Document ID: FDA-2021-N-1349-0001
Agency: fda
Document Type: Proposed Rule
Title: Tobacco Product Standard for Menthol in Cigarettes
Posted Date: 2022-05-04T04:00Z

[Federal Register Volume 87, Number 86 (Wednesday, May 4, 2022)]
[Proposed Rules]
[Pages 26454-26502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-08994]

[[Page 26453]]

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  

[[Page 26454]]

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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, 240-402-7500.
     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, 240-402-7500.

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, 877-287-1373, 
[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

[[Page 26455]]

    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

[[Page 26456]]

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

[[Page 26457]]

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

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

    \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.
---------------------------------------------------------------------------

    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

[[Page 26458]]

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

    \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

[[Page 26459]]

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

[[Page 26460]]

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

[[Page 26461]]

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

[[Page 26462]]

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

[[Page 26463]]

(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

[[Page 26464]]

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

[[Page 26465]]

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

[[Page 26466]]

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)

[[Page 26467]]

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

[[Page 26468]]

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

[[Page 26469]]

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

[[Page 26470]]

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 
progression or failed cessation attempts (Refs. 186 and 187). The 
addition of menthol as a characterizing flavor used in cigarettes 
enhances nicotine addiction, particularly for youth and young adults, 
through a combination of its flavor, sensory effects, and interaction 
with nicotine in the brain.
    If this proposed rule is finalized, menthol as a characterizing 
flavor would not be available to mask the harshness of smoking 
cigarettes and make initial smoking experiences more appealing for new 
users. FDA anticipates that implementation of the proposed standard 
would result in fewer youth and young adults experimenting repeatedly 
with cigarettes, becoming nicotine dependent, and progressing to 
regular cigarette smoking. Through these impacts alone, the proposed 
standard is appropriate for the protection of the public health, as it 
would lead to a significant reduction in the number of new regular 
cigarette smokers and the well-documented health impacts associated 
with regular cigarette smoking.
    If this proposed rule is finalized, FDA expects a significant 
reduction in youth initiation and progression to regular cigarette 
smoking, which would ultimately protect youth from a lifetime of 
addiction and disease, and premature death, attributable to cigarette 
smoking. To the extent that youth and young adults in the United States 
who would have initiated with menthol cigarettes do not initiate with 
non-menthol cigarettes or other tobacco products, the proposed standard 
would prevent future cigarette-related disease and death.
    FDA's expectation of a significant reduction in youth initiation 
and progression to regular cigarette smoking is supported by real-world 
experience of youth tobacco use prevalence decreasing following 
implementation of policies restricting the sales of flavored tobacco 
products. Two nationally representative studies assessing the impact of 
the Special Rule for Cigarettes (section 907(a)(1)(A) of the FD&C Act), 
which banned non-menthol flavored cigarettes, both found that youth 
cigarette smoking rates decreased following implementation. In a study 
using 2002-2017 NSDUH quarterly data with older adults (aged 50 and 
older) as a comparison group, there was a temporary increase 
(``temporary'' was undefined in the study) in the odds of past 30-day 
cigarette smoking and past 30-day menthol cigarette smoking in youth 
and young adults immediately after the Special Rule went into effect 
(Ref. 188). Following the temporary increase, odds of past 30-day 
cigarette smoking and past 30-day menthol cigarette smoking in youth 
and young adults decreased through 2017 (Ref. 188). No increase in odds 
of past 30-day cigarette smoking and past 30-day menthol cigarette 
smoking was observed immediately after the Special Rule went into 
effect or following through 2017 among older adults (ages 50 and 
older). The study estimated the total effect of the Special Rule for 
Cigarettes and

[[Page 26471]]

found that the flavored cigarette ban overall was associated with a 
significant reduction in cigarette smoking for youth (ages 12-17), 
young adults (ages 18-25), and adults (ages 26-49), but not older 
adults (ages 50 and older). This includes reductions in menthol 
cigarette smoking among youth and youth adults likely due to the 
overall effect the Special Rule had on decreasing rates of smoking 
among these groups over time.
    Another nationally representative study examining tobacco use among 
U.S. middle and high school students before and after the Special Rule 
for Cigarettes banning non-menthol flavored cigarettes, found an 
overall decrease in the prevalence of youth cigarette smoking, fewer 
number of cigarettes smoked per month, and an overall reduction in the 
probability of using any type of tobacco (Ref. 189). Adjusting for 
demographic variables, national-level tax inclusive price indices for 
cigarettes and non-cigarette tobacco products, youth unemployment rate, 
and time trends, there was a 17.1 percent reduction in the probability 
of middle and high school students being a cigarette smoker after the 
Special Rule for Cigarettes (Ref. 189). Additionally, middle and high 
school smokers reported smoking 59 percent fewer cigarettes per month 
after the Special Rule for Cigarettes (Ref. 189). While there were 
increases in the use of some types of tobacco products, including 
cigars (34.4 percent) and pipe tobacco (54.6 percent) that remained 
available in flavored varieties, the probability of using any type of 
tobacco overall was reduced by 6 percent (Ref. 189).
    In recent years, several U.S. localities and some states have 
placed restrictions on the sale of menthol cigarettes in addition to 
restrictions on the sale of other flavored tobacco products. Results 
from evaluations of these policies provide evidence of decreases in use 
and sales of tobacco products after policy implementation (Refs. 190-
193). In 2018, Minneapolis and St. Paul, Minnesota, expanded their 
sales restrictions on flavored tobacco products (including e-
cigarettes) to include menthol, mint, and wintergreen tobacco products. 
An evaluation of this sales restriction found decreases in youth 
cigarette (3.8 percent to 2.3 percent), cigar (2.7 percent to 1.6 
percent), smokeless tobacco (1.6 percent to 1.2 percent), and hookah 
(2.4 percent to 1.3 percent) product use after policy implementation in 
the Twin Cities metro area, which includes Minneapolis and St. Paul 
(Ref. 192). An increase in youth e-cigarette prevalence from 10.5 
percent to 15.7 percent occurred after the policy in the Twin Cities, 
but this increase was lower than the rest of the State of Minnesota 
where e-cigarette prevalence increased from 10.0 percent to 18.8 
percent (Ref. 192). Although prevalence of youth overall tobacco use 
increased after the policy in the Twin Cities from 12.2 percent to 16.5 
percent and increased in the rest of the State from 13.9 percent to 
20.1 percent, these increases were driven by youth e-cigarette use and 
align with national youth tobacco use trends (Ref. 192). Importantly, 
the increases in youth overall tobacco use after the policy were lower 
in the Twin Cities than in the rest of the State, suggesting that the 
policy mitigated increases in overall tobacco use.
    In July 2018, San Francisco, California, implemented a sales 
restriction on all flavored tobacco products, including menthol 
cigarettes. The San Francisco Department of Public Health announced 
that enforcement would begin January 2019 and enforcement with routine 
retailer compliance inspections began April 2019 (Ref. 194). An 
evaluation of the impact of the San Francisco policy on tobacco product 
sales, a proxy for consumption, found that total tobacco sales 
decreased by a statistically significant 25 percent from before policy 
implementation (July 2015-July 2018) to a post-policy enforcement 
period (January-December 2019) (Ref. 190). This study also found a 
statistically significant decrease in the overall sales of flavored 
tobacco products (from 39,350 average weekly unit sales to 1,546 
average weekly unit sales), including menthol cigarettes (from 21,463 
average weekly unit sales to 860 average weekly unit sales), to low 
levels after policy enforcement (Ref. 190). Findings that total tobacco 
sales and flavored tobacco sales decreased post policy suggest that 
consumers did not completely substitute non-flavored tobacco products 
for flavored tobacco products, and that such a policy can be 
implemented effectively and reduce sales of products as intended.
    Changes in sales of tobacco products in San Francisco after policy 
enforcement were also reflected in young adult tobacco use patterns. A 
retrospective study of a convenience sample of young adult ever tobacco 
users in San Francisco found a statistically significant lower 
prevalence of overall tobacco use among 18-to 24-year-olds (from 100 
percent to 82.3 percent) and 25-to 34-year-olds (from 100 percent to 
92.4 percent) about 11 months after policy enforcement (November 2019) 
(Ref. 191).
    One study on San Francisco's flavored tobacco policy using Youth 
Risk Behavior Survey (YRBS) data reported that San Francisco's flavor 
restriction was associated with increased odds of cigarette smoking 
among high school students relative to other school districts (Ref. 
195). However, another study reported a methodological mistake with 
these findings: Data collection for the 2019 YRBS in San Francisco 
occurred in Fall 2018, prior to when the San Francisco flavor 
restriction was enforced in April 2019 (Ref. 196). As previously noted, 
another study of the San Francisco policy observed an overall decline 
in tobacco product sales and total cigarette sales, suggesting that 
there was not complete substitution of tobacco or unflavored products 
for flavored products following the flavor restriction in San Francisco 
(Ref. 190).
    In June 2020, Massachusetts implemented a statewide sales 
restriction on flavored tobacco products (including menthol cigarettes) 
(Ref. 193). An evaluation of retail sales data assessed State-level 
cigarette sales per 1000 people in Massachusetts and comparison states 
without statewide flavor sales restrictions (Ref. 193). After the 
flavor sales restriction, the adjusted sales of cigarettes in 
Massachusetts versus the comparison states decreased by 372.27 packs 
per 1000 people for menthol cigarettes and by 282.65 pack per 1000 
people for all cigarettes (Ref. 193).
    In addition to state and local menthol sales restrictions, in 
recent years many provinces in Canada have implemented menthol sales 
restrictions. An evaluation of provincial menthol sales restrictions in 
Canada on youth and adult cigarette use found that provincial menthol 
sales restrictions were associated with decreases in menthol cigarette 
smoking (Ref. 197). While this study found that provincial menthol 
sales restrictions were not associated with an overall change in youth 
and adult past 30-day cigarette use, this finding is inconsistent with 
the authors' supplemental analysis that found decreases in menthol 
cigarette sales and no effect on non-menthol cigarette sales post-
implementation (Ref. 197). The study also found an increase in adult 
self-reported purchasing of cigarettes from First Nations reserves, 
which were exempt from the sales restriction (Ref. 197). This 
purchasing behavior was not assessed among youth. In the United States, 
however, the proposed menthol product standard would apply nationwide, 
including on Tribal lands, which likely would increase the 
effectiveness of a nationwide menthol standard as compared to Canada.

