\5\ Waterpipe tobacco (also known as hookah tobacco) is a type
of tobacco product that produces smoke that people inhale when a
hookah device is heated. Hookah tobacco (also known as waterpipe
tobacco, maassel, shisha, narghile, or argileh) typically contains a
mixture of tobacco, sweeteners, and flavoring. The hookah device (or
waterpipe) used to smoke the hookah tobacco works by passing
charcoal or electric heated air through the tobacco mixture and
ultimately through a water-filled chamber (Ref. 7).
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FDA is proposing to exclude noncombusted cigarettes, such as HTPs
that meet the definition of a cigarette in section 900(3) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387(3)) from
the scope of this proposed product standard (proposed Sec. 1160.3
includes a definition of cigarette). Therefore, ``cigarettes'' in this
proposed rule refers to combusted cigarettes, not HTPs. Based on FDA's
experience with application review, certain noncombusted cigarettes
produce fewer or lower levels of some toxicants than combusted
cigarettes. FDA recognizes that tobacco products exist on a continuum
of risk, with combusted cigarettes being the deadliest, and that
certain non-combusted cigarettes pose less risk to individuals who use
cigarettes or certain other combusted tobacco products or to population
health than other products meeting the definition of a cigarette.
Accordingly, FDA requests comments, data, and research regarding the
proposal to exclude noncombusted cigarettes from the scope of this
proposed rule, including any data that could justify otherwise.
FDA also proposes to exclude waterpipe tobacco from the proposed
product standard because, unlike cigarette tobacco, pipe tobacco, RYO
tobacco, and cigars (other than premium cigars), FDA believes there is
little risk of switching under the proposed product standard.
Waterpipes as currently marketed and used generally require substantial
time for preparation and use (i.e., an approximately 1-hour session
with waterpipes compared to 5-7 minutes with cigarettes). In addition,
they are generally large and unwieldy and thus ill-suited for mobile
usage, such as while driving or walking. FDA requests comments, data,
and research regarding the proposal to exclude waterpipe tobacco from
the scope of this proposed rule, including any data that could justify
otherwise.
FDA is also not including noncombusted non-cigarette tobacco
products, such as electronic nicotine delivery systems (ENDS) (which
include e-cigarettes) and smokeless tobacco products, in the scope of
this proposed product standard. As discussed throughout this document,
nicotine is the primary addictive constituent in
[[Page 5035]]
tobacco products, and it is the nicotine in such products that both
creates and sustains addiction and ultimately leads to the significant
adverse health effects caused by these products. While these effects
raise concerns in the context of any tobacco product--none of which is
without risk--at this time, FDA is focusing this proposed rule on
nicotine levels in cigarettes and certain other combusted tobacco
products because combusted tobacco products are responsible for the
majority of death and disease due to tobacco use. FDA expects that, if
this proposed rule is finalized as proposed, many people who smoke
cigarettes will quit smoking, either by quitting all tobacco use or by
completely switching to a noncombusted tobacco product. Those who
switch completely to use of a noncombusted tobacco product may sustain
their nicotine dependence but may significantly reduce their risk of
tobacco-related death and disease because switching completely to a
noncombusted tobacco product would reduce exposure to the chemical
constituents created through combustion, which are currently the
primary contributors of tobacco-related harm (Ref. 8). Importantly,
this action would also help to prevent people who experiment with
cigarettes and cigars (mainly youth) from moving beyond
experimentation, developing an addiction to nicotine, and progressing
to regular use of combusted tobacco products as a result of that
addiction. We request comments, data, and research regarding the
proposed scope of this rule.
For further discussion regarding considerations and request for
comments on the proposed scope of this rule, see section IX.C of this
document.
Proposed product standard for nicotine--FDA is proposing to make
cigarettes and certain other combusted tobacco products minimally
addictive or nonaddictive \6\ by limiting the nicotine yield of these
products. We propose to limit nicotine yield by setting a maximum
nicotine content level of 0.70 milligrams (mg) of nicotine per gram of
total tobacco in these tobacco products. For comparison, the average
nicotine content in the top 100 cigarette brands for 2017 is 17.2 mg/g
of total tobacco (Ref. 9). Nicotine yield is the amount of nicotine in
smoke, in other words, the amount of nicotine to which a smoker
potentially is exposed. While nicotine yield can be measured through
machine-generated smoking methods (e.g., International Organization for
Standardization (ISO) machine smoking method, Canadian Intense (CI)
smoking method, Federal Trade Commission (FTC) smoking method), it can
vary due to a user's compensatory behaviors--e.g., inhaling more
deeply, taking larger puffs, and blocking cigarette features designed
to reduce nicotine yield--such that users can increase the amount of
nicotine yield compared to the machine-generated yield. In contrast,
nicotine ``content,'' which refers to the amount of nicotine present in
tobacco filler, is not affected by smoking behavior or cigarette design
features. Reducing the nicotine content to the proposed 0.70 mg of
nicotine per gram of total tobacco limit in the finished tobacco
products subject to this proposed product standard places an absolute
maximum limit on the amount of nicotine present in tobacco smoke
available for intake by users of these products. There are many
different tobacco product characteristics that can be manipulated to
affect nicotine yield, one of which is nicotine content. Setting a
limit on nicotine content and measuring that content is more effective
in reducing yield (i.e., the amount of nicotine the user is exposed to)
than setting a limit based on a direct measurement of yield under
standardized smoking-machine protocols because nicotine content cannot
be affected by the compensatory behavior described above. Therefore,
limiting nicotine yield through a maximum nicotine content level would
better achieve the public health benefits that come from reducing the
amount of the nicotine to which a user is exposed than would setting a
limit based on a measurement of the maximum machine-measured yield of
tobacco products. For further discussion, see section VII.A.
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\6\ FDA is using the term ``nonaddictive'' throughout this
preamble specifically in the context of the available data on very
low nicotine content cigarettes. We acknowledge the highly addictive
potential of nicotine itself depending upon the route of delivery.
As discussed elsewhere in this preamble, questions remain with
respect to the precise level of nicotine in cigarettes that might
render them either minimally addictive or nonaddictive for specific
individual members or segments of the population.
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The proposed limit of 0.70 mg of nicotine per gram of total tobacco
is based on FDA's analysis of studies regarding the likely effects of
reducing nicotine, which shows that extended exposure to very low
nicotine content (VLNC) combusted cigarettes is associated with reduced
addiction potential, dependence levels, number of cigarettes smoked per
day and increased quit attempts among people who currently smoke
cigarettes, without increasing toxicant exposure, craving, withdrawal,
or compensatory smoking. Throughout this preamble, ``VLNC cigarettes''
refers to combusted cigarettes that have been reported to contain <=
1.0 mg nicotine per gram of total tobacco, ``low nicotine content (LNC)
cigarettes'' refers to cigarettes with > 1.0 mg and < 11.4 mg nicotine
per gram of total tobacco, and ``normal nicotine content (NNC)
cigarettes'' refers to cigarettes with >= 11.4 mg nicotine per gram of
total tobacco.\7\ FDA uses these acronyms in places where we have
confirmed that the nicotine content of the cigarettes referenced meets
these definitions. In documents that reference nicotine content in
tobacco, but do not specify the levels of nicotine and therefore cannot
be confirmed to meet these definitions, we have maintained the full
description that best reflects what was used in the original document
(e.g., low nicotine content tobacco).
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\7\ The term VLNC should not be confused with the cigarette
brand name ``VLN;'' ``VLN'' refers to cigarette products authorized
for marketing by FDA in 2019. See <a href="https://www.fda.gov/media/133633/download?attachment">https://www.fda.gov/media/133633/download?attachment</a> and <a href="https://www.fda.gov/media/133635/download?attachment">https://www.fda.gov/media/133635/download?attachment</a>.
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FDA is not seeking to require the reduction of nicotine yields in
any tobacco product to zero, which would violate section 907(d)(3) of
the FD&C Act (21 U.S.C. 387g(d)(3)). FDA requests comments, data, and
research regarding this proposed maximum nicotine level.
Immediate nicotine reduction approach--FDA is proposing an
immediate nicotine reduction (i.e., single target) approach to reach
the proposed maximum nicotine level (rather than a gradual reduction,
or stepped-down, approach) to limit additional toxicant exposure. Based
on studies involving VLNC cigarettes and other reduced nicotine content
(RNC) cigarettes, we expect that there would be very little or no
compensatory smoking (and, consequently, additional limited toxicant
exposure) with an immediate reduction approach, as opposed to a gradual
reduction approach which showed evidence of increased compensatory
smoking. As such, an immediate reduction approach would increase the
benefits of the proposed product standard. FDA also notes that this
immediate nicotine reduction approach would reduce manufacturing costs
for those products covered by the proposed standard because
manufacturers would not have reason to formulate multiple products and
then prepare and submit premarket review applications at each phase of
a gradual reduction approach. We request comments, data, and
information regarding the selection of an immediate reduction approach.
Analytical test method--To assist FDA in determining compliance
with this rule, the proposed product standard would require
manufacturers to analyze
[[Page 5036]]
the nicotine levels of cigarettes and certain other combusted tobacco
products covered by the rule using an analytical test method that has
been validated in an analytical test laboratory. In addition, FDA is
proposing to require product testing prior to commercial distribution
in the United States to prevent nonconforming tobacco products from
entering the stream of commerce and reaching consumers.
Sampling plan--The proposed product standard would require tobacco
product manufacturers to design and implement a sampling plan that
covers each batch of finished tobacco product \8\ that they
manufacture. This sampling plan would be based on a valid scientific
rationale (such as representative sampling) to ensure that each product
complies with the proposed product standard. This sampling plan would
provide procedures for the manufacturer to select samples to
demonstrate conformance to the proposed product standard requirement.
The required procedures would help ensure that products that do not
conform to the product standard are not sold or distributed to
consumers.
---------------------------------------------------------------------------
\8\ For the purpose of this document, the term ``finished
tobacco product'' refers to those products subject to this proposed
rule. FDA proposes to define a ``finished tobacco product'' to mean
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. For a discussion of products FDA
proposes to include within the scope of this product standard, see
sections IX.C and X.A.1 of this document.
---------------------------------------------------------------------------
Nonconforming tobacco product--The proposed product standard would
require tobacco product manufacturers to establish procedures for the
control and disposition of tobacco products that do not conform to the
requirements of this rule. These procedures are necessary to help
prevent the distribution of nonconforming tobacco products by ensuring
that all potential nonconforming products are identified, investigated,
and segregated and that appropriate disposition and followup are taken
for products determined to be nonconforming. This proposed requirement
would ensure that any reports of nonconforming products, whether as a
result of manufacturer testing or otherwise, are examined and
investigated and that appropriate measures are taken to ensure that
nonconforming products are not distributed to consumers and to prevent
future nonconformity.
Manufacturing code--Currently, there is no requirement for the use
of a manufacturing code for tobacco products. However, the proposed
regulation Requirements for Tobacco Product Manufacturing Practice
(TPMP) (see <a href="https://www.federalregister.gov/documents/2023/03/10/2023-04591/requirements-for-tobacco-product-manufacturing-practice">https://www.federalregister.gov/documents/2023/03/10/2023-04591/requirements-for-tobacco-product-manufacturing-practice</a>) includes
a requirement for a manufacturing code, and this rulemaking's provision
is modeled on the proposed TPMP provision. The proposed product
standard would require the use of a manufacturing code to serve as a
common identifier for production and distribution records. The purpose
of the manufacturing code is to allow manufacturers and FDA to identify
the production batch of a particular finished product that has been
released for distribution. This information is intended to help
determine the product's history (e.g., batch production records) and
assist manufacturers and FDA in the event of a nonconforming tobacco
product investigation and any corrective actions to be taken by a
manufacturer as a result of the investigation.
Recordkeeping requirements--To assist FDA in determining compliance
with the rule and aid in nonconforming product investigations, the
proposed product standard would require that manufacturers establish
and maintain records regarding the results of testing conducted on each
batch to determine conformance with the proposed standard. In addition,
this proposed product standard would require that manufacturers
maintain records of sampling plans and sampling procedures, records
related to manufacturing controls, and all records related to its
analytical test method validation. FDA also is proposing to require
that it be possible to identify the production batch of a particular
finished product that has been released for distribution.
Proposed effective date--FDA proposes that any final rule that may
issue based on this proposed rule become effective 2 years after the
date of publication of the final rule. Therefore, after the effective
date no person could distribute, sell, or offer for sale or
distribution within the United States finished tobacco products that
are not in compliance with part 1160 (21 CFR part 1160). Prior to the
effective date of any final rule that may issue based on this proposed
rule, wholesalers, retailers, and related entities would be able to
sell available stock of finished tobacco products were not in
compliance with part 1160 while transitioning inventory in anticipation
of the effective date of the final rule; however, they would not be
permitted to sell off such stock after the effective date. FDA believes
this approach would allow adequate time for developing any necessary
changes in technology or inputs to comply with a finalized product
standard. It also would provide sufficient time for tobacco product
manufacturers to submit, and FDA to review, applications for new
tobacco products that comply with the finalized product standard.
Additionally, FDA believes that this approach would allow adequate time
for making any changes to tobacco purchasing choices and curing
methods, and for preparation or changes needed in facilities and
processes. FDA requests comments and data on this proposed effective
date. For further discussion regarding considerations and request for
comments on the proposed effective date of this rule, see section XI of
this document.
Given that any new tobacco products that comply with this product
standard would be required to undergo premarket review, FDA is
considering options for addressing any influx of applications.
C. Legal Authority
Section 907 of the FD&C Act authorizes FDA to adopt tobacco product
standards, including product standards that include provisions for
nicotine yields; for the reduction or elimination of other constituents
(including smoke constituents) or harmful components; respecting the
construction, components, ingredients, additives, constituents
(including smoke constituents), and properties of tobacco products; for
the testing of tobacco products; and for restricting the sale of
tobacco products to the extent consistent with section 906 (21 U.S.C.
387f) (section 907(a)(3), (a)(4)(A)(i) to (iii), and (a)(4)(B)(i) to
(ii) and (iv) to (v)). The FD&C Act also establishes FDA's authority to
require tobacco product manufacturers to establish and maintain records
in section 909 (21 U.S.C. 387i); authority related to adulterated and
misbranded tobacco products in sections 902 and 903 (21 U.S.C. 387b and
387c); authority regarding premarket review of new tobacco products in
section 910 (21 U.S.C. 387j); authority related to prohibited acts in
section 301 (21 U.S.C. 331); and FDA's rulemaking and inspection
authorities in sections 701 and 704 (21 U.S.C. 371 and 374).
D. Costs and Benefits
The main quantified benefits come from averted mortality and
morbidity as a result of reduced prevalence for people who currently
use combusted
[[Page 5037]]
tobacco products, and reduced mortality from reduced exposure to
secondhand smoke among people. Unquantified benefits include medical
cost savings, productivity loss savings, reduced exposure to thirdhand
smoke, and environmental impacts. We expect this proposed rule, if
finalized, to impose costs on industry to follow the product standard,
on the broader economy to repurpose land, labor, and capital, on
consumers impacted by the product standard, and on FDA to enforce this
product standard. In addition to benefits and costs, this rule would
cause transfers from the Federal Government and State governments in
the form of tax revenue, from firms in the form of reduced revenue, and
transfers between or within firms to cover shifts in user fee
obligations.
The annualized monetized benefits over a 40-year time horizon far
exceed the annualized monetized costs over the same time. We estimate
that the annualized benefits over a 40-year time horizon would be $1.1
trillion at a 2 percent discount rate, with a low estimate of $0.27
trillion and a high estimate of $1.2 trillion. Over a 40-year time
horizon, we estimate that the annualized costs would be $2.07 billion
at a 2 percent discount rate, with a low estimate of $0.7 billion and a
high estimate of $2.73 billion.
II. Table of Abbreviations/Commonly Used Acronyms in This Document
------------------------------------------------------------------------
Abbreviation/ acronym What it means
------------------------------------------------------------------------
3-HPMA....................... 3-hydroxypropyl mercapturic acid.
AI/AN........................ American Indians/Alaska Native.
ANPRM........................ Advance Notice of Proposed Rulemaking.
BAP.......................... Benzo[a]pyrene.
CDC.......................... Centers for Disease Control and
Prevention.
CFR.......................... Code of Federal Regulations.
CISNET....................... Cancer Intervention and Surveillance
Modeling Network.
CO........................... Carbon monoxide.
COHb......................... Carboxyhemoglobin.
COPD......................... Chronic obstructive pulmonary disease.
CORESTA...................... Cooperation Centre for Scientific
Research Relative to Tobacco.
CPD.......................... Cigarettes per day.
CPS-I........................ Cancer Prevention Study I.
CPS-II....................... Cancer Prevention Study II.
CRM.......................... CORESTA Recommended Method.
DSM.......................... Diagnostic and Statistical Manual of
Mental Disorders.
ENDS......................... Electronic nicotine delivery systems.
E.O.......................... Executive Order.
FD&C Act..................... Federal Food, Drug, and Cosmetic Act.
FDA.......................... Food and Drug Administration.
FR........................... Federal Register.
FTCD......................... Fagerstr[ouml]m Test for Cigarette
Dependence.
FTND......................... Fagerstr[ouml]m Test for Nicotine
Dependence.
GC-MS........................ Gas chromatography-mass spectrometry.
HHS.......................... U.S. Department of Health and Human
Services.
HPHCs........................ Harmful and potentially harmful
constituents.
HTP.......................... Heated tobacco product.
IOM.......................... Institute of Medicine.
LGBTQI+...................... Lesbian, gay, bisexual, transgender,
queer, and intersex.
LNC.......................... Low nicotine content.
mg........................... milligram.
MNWS......................... Minnesota Nicotine Withdrawal Scale.
MRI.......................... Magnetic resonance imaging.
nAChR........................ Nicotinic acetylcholine receptor.
NATS......................... National Adult Tobacco Survey.
NCI.......................... National Cancer Institute.
NDSS......................... Nicotine Dependence Syndrome Scale.
NHANES....................... National Health and Nutrition Examination
Survey.
NHIS......................... National Health Interview Survey.
NHIS-LMF..................... National Health Interview Survey-Linked
Mortality Files.
NIDA......................... National Institute on Drug Abuse.
