[Federal Register Volume 87, Number 86 (Wednesday, May 4, 2022)]
[Proposed Rules]
[Pages 26454-26502]
[FR Doc No: 2022-08994]

Vol. 87

Wednesday,

No. 86

May 4, 2022

Part III

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Part 1162

Tobacco Product Standard for Menthol in Cigarettes; Proposed Rule

Federal Register / Vol. 87 , No. 86 / Wednesday, May 4, 2022 /
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1162

[Docket No. FDA-2021-N-1349]
RIN 0910-AI60

Tobacco Product Standard for Menthol in Cigarettes

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 prohibit menthol as a
characterizing flavor in cigarettes. Tobacco use is the leading
preventable cause of death and disease in the United States. Menthol's
flavor and sensory effects increase appeal and make menthol cigarettes
easier to use, particularly among youth and young adults. There are
over 18.5 million menthol cigarette smokers ages 12 and older in the
United States. This proposed product standard would reduce the appeal
of cigarettes, particularly to youth and young adults, and thereby
decrease the likelihood that nonusers who would otherwise experiment
with menthol cigarettes would progress to regular smoking. In addition,
the proposed tobacco product standard would improve the health and
reduce the mortality risk of current menthol cigarette smokers by
decreasing cigarette consumption and increasing the likelihood of
cessation. FDA is taking this action to reduce the tobacco-related
death and disease associated with menthol cigarette use. The proposed
standard also is expected to reduce tobacco-related health disparities
and advance health equity.

DATES: Submit either electronic or written comments on the proposed
rule by July 5, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 5, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-N-1349 for ``Tobacco Product Standard for Menthol in
Cigarettes.'' 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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beth Buckler or Eric Mandle, Center
for Tobacco Products, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

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 of Menthol Cigarettes
    C. Legal Authority
    D. FDA's Consideration of Health Equity
IV. Menthol Cigarette Use Is Common, Addictive, and Harmful
    A. Background
    B. Menthol Smoking Is Widespread and Disproportionately Impacts
Youth, Young Adults, and Other Vulnerable Populations in the United
States

    C. Menthol in Cigarettes Increases Smoking Initiation, Increases
Progression to Regular Use, and Contributes to Nicotine Dependence
    D. Menthol in Cigarettes Makes Quitting Smoking More Difficult
    E. Menthol Cigarettes Are Marketed Disproportionately in
Underserved Communities and to Vulnerable Populations
V. Determination That the Standard Is Appropriate for the Protection
of the Public Health
    A. The Likelihood That Nonusers Would Start Using Cigarettes
    B. The Likelihood That Existing Menthol Cigarette Users Would
Reduce Cigarette Consumption or Stop Cigarette Smoking
    C. Benefits and Risks to the Population as a Whole
    D. Conclusion
VI. Additional Considerations and Requests for Comments
    A. Section 907 of the FD&C Act
    B. Request for Comments on the Potential Racial and Social
Justice Implications of the Proposed Product Standard
VII. Description of the Proposed Rule
    A. Scope (Proposed Sec.  1162.1)
    B. Definitions (Proposed Sec.  1162.3)
    C. Prohibition on Use of Menthol as a Characterizing Flavor in
Cigarettes (Proposed Sec.  1162.5)
VIII. Proposed Effective Date
IX. Preliminary Economic Analysis of Impacts
    A. Introduction
    B. Summary of Costs and Benefits
X. Analysis of Environmental Impact
XI. Paperwork Reduction Act of 1995
XII. Federalism
XIII. Consultation and Coordination With Indian Tribal Governments
XIV. References

I. Executive Summary

A. Purpose of the Proposed Rule

    FDA is proposing a tobacco product standard that would prohibit
menthol as a characterizing flavor in cigarettes. In developing this
proposed rule, FDA carefully considered the scientific evidence and
complex policy issues related to menthol cigarettes. As described in
the preamble of this rule, FDA has conducted multiple scientific
reviews related to menthol cigarettes, issued two advance notices of
proposed rulemaking (ANPRMs) to solicit data and information about
menthol cigarettes, considered a citizen petition requesting that FDA
ban menthol as a characterizing flavor in cigarettes, and sponsored
research on a variety of menthol-related topics.
    Each year, 480,000 people die prematurely from a smoking-
attributable disease, making tobacco use the leading cause of
preventable death and disease in the United States. In 2009, the Family
Smoking Prevention and Tobacco Control Act (Tobacco Control Act) banned
characterizing flavors in cigarettes, other than tobacco or menthol,
based on their appeal to youth, in order to reduce the number of
children and adolescents who smoke cigarettes. As a result, menthol
cigarettes are the only cigarettes with a characterizing flavor still
marketed in the United States.
    In 2019, there were more than 18.5 million current smokers of
menthol cigarettes ages 12 and older in the United States. Although
menthol cigarette smoking is widespread in the United States, menthol
cigarettes are used at a particularly high rate by youth, young adults,
and certain other vulnerable populations such as African American and
other racial and ethnic groups. Menthol is a flavor compound added to
cigarettes, which produces a minty taste and cooling sensation when
inhaled. Menthol's flavor and sensory effects reduce the harshness of
cigarette smoking and make it easier for new users, particularly youth
and young adults, to continue experimenting and progress to regular
use. In addition, data show that menthol cigarettes contribute to
greater nicotine dependence in youth and young adults than non-menthol
cigarettes. By prohibiting menthol as a characterizing flavor in
cigarettes, this proposed product standard would reduce the appeal of
cigarettes, particularly to youth and young adults, who are more likely
to try a menthol cigarette as their first cigarette than a non-menthol
cigarette. And because almost all daily smokers started smoking before
the age of 25, it would thereby decrease the likelihood that nonusers
who would otherwise experiment with menthol cigarettes would progress
to regular smoking. By prohibiting menthol as a characterizing flavor
in cigarettes, FDA expects a significant reduction in the likelihood of
youth and young adult initiation and progression to regular cigarette
smoking, which is expected to prevent future cigarette-related disease
and death.
    In addition, the proposed tobacco product standard would improve
the health and reduce the mortality risk of current menthol cigarette
smokers by substantially decreasing cigarette consumption and
increasing the likelihood of cessation. Published modeling studies have
estimated a 15.1 percent reduction in smoking prevalence within 40
years if menthol cigarettes were no longer available in the United
States. These studies also estimate that 324,000 to 654,000 smoking
attributable deaths overall (92,000 to 238,000 among African Americans)
would be avoided within 40 years. FDA expects the public health benefit
of this rule to be particularly pronounced among vulnerable
populations, including youth and young adults, as well as Black
smokers, who have the highest prevalence of menthol cigarette smoking
and experience a disproportionate burden of the related harms. For the
reasons discussed in the preamble of this proposed rule, FDA finds that
the proposed tobacco product standard would be appropriate for the
protection of the public health. Additionally, this proposed product
standard is expected to substantially decrease tobacco-related health
disparities and to advance health equity across population groups.

B. Summary of the Major Provisions of the Proposed Rule

    The proposed rule would prohibit the use of menthol as a
characterizing flavor in cigarettes and cigarette components and parts,
including those that are sold separately to consumers. Specifically,
the rule would provide that a cigarette or any of its components or
parts (including the tobacco, filter, wrapper, or paper, as applicable)
shall not contain, as a constituent (including a smoke constituent) or
additive, menthol that is a characterizing flavor of the tobacco
product or tobacco smoke. Under the proposed rule, no person may
manufacture, distribute, sell, or offer for distribution or sale,
within the United States a cigarette or cigarette component or part
that is not in compliance with the product standard. Among the factors
that FDA believes are relevant in determining whether a cigarette has a
characterizing flavor are:
     The presence and amount of artificial or natural flavor
additives, compounds, constituents, or ingredients, or any other
flavoring ingredient in a tobacco product, including its components or
parts;
     The multisensory experience (i.e., taste, aroma, and
cooling or burning sensations in the mouth and throat) of a flavor
during use of a tobacco product, including its components or parts;
     Flavor representations (including descriptors), either
explicit or implicit, in or on the labeling (including packaging) or
advertising of tobacco products; and
     Any other means that impart flavor or represent that the
tobacco products has a characterizing flavor.
    FDA is proposing that any final rule that may issue based on this
proposed rule become effective 1 year after the date of publication of
the final rule. Therefore, after the effective date, no person may
manufacture, sell, or offer for sale or distribution within the United
States a cigarette or any of its components or parts that is not in

compliance with part 1162. This regulation does not include a
prohibition on individual consumer possession or use, and FDA cannot
and will not enforce against individual consumers for possession or use
of menthol cigarettes. FDA's enforcement will only address
manufacturers, distributors, wholesalers, importers, and retailers.
State and local law enforcement agencies do not independently enforce
the Federal Food, Drug and Cosmetic Act (FD&C Act). These entities do
not and cannot take enforcement actions against any violation of
chapter IX of the Act or this regulation on FDA's behalf. We recognize
concerns about how State and local law enforcement agencies enforce
their own laws in a manner that may impact equity and community safety
and seek comment on how FDA can best make clear the respective roles of
FDA and State and local law enforcement.

C. Legal Authority

    Section 907 of the FD&C Act (21 U.S.C. 387g) prohibited
characterizing flavors, other than menthol and tobacco, in cigarettes.
Section 907 expressly preserved FDA's ability to prohibit menthol as an
exercise of FDA's authorities to revise or issue tobacco product
standards, including provisions that would require the reduction or
elimination of a constituent (including a smoke constituent), or
harmful component of tobacco products; and provisions respecting the
construction, components, ingredients, additives, constituents
(including smoke constituents), and properties of the tobacco product
(section 907(a)(2), (a)(3), (a)(4)(A)(ii), and (a)(4)(B)(i) of the FD&C
Act). FDA's authorities related to the sale and distribution of tobacco
products are established under sections 907(a)(4)(B)(v) and 906(d) (21
U.S.C. 387f(d)) of the FD&C Act.

D. Costs and Benefits

    The quantified benefits of this proposed rule come from lower
smoking-attributable mortality in the U.S. population due to diminished
exposure to tobacco smoke for both users and nonusers of cigarettes.
The costs of this proposed rule are those to firms to comply with the
rule, to consumers impacted by the rule, and to the government to
enforce this product standard. In addition to benefits and costs, this
rule will cause transfers from State governments, Federal Government,
and firms to consumers in the form of reduced revenue and tax revenue.
    We estimate that the annualized benefits over a 40-year time
horizon will equal $220 billion at a 7 percent discount rate, with a
low estimate of $102 billion and a high estimate of $334 billion, and
$232 billion at a 3 percent discount rate, with a low estimate of $108
billion and a high estimate of $353 billion.
    Over a 40-year time horizon, we estimate that the annualized costs
will equal $307 million at a 7 percent discount rate, with a low
estimate of $16 million and a high estimate of $601 million, and $291
million at a 3 percent discount rate, with a low estimate of $9 million
and a high estimate of $573 million.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

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       Abbreviation/acronym                     What it means
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Addiction Review..................  Scientific Review of the Effects of
                                     Menthol in Cigarettes on Tobacco
                                     Addiction: 1980-2021.
ANPRM.............................  Advance notice of proposed
                                     rulemaking.
CARDIA............................  Coronary Artery Risk Development in
                                     Young Adults.
CFR...............................  Code of Federal Regulations.
CPS II............................  Cancer Prevention Study II.
CTP...............................  FDA's Center for Tobacco Products.
EE................................  Expert Elicitation.
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.
FTC...............................  Federal Trade Commission.
HHS...............................  U.S. Department of Health and Human
                                     Services.
HTP...............................  Heated Tobacco Product.
IOM...............................  Institute of Medicine.
LGBTQ+............................  Lesbian, gay, bisexual, transgender,
                                     or queer.
Nav Guide.........................  Navigation Guide Systematic Review
                                     Methodology.
NCI...............................  National Cancer Institute.
NHANES............................  National Health and Nutrition
                                     Examination Survey.
NHIS..............................  National Health Interview Survey.
NRC...............................  National Research Council.
NSDUH.............................  National Survey on Drug Use and
                                     Health.
NYC...............................  New York City.
NYAHS.............................  National Young Adult Health Survey.
NYTS..............................  National Youth Tobacco Survey.
PATH..............................  Population Assessment of Tobacco and
                                     Health.
PRIA..............................  Preliminary Regulatory Impact
                                     Analysis.
RYO...............................  Roll-your-own.
SAVM..............................  Smoking and Vaping Model.
SGR...............................  Surgeon General Report.
SIDS..............................  Sudden infant death syndrome.
Tobacco Control Act...............  Family Smoking Prevention and
                                     Tobacco Control Act.
TPSAC.............................  Tobacco Product Scientific Advisory
                                     Committee.
TUS-CPS...........................  Tobacco Use Supplement to the
                                     Current Population Survey.
YRBS..............................  Youth Risk Behavior Survey.
------------------------------------------------------------------------