[[Page 26472]]

    In addition to the studies discussed in this section, as of 
November 2021, at least 145 localities in the United States have passed 
restrictions on the sale of menthol cigarettes in addition to other 
flavored tobacco products (Ref. 198). FDA requests comments and data on 
the impact of these menthol cigarette sales restrictions on non-users 
and users of tobacco products.
    Evaluations of local non-menthol flavored tobacco product sales 
restrictions also provide evidence of decreases in the use and sales of 
tobacco products after policy implementation (Refs. 199-203). In 
November 2010, New York City (NYC) began enforcing a sales restriction 
on all flavored tobacco products except for menthol-flavored, mint-
flavored, and wintergreen-flavored tobacco products; all e-cigarettes 
were excluded from the sales restrictions. An evaluation of the impact 
of the policy on youth tobacco product use found that NYC youth (aged 
13-17 years) had 37 percent lower odds of ever trying a flavored 
tobacco product in 2013 after the policy was enforced compared to youth 
in 2010. Similarly, youth in 2013 had 28 percent lower odds of ever 
using any tobacco products compared to youth before the policy was 
enforced (Ref. 199). Changes in youth flavored tobacco use patterns 
were also reflected in changes in overall sales of flavored tobacco 
products. Analyses of tobacco product sales found a statistically 
significant decline in sales of overall flavored tobacco products 
following policy implementation and enforcement (Refs. 199 and 200). 
Similar to findings in NYC, an evaluation of a policy restricting the 
sale of flavored tobacco products, including e-cigarettes and excluding 
menthol cigarettes, in Providence, Rhode Island, found a decrease in 
any tobacco product use among high school students after active 
enforcement of the policy began (Ref. 202). More specifically, this 
analysis found that youth current use of any tobacco product declined 
from 22.2 percent in 2016 to 12.1 percent in 2018 (Ref. 202).
    In October 2016, Lowell, Massachusetts, a small locality, began 
enforcing a sales restriction on all flavored tobacco products, except 
for menthol; e-cigarettes were included in the sales restriction. An 
evaluation of the short-term (6-month) impact of the policy found that 
youth use of any flavored tobacco products and any non-flavored or 
menthol tobacco products decreased in Lowell from baseline to followup 
and increased in the comparison community; statistically significant 
decreases in both any flavored and any non-flavored or menthol tobacco 
use were observed when comparing changes from baseline to followup 
between the two communities (Ref. 201). More specifically, youth self-
reported current use of any non-flavored tobacco products decreased 1.9 
percent in Lowell while increasing in the comparison city by a 
statistically significant 4.3 percent for a statistically significant 
estimated difference of -6.2 percent between the communities (Ref. 
201). These data suggest that overall, youth did not switch to non-
flavored or menthol tobacco products and that the policy helped reduce 
use of tobacco products among youth (Ref. 201).
    Additionally, a study of local level restrictions across 
Massachusetts from 2011-2017 found that counties with a greater 
proportion of county residents covered by local policies that limit the 
sale of flavored tobacco products (excluding menthol) were associated 
with a decrease in the number of days smoked in the past 30 days and a 
decrease in the likelihood of e-cigarette use among high school 
students (Ref. 203). Another study evaluated the impact of flavored 
tobacco sales restrictions (excluding menthol) in Attleboro and Salem, 
Massachusetts, on tobacco use among high school students (Ref. 204). 
While youth use of flavored tobacco products and nonflavored or menthol 
tobacco products increased from baseline to followup in Attleboro and 
Salem and in the comparison municipality, the increases were 
significantly smaller in Attleboro and Salem than the comparison 
municipality, suggesting that the policy mitigated increases in 
flavored and nonflavored or menthol tobacco use (Ref. 204). 
Furthermore, while no changes in youth overall tobacco use were 
observed after a sales restriction on flavored tobacco products 
(excluding menthol, mint, and wintergreen products) in Minneapolis and 
St. Paul, Minnesota (18.1 percent to 17.6 percent), significant 
increases in the prevalence of youth overall tobacco use were observed 
in the rest of the state (12.4 percent to 15.7 percent), suggesting 
that the policy may have prevented increases in overall tobacco use 
(Ref. 192). As discussed previously, after this sales restriction was 
expanded to include menthol, mint, and wintergreen tobacco products, 
increases in youth overall tobacco use were lower in the Twin Cities 
than in the rest of the State, suggesting that the expanded policy 
diminished increases in overall tobacco use (Ref. 192).
    FDA acknowledges there may be limitations to relying on aggregate 
tobacco sales information as a proxy for consumption. In addition, 
overall sales data are more likely to be driven by adult than 
adolescent use, given the larger size of the adult population as well 
as the tendency for youth to acquire tobacco via social sources (Ref. 
205). However, studies have shown that sales and consumption tend to be 
highly correlated (Refs. 206-208). Additionally, sales data provide 
information on purchases of tobacco products in a defined area (which 
could include neighboring jurisdictions) (Refs. 200 and 209) and can 
serve as a proxy for consumption of tobacco products after policy 
implementation.
    Evaluations of local policies may underestimate the potential 
impact of a national policy. Depending on availability of tobacco 
products in jurisdictions neighboring those where local policies were 
passed, users and non-users may easily be able to access tobacco 
products from these locations. Even with these limitations, FDA finds 
sales and local policy evaluation data useful and supportive in 
informing our expectations about the impact of the proposed product 
standard on tobacco product use and potential product substitution. 
Overall, the evidence supports that sales and use of tobacco products 
decrease as a result of flavored tobacco product sales restrictions. 
FDA anticipates that a nationwide standard that prohibits the 
manufacture and sale of menthol cigarettes would likely have a greater 
impact in decreasing youth cigarette use compared to that observed from 
policies from limited jurisdictions, because a nationwide product 
standard would eliminate the manufacture of these products as well as 
the opportunity to easily travel to neighboring jurisdictions within 
the United States that do not have a menthol sales restriction or use 
online retailers to purchase menthol cigarettes.
    Although there are limitations in attributing public health 
outcomes to the evaluations described in this section, such evaluations 
are useful to understand the anticipated effect of the proposed menthol 
product standard. Findings from these evaluations generally suggest 
that youth use of cigarettes would decrease following implementation of 
the proposed product standard. With reduced menthol cigarette smoking, 
we would see reduced smoking-related morbidity and mortality along with 
diminished exposure to secondhand smoke among non-smokers, decreased 
potential years of life lost, decreased disability, and improved 
quality of life for the current and future generations to come. For 
these reasons, FDA expects that prohibiting menthol as a characterizing

[[Page 26473]]

flavor in cigarettes would reduce the likelihood that youth and young 
adults would initiate with and progress to regular menthol cigarette 
smoking, thereby protecting many youth from a lifetime of addiction and 
disease, and premature death, attributable to cigarette smoking. From 
the expected impact on non-users alone, especially youth and young 
adults, this proposed product standard is appropriate for the 
protection of public health.