NIH.......................... National Institutes of Health.
NJATS........................ New Jersey Adult Tobacco Survey.
NLMS......................... National Longitudinal Mortality Study.
NNAL......................... 4-(methylnitrosamino)-1-(3-pyridyl)-1-
butanol.
NNC.......................... Normal nicotine content.
NNN.......................... N-Nitrosonornicotine.
NPRM......................... Notice of proposed rulemaking.
NRC.......................... National Research Council.
NRT.......................... Nicotine replacement therapy.
NSDUH........................ National Survey on Drug Use and Health.
NYTS......................... National Youth Tobacco Survey.
OOS.......................... Out-of-specification.
PAH.......................... Polycyclic aromatic hydrocarbon.
PATH......................... Population Assessment of Tobacco and
Health.
PET.......................... Position emission tomography.
PD........................... Product static ID number.
QALYs........................ Quality-adjusted life years.
[[Page 5038]]
QSU.......................... Questionnaire of Smoking Urges.
RCT.......................... Randomized clinical trial.
RNC.......................... Reduced nicotine content.
RR........................... Relative risk.
RYO.......................... Roll-your-own.
S-PMA........................ S-phenylmercapturic acid.
SE........................... Substantial Equivalence.
SES.......................... Socioeconomic status.
STN.......................... Submission tracking number.
TNE.......................... Total nicotine equivalents.
TPSAC........................ Tobacco Products Scientific Advisory
Committee.
TUS-CPS...................... Tobacco Use Supplement to the Current
Population Survey.
U.S.......................... United States.
VLNC......................... Very low nicotine content.
WISDM........................ Wisconsin Inventory of Smoking Dependence
Motives.
YRBS......................... Youth Risk Behavior Survey.
------------------------------------------------------------------------
III. Background
A. Need for the Regulation
Cigarettes are responsible for the majority of tobacco-related
death and disease in the United States. Each year, 480,000 people die
prematurely from a smoking-attributable disease, putting a substantial
burden on the U.S. healthcare system and causing massive economic
losses to society (Ref. 1). In terms of a monetary measure of the
impact of cigarette smoking on the public health, in 2018, cigarette
smoking cost the United States more than $600 billion, including more
than $240 billion in healthcare spending (Ref. 10), nearly $185 billion
in lost productivity from smoking-related illnesses and health
conditions (Ref. 10), nearly $180 billion in lost productivity from
smoking-related premature death (Refs. 1 and 10), and $7 billion in
lost productivity from premature death from secondhand smoke exposure
(Refs. 1 and 11). The mortality rate among people who currently smoke
cigarettes is 2 to 3 times as high as that among individuals who never
smoked (Ref. 12). Nicotine, the primary addictive constituent in
tobacco products, can be delivered through a variety of products along
a continuum of risk, with combusted tobacco products at the most
harmful end of this continuum. To protect youth and reduce tobacco-
related disease and death, FDA utilizes a comprehensive approach to
tobacco and nicotine regulation. Shortly after FDA announced its
comprehensive approach in 2017 (<a href="https://www.fda.gov/news-events/press-announcements/fda-announces-comprehensive-regulatory-plan-shift-trajectory-tobacco-related-disease-death">https://www.fda.gov/news-events/press-announcements/fda-announces-comprehensive-regulatory-plan-shift-trajectory-tobacco-related-disease-death</a>), the Agency began a public
dialogue about lowering nicotine levels in combusted cigarettes to
minimally addictive or nonaddictive levels through achievable product
standards. On March 16, 2018, FDA issued a Nicotine ANPRM to seek input
on the potential public health benefits and any possible adverse
effects of regulating nicotine yield by lowering nicotine levels in
cigarettes and invited comments on many issues associated with the
development of a product standard to establish a maximum nicotine level
(83 FR 11818). The Nicotine ANPRM also acknowledged that if FDA were to
establish a nicotine tobacco product standard that covered only
cigarettes, some number of people who smoke cigarettes could migrate to
other similar combusted tobacco products to maintain their nicotine
dependence (or engage in dual use with other combusted tobacco
products), potentially reducing the positive public health impact of
such a rule. FDA sought comments on whether the standard therefore
should cover other combusted tobacco products. Based on FDA's
scientific knowledge, extensive research regarding VLNC cigarettes, and
comments submitted in response to this Nicotine ANPRM, FDA is proposing
a tobacco product standard that would regulate nicotine yield by
establishing a maximum nicotine level in cigarettes and certain other
combusted tobacco products.
As the U.S. District Court for the District of Columbia recognized
in United States v. Philip Morris USA, Inc. et al., 449 F.Supp.2d 1
(D.D.C. 2006), aff'd in relevant part, 566 F.3d 1095 (D.C. Cir. 2009),
the tobacco industry has long known that nicotine creates and sustains
addiction, and the industry is dependent on maintaining this addiction.
Id. at 307. The court noted how cigarette companies have engaged in
extensive research to understand how nicotine operates within the human
body and then designed their cigarettes to precisely control nicotine
delivery and provide nicotine doses to create and sustain addiction.
Id. at 307-309. Moreover, the court confirmed that industry documents
supported the conclusion that these companies ``knew early on in their
research that if a cigarette did not deliver a certain amount of
nicotine, new smokers would not become addicted, and `confirmed'
smokers would be able to quit.'' Id. at 219. In fact, the tobacco
industry has had programs in place since the 1960s to obtain ``any
level of nicotine desired'' (Ref. 2). These companies sought to
identify the ``optimum'' dose needed to ``satisfy'' people who smoke
cigarettes and, thereby, assure their continued smoking. Philip Morris
449 F.Supp.2d at 309-11. This proposed product standard would seek to
set a maximum nicotine level requirement such that cigarettes and
certain other combusted tobacco products would no longer be able to
create and sustain this addiction among people who smoke cigarettes.
The proposed product standard would limit the addictiveness of the
most toxic and widely used products, which would have significant
benefits for all age groups. Adults who use tobacco products, most of
whom want to quit, are often unsuccessful because of the highly
addictive nature of these products (Ref. 13). Researchers estimate that
each year, only between 5.4 and 5.6 percent of adults who use
cigarettes successfully quit for good (Ref. 14). Similar analysis of
2022 NHIS data indicates that only 8.8 percent of adults who formerly
smoked cigarettes had quit smoking cigarettes in the past year (Ref.
4). Lowering nicotine to minimally addictive or nonaddictive levels
would improve their ability to successfully quit using the products
within the proposed scope of this rule. It also would prevent people
who experiment with cigarettes and non-premium cigars, including youth,
from moving beyond experimentation, developing an
[[Page 5039]]
addiction to nicotine, and progressing to regular use as a result of
that addiction. Furthermore, it is well-established that secondhand
tobacco smoke causes premature death and disease in children and in
adults who do not smoke (Ref. 15 at p.11). It is estimated that
exposure to secondhand smoke caused 41,280 deaths per year in the
United States from 2005 to 2009 (Ref. 1 at Table 12.4). This increased
cessation and reduced initiation, in turn, would result in a
significant decrease in harms from the products to people who currently
or would otherwise use cigarettes and certain other combusted tobacco
products, as well as harms to people who do not use the products,
including harms caused by secondhand smoke to both adults and children,
harmful perinatal effects due to parental tobacco use, and fires.
Preventing people who do not smoke cigarettes, particularly youth,
from regularly smoking cigarettes due to nicotine addiction would allow
them to avoid the severe adverse health consequences of smoking and
would result in significant public health benefits. Without changes
like those proposed here, an estimated 3.66 million youth under the age
of 18 who were alive in 2018--and 2.54 million youth who are alive in
2024, accounting for the projected continued decline in smoking
prevalence--will die prematurely later in life from a smoking-related
disease (Ref. 16). As a result of the proposed product standard, many
youth and young adults would not be subjected to the impacts of
nicotine addiction from cigarette smoking and certain other combusted
tobacco products (which have a significantly stronger effect on youth
due, in part, to their developing brains, as described in sections IV.B
and IV.C of this document), nor would they suffer from the adverse
health effects and mortality that these products cause.
Nicotine is powerfully addictive, and youth and young adults \9\
are particularly susceptible to developing a nicotine addiction.
Multiple Surgeon General's Reports on smoking and health have noted
that almost 90 percent of adults who regularly smoke cigarettes
initiated smoking by age 18, and 98 percent initiated smoking by age
26, which is notable given that 25 is the approximate age at which the
brain has completed development (Refs. 1, 17 to 19). The developing
brain is more vulnerable to nicotine dependence than the adult brain
is, and the earlier an individual begins smoking the less likely they
are to quit (Ref. 20). Generally, those who begin smoking before the
age of 18 are not aware of the degree of addictiveness and the full
extent of the consequences of smoking (Ref. 21). It is clear that many
youth who smoke cigarettes want to quit but have difficulty doing so.
An analysis of data from the 2015 Youth Risk Behavior Survey (YRBS)
looking at youth cigarette quit attempts found that 45.4 percent of
high school students currently smoking cigarettes had sought to quit in
the previous year (Ref. 22); 2020 National Youth Tobacco Survey (NYTS)
data were congruent, indicating that 68.1 percent of middle and high
school students who smoke cigarettes had sought to quit in the previous
year (Ref. 23).
---------------------------------------------------------------------------
\9\ Though age ranges for youth and young adults vary across
studies, in general, ``youth'' or ``adolescent'' encompasses those
ages 11-17, while those who are ages 18-25 are considered ``young
adults'' (even though, developmentally, the period between 18-20
years of age is often labeled late adolescence); those ages 26 and
or older are considered ``adults'' (Ref. 17).
---------------------------------------------------------------------------
More than half (52.2 percent) of U.S. middle and high school
students who use cigarettes, cigars, smokeless tobacco--including those
with low levels of use--report experiencing at least one symptom of
nicotine dependence (Ref. 24). Notably, 12.7 percent of youth using
tobacco products 1 to 2 days per month and 21.2 percent of youth using
tobacco products 3 to 5 days per month reported sometimes/often/always
feeling irritable or restless when not using tobacco products for a
while, and 15.6 percent of youth using tobacco products 1 to 2 days per
month and 32.0 percent of youth using tobacco products 3 to 5 days per
month reported having strong cravings for a tobacco product during the
past 30 days (Ref. 24). Additionally, other researchers analyzing data
from the 2021 NYTS found that a sizeable proportion of high school
students using tobacco products in the past 30 days report symptoms of
nicotine dependence, including 27.2 percent reporting a strong craving
for tobacco use and 19.5 percent reporting wanting to first use tobacco
products within 30 minutes of waking (Refs. 25 and 26). While
prevalence rates of youth use of noncombusted tobacco products (e.g.,
ENDS) in recent years have exceeded those of cigarettes and other
combusted tobacco products (Refs. 25 and 26), FDA expects that this
proposed product standard would have significant benefits for youth by
reducing the risk that youth who experiment with cigarettes and certain
other combusted tobacco products, or who may consider using these
products as an alternative to noncombusted tobacco products, would
progress to regular use of these products as a result of nicotine
dependence.
The adolescent and young adult brain is more vulnerable to
developing nicotine dependence than the adult brain is; data indicate
that nicotine has stronger rewarding effects in adolescents than in
adults (Ref. 17). Adolescents who use tobacco and initiated use at
earlier ages were more likely than those initiating at older ages to
report symptoms of tobacco dependence, putting them at greater risk for
maintaining tobacco product use into adulthood (Ref. 24). Additionally,
the earlier that individuals begin smoking--and therefore the greater
amount of time that individuals experience nicotine dependence--the
less likely they are to successfully quit (Ref. 27). Evidence indicates
that exposure to substances such as nicotine can disrupt brain
development and have long-term consequences for executive cognitive
functioning (such as decreased attention and working memory and
increased impulsivity) and for the risk of developing a substance use
disorder and various mental health problems (particularly affective
disorders such as anxiety and depression) as an adult (Ref. 27).
Furthermore, the 2010 Surgeon General's report noted that adolescents
report symptoms of dependence even at low levels of cigarette smoking,
and thus may be particularly vulnerable to addiction (Ref. 28). FDA
expects that this proposed product standard, therefore, would have
significant benefits for youth and young adults by reducing the risk
that those who experiment with cigarettes and certain other combusted
tobacco products would progress to regular use as a result of nicotine
dependence.
Research studies involving VLNC cigarettes--defined previously in
this document as cigarettes containing up to 1.0 mg of nicotine per
gram of total tobacco--demonstrate that setting the maximum nicotine
level we are proposing here, would lead to a reduction in nicotine
dependence, which would help people who smoke cigarettes quit smoking.
In studies that immediately reduced the nicotine content of cigarettes
by switching participants from usual brand cigarettes to LNC or VLNC
cigarettes, dependence decreased in people who smoked cigarettes who
were not interested in quitting compared to those who smoked normal
nicotine content (NNC) or usual brand cigarettes for 6 weeks (Ref. 29),
10 weeks (Ref. 30), or 12 weeks (Ref. 31). In smoking cessation studies
in which participants endorsed wanting to quit, VLNC cigarettes were
also associated
[[Page 5040]]
with reductions in nicotine dependence over time (Refs. 32 to 35).
FDA is issuing this proposal because the tobacco products subject
to this proposed product standard remain addictive due to the nicotine
yield they offer users and because combusted tobacco products are
responsible for the majority of tobacco-related death and disease (see
section IV.D of this document for a discussion regarding the serious
negative health effects of smoking cigarettes and other combusted
tobacco products). Cigarettes have been precisely designed to create
and maintain addiction among people who smoke. United States v. Philip
Morris USA, Inc. et al., 449 F.Supp.2d 1, 307 (D.D.C. 2006). To protect
the public health, particularly youth, FDA is proposing this standard,
in part, to ensure that people who smoke these products would be less
likely to: (1) initiate regular use; (2) become addicted to these
products; and (3) suffer from the many diseases and debilitating
effects, including death, caused by combusted tobacco product use.
Similarly, FDA expects that the proposed product standard would
have significant benefits for adults who use combusted tobacco
products, most of whom want to quit but are often unsuccessful because
of the highly addictive nature of these products (Ref. 13). Data from
the 2022 National Health Interview Survey (NHIS) and 2018-2019 Tobacco
Use Supplement to the Current Population Survey (TUS-CPS) indicate that
67.7 and 76.6 percent, respectively, of adults who smoke cigarettes
wanted to quit (Ref. 36), while 2022 NHIS data (Ref. 4) and 2018-2019
TUS-CPS data (Ref. 36) show that 53.3 and 51.3 percent, respectively,
of adults who smoke cigarettes in the United States actually made a
quit attempt within the past year. However, analyses of NHIS and TUS-
CPS data for these years indicate that only 8.8 and 7.5 percent of
adults had successfully quit smoking cigarettes, respectively (Refs. 4
and 36). Adults who smoke cigarettes may make 30 or more quit attempts
before succeeding (Ref. 37). FDA expects that decreasing the nicotine
yield of cigarettes and certain other combusted tobacco products
covered by this rule, by reducing nicotine content, so that they are
minimally addictive or nonaddictive would likely help people who smoke
reduce their dependence on combusted tobacco products, thereby making
it easier for them to quit smoking. As discussed throughout this
document, FDA also expects that decreasing the nicotine content in
these products, and thus the nicotine yield offered to users, would
prevent people who experiment with cigarettes and cigars (mainly youth)
from moving beyond experimentation, developing an addiction to
nicotine, and progressing to regular use as a result of that addiction.
Although many factors contribute to an individual's initial
experimentation with tobacco products, the addictive nature of tobacco
is the key reason people progress to regular use, and scientists agree
that it is the presence of nicotine that causes addiction and sustains
a person's tobacco use (Refs. 1 HHS at p. 113 and 28). While nicotine
is the primary addictive chemical in tobacco, sensorimotor stimuli
(e.g., smell/taste of smoke; airway sensations; holding the cigarette)
repeatedly occur during smoking (Ref. 38). These stimuli often act as
secondary or conditioned reinforcers that contribute to the cycle of
nicotine dependence by motivating and maintaining smoking behavior
(Ref. 38). Once people who use tobacco become addicted to nicotine,
they require nicotine to avoid withdrawal symptoms. In the process of
obtaining their nicotine, people who use combusted tobacco products are
exposed to an array of toxicants in tobacco and tobacco smoke that lead
to a substantially increased risk of morbidity and mortality (Ref. 28).
Because of their nicotine addiction, many people who smoke cigarettes
struggle to stop using these toxic tobacco products despite their
stated desire to quit (Ref. 28).
An advisory report from the World Health Organization notes that
the ultimate health benefits of a nicotine reduction strategy, like the
one FDA is proposing here, would require that the standard cover other
combusted tobacco products--not just cigarettes (Ref. 39). In alignment
with this recommendation from the World Health Organization, this
proposed rule would cover combusted cigarettes and certain other
combusted tobacco products (i.e., cigarette tobacco, RYO tobacco,
cigars other than premium cigars, pipe tobacco). The World Health
Organization report also noted that such a strategy should be
accompanied by the provision of cessation treatments to help people
quit, including behavioral support and nicotine replacement therapy
(NRT) or other medications (Ref. 39). FDA remains committed to
facilitating the development and use of therapeutic nicotine products
for tobacco product cessation and increased availability of services
alongside enhanced outreach efforts to support tobacco use cessation.
For example, FDA's Nicotine Steering Committee, which helps to develop
and implement nicotine policy and regulation for the Agency, held a 21
CFR part 15 hearing in early 2018 on the Agency's approach to
evaluating the safety and efficacy of NRT products, including how they
should be used and labeled (82 FR 56759 (November 30, 2017)). Also, in
May 2023, FDA's Center for Drug Evaluation and Research announced the
availability of a final guidance for industry entitled ``Smoking
Cessation and Related Indications: Developing Nicotine Replacement
Therapy Drug Products,'' which provides guidance to assist sponsors in
the clinical development of NRT drug products, including but not
limited to those intended for smoking cessation and related chronic
conditions (88 FR 26559, May 1, 2023; see <a href="https://www.fda.gov/media/167599/download">https://www.fda.gov/media/167599/download</a>). Additionally, as described further below, the Agency
is contributing to a comprehensive effort coordinated by the U.S.
Department of Health and Human Services (HHS or the Department) to
support tobacco use cessation.