III. Background

A. Need for the Regulation

    FDA is proposing to prohibit menthol as a characterizing flavor in
cigarettes. Cigarette smoking is the leading cause of preventable death
and disease in the United States and is responsible for more than
480,000 premature deaths per year (Ref. 1). Menthol is a flavor
compound that is added to cigarettes, which produces a minty taste and
cooling sensation when inhaled (Ref. 2). These sensory properties
contribute to smoker perceptions that menthol cigarettes are easier to
inhale, are less irritating, have a better taste, are smoother and more
refreshing than non-menthol cigarettes (Refs. 3-5). Menthol's flavor
and sensory effects reduce the harshness of cigarette smoking among new
users and facilitate experimentation and progression to regular smoking
of menthol cigarettes, particularly among youth and young adults (Refs.
6-7, 5, 8). As a result, the brain is repeatedly exposed to nicotine
and susceptible to nicotine addiction (Ref. 9).
    In addition to its flavor and sensory effects, menthol contributes
to a greater risk of nicotine dependence by enhancing the addictive
effects of nicotine in the brain by affecting mechanisms involved in
nicotine addiction (Refs. 10-13). Clinical data show that menthol
cigarette smokers have higher levels of brain nicotinic receptors
compared to non-menthol smokers (Ref. 14). Studies demonstrate that
menthol, like nicotine, binds to nicotinic receptors in the brain
(Refs. 15 and 16), and menthol alone can increase the number of
nicotinic receptors in the brain (Refs. 10 and 11). Evidence
demonstrates that the combined effects of menthol and nicotine in the
brain are associated with behaviors indicative of greater addiction to
nicotine compared to nicotine alone (Refs. 10 and 12).
    Youth and young adults are particularly susceptible to becoming
addicted to nicotine. Due to its ongoing development, the adolescent
brain, which continues to develop until about age 25, is more
vulnerable to nicotine's effects than the adult brain (Refs. 17-19).
The combined effects of nicotine and menthol in the developing brain
make youth who smoke menthol cigarettes particularly vulnerable to the
effects of menthol on nicotine dependence.
    Data from multiple studies across different populations and time
periods demonstrate that menthol cigarettes contribute to greater
nicotine dependence in youth and young adults \1\ than non-menthol
cigarettes (Refs. 20-28). Menthol is a significant contributor to
experimentation and progression to regular cigarette smoking among this
population (Refs. 25, 29-31, 8). This is of particular concern since
the vast majority of smoking initiation occurs during adolescence
(Refs. 32, 8, 31, 33) and youth and young adults are more likely to try
a menthol cigarette as their first cigarette than a non-menthol
cigarette (Refs. 8, 31, and 33).
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    \1\ Though age ranges for youth and young adults vary across
studies, in general, ``youth'' or ``adolescent'' encompasses those
11-17 years of age, while those who are 18-25 years old are
considered ``young adults'' (even though, developmentally, the
period between 18-20 years of age is often labeled late
adolescence); those 26 years of age or older are considered
``adults'' or ``older adults'' (Ref. 32).
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    In addition to the impacts on progression to regular use and
dependence, menthol contributes to reduced cessation success,
particularly among Black smokers \2\ (Refs. 34-41) (see section IV.D of
this document). A number of nationally representative studies among
young adult and adult smokers show that menthol in cigarettes
contributes to reduced cessation success (Refs. 34-35, 42, 36-38, 40,
43). Among Black smokers, this effect is consistent across large
nationally representative studies, smaller clinical studies of smokers,
reviews of the menthol and cessation literature, and meta-analyses,
which examined outcomes from multiple menthol and cessation studies.
Although findings among smokers in the general population produce more
mixed results than findings specific to Black smokers, the strongest
studies on the general population support an effect of menthol on
reduced cessation. For example, two recent studies using data from the
nationally representative longitudinal Population Assessment of Tobacco
and Health (PATH) study found that menthol is associated with reduced
smoking cessation across multiple years of followup (Refs. 40 and 43).
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    \2\ Throughout the preamble of this proposed rule, 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 both of 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.
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    In 2019, there were more than 18.5 million current smokers of
menthol cigarettes ages 12 and older in the United States (Ref. 44).
Data show that menthol cigarettes are used at a particularly high rate
by youth (aged 12-17), young adults (aged 18-25), and other vulnerable
populations \3\ such as African American and other racial and ethnic
groups (Ref. 44). Prohibiting menthol as a characterizing flavor in
cigarettes would help to decrease the nicotine addiction resulting from
menthol cigarette use, and thereby, decrease disease and death.
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    \3\ Throughout the preamble of this proposed rule, the term
``vulnerable populations'' refers to groups that are susceptible to
tobacco product risk and harm due to disproportionate rates of
tobacco product initiation, use, burden of tobacco-related diseases,
or decreased cessation. Examples of vulnerable populations include
those with lower household income and educational attainment,
certain racial or ethnic populations, individuals who identify as
LGBTQ+, underserved rural populations, those pregnant or trying to
become pregnant, those in the military or veterans, or those with
behavioral health conditions or substance use disorders.
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    In 2009, the Tobacco Control Act established the ``Special Rule for
Cigarettes'' (section 907(a)(1)(A) of the FD&C Act (Special Rule for
Cigarettes).\4\ The Special Rule for Cigarettes banned characterizing
flavors in cigarettes, other than tobacco or menthol, based on their
appeal to youth, in order to reduce the number of children and
adolescents who smoke cigarettes (see H.R. Rep. No. 111-58, pt. 1, at
37 (2009)). As a result, menthol cigarettes are the only cigarettes
with a characterizing flavor still marketed in the United States.
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    \4\ Section 907(a)(1)(A) of the FD&C Act states that beginning 3
months after the date of enactment of the Tobacco Control Act, a
cigarette or any of its component parts (including the tobacco,
filter, or paper) shall not contain, as a constituent (including a
smoke constituent) or additive, an artificial or natural flavor
(other than tobacco or menthol) or an herb or spice, including
strawberry, grape, orange, clove, cinnamon, pineapple, vanilla,
coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a
characterizing flavor of the tobacco product or tobacco smoke.
Nothing in this subparagraph (section 907(a)(1)(A) of the Tobacco
Control Act) shall be construed to limit the Secretary of HHS's
authority to take action under this section or other sections of
this Act applicable to menthol or any artificial or natural flavor,
herb, or spice not specified in this section.
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    In establishing the Special Rule for Cigarettes, Congress noted
that, ``[g]iven the number of open questions related to menthol
cigarettes, the legislation authorizes the Secretary to ban or modify
the use of menthol in cigarettes based on scientific evidence'' (H.R.
Rep. No. 111-58, pt. 1, at 39 (2009)). Specifically, the Tobacco
Control Act authorizes FDA to adopt or revise product standards where
FDA determines that such standard is appropriate for the protection of
the public health (section 907(a)(2) and (3) of the FD&C Act).
    After careful consideration of the scientific evidence, FDA is
proposing to prohibit the use of menthol as a characterizing flavor in
cigarettes in

order to reduce the death and disease caused by cigarette use. For the
reasons described in the preamble of this rule, FDA finds that this
product standard would be appropriate for the protection of the public
health because it would prohibit menthol cigarettes, which will reduce
initiation rates of smoking cigarettes, particularly for youth and
young adults, and thereby decrease the likelihood that nonusers of
cigarettes who experiment with these tobacco products would progress to
regular cigarette smoking. Additionally, the proposed tobacco product
standard is anticipated to improve the health of current smokers of
menthol cigarettes by decreasing cigarette consumption and increasing
the likelihood of cessation among this population. Published modeling
studies have estimated that 324,000 to 654,000 smoking attributable
deaths would be avoided by the year 2060 if menthol cigarettes were no
longer available in the United States (Refs. 45 and 46). These figures
significantly understate the public-health benefits because they
undercount lives saved of youth and young adults who, as the result of
the menthol ban, do not begin to smoke. Beyond averted deaths, societal
benefits would include reduced smoking-related morbidity and health
disparities, diminished exposure to secondhand smoke among non-smokers,
decreased potential years of life lost, decreased disability, and
improved quality of life among former smokers. FDA expects the public
health benefit of this rule to be particularly pronounced among
vulnerable populations, including youth and young adults, as well as
Black smokers, who have the highest prevalence of menthol cigarette
smoking and experience a disproportionate burden of the related harms.
    This proposed product standard is also expected to substantially
decrease tobacco-related health disparities and to advance health
equity across population groups. Tobacco-related health disparities are
the differences observed in population groups regarding: The patterns
(e.g., initiation, dual or polyuse, cessation), prevention, and
treatment of tobacco use; the risk, incidence, morbidity, mortality,
and burden of tobacco-related illness; and in capacity and
infrastructure (e.g., political systems, educational institutions),
access to resources (e.g., health services and programs), and
environmental secondhand smoke exposure (Refs. 47-49). Tobacco-related
health disparities affect those who have systematically experienced
greater obstacles to health based on group membership due to the
inequitable distribution of social, political, economic, and
environmental resources (Refs. 50, 49, and 51). Health equity is the
attainment of the highest level of health for all people (Ref. 51). It
is achieved by equally valuing all individuals regardless of group
membership; removing social, economic, and institutional obstacles to
health; and addressing historical and contemporary injustices (Refs.
51-53). The advancement of health equity is integral to the reduction
and elimination of tobacco-related health disparities, which result
from denied opportunity and access to economic, political, and social
participation (Refs. 49 and 54).
    Despite significant declines in cigarette smoking since 1964,
``very large disparities in tobacco use remain across groups defined by
race, ethnicity, educational level, and socioeconomic status and across
regions of the country'' (Ref. 1). Menthol cigarettes contribute to
these disparities in cigarette use (Refs. 55-56, 21-24, 57-59) and the
resulting disparities in health outcomes (Refs. 60-63, 50, 49). Members
of underserved communities,\5\ such as African American and other
racial and ethnic populations, individuals who identify as LGBTQ+,
pregnant persons, those with lower household income or educational
attainment, and individuals with behavioral health disorders are more
likely to report smoking menthol cigarettes than other population
groups (Refs. 64-67, 55, 57-59, 68-69, 44, 70-71). Due to this
increased prevalence of menthol cigarette smoking, members of
underserved communities bear a disproportionate burden of tobacco-
related morbidity and mortality (see section V.C of this document).
This proposed product standard is anticipated to promote better public
health outcomes across population groups.
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    \5\ As defined by Executive Order (E.O.) 13985, ``Advancing
Racial Equity and Support for Underserved Communities Through the
Federal Government,'' (86 FR 7009, January 25, 2021) the term
``underserved communities'' refers to populations sharing a
particular characteristic, as well as geographic communities, that
have been systematically denied a full opportunity to participate in
aspects of economic, social, and civic life. In the context of
tobacco products and tobacco-related health disparities, such
communities may include populations disproportionately impacted by
marketing and promotion targeted on the basis of such shared
characteristics.
---------------------------------------------------------------------------

B. Relevant Regulatory History of Menthol Cigarettes

    In its implementation of the Tobacco Control Act over the past
several years, FDA has engaged in close study and careful consideration
of the scientific evidence and complex policy issues related to menthol
cigarettes. FDA has conducted multiple scientific reviews related to
menthol cigarettes, issued two ANPRMs to solicit data and information
about menthol cigarettes, considered a citizen petition requesting that
FDA ban menthol as a characterizing flavor in cigarettes, and sponsored
research on a variety of menthol-related topics through contracts and
interagency agreements with Federal partners, including the National
Institutes of Health (NIH).\6\ Among other things, FDA has considered
the comments and information received in response to the scientific
reviews, ANPRMs, and citizen petition in developing this proposed rule.
---------------------------------------------------------------------------

    \6\ Information on specific projects supported by FDA is
available at https://www.fda.gov/tobacco-products/tobacco-science-research/research (search ``menthol'' or ``flavors'').
---------------------------------------------------------------------------