B. The Likelihood That Existing Menthol Cigarette Users Would Reduce 
Cigarette Consumption or Stop Cigarette Smoking

    In addition to the long-term public health benefits that would 
accrue from the prevention or reduction of menthol cigarette smoking 
among youth and young adults, FDA anticipates that the proposed 
standard would increase the likelihood that many existing menthol 
cigarette smokers would stop smoking cigarettes altogether, yielding 
health benefits from smoking cessation. FDA expects that the proposed 
prohibition of menthol as a characterizing flavor in cigarettes would 
result in substantial changes in tobacco use patterns among current 
tobacco users. Current menthol smokers would either: (1) Quit smoking 
or tobacco use altogether; (2) transition to non-menthol cigarettes or 
other combusted tobacco products; or (3) switch to other tobacco 
products, including potentially less harmful products. Given the large 
proportion of menthol cigarette use among smokers, the role of menthol 
in reducing cessation success among cigarette smokers, and the 
empirical evidence published through 2021 from policies restricting the 
sales of flavored tobacco products in the United States and Canada, FDA 
expects that the proposed product standard would lead many menthol 
cigarette smokers to stop using cigarettes.
    As discussed previously, menthol's flavor and sensory properties 
influence initiation and continued experimentation (see section IV.C of 
this document). Additionally, these sensory properties are a major 
factor for a smoker's continued use of menthol cigarettes. Smokers note 
that menthol in cigarettes impacts their sensory experience, including 
the perception of a better tasting, smoother, and more refreshing 
cigarette that is easier to inhale and produces a cooling effect in the 
mouth and throat; smokers report that these sensory effects from 
menthol contribute to their continued smoking (Refs. 3-5, 107-108). In 
a qualitative study, young adult menthol smokers (aged 18-24) reported 
that the taste of menthol made cigarettes ``minty'', ``cool'', and 
``refreshing'', stating that these factors influenced their initial 
preference for menthol cigarettes (Ref. 5). They perceived menthol 
cigarettes as smoother, less harsh, and ``easier to inhale'' than non-
menthol cigarettes, which were generally regarded as strong, harsh, and 
``gross'' (Ref. 5). They also reported that menthol cigarettes deliver 
a ``fuller'' smoke and ``hit hard,'' and seemingly require fewer 
cigarettes to feel ``satisfied'' (Ref. 5). Among adult smokers aged 18 
and older, another recent study found menthol cigarette smoking to be 
associated with self-reported subjective reward, satisfaction, and 
throat hit (Ref. 108). Similar findings have been noted in youth. In a 
PATH Study of Wave 1 data, youth cigarette smokers (aged 12-17), 
regardless of menthol use status, reported that menthol cigarettes are 
easier to smoke (Ref. 107). The menthol product standard, if finalized, 
would prohibit menthol as a characterizing flavor in cigarettes, 
eliminating menthol's sensory cue, thereby reducing the reinforcing 
appeal of cigarettes for current menthol smokers, and encouraging 
current menthol smokers to quit smoking.
    The sensory effects of menthol serve to reinforce the effects of 
nicotine. While nicotine dependence is the driving factor for all 
tobacco use, including cigarettes, menthol's enhancement of nicotine 
dependence and the sensory properties of menthol contribute to 
continued use of menthol cigarettes, making it even more difficult to 
quit smoking (Refs. 1, 34-35, 42, 36-37). While there is some 
inconsistency in the literature regarding menthol's role on smoking 
cessation, when considering the evidence from systematic reviews, 
national 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 among smokers, particularly 
among Black smokers (Refs. 34-35, 42, 36-41).
    Data from TUS-CPS found that in 2007, reporting a quit attempt in 
the past year was 8.8 percent higher among menthol smokers (41.4 
percent) compared to non-menthol smokers (38.1 percent), but menthol 
smokers had 3.9 percent lower rates of quitting within the past year 
(menthol: 4.2 percent versus non-menthol: 4.4 percent) and 11.3 percent 
lower rates of quitting within the past 5 years (menthol: 18.8 percent 
versus non-menthol: 21.1 percent) compared to non-menthol smokers (Ref. 
37). After adjusting for covariates, including nicotine dependence and 
race/ethnicity, the likelihood of quitting was 3.5 percent lower for 
quitting in the past year and 6 percent lower for quitting in the past 
5 years in menthol compared with nonmenthol smokers (Ref. 37). Similar 
results have been noted in more recent data from Waves 1-4 of the PATH 
Study (2013-2018), which found that daily adult menthol smokers (ages 
18 and older) had 24 percent lower odds of quitting smoking compared to 
daily non-menthol smokers (Ref. 40). Another PATH study 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 (Ref. 43). The majority of cigarette smokers in the United 
States report wanting to quit smoking (2015 NHIS: 68.0 percent) (Ref. 
210), and thus, in response to the proposed product standard, many 
menthol cigarette smokers may seek to quit tobacco altogether or switch 
to other, potentially less harmful products.
    FDA expects that, if this proposed rule is finalized and menthol is 
prohibited as a characterizing flavor in cigarettes, many menthol 
cigarette smokers will either quit smoking or switch to a non-combusted 
tobacco product, such as ENDS. In an expert elicitation study 
estimating transitions in use under both menthol ban and status quo 
scenarios, the panel of experts estimated that an additional 20.1 
percent of menthol smokers ages 35 to 54 would cease combustible 
tobacco use over 2 years under a menthol ban compared to the status 
quo, with about half (10.3 percent) switching to ENDS and about half 
(10 percent) quitting all tobacco use (Ref. 211). The expert panel also 
estimated that an additional 30.1 percent of menthol smokers ages 18 to 
24 would cease combustible tobacco use over 2 years, with 15.6 percent 
switching to ENDS and 12.3 percent quitting all tobacco use (Ref. 211). 
Some menthol cigarette smokers may switch to non-menthol cigarettes. 
The expert elicitation study suggested that among menthol smokers age 
35 to 54, 45.7 percent would become non-menthol cigarette smokers 
(compared to 4.6 percent under the status quo) while 3.7 percent would 
become non-menthol cigar smokers (compared to no change under the 
status quo) (Ref. 211). The expert elicitation study and the resulting 
population modeling study,

[[Page 26474]]

which utilized the expert elicitation, are discussed in further detail 
in section V.C.5 of this document.
    Among Hispanic and Latino smokers, studies also suggest that 
menthol smokers have more difficulty quitting than non-menthol smokers 
(Refs. 34, 151, 42, 36). Data from cross-sectional surveys using 
nationally representative online cohorts of U.S. adults indicated that 
Hispanic, non-Hispanic African American, and non-Hispanic other (those 
who identified with more than two races) adults were more supportive of 
a menthol ban than non-Hispanic White adults (Ref. 212) and that, among 
menthol smokers, both African American and Hispanic adults were more 
supportive of a menthol ban than White adults (Ref. 213). African 
American adults and Hispanic adults are two of the three racial and 
ethnic groups that, in 2019, had the highest prevalence of menthol 
cigarette smoking.
    Prohibiting menthol as a characterizing flavor in cigarettes would 
likely result in increased cigarette cessation among members of 
historically underserved communities, including Black smokers, due to 
increased quit attempts and lower likelihood of switching to non-
menthol cigarettes. A recent review of the literature found that among 
smokers, African American menthol smokers had lower odds of smoking 
cessation compared to non-menthol smokers (Ref. 41). As discussed 
above, the totality of evidence supports that menthol in cigarettes 
contributes to reduced cessation success. Data from national surveys 
suggests that menthol likely plays a role in making quitting 
particularly difficult for African American cigarette smokers (Refs. 
34-37, 40). A focus group study among Black smokers found that taste 
was the main reason for continuing to smoke a particular brand and was 
a reason for smoking menthol rather than non-menthol cigarettes (Ref. 
4). Additionally, participants agreed that menthol cigarettes were 
``refreshing'', ``soothing'', and ``smooth'' while non-menthol 
cigarettes were ``strong'' or ``harsh'' (Ref. 4). Participants' 
preference for menthol cigarettes in this study was so strong that non-
menthol cigarettes were viewed as a cessation aid (Ref. 4). These 
findings support that prohibiting menthol as a characterizing flavor in 
cigarettes will reduce the appeal of cigarettes, lead to reduced 
initiation and experimentation, and reduce the likelihood of subsequent 
progression to regular, established smoking and smoking dependence 
among vulnerable populations.
    While a menthol restriction is anticipated to benefit the general 
population, the benefits of a menthol restriction on smoking cessation 
are likely to be more pronounced among Black menthol smokers, as they 
are less likely to switch to non-menthol cigarettes. Older and more 
recent studies are consistent in their findings that there would be 
increased likelihood of quitting smoking altogether for many menthol 
smokers under a menthol ban. A 1993 study of adult cigarette smokers 
found that 56 percent of Black smokers, compared to 28 percent of White 
smokers, responded that they would not smoke non-menthol cigarettes if 
they could not smoke menthol cigarettes (Ref. 214). While all menthol 
smokers in a nationally representative study had lower odds of smoking 
cessation compared to non-menthol smokers, when stratified by race and 
ethnicity, African American menthol smokers had the lowest odds of 
smoking cessation of any group (Ref. 40). A 2011-2016 analysis of data 
from the Truth Initiative Young Adult Cohort showed that among past 30-
day menthol smokers, African American smokers had greater odds of 
reporting that they would quit smoking if menthol cigarettes were 
unavailable compared to White smokers (Ref. 215). Another study 
evaluating the effect of a menthol sales restriction in seven Canadian 
provinces indicated that non-White cigarette smokers were more likely 
than White cigarette smokers to make a quit attempt (Ref. 216). 
Additionally, one experimental study recruited 29 current menthol adult 
smokers who were not currently using cessation treatments and were not 
trying to quit (Ref. 217). Participants were switched from smoking 
their usual brand menthol cigarettes to a matched-brand non-menthol 
cigarette and were monitored multiple times across 2 weeks to model a 
potential ban of menthol cigarettes (Ref. 217). After switching to non-
menthol cigarettes, participants had significantly lower nicotine 
dependence scores and greater increases in quitting motivation and 
confidence (Ref. 217). Findings from this study indicated that Black 
smokers had greater reductions in cigarettes per day when compared to 
non-Black smokers (defined as Hispanic, White, or ``Other'' smokers) 
(Ref. 217). Taken together, these research findings suggest that the 
proposed menthol product standard could help to reduce tobacco-related 
health disparities as experienced by vulnerable populations.
    Findings from surveys asking menthol cigarette smokers what they 
would do if menthol cigarettes were to be banned are consistent with 
the Agency's expectation that many menthol smokers would attempt to 
quit smoking following the implementation of the proposed menthol 
standard. A recent literature review examined such surveys and based on 
responses from U.S. menthol smokers, concluded that banning menthol 
cigarettes would increase quit attempts and switching to potentially 
less harmful tobacco products (Ref. 218). Across several surveys, 
menthol smokers have said that if menthol cigarettes were no longer 
available, they would consider quitting smoking altogether (Refs. 213, 
219-223, 215). For example, a 2010 nationally representative survey 
found that approximately 39 percent of adult menthol cigarette smokers 
said they would ``try to stop smoking'' if menthol cigarettes were 
banned (Ref. 213). In a 2014 survey, adult menthol smokers in Minnesota 
were asked whether they would quit smoking if menthol cigarettes were 
no longer sold in U.S. stores (Ref. 221). Just under half (46.4 
percent) of menthol smokers responded that they would quit smoking 
(Ref. 221). A longitudinal survey from 2011-2016 of young adult menthol 
smokers found that an average of 23.5 percent of menthol smokers 
reported that they would most likely quit smoking and not use any other 
tobacco product in response to a menthol ban (Ref. 215).
    In another study of adolescent and adult cigarette smokers, more 
than 35 percent of menthol smokers indicated their intentions to try to 
quit smoking if a ban of menthol in cigarettes was enacted (Ref. 219). 
Two studies report higher proportions of non-Hispanic Black menthol 
smokers indicating their intentions to quit smoking than non-Hispanic 
White menthol smokers following a menthol cigarette flavor ban; 
however, these differences were not statistically significant in either 
study (Refs. 219 and 213). In a longitudinal study of young adults, 
non-Hispanic Black participants had significantly higher odds of 
reporting that they would most likely quit smoking if menthol 
cigarettes were no longer available compared to non-Hispanic White 
participants (Ref. 215). A study in Ontario, Canada, that compared 
individuals' behavioral intentions before a menthol sales restriction 
was implemented with actual responses 1 year after implementation found 
38 percent of those with behavioral intentions to quit cigarettes in 
response to a menthol ban reported quitting 1 year after the menthol 
ban was implemented (Ref. 224). Fifteen percent of those who planned to 
switch to non-