Rendering cigarettes and certain other combusted tobacco products
minimally addictive or nonaddictive through a nicotine product standard
would address the principal reason that people who smoke cigarettes
have difficulty quitting smoking. If this proposed product standard is
finalized, people who use cigarettes and other combusted tobacco
products covered by this rule would be unable to obtain enough nicotine
from those products to sustain addiction no matter how they smoked the
products (e.g., more frequent smoking, intensive puffing) (Refs. 32,
40, and 41), facilitating people who currently smoke cigarettes to make
more successful quit attempts.\10\ At the same time, combusted tobacco
products at minimally addictive or nonaddictive levels of nicotine
would remain on the market for those who currently smoke and would like
to continue to do so.
---------------------------------------------------------------------------
\10\ As stated throughout this preamble, in the event that a
nicotine product standard addresses only cigarettes, FDA expects
that, to maintain their nicotine dependence, some number of people
who are addicted to cigarettes would likely migrate to other similar
combusted tobacco products (or engage in dual use with such
products) after the product standard goes into effect, reducing the
benefits of the standard.
---------------------------------------------------------------------------
FDA expects that, if this proposed rule is finalized and a nicotine
product standard for cigarettes and certain other combusted tobacco
products is in place, many people who smoke cigarettes will either quit
all tobacco-product use or switch to a noncombusted tobacco product.
Those who switch completely to use of a noncombusted tobacco product
may sustain their nicotine dependence but may significantly
[[Page 5041]]
reduce their risk of tobacco-related death and disease because
switching completely to a noncombusted tobacco product would reduce
exposure to the chemical constituents created through combustion, which
are the primary contributors of tobacco-related harm (Ref. 8).
The benefits of this rule have been determined without taking into
consideration the impact of any smoking cessation services that may be
coordinated by HHS, and are expected to be significant. Also, FDA
expects that unassisted cessation attempts, i.e., those made by people
who smoke without help, may be more successful in an environment in
which the product being quit is no longer addictive as compared to
historic quitting success rates where it has been easy to relapse to
the same highly addictive product. Nevertheless, FDA recognizes that
increasing and improving cessation resources, particularly in
communities where access to cessation resources have been historically
lacking, may provide an opportunity to further increase the expected
benefits of this proposed product standard and to enhance the degree to
which such benefits are experienced by people in populations that are
disproportionately impacted by combusted tobacco use. Accordingly, FDA
is contributing to a comprehensive effort being coordinated by HHS to
support and accelerate cessation of combusted tobacco products.\11\
With input from subject matter experts from across HHS Operating
Divisions, the Department has finalized the ``HHS Framework To Support
and Accelerate Smoking Cessation'' (Framework). The Framework aims to
accelerate smoking cessation and reduce smoking-related disparities by
building on current activities and collaborations across the
Department. The Framework vision is to ensure that every person in
America has access to comprehensive, evidence-based cessation treatment
and can benefit from HHS cessation supports, programs, and policies.
Specific Framework goals are to: (1) reduce smoking and cessation-
related disparities; (2) increase awareness and knowledge related to
smoking and cessation; (3) strengthen, expand, and sustain cessation
services and supports; (4) increase access to and coverage of
comprehensive, evidence-based cessation treatment; (5) advance, expand,
and sustain surveillance and strengthen performance measurement and
evaluation; and (6) promote ongoing and innovative research to support
and accelerate smoking cessation (<a href="https://www.hhs.gov/about/news/2024/03/08/hhs-announces-new-smoking-cessation-framework-support-quitting.html">https://www.hhs.gov/about/news/2024/03/08/hhs-announces-new-smoking-cessation-framework-support-quitting.html</a>). With increased availability and accessibility of
services, more people who smoke may be motivated to take advantage of
cessation resources, whether they smoke cigarettes or other combusted
tobacco products. Additionally, FDA has numerous processes and tools at
its disposal to communicate directly with consumers, including
communities that are underserved by cessation services and/or are
disproportionately impacted by tobacco use, and will continue to
evaluate the need for additional public outreach, including targeted
education initiatives, in support of this proposed rule. However, the
Agency does not have evidence to suggest that such an effort is
necessary at this time in order to experience the public health
benefits of this proposed product standard.
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\11\ See, for e.g., <a href="https://www.fda.gov/tobacco-products/ctp-newsroom/fda-and-nih-joint-public-meeting-advancing-smoking-cessation-priorities-registration-open?utm_campaign=ctp-research&utm_content=landingpage&utm_medium=email&utm_source=govdelivery&utm_term=stratcomms">https://www.fda.gov/tobacco-products/ctp-newsroom/fda-and-nih-joint-public-meeting-advancing-smoking-cessation-priorities-registration-open?utm_campaign=ctp-research&utm_content=landingpage&utm_medium=email&utm_source=govdelivery&utm_term=stratcomms</a>.
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For the reasons stated here and throughout this document, FDA is
proposing this tobacco product standard to: (1) reduce the risk of
progression to regular use and nicotine dependence for those who
experiment with such tobacco products, especially youth and (2) make it
easier for people who are addicted to cigarettes and certain other
combusted tobacco products and who are interested in quitting to quit
by reducing the nicotine in these products to minimally addictive or
nonaddictive levels. FDA expects that this proposed product standard
would significantly reduce the morbidity and mortality caused by
smoking. Based on FDA's population health model, by the year 2100, in
the United States, approximately 48 million youth and young adults who
would have otherwise initiated smoking would not start as a result of
the proposed product standard. The model also projects that more than
12.9 million additional people who smoke cigarettes would quit smoking
(including those who switch to noncombusted tobacco products) 1 year
after implementation of the proposed product standard, increasing to
19.5 million additional people who formerly smoked cigarettes within 5
years of implementation. Section XII discusses that the main quantified
benefits come from averted mortality and morbidity, as a result of
tobacco use transitions, including switching. In terms of mortality
benefits, the model considers a higher risk for people who switch to
noncombusted products compared to those who quit tobacco product use
entirely. Specifically, the model assumes that the risk for people who
switch to noncombusted product use is 8 percent higher than the risk
for those who quit tobacco use entirely. Details of this approach can
be found in the FDA's modeling document (Ref. 42). In addition, the
model estimates that, by the year 2060, in the United States, this
proposed product standard would result in 1.8 million tobacco-related
deaths averted, rising to 4.3 million deaths averted by the end of the
century (Ref. 42). The reduction in premature deaths attributable to
the proposed product standard would result in 19.6 million life years
gained by 2060 and 76.4 million life years gained by 2100 (see section
VIII.A of this document for further discussion of the model) (Ref. 42).
B. Relevant Regulatory History
In its implementation of the Family Smoking Prevention and Tobacco
Control Act (Tobacco Control Act) (Pub. L. 111-31) since its passage in
2009, FDA has engaged in close study and careful consideration of the
scientific evidence and complex policy issues related to nicotine in
cigarettes and other combusted tobacco products. FDA issued an ANPRM to
solicit data and information for consideration in developing a tobacco
product standard to regulate nicotine yield by setting the maximum
nicotine level for cigarettes, conducted a robust scientific assessment
related to a nicotine product standard for combusted tobacco products,
developed a population health model to assess the potential public
health impacts of such a product standard, and sponsored research on a
variety of nicotine-related topics through contracts and interagency
agreements with Federal partners, including the National Institutes of
Health (NIH).\12\ FDA has considered the comments and information
received in response to the ANPRM, scientific assessment, and
population health model in developing this proposed rule. Please see
the remainder of this section for further discussion.
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\12\ Information on specific projects supported by FDA is
available at <a href="https://www.fda.gov/tobacco-products/tobacco-science-research/research">https://www.fda.gov/tobacco-products/tobacco-science-research/research</a>.
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1. ANPRM
In July 2017, FDA announced a comprehensive approach to tobacco and
nicotine regulation to protect youth and reduce tobacco-related disease
and death (Ref. 43). As part of the public dialogue on the
comprehensive approach, in March 2018, FDA issued three ANPRMs related
to the regulation
[[Page 5042]]
of nicotine in combusted cigarettes (83 FR 11818), flavors (including
menthol) in tobacco products (83 FR 12294, March 21, 2018) (Flavors
ANPRM), and premium cigars (83 FR 12901, March 26, 2018). In addition,
FDA announced the availability of a draft concept paper entitled
``Illicit Trade in Tobacco Products After Implementation of a Food and
Drug Administration Product Standard,'' and sought public comment (83
FR 11754, March 16, 2018). This paper analyzes the potential for
illicit trade markets to develop in response to a tobacco product
standard (Ref. 44).
The Nicotine ANPRM requested data and information for consideration
in developing a tobacco product standard to set a maximum nicotine
level for cigarettes to make them minimally addictive or nonaddictive.
Specifically, FDA sought comments, evidence, and other information
regarding whether a potential tobacco product standard should cover
tobacco products other than cigarettes (e.g., cigarette tobacco, RYO
tobacco, some or all cigars, pipe tobacco, waterpipe tobacco); what
maximum level of nicotine would be appropriate for the protection of
the public health, in light of scientific evidence about the addictive
properties of nicotine in cigarettes; whether such a standard should
propose either a single target (i.e., an immediate reduction, where the
nicotine is reduced all at once) or a stepped-down approach (i.e., a
gradual reduction, where the nicotine is reduced gradually over time)
to reach the desired maximum nicotine level; whether such a product
standard should specify a method for manufacturers to use to detect the
level of nicotine in their products; the technical feasibility of
current as well as more recent, novel nicotine reduction techniques;
and the proper timeframe for implementation of a possible nicotine
tobacco product standard to allow adequate time for industry to comply.
The Nicotine ANPRM also requested comment on possible negative effects
that could diminish the population health benefits expected as a result
of a nicotine product standard, such as continued combusted tobacco
product use, where people who currently use tobacco products subject to
a nicotine tobacco product standard could turn to other combusted
tobacco products to maintain their nicotine dependence, both in
combination with cigarettes (i.e., dual use) or in place of cigarettes
(i.e., switching); the potential for increased harm due to continued
VLNC cigarette smoking with altered smoking behaviors (e.g., increase
in number of cigarettes smoked, increased depth of inhalation); people
seeking to add nicotine in liquid or other form to their combusted
tobacco product; and whether illicit trade could occur as a result of a
nicotine product standard and how that could impact public health.
Finally, FDA also sought comments, data, research results, and other
information regarding economic impacts of a potential nicotine tobacco
product standard.
FDA received over 7,700 comments on the Nicotine ANPRM, with
approximately 6,700 of those comments submitted as part of 20 different
organized campaigns. The key ANPRM areas of comments are covered in the
relevant sections in this document and include the possible scope of
products covered by the rule (section IX.C), technical achievability
(section VII.E), illicit trade (section IX.D), and implementation/
effective date (section XI). Some of the issues raised in the comments
to the ANPRM are highlighted below.
Comments generally in support of setting a maximum nicotine level
in cigarettes stated that a nicotine product standard would be
appropriate for the protection of the public health. In particular,
many comments argued that reducing the nicotine content in cigarettes
to minimally addictive or nonaddictive levels would be appropriate for
the following reasons: (1) reduced nicotine content in cigarettes will
contribute to smoking cessation, as well as decreased initiation and
addiction by people newly using cigarettes and certain other combusted
tobacco products and youth and (2) such increased cessation and
decreased initiation will reduce the instances of preventable deaths
and other negative health effects caused by smoking. Some comments also
urged FDA to issue a nicotine product standard as part of a
comprehensive package of tobacco regulatory measures, including
increasing consumer access to reduced risk products, regulating flavors
in tobacco products, taking action as soon as possible, fully reviewing
premarket applications for new tobacco products, and making effective
smoking cessation treatments and ongoing cessation support accessible
and affordable to people who smoke cigarettes.
FDA received many comments expressing concern about the effect of
nicotine on the adolescent brain and its role in addicting those who
experiment with tobacco products, particularly youth and young adults,
leading them to progress to regular use. Some comments recommended
extending the scope of a nicotine product standard to noncombusted
tobacco products (e.g., smokeless, ENDS) to prevent migration to such
products, particularly among youth; a significant number of comments
urged FDA to extend the scope of a nicotine product standard to
combusted tobacco products other than cigarettes. Citing national
survey data trends and various recent studies, numerous comments--
including those from public health associations, government agencies,
and advocacy groups--asserted that including all combusted tobacco
products, not only cigarettes, would prevent potential youth initiation
of, migration to, and dual use with other combusted products with
higher nicotine content that may be harmful to health, thus aligning
with the public health goals of a nicotine product standard.
Additionally, citing studies relating to tobacco use patterns by young
people, a joint submission from several nicotine and tobacco
researchers stated that adolescents who use tobacco are particularly
prone to dual and multiple tobacco product use; therefore, the
potential for adolescents to shift to other nicotine-containing tobacco
products underscores the need for a nicotine reduction policy to cover
all combusted tobacco products. The joint submission comment further
stated that if the scope of a nicotine product standard only covered
combusted cigarettes, there is evidence from adult studies that
cigars--and in particular little cigars--would be an attractive
substitute for full nicotine content combusted cigarettes. These
researchers noted, if the scope of a proposed nicotine product standard
included combusted cigarettes and other combusted products, it would
increase the likelihood that people who use combusted cigarettes,
including youth and young adults, who migrate to other nicotine-
containing products (rather than quit), would transition to
noncombusted products, thereby increasing the health benefits of the
policy.
FDA also received comments from individuals, advocacy groups, and
members of the tobacco industry generally opposing efforts to reduce
nicotine levels in cigarettes to minimally addictive or nonaddictive
levels. These comments generally stated that such a regulation would
stifle free enterprise or would negatively limit consumer freedom of
choice and that the regulation would result in a de facto ban on
cigarettes that would have a devastating impact on tobacco farming, as
well as the manufacturing, distribution, and retail sectors. Some
comments discussed the technical feasibility of achieving lower
nicotine
[[Page 5043]]
levels. Some comments opposed to a nicotine product standard stated
that there is not enough scientific research to support reducing
nicotine in cigarettes. Other comments argued that FDA should instead
focus on giving adults who smoke cigarettes access to a wider choice of
less harmful tobacco products and truthful information about the
benefits of switching to those products, as well as focus resources on
a plan to reduce harm through proven strategies to prevent initiation
and encourage cessation.
FDA has reviewed and closely considered the comments to the
Nicotine ANPRM, as well as additional evidence and information not
available at the time of the Nicotine ANPRM, in developing this
proposed rule.
2. Scientific Review
As the body of evidence has continued to grow, FDA undertook a
robust systematic review of the scientific evidence regarding the
likely effects of reducing nicotine in combusted tobacco products. This
review, entitled ``The Science of a Nicotine Standard for Combusted
Tobacco Products'' (Ref. 45), covers peer-reviewed, publicly available
literature and focuses on the likely effects of reducing nicotine in
combusted tobacco products. This scientific assessment has been peer
reviewed by independent external experts. Taking into consideration
comments from this peer review (Ref. 46), FDA revised the scientific
assessment, and the final peer-reviewed document is available in the
docket for this proposed rule (Ref. 45). Additionally, this final peer-
reviewed document and other related documents such as FDA's response to
the peer review comments can be found at <a href="https://www.fda.gov/science-research/peer-review-scientific-information-and-assessments/completed-peer-reviews">https://www.fda.gov/science-research/peer-review-scientific-information-and-assessments/completed-peer-reviews</a>.
FDA's peer reviewed scientific assessment examined the effects of
reducing the level of nicotine in combusted tobacco products on use
behavior, dependence, and toxicant exposure, as well as the knowledge,
beliefs, and perceptions around nicotine and VLNC cigarettes. This
scientific review found that the totality of the evidence supports that
extended exposure to combusted cigarettes containing VLNC tobacco
filler is associated with reduced addiction potential, dependence
levels, and number of cigarettes smoked per day, and increased quit
attempts among people who currently smoke cigarettes, without evidence
of increased toxicant exposure, craving, withdrawal, or compensatory
smoking. The review also determined that if FDA were to establish a
nicotine product standard that covered only cigarettes, a portion of
people who are currently addicted to cigarettes would likely migrate to
other, similar combusted tobacco products to maintain their nicotine
dependence (or engage in dual use without substantially reducing their
combusted tobacco product use), thereby reducing the positive public
health impact of such a rule. Based on FDA's review of the literature
on combusted tobacco products, including cigarettes, cigarette tobacco,
RYO tobacco, cigars, and pipe tobacco, the final scientific assessment
concluded that use of any of these combusted products is sufficient to
create or sustain nicotine dependence and would therefore continue to
expose people who use these products to toxicants. Further, FDA's
scientific assessment concluded that the establishment of a maximum
nicotine level in combusted tobacco products that would render them
minimally addictive or nonaddictive could increase the likelihood of
successful quit attempts and help prevent people who experiment with
cigarettes and cigars (mainly youth) from progressing to regular use,
thereby significantly reducing the morbidity and mortality caused by
smoking. FDA has considered the scientific assessment conclusions in
the development of this proposed product standard.
In addition, to assess the potential public health impacts of a
nicotine product standard, FDA developed a population health model
using inputs derived from available empirical evidence and expert
opinion to estimate the impact of changes in tobacco product
initiation, cessation, switching, and dual use on tobacco use
prevalence, morbidity, and mortality in the United States. Details of
this modeling approach have been previously published in two peer-
reviewed publications (Refs. 47 and 48), which describe the overall
model in terms of the inputs, transition behaviors, and outputs that it
contains, along with results from simulation studies. In preparation
for this proposed product standard, FDA updated a previously-published
model (Ref. 47), which describes the impact of a potential product
standard that limits the level of nicotine in cigarettes, RYO tobacco,
non-premium cigars, and pipe tobacco so that they are minimally
addictive or nonaddictive. In this updated modeling document, entitled
``Methodological Approach to Modeling the Potential Impact of a
Nicotine Product Standard on Tobacco Use, Morbidity, and Mortality in
the U.S.'' (Ref. 42), we estimated the potential impacts of a nicotine
product standard by modeling a baseline scenario of use of cigarettes
and noncombusted tobacco products including smokeless tobacco, e-
cigarettes, and HTPs. These product classes (cigarettes and
noncombusted products) were selected because of the magnitude of
population health effects from cigarette smoking and the likelihood of
product switching to noncombusted products, especially e-cigarettes.