1. Scientific Reviews
    In March 2010, FDA's Tobacco Product Scientific Advisory Committee
(TPSAC) undertook a review of the available evidence concerning menthol
cigarettes and solicited and received input from many public
commenters, including researchers, tobacco industry representatives,
consultants to the tobacco industry, and public health experts. As
required by section 907(e) of the FD&C Act, on March 23, 2011, TPSAC
submitted its report and recommendation to the Secretary of HHS on the
impact of the use of menthol in cigarettes on the public health,
including use among children, African Americans, Hispanics, and other
racial and ethnic populations (Ref. 72).7 8 In addition, the
nonvoting

industry representatives of TPSAC submitted a separate document
reflecting the tobacco industry perspective (Ref. 73).
---------------------------------------------------------------------------

    \7\ Based on evidence available at that time, TPSAC concluded
that removing menthol cigarettes from the market would benefit the
public health and noted that the statute provides a ``variety of
mechanisms for FDA to consider, if it concludes that it should
pursue this recommendation,'' but it offered ``no specific
suggestions for FDA to follow-up'' on its recommendations (Ref. 72
at 225). TPSAC also noted that, although the FD&C Act requires FDA
to consider information submitted on potential countervailing
effects of any proposed product standard, such as the creation of a
black market, the advisory committee was not ``constituted to carry
out analyses of the potential for and impact of a black market for
menthol cigarettes'' and did not analyze that issue (Ref. 72).
Therefore, ``FDA would need to assess the potential for contraband
menthol cigarettes as required by the [FD&C] Act.'' (Ref. 72).
    \8\ Two tobacco companies challenged the TPSAC menthol report in
court, alleging that certain TPSAC members had conflicts of interest
that led them to shape the recommendations in a manner that injured
the tobacco companies. In 2014, the U.S. District Court for the
District of Columbia held that TPSAC members were improperly
appointed. Lorillard, Inc. v. FDA, 56 F. Supp. 3d 37 (D.D.C. 2014).
The court ordered FDA to reconstitute TPSAC and enjoined FDA from
using the TPSAC menthol report. Id. at 57. This holding was vacated
by the U.S. Court of Appeals for the D.C. Circuit on the ground that
the tobacco companies failed to show any imminent injury from the
report. R.J. Reynolds Tobacco Co. v. FDA, 810 F.3d 827, 832 (D.C.
Cir. 2016).
    Because of the pendency of this lawsuit at the time FDA began to
develop the Preliminary Evaluation discussed below, FDA did not rely
on the findings in the TPSAC menthol report in conducting its
independent review of the scientific evidence related to menthol.
Similarly, in connection with developing this proposed rule, FDA has
reviewed the TPSAC menthol report, as well as the industry
perspective document submitted by the non-voting industry
representatives on TPSAC, but did not rely directly on any findings
or recommendations in the TPSAC menthol report. Although the
conclusions reached in the TPSAC menthol report are generally
consistent with the determinations reached by FDA in support of this
proposed rule, FDA conducted an independent analysis of the
scientific evidence, including evidence that has developed since the
report issued more than 10 years ago. FDA also notes that it has
reviewed but did not rely on an additional analysis that builds on
modeling prepared in connection with the TPSAC menthol report. That
evidence is discussed in the Evaluation of Potential Impacts.
---------------------------------------------------------------------------

    Shortly thereafter, independent of TPSAC's work and report,
including the nonvoting industry representatives' report, experts
within FDA's Center for Tobacco Products (CTP) conducted an evaluation
of the available science related to the impact of the use of menthol in
cigarettes on public health. This evaluation is titled ``Preliminary
Scientific Evaluation of the Possible Public Health Effects of Menthol
Versus Nonmenthol Cigarettes'' (Preliminary Evaluation) and has been
peer reviewed (Ref. 74). FDA evaluated peer-reviewed literature,
tobacco industry submissions and other materials provided to TPSAC,
secondary data analyses, and CTP's own analyses of relevant large data
sets (Ref. 74). The Preliminary Evaluation concluded that menthol in
cigarettes is likely associated with increased smoking initiation and
progression to regular smoking, increased dependence, and reduced
cessation success, particularly among African American smokers (Ref.
74).
    As the body of evidence has continued to grow, FDA recently
undertook an updated robust review of the science on menthol in
cigarettes. This review, titled ``Scientific Review of the Effects of
Menthol in Cigarettes on Tobacco Addiction: 1980-2021'' (Ref. 75)
(Addiction Review), covers the peer-reviewed, publicly available
literature spanning the period from 1980 to April 30, 2021, and focuses
on the impact of menthol cigarettes on outcomes related to addiction,
including progression to regular use, dependence, and cessation. The
Addiction Review has been peer reviewed by independent external
experts. Taking into consideration comments from this peer review (Ref.
76), FDA revised the Addiction Review, and the final peer-reviewed
document is available in the docket for this proposed rule (Ref. 75).
    FDA's process for this scientific evaluation is described in detail
in the Addiction Review (see Ref. 75). In sum, FDA used several
scientific publication databases to retrieve articles published between
1980 and April 30, 2021, and developed a screening process, including
eligibility criteria, to identify articles for inclusion in the final
review (Ref. 75). FDA scored the individual quality of each study using
the ``QualSyst'' systematic review tool (Ref. 75). For the weight of
evidence approach, FDA adapted and used the Navigation Guide Systematic
Review Methodology (NavGuide), an integrated Cochrane-style risk of
bias analysis and weight of evidence approach (Ref. 75). The NavGuide
approach was selected due to the rigor of its systematic review methods
(e.g., specifying explicit study questions, conducting a comprehensive
search, rating the quality and strength of the evidence according to
consistent criteria). The approach also allowed for combining the
results of clinical and nonclinical evidence into a single conclusion
about the effects of menthol on the outcomes of interest (Ref. 75).
This weight of the evidence approach allowed FDA to assess the quality
of the available evidence and determine the role of menthol in
cigarettes on the sensory effects of smoking, as well as the impact of
menthol in cigarettes on the progression to regular use, dependence,
and cessation.
    The Addiction Review found the totality of evidence from 1980 to
2021 supports that: (1) The sensory effects of menthol are associated
with positive subjective smoking experiences, such as those that mask
and reduce the harshness of cigarette smoking; these effects facilitate
continued smoking, (2) menthol is associated with progression to
regular cigarette smoking in youth and young adults, (3) menthol in
cigarettes is associated with greater dependence among youth, (4)
menthol is likely associated with reduced cessation success among the
general population, and (5) menthol in cigarettes is associated with
reduced cessation success among African American cigarette smokers
(Ref. 75). FDA has considered the Addiction Review conclusions based on
weighted scientific evidence in the development of this proposed
product standard.
    In addition, FDA undertook a review of scientific evidence related
to the potential impacts of a menthol product standard. This review,
titled ``Review of Studies Assessing the Potential Impact of
Prohibiting Menthol as a Characterizing Flavor in Cigarettes'' (Ref.
77) (Evaluation of Potential Impacts), is comprised of three distinct
evaluations. Section 1 describes the results of a reproducible,
transparent, and documented review of the scientific evaluation
literature regarding the tobacco use behaviors of young people, tobacco
use behaviors of adults, sales of tobacco products, illicit sales of
tobacco products, and user modification of tobacco products (Ref. 77).
Section 2 describes the scientific evidence relevant to consumers'
product choices and intended use behaviors in response to a
hypothetical menthol cigarette ban (Ref. 77). And section 3 summarizes
and evaluates modeling studies that quantify the effects of a menthol
cigarette ban to inform an assessment of the potential behavioral
responses to a menthol product standard (Ref. 77).
    The Evaluation of Potential Impacts has been peer reviewed by
independent external experts. Taking into consideration comments from
this peer review (Ref. 76), FDA revised the Evaluation of Potential
Impacts, and the final peer-reviewed document is available in the
docket for this proposed rule (Ref. 77). As with the Addiction Review,
FDA has considered this scientific review in the development of this
proposed product standard.
2. ANPRMs
    In July 2013, FDA issued an ANPRM to obtain information related to
the potential regulation of menthol in cigarettes, including any data,
research, or other information that may inform regulatory actions FDA
might take with respect to menthol in cigarettes (78 FR 44484, July 24,
2013) (Menthol ANPRM). FDA sought data and information on a number of
complex questions, including whether FDA should consider establishing a
tobacco product standard for menthol in menthol cigarettes; if so, what
level of menthol would be appropriate for the protection of public
health; whether FDA should address menthol in other tobacco products;
whether alternatives and substitutes might appear on the market and how
those substances might be regulated; whether and how restrictions on
advertising and promotion of menthol cigarettes would influence
consumer behavior; and whether there was evidence that illicit trade in
menthol cigarettes would become a significant problem if menthol

cigarettes were banned (78 FR 44484 at 44485). The Menthol ANPRM also
requested comment on the Preliminary Evaluation and made available an
addendum with articles published since the evaluation was submitted for
peer review in 2011 (id.).
    In July 2017, FDA announced a comprehensive approach to tobacco and
nicotine regulation to protect youth and reduce tobacco-related disease
and death (Ref. 78). As part of the public dialogue on the
comprehensive approach, in March 2018, FDA issued three ANPRMs related
to the regulation of nicotine in combustible cigarettes (83 FR 11818,
March 16, 2018), 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 titled ``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. 79 at 2).
    The Flavors ANPRM requested data and information about the role
that flavors play in tobacco products (83 FR 12294). With regard to
menthol, FDA requested additional data or information about the role of
menthol in cigarettes, including the role menthol plays in: (1) Smoking
initiation, (2) the likelihood of smoking cessation in youth, young
adults, and adults, (3) the likelihood that menthol smokers would
switch to another tobacco product or start dual use with another
tobacco product, instead of quitting smoking, if a tobacco product
standard prohibited or limited menthol in cigarettes, and (4) the use
of tobacco products other than cigarettes (e.g., electronic nicotine
delivery systems (ENDS) and cigars) (83 FR 12294 at 12299).
3. Comments to the ANPRMs
    While the Menthol ANPRM and the Flavors ANPRM discussed two
different potential product standards and a range of product types,
both specifically requested public input on the role of menthol in
cigarettes. FDA received over 174,000 comments on the Menthol ANPRM,
with approximately 165,000 of those comments submitted as part of 41
different organized campaigns. FDA also received over 525,000 comments
on the Flavors ANPRM, a large proportion of which were form letters
related to 61 different organized campaigns. Some of the issues raised
in the comments to the ANPRMs are highlighted below.
    Comments generally in support of any proposed menthol product
standard stated that a product standard would protect the health of
smokers and non-smokers, provide current menthol cigarette smokers an
incentive to quit smoking, and protect youth, African Americans, and
other vulnerable populations from the dangers of menthol cigarettes.
FDA received many comments suggesting a specific, nonzero allowable
level of menthol in cigarettes; many comments suggested a prohibition
on menthol at any level and noted this would be the easiest standard to
enforce. Other comments, without specifying a specific level or amount,
argued that FDA should determine the nonzero allowable level of menthol
in cigarettes. Many others urged FDA to adopt a product standard
prohibiting menthol as a characterizing flavor in cigarettes without
specifying a specific level or amount. Many of the comments in favor of
prohibiting menthol as a characterizing flavor stated that FDA should
be responsible for determining the definition of ``characterizing
flavor'' to avoid reliance on industry practices or standards.
Regardless of the formulation of a product standard, many comments
stated that any menthol product standard is technically achievable and
noted the prior ban on other characterizing flavors (other than tobacco
and menthol) in cigarettes.
    Many comments stated that a product standard should apply to
menthol (natural or artificial) and any additive, constituent,
artificial or natural flavor, component, or insert which conveys
menthol or flavoring to cigarettes or cigarette smoke, including
through the tobacco or something other than the tobacco itself. These
commenters often noted that there are additives beyond natural and
synthetic menthol that can create a similar flavor and sensation in
cigarettes.
    FDA also received comments from individuals and members of the
tobacco industry generally opposing the establishment of any product
standard for menthol cigarettes. These comments generally stated there
was insufficient scientific evidence to support a menthol product
standard. Industry comments also argued menthol cigarettes do not
present a greater health risk when compared to non-menthol cigarettes,
arguing that menthol does not increase the risk of disease or increase
markers for dependence and addiction. Some comments opposed to a
menthol product standard stated it would not be appropriate for the
protection of the public health, as a standard would not lead to an
increase in cessation and would result in consumers adding menthol to
non-menthol cigarettes or the use of illicit or unregulated products.
    Many comments received from industry noted concern with how FDA
would define ``characterizing flavors,'' arguing that any such
definition must use clear and science-based criteria. Some comments
argued that, without a definition for ``characterizing flavors,'' it
could be difficult for industry to comply with a menthol product
standard. FDA also received comments from industry suggesting that any
standard apply only to known natural or synthetic menthol additives
currently used in the manufacture of cigarettes, stating that it was
not logical for a product standard to apply to unknown additives or
additives not currently in use.
    FDA has reviewed and closely considered the comments to the ANPRMs,
as well as additional evidence and information not available at the
time of the ANPRMs, in developing this proposed rule.
4. Citizen Petition
    On April 12, 2013, the Tobacco Control Legal Consortium (now known
as the Public Health Law Center) submitted a citizen petition on behalf
of themselves, several other public health organizations, and an
individual requesting that FDA ban menthol as a characterizing flavor
in cigarettes (Ref. 80). FDA issued an interim response in 2013,
stating that the Agency had not yet reached a decision on the petition
``because it raises significant, complex issues requiring extensive
review and analysis by Agency officials'' (Ref. 81).
    In 2020, the African American Tobacco Control Leadership Council
and several other public health organizations filed a lawsuit alleging
that FDA unreasonably delayed addressing menthol as a characterizing
flavor in cigarettes and responding to the citizen petition. Compl.,
African Am. Tobacco Control Leadership Council v. U.S. Dep't. of Health
& Human Servs., No. 20-cv-04012 (N.D. Cal. June 17, 2020), ECF No. 1.
Before any action by the court, FDA committed to responding to the
petition by a date certain. Subsequently, the U.S. District Court of
the Northern District of California held that section 907(a)(5) of the
FD&C Act ``does not necessarily require that FDA modify the [Special
Rule for Cigarettes], but a determination of whether the [Special Rule
for Cigarettes] should be modified is required by the statute.'' Order
Granting in Part and Denying in Part Motion To Dismiss, African Am.
Tobacco Control Leadership Council v. U.S. Dep't. of