[[Page 26475]]

menthol cigarettes, 34 percent of those who planned to switch to other 
flavored tobacco products, 19 percent of those who planned to switch to 
contraband, and 24 percent of those who were unsure of their response 
before the menthol ban also reported quitting cigarettes 1 year after 
the menthol ban (Ref. 224).
    An additional study asked U.S. adult menthol smokers to complete a 
hypothetical shopping task in a virtual store under one of four 
experimental conditions that simulated various policy scenarios (1--no 
ban, 2--replacement of menthol cigarettes and ads with green 
replacement versions (i.e., the term ``menthol cigarettes'' is replaced 
with the term ``green cigarettes''), 3--menthol cigarette ban, 4--all 
menthol tobacco product ban) and assessed tobacco purchases (Ref. 225). 
This study found that participants in scenarios with a menthol 
cigarette ban and all menthol tobacco product bans were less likely to 
purchase cigarettes than participants who were exposed to no ban (Ref. 
225). This finding supports FDA's expectation that many menthol 
cigarette smokers would quit smoking altogether after implementation of 
a menthol product standard.
    Real-world experience from Canada's laws prohibiting the sale of 
menthol tobacco products provides information on the potential 
behavioral impacts the menthol product standard could have on cigarette 
use in the United States. Studies evaluating the impact of these laws 
have found increased reports of quit attempts and quitting smoking 
following policy implementation (Refs. 226, 224, 227, 216). These 
findings are consistent with the Agency's expectation that, following 
implementation, the proposed menthol product standard would increase 
the number of menthol cigarette smokers who quit cigarette use. After 
menthol sales restrictions in Quebec, Ontario, Prince Edward Island, 
Newfoundland, and Labrador, and a nationwide restriction covering 
British Columbia, Saskatchewan, and Manitoba, smokers from these 
provinces reported high rates of quit attempts and quitting smoking 
(Refs. 226, 224, 227, 216). In a study of Ontario 1 year after policy 
implementation, 56 percent of study participants who were smokers 
before the sales restriction reported making a quit attempt and 19 
percent reported quitting smoking (Ref. 224). In a study of smokers 
from the Canadian provinces previously mentioned, 21.5 percent of pre-
ban menthol smokers reported quitting smoking (defined as those who had 
currently quit or cut down to smoking less than monthly) after policy 
implementation (Ref. 216). Another study of adult smokers from Canadian 
provinces that implemented menthol sales restrictions found a small 
non-significant increase in the likelihood of ever trying to quit 
following policy implementation (Ref. 197). While the percent of 
smokers who reported quitting post-policy in these studies varies based 
on the length of time after policy implementation, geographic location, 
and definition of quitting, the percent of quitting post-policy in 
these studies was higher than the percent of current smokers from 
Ontario who reported quitting smoking 30 days or longer pre-policy in 
2014 (7.9 percent) (Ref. 228). This suggests the various Canadian 
menthol sales restrictions contributed to increases in the number of 
smokers who quit smoking. The high rates of quit attempts and quitting 
smoking in Canada after menthol sales restrictions support FDA's 
expectation that a ban on menthol cigarettes would increase the 
likelihood that existing menthol cigarette smokers will stop smoking 
cigarettes altogether. For reference, in 2018 in the United States, 
recent successful quitting (quit smoking for >=6 months during the past 
year) was 7.5 percent among those who were either current smokers who 
smoked for >=2 years or former smokers who quit during the past year 
(Ref. 229). Even if only a portion of the increase in cessation seen in 
Canada is experienced in the United States as a result of the proposed 
menthol standard, there would still be a significant net public health 
benefit.
    Further supporting FDA's expectation that a prohibition on menthol 
cigarettes would increase quitting by menthol cigarette smokers is 
evidence from Canada that menthol smokers there report higher rates of 
quit attempts and quitting smoking than non-menthol smokers (Refs. 224, 
227, and 216). Studies from Ontario 1 year and 2 years after policy 
implementation found a higher likelihood of quit attempts and quitting 
smoking among those who reported smoking menthol cigarettes daily 
before the sales restriction (baseline) when compared with smokers who 
reported smoking non-menthol cigarettes daily (Refs. 224 and 227). 
Similarly, in a study looking across seven Canadian provinces with 
menthol sales restrictions, menthol smokers were more likely than non-
menthol smokers to make a quit attempt and remain quit (quit greater 
than 6 months at follow-up and were long-term quitters who stopped 
smoking before the nationwide ban and remained quit) (Ref. 216). In 
addition, there is evidence that previous menthol smoking is not 
associated with relapse (Refs. 227 and 216). This suggests that menthol 
sales restrictions help those who quit smoking menthol cigarettes to 
stay quit. Taken together, the results from these studies support FDA's 
expectation that menthol smokers will achieve quit rates similar to or 
higher than non-menthol smokers because of a menthol product standard.
    Findings on cessation from Ontario are consistent with analyses of 
tobacco manufacturer wholesale sales data and retail scanner data 
(Refs. 230 and 231). These data are often used as a proxy for cigarette 
consumption. An analysis of wholesale cigarette sales data in 10 
Canadian provinces found an overall decrease of 4.6 percent in total 
cigarette sales after menthol cigarette bans (Ref. 232). Another 
analysis of tobacco manufacturer wholesale sales data showed that total 
cigarette sales declined by 128 million units following the Ontario 
menthol sales restriction compared to British Columbia, a Canadian 
province demographically similar to Ontario that did not have a menthol 
sales restriction in place at the time of the study, in which no 
significant changes were observed (Ref. 230).
    There are considerations in relying on: (1) Canadian-based data to 
inform U.S. policy and (2) tobacco manufacturer wholesale sales and 
retail sales data as a proxy for consumption. With regard to the 
Canadian-based data to inform U.S. policy, it is important to note that 
menthol cigarettes comprise a larger proportion of cigarettes sales in 
the United States (e.g., 26 percent in the United States versus 4 
percent in Canada in 2001) and that a larger proportion of Black 
cigarette smokers in the United States use menthol cigarette brands 
(e.g., 78.4 percent of Black cigarette smokers in the United States 
versus 9.8 percent of Black cigarette smokers in Canada in 2002) (Ref. 
88). Therefore, findings from Canada likely underestimate the impact of 
a menthol cigarette ban in the United States. Findings from Canada's 
menthol sales restrictions corroborate evidence from evaluations of 
flavored tobacco product sales restrictions in the United States (e.g., 
Massachusetts; Providence, RI; New York City, NY; San Francisco, CA) 
that found that sales and use of tobacco products covered by the flavor 
restriction decreased after implementation (Refs. 193, 200, 199, 209, 
190).
    With regard to relying on tobacco manufacturer wholesale sales and 
retail sales data as a proxy for consumption, such data do not 
completely reflect individual-level tobacco use behaviors.