Estimates of changes in mortality from other exposures including non-
premium cigar and pipe tobacco use are not produced directly by the
model but are derived from model outputs instead. We then compared the
baseline scenario to a product standard scenario characterized by the
introduction of a potential nicotine product standard that would apply
to cigarettes, cigarette tobacco, RYO tobacco, non-premium cigars, and
pipe tobacco. FDA's modeling framework and methodological approach and
the associated data inputs and assumptions have been peer reviewed by
independent external experts. Taking into consideration comments from
this peer review (Ref. 49), FDA revised the modeling document, and the
final modeling document is available in the docket for this proposed
product standard (Ref. 42). FDA's modeling work informed the
development of this proposed product standard. Additionally, the
modeling document, model code, and inputs are publicly available at
<a href="https://www.fda.gov/science-research/peer-review-scientific-information-and-assessments/completed-peer-reviews">https://www.fda.gov/science-research/peer-review-scientific-information-and-assessments/completed-peer-reviews</a>. Further discussion
of FDA's estimates of the public health impact of this proposed product
standard can be found in section VIII of this document.
3. Premium Cigars
On August 9, 2023, the U.S. District Court for the District of
Columbia issued an order vacating FDA's rule deeming tobacco products
to be subject to FDA's tobacco product authorities ``insofar as it
applies to premium cigars.'' \13\ Cigar
[[Page 5044]]
Ass'n of Am. v. FDA, No. 16-cv-01460, 2023 WL 5094869 (D.D.C. Aug. 9,
2023), appeal docketed, No. 23-5220 (D.C. Cir. argued Sept. 13, 2024).
The government has appealed this decision. When the deemed status of
premium cigars is resolved, FDA will consider any impacts with respect
to this proposed rule and take additional steps as warranted, including
for example, by reopening the comment period and/or issuing a
supplemental notice of proposed rulemaking. References to premium
cigars in this document serve merely to clarify the current proposed
scope of products covered, evaluate the scientific evidence related to
non-premium cigars, and describe FDA's approach to modeling the
projected public health impacts of this proposed standard.
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\13\ For purposes of its ruling, the court specified that a
premium cigar is a 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.
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C. Legal Authority
1. Product Standard Authority
The Tobacco Control Act was enacted on June 22, 2009, amending the
FD&C Act and providing FDA with the authority to regulate tobacco
products. Section 901 of the FD&C Act (21 U.S.C. 387a) granted FDA the
authority to regulate the manufacture, marketing, and distribution of
cigarettes, cigarette tobacco, RYO tobacco, and smokeless tobacco to
protect the public health and to reduce tobacco use by youth. The
Tobacco Control Act also gave the Agency authority to conduct
rulemaking to ``deem'' any other tobacco products subject to chapter IX
of the FD&C Act (21 U.S.C. 387 to 387t). In 2016, FDA issued a final
rule deeming products meeting the statutory definition of ``tobacco
product'' (including cigars and pipe tobacco), except accessories of
the newly deemed products, to be subject to chapter IX of the FD&C Act,
as amended by the Tobacco Control Act (81 FR 28974) (deeming final
rule).
Among the tobacco product authorities provided to FDA is the
authority to adopt tobacco product standards where FDA determines that
such standard is appropriate for the protection of the public health
(section 907(a)(3)(A) of the FD&C Act). To establish a tobacco product
standard, section 907(a)(3)(A) and (B) of the FD&C Act requires that
FDA find that the standard is appropriate for the protection of the
public health, taking into consideration scientific evidence
concerning:
<bullet> The risks and benefits to the population as a whole,
including users and nonusers of tobacco products, of the proposed
standard;
<bullet> The increased or decreased likelihood that existing users
of tobacco products will stop using such products; and
<bullet> The increased or decreased likelihood that those who do
not use tobacco products will start using such products.
2. Authority To Establish a Maximum Nicotine Level and Related
Provisions
Section 907 of the FD&C Act authorizes FDA to adopt tobacco product
standards that are appropriate for the protection of the public health,
including expressly authorizing FDA to adopt product standards with
provisions for nicotine yields; for the reduction or elimination of
other constituents (including smoke constituents) or harmful
components; and respecting the construction, components, ingredients,
additives, constituents (including smoke constituents), and properties
of tobacco products (section 907(a)(3), (a)(4)(A)(i) to (iii), and
(a)(4)(B)(i)). This includes the authority to issue a new product
standard to establish a maximum level of nicotine in tobacco products.
FDA is proposing to limit nicotine yield by setting a maximum
nicotine content level for finished cigarettes and certain other
finished combusted tobacco products not to exceed 0.70 mg of nicotine
per gram of total tobacco. FDA is not seeking to require the reduction
of nicotine yields in any tobacco product to zero, which is prohibited
under section 907(d)(3) of the FD&C Act. To ensure that tobacco
products subject to the product standard comply with the proposed
maximum nicotine level, FDA also is including provisions that would
require manufacturers to test their products using an analytical test
method for conformance with the maximum nicotine level pursuant to
section 907(a)(4)(B)(ii) and (iv) of the FD&C Act.
3. Sale and Distribution Restrictions
Section 907(a)(4)(B)(v) of the FD&C Act states that product
standards shall, where appropriate for the protection of the public
health, include provisions requiring that the sale and distribution of
tobacco products be restricted but only to the extent that the sale and
distribution of a tobacco product may be restricted under section
906(d) of the FD&C Act. Similar to section 907, section 906(d) of the
FD&C Act gives FDA authority to require restrictions on the sale and
distribution of tobacco products by regulation if the Agency determines
that such regulation would be appropriate for the protection of the
public health. The finding as to whether a regulation is appropriate
for the protection of the public health must be determined with respect
to the risks and benefits to the population as a whole, including users
and nonusers of the tobacco products, and must take into account:
<bullet> The increased or decreased likelihood that existing users
of tobacco products will stop using such products; and
<bullet> The increased or decreased likelihood that those who do
not use tobacco products will start using such products (see section
906(d)(1) of the FD&C Act).
Under these authorities and section 701 of the FD&C Act, which
provides FDA with the authority to promulgate regulations for the
efficient enforcement of the FD&C Act, FDA is proposing provisions that
would restrict the manufacture, sale, and distribution of cigarettes
and certain other combusted tobacco products that are not in compliance
with this standard. These provisions are not intended to restrict the
manufacture of cigarettes intended for export. Consistent with section
801(e)(1) of the FD&C Act (21 U.S.C. 381(e)(1)), a tobacco product
intended for export shall not be deemed to be in violation of section
907 of the FD&C Act or this product standard, if it meets the criteria
enumerated in section 801(e)(1) of the FD&C Act, including not being
sold or offered for sale in domestic commerce. These provisions are
critical to maintain the purpose of the standard by helping to ensure
that the tobacco products conform to the proposed maximum nicotine
level when used by consumers.
FDA is also proposing, under these authorities and others described
herein regarding testing and recordkeeping, a requirement that the
labels of tobacco products covered under this proposed product standard
contain a manufacturing code to identify, among other things, the date
of manufacture of a production batch, so that FDA can determine whether
a product on store shelves is in conformance with the proposed product
standard. The proposed manufacturing code would allow manufacturers and
FDA to identify the production batch of a particular finished product
that has been released for distribution. This information is intended
to help determine the product's history (e.g., batch production
records) and assist manufacturers and FDA in the event of a
nonconforming tobacco product investigation and any corrective actions
to be taken by a manufacturer as a result
[[Page 5045]]
of the investigation. The manufacturing code must also contain an ``-
NS'' designation. The ``-NS'' designation will enable retailers to
readily identify that a finished tobacco product conforms with this
standard. Finished tobacco products that do not have this designation
do not conform to this standard. The manufacturing code information
also would aid FDA in ensuring compliance with this proposed product
standard by clearly identifying those products that conform to the
standard and linking those products to records that substantiate their
conformance.
4. Testing Requirements
This proposal contains provisions regarding testing requirements
pursuant to sections 907(a)(4)(A)(iii) and 907(a)(4)(B) of the FD&C Act
to help ensure that finished cigarettes and certain other finished
combusted tobacco products conform to the requirements of the proposed
product standard before they are distributed to consumers.
Section 907(a)(4)(A)(iii) states that product standards shall
include provisions that are appropriate for the protection of the
public health, including provisions, where appropriate, relating to any
requirement under section 907(a)(4)(B) of the FD&C Act. Section
907(a)(4)(B)(ii) of the FD&C Act, in turn, provides that a product
standard shall, where appropriate for the protection of the public
health, include provisions for testing the tobacco product. In
addition, section 907(a)(4)(B)(iv) of the FD&C Act provides that, where
appropriate for the protection of the public health, a product standard
shall include provisions requiring that the results of test(s) required
under section 907(a)(4)(B)(ii) show that the product is in conformity
with the portions of the standard for which the test(s) were required.
FDA is proposing testing requirements because it finds that such
requirements are appropriate for the protection of the public health.
Consistent with these statutory provisions, proposed Sec. Sec.
1160.12, 1160.14, and 1160.16 would establish product testing and
sampling plan requirements. Proposed Sec. 1160.12 would require that a
manufacturer conduct testing on each batch of finished cigarettes and
certain other finished combusted tobacco products to determine whether
the products conform to the proposed maximum nicotine level requirement
and would also require the manufacturer to document all testing.
Proposed Sec. 1160.14 would require manufacturers to use an analytical
test method and to demonstrate that the test method was validated in an
analytical test laboratory. Proposed Sec. 1160.16 would require that
manufacturers design and implement a sampling plan for finished
cigarettes and certain other finished combusted tobacco products to
ensure the batch consistently conforms to the proposed maximum nicotine
level.
To support these proposed requirements, proposed Sec. 1160.18(b)
would require each tobacco product manufacturer to investigate all
potential nonconforming tobacco products to determine if the product is
nonconforming. For example, if any representative samples from a batch
of finished cigarettes or certain other finished combusted tobacco
products are determined to be out of conformance or if FDA notifies a
tobacco product manufacturer that a finished tobacco product in
commercial distribution does not conform to the requirements of this
part, the manufacturer must conduct an investigation to determine the
extent of the nonconformity and locations to which nonconforming
tobacco products have been distributed. This proposed requirement would
ensure that any reports of nonconforming products, whether as a result
of manufacturer testing or otherwise, are examined and investigated and
that appropriate measures are taken to ensure that nonconforming
products are not distributed to consumers and to prevent future
nonconformity.
5. Recordkeeping
Section 909 of the FD&C Act authorizes FDA to require tobacco
product manufacturers to establish and maintain records, make reports,
and provide such information as the Agency may by regulation reasonably
require to assure that a tobacco product is not adulterated or
misbranded and to otherwise protect public health.
FDA is proposing a requirement that manufacturers maintain certain
records, including the results of batch testing and analyses conducted
to determine conformance with the proposed product standard, records of
sampling plans and sampling procedures, records related to
manufacturing controls, and all records related to the analytical test
method used to assess finished cigarettes and certain other finished
combusted tobacco products for conformance with the proposed maximum
nicotine level requirement. FDA is also proposing to require that
manufacturers use a manufacturing code, from which the Agency must be
able to identify the production batch of finished cigarettes and
certain other finished combusted tobacco products that have been
released for distribution. The maintenance of these records for the
time period specified in this proposed product standard is necessary to
help ensure that such tobacco products are in conformance with the
proposed product standard and are not adulterated or misbranded,
consistent with the authority provided in section 909 of the FD&C Act.
FDA has authority to inspect manufacturers, including access to these
records, under, among other authorities, section 704 of the FD&C Act.
In addition, the recordkeeping and record access requirements would
help FDA with the efficient enforcement of the Act, consistent with the
rulemaking authority provided by section 701(a) of the FD&C Act.
IV. Nicotine in Cigarettes and Other Combusted Tobacco Products:
Addiction, Initiation, Dependence, Cessation, Relapse, Health Effects,
and Consumer Perceptions
Tobacco products are addictive, primarily due to the presence of
nicotine, and the magnitude of public health harm caused by tobacco
products is inextricably linked to their addictive nature (Ref. 50 at
p. xi). Some evidence suggests that nicotine is more addictive than
many other addictive substances. For example, one study showed the
probability of transitioning from first use to dependence was 68
percent for nicotine, but less than 23 percent for alcohol, cocaine,
and cannabis (Ref. 51). While cigarettes are the most widely used
tobacco products among adults, other combusted tobacco products that
are possible targets of product migration (i.e., alternatives that
allow people who smoke cigarettes to maintain their nicotine addiction)
or dual use have similar adverse health effects, and also cause
nicotine dependence (Refs. 52 and 53). For example, persons who use
cigars and pipe tobacco are still subject to the addictive effects of
nicotine through nicotine absorption (and to the health impacts of
long-term use that may follow from regular use due to addiction) even
if they report that they do not inhale (Refs. 54 to 56).
A. Nicotine Is Addictive
The scientific evidence is clear that nicotine is the primary
chemical in tobacco products that causes addiction through its
psychoactive and reinforcing effects (Ref. 57). Since 1988, the U.S.
Surgeon General has determined that there is a causal relationship
between smoking and addiction to nicotine (Refs. 1 and 57), and the
earlier that individuals begin smoking, the less likely they are to
successfully quit (Ref.
[[Page 5046]]
27). Upon inhaling smoke from a burning cigarette, nicotine is absorbed
into the lungs and rapidly travels to the brain. Once in the brain,
nicotine produces its initial effects by binding to nicotinic
receptors--the primary targets for nicotine in the brain--and inducing
release of the chemical dopamine (Refs. 58 and 59). Dopamine plays a
major role in the pleasurable and reinforcing effects of smoking that
promote continued use (Refs. 58 and 59). Nicotine addiction occurs as
the result of repeated exposure to nicotine, which induces changes in
the brain (Refs. 58 to 60). Addiction to nicotine can lead to symptoms
of nicotine dependence, which may include tolerance to the effects of
nicotine, withdrawal symptoms upon cessation of use, and craving
cigarettes (Refs. 1 and 58).
The addiction potential of a nicotine delivery system varies as a
function of its total nicotine dosing capability, the speed at which it
can deliver nicotine, the rate of absorption, its palatability and
sensory characteristics, how easy it is for the person using the
product to extract nicotine, and its cost (Ref. 61). The amount of
nicotine delivered and the means through which it is delivered can
either reduce or enhance a product's potential for abuse and
physiological effects (Ref. 28 at p.113). Quicker delivery, higher rate
of absorption, and higher resulting concentration of nicotine increase
the potential for addiction (Ref. 28 at p.113). A cigarette is an
inexpensive and extremely effective nicotine delivery system that
maximizes the cigarette's addicting and toxic effects (Ref. 61).
Tobacco use disorder is a psychiatric disorder, defined by the
Diagnostic and Statistical Manual of Mental Disorders (DSM) as being
characterized by tolerance to the effects of tobacco products,
withdrawal symptoms that are mitigated by the self-administration of
nicotine-containing products, and unsuccessful attempts at reducing or
quitting the use of nicotine-containing products (Ref. 62). Researchers
consider several behaviors indicative of a substance with addictive
properties. These behaviors include reinforcement, tolerance,
withdrawal, and craving--all of which support the fact that nicotine is
the primary addictive constituent in tobacco products. The scientific
evidence is clear that nicotine is the primary chemical in tobacco
products that causes and maintains addiction.
1. Reinforcement
The reinforcement threshold for nicotine can be defined as the
lowest nicotine level that would maintain or increase nicotine self-
administration behavior. Currently, most marketed cigarettes are above
that threshold; people who smoke cigarettes develop and maintain their
addiction through continued smoking (Refs. 17 and 63). Evidence
supports that VLNC cigarettes (see table 1 of this document) are below
that threshold, as studies show a reduction in the level of addiction
based on dependence scales (Ref. 32) and cigarettes per day (CPD)
(Refs. 32, 64, and 65). The maximum nicotine level included in this
proposed product standard is based on FDA's analysis of studies
regarding the likely effects of reducing nicotine, which demonstrates
that extended exposure to VLNC cigarettes, which result in very low
nicotine yield that cannot be overcome by use behaviors, is associated
with reduced addiction potential, dependence levels, number of
cigarettes smoked per day, and increased quit attempts among people who
currently smoke cigarettes, without evidence of increased toxicant
exposure, craving, withdrawal, or compensatory smoking (Ref. 45).
2. Tolerance
Tolerance is defined as a state in which, after repeated exposure,
a substance produces less of an effect than previously (Ref. 66) and
increasing amounts are required to achieve the effect observed with the
first exposure. Both clinical and preclinical research has shown that
nicotine has euphoric effects, produces a ``pleasurable buzz,'' and
directly enhances positive affect or indirectly increases the reward
value of pleasurable situations (Refs. 67 to 70). With repeated
exposure to nicotine, neuroadaptation occurs to some of these positive
effects, and symptoms of craving and withdrawal begin during periods of
abstinence (Ref. 58). Nicotine addiction results from a combination of
positive reinforcement from smoking and avoidance of these withdrawal
symptoms (Ref. 58). Evidence of tolerance in people who smoke
cigarettes is demonstrated as they tend to progressively increase the
number of cigarettes they smoke over a period of several years before
plateauing to a relatively constant level of use (Ref. 71).
3. Withdrawal and Craving
Nicotine produces a characteristic withdrawal syndrome manifested
by irritability/anger/frustration, anxiety, depressed mood, difficulty
concentrating, increased appetite, insomnia, and restlessness (Ref.
72). Symptoms typically emerge within the first 1-2 days following
abstinence, peak within the first week, and last 2-4 weeks (Ref. 73).
The symptoms and time course are consistent with most prototypical
addictive substances (e.g., alcohol, benzodiazepines, opioids,
amphetamines, cocaine, caffeine) (Ref. 74). While some have asserted
that people smoke cigarettes as a ``tool'' or ``resource'' that
provides them with needed ``psychological benefits,'' such as increased
mental alertness and anxiety reduction (Ref. 75), this view is not
borne out by the scientific evidence. In fact, the claimed
``psychological benefits'' (i.e., increased mental alertness, anxiety
reduction, coping with stress) that have been ascribed to a smoking
``habit'' are actually symptoms of withdrawal suppression (Ref. 76).