Health & Human Servs., ECF No. 34 at 8 (emphasis in original).
    On January 14, 2021, the Petitioners submitted a citizen petition
supplement pursuant to 21 CFR 10.30(g) to update the administrative
record with research developed since 2013 on the impact of menthol in
cigarettes. The supplement identified and discussed evidence related to
the following topics: Menthol's impact on youth initiation, adult and
youth cessation, the impact on non-users of menthol cigarettes caused
by secondhand smoke exposure, thirdhand smoke exposure, tobacco waste
pollution, the disproportionate impact that menthol has had on several
populations (e.g., African Americans), evaluation data from several
jurisdictions that have implemented prohibitions on menthol, technical
achievability, and illicit trade (Ref. 82).
    On April 29, 2021, FDA issued its final response to the citizen
petition and included in its response a determination that the Special
Rule for Cigarettes should be changed to include menthol (Ref. 83). In
its response, FDA stated that it interpreted the petition ``as a
request that the Agency engage in the rulemaking process by proposing a
rule to prohibit menthol as a characterizing flavor in cigarettes.''
FDA granted the request, stating it intends to issue a proposed rule to
prohibit menthol as a characterizing flavor in cigarettes (Ref. 83).
FDA also stated that it intends to work with HHS to enlist and
collaborate with other entities at the Federal, Tribal, State, and
local levels who provide support to menthol smokers who quit or want to
quit as a result of a prohibition of menthol as a characterizing flavor
in cigarettes going into effect (Ref. 83). To reach this decision, the
Agency considered, among other things, the petition, the January 2021
supplement filed by the Petitioners that updated the administrative
record with research developed since 2013 on the impact of menthol
cigarettes, and the comments submitted to the petition docket (Ref.
83).

C. Legal Authority

1. Product Standard Authority Generally
    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 to protect the public health, including reducing tobacco use
by youth (Pub. L. 111-31). 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, roll-your-own (RYO)
tobacco, and smokeless tobacco as well as any other tobacco product FDA
deemed by regulation.
    Among the tobacco product authorities provided to FDA is the
authority to revise or-adopt tobacco product standards where FDA
determines that such standard is appropriate for the protection of the
public health (section 907(a)(2) and (3) of the FD&C Act). This
includes a tobacco product standard to prohibit the use of menthol as a
characterizing flavor. 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:
     The risks and benefits to the population as a whole,
including users and nonusers of tobacco products, of the proposed
standard;
     The increased or decreased likelihood that existing users
of tobacco products will stop using such products; and
     The increased or decreased likelihood that those who do
not use tobacco products will start using such products.
2. Authority To Prohibit Menthol as a Characterizing Flavor in
Cigarettes
    The Tobacco Control Act established the Special Rule for Cigarettes
that prohibited cigarettes or any of its component parts from
containing, as a constituent (including smoke constituent) or additive,
an artificial or natural flavor or an herb or spice that is a
characterizing flavor of the tobacco product or tobacco smoke (section
907(a)(1)(A) of the FD&C Act). This rule exempted menthol from the
prohibition but stated that ``nothing in this subparagraph shall be
construed to limit the Secretary's authority to take action under this
section or other sections of this Act applicable to menthol'' (id.).
Further, section 907(a)(2) states that FDA ``may revise'' the Special
Rule in accordance with the rulemaking provisions outlined in section
907 of the FD&C Act.
    Section 907 of the FD&C Act authorizes FDA to issue tobacco product
standards that are appropriate for the protection of the public health,
including provisions that would require the reduction or elimination of
a constituent (including a smoke constituent), or harmful component of
tobacco products and provisions respecting the construction,
components, ingredients, additives, constituents (including smoke
constituents), and properties of the tobacco product (section
907(a)(3), (a)(4)(A)(ii), and (a)(4)(B)(i) of the FD&C Act). This
includes the authority to issue a new product standard prohibiting
characterizing flavors in tobacco products pursuant to section
907(a)(3) and (4) and to amend or revoke an existing product standard
pursuant to section 907(d)(4) of the FD&C Act. Section 907(a)(4)(B)(v)
also authorizes FDA to include in a product standard a provision
restricting the sale and distribution of a tobacco product to the
extent that it may be restricted by a regulation under section 906(d)
of the FD&C Act. Similar to section 907(a)(4)(B)(v), 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. Section 701 of the FD&C Act (21 U.S.C. 371)
provides FDA with the authority to ``promulgate regulations for the
efficient enforcement of'' the FD&C Act.
    Pursuant to section 907(a)(2) and (3) and (c) of the FD&C Act, FDA
is proposing this tobacco product standard that would prohibit menthol
as a characterizing flavor in cigarettes, because it would reduce the
tobacco-related death and disease associated with menthol cigarette
use, and FDA has found the standard to be appropriate for the
protection of the public health consistent with section 907(a)(3),
(a)(4)(A)(ii), and (a)(4)(B)(i). In addition, this proposed rule would
prohibit the distribution, sale, and offer for distribution or sale of
cigarettes with menthol as a characterizing flavor. This sale and
distribution restriction would also assist FDA in enforcing the
standard and would ensure that manufacturers, distributors, and
retailers are selling product that complies with the standard. For
these reasons, the Agency has found such restriction to be appropriate
for the protection of the public health consistent with sections
907(a)(4)(B)(v) and 906(d) of the FD&C Act. FDA's analysis showing that
the proposed tobacco product standard is appropriate for the protection
of the public health is discussed in section V of this document.

D. FDA's Consideration of Health Equity

    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 now recognize the advancement of
health equity as ``both a moral imperative and pragmatic policy,'' as
E.O. 13995 states.
    Considerations related to health equity helped inform FDA's
decision to

prioritize this proposed product standard. In particular, FDA took into
account the disproportionate toll menthol cigarettes have taken on
certain population subgroups. We note that the expected health benefits
of this proposed standard are expected to be greater in these subgroups
than in the population more generally.
    This proposed product standard easily clears the threshold of being
appropriate for the protection of the public health, due to the large
health benefits from the expected reduced initiation and increased
cessation when looking at the population generally. We make this
finding even without taking into account the specific expected greater
health benefits from this product standard among certain population
subgroups.

IV. Menthol Cigarette Use Is Common, Addictive, and Harmful

A. Background

    Menthol is a flavor additive widely used in consumer and medicinal
products, including cigarettes (Refs. 1 at 782, 84). It is a compound
that can be derived from plants or synthetically produced and has a
minty taste and cooling properties (Refs. 84 and 2). Menthol is added
to cigarettes in a variety of ways (e.g., sprayed on the cut tobacco
during blending; placed in a capsule in the filter) and eventually
diffuses throughout the cigarette (Refs. 84-86). Menthol may be present
in cigarettes not labeled as menthol cigarettes (Refs. 87, 84-85, 88-
89).
    The first menthol cigarette was marketed in the late 1920s, and the
menthol share of the cigarette market has continued to increase since
then (Refs. 90-92). Federal Trade Commission (FTC) data on market share
of the largest cigarette manufacturers indicate that the menthol
cigarette market increased from 16 percent in 1963 to 29 percent in
1979 (Ref. 92). From 1980 to 2009, it remained relatively constant
ranging from 25 to 29 percent (Ref. 92) and, from 2010 to 2019, it
increased from 31 to 37 percent (Ref. 92). Market trend research
evaluating mass retail and convenience store cigarette sales indicates
that, from 2011-2015, 31.5 percent of the cigarette market was menthol
(Ref. 93). Estimates of cigarette consumption from 2000 to 2018 in the
United States show an overall decline of 46 percent in cigarette
consumption (435.6 to 235.6 billion), but the decline was greater among
non-menthol (52.9 percent; 322.8 billion to 152.0 billion cigarettes)
than menthol cigarettes (26.1 percent; 112.8 billion to 83.3 billion
cigarettes) (Ref. 94).

B. Menthol Smoking Is Widespread and Disproportionately Impacts Youth,
Young Adults, and Other Vulnerable Populations in the United States

    In 2019, there were more than 18.5 million current smokers of
menthol cigarettes ages 12 and older in the United States (Ref. 44).
Although menthol cigarette smoking is widespread in the United States,
menthol cigarettes are used at a particularly high rate among youth,
young adults, and other vulnerable populations such as African
Americans and other racial and ethnic groups (Ref. 44).
    In 2019, researchers estimated that approximately 1.15 million U.S.
middle and high school students had smoked a cigarette in the prior
month based on data from the NYTS, a nationally representative survey
(Ref. 95). Of these youth smokers, 46.7 percent reported smoking a
menthol cigarette in the prior month, representing an estimated 530,000
youths (Ref. 95). Additionally, data from the 2019 NSDUH estimates that
nearly 5.7 million U.S. young adults aged 18-25 years were current
smokers, of which 51 percent (2.96 million young adults) smoked menthol
cigarettes (Refs. 96 and 44). Using the same 2019 NSDUH data, an
additional 39.4 million older adults (aged 26 and older) were current
cigarette smokers, of which, 39 percent were current menthol smokers
(15.4 million older adults) (Refs. 96 and 44).
    The disproportionate use of menthol cigarettes by youth and young
adult smokers compared to older adults has been consistent over time
and across multiple studies with nationally representative populations.
A study that examined changes in menthol smoking prevalence among
cigarette smokers using NSDUH data from 2004 to 2014 found that the
prevalence of past-month menthol smoking between 2008-2010 and 2012-
2014 was highest among youth smokers aged 12-17 years (52.5 percent to
53.9 percent), followed by young adult smokers aged 18-25 years (43.6
percent to 50 percent), adult smokers aged 26-34 (34.6 percent to 43.9
percent), adult smokers aged 35-49 (30.3 percent to 32.3 percent), and
adult smokers aged 50 and older (30.6 percent to 32.9 percent) (Ref.
57). In 2019 NSDUH data, past-month menthol use among cigarette smokers
was highest among young adults aged 18-25 years (51 percent), followed
by youth aged 12-17 years (48.6 percent) and older adults aged 26 and
older (39 percent) (Ref. 44). Results from a study of Wave 2 data from
the PATH Study (2014-2015) support these data and indicate age-related
differences in past-month menthol cigarette smoking, with a higher
proportion of youth aged 12-17 years (46.6 percent) and young adult
aged 18-24 years (50 percent) cigarette smokers being menthol smokers
compared to older adults aged 25 and older (34.4 percent) (Ref. 97).
While data on trends of cigarette smoking from NYTS show a decline in
overall cigarette smoking and in menthol cigarette smoking among middle
and high school student smokers from 2011 to 2018, nearly half reported
smoking menthol cigarettes in 2018 (Ref. 56).
    African American smokers, regardless of age, are disproportionately
more likely to smoke menthol cigarettes than smokers of any other race
(Refs. 55-56, 21-24, 57-59, 44), and are also more likely than other
racial and ethnic groups to try a menthol cigarette as their first
cigarette, regardless of age (Refs. 33, 25, and 31).
    Findings from 2018 NYTS data show that, among middle and high
school students who were current cigarette smokers, 51.4 percent of
non-Hispanic Black youth and 50.6 percent of Hispanic youth reported
smoking menthol cigarettes, compared to 42.8 percent of non-Hispanic
White youth (Ref. 56). Statistically significant differences in this
proportion by race and ethnicity have been observed in the NYTS over
the 2011-2018 period. While declines in menthol cigarette use from
2011-2018 have been observed among non-Hispanic White youth, declines
were not observed among non-Hispanic Black youth or Hispanic youth
(Ref. 56). Similarly, among all adults, data from the National Health
Interview Survey (NHIS) indicate that cigarette smoking decreased from
20.9 percent in 2005 to 15.1 percent in 2015 (Ref. 70). While there was
a significant decrease in the prevalence of menthol cigarette smoking
overall (5.3 percent in 2005 to 4.4 percent in 2015), the prevalence of
menthol cigarette smoking did not decrease among male smokers, adult
smokers aged 25-34, adult smokers aged 55 and older, non-Hispanic Asian
smokers, Hispanic smokers, or smokers who had less than a high school
education (Ref. 70). Additionally, this study highlights that while the
prevalence of all cigarette smoking and menthol smoking, specifically,
have decreased over time (2005-2015), the prevalence of menthol smoking
in 2015 remained highest among specific groups, such as non-Hispanic
Blacks (11.9 percent) (Ref. 70).
    A systematic literature review of menthol smoking by gender found
that female smokers are more likely to smoke menthol cigarettes
compared to men