[[Page 26476]]

For example, smokers may have obtained cigarettes through channels not 
included in the Ontario sales data (e.g., other provinces) or switched 
to non-restricted products, which may result in an overestimation of 
the impacts. The analysis of tobacco manufacturer wholesale data found 
a significant decline in the overall cigarette sales in Ontario in the 
month following Ontario's menthol sales restriction. This was followed 
by a statistically significant increase in the sales of overall 
cigarettes driven by an increase in non-menthol cigarettes in Ontario, 
suggesting a slight rebound effect; however, overall cigarette sales 
approximately 8 months following the menthol sales restriction were 
lower than study baseline (October 2012) (Ref. 230). Similarly, an 
analysis of retail sales data found a small increase (0.4 percent) in 
sales of non-menthol cigarettes in the 6 months following policy 
implementation (Ref. 231). In spite of this limitation, considering 
sales data with the self-report data suggests increased smoking 
cessation occurred as a result of the sales restriction.
    As mentioned previously, several U.S. localities have placed 
restrictions on the sale of menthol cigarettes in addition to 
restrictions on the sale of flavored tobacco products. FDA is aware of 
two studies that report on the impact of the policy in San Francisco on 
cessation. The first, a retrospective study with a relatively small 
convenience sample of young adult ever tobacco users in San Francisco 
found of 20 exclusive menthol cigarette smokers before the policy, 5 
percent (n=1) quit any tobacco use after the policy and, among 61 
menthol cigarette and other tobacco users before the policy, 3.3 
percent (n=2) quit after the policy (Ref. 191). A second study 
examining the impact of the same policy among clients enrolled in a San 
Francisco residential substance use disorder treatment facility found 
that participants surveyed about 5 months after the policy (n=102) were 
statistically significantly less likely to report menthol as the usual 
cigarette smoked compared to participants surveyed before the policy 
(Ref. 233). This study found no evidence that the policy was associated 
with decreased number of cigarettes per day or increased readiness to 
quit among current smokers (Ref. 233). The marginal effects observed in 
this study are not entirely unanticipated. Smoking prevalence rates are 
substantially higher among individuals with substance use disorder 
compared to those in the general population (Refs. 234-237), and these 
individuals report increased nicotine dependence levels (Ref. 238) and 
have less success at quitting smoking than individuals without 
substance use disorders (Refs. 239 and 240). Additionally, studies show 
that drugs of abuse may have unique pharmacological interactions with 
nicotine, increasing the reinforcing effects of both smoking and drug 
use among these populations (Refs. 241-244). This population with 
substance use disorder may have been less sensitive to the regional 
menthol ban compared to the general population due to their unique risk 
factors and pervasive patterns of tobacco use.
    Taken together, these two San Francisco studies provide limited 
evidence of the impact of a menthol cigarette sales restriction on 
cessation in the United States (Refs. 191 and 233). Both studies rely 
on convenience samples and do not include a control group (Refs. 191 
and 233) limiting their generalizability to people other than study 
participants. In addition, the retrospective study of a convenience 
sample of young adult ever tobacco users in San Francisco (Ref. 191), 
only collects data after the policy was implemented. Given this, FDA 
relies more on the evidence from Canada which includes multiple 
longitudinal cohort studies of the general population at different time 
points following policy implementation and in various locations that 
have implemented menthol sales restrictions to inform expectations on 
the impact of the proposed product standard on cessation.
    As discussed previously, evaluations of local policies may 
underestimate the potential impact of a national policy. Depending on 
availability of tobacco products in jurisdictions neighboring those 
where local policies were passed, users and non-users may easily be 
able to access tobacco products from these locations. For example, in 
the study examining clients enrolled in San Francisco residential 
substance use disorder treatment facilities, 50 percent of menthol 
smokers reported purchasing menthol cigarettes in San Francisco after 
the menthol sales restriction (Ref. 233). Overall, the evidence 
supports that following a menthol sales restriction or ban, adult 
menthol cigarette smokers' quit attempts and quitting smoking 
increases. FDA anticipates that a nationwide standard that prohibits 
the manufacture and sale of menthol cigarettes would likely have a 
greater impact in increasing cigarette smokers' quit attempts and 
quitting smoking compared to that observed from policies from limited 
jurisdictions, because a nationwide product standard would eliminate 
the manufacture of these products as well as the opportunity to easily 
travel to neighboring jurisdictions within the United States that do 
not have a menthol sales restriction or use online retailers to 
purchase menthol cigarettes. While the 2020 Surgeon General's Report, 
``Smoking Cessation'', concluded that ``the evidence is suggestive but 
not sufficient to infer that restricting the sale of certain types of 
tobacco products . . . increases smoking cessation . . . ,'' this 
assessment was based on empirical evidence published through 2019 (Ref. 
245). Numerous studies have been published since the 2020 Surgeon 
General's Report and were considered in FDA's assessment of the impact 
of a proposed product standard on cessation. The recently published 
evaluation studies have examined the impact of menthol sales 
restrictions in multiple Canadian provinces (Refs. 216, 230, 227, 231-
232, 197) and state and local jurisdictions in the United States (Refs. 
190-191, 233, 193). When these studies are considered with the 
evaluation evidence published before 2020, FDA concludes that there is 
substantial evidence of increases in quit attempts and quitting by 
adult smokers after a menthol cigarette sales restriction (Refs. 77, 
197, and 193). Further, recent longitudinal data from the PATH study 
and a systematic review of the literature all indicate that menthol 
cigarette smoking is associated with reduced cessation success compared 
to non-menthol smokers (Refs. 40, 43, and 41). Thus, by banning menthol 
cigarettes, FDA expects to increase smoking cessation across the 
population. This is further evidenced by expert elicitation and 
simulation studies, which assessed and modeled menthol restrictions in 
the United States, resulting in substantial estimated public health 
benefits (Refs. 46 and 211). These findings, all more recent than the 
2020 Surgeon General's Report, suggest that a menthol ban is 
appropriate for the protection of the public health.
    The sum of the available evidence, including the interaction of 
menthol and nicotine in the brain, the continued use of menthol 
cigarettes by millions of Americans, the difficulties of quitting 
smoking for menthol smokers, and the empirical evidence from policies 
restricting the sales of menthol cigarettes in Canada and flavored 
tobacco products in the United States, suggest that the proposed 
standard would lead many menthol cigarette smokers to stop using 
cigarettes, yielding considerable health benefits. There are currently 
more than 18.5 million menthol cigarette smokers ages

[[Page 26477]]

12 and older in the United States (Ref. 44). Thus, even small changes 
in initiation and cessation would result in a significant reduction in 
the burden of death and disease caused by smoking. Further, given the 
high concentration of menthol cigarette smoking among underserved 
communities, the effect of the standard on reducing cigarette smoking 
would be expected to be greater in these populations. From the expected 
public health impact on current adult menthol cigarette smokers alone, 
this proposed product standard is appropriate for the protection of the 
public health.
    As discussed in section III.B.4 of this document, FDA 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.

C. Benefits and Risks to the Population as a Whole

    We expect that the proposed menthol product standard, if finalized, 
would reduce tobacco-related harms. As discussed in section IV of this 
document, the addition of menthol as a characterizing flavor to 
cigarettes makes it easier to start smoking, easier to continue 
smoking, and harder to quit smoking. By prohibiting the addition of 
menthol as a characterizing flavor to cigarettes sold in the United 
States, FDA anticipates that reductions in population harm would be 
realized through long-term health benefits resulting from prevention of 
cigarette uptake and progression to regular cigarette smoking among 
youth and young adults, as described in section V.A of this document, 
as well as shorter-term health benefits resulting from increased 
cessation of cigarette smoking among current menthol smokers, as 
described in section V.B of this document. Each of these impacts alone 
would result in significant health benefits to the U.S. population. In 
totality, they provide overwhelming evidence that the proposed standard 
would result in substantial health benefits over both the short- and 
long-term. In this section, we summarize the health benefits of never 
progressing to regular cigarette smoking, the health benefits of 
quitting smoking, the potential health benefits of switching from 
cigarettes to potentially less harmful tobacco products, and the health 
benefits of not being exposed to secondhand smoke. We also describe 
findings from population modeling studies that estimate the public 
health impact of the proposed standard. Finally, we describe potential 
risks of the product standard, including risks of countervailing 
effects of the tobacco standard such as increasing demand for 
contraband.
1. Given the Harmful Effects of Cigarette Smoking, Never Progressing to 
Regular Smoking Prevents Death and Disease
    Never progressing to regular cigarette smoking prevents death and 
disease caused by smoking. Any effects of a menthol ban on preventing 
youth, young adult, and even adult never smokers from initiating/
experimenting and progressing to regular cigarette smoking will have a 
population health benefit. According to the 2014 Surgeon General's 
Report, ``The Health Consequences of Smoking: 50 Years of Progress'', 
which summarizes thousands of peer-reviewed scientific studies and is 
itself peer-reviewed, smoking remains the leading preventable cause of 
death in the United States, and cigarettes have been shown to cause an 
ever-expanding number of diseases and health conditions (Ref. 1). As 
stated in the report, ``cigarette smoking has been causally linked to 
disease of nearly all organs of the body, to diminished health status, 
and to harm to the fetus'' and ``[t]he the burden of death and disease 
from tobacco use in the United States is overwhelmingly caused by 
cigarettes and other combusted tobacco products'' (Ref. 1 at 37).
    The 2014 Surgeon General's Report estimates that 16 million people 
live with diseases caused by smoking cigarettes (Ref. 1). Comparing 
mortality to morbidity, for every person who dies from smoking, 30 more 
are living with a smoking-attributable disease (Ref. 1). Smoking is 
causally associated with a number of diseases affecting nearly all 
organs in the body, such as numerous types of cancer, heart disease, 
stroke, lung diseases such as chronic obstructive pulmonary disease, 
and diabetes, in addition to putting individuals at increased risk for 
tuberculosis, certain eye diseases, and immune system issues (Ref. 1). 
Furthermore, maternal smoking is causally associated with multiple 
adverse fetal outcomes, including fetal growth restriction and low 
birth weight, premature rupture of the membranes, placenta previa, 
placental abruption, preterm birth, preeclampsia, reduction of lung 
function in infants, and sudden infant death syndrome (SIDS) (Ref. 1).
    A study using 2006-2012 data from the NHIS estimated that 6.9 
million U.S. adults had a combined 10.9 million self-reported smoking-
attributable medical conditions, highlighting that smoking cigarettes 
often causes co-morbid diseases (Ref. 246). The study noted that the 
morbidity estimates are likely underestimates due to underreporting of 
diseases in surveys and the lack of assessment of several major medical 
conditions (Ref. 246). Thus, it is likely that the true morbidity 
burden in the United States is substantially more than these estimates.
    An analysis of the National Longitudinal Mortality Study, a 
longitudinal population-based, nationally representative health survey 
with mortality data from the National Death Index, found that exclusive 
regular cigarette smokers had substantially higher all-cause mortality 
risks than never tobacco users (Ref. 247). Another analysis, which 
examined NHIS data, found that life expectancy was shortened by more 
than 10 years among current cigarette smokers, compared with those who 
had never smoked (Ref. 248). Even non-daily smokers have higher 
mortality risk than never smokers. A recent study pooled data from the 
1991, 1992, and 1995 NHIS and were linked to data from the National 
Death Index through 2011 (Ref. 249). The study indicated that lifelong 
non-daily smokers, who had smoked cigarettes on a median of 15 days and 
50 cigarettes per month, had a 72 percent higher overall mortality risk 
resulting in about a 5-year shorter lifespan, than never smokers (Ref. 
249). The study also found a gradient in number of cigarettes smoked 
among non-daily users, with higher mortality risks observed among 
lifelong non-daily smokers who reported 31-60 cigarettes per month and 
more than 60 cigarettes per month than never smokers, but no difference 
among those who smoked 11-30 cigarettes per month (Ref. 249). Daily 
smokers in the study had an even higher mortality risk and shorter 
survival (about 10 years less) than never smokers (Ref. 249).
    As previously discussed, menthol cigarette smoking facilitates 
progression to regular cigarette smoking among youth and young adults. 
African American smokers are more likely than smokers from other racial 
and ethnic groups to try a menthol cigarette as their first cigarette, 
regardless of age (Refs. 33, 25, and 31). FDA anticipates that a 
menthol restriction will prevent a substantial number of youth, and 
especially Black youth, from initiating menthol cigarette smoking, 
thereby decreasing progression to regular cigarette smoking, resulting 
in reduced tobacco-related morbidity and mortality associated with 
menthol cigarette smoking.