Craving or urge is described as a motivation for substance use, which
is seen in people who use nicotine (Refs. 77 to 79). Although craving
is often characterized as a symptom of nicotine and tobacco withdrawal,
it is also a prominent symptom of nicotine dependence (Ref. 72), and it
can occur in the absence of other withdrawal symptoms.
4. Nicotine Use Is an Addiction, Not a Habit
A few individual reports have challenged the conclusion that
nicotine is the constituent in tobacco products that causes addiction,
stating that nicotine only causes habitual behavior (Refs. 67 and 75),
and that the craving associated with nicotine is determined by
nonpharmacological factors that are disassociated from smoking
withdrawal (Ref. 80). However, nicotine has been extensively studied
and the evidence overwhelmingly demonstrates that nicotine is an
addictive drug and the fundamental reason that individuals continue
using tobacco products (Refs. 57 and 28). Since 1988, the U.S. Surgeon
General has concluded that nicotine is the substance in tobacco
products that causes addiction through its psychoactive effects,
reinforcing effects, tolerance, and physical dependence/withdrawal, and
that nicotine use is not habitual (Ref. 57). The tobacco industry also
has acknowledged that nicotine is addictive (Refs. 81 and 82).
For these reasons, FDA concludes that the addictiveness of nicotine
in tobacco products leads to regular use (even when people wish to
quit), which is at the root of tobacco-related disease and death from
cigarettes and certain other combusted tobacco products.
[[Page 5047]]
B. The Developing Brain's Vulnerability to the Effects of Nicotine
Leads to Progression to Regular Cigarette Use Among Youth and Young
Adults Who Experiment
Youth and young adults are particularly susceptible to developing
an addiction to nicotine. Due to the brain's ongoing development during
adolescence and young adulthood--until about age 25--it is more
vulnerable to nicotine's effects than the adult brain is (Refs. 83 to
85). The 1994, 2012, 2014, and 2020 Surgeon General's Reports on
smoking and health note that almost 90 percent of adults who currently
and regularly smoke initiated smoking by age 18, and 98 percent
initiated smoking by age 26, which is notable given that 25 is the
approximate age at which the brain has completed development (Refs. 1,
17 to 19). The developing brain is more vulnerable to developing
nicotine dependence than the adult brain is, and the earlier an
individual begins smoking the less likely they are to quit (Ref. 20).
The maximum nicotine level requirement included in this proposed
product standard to regulate nicotine yield would make cigarettes and
certain other combusted tobacco products minimally addictive or
nonaddictive, limiting the number of youth and young adults who
progress from experimentation to regular use and reducing their risk
for smoking-related diseases.
There are three primary stages that occur as an individual
transitions from never smoking to smoking cigarettes regularly:
initiation, experimentation, and regular use. An individual initiates
smoking once he or she first tries a cigarette, even one or two puffs
(Ref. 17). The vast majority of smoking initiation occurs during
adolescence (Ref. 17). Initiation can progress to experimentation,
where individuals continue to occasionally try cigarettes, but do not
smoke every day, and then to smoking regularly (i.e., smoking daily or
on most days) (Ref. 17).
Adolescence is a period of development when individuals who
experiment with tobacco products are more susceptible to transitioning
to regular use and developing addiction to nicotine. Data from the 2024
NYTS found that 10.1 percent of high school students and 5.4 percent of
middle school students reported current use of any tobacco product
(Ref. 3). Each day, approximately 1,200 youth (ages 18 and below) try
their first cigarette (Ref. 86 at Table A.13A). The transition to
regular cigarette use (i.e., smoking on >=20 of the past 30 days) can
occur relatively quickly and can be achieved by smoking as few as 100
cigarettes (Ref. 17). Longitudinal and nationally representative cross-
sectional data indicate that an established pattern of cigarette use--
including those who ``rapidly escalate'' to regular use--typically
occurs by early adulthood (ages 20-22) (Refs. 87 and 88). The Centers
for Disease Control and Prevention (CDC) and other researchers have
estimated that 30 percent or more of people who experiment with
cigarettes transition to regular cigarette use (Refs. 89 to 92).
Researchers applied the 30 percent estimate to the number of
adolescents who were at the early experimentation stage in 2000,
translating to approximately 2.9 million of these adolescents who have
or will become people who regularly smoke cigarettes (Ref. 91). Based
on the number of persons under the age of 18 in 2012 in the United
States, the U.S. Surgeon General estimated that 17,371,000 of that
group would begin smoking cigarettes regularly and 5,557,000 will die
from a smoking-related disease (Ref. 1 at Table 12.2.1). These
concerningly high numbers speak to the extreme vulnerability of youth
and young adults to the health harms of tobacco use resulting from
addiction to nicotine.
Nicotine addiction is a critical factor in the transition of people
who smoke cigarettes from experimentation to regular smoking and in the
continuation of smoking for those who want to quit (Ref. 28 at p.113,
Ref. 1). Although the majority of adolescents who smoke daily meet the
criteria for nicotine dependence, one study found that the most
susceptible youth lose autonomy (i.e., independence in their actions)
regarding tobacco within 1 or 2 days of first inhaling from a cigarette
(Refs. 93 and 94). Another study found that 19.4 percent of adolescents
(initially ages 12-13 and followed over 6 years) who smoked weekly were
dependent on nicotine (Ref. 95). In a study regarding nicotine
dependence among adolescents who recently initiated smoking (9th and
10th grade students), adolescents who smoked cigarettes at the lowest
levels (i.e., smoking on only 1 to 3 days of the past 30 days)
experienced nicotine dependence symptoms such as loss of control over
smoking (42 percent) and irritability after not smoking for a while (23
percent) (Ref. 96). Researchers in a 4-year study of 6th grade students
also found that ``[e]ach of the nicotine withdrawal symptoms appeared
in some subjects prior to daily smoking'' (Ref. 93) (emphasis added).
Ten percent of the study participants showed signs of tobacco
dependence within 1 or 2 days of first inhaling from a cigarette, and
half had done so by the time they were smoking seven cigarettes per
month (Ref. 93).
Similarly, researchers have found that among the 3.9 million middle
and high school students who reported current use of tobacco products
(including cigarettes and cigars) in 2012, 2 million of those
students--including those who used intermittently (e.g., smoking
cigarettes on a monthly basis)--reported at least one symptom of
dependence (Ref. 24). Other researchers analyzing data from the 2021
NYTS found that a sizeable proportion of high school students using
tobacco products in the past 30 days report symptoms of nicotine
dependence, including 27.2 percent reporting a strong craving for
tobacco use and 19.5 percent reporting wanting to first use tobacco
products within 30 minutes of waking (Ref. 25). Overall, these findings
demonstrate that youth and young adults who experiment with cigarettes
(and other tobacco products) are particularly vulnerable to the effects
of nicotine on progression to regular use and dependence, leading to
maintained tobacco product use into adulthood.
C. Youth and Adult Cigarette Smoking Cessation and Relapse
Like adults, many youths who smoke cigarettes want to quit but have
difficulty doing so. An analysis of data from the 2015 YRBS looking at
youth cigarette quit attempts found that 45.4 percent of high school
students currently smoking cigarettes had sought to quit in the
previous year (Ref. 22); 2012 NYTS data were congruent, indicating that
51.5 percent of middle and high school students who smoke cigarettes
had sought to quit all tobacco use in the previous year (Ref. 22).
For adults who smoke who report quit attempts, few are successful.
As of 2019, researchers estimate that only between 5.4 and 5.6 percent
of people who smoked cigarettes successfully quit for good, according
to data from the NHIS and National Survey on Drug Use and Health
(NSDUH), respectively (Ref. 14). According to recent data regarding
adult quit attempts, analyses of 2022 NHIS and 2018-2019 TUS-CPS data
indicate that 67.7 and 76.6 percent of adults, respectively, who smoke
cigarettes were interested in quitting (Refs. 4 and 36), while the 2022
NHIS data and 2018-2019 TUS-CPS data show that only 53.3 and 51.3
percent, respectively, of U.S. adults who smoke actually made a quit
attempt within the past year (Refs. 4 and 36). Analyses of 2022 NHIS
and 2018-2019 TUS-CPS data indicates that only 8.8 and 7.5 percent of
adults who
[[Page 5048]]
formerly smoked cigarettes had successfully quit smoking cigarettes,
respectively (Ref. 4 and 36). Adults who smoke may make 30 or more quit
attempts before succeeding (Ref. 37). Some population groups are less
successful than others: for example, adults with education levels at or
below the equivalent of a high school diploma have the highest smoking
prevalence levels but the lowest quit ratios (i.e., the ratio of
persons who have smoked at least 100 cigarettes during their lifetime
but do not currently smoke to persons who report smoking at least 100
cigarettes during their lifetime) (Ref. 97). Nicotine addiction and
associated withdrawal symptoms make it difficult for people who smoke
cigarettes to quit, and quit rates rarely exceed 25 percent (Ref. 98).
Relapse is the principal limiting factor in the transition from
smoking to nonsmoking status (Ref. 28). Relapse refers to the point
after an attempt to stop smoking when a person's tobacco use again
becomes ongoing and persistent (Ref. 28 citing Brandon et al., 1986).
Most people who relapse do so soon after their quit attempt (Ref. 28).
One study found that 80 to 90 percent of individuals who were smoking
at 6 months following a quit attempt had resumed smoking within 2 weeks
following their quit attempt (Ref. 99). However, even those who quit
smoking for longer periods of time frequently relapse. Long-term
studies of individuals trying to quit smoking reveal that 30 to 40
percent of those who quit smoking for 1 year eventually relapsed (Ref.
99). In addition, one study following 840 participants for more than 8
years found that approximately one-half of people who smoke who stopped
smoking for 1 year relapsed to regular smoking within the subsequent 7
years (Ref. 100). Researchers have found that a higher frequency of
smoking is associated with earlier lapses after cessation (e.g.,
smoking on the first day of cessation or within the first 2 weeks),
which in turn is strongly associated with an increased risk of relapse,
and is also associated with more severe withdrawal symptoms and earlier
relapse after an attempt to quit smoking (Ref. 28 at p.119). These
findings confirm the powerful addictive properties of nicotine in
tobacco products, a principal factor limiting the ability to quit for a
person who uses combusted tobacco products, and further underscore the
public health importance of decreasing the addictiveness of these
products by decreasing nicotine yield, particularly for youth and young
adults who experiment with smoking and for people currently smoking and
who hope to quit.
D. Smoking Cigarettes and Other Combusted Tobacco Products Causes
Serious Negative Health Effects
Nicotine is a powerfully addictive chemical. The effects of
nicotine on the central nervous system occur rapidly after absorption
(Ref. 57 at p.12). People who use cigarettes and other combusted
tobacco products absorb nicotine readily from tobacco smoke through the
lungs (Ref. 57 at p. iii), and, from the lungs, nicotine is then
rapidly transmitted to the brain (Ref. 57 at p.13). In the case of
cigars, nicotine is also absorbed through the mouth. With regular use,
nicotine levels accumulate in the body during the day from tobacco
product use and the nicotine persists overnight, allowing for
continuous exposure throughout the entire 24-hour period (Ref. 57 at
p.38). While mild nicotine intoxication can occur among people who are
smoking for the first time (Ref. 57 at p. 15-16), tolerance to the
effects of nicotine develops rapidly.
Cigarette smoking is responsible for 480,000 premature deaths every
year from many diseases, puts a substantial burden on the U.S.
healthcare system, and causes massive economic losses to society (Ref.
1 at p. 659-666). In terms of a monetary measure of the impact of
cigarette smoking on the public health, in 2018 smoking cost the United
States more than $600 billion, including more than $240 billion in
healthcare spending (Ref. 10), nearly $185 billion in lost productivity
from smoking-related illnesses and health conditions (Ref. 10), nearly
$180 billion in lost productivity from smoking-related premature death
(Refs. 1 and 10), and $7 billion in lost productivity from premature
death from secondhand smoke exposure (Refs. 1 and 11). Current evidence
shows that, while nicotine itself is not the direct cause of most
smoking-related diseases, addiction to the nicotine in tobacco products
is the proximate driver of tobacco-related death and disease because it
sustains tobacco use even when people who smoke want to quit (which
most people who smoke report wanting to do) (Refs. 1, 13, 28, 58, and
61). Inhalation of smoke from cigarettes and other combusted tobacco
products exposes people who use the products to over 7,000 chemicals,
many known to be hazardous to health and lead to disease (Ref. 28).
According to the 2014 Surgeon General's Report, which summarizes
thousands of peer-reviewed scientific studies and is itself peer-
reviewed, smoking remains the leading preventable cause of disease and
death in the United States, and cigarettes have been shown to cause an
ever-expanding number of diseases and health conditions (Ref. 1). Every
year, cigarette smoking is the primary causal factor for 163,700 deaths
from cancer, 160,600 deaths from cardiovascular and metabolic diseases,
and 131,100 deaths from pulmonary diseases (Ref. 1 at p.659). In the
United States, about 87 percent of all lung cancer deaths, 32 percent
of coronary heart disease deaths, and 79 percent of all cases of
chronic obstructive pulmonary disease (COPD) are attributable to
cigarette smoking (Ref. 1). Smoking during pregnancy can result in
negative outcomes for a newborn baby, such as low birth weight, lungs
that fail to develop properly, birth defects such as cleft lip and/or
cleft palate, and Sudden Infant Death Syndrome (Ref. 101). As stated in
the 2014 Surgeon General's Report, ``[c]igarette smoking has been
causally linked to diseases of nearly all organs of the body, to
diminished health status, and to harm to the fetus . . . [and] the
burden of death and disease from tobacco use in the United States is
overwhelmingly caused by cigarettes and other combusted tobacco
products'' (Ref. 1 at p.7).
Tobacco and cigarette smoking-related morbidity and mortality also
have been experienced differentially across different sociodemographic
characteristics, such as race, ethnicity, socioeconomic status,
educational attainment, mental health status, and homelessness. Black
\14\ adults, and in particular Black men, experience the highest rates
of incidence and mortality from many tobacco-related cancers, such as
lung and bronchus cancer and head and neck cancer, compared to those
from other racial and ethnic groups (Refs. 102 to 104). Deaths from
other tobacco-related conditions such as heart disease, stroke, and
hypertension are higher among Black individuals compared to other
racial and ethnic groups regardless of tobacco use status (Refs. 105 to
110). Compared to persons identifying as non-Hispanic White, Hispanic
and Black persons smoke fewer cigarettes (Refs. 111 to 113) and are
more likely to be people who do not smoke daily (Refs. 111 and 114),
yet
[[Page 5049]]
have greater risk of lung cancer morbidity and mortality (Refs. 1, 115
to 118). Additionally, American Indian/Alaska Native (AI/AN)
populations have the highest cigarette use prevalence (Refs. 119 to
121) and are more likely to suffer disproportionate rates of tobacco-
related death (Ref. 119). An analysis of 2001-2009 mortality data for
people living in the Indian Health Service Contract Health Service
Delivery Area counties in the United States indicated that age-adjusted
death rates, smoking-attributable fractions, and smoking-attributable
mortality for all-cause mortality were statistically significantly
higher among AI/AN populations than among White populations for adult
men and women aged 35 years and older (Ref. 122). Cigarette smoking
caused 21 percent of ischemic heart disease, 15 percent of other heart
disease, and 17 percent of stroke deaths in AI/AN men, compared with 15
percent, 10 percent, and 9 percent, respectively, for White men (Ref.
122). Among AI/AN women, smoking caused 18 percent of ischemic heart
disease deaths, 13 percent of other heart disease deaths, and 20
percent of stroke deaths, compared with 9 percent, 7 percent, and 10
percent, respectively, among White women (Ref. 122). Some Asian
populations, Native Hawaiians, and other Pacific Islander populations
also suffer from disproportionate rates of tobacco-related mortality as
compared to non-Hispanic White persons (Refs. 115, 117, 123, and 124).
---------------------------------------------------------------------------
\14\ Throughout this document, FDA uses both the terms ``Black''
and ``African American.'' The term ``African American'' is used to
describe or refer to a person of African ancestral origins or who
identifies as African American. ``Black'' is used to broadly
describe or refer to a person who identifies with that term. Though
these terms may overlap, they are distinct concepts (e.g., a Black
person may not identify as African American). As a result, FDA
relies on the specific term used by researchers when citing to
specific studies. FDA uses the term ``Black'' when not citing to a
specific study.
---------------------------------------------------------------------------
Disparities in tobacco-related morbidity and mortality have also
been observed for additional population groups that have higher levels
of tobacco use. Those with low household income and/or educational
attainment bear a disproportionate burden of myocardial infarction
prevalence and coronary heart disease-related mortality (Ref. 125).
National Health and Nutrition Examination Survey (NHANES) data from
2007 to 2010 indicate that prevalence of co-occurring obesity and
smoking was linearly associated with educational attainment as women
with the lowest levels of education had greater likelihood of being
obese and smoking than women with the highest levels of education (Ref.
126). Some research also indicates that race/ethnicity status interacts
with the effects of higher educational attainment on the likelihood of
current smoking. The protective effect of higher education against
current smoking was shown to be a stronger effect for White as compared
to Black respondents (Ref. 127). Research has also demonstrated that
individuals with behavioral health conditions and other medical
comorbidities have higher prevalence of combusted tobacco use compared
to those without these conditions (Refs. 128 and 129) and have
increased risk of tobacco-related morbidity and mortality (Refs. 120,
130, and 131). Inpatient hospital admission data from 1990 to 2005 from
California indicate that approximately half of the deaths in those who
had been hospitalized for schizophrenia, bipolar disorder, or major
depressive disorder were due to diseases causally linked to tobacco use
(Ref. 130) and that the majority of deaths for those hospitalized for
opioid-related conditions were related to tobacco and alcohol, not to
opioids (Ref. 132). Tobacco-related cancers are a leading cause of
death among adults experiencing homelessness (Ref. 133). While
cigarette smoking and exposure to cigarette smoke are responsible for
significant mortality--480,000 premature deaths annually, as previously
stated--this estimate does not include deaths caused by other tobacco
products, such as cigars and pipes (Ref. 1 at p. 665).\15\
Additionally, for every person who dies from a smoking-related disease
in the United States, approximately 30 more people will suffer from at
least one smoking-related disease (Ref. 1).