(Ref. 98). Additionally, in another study of trends in menthol smoking
from 2004 to 2014, the NSDUH data showed that women are significantly
more likely to smoke menthol cigarettes than men (Ref. 57). This is
consistent with data from the 2019 NSDUH, which indicated that a higher
proportion and number of female cigarette smokers smoked menthol (44.8
percent; 9.49 million) than male cigarette smokers (37.1 percent; 9.10
million) (Ref. 44). High levels of menthol cigarette smoking have also
been reported in pregnant smokers. An analysis of 2006 to 2015
participant data from two racially and ethnically diverse cohorts of
pregnant smokers with lower educational attainment and lower household
income indicated high prevalence of menthol use in both cohorts (85
percent and 87 percent) (Ref. 71).
    Study findings indicate that individuals who identify as lesbian,
gay, or bisexual are more likely to report smoking menthol cigarettes
compared to those who identify as heterosexual, as well as other
disparities related to gender identity or sexual
orientation.9 10 A study examining menthol use by LGBT
status found a higher prevalence and a higher likelihood of smoking
menthol cigarettes among LGBT smokers compared to heterosexual smokers,
and that these differences in use were even greater among LGBT female
respondents compared to heterosexual women (Ref. 69). In national data
from the 2019 NSDUH, only 6.9 percent of those identifying as straight
or heterosexual reported smoking menthol (15.95 million) compared to 14
percent of those identifying as lesbian, gay, or bisexual (2.04
million) (Ref. 44). An analysis of pooled data from the 2015-2019 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. 99). Additionally, compared to heterosexual/straight respondents,
gay males, and bisexual males, findings indicated that lesbian/gay
females and bisexual females had higher menthol preference (defined as
past 30-day use of menthol cigarettes among those who smoked cigarettes
in the past 30-days) (Ref. 99).
---------------------------------------------------------------------------

    \9\ Throughout the preamble of this proposed rule, FDA uses the
terminology cited in the scientific studies.
    \10\ The relevant scientific studies cited herein do not provide
data separated by sexual orientation and gender identity. Due to
these study limitations, we discuss sexual orientation and gender
identity in a combined manner, despite their important distinctions.
---------------------------------------------------------------------------

    Study findings show social gradient effects (where higher levels of
indicators such as household income are linked to better health
outcomes and lower levels are linked to poorer health outcomes) for
menthol cigarette use (Refs. 44, 57, and 59). In 2019 NSDUH data, the
prevalence of menthol smoking was 13.5 percent among those with a total
family income less than $20,000, 8.4 percent between $20,000 and
$49,999, 6 percent between $50,000 and $74,999, and 3.6 percent above
$75,000 (Ref. 44). In another study of 2012-2014 NSDUH data, among past
30-day smokers, 43.7 percent of smokers with household income less than
$30,000 smoked menthol cigarettes compared to 32.1 percent of smokers
with household incomes greater than $75,000 (Ref. 57). Additionally, a
study using 2018 NSDUH data found that menthol preference among
cigarette smokers was 46.8 percent among those living in poverty,\11\
42.3 percent among those with income up to two times above the Federal
Poverty Threshold, and 35.8 percent among those with income more than
two times above the Federal Poverty Threshold (Ref. 59).
---------------------------------------------------------------------------

    \11\ ``Living in poverty'' was determined and recoded in the
NSDUH public use file based on a person's family income relative to
poverty thresholds. The full definition of this variable can be
found in the 2019 NSDUH codebook at: https://www.datafiles.samhsa.gov/sites/default/files/field-uploads-protected/studies/NSDUH-2019/NSDUH-2019-datasets/NSDUH-2019-DS0001/NSDUH-2019-DS0001-info/NSDUH-2019-DS0001-info-codebook.pdf. The U.S.
Census Bureau assigns a poverty threshold for each combination of
family size and number of children in the household. To be at 100
percent of the poverty threshold is equivalent to having a family
income that is the same as the poverty threshold. A poverty level
less than 100 percent indicates having a family income less than the
poverty threshold and therefore defined by the Federal Government as
living in poverty. A poverty level greater than 100 percent
indicates having a family income greater than the poverty threshold.
---------------------------------------------------------------------------

    Menthol cigarette use is also higher among adults with behavioral
health conditions or illness (Refs. 44, 100, 68, 59, 101). In 2019
NSDUH data, 17.4 percent of adults age 18 and older who reported past-
month serious psychological stress reported past-month menthol smoking
compared to only 6.6 percent of those who did not report past month
serious psychological distress (Ref. 44). An analysis of young adults
(aged 18-30 years) with a serious mental illness who were receiving
treatment for smoking cessation, more than half (58 percent) smoked
menthol cigarettes (Ref. 101). In national data, a study utilizing
2008/2009 NSDUH data also found that cigarette smokers with mental
health symptoms were significantly more likely to smoke menthol
cigarettes than smokers who report mild or no mental health symptoms
(Ref. 68). Another national study of women aged 18-34 years indicated
that menthol smokers had higher odds of reporting anxiety or depression
compared to non-menthol smokers (Ref. 100). Lastly, an analysis of
young adults (aged 18-30 years) receiving treatment for smoking
cessation also found that of those with severe mental illness, more
than half (58 percent) smoked menthol cigarettes (Ref. 101).

C. Menthol in Cigarettes Increases Smoking Initiation, Increases
Progression to Regular Use, and Contributes to Nicotine Dependence

1. Menthol's Flavor and Sensory Properties Make Cigarette Smoking
Easier and the Initial Response to Cigarettes More Palatable
    Menthol is a flavor compound that is added to cigarettes, which
produces a minty taste and cooling sensation when inhaled (Ref. 2). As
a result of its sensory properties, menthol can reduce irritation
(Refs. 102 and 103), reduce coughing (Refs. 104 and 105), and relieve
pain (Ref. 106). For this reason, compared to non-menthol cigarettes,
menthol smokers perceive menthol cigarettes as easier to smoke, less
irritating, smoother and more refreshing, and having a better taste
(Refs. 4-5, 107-108). Such flavor and sensory effects of menthol reduce
the harshness of cigarette smoking among new users, facilitating
experimentation and regular use, particularly among younger smokers
(Refs. 6, 7, and 5).
    An individual initiates smoking upon first trying a cigarette, even
if they take just one or two puffs (Ref. 32). The vast majority of
smoking initiation occurs during adolescence (Ref. 32). Initiation can
progress to repeated experimentation, where individuals continue to
occasionally try cigarettes, but do not smoke every day, and then to
smoking regularly (Ref. 32). When an individual first tries a menthol
cigarette, the flavor and sensory effects of menthol make initial
smoking experiences more palatable. This makes it easier for new users,
particularly youth and young adults, to continue experimenting with
smoking and progress to regular use. The 2019 NSDUH found that each
day, approximately 1,500 youth (under the age of 18 years) and 2,600
young adults (aged 18-25 years) first smoke a cigarette (Ref. 96).
Results from Waves 1-4 of the PATH Study (2013-2017) and the Truth
Initiative Young Adult Cohort Study show that youth (aged 12-17

years) and young adults (aged 18-24 years) are more likely to try a
menthol cigarette as their first cigarette than a non-menthol cigarette
(Refs. 8, 31, and 33). A separate cross-sectional analysis of Wave 1
PATH Study data (2013-2014) also found that among ever cigarette
smokers (i.e., those who reported ever trying a cigarette, even one or
two puffs), nearly 43 percent of youth (aged 12-17 years) and 45
percent of young adults (aged 18-24 years) reported that the first
cigarette they smoked was mentholated, compared to 30 percent of adults
(aged 25 years and older) (Ref. 109).
    Consistent with the evidence that menthol makes cigarettes easier
to use and reinforces tobacco use among new users, results from Wave 2
of the PATH Study (2014-2015) indicate that youth (aged 12-17 years)
and young adults (aged 18-24 years) who initiate smoking with menthol
cigarettes are more likely to report having a pleasant first smoking
experience compared to smokers who initiate with non-menthol cigarettes
(Ref. 110). Smokers in the study who reported a pleasant first smoking
experience were more likely to smoke regularly (Ref. 110). In another
study, young adult smokers (aged 18-24 years) reported that the taste
of menthol (e.g., ``minty'', ``cool'', ``refreshing'') made cigarettes
``less harsh'' and ``easier to inhale'' than non-menthol cigarettes,
and these factors influenced their initial preference for menthol
cigarettes (Ref. 5). A study evaluating the sensory experiences of
first cigarette use among young adult and adult smokers (aged 18-34
years) also found that fewer menthol smokers reported experiencing
nausea during their first smoking experience compared to non-menthol
smokers (Ref. 33). Regular menthol smokers also cite the flavor and
sensory factors as primary reasons for continuing to smoke menthol
cigarettes (Refs. 4, 5, and 111).
    Evidence from tobacco industry documents indicates that the
industry has been adding menthol to cigarettes because of perceptions
among new users that menthol cigarettes are less harsh and easier to
smoke (Ref. 7). These documents indicate that menthol has traditionally
been added to cigarettes as a design feature to attract new youth and
young adult smokers (Refs. 7 and 6). For example, a 1987 document from
one company states: ``Menthol brands have been said to be good starter
products because new smokers appear to know that menthol covers up some
of the tobacco taste and they already know what menthol tastes like,
vis-[agrave]-vis candy'' (Ref. 112). Additionally, a 1978 document
about a traditionally menthol-only cigarette brand states that the
brand is ``being purchased by Black people (all ages), young adults
(usually college age), but the base of our business is the high school
student'' (Ref. 113). Menthol cigarettes continue to be used
disproportionately by youth and new smokers (Ref. 44).
    These findings support that menthol's flavor and sensory effects
make cigarettes easier to smoke by masking the harshness and irritation
of tobacco and reducing unpleasant smoking experiences that can deter
new users from repeated experimentation.
2. Menthol Enhances Nicotine Addiction in the Brain
    Menthol enhances the effects of nicotine in the brain by affecting
mechanisms involved in nicotine addiction. Nicotine is the primary
chemical in tobacco products that causes addiction through its
psychoactive and reinforcing effects (Ref. 114). Nicotine addiction
occurs as the result of repeated exposure to nicotine, which induces
changes in the brain (Refs. 115, 9, and 116). 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. 9 and 1).
    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. 115 and 9). Dopamine plays a
major role in the pleasurable and reinforcing effects of smoking that
promote continued use (Refs. 115 and 9). After repeated exposure to
nicotine, nicotinic receptors become less responsive, prompting an
increase in the number of brain nicotinic receptors; this process has
been implicated in the development of nicotine addiction (Ref. 9).
    A clinical study that analyzed brain images of adult non-smokers,
menthol smokers, and non-menthol smokers found that menthol cigarette
smokers have higher levels of brain nicotinic receptors than non-
menthol smokers (Ref. 14). Studies in rodents have been used to provide
insight into a mechanism for how menthol produces this effect in the
brains of smokers. The nicotinic receptor composition, distribution,
and function in the rodent brain is comparable to that of humans, and
rodents can be trained to perform a variety of behavioral tasks (Refs.
117-119). Therefore, rodents serve as an appropriate model to examine
the behavioral effects of nicotine and the effects of nicotine in the
brain.
    Studies demonstrate that menthol, like nicotine, binds to nicotinic
receptors in the brain (Refs. 15 and 16), and menthol alone can
increase the number of nicotinic receptors in the brain (Refs. 10 and
11). Consistent with clinical findings in menthol smokers (Ref. 14),
animal studies also demonstrate that menthol in combination with
nicotine increases the number of nicotinic receptors in the brain to a
greater extent than nicotine alone (Refs. 10-12). This effect in the
brain was accompanied by greater intensity of nicotine withdrawal signs
in rodents treated with nicotine and menthol compared to those treated
with nicotine alone (Ref. 10). Menthol also enhances nicotine's effects
on dopamine in the rodent brain. Animal studies demonstrate that
nicotine-induced dopamine release is greater in the presence of menthol
(Ref. 13). Additionally, menthol enhances nicotine-induced increases in
dopamine cell activity to a greater extent than nicotine alone; these
changes were associated with differences in behavioral responses to the
rewarding effects of nicotine, where menthol-treated rodents exhibited
greater reward for nicotine than those treated with nicotine alone
(Ref. 12). These findings demonstrate that menthol's effects on
nicotine in the brain are associated with behaviors indicative of
greater addiction to nicotine.
    In combination with menthol's flavor and sensory effects, menthol's
interaction with nicotine in the brain plays a role in making it easier
to experiment, progress to regular smoking and dependence, and harder
to quit smoking.
3. The Adolescent Brain Is Particularly Vulnerable to the Effects of
Nicotine
    Youth and young adults are particularly susceptible to becoming
addicted to nicotine. Due to its ongoing development, the adolescent
brain, which continues to develop until about age 25, is more
vulnerable to nicotine's effects than the adult brain (Refs. 17-19).
The 1994, 2012, 2014, and 2020 Surgeon General's Reports on smoking and
health note that almost 90 percent of current adult regular smokers
initiated smoking before age 18, and 99 percent initiated smoking
before the age of 25, which is the approximate age at which the brain
has completed development (Refs. 120, 32, 1, 245). Though age ranges
for youth and young adults vary across studies, in general, ``youth''
or ``adolescent'' encompasses