[[Page 26478]]

2. Given the Harmful Effects of Cigarette Smoking, Quitting Smoking 
Reduces Death and Disease
    Quitting cigarette smoking, including menthol cigarettes, 
substantially reduces the likelihood of tobacco-related death and 
disease. As stated in the 2004 Surgeon General's Report, ``[q]uitting 
smoking has immediate as well as long-term benefits, reducing risks for 
diseases caused by smoking and improving health in general'' (Ref. 
250). The 2020 Surgeon General's Report also concluded, ``[s]moking 
cessation is beneficial at any age. Smoking cessation improves health 
status and enhances quality of life.'' (Ref. 245). As previously noted, 
FDA expects that, if this proposed rule is finalized, there will be a 
significant increase in smoking cessation in the U.S. population (see 
section V.B).
    The benefits associated with smoking cessation happen quickly (Ref. 
250). Within 2 to 12 weeks of quitting smoking, an individual's lung 
function and blood circulation improve (Ref. 250). During the first 1 
to 9 months after cessation, coughing and shortness of breath decrease 
(Ref. 250). Within several months of quitting smoking, individuals can 
expect improvement in lung function (Ref. 250).
    The benefits continue for those who remain smoke-free. Smoking 
cessation reduces the risk of cancers and other diseases (Ref. 245). 
For example, the risk of fatal lung cancer in adults over 55 is about 
25 times higher among smokers relative to people who have never smoked 
(Ref. 251). After 10-15 years of abstinence from smoking, the risk of 
lung cancer is about 50 percent of the risk for individuals who 
continue to smoke (Ref. 245). The risk of cancer of the mouth, throat, 
esophagus, stomach, bladder, cervix, pancreas, liver, kidney, colon, 
rectum, and the risk of acute myeloid leukemia also decreases (Refs. 
252 and 245). The evidence is also sufficient to infer that the risk of 
stroke decreases after smoking cessation, and approaches that of never 
smokers over time (Ref. 245). Furthermore, the evidence is sufficient 
to infer that the relative risk of coronary heart disease among former 
smokers compared with never smokers falls rapidly after cessation and 
then declines more slowly (Ref. 245).
    Even smokers who quit smoking after the onset of life-threatening 
disease experience health benefits from cessation. Quitting smoking 
after a diagnosis reduces the chance of recurrences and future health 
problems. For example, people who quit smoking after having a heart 
attack can reduce their chances of having a second heart attack by 50 
percent (Ref. 252). For those persons who have already developed 
cancer, quitting smoking reduces the risk of developing a second cancer 
(Refs. 253-256). Additionally, quitting smoking after a diagnosis of 
lung cancer reduces the risk of cancer progression and mortality (Ref. 
257). Researchers also estimate that for current smokers diagnosed with 
coronary heart disease, quitting smoking reduces the risk of death 
overall, and reduces the risk of recurrent heart attacks and 
cardiovascular death by 30 to 40 percent (Refs. 245 and 256). The 2020 
Surgeon General's Report concluded that quitting smoking reduces the 
risk of fatal stroke, and earlier reports have also said that it is 
reasonable to assume that quitting smoking would reduce the risk of 
recurrent strokes (Refs. 245 and 256). Quitting smoking also helps the 
body tolerate the surgery and treatments, such as chemotherapy and 
radiation, associated with certain smoking-related diseases (Refs. 250, 
253, 256, 258) and reduces the risk of respiratory infections compared 
to continued smoking (Refs. 256 and 259).
    Given the reduction in risk of smoking-related death and disease 
associated with cessation, those who successfully quit smoking increase 
their life expectancy. Using data from the Cancer Prevention Study II 
(CPS II), an ongoing study of 1.2 million adults, scientists have found 
that men who smoked at 35 years old and continued to smoke until death 
had a life expectancy of 69.3 years, compared with a life expectancy of 
76.2 years for those who stopped smoking at age 35 (Ref. 260). After 
adjusting for the subsequent quit rate among current smokers at 
baseline (to account for the possibility that some current smokers at 
baseline quit smoking or some former smokers relapsed during followup 
and, thus, were incorrectly classified as continuing smokers in the 
unadjusted analysis), the life expectancy for male former smokers 
increased to 77.8 years (a life extension of 8.5 years) (Ref. 260). 
Women who smoked at 35 years old and continued to smoke until death had 
a life expectancy of 73.8 years, compared with a life expectancy of 
79.7 years for those who stopped smoking at age 35 (Ref. 260). After 
adjustment for the subsequent quit rate among current smokers at 
baseline, the life expectancy for female former smokers increased to 81 
years (a life extension of 7.7 years) (Ref. 260). Further, a man aged 
60 to 64 who smokes 20 cigarettes (one pack) or more per day and then 
quits smoking reduces his risk of dying during the next 15 years by 10 
percent (Ref. 256).
    While cessation is beneficial for all ages, the health benefits are 
greatest for people who stop smoking at earlier ages (Refs. 256 and 
250). Scientists in the United Kingdom found those who quit smoking at 
age 30 reduce their risk of dying prematurely from smoking-related 
diseases by more than 90 percent (Refs. 261 and 262). Those who quit at 
age 50 reduce their risk of dying prematurely by 50 percent compared to 
those who continue to smoke (Ref. 262). Using data from the NHIS, 
researchers also estimated that life expectancy in the United States 
would increase 4 years among smokers quitting cigarettes at 55 to 64 
years of age, and 10 years among smokers quitting cigarettes at 25 to 
34 years of age (Ref. 248). Scientists using the CPS II data (while 
accounting for the possibility that some current smokers at baseline 
quit smoking and some former smokers relapsed during followup) found 
that even smokers who quit at age 65 had an expected life increase of 2 
years for men and 3.7 years for women (Ref. 260).
    As discussed previously, there is a lower quit rate among smokers 
of menthol cigarettes than there is for non-menthol cigarettes. FDA 
anticipates that prohibiting menthol as a characterizing flavor in 
cigarettes would improve smoking cessation outcomes in adult smokers 
and result in longer life expectancies for more individuals. 
Additionally, FDA anticipates that this proposed product standard will 
benefit vulnerable populations by reducing tobacco-related morbidity 
and mortality by improving quitting and cessation among these 
populations. As previously discussed, the role of menthol in cigarettes 
in reducing cessation success among smokers is more pronounced among 
certain population groups, in particular, among Black smokers. 
Additionally, research has shown that cigarette smokers from 
underserved communities bear a disproportionate burden of tobacco-
related morbidity and mortality. African Americans, and in particular 
African American men, experience the highest rates of incidence and 
mortality from tobacco-related cancers compared to people from other 
racial and ethnic groups (Refs. 263 and 264). Additionally, mortality 
due to tobacco-related disease such as heart disease, stroke, and 
hypertension is higher among African Americans compared to other racial 
and ethnic groups (Refs. 265-270, 50). Furthermore, as previously 
discussed, compared to White smokers, Black smokers report they may be 
more likely to quit smoking altogether if menthol