---------------------------------------------------------------------------
\15\ Regular cigar smoking was responsible for approximately
9,000 premature deaths and more than 140,000 years of potential life
lost among adults aged 35 years or older in 2010 (Ref. 134). The
2014 Surgeon General's Report states that the methodology for
estimating the current population burden for use of combusted
tobacco products other than cigarettes remains under discussion, but
the number of added deaths is expected to be in the thousands per
year (Refs. 1 and 135).
---------------------------------------------------------------------------
Inhalation of the chemicals produced by combustion results in
numerous adverse health outcomes through mechanisms that include DNA
damage, inflammation, and oxidative stress (Ref. 28). The three leading
causes of smoking-attributable death for people who currently and
formerly smoke cigarettes are lung cancer, heart disease, and COPD
(Ref. 1 at p. 660). Cigarette smoking results in a chronic inflammatory
state in the cardiovascular system that is known to be a powerful
predictor of cardiovascular events including heart disease (Ref. 28).
For COPD, although studies have shown that the disease can be almost
completely prevented with the elimination of smoking (Ref. 63), for
those who have already developed the disease, evidence indicates that
the related morbidity persists long after cessation of smoking (Ref.
28). In addition, it has been established that more than 85 percent of
lung cancers are due to smoking, and lung cancer is the country's
leading cause of cancer death (Refs. 1, 28, 63, and 136).
Cigarettes and other combusted tobacco products also have deadly
effects on people who do not smoke because they produce secondhand
smoke. It is well-established that secondhand tobacco smoke causes
premature death and disease in children and in adults who do not smoke
(Ref. 15 at p.11). Secondhand smoke exposure is currently estimated to
be responsible for over 41,000 deaths annually in the United States
(Ref. 1). For example, an estimated 7,300 lung cancer deaths and nearly
34,000 coronary heart disease deaths annually can be attributed to
secondhand smoke (Ref. 1). Additionally, productivity losses due to
secondhand smoke-attributable deaths are estimated to cost the United
States $5.6 billion each year (Ref. 1).
Secondhand smoke is particularly harmful to children. For instance,
the 2014 Surgeon General's Report estimated that each year, secondhand
smoke is associated with 150,000 to 300,000 lower respiratory tract
infections in infants and children under 18 months of age, 790,000
doctor's office visits related to ear infections, and 202,000 asthma
cases (Refs. 1 and 137). In addition, thirdhand smoke--the chemical
residue from combusted tobacco smoke that can become embedded in the
environment (e.g., carpet, dust)--results in exposure to harmful
constituents such as tobacco specific nitrosamines (Ref. 138). Exposure
to thirdhand smoke is especially concerning for young children given
their size and behaviors, like crawling on the ground and frequently
putting their hands in their mouths.
Additionally, the burden of secondhand smoke exposure is
experienced disproportionately among members of some racial and ethnic
groups and people with lower household income and educational
attainment. Among people who do not smoke, ages 3 and older, findings
from 2011 to 2018 NHANES data indicate that non-Hispanic Black
respondents and those living below the poverty level had the highest
levels of secondhand smoke exposure compared to people of other races
and those living above the poverty level, respectively; these
disparities persisted across all years of the study analysis from 2011
to 2018 (Ref. 139). From 1999 to 2012, the percentage of persons who do
not smoke (ages 3 and older) with detectable serum
[[Page 5050]]
cotinine \16\ levels (defined in the study as levels >=0.05 nanogram
per milliliter to indicate secondhand smoke exposure) declined across
all racial and ethnic groups (Ref. 141). However, a higher proportion
of non-Hispanic Black individuals who do not smoke continued to have
detectable serum cotinine levels, compared to Hispanic and non-Hispanic
White individuals who do not smoke. For example, in 2017-2018, nearly
50 percent of non-Hispanic Black people who do not smoke had detectable
serum cotinine levels, compared with 22 percent of non-Hispanic White
and 17 percent of Mexican American people who do not smoke (Ref. 141).
Moreover, disparities in trends in detectable serum cotinine levels
among people who do not use cigarettes over time have been observed on
the basis of race/ethnicity. One analysis of NHANES data and found that
from 1999 to 2012 among children ages 3-11, comparable levels of
decline were observed among non-Hispanic White (percentage change: 41.2
percent) and Mexican American (percentage change: 39.0 percent) youth,
but a lesser decline was observed among non-Hispanic Black youth
(percentage change: 19.8 percent) (Ref. 141). A more recent analysis of
NHANES data also indicated that, between 2011 and 2018, the percentage
of people who do not use cigarettes with detectable serum cotinine
levels increased among non-Hispanic Black youth ages 12-19 but remained
stagnant among non-Hispanic White youth of the same ages (Ref. 142).
---------------------------------------------------------------------------
\16\ Cotinine is an alkaloid found in tobacco leaves and is the
main metabolite of nicotine. Measuring cotinine in people's blood is
a reliable way to determine exposure to nicotine for both people who
smoke and those exposed to environmental tobacco smoke (Ref. 140).
---------------------------------------------------------------------------
Moreover, there is also some scientific evidence supporting
disparities in secondhand smoke exposure by sexual orientation. An
analysis of NHANES data from 2003-2010 found that secondhand smoke
exposure (defined as a serum continine \17\ levels >=0.05 nanogram per
milliliter) differed by sexual orientation among women 20-59 years of
age (Ref. 143). This study found that among women 20-59 years of age,
secondhand smoke exposure was higher among non-smoking women who
identified as lesbian (56.2 percent) or who reported a lifetime
experience with a same-gender partner (47.7 percent) than those women
who identified as exclusively heterosexual (33.0 percent; p<0.001)
(Ref. 143). However, among men 20-59 years of age, exposure to
secondhand smoke did not significantly differ by sexual orientation.
Disparities in the secondhand smoke exposure are found across
various environmental settings. These disparities speak to the
interrelated influences of individual factors (e.g., age, race and
ethnicity, sexual orientation, income) and existing inequities in
places where members of communities disproportionally impacted by
tobacco-related health disparities are likely to reside, spend time,
and work (Refs. 53 and 120). For example, an analysis of NHANES data
from 2017-2018 found that 87.8 percent of non-smoking persons 3 years
of age and older who lived with someone who smoked inside the home was
exposed to secondhand smoke based on serum cotinine values of 0.05-
10.00 nanogram per milliliter compared to 21.4 percent of non-smoking
persons 3 years of age and older not living with someone who smoked
inside the home (Ref. 142). In terms of race and ethnicity, findings
drawn from the 2013-2016 NHANES data indicate that compared to non-
Hispanic White respondents, non-Hispanic Black respondents had higher
odds of secondhand smoke exposure in homes other than their own (Ref.
144). An analysis of NYTS data indicates that non-Hispanic Black and
non-Hispanic White students both had higher prevalence of secondhand
smoke exposure at home and in vehicles than Hispanic and non-Hispanic
other race/ethnicity students (Ref. 145). While secondhand smoke
exposure in homes and vehicles declined from 2011 to 2018, secondhand
smoke exposure in homes among non-Hispanic Black students did not
change (Ref. 145). Additionally, a study using data from Wave 1 (2013-
2014) of the Population Assessment of Tobacco and Health (PATH) Study
found that the odds of exposure to secondhand smoke at home were higher
for Black adults (OR=1.12, 95 percent CI:1.00-1.24; p-value=0.042) than
White adults; and higher for those adults who self-identified as being
LGBT (OR=1.30, 95 percent CI:1.11-1.52; p-value=0.001) than for
heterosexual adults (Ref. 146). Home smoking bans (i.e., when people
decide to have their own rules that restrict or ban smoking inside
their own home)--can reduce secondhand smoke exposure. For example, a
study using data from the 2009-2010 National Adult Tobacco Survey
(NATS) found the prevalence of exposure to secondhand smoke varied
based on the presence (or absence) of smokefree rules in the home (Ref.
147). This study found that overall, 1.4 percent of people who did not
smoke and had a smokefree rule at home were exposed to secondhand smoke
in their homes in the past 7 days, compared with 43.9 percent of people
who did not smoke and did not have a smokefree rule at home (Ref. 147).
A similar pattern was observed across age groups, race and ethnicity,
and levels of educational attainment. For example, a higher percentage
of Black and Hispanic people were exposed to secondhand tobacco smoke
in homes with and without smokefree rules than White people.
Additionally, a study using 1995-2007 TUS-CPS data found that among two
parent households, higher levels of parental educational level and
annual household income were associated with the higher reporting of a
complete home ban as compared to lower levels of parental educational
and annual household income (Ref. 148). Such findings emphasize the
degree to which certain aspects of disadvantage (such as lower family
income, lack of access to single-family housing, or lack of autonomy
over the home environment) may compound tobacco-related health
disparities.
Individuals who live in multi-unit housing, including apartments,
are particularly susceptible to involuntary secondhand smoke exposure
in the home, as secondhand smoke can infiltrate throughout a building
along various pathways (Refs. 149 to 153). Exposures to secondhand
smoke in multi-unit housing are potentially concerning given a study
drawing on the 2013-2014 National Adult Tobacco Survey (NATS) found
that tobacco use was higher among adults living in multi-unit housing
(24.7 percent) than those in single-family housing (18.9 percent) (Ref.
154). This study also found that smoke-free home rules (i.e., home
smoking bans) were higher among adults living in single-family housing
(86.7 percent) than those in multi-unit housing (80.9 percent) (Ref.
154). However, more than a third (34.4 percent) of multi-unit housing
residents with home smoking bans have experienced secondhand smoke
incursions (Ref. 154). Recent estimates indicate that approximately 80
million residents in the United States are currently living in some
type of multi-unit housing (Ref. 150). Among those living in multi-unit
housing with a home smoking ban, an estimated 27.6-28.9 million are
exposed to secondhand smoke incursions from neighboring units and/or
shared common areas (Ref. 150). Moreover, a 2013 nationally
representative study conducted among U.S. adults living in multi-unit
housing found that 25.2 percent of non-smoking residents who had no
smoking in the home for at least 3 months and who also
[[Page 5051]]
had a child in the home had a recent secondhand smoke incursion into
their unit; 99 percent of these residents also reported being bothered
by the incursion (Ref. 155). Multi-unit housing secondhand smoke
incursions have also been found to be greater among specific
populations that are already disproportionately burdened by tobacco-
related disease and death, including women, younger adults, and non-
Hispanic Black, Hispanic, and lower income populations (Ref. 154).
Workplace secondhand smoke exposure has also been shown to vary
across population groups. A study using data from the 2009-2010 NATS
show the prevalence of secondhand smoke exposure from employed
nonsmoking adults was higher among males, non-Hispanic Black, Hispanic,
and AI/AN people compared with White people, and people with low
education and low income (Ref. 156). Similarly, data from the 2010 and
2015 NHIS show that exposure to secondhand smoke in the workplace was
disproportionately high among non-Hispanic Black respondents, Hispanic
respondents, and workers with low education and low income (Ref. 157).
Additionally, the study findings indicated that ``blue-collar workers''
(defined as those who performed manual labor such as manufacturing,
mining, sanitation, and construction) experienced higher prevalence of
secondhand smoke exposure compared to ``white-collar workers'' (defined
as those who primarily work in an office, with computer and desk
setting, and perform professional, managerial, or administrative work)
(Ref. 157).
The disparities observed in tobacco use, as well as disparities in
secondhand smoke exposure, contribute to the disparities in tobacco-
related morbidity and mortality experienced by some population groups.
This proposed product standard is anticipated to reduce smoking-related
morbidity and mortality for the population as a whole, including these
populations that use tobacco or are exposed to secondhand smoke at
disproportionately high levels.
Other combusted tobacco products, particularly those that could
serve as alternatives to cigarettes if people who smoke cigarettes no
longer had access to normal nicotine cigarettes (NNC), cause similar
negative health effects. For example, cigar smoke contains many of the
same harmful constituents as cigarette smoke, and cigar smoke may have
even higher levels of several harmful compounds compared to cigarette
smoke (Refs. 1, 134 and 158). For example, cigar smoke contains higher
amounts of carcinogenic, tobacco-specific N-nitrosamines than cigarette
smoke due to the relatively high concentration of nitrate in cigar
tobacco, which leads to formation of cancer-causing nitrosamines during
the fermentation process (Refs. 1; 53 at Chapter 3; and 158).
Researchers have found urinary concentrations of 4-(methylnitrosamino)-
1-(3-pyridyl)-1-butanol (NNAL) (a hazardous tobacco-specific
nitrosamine) measured in people who smoke cigars daily to be as high as
those measured in people who smoke cigarettes daily (Refs. 159 and
160). Like exposure to cigarette smoke, exposure to higher levels of
cigar smoke for longer time periods increases the adverse health risks
caused by cigar smoking (Ref. 28).
Consequently, there is a long-standing body of research, including
reports from the U.S. Surgeon General and National Cancer Institute
(NCI), demonstrating that cigar use causes serious adverse health
effects (Ref. 53 at p.119-155; Refs. 55; 161, and 162). NCI's Smoking
and Tobacco Control Monograph No. 9 (``Cigars: Health Effects and
Trends''), which provides a comprehensive, peer-reviewed analysis of
the trends in cigar smoking and potential public health consequences,
as well as other research, demonstrates that cigar smoking leads to an
increased risk of oral, laryngeal, esophageal, pharyngeal, and lung
cancers, as well as coronary heart disease and aortic aneurysm, with
the magnitude of risk a function of the amount smoked and depth of
inhalation (Ref. 53 at p.119-155). Likewise, a systematic review of the
mortality risks associated with cigar smoking that identified 22
studies found that people who regularly smoke cigars are at increased
risk for many of the same diseases as people who smoke cigarettes,
including oral, laryngeal, esophageal, and lung cancer; cardiovascular
diseases; and COPD (Ref. 163).
Research indicates that most people who smoke cigars do inhale some
amount of smoke, even when they do not intend to inhale, and are not
aware of doing so (Refs. 54 and 55). Even when people who smoke cigars
do not breathe smoke into their lungs, they are still subject to the
addictive effects of nicotine through nicotine absorption (Refs. 55 and
56). This nicotine absorption occurs because cigar smoke dissolves in
saliva, allowing the person smoking the cigar to absorb sufficient
nicotine by holding the smoke in their mouths, even if the smoke is not
inhaled (Refs. 53, 56, and 164). Cigar and/or pipe smoking causes
cancers of the lung and upper aerodigestive tract, including the oral
cavity, oropharynx, hypopharynx, larynx and esophagus (Ref. 158).
Additional evidence suggests that cigar and/or pipe smoking is causally
associated with cancers of the pancreas, stomach, and bladder (Ref.
165). People who smoke cigars also have increased risks for coronary
heart disease and COPD compared with people who never used tobacco
(Ref. 166).
One study using NATS data from 2009 to 2010 found that regular
cigar smoking (defined as use on at least 15 of the past 30 days) was
responsible for approximately 9,000 premature deaths and more than
140,000 years of potential life lost among adults aged 35 years or
older in 2010 (Ref. 134). A study of healthcare expenditures from 2000
to 2015 found that cigar-attributable healthcare expenditures for
adults totaled $1.75 billion per year, with $284 million attributed to
exclusive cigar smoking and $1.5 billion attributed to poly tobacco use
(i.e., use of multiple tobacco products) involving cigar smoking plus
cigarette or smokeless tobacco use (Ref. 167). In addition, overall
mortality rates for all people who smoked cigars (i.e., those who
report inhaling as well as those who report not inhaling cigar smoke)
are higher than rates for those who have never smoked, although they
are generally lower than the rates observed for people who smoke
cigarettes (Ref. 53 at p. 112). In an analysis of National Longitudinal
Mortality Study (NLMS) data, researchers also found that the risk of
dying from tobacco-related cancers is higher for people who currently
exclusively use pipe tobacco and those who currently exclusively smoke
cigars than for those who reported never using combusted tobacco
products (Ref. 168). Another similar analysis using the restricted-use
National Health Interview Survey-Linked Mortality Files (NHIS-LMF),
following participants for mortality from 2000 through 2015, observed
that people who currently smoked cigars daily had elevated risk of all-
cause mortality compared to those who had never used tobacco (Ref.
169). In addition, researchers studying people who smoke cigars in 2009
and 2010 found that the average person who smokes cigars or pipes loses
approximately 15 life years (Ref. 134).
Disparities in cigar-related health outcomes have also been
observed by gender and race/ethnicity. Likely due to the greater
prevalence of cigar use among men versus women, one analysis observed a
significantly greater number of years of potential life lost for men
than women (117,440 for men; 22,284 for women) associated with cigar
use, as well as disparate monetary losses associated with cigar use
($19.5 billion
[[Page 5052]]
for men; $3.4 billion for women) based on the value of a statistical
life year (Ref. 134). Studies have shown that levels of nicotine and
other carcinogens in cigars can be higher than those in cigarettes and
may be at levels that lead to increased risk of morbidity and mortality
from conditions such as cancer, cardiovascular disease, and COPD (Refs.
134, 163, and 164). The prevalence of cigar smoking among AI/AN
populations is lower than prevalence among Black populations, but
higher than among Hispanic and Asian populations (Refs. 120 and 121),
contributing to the disproportionate prevalence of lung cancer and
cardiovascular diseases in these populations (Refs. 170 and 171).
E. Tobacco Product Marketing Has Contributed to Disparities in Use and
Health Outcomes
Tobacco companies have long understood the complexities of nicotine
addiction (Ref. 172) and have capitalized on the psychological and
sociological aspects of tobacco use to market their products
disproportionately to specific populations, such as youth and young
adults, some racial and ethnic populations, individuals who identify as
lesbian, gay, bisexual, transgender, queer, and intersex (LGBTQI+),\17\
those with lower household income and educational attainment, and
individuals with behavioral health conditions (Refs. 173 and 174). For
example, retail advertising for tobacco products is more common in
neighborhoods with greater proportions of Black residents and in lower
income neighborhoods (Refs. 175 to 179). Storefront and outdoor tobacco
marketing, as well as point-of-sale marketing, are all
disproportionately present in Black, Hispanic/Latino, AI/AN, and low-
income communities (Refs. 175, 179, 180 to 187). Higher exposure to
tobacco advertisements and retailing is associated with tobacco use
susceptibility and tobacco use among youth, with observed disparities
impacting youth who are Black, Hispanic, or lower socioeconomic status
(Refs. 188 to 192). For example, a systematic review of 35 studies
found that a higher density of tobacco retailers near the home is
associated with increased combustible tobacco product use among youth
(Ref. 193).