those 11-17 years of age, while those who are 18-25 years old are
considered ``young adults'' (even though, developmentally, the period
between 18-20 years of age is often labeled late adolescence); those 26
years of age or older are considered ``adults'' (Ref. 32).
    Studies in adolescent and adult rodents show that adolescents are
more sensitive to the rewarding and reinforcing effects of nicotine
than adults (Refs. 121-124). In particular, animal studies highlight
that early adolescence is a critical period for vulnerability to
nicotine addiction (Refs. 125-127). Studies have also found that
nicotine exposure during adolescence induces changes in the brain that
either do not occur in animals exposed to nicotine in adulthood or are
observed to a lesser extent following adult nicotine exposure. For
example, studies using adolescent and adult rodents show that nicotine
exposure during adolescence induces changes in gene expression, changes
in brain structure and activity, and greater, more widespread increases
in brain nicotinic receptor expression compared to exposure in
adulthood (Refs. 128-131). These effects of nicotine on the developing
brain largely occur in brain regions involved in addiction, learning,
and memory (Refs. 132-133, 129, 131). Rodent studies also support that
many of these changes remain after nicotine exposure has ended, and
persist into adulthood (Refs. 133, 132, 130, 17-18).
    Studies among youth support the findings from animal studies and
show that adolescence is a vulnerable period for nicotine addiction.
Youth who initiate tobacco use at earlier ages are more likely than
those initiating at older ages to report current daily smoking and
symptoms of tobacco dependence (Refs. 134-136). Researchers in a 4-year
study of sixth grade students 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 (Ref. 137). The
study also found that ``[e]ach of the nicotine withdrawal symptoms
appeared in some subjects prior to daily smoking'' (Ref. 137) (emphasis
added). Ten percent of youth showed signs of dependence to tobacco use
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.
137). Another study that followed 12-13 year old adolescents over 6
years found that 19.4 percent of adolescents who smoked weekly were
nicotine dependent (Ref. 138). In a study of nicotine dependence among
recent onset adolescent smokers (9th and 10th grade students),
individuals who smoked cigarettes only 1 to 3 days of the past 30 days
experienced nicotine dependence symptoms such as loss of control over
smoking and irritability after not smoking for a while (Ref. 139).
Overall, these findings demonstrate that, due to ongoing brain
development, youth and young adults who experiment with smoking are at
greater risk of becoming addicted to nicotine and maintaining tobacco
product use into adulthood (Refs. 17, 18, and 32). Therefore, due to
the combined effects of nicotine and menthol in the developing brain,
youth who smoke menthol cigarettes are particularly vulnerable to the
effects of menthol on progression to regular use and dependence.
4. Menthol Facilitates Experimentation and Progression to Regular
Cigarette Use Among Youth and Young Adults
    Consistent with the impact of menthol in cigarettes on smoking ease
and nicotine addiction, menthol cigarettes have been shown to
facilitate progression to regular use in new smokers, particularly in
youth and young adults. A longitudinal study that evaluated smoking
behaviors in middle and high school students over the course of 3 years
(2000-2003) found that youth who initiate smoking with menthol
cigarettes are more likely to progress to regular cigarette smoking
compared to youth who initiate smoking with non-menthol cigarettes
(Ref. 25). These findings are supported by nationally representative
data from the Evaluation of Public Education Campaign on Teen Tobacco
longitudinal national youth survey, which examined youth over 3 years
(2013-2016) (Ref. 30). Youth in the study who reported experimenting
with menthol cigarettes in a prior year were more likely to report
progressing to regular smoking than youth who smoked non-menthol
cigarettes (Ref. 30). Additionally, data from the 2011 National Young
Adult Health Survey (NYAHS) found that young adult (aged 18-34 years)
current menthol smokers had double the odds of reporting an increase in
cigarette smoking over the previous year compared to non-menthol
smokers (Ref. 29).
    Similarly, longitudinal data from Waves 1 and 2 of the PATH Study
(2013-2015) were used to evaluate the association of flavored tobacco
use with product initiation among youth (aged 12-17 years), young
adults (aged 18-24 years), and older adults (aged 25 and older) over a
10-13 month timeframe (Ref. 31). The study found that among all age
groups, those that first used a menthol cigarette were more likely to
report any past 12-month or past 30-day smoking at followup compared to
those who reported a non-menthol cigarette as the first cigarette
smoked (Ref. 31). Further, among those in all age groups, those whose
first cigarette was menthol were more likely to report smoking every
day in the past 30 days at followup compared to smokers who initiated
with non-menthol cigarettes (Ref. 31). Expanding on these findings,
longitudinal data across Waves 1-4 of PATH data (2013-2017) showed that
among young adults, those who smoked menthol as the first cigarette
were more likely to report continued smoking over the past 12 months
compared to smokers who initiated with non-menthol cigarettes (Ref. 8).
    Overall, the evidence supports that menthol facilitates repeated
experimentation and progression to regular smoking among youth and
young adults. This finding is consistent across different populations
and time periods, including in studies that assess large, nationally
representative populations.
5. Menthol Contributes to Nicotine Dependence in Young People
    Data from multiple studies across different populations and time
periods demonstrate that menthol cigarettes contribute to greater
nicotine dependence in youth (Refs. 20-28). One longitudinal study
evaluated middle and high school students over 3 years (2000-2003) in
83 schools in 7 communities across 5 states. Data from the study show
that youth who initiated smoking with menthol cigarettes scored higher
on a scale of dependence than youth who initiated with non-menthol
cigarettes (Ref. 25). Nationally representative data from the 2000 and
2002 NYTS found that youth who smoked menthol cigarettes on at least 1
day in the past month reported higher scores on a scale of nicotine
dependence compared to non-menthol smokers (Ref. 21). In addition,
studies using 2004 and 2006 NYTS data found that, compared to youth
non-menthol smokers, youth menthol smokers report multiple indicators
of nicotine dependence, including higher levels of craving for
cigarettes, needing a cigarette within one hour after smoking, and
increased feelings of restlessness and irritability without smoking
(Refs. 22 and 24). Pooled NYTS analyses (2017-2020) also indicate that
youth menthol smokers have greater odds of experiencing tobacco
cravings and using tobacco within 30 minutes of waking than non-menthol
smokers (Ref. 28). Similarly, results from Wave 2 PATH Study data
(2014-2015) show that youth menthol

smokers report higher levels of craving, tolerance to the effects of
nicotine, and affiliative attachment (feeling ``alone'' without
cigarettes), indicating that youth menthol smokers are more physically
dependent on nicotine and experience greater emotional attachment to
cigarettes than youth non-menthol smokers (Ref. 26).
    Studies also demonstrate that youth menthol smokers smoke more
frequently than non-menthol smokers, indicating an increased risk of
being more nicotine dependent than non-menthol smokers. Youth who smoke
more frequently display greater symptoms of nicotine dependence (Ref.
138). Compared to smokers of ``other brands'' (at the time of the study
``other brands'' may have included non-menthol flavored and unflavored
cigarettes), youth menthol smokers have reported greater levels of
smoking, including having smoked more total cigarettes, smoking on more
days and more cigarettes in a month, having smoked more recently, and
having ever smoked daily (Ref. 23). Nationally representative data also
indicate that higher proportions of youth menthol smokers report
smoking more frequently compared to non-menthol smokers (Refs. 56, 27,
and 28). In analyses of pooled 2016-2018 NYTS data, higher proportions
of youth menthol smokers reported smoking on more days during the
month, smoking more cigarettes per day, and smoking 100 or more
cigarettes in their lifetime compared to non-menthol smokers (Ref. 56).
These findings are supported by 2017-2020 NYTS data, which show that
youth menthol smokers have greater odds of smoking 10-30 days out of
the month compared to non-menthol smokers (Refs. 27 and 28).
Furthermore, 2017 and 2018 NYTS data indicate that, compared to youth
non-menthol smokers, youth menthol smokers are more likely to report
intentions to continue smoking cigarettes in the following year (Ref.
27).
    Some studies have not found a significant difference in dependence
outcomes between youth menthol and non-menthol smokers. One study,
using data from the Development and Assessment of Nicotine Dependence
in Youths study, examined the relationship between the first smoking
experience and the development of nicotine dependence symptoms in youth
and did not find a difference in dependence level between menthol and
non-menthol smokers (Ref. 140). A study that used PATH data to examine
the association between first use of menthol cigarettes and nicotine
dependence scores at a subsequent wave, also did not find a
relationship between menthol cigarette use and dependence among youth
(Ref. 8). Furthermore, a nationally representative study that evaluated
associations between menthol use and dependence among youth (aged 15-19
years) in the 2003 and 2006-2007 Tobacco Use Supplement to the Current
Population Survey (TUS-CPS) and youth (aged 12-19 years) in the 1999-
2010 National Health and Nutrition Examination Survey (NHANES) did not
find an association between menthol smoking and level of dependence
(Ref. 141).
    Studies that found no effect of menthol on dependence in youth
constitute a smaller number of studies in the totality of evidence. The
few studies (discussed in the previous paragraph) that did not find an
effect of menthol in cigarettes on greater dependence in youth were
either not nationally representative or had other limitations that
reduced the generalizability or influenced the validity of the
findings. These study limitations include small samples sizes, which
may reduce ability to detect significant between-group differences;
failure to report sample sizes for populations assessed; and survey
data that included participants beyond the typical age range for youth
studies (age 12-17 years), which reduces generalizability of the
findings to youth.
    Based on the number and strength of the studies that support the
conclusion that menthol is associated with greater dependence among
youth and the limitations of the evidence that did not find an effect
of menthol on youth dependence, the totality of evidence supports that
menthol in cigarettes contributes to greater dependence among youth.
This conclusion is supported by multiple nationally representative
studies that were designed to collect and evaluate survey data on
tobacco use in youth populations.