[[Page 26479]]

cigarettes were unavailable following a menthol restriction (Refs. 214, 
215, and 217). Based on these collective findings, FDA anticipates that 
the proposed product standard will improve smoking cessation outcomes 
among vulnerable populations, in particular, Black smokers, leading to 
a reduction in adverse tobacco-related health effects in these 
populations.
3. Given the Harmful Effects of Cigarette Smoking, Switching to a 
Potentially Less Harmful Nicotine Delivery Product May Reduce Death and 
Disease
    FDA recognizes that smokers who choose to switch completely to a 
potentially less harmful nicotine delivery product to maintain their 
nicotine dose also could, to the extent that those products result in 
less harm, significantly reduce their risk of tobacco-related death and 
disease (Ref. 271). The least harmful nicotine delivery products 
available to smokers are the pharmaceutical nicotine replacement 
therapies already approved by FDA as both safe and effective cessation 
tools, many of which are available in a variety of flavors, including 
mint, which could appeal to menthol smokers. However, smokers may also 
transition to tobacco products which utilize other forms of nicotine 
delivery in place of smoking combusted cigarettes. These include 
smokeless tobacco, dissolvable products, and ENDS products, among 
others.
    In surveys, some menthol cigarette smokers and some dual users of 
menthol cigarettes and ENDS report intending to use ENDS if menthol 
cigarettes were no longer available (Refs. 221, 272, and 222). 
Experimental marketplace studies also suggest that, in addition to 
taking other actions, some menthol smokers may switch partially or 
fully to ENDS in the event of a menthol cigarette ban (Refs. 273 and 
225). These empirical findings are consistent with the 2020 Surgeon 
General's Report, titled ``Smoking Cessation,'' and several systematic 
reviews, which suggest that some adult cigarette smokers report using 
ENDS to try to reduce or quit smoking (Refs. 245, 274-276). The 
literature also suggests that cigarette smokers who use ENDS more 
frequently (versus less frequently) have improved success in switching, 
however the long-term patterns of use remain unknown (Refs. 271, 277-
279).
    In an expert elicitation study estimating effects of a menthol ban 
on transitions in use, the panel of experts estimated that among 
menthol smokers aged 35 to 54 years, 55.1 percent would remain 
combustible tobacco users (a reduction of 20.1 percent from the status 
quo), with another 20 percent switching to a ``novel nicotine delivery 
product,'' defined in the study as ENDS or heated tobacco products 
(HTPs) (a 10.3 percent increase from the status quo), and about 22.5 
percent quitting all tobacco use (a 10.0 percent increase from the 
status quo) (Ref. 211). Additionally, the experts estimated that among 
those aged 12 to 24 years who would have initiated as menthol cigarette 
smokers, under the menthol ban, 41.1 percent would still initiate 
combustible tobacco use (including non-menthol cigarettes, cigars, or 
illegal menthol cigarettes), while 17.6 percent would instead initiate 
with a ``novel nicotine delivery product,'' such as ENDS or HTPs; the 
result is a 58.9 percent reduction in combustible tobacco initiation 
from the status quo (Ref. 211). Additional details of the expert 
elicitation study and resulting population model study can be found in 
section V.C.5 of this document.
    Data from the 2017 Ontario menthol sales restriction did not show 
increases in menthol smokers' self-reported use of e-cigarettes (Ref. 
280) or increases in retail sales of e-cigarettes (Ref. 231) following 
policy implementation. To the extent that this may occur following 
implementation of this product standard, FDA recognizes that completely 
switching from combusted tobacco products to ENDS has the potential to 
reduce some tobacco-related disease risks among individual users (Ref. 
271). However, cessation of all tobacco products leads to the greatest 
reduction in tobacco-related disease and death (Ref. 245).
4. Having Fewer People Smoke Cigarettes Will Reduce Smoking-Related 
Death and Disease Associated With Secondhand Smoke Exposure
    Secondhand smoke exposure is harmful to the health of non-smokers. 
The 2006 Surgeon General's Report, ``The Health Consequences of 
Involuntary Exposure to Secondhand Smoke,'' concluded that ``secondhand 
smoke exposure causes premature death and disease in children and in 
adults who do not smoke'' (Ref. 281). Exposure to secondhand smoke is a 
cause of cancer and respiratory and cardiovascular disease (Ref. 1). 
According to the 2014 Surgeon General's Report, more than 437,000 
premature deaths per year are caused by active cigarette smoking, and 
an additional 41,280 premature deaths among adults aged 35 years and 
older are due to secondhand smoke (Ref. 1). Specifically, the 2014 
Surgeon General's Report estimated secondhand smoke causes 
approximately 7,330 deaths from lung cancer and 33,950 deaths from 
coronary heart diseases in non-smokers annually (Ref. 1).
    Secondhand smoke is particularly harmful to children. The 2014 
Surgeon General's Report estimated that secondhand smoke is associated 
with 150,000 to 300,000 lower respiratory tract infections in infants 
and children under 18 months of age, 790,000 doctor's office visits 
related to ear infections per year, and 202,000 asthma cases each year 
(Refs. 282 and 1). In 2014, the Surgeon General reported 400 SIDS 
deaths related to perinatal smoking or exposure to secondhand smoke; 
the ``Reproductive Outcomes'' section describes the impact of perinatal 
smoking (Ref. 1). Children of parents who smoke, when compared with 
children of nonsmoking parents, have an increased frequency of 
respiratory infections like pneumonia and bronchitis (Ref. 256). 
Children exposed to tobacco smoke in the home are also more likely to 
develop acute otitis media (middle ear infections) and persistent 
middle ear effusions (fluid behind the eardrum) (Ref. 256).
    More recent data from the 2013-2014 NHANES estimates that 
approximately 58 million American non-smokers (1 in 4) were exposed to 
secondhand smoke, including 14 million children (Ref. 283). 
Approximately half of all U.S. children aged 3 to 18 years are exposed 
to cigarette smoke regularly at home or other locations that still 
permit smoking (Ref. 1). In 2019, approximately one-quarter of middle 
and high school students reported breathing in secondhand smoke in 
their homes or in a vehicle (Ref. 284).
    The burden of secondhand smoke exposure is experienced 
disproportionately among members of some racial or ethnic groups and 
lower income groups. Among nonsmokers age 3 and older, findings from 
2011-2018 NHANES data indicate that non-Hispanic Black persons and 
those living below the poverty level had the highest levels of 
secondhand smoke exposure compared to people of other races and those 
living above the poverty level, respectively; these disparities 
persisted across all years of the study analysis from 2011 to 2018 
(Ref. 285). From 1999 to 2012, the percentage of the nonsmoking 
population age 3 and older exposed to secondhand smoke (defined in the 
study as levels 0.05-10 ng/mL) declined across all racial and ethnic 
groups (Ref. 286). However, a significantly higher proportion of non-
Hispanic Black nonsmokers continued to have detectable serum cotinine 
levels, compared to Mexican American and non-Hispanic White nonsmokers. 
For example, in 2011-2012, nearly 50

[[Page 26480]]

percent of non-Hispanic Black nonsmokers had detectable serum cotinine 
levels, compared with 22 percent of non-Hispanic White and 24 percent 
of Mexican American nonsmokers (Ref. 286).
    Disparities in the secondhand smoke exposure are found across 
various environmental settings. These disparities speak to the 
interrelated influences of individual factors (e.g., age, race and 
ethnicity, income) and existing inequities in places where members from 
underserved communities are likely to reside, spend time, and work 
(Ref. 49). Findings drawn from the 2013-2016 NHANES data indicate that 
compared to non-Hispanic Whites, non-Hispanic Blacks had higher odds of 
secondhand smoke exposure in homes other than their own (Ref. 27). An 
analysis of NYTS data indicates that non-Hispanic Black and non-
Hispanic White students both had higher prevalence of secondhand smoke 
exposure at home and in vehicles than Hispanic and non-Hispanic other 
students (Ref. 284). While secondhand smoke exposure in homes and 
vehicles significantly declined from 2011 to 2018, secondhand smoke 
exposure in homes among non-Hispanic Black students did not change 
(Ref. 284). Home smoking bans (or household rules that restrict or ban 
smoking inside the home) can reduce secondhand smoke exposure. A study 
using 1995-2007 data from the TUS-CPS found that among two parent 
households, higher levels of parental educational level, higher levels 
of annual household income, and both parents being Hispanic, non-
Hispanic, Other race, or other combinations of parents of different 
race/ethnicities were associated with the higher reporting of a 
complete home ban as compared to lower levels of parental educational, 
lower levels of annual household income, and both parents being non-
Hispanic White, respectively (Ref. 287). Such findings are consistent 
with a higher degree of autonomy over home environment for households 
with greater economic resources and housing flexibility, emphasizing 
the degree to which certain aspects of disadvantage (such as lower 
family income, lack of access to single-family housing, or lack of 
autonomy over the home environment) may compound tobacco-related health 
disparities. Workplace secondhand smoke exposure has also been shown to 
vary across population groups. Data from the 2010 and 2015 NHIS show 
that exposure to secondhand smoke in the workplace was 
disproportionately high among non-Hispanic Blacks, Hispanics, and 
workers with low education and low income (Ref. 288). Additionally, the 
study findings indicated that ``blue-collar workers'' (defined as those 
who performed manual labor such as manufacturing, mining, sanitation, 
and construction) experienced higher prevalence of secondhand smoke 
exposure as compared to ``white-collar workers'' (defined as those who 
primarily work in an office, with computer and desk setting, and 
perform professional, managerial, or administrative work) (Ref. 288). 
The proposed product standard is anticipated to reduce smoking-related 
morbidity and mortality for these vulnerable populations, especially 
youth.
    FDA expects that the proposed menthol product standard would reduce 
the number of smokers and decrease non-smokers' exposures to secondhand 
smoke. As evidenced by evaluations of smoke-free policies, decreasing 
exposure to secondhand smoke will reduce exposure to tobacco smoke 
pollution and decrease smoking-related death and disease (Refs. 289 and 
290).
5. Results From Simulation Models Are Consistent With the Findings That 
Prohibiting Menthol Cigarettes Would Benefit the Population's Health
    The population health benefit of prohibiting menthol cigarettes has 
been examined in several simulation studies conducted in the past 
decade (Refs. 46, 211, 291, 45). A 2021 study by Levy et al. simulated 
the future benefit of a menthol cigarette ban on the U.S. population as 
a whole over the 2021-2060 period (Ref. 46). This model compared a 
Status Quo Scenario, in which no menthol ban was implemented, to a 
simulated Menthol Ban Scenario in which a complete ban on menthol 
cigarettes and cigars was implemented in 2021.\12\ Additionally, as 
part of the model, it took into account the use of ENDS products 
(``nicotine vaping products'') by smokers and non-smokers over the 
study period (Refs. 46, 211, and 291).
---------------------------------------------------------------------------