---------------------------------------------------------------------------
\17\ Throughout this document, FDA uses the term ``LGBTQI+''
broadly when referring to lesbian, gay, bisexual, transgender,
queer, and intersex communities. When we describe findings from the
published literature, we refer specifically to the groups that are
studied. For example, some authors examine tobacco-related outcomes
for members who identify as lesbian, gay, bisexual, or transgender
only; as such, the data are limited to those who identify as LGBT,
and authors interpret the findings for those specific groups.
---------------------------------------------------------------------------
Industry marketing tactics have also included the incorporation of
culture-specific imagery, traditional practices, and events that target
specific racial and ethnic groups. For instance, tobacco companies have
sponsored cultural events such as Cinco de Mayo celebrations, Chinese
New Year celebrations, and activities related to Black History Month
(Refs. 173 and 194) and have used the cultural significance of
traditional tobacco to validate the authenticity of commercially
available cigarettes, exploiting the traditions of Native people to
encourage cigarette use (Ref. 195). Tobacco industry documents show
that tobacco companies have strategically marketed their products to
women with lower income, particularly Black and Hispanic women, (Ref.
196), people experiencing homelessness and people with mental illness
(Refs. 197 and 198), and the LGBTQI+ community (Refs. 199 to 201).
Research also demonstrates that since at least the 1960s, the tobacco
industry has made strategic donations to organizations representing and
affiliated with these communities (Refs. 120, 202 to 205). Internal
industry documents reveal that at least one tobacco company considered
such donations to be a ``quid pro quo,'' because they could result in
the normalization of tobacco use, development of brand loyalty, and
opposition to health-protective tobacco control policies (Ref. 206).
The industry's practices have resulted in long-term consequences
for communities. Tobacco marketing influences social norms around
tobacco use, making it more socially acceptable and increasing the
likelihood of use (Refs. 207 to 209). In communities where the tobacco
industry has disproportionately marketed to historically marginalized
populations over decades, these social norms are transferred through
peers and family generations, perpetuating the use of harmful combusted
tobacco products, and contributing to present-day tobacco-related
health disparities in these populations (Refs. 207, 210, and 211).
Moreover, recent scientific evidence indicates that tobacco companies
continue to target populations that experience tobacco-related health
disparities with tobacco marketing (Refs. 178, 180, 191, 207, 212 to
226).
Although targeted marketing is only one factor in the development
and perpetuation of combusted tobacco product use and related harms, it
contributes to disparities that affect public health and are of great
concern to FDA. Advancing health equity is a policy priority and an
important component of fulfilling FDA's mission to protect and promote
public health. FDA and the Federal Government recognize the advancement
of health equity as ``both a moral imperative and pragmatic policy,''
as Executive Order 13995 states. Considerations related to health
equity helped inform FDA's decision to prioritize this proposed product
standard.
F. Consumer Knowledge, Attitudes, Beliefs, and Perceptions About
Nicotine
The science on consumer knowledge, attitudes, beliefs, and
perceptions about nicotine demonstrates that a majority of consumers
correctly understand that nicotine is the substance in cigarettes that
causes addiction. Nationally representative studies that examined
nicotine addiction beliefs in the general population reported that the
belief that nicotine is addictive was endorsed by approximately 85.8
percent of the population, and the belief that nicotine is responsible
for driving continued cigarette use was endorsed by approximately 82.9
percent of the population (Refs. 227 to 233). A nationally
representative survey found that 88 percent of people who currently
smoke cigarettes and 91 percent of people who use e-cigarettes agreed
that nicotine makes people want to smoke (Ref. 227). A nationally
representative study of youth suggests that about 77.1 percent of
respondents believe that nicotine definitely or probably causes
addiction (Ref. 234).
However, in contrast to high rates of correct beliefs about the
addictiveness of nicotine, there are high rates of incorrect beliefs
about the harms of nicotine. Studies that examined nicotine harm
beliefs in the general population reported that the belief that
nicotine causes cancer was endorsed by 40 to 78 percent of adult
participants (Refs. 227, 228, 232, 233, 235 to 245). Additionally, a
nationally representative study of youth suggests that about 74.7
percent believe that nicotine definitely or probably causes cancer
(Ref. 234). Multiple nationally representative studies that examined
nicotine harm perceptions by tobacco use status found that 52 to 61
percent of people who currently use cigarettes and up to 84 percent of
people who do not use cigarettes endorsed the belief that nicotine
itself causes cancer or that nicotine is the major contributing
constituent in cigarettes that causes cancer (Refs. 228, 241, and 245).
A more recent qualitative study of people who currently use little
cigars and cigarillos suggests that the misperception that nicotine has
significant adverse health
[[Page 5053]]
effects is also common among people who use these products (Refs. 228,
241, 245, and 246). Although nicotine creates and sustains addiction
and therefore is the driver of the death and disease associated with
smoking, it is the repeated exposure to toxicants from tobacco products
that directly causes most of the serious health effects among those who
use tobacco products, including fatal lung diseases, such as COPD, and
cancer (Ref. 28).
Consumer misperceptions regarding the harms associated with
nicotine may lead to inaccurate judgments about the risks of using
products that contain nicotine, including NRT. For example, individuals
who hold a misperception about nicotine may be less likely to use NRT
as a smoking cessation aid. Furthermore, there is evidence that
misperceptions of nicotine harm vary by gender, ethnicity, and age, and
may contribute to unequal health outcomes (Ref. 233). FDA recognizes
the importance of addressing nicotine misperceptions in the context of
a proposed product standard that limits the level of nicotine in
cigarettes and certain other combusted tobacco products in order to
make those products minimally addictive or nonaddictive. FDA will
continue to conduct research and develop communication tools (e.g.,
consumer outreach, public education initiatives, engagement with
interested parties) to ensure that consumers are informed of the risks
of using tobacco products that contain nicotine, including the products
covered under this proposed product standard.
V. History and Perceptions of VLNC Cigarettes
A. History of LNC and VLNC Cigarettes
Tobacco companies had the technical expertise to manipulate the
nicotine content in tobacco as early as the 1920s and then began to
market products that may have met very low nicotine content (VLNC) \18\
cigarette levels throughout the late 1970s and early 1980s (Ref. 247).
As discussed above, the term ``VLNC cigarettes'' generally refers to
combusted cigarettes that have been reported to contain <=1.0 mg
nicotine per gram of total tobacco. For a detailed discussion of the
scientific evidence that supports the technical achievability of this
proposed product standard, see section VII.E of this document. In this
section, we describe some of the industry's early and continuing
efforts to develop VLNC cigarettes.
---------------------------------------------------------------------------
\18\ As previously noted in footnote 7, the term VLNC should not
be confused with the cigarette brand name ``VLN;'' ``VLN'' refers to
cigarette products authorized for marketing by FDA in 2019. See
<a href="https://www.fda.gov/media/133633/download?attachment">https://www.fda.gov/media/133633/download?attachment</a> and <a href="https://www.fda.gov/media/133635/download?attachment">https://www.fda.gov/media/133635/download?attachment</a>.
---------------------------------------------------------------------------
Some of the earliest VLNC cigarettes studied by academic
researchers were produced by Philip Morris and marketed under the brand
name ``Next,'' which was reported to contain 0.4 mg nicotine per gram
of total tobacco (Ref. 248). Later, the National Institute on Drug
Abuse (NIDA) contracted with the Ultratech/Lifetech Corporation \19\ to
produce VLNC cigarettes for research purposes only (Refs. 249 and 250).
The two types of cigarettes produced were: (1) 8.0-10.3 mg nicotine per
gram of total tobacco and (2) 0.6-0.7 mg nicotine per gram of total
tobacco (Ref. 250).
---------------------------------------------------------------------------
\19\ Both Ultratech and Lifetech have been reported as being the
company through which NIDA manufactured research cigarettes.
---------------------------------------------------------------------------
Commercially available Quest cigarettes were produced and marketed
by Vector Tobacco in the early 2000s and utilized genetically
engineered tobacco to create cigarettes with three distinct nicotine
content levels (i.e., Quest 1 (12.7 mg/g), Quest 2 (7.3 mg/g), Quest 3
(0.9 mg/g)) (table 1). These cigarettes were used in much of the VLNC
research conducted prior to the development of SPECTRUM Nicotine
Research Cigarettes; they are no longer on the market. Philip Morris
also manufactured cigarettes with varying nicotine levels for research
only (Ref. 251). In a public statement issued on July, 2018, 22nd
Century Group, Inc. stated that they were already using genetic
engineering and plant breeding to produce VLNC tobacco for cigarettes
(Ref. 252). In 2014, the company was granted patents for its process to
dramatically reduce the nicotine in tobacco plants (Ref. 253). This
tobacco has been used to generate low nicotine content research
cigarettes, produced and distributed by RTI International, under a
contract with the NIDA Drug Supply Program (Ref. 254). 22nd Century
Group, Inc. acts as a vendor for RTI for this contract, manufacturing
SPECTRUM Nicotine Research Cigarettes that were reported to contain 0.4
mg nicotine per gram of tobacco (Ref. 254), and they also manufacture
cigarettes with other reduced levels of nicotine. These SPECTRUM
Nicotine Research Cigarettes are similar in many sensory
characteristics to NNC cigarettes, but with VLNC (Refs. 255 and 256).
In 2019, 22nd Century Group, Inc. received FDA marketing
authorization and, in 2021, received exposure modification orders for
their VLNC cigarettes under the names VLN King and VLN Menthol King.
VLN cigarettes are currently being marketed and sold to consumers in
select U.S. markets as cigarettes with 95 percent less nicotine than
conventional cigarettes. From January 1, 2023, to November 22, 2024,
22nd Century VLN cigarette dollar sales accounted for less than 0.001
percent of total cigarette dollar sales in any 4week period. Menthol
flavored 22nd Century VLN cigarettes over the same time accounted for
less than 0.001percent of any 4-week menthol flavored cigarette dollar
sales.\20\
---------------------------------------------------------------------------
\20\ FDA's own analyses, calculations and conclusions informed
in part by the NielsenIQ Retail Measurement Service (RMS) data
through NielsenIQ's RMS for the tobacco product category
``Cigarettes'' for the time period January 1, 2023 through November
2, 2024 for Total US Expanded All Outlets Combined (xAOC) and
convenience stores are those of FDA and do not reflect the views of
NielsenIQ. NielsenIQ is not responsible for, had no role in, and was
not involved in analyzing and preparing the results reported herein,
or in developing, reviewing, or confirming the research approaches
used in connection with this report. NielsenIQ RMS data consist of
weekly purchase and pricing data generated from participating retail
store point-of-sale systems in all U.S. markets. See <a href="https://NielsenIQ.com/global/en/">https://NielsenIQ.com/global/en/</a> for more information.
---------------------------------------------------------------------------
Currently, these are the only authorized VLNC cigarettes. As we
discuss in other parts of this document (see section VII.E), we believe
the scientific evidence supports the technical achievability of the
proposed standard; additionally, the tobacco industry and consumer
product companies have developed a range of brands with differing
nicotine levels. Thus, it appears there would be opportunities for any
manufacturer who chooses to enter the market for products covered by
this proposed product standard.
Although many of the studies discussed in this section investigated
the effects of VLNC cigarettes, some studies also investigated the
effects of cigarettes with higher levels of nicotine, often as
comparators. Table 1 displays the reduced nicotine content cigarettes
that were administered in studies summarized in this document and their
reported nicotine levels. The nicotine content values in table 1 are
approximate, and they are primarily based on published reports from the
peer-reviewed scientific literature. Most studies that investigated the
clinical effects of reduced nicotine content cigarettes did not
chemically analyze the study cigarettes. For example, many studies that
examined the effects of VLNC SPECTRUM Nicotine Research Cigarettes did
not chemically characterize these cigarettes, but the authors of these
studies reported that the nicotine content of the cigarettes was 0.4 mg
nicotine per gram of
[[Page 5054]]
tobacco. The actual nicotine content of these cigarettes is expected to
vary around this value. For example, the results of one study that
chemically characterized SPECTRUM Nicotine Research Cigarettes showed
that the nicotine content of the sampled VLNC cigarettes ranged between
0.28 and 0.33 mg nicotine per gram (Ref. 256), which is lower than the
0.4 mg nicotine per gram level typically reported in the literature. In
22nd Century Group, Inc.'s modified risk tobacco product applications,
the company reported that after 9 years of sampling by the company, the
average nicotine content of its genetically engineered VLNC tobacco is
0.6 mg nicotine per gram of total tobacco, with a range of 0.4 to 0.7
mg nicotine per gram of total tobacco. It is likely that the Quest and
SPECTRUM Nicotine Research Cigarettes, used throughout the scientific
literature, also contained between 0.4 to 0.7 mg nicotine per gram of
total tobacco (Ref. 257).
Table 1--Nicotine Content for Normal, Low, and Very Low Nicotine Content Cigarettes Used in the Research Studies
Cited in This Document
----------------------------------------------------------------------------------------------------------------
Nicotine content Nicotine content
Brand Manufacturer category (mg/g)
----------------------------------------------------------------------------------------------------------------
Magic \1\............................. 22nd Century Group, Inc..... VLNC................... * 1.0
Next \2\.............................. Philip Morris International. VLNC................... * 0.4
Philip Morris 1 mg \3\................ Philip Morris Tobacco VLNC................... * 0.7-0.9
Company.
Philip Morris 2 mg \3\................ Philip Morris Tobacco LNC.................... * 2.1-2.4
Company.
Philip Morris 4 mg \3\................ Philip Morris Tobacco LNC.................... * 5.0-5.6
Company.
Philip Morris 8 mg \3\................ Philip Morris Tobacco LNC.................... * 9.3-10.6
Company.
Philip Morris 12 mg \3\............... Philip Morris Tobacco NNC.................... * 14.4-14.7
Company.
Quest 1............................... Vector Group Ltd............ NNC.................... * 12.7
Quest 2............................... Vector Group Ltd............ LNC.................... * 7.3
Quest 3............................... Vector Group Ltd............ VLNC................... * 0.9
SPECTRUM 0.4 mg (NRC102-NRC105) \4\... 22nd Century Group, Inc..... VLNC................... 0.4-0.7
SPECTRUM 1.3 mg (NRC200, NRC201) \5\.. 22nd Century Group, Inc..... LNC.................... 0.9-1.3
SPECTRUM 2.4 mg (NRC300, NRC301) \5\.. 22nd Century Group, Inc..... LNC.................... 1.9-2.4
SPECTRUM 5.2 mg (NRC400, NRC401) \5\.. 22nd Century Group, Inc..... LNC.................... 4.6-5.2
SPECTRUM 15.8 mg (NRC600, NRC601) \5\. 22nd Century Group, Inc..... NNC.................... 15.5-17.3
Ultratech/Lifetech denicotinized \6\.. Ultratech Inc./Lifetech Corp VLNC................... * 0.6-0.7
Ultratech/Lifetech nicotine \6\....... Ultratech Inc./Lifetech Corp LNC.................... * 8.0-10.3
Xodus \7\............................. 22nd Century Ltd., LLC...... LNC.................... * 1.2-1.7
----------------------------------------------------------------------------------------------------------------
Abbreviations: VLNC: <=1.0 mg nicotine per gram of total tobacco; LNC: >1.0 mg and <11.4 mg nicotine per gram of
total tobacco; NNC: >=11.4 mg nicotine per gram of total tobacco.
\1\ Nicotine content from (Ref. 31).
\2\ Nicotine content from (Ref. 248).
\3\ Nicotine content from (Refs. 258 and 259).
\4\ Nicotine content from (Ref. 257).
\5\ Nicotine content from (Ref. 29) (supplement).
\6\ Nicotine content estimated by FDA based on nicotine yield data from (Ref. 250).
\7\ Nicotine content from (Ref. 41).
* For these cigarettes, FDA calculated milligrams of nicotine per gram of total tobacco based on reports of
milligrams of nicotine per cigarette. Calculations were based on an estimate of 0.7 grams of tobacco per
cigarette.
B. Consumer Knowledge, Attitudes, Beliefs, and Perceptions Regarding
VLNC Cigarettes and FDA Regulation of Levels of Nicotine in Tobacco
In this section we describe the science related to consumer
knowledge, attitudes, and beliefs about reduced nicotine content (RNC)
\21\ cigarettes and consumers' perceptions about a hypothetical policy
reducing nicotine levels in cigarettes and certain combustible tobacco
products. These concepts are important because they are associated with
the behavioral responses consumers believe they would take if such a
policy is in effect.
---------------------------------------------------------------------------
\21\ RNC cigarettes in this context refers to any cigarette with
a lower amount of nicotine than NNC cigarettes. FDA notes that
studies focusing on consumer perceptions of RNC cigarettes typically
do not differentiate between RNC, LNC, and VLNC cigarettes. However,
when describing studies that focus on consumer behavior and
perceptions of VLNC cigarettes specifically, FDA uses the term VLNC
cigarettes. FDA notes that studies in this domain typically use
consumer perceptions of RNC cigarettes to form conclusions about
consumer perceptions about VLNC cigarettes and FDA's proposed
reduction of nicotine more broadly.
---------------------------------------------------------------------------
The science on consumer knowledge, attitudes, beliefs, and
perceptions about RNC cigarettes demonstrates that a majority of
consumers perceive that RNC cigarettes are equally or more harmful than
NNC cigarettes. Nationally representative studies suggest that 50 to 71
percent of consumers perceive RNC cigarettes to be as or more harmful
to health than NNC cigarettes, while 25 to 35 percent perceive them to
be less harmful than NNC cigarettes (Refs. 260 to 262). Recent
nationally representative findings estimate that between 12 and 25
percent of people who smoke or use e-cigarettes believe RNC cigarettes
are less harmful than NNC cigarettes (Refs. 227 and 236). In studies
where participants actually use VLNC cigarettes, they tend to perceive
them as significantly less harmful to health and less likely to cause
cancer than NNC cigarettes (Refs. 230, 263 to 265). Furthermore, there
is evidence that perceptions about the harms of VLNC cigarettes
relative to NNC cigarettes vary by race and age (Refs. 236, 266 to
268). The science on consumer knowledge, attitudes, beliefs, and
perceptions about RNC cigarettes also demonstrates that there are
widespread misperceptions about the addictiveness of RNC cigarettes
relative to NNC cigarettes. Studies that use nationally representative
surveys report that 60 to 77 percent of consumers incorrectly believe
that RNC cigarettes are equally or more addictive than NNC cigarettes
(Refs. 260 and 261). Tobacco use status does not appear to
significantly change misperceptions about the addictiveness of RNC
cigarettes (Ref. 228).