D. Menthol in Cigarettes Makes Quitting Smoking More Difficult

1. Menthol Contributes to Reduced Cessation Success, Particularly Among
Black Smokers
    A number of nationally representative studies among young adult and
adult smokers show that menthol in cigarettes contributes to reduced
cessation success (Refs. 34-35, 42, 36-38, 40, 43). A study from the
2003 and 2006-2007 TUS-CPS examined quit attempts and quit rates in
menthol and non-menthol smokers (Ref. 37). Overall, quit attempts were
8.8 percent higher among menthol smokers compared to non-menthol
smokers, but menthol smokers had 3.5 percent lower rates of quitting
within the past year and 6 percent lower rates of quitting within the
past 5 years compared to non-menthol smokers (Ref. 37). Young adults
(aged 18-24 years) who smoked menthol cigarettes made more quit
attempts than menthol smokers of older adult age groups (aged 25 and
older) and had higher rates of quitting for 3 months to 1 year than
non-menthol smokers; however, when evaluating longer term quitting
(i.e., within the past 5 years) young adult menthol smokers were less
likely to have successfully quit smoking than non-menthol smokers (Ref.
37). Taken together, these findings suggest that short-term quitting
does not translate to long-term success in quitting among young adult
menthol smokers. Other studies that used 2003 and 2006-2007 TUS-CPS
data examined the role of menthol in cessation and found that, compared
to non-menthol smokers, menthol smokers were less likely to have
successfully quit smoking for at least 6 months (Ref. 42) and were less
likely to report having quit smoking in the past 5 years (Ref. 36).
Data from the 2010-2011 TUS-CPS also found that menthol smokers were
less likely than non-menthol smokers to report having abstained from
smoking for 1-3 years (Ref. 38).
    Additionally, longitudinal studies demonstrate that menthol smokers
have more difficulty quitting compared to non-menthol smokers. One PATH
Study using data from Waves 1-4 (2013-2017) found that, after 12
months, quit rates were significantly lower among daily menthol smokers
(4 percent) compared to daily non-menthol smokers (5.3 percent) after
adjusting for age, sex, race and ethnicity, education, nicotine
dependence, and past quit attempts (Ref. 40). Daily menthol smokers
also had 24 percent lower odds of quitting smoking compared to non-
menthol smokers (Ref. 40). Another PATH Study using data from Waves 1-4
(2013-2017) evaluated short-term (30-day) and long-term (12-month)
smoking abstinence among menthol and non-menthol smokers who had
attempted to quit smoking in the past 12 months (Ref. 43). Menthol
smoking decreased the probability of 30-day smoking abstinence by 28
percent and the probability of 12 month smoking abstinence by 53
percent compared to smoking non-menthol cigarettes after adjusting for
race, sex, age and frequency of smoking (Ref. 43). The Coronary Artery
Risk Development in Young Adults (CARDIA) study, which evaluated
smoking cessation behavior in young adult smokers (age 18-30 years)

across 15 years (1985-2000), also found that menthol smokers were more
likely to report continued smoking at two consecutive followups and
were almost twice as likely to have relapsed compared to non-menthol
smokers (Ref. 142).
    Short- and long-term clinical longitudinal studies of cessation
also show that menthol smokers are less likely than non-menthol smokers
to achieve cessation success (Refs. 143-147). A short-term cessation
study found that menthol smokers were more likely than non-menthol
smokers to relapse within 48 hours of quitting smoking (Ref. 147). A
long-term cessation study evaluated the effectiveness of smoking
cessation therapies and tested smokers for cessation success at several
timepoints throughout the study (Ref. 146). Menthol smoking was
associated with reduced likelihood of successful quitting at the 4-
week, 8-week, and 26-week followup assessments (Ref. 146). These
findings are supported by data from studies of smokers interested in
quitting smoking, which show that menthol smokers are less likely to
achieve cessation success than non-menthol smokers at study followups
ranging from 3 weeks to 6 months (Refs. 148, 143-145).
    Evidence from nationally representative studies show that the
effect of menthol on reduced cessation success is particularly evident
among Black smokers (Refs. 34-38, 40). Data from the 2005 NHIS Cancer
Control Supplement were used to examine racial and ethnic differences
in menthol cigarette smoking and found that African American menthol
smokers had a significantly decreased likelihood of quitting smoking
compared to African American and White non-menthol smokers (Ref. 35).
Data from the 2005 and 2010 NHIS were also used to evaluate the
association between menthol cigarette smoking and likelihood of being a
former smoker (Ref. 38). Black menthol smokers were less likely than
Black non-menthol smokers to report not having smoked in the past year
(Ref. 38). Additional analyses of 2005 NHIS and 2003 and 2006-2007 TUS-
CPS data found that, compared to Black non-menthol smokers, Black
menthol smokers were less likely to report smoking ``not at all'' at
the time of the survey and less likely to report having quit smoking in
the past 5 years (Refs. 34 and 36).
    Longitudinal studies using Waves 1-4 PATH data (2013-2017) and data
from the CARDIA Study also demonstrate that African American menthol
smokers have more difficulty quitting compared to African American non-
menthol smokers. These studies evaluated the effect of menthol on
cessation at multiple timepoints in the same population of smokers. A
recent study using nationally representative PATH data found that,
after 12 months, quit rates were significantly lower among African
American daily menthol smokers (3 percent) compared to African American
daily non-menthol smokers (6.2 percent) (Ref. 40). Among Black daily
smokers, menthol smokers also had 53 percent lower odds of quitting
smoking compared to non-menthol smokers after controlling for age, sex,
education, nicotine dependence, and past quit attempts (Ref. 40).
Additionally, the CARDIA study measured smoking cessation behaviors in
young adult (aged 18-30 years) menthol and non-menthol smokers from
four U.S. cities over 15 years (1985-2000) (Ref. 142). After adjusting
for health insurance status and other factors, the study found that
African American menthol smokers were less likely to report having
sustained cessation at two consecutive followups than African American
non-menthol smokers (Ref. 142). Among African Americans, menthol
smokers were also more likely to have relapsed back to smoking (Ref.
142).
    Clinical longitudinal studies have also evaluated short- and long-
term cessation success in current smokers and smokers seeking treatment
to quit. These studies show that among African Americans, menthol
smokers are less likely than non-menthol smokers to remain abstinent
from smoking (Refs. 149-152, 146). A cessation study in African
American smokers determined that the smokers who had quit by the end of
the 7-week study treatment were more likely to smoke non-menthol
cigarettes, compared to menthol cigarettes (Ref. 152). Furthermore, a
long-term cessation study found that, among African American smokers,
menthol smokers were significantly less likely to have quit at the 6-
month followup assessment (Ref. 151). Another clinical study in African
American smokers found that menthol smokers were less likely to have
quit smoking at the 6-month followup than non-menthol smokers (Ref.
150). Data from the 2003 and 2006-2007 TUS-CPS also found that African
American menthol smokers made more quit attempts and had higher rates
of quitting for 3 months to 1 year than smokers of other racial and
ethnic groups; however, when evaluating quitting in the past 5 years,
quit success was lower among African American menthol smokers compared
to other racial/ethnic groups (Ref. 37).
    Taken together, these findings suggest that short term quitting
does not translate to long term success in quitting among African
American menthol smokers. Furthermore, studies using 2006-2007 and
2010-2011 TUS-CPS data show that African American menthol smokers are
more likely to make a quit attempt than African American non-menthol
smokers, but these attempts do not necessarily translate into
successful cessation (Refs. 153 and 154). Additionally, a community-
based survey of African American adults in Minnesota aimed to
understand African Americans' perceptions of menthol cigarettes and
reasons for unsuccessful quit attempts among menthol smokers (Ref.
155). Menthol smokers in the study were more likely than non-menthol
smokers to perceive menthol as harder to quit. Forty-five percent of
menthol smokers who reported a failed quit attempt reported craving as
the reason for the unsuccessful attempt (Ref. 155).
    Some studies do not show that menthol smokers have more difficulty
quitting than non-menthol smokers (Refs. 156-159, 67, 160, 64, 29, 161-
163). For example, data from the 2003 and 2006-2007 TUS-CPS that
evaluated smoking abstinence at 2 weeks did not find a difference in
cessation success between menthol and non-menthol smokers (Ref. 64).
Data from the nationally representative 2011 NYAHS study of young
adults (aged 18-34 years) who self-reported past year smoking behaviors
also did not find significant differences in the proportion of menthol
and non-menthol smokers who reported quitting (Ref. 29). Among
longitudinal studies, some studies have reported no difference in quit
rates or odds of quitting between menthol and non-menthol smokers at 6-
month, 7-month, 12-month, and 5-year followup assessments based on
individual self-report (Refs. 159, 158, 156, 163). In another
longitudinal study, researchers analyzed data from a randomized
controlled trial of smoking cessation that tested breath carbon
monoxide to confirm self-reported smoking status at an 8-week follow-up
assessment (Ref. 161). The study found no difference in smoking
abstinence rates between menthol and non-menthol smokers (Ref. 161).
    Two meta-analyses of the literature that combined the results of
multiple menthol and cessation studies, as well as one systemic
literature review, all found statistically significant reductions in
the likelihood of cessation among African American menthol smokers, and

two of the three found reductions for cessation in the general
population (Refs. 39, 41, and 164). These studies highlight the large
amount of variability across the different studies in this body of
literature. For example, across menthol and cessation studies,
populations varied by sociodemographic factors such as race or
ethnicity, gender, and geographic region; studies ranged from large
nationally representative samples to small clinical trials of
cessation; studies varied by the followup timepoints at which they
assessed cessation, ranging from 48 hours to 15 years; studies did not
use the same methods or definitions to measure cessation; and studies
did not control for the same factors that may influence cessation
outcomes (e.g., demographics, nicotine dependence, use behaviors). This
variability may in part explain the inconsistencies across study
findings related to menthol and cessation.
    Of studies that evaluated menthol in populations of current and
former smokers, studies which found that menthol smokers have more
difficulty quitting were more likely to be longitudinal, allowing for
assessments of cessation across multiple time points among the same
individuals, and generally had longer followup periods than studies
that found no effect of menthol on cessation success. Several studies
which found that menthol reduces cessation success also confirmed
whether menthol smokers had quit at followup assessments by testing for
indicators of cigarette smoking in saliva and/or through breath carbon
monoxide, in addition to individual self-report. An individual's self-
report of quitting may not always be accurate (e.g., individuals may
not remember correctly or may not be truthful in responding);
therefore, studies that also test for indicators of cigarette smoking
through biochemical verification, such as levels of carbon monoxide in
breath and/or nicotine metabolites in blood, urine, or saliva, provide
strong evidence to validate individual responses (Ref. 165).
Furthermore, the meta-analyses of the cessation literature only
included studies published through 2017 (Refs. 39 and 41). Two recent
studies using data from the nationally representative, longitudinal
PATH Study, are thus not included in these meta-analyses; both PATH
studies suggest that menthol smoking is associated with reduced smoking
cessation across multiple years of data (Refs. 40 and 43). Therefore,
despite some contrary findings, the studies that utilized designs that
allowed for long-term assessments of menthol and cessation success and
that used multiple methods to confirm smoking status at followups were
more likely to find an effect of menthol on reduced cessation success
in the general population.
2. Menthol's Interaction With Nicotine in the Brain Makes it Harder To
Quit Smoking
    Addiction to nicotine makes it difficult to quit smoking (Ref. 1).
As discussed in section IV.C.2, repeated exposure to nicotine through
smoking leads to an increase in nicotinic receptor levels in the brains
of smokers; this process is associated with the development of nicotine
addiction (Ref. 9). When an individual stops smoking, such as overnight
or when attempting to quit, the nicotine levels in the brain decrease
as the body clears nicotine, but the number of nicotinic receptors does
not (Ref. 115). The combination of high levels of nicotinic receptors
and low levels of nicotine in the brain produces the discomfort smokers
feel when experiencing symptoms of nicotine withdrawal (Ref. 115). This
is consistent with reports that smokers with greater brain nicotinic
receptor levels have more difficulty quitting than smokers with lower
brain nicotinic receptor levels (Ref. 166).
    Clinical and animal studies show that menthol enhances brain
nicotinic receptor levels to a greater extent than nicotine alone
(Refs. 14, 10, and 11). These changes occur in brain regions involved
in the development of nicotine addiction (Refs. 10-12). Therefore,
menthol's ability to enhance the effects of nicotine in the brain
contributes to why menthol smokers have greater difficulty quitting
smoking compared to non-menthol smokers.
3. Conclusion
    The totality of scientific evidence on menthol and cessation
supports the conclusion that menthol cigarettes contribute to reduced
cessation success, particularly among Black smokers. This effect of
menthol among Black smokers is consistent across large nationally
representative studies, smaller clinical studies of smokers, reviews of
the menthol and cessation literature, and meta-analyses, which examined
outcomes from multiple menthol and cessation studies. Findings among
smokers in the general population produce more mixed results, which may
be attributed in part to heterogeneity across study designs, methods,
and populations; however, the evidence that supports an effect of
menthol on reduced cessation success includes longitudinal studies that
evaluated quitting outcomes in the same population of smokers for up to
15 years and studies of up to 6 months that tested for indicators of
continued cigarette smoking to strengthen the validity of individual
self-report.
    When considering the evidence from nationally representative
surveys, longitudinal studies that evaluated cessation outcomes over
time, and menthol's effects on nicotinic receptors in the brain, the
totality of evidence supports that menthol in cigarettes contributes to
reduced cessation success, particularly among Black smokers.

E. Menthol Cigarettes Are Marketed Disproportionately in Underserved
Communities and to Vulnerable Populations

    Tobacco marketing activities (e.g., advertising and promotions) are
effective in promoting sales, increasing tobacco use, and engendering
positive attitudes about tobacco products among youth, young adults,
and other vulnerable populations (Refs. 167, 32, and 49). With regard
to menthol cigarettes, decades of targeted marketing activities have
helped to make menthol cigarettes more appealing and affordable and
contributed to the pervasive and enduring nature of disparities in
menthol cigarette smoking observed in vulnerable populations,
particularly the Black community.
    Tobacco industry research on menthol cigarettes illustrates that
the industry ``carefully researched the menthol segment of the market''
and ``added [menthol] to cigarettes in part because it is known to be
an attractive feature to inexperienced smokers'' (Ref. 7). In addition,
evidence shows the tobacco industry employed a wide range of marketing
activities, including branding, advertising and promotion, product
placement, and pricing, to promote sales and increase menthol cigarette
use by certain populations.
    For example, research indicates that in the 1960s and 1970s, the
tobacco industry's menthol cigarette advertising and promotion heavily
targeted the African American community by use of darker-skinned
models, tailored messaging and language, and reliance on media such as
magazines with a high Black readership (Refs. 168, 90, and 92).
Industry research identified the cultural values, geographic location,
and taste preferences of Black smokers, which was then used to inform
tobacco product branding (e.g., ``Kool'' cigarettes), culturally-
tailored imagery in advertisements, and locations to

reach and appeal to Black menthol smokers (Refs. 169, 168, 90-91).
    Over many decades, tobacco companies continued to employ marketing
strategies to promote menthol cigarette use among youth, young adults,
and underserved communities, such as low-income Black communities. The
strategies used to target underserved communities included discounts
(Ref. 170), distribution of free samples (Refs. 168, 171, and 172), and
advertising in nightclubs, bars, and special events (Ref. 171). The
tobacco industry also marketed menthol cigarettes to low-income Black
communities and youth, including Black teens as young as 16 years of
age, by selling menthol cigarettes in smaller package quantities to
encourage trial and initiation, and to provide a lower price point
(Refs. 173 and 174).
    Recent scientific evidence indicates that tobacco companies market
menthol cigarettes in the retail environment to continually appeal to
underserved communities. For example, menthol marketing is more
prevalent in neighborhoods that have more Black and low-income
residents (Refs. 170 and 175). Furthermore, tobacco retailers in
predominantly Black neighborhoods are more likely to advertise discount
promotions for menthol cigarettes, and sell menthol cigarettes at a
lower price, as compared to tobacco retailers in predominantly White
neighborhoods (Refs. 175, 170, and 176). Menthol marketing is also more
visible in neighborhoods with predominately Black residents as compared
to predominately White neighborhoods, as well as in urban neighborhoods
(Ref. 175). A recent nationally representative study of tobacco
retailers in the contiguous United States found that retail menthol
advertising was more common in neighborhoods with more Black and low-
income residents (Ref. 177). Furthermore, price promotions for Newport
brand menthol cigarettes were more common in retailers in neighborhoods
with more Black residents (Ref. 177).
    Higher exposure to tobacco advertisements and retailing are
associated with disparities in tobacco use susceptibility and tobacco
use among youth. For example, youth who live or go to school in
neighborhoods where tobacco retailers are disproportionately present
are more susceptible to smoking (Refs. 178 and 179), are more likely to
experiment with smoking (Refs. 180 and 179), and are more likely to
smoke currently (Ref. 181).
    Taken together, scientific evidence indicates that menthol
cigarettes have historically and continue to be disproportionately
marketed in underserved communities and contribute to the longstanding
disparities in menthol cigarette smoking and health outcomes observed
in vulnerable populations, particularly the Black community. While
targeted marketing is only one factor in the development and
perpetuation of menthol cigarette use and related harms, this
background helps to explain and provide critical context for the
outcomes and disparities that undermine public health and are of
concern to FDA. Addressing how these products disproportionately affect
vulnerable populations supports the Agency's mission of promoting
public health.

V. Determination That the Standard Is Appropriate for the Protection of
the Public Health

    The Tobacco Control Act authorizes FDA to revise or adopt tobacco
product standards by regulation if it finds that such tobacco product
standards are appropriate for the protection of the public health
(section 907(a)(2) and (a)(3)(A) of the FD&C Act). The notice of
proposed rulemaking for such a product standard must set forth this
finding with supporting justification, which FDA is doing here (section
907(c)(2)(A) of the FD&C Act).
    In order to make this finding, FDA must consider scientific
evidence concerning:
     The risks and benefits to the population as a whole,
including users and nonusers of tobacco products, of the proposed
standard;
     The increased or decreased likelihood that existing users
of tobacco products will stop using such products; and
     The increased or decreased likelihood that those who do
not use tobacco products will start using such products.

(Section 907(a)(3)(B)(i) of the FD&C Act)

    FDA has considered scientific evidence related to all three
factors. Based on these considerations, as discussed below, we find
that the proposed standard is appropriate for the protection of the
public health because the prohibition of menthol as a characterizing
flavor in cigarettes: Decreases the likelihood that nonsmokers would
experiment with cigarettes, develop tobacco dependence symptoms, and
progress to regular cigarette smoking and/or use of other tobacco
products, while also decreasing the likelihood that current smokers
would continue to smoke cigarettes. Cigarettes are the most toxic
consumer product when used as intended and adding menthol as a
characterizing flavor makes cigarettes more appealing and easier to
smoke. The proposed standard is anticipated to decrease the likelihood
of menthol cigarette experimentation and the subsequent progression to
regular, established cigarette smoking and cigarette consumption.
Further, the proposed standard is anticipated to improve the health of
current smokers of menthol cigarettes by increasing the likelihood of
cessation, which would lead to lower disease and death in the U.S.
population due to diminished exposure to tobacco smoke for both users
and nonusers of cigarettes. Prohibiting menthol as a characterizing
flavor in cigarettes would reduce the death and disease caused by
cigarette use.

A. The Likelihood That Nonusers Would Start Using Cigarettes

    Menthol in cigarettes is a significant contributor to youth and
young adult initiation of cigarette smoking. In this section, we
summarize evidence from multiple study designs, incorporating findings
from longitudinal studies, national surveys, policy evaluations, and
qualitative research that illustrate the role menthol plays in
facilitating initiation and experimentation of cigarettes. We also
discuss how the proposed prohibition on menthol as a characterizing
flavor in cigarettes would decrease experimentation and thus, reduce
progression to regular cigarette smoking among current nonusers.
    Menthol is a flavor compound that is added to cigarettes, which
produces a minty taste and cooling sensation when inhaled (Ref. 2).
These sensory properties are pleasing and drive smoker beliefs that
menthol cigarettes have a better taste, are smoother and more
refreshing, are easier to inhale, and are less irritating than non-
menthol cigarettes (Refs. 3-5). These properties also mask the
harshness of smoking for new smokers and facilitate repeated
experimentation and progression to regular smoking of menthol
cigarettes, particularly among youth and young adults (Refs. 6-7, 5,
8).
    When an individual tries a menthol cigarette, the sensory effects
associated with menthol make initial and continued smoking experiences
more palatable. In a focus group study conducted with young adult (aged
18-24) menthol smokers, participants reported that the taste of menthol
made cigarettes as ``minty'', ``cool'', and ``refreshing'', stating
that these factors influenced their initial preference for menthol
cigarettes (Ref. 5). Further, these young adults indicated that they

continued to smoke menthol cigarettes because they taste and smell
better than non-menthol cigarettes (Ref. 5). In addition, a study
evaluating the sensory experiences of first cigarette use among young
adult smokers found that fewer menthol smokers reported experiencing
nausea during their first smoking experience compared to non-menthol
smokers (Ref. 33). Evidence from tobacco industry documents also
support that menthol is added to cigarettes in part because it is known
to be an attractive feature to new and younger inexperienced smokers
who perceive menthol cigarettes as less harsh and easier to smoke than
non-menthol cigarettes (Ref. 7).
    The increased likelihood of initiation of menthol cigarettes is
reflected in the high proportion of youth and young adults who report
that their first cigarette was menthol as compared to older adult
smokers and the high proportion of past 30-day menthol smoking among
youth as compared to older adult smokers (Refs. 8, 31, 33, 65-66, 182-
183, 55-57, 44, 95). National studies and data also show that younger
smokers (aged approximately 12-25 years) are more likely to smoke
menthol cigarettes than older adult smokers (aged 26 and older) (Refs.
65-66, 182-183, 57, 55, 44). Among middle and high school students, the
prevalence of current past 30-day menthol cigarette smoking decreased
from 2011 to 2018 in NYTS data (Ref. 56), however approximately 47
percent of youth who smoke cigarettes reported smoking menthol
cigarettes in 2019 (Ref. 95). Baseline findings from PATH Study data
indicate similar findings, with nearly 43 percent of youth (12 to 17
years of age) and 45 percent of young adult (18 to 24 years of age)
ever cigarette smokers (i.e., those young adults who have used a
tobacco product even once or twice in their lifetimes) reported that
the first cigarette they smoked was mentholated (Ref. 31). In a
followup study examining Waves 1-4 (2013-2017) of PATH data, youth
(aged 12-17 years) and young adult (aged 18-24 years) new smokers
(smokers who reported trying a cigarette for the first time between any
adjacent waves) were more likely to report smoking menthol cigarettes
than adults aged 25 and older (Ref. 8). These findings are consistent
across studies encompassing different populations and time periods,
including studies that assess large, nationally representative
populations (Refs. 65-66, 182-183, 55-57, 44, 95, 31, 8). Data
indicating youth and young adults are more likely to smoke menthol
cigarettes points to the importance of the proposed product standard in
protecting these vulnerable populations.
    Experimentation with cigarettes can lead to nicotine dependence,
which in turn increases the likelihood that experimenters will progress
to regular cigarette smoking. As discussed in section IV.C of this
document, studies have long provided clear evidence that signs of
nicotine dependence in youth can arise soon after they first start
smoking cigarettes, even among intermittent users (Refs. 184, 137, and
135). Such results suggest that even infrequent experimentation can
lead to early signs of dependence, which underscores the public health
importance of decreasing the likelihood of cigarette experimentation
among youth and young adults in the United States.
    Menthol's flavor, sensory effects, and interaction with nicotine in
the brain contribute to an even greater risk of nicotine dependence by
facilitating repeated experimentation and progression to regular
smoking. Youth who smoke menthol cigarettes have statistically
significant higher scores for several indicators of nicotine dependence
(i.e., craving, affiliative attachment, and tolerance) compared to
youth who smoke non-mentholated cigarettes (Ref. 26). Pooled data from
2017-2020 NYTS of past 30-day youth cigarette smokers also indicates
menthol smokers have greater risk of smoking more frequently (20-30
days per month versus 1-5 days per month) and more cigarettes per day
(11+ versus 1-5), and that they report higher levels of dependence
(cravings for tobacco and wanting tobacco within 30 minutes of waking)
and have lower intentions to quit smoking (Ref. 28).
    The reported dependence on tobacco, even at low levels of use, puts
adolescents at greater risk of continuing to use tobacco products into
adulthood (Refs. 135 and 185). The adolescent brain, which continues to
develop until about age 25, is particularly vulnerable to nicotine's
addictive effects (Refs. 17, 18, and 32). Several studies among
adolescent and young adult cigarette smokers have shown that early
dependence symptoms are predictive of smoking continuation and