    \12\ The Menthol Ban Scenario models a ban of menthol in 
cigarettes and cigars, but includes only the benefits attributed to 
the menthol cigarette ban. Cigars are covered in the model because 
it is assumed that menthol cigarette smokers could simply switch to 
menthol cigars if a menthol cigarette ban was put in place and if 
menthol cigars were still available. FDA's expectation is that, even 
if menthol was not prohibited as a characterizing flavor in cigars, 
this rule would still reduce initiation and experimentation of 
cigarette smoking, decrease nicotine dependence and addiction, and 
increase cessation among current menthol cigarette smokers. However, 
since FDA is concurrently pursuing a proposed rule, published 
elsewhere in this issue of the Federal Register, that would prohibit 
characterizing flavors (other than tobacco) in cigars, the Menthol 
Ban Scenario is directly applicable.
---------------------------------------------------------------------------

    The simulation used the Smoking and Vaping Model (SAVM), a model 
capable of simulating the population health effects of cigarette 
smoking and ENDS use for specific birth cohorts. For this study, the 
model was extended to evaluate non-menthol and menthol cigarettes 
separately, with the following use states captured in the model 
compartments: (1) Never users, (2) menthol smokers, (3) non-menthol 
smokers, (4) exclusive ENDS users, (5) former smokers using ENDS, (6) 
former smokers, and (7) former ENDS users.
    The SAVM first utilized historical data from the NHIS (1965-2013) 
for estimates of smoking prevalence (specific model inputs can be found 
in the manuscript) (Refs. 46, 211, and 291). The model projected 
prevalence estimates of never, current, and former smoking by age and 
gender beginning in 2013. The model was then recalibrated using 2013-
2018 NHIS data to improve model estimates of smoking prevalence after 
ENDS products became more widely available around 2013. Next, age- and 
gender-specific rates of smoking initiation (i.e., any initiation of 
regular cigarette smoking by age 40) and cessation (i.e., cessation of 
regular cigarette smoking for 2 years, including those who temporarily 
use ENDS but ultimately quit all tobacco use), cigarettes-to-ENDS 
switching (i.e., cessation of regular cigarette smoking with initiation 
of regular ENDS smoking), and initiation of ENDS use (i.e., initiation 
of regular ENDS use without regular cigarette smoking) were modeled 
using PATH Study data, with separate rates of initiation, cessation and 
switching for menthol and non-menthol smokers. To simplify the model, 
dual users of cigarettes and ENDS were not modeled separately from 
current smokers. Smokers who switched to ENDS before age 35 were 
treated the same as exclusive ENDS users, while smokers who switched to 
ENDS age 35 or later were considered separately as former smokers using 
ENDS. Additionally, the transitions modeled were unidirectional; 
relapse (i.e., reinitiating regular cigarette smoking or ENDS use after 
entering any group containing former smokers/users) was not considered 
in the model. Although age- and gender-specific effects were modeled, 
other sources of population heterogeneity, such as race, ethnicity, 
socioeconomic status, and geographical location, were not simulated.
    Based on PATH Study data and other publications, the ratio of 
menthol to non-menthol cessation was modeled as 0.8 and the ratio of 
menthol to non-

[[Page 26481]]

menthol switching was modeled as 0.9, in effect modeling menthol 
cigarette smokers as 20 percent less likely to quit smoking and 10 
percent less likely to switch to ENDS than non-menthol smokers (Refs. 
46 and 211). Based on PATH Study data, all cigarettes-to-ENDS switching 
was assumed to decline 10 percent annually from 2018. The excess 
relative risk of mortality for ENDS products compared to cigarettes was 
set at 0.15, in effect modeling the mortality risk of ENDS use as 15 
percent of the mortality risk of cigarette smoking over the same 
period.
    To estimate the specific effects of a menthol ban on current and 
future tobacco use, an expert elicitation (EE) was conducted (Ref. 
211). The EE used a systematic approach to identify eleven leading 
academic experts on topics related to the impacts of menthol flavor 
bans in tobacco products. Experts estimated a number of behaviors under 
a menthol ban, such as continued (illicit) menthol product use, menthol 
to non-flavored product switching, switching to other nicotine products 
(e.g., ENDS, smokeless tobacco products), and tobacco cessation. These 
estimates were adapted to fit the simpler structure of the SAVM. For 
example, transitions from cigarettes to HTPs were treated as 
transitions to ENDS, while transitions from menthol cigarettes to non-
menthol cigars were treated as a transition to non-menthol cigarettes. 
Transitions to smokeless tobacco products were also treated as 
transitions to non-menthol cigarettes. Experts estimated the effects of 
a menthol ban for youth and young adults ages 12-24 who would otherwise 
have initiated menthol smoking by age 24 (i.e., counterfactual menthol 
smokers), which were used to calculate the ongoing initiation rates 
beginning with the simulated ban in 2021 in the Menthol Ban Scenario. 
Among menthol smokers in both the Status Quo Scenario and Menthol Ban 
Scenario, experts estimated transitions over a 2-year period for ages 
18-24 and 35-54, which were modeled as mean net differences applied to 
menthol smokers up to age 30 and over age 30, respectively. The ban was 
assumed to have no effects on non-menthol smokers. In the expert 
elicitation study, it is likely that when the experts were answering 
survey questions around tobacco use behaviors under a future menthol 
ban, they considered the products available in the market at the time. 
The marketplace of products may change over time due to a variety of 
reasons, and it is possible that changes in the marketplace, if known, 
may impact experts' judgements about how menthol smokers and non-users 
at risk for initiation may act in response to a menthol ban.
    The model estimated smoking-attributable deaths averted and life-
years lost averted over the 2021-2060 period (Ref. 46). Compared to the 
Status Quo Scenario, in which no menthol ban was implemented, under the 
Menthol Ban Scenario the estimated overall smoking prevalence declined 
14.7 percent by 2026 and 15.1 percent by 2060. This overall decrease 
was due to a sharp reduction in menthol smoking (down 92.5 percent by 
2026, and 96.5 percent by 2060), coupled with a smaller increase in 
non-menthol smoking (up 47.4 percent by 2026, and 58.0 percent by 2060) 
over the same time period. The ban was also estimated to increase ENDS 
use 22.6 percent by 2026, up to a 26.5 percent relative increase by 
2060. Totaling the effects, the model estimated 654,000 premature 
deaths and 11,300,000 life-years lost averted by 2060.
    The study authors also conducted several sensitivity analyses to 
determine which model parameters had the greatest influence on outcome 
estimates (Ref. 46). Increasing the ratio of menthol to non-menthol 
cessation rate from 0.8 to 1.0, in effect making menthol cigarettes no 
harder to quit than non-menthol cigarettes, had the greatest impact on 
the model estimates, resulting in decreasing deaths averted by 29.5 
percent (to 461,000) and life-years lost averted by 24.2 percent (to 
8.58 million). Eliminating the 10 percent annual declines in cigarette-
to-ENDS switching from the model, in effect increasing the appeal of 
complete switching for smokers in later years of the model, reduced 
deaths averted by 20.5 percent (to 520,000) and life-years lost averted 
by 21.9 percent (to 8.83 million). Other sensitivity analyses included 
10 percent absolute increases and decreases in the excess relative risk 
of ENDS products to cigarettes, and 10 percent relative changes in 
smoking initiation, smoking cessation, time-independent cigarette-to-
ENDS switching, ENDS initiation, and ENDS cessation. All of these 
sensitivity analyses resulted in modest (under 10 percent) changes to 
model-predicted deaths and life-years lost averted.
    In addition to the SAVM study, a 2011 study by Levy et al. that 
simulated the future benefit of a menthol cigarette ban was also 
consistent with the findings of other studies. This study estimated 
potential impacts of a U.S. menthol ban on future smoking prevalence 
and smoking attributable mortality for the total population, and for 
African Americans specifically (Ref. 45). The model used data from the 
2003 TUS-CPS to characterize current smoking status, initiation and 
cessation rates by cigarette type, various other sources to 
characterize smoking relapse rates, and CPS II to characterize 
mortality risks, which were treated as equivalent for menthol and non-
menthol smokers. The analysis simulated the 2010-2050 period, with a 
menthol ban going into effect in 2011. The study compared three menthol 
ban scenarios against a status quo scenario with no menthol ban:
    1. 10 percent of menthol smokers quit permanently and 10 percent 
who would have initiated as menthol smokers do not take up smoking,
    2. 20 percent of menthol smokers quit permanently and 20 percent 
who would have initiated as menthol smokers do not take up smoking, and
    3. 30 percent of menthol smokers quit permanently and 30 percent 
who would have initiated as menthol smokers do not take up smoking.
    The study estimated that by 2050, under these menthol ban 
scenarios, 324,000 (scenario 1) to 634,000 (scenario 3) smoking 
attributable deaths would have been averted in the United States 
overall, while relative declines in smoking prevalence were expected to 
range from 4.8 percent to 9.7 percent, under scenarios 1 and 3, 
respectively. Among African Americans, by 2050, an estimated 92,000 to 
238,000 smoking attributable deaths would have been prevented, while 
relative declines in smoking prevalence