A 2019 nationally representative study of consumer support for a
policy ``requiring cigarette makers to lower the
[[Page 5055]]
nicotine levels in cigarettes so that they are less addictive''
reported that 81 percent of study participants favored the policy (52.4
percent strongly favored, 28.6 somewhat favored) and 19 percent opposed
the policy (10.3 percent somewhat opposed, 8.7 percent strongly
opposed) (Ref. 269). However, consumer misperceptions about the harm
and addictiveness of reduced nicotine content combustible tobacco
products impact understanding of the purpose of a reduced nicotine
product standard. For example, respondents in some studies did not
understand why FDA would choose to remove nicotine from cigarettes or
little cigars and cigarillos but not remove other chemicals that are
harmful (Ref. 229, 270, and 271). Respondents also stated that they
believed other chemicals besides nicotine make cigarettes addictive,
and that removing nicotine from cigarettes would not eliminate their
addictiveness (Refs. 229 and 270). Misperceptions may also serve as
potential determinants of consumer responses to a reduced nicotine
product standard. For example, one study suggests that misperceptions
among people who smoke regarding the harm of RNC cigarettes is
correlated with quit intentions in responses to a hypothetical
government policy reducing most of the nicotine in cigarettes (Ref.
267). FDA recognizes the importance of addressing consumers'
misperceptions about the relative harm and addictiveness of VLNC
cigarettes as compared to other products. FDA will continue to conduct
research (e.g., assess changes over time in knowledge, attitudes, and
perceptions relative to tobacco product characteristics including
nicotine content) to inform regulatory decisions and other actions.
VI. Rationale for Products Covered by the Proposed Product Standard
FDA has reviewed and closely considered the comments to the
Nicotine ANPRM, as well as additional evidence and information not
available at the time of the ANPRM, in developing the scope of products
for this proposed product standard. Specifically, we considered several
factors, such as the strength and breadth of the available data on the
likely effects of reducing nicotine derived from studies of VLNC
cigarettes; current prevalence and initiation rates for different
classes of tobacco products; the available data on product toxicity,
addictiveness, and appeal; product use topography \22\ (including
quantity, intensity, and duration of use); and the potential for
migration to different products. These data indicate that reduction of
nicotine in cigarettes would reduce addiction potential, dependence
levels, number of cigarettes smoked per day, and increase quit attempts
among people who currently smoke cigarettes. In light of these data,
FDA also expects that reduction of nicotine would prevent people who
experiment with cigarettes and cigars from developing an addiction to
tobacco and progressing to regular tobacco use.
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\22\ Smoking topography measures provide data on various aspects
of smoking behavior, including number of puffs per cigarette, total
time spent smoking, puff volume (i.e., puff size), puff velocity
(i.e., puff intensity), puff duration, and inter-puff interval
(i.e., length of time between puffs).
---------------------------------------------------------------------------
This proposed product standard is intended to address one of our
nation's greatest public health challenges: the death and disease
caused by combusted tobacco use. Approximately 480,000 people die every
year from smoking cigarettes (Ref. 1 at p. 659) and another 9,000 die
from smoking cigars (Ref. 1 at p. 659; Ref. 134). Cigarettes are the
tobacco product category that causes the greatest amount of harm to the
public health as a result of the prevalence of cigarette use among
adults and cigarette toxicity and addictiveness. This proposed product
standard is expected to increase cessation and switching to potentially
less harmful tobacco products and prevent people who are experimenting
with use--mainly youth and young adults--from transitioning to regular
use of cigarettes. However, if the product standard were only to cover
cigarettes, it would likely be less effective. Specifically, a
significant number of people who are addicted to smoking cigarettes
would likely migrate to similar combusted tobacco products after the
standard went into effect to maintain their nicotine exposure, thereby
undermining the significant health benefits of the proposed product
standard (Ref. 5) (see also section VI.B of this document for further
discussion of the potential for non-cigarette combusted tobacco product
switching). Therefore, to increase public health benefits, FDA also is
proposing to cover certain other combusted tobacco products in addition
to cigarettes.
Based on these considerations, FDA is proposing to cover the
following products under this product standard:
<bullet> Cigarettes (other than noncombusted cigarettes, such as
HTPs that meet the definition of a cigarette),
<bullet> Cigarette tobacco,
<bullet> RYO tobacco,
<bullet> Cigars (including little cigars, cigarillos, and large
cigars but excluding premium cigars), and
<bullet> Pipe tobacco (other than waterpipe tobacco).
FDA has determined that research regarding the public health
impacts of potential maximum nicotine level policies applies across the
tobacco products covered under this proposed product standard. As
discussed in greater detail in section VII.B.12 of this document, given
that cigarette tobacco, RYO tobacco, and pipe tobacco can be
effectively used in cigarettes, the VLNC cigarette research discussed
in this proposed rule applies to these products, and any expected
benefits that would accrue as a result of instituting the proposed
product standard for cigarettes would also be expected to accrue for
these product categories. FDA also concludes that the VLNC cigarette
research applies to cigars, given the similarities between cigarettes
and most cigars (e.g., use topography). For further discussion of FDA's
findings that VLNC cigarette research applies to other covered products
under this proposed product standard, see section VII.B.12 of this
document. In addition, as discussed in section VI.A.3 of this document,
FDA finds that the non-cigarette combusted products within the proposed
scope of this rule (i.e., RYO tobacco, cigars, pipe tobacco) could
function as acceptable substitutes for many people who smoke cigarettes
while exposing them to similar risks and toxicity as cigarettes.
As discussed in section VIII of this document, FDA finds that the
proposed product standard, with this scope, is appropriate for the
protection of the public health and would provide substantial benefits
for people who currently use cigarettes and certain other combusted
tobacco products and for people who experiment with cigarettes and
cigars and people who do not use such tobacco products. FDA seeks
comments on this proposed scope, particularly on how it may affect
youth initiation and use of combusted tobacco products.
A. Prevalence and Abuse Potential of Cigarettes and Other Combusted
Tobacco Products
Cigarettes, the most frequently used tobacco products, are the
tobacco product category that causes the greatest burden of harm to
public health given that approximately 28 million adults and 380,000
youth currently smoke cigarettes (Ref. 3); the toxicity and
addictiveness of these products; and the resulting tobacco-related
disease and death across the population, including among people who do
not smoke. Cigarettes are highly addictive and harmful tobacco
products; however, the other combusted tobacco products
[[Page 5056]]
covered in this proposed product standard are similarly addictive and
harmful. If the proposed product standard covered only cigarettes, some
number of people who smoke cigarettes and are addicted to nicotine
would likely migrate to similar combusted tobacco products to maintain
their nicotine exposure (or engage in dual use with other similar
combusted tobacco products), thus reducing the positive public health
impact of this proposed product standard.
Regulating the nicotine yield of cigarettes and certain other
combusted tobacco products through setting a maximum nicotine level for
them would make these dangerous combusted products minimally addictive
or nonaddictive, making cessation easier and helping to prevent people
who are experimenting with smoking from developing nicotine dependence
and progressing to regular use. As stated elsewhere in this document,
FDA's approach in proposing this product standard for cigarettes and
certain other combusted tobacco products protects public health by
reducing combusted tobacco product use (and therefore reducing exposure
to harmful toxicants created through combustion) by making it
considerably easier for people who want to quit cigarette use to quit
all tobacco products or switch to potentially less harmful,
noncombusted tobacco products which remain available. Therefore, to
increase the public health benefits, FDA is focusing this proposed rule
on nicotine levels in cigarettes and certain other combusted tobacco
products because combusted products are responsible for the majority of
death and disease due to tobacco use.
1. Cigarettes
Data from the 2024 NYTS indicate that 1.7 percent of high school
students (approximately 250,000) and 1.1 percent of middle school
students (approximately 120,000) reported current use of cigarettes
(i.e., smoked at least once during the past 30 days) (Ref. 3). In
addition, 11.6 percent of adults reported that they currently smoked
cigarettes in 2022 (i.e., smoked at least 100 cigarettes during their
lifetime and now smoke cigarettes every day or some days); this means
an estimated 28.8 million adults in the United States currently smoke
cigarettes (Ref. 4). Although cigarette smoking is present in all
population groups in the United States, the prevalence of cigarette use
differs based on sociodemographic characteristics.
Findings from the 2024 NYTS show that, among middle and high school
students, 1.4 percent of non-Hispanic White students, 0.9 percent of
non-Hispanic Black students, and 1.6 percent of Hispanic students
currently smoked cigarettes (Ref. 3). Additionally, data from the 2022
NHIS show differences in smoking prevalence on the basis of race/
ethnicity among adults (age 18 and over). Specifically, 4.6 percent of
non-Hispanic Asian, 8.0 percent of Hispanic, 12.7 percent of non-
Hispanic White, 14.2 percent of non-Hispanic Black, 19.3 percent of
non-Hispanic AI/AN, and 11.9 percent of non-Hispanic Other participants
reported current cigarette smoking (Ref. 272). Data from the 2005 and
2015 NHIS also indicate that the prevalence of cigarette smoking has
statistically significantly declined over this time period for non-
Hispanic white, Black, Asian, and AI/AN adults and Hispanic adults
(Ref. 273).
Data from an analysis of the 2005 and 2015 NHIS indicate that the
prevalence of smoking has declined significantly over that time period
among both adult male and female participants (29.9 and 25.2 percent
relative decrease, respectively) (Ref. 273). Currently, according to
data from the 2022 NHIS, smoking remains more prevalent among males
(13.2 percent) as compared to females (10.0 percent) in the United
States (Ref. 272).
Study findings indicate that individuals who identify as lesbian,
gay, or bisexual are more likely to report smoking cigarettes as
compared to those who identify as heterosexual (Refs. 274 to 277).
Among adults in the 2022 NHIS, cigarette smoking among persons
identifying as lesbian, gay, and bisexual was 12.8 percent and among
those identifying as heterosexual/straight it was 11.6 percent (Ref.
272), and smoking was more prevalent among youth identifying as
lesbian, gay, and bisexual (7.0 percent) in the 2020 NYTS than among
those ``not sure'' of their sexual identity (3.5 percent) or youth
identifying as heterosexual (2.7 percent) (Ref. 275). Current tobacco
use for lesbian, gay, bisexual, and transgender youth in the 2022 NYTS
was reported for ``any'' tobacco use (i.e., current use of one or more
of the following: e-cigarettes, cigarettes, cigars, smokeless tobacco,
hookah, HTPs, nicotine pouches, pipe tobacco, or bidis), but not for
individual tobacco products (Ref. 278). Pooled data from the 2015 to
2019 NSDUH indicate that compared to heterosexual/straight respondents,
respondents who identified as gay males, lesbian/gay females, or
bisexual females reported higher prevalence of past 30-day smoking
(Ref. 279). Additionally, in data from the 2015/2016 NSDUH, relative to
same-age heterosexual men, lifetime rates of daily cigarette smoking
were significantly elevated among gay men ages 18-25 (30 percent versus
23 percent) and ages 35-49 years (44 percent versus 38 percent) (Ref.
277). Similarly, relative to same-age heterosexual women, lifetime
daily cigarette smoking was significantly greater among lesbian/gay
women ages 18-25 (37.7 percent versus 16.3 percent), ages 26-34 (42.2
percent versus 30.3 percent), and ages 35-49 (42.7 percent versus 32.6
percent) (Ref. 277).
As evidenced in a systematic review and meta-analysis (Ref. 280),
studies have consistently shown a relationship between socioeconomic
status and the prevalence of cigarette smoking, such that greater
levels of educational attainment and greater total family income are
inversely associated with the prevalence of smoking. Specifically, in
2021 NHIS data, the prevalence of cigarette smoking was 18.3 percent
for adults with a low income, 12.3 percent for those with a medium
income, and 6.7 percent for those with a high income (Ref. 274).
Similarly, by and large, there is an inverse relationship between
educational attainment and the prevalence of smoking. For instance,
according to the 2021 NHIS, the prevalence of smoking was 20.1 percent
among adults with some high school education but no degree, 30.7
percent among persons with a general equivalency degree, 17.1 percent
among those with a high school diploma, 13.7 percent among persons with
an associate's degree, 5.3 percent among those with an undergraduate
degree, and 3.2 percent among persons who had received a graduate
degree (Ref. 274).
The prevalence of cigarette smoking is also higher among adults
with mental health symptoms or substance use disorder (Refs. 281 to
284). Findings from the 2022 NHIS show that 27.2 percent of persons
reporting severe generalized anxiety disorder (GAD) currently smoke
cigarettes, as compared with 10.1 percent who report no or minimal GAD
(Ref. 272). Similarly, 27.1 percent of adults who report severe
depression currently smoke cigarettes, versus 10.1 percent among those
who report no or minimal depression (Ref. 281). Additionally, findings
from the 2021 NHIS show that 28.1 percent of persons reporting serious
psychological distress also reported smoking cigarettes, compared to
10.9 percent of persons not reporting serious psychological distress
(Ref. 274). Analyses of data from the 2015 NSDUH for individuals aged
12 years and over also show that cigarette smoking is significantly
more prevalent among
[[Page 5057]]
persons who use cannabis (daily cannabis use: 54.6 percent; nondaily
cannabis use: 40.2 percent) as compared to those who do not use
cannabis (15.1 percent) (Ref. 282). An analysis of 2016 NSDUH data
indicates that cigarette smoking is more than twice as prevalent among
persons with alcohol use disorder, as compared to those without (37.8
percent versus 16.3 percent) (Ref. 283), while data from the 2014 NSDUH
show that the prevalence of cigarette smoking is also more than twice
as high among persons with mental health and/or substance use problems
than among persons without (38.5 percent versus 15.4 percent) (Ref.
284).
2. Cigars
Cigar smoke contains many of the same constituents as cigarette
smoke, including nicotine, many of which can cause significant harm to
those who use cigars (Ref. 53). According to the 2024 NYTS, 330,000
middle and high school students,\23\ including 1.5 percent (an
estimated 230,000) of high school students (grades 9-12) and 0.8
percent (an estimated 80,000) of middle school students (grades 6-8),
had smoked a cigar (cigar, cigarillo, or little cigar) on at least 1
day during the past 30 days (Ref. 3). Overall, the prevalence of cigar
smoking among middle and high school students is comparable to the
prevalence of cigarette smoking, with 1.7 percent (an estimated
250,000) of high school students and 1.1 percent (an estimated 120,000)
of middle school students having smoked cigarettes on at least 1 day
during the past 30 days (Ref. 3). Cigars are also a popular tobacco
product among adults. In the 2022 NHIS, 3.7 percent of adults aged 18
or older reported currently using cigars some or every day, behind
cigarettes (11.6 percent) and e-cigarettes (6.0 percent) (Ref. 272).
---------------------------------------------------------------------------
\23\ The weighted population estimate reported in the scientific
publication is 500,000 students. As noted in the scientific
publication, overall population estimates might not sum to
corresponding population estimates because of rounding or inclusion
of students who did not self-report sex, race and ethnicity, or
grade level.
---------------------------------------------------------------------------
Evidence from national surveys--including the Monitoring the Future
study and NSDUH--indicate that, similar to cigarettes, cigar use has
been on the decline among U.S. youth and adults in recent years (Refs.
285 to 287). However, among youth, this decrease has not been equitably
experienced. The popularity of cigar use is disproportionately high
among groups such as lesbian, gay, and bisexual youth and young adults
(3.2 percent among transgender youth, 3.2 percent among sexual minority
females, and 3.9 percent among sexual minority males) (Ref. 288), and
youth with disabilities (7.0 percent among those who reported using
little cigars and 2.6 percent among those who reported using large
cigars) (Ref. 289). Cigar smoking also occurs disproportionately among
specific populations of adults as well, with greater prevalence of
cigar smoking reported among non-Hispanic Black adults (5.1 percent)
(Ref. 274), individuals of lower educational attainment and lower
annual household income (Refs. 290 and 291), and LGBTQI+ adults (Refs.
292 to 296).
Additionally, when comparing data from 2011 to 2019, while past
month cigarette smoking and cigar use were both statistically
significantly lower in young adults (ages 18-25), the absolute and
relative declines in cigar use were less than the declines in cigarette
use (33.5 percent in 2011 to 17.5 percent in 2019 for cigarettes; 10.9
percent in 2011 to 7.7 percent in 2019 for cigars) (Ref. 286). For
adults (ages 26 or older), cigarette use in 2011 was statistically
significantly higher compared to in 2019; however, cigar use remained
relatively stable and did not significantly change (21.9 percent in
2011 to 18.2 percent in 2019 for cigarettes; 4.2 percent in 2011 to 4.0
percent in 2019 for cigars) (Ref. 286). The 2023 NSDUH found that among
adults ages 26 or older in 2019, 1,847 individuals initiated cigar use
each day, considerably more than the 282 who initiated cigarette
smoking each day in that year (Ref. 86).
While these data indicate a high burden of current cigar smoking,
the true prevalence of cigar use is likely higher. Little cigars often
closely resemble cigarettes, given their shape, size, filters, and
packaging, and are perceived by many as being healthier than cigarettes
(Refs. 297 and 298). Several studies have shown that youth tend to
underreport cigar smoking if brand name identifiers are not provided
(Refs. 299 to 301). For example, in one study of Virginia high school
students, the reported prevalence of cigar use nearly doubled after
accounting for students who reported smoking Black & Mild (a brand name
of cigarillos); in the original survey results, more than half of the
students who used Black & Mild cigarillos did not report using cigars,
cigarillos, or little cigars (Ref. 299).
Research indicates that most people who smoke cigars unknowingly
inhale some amount of smoke, including people who smoke cigars who
report tha
[…truncated; see source link]Indexed from Federal Register on January 16, 2025.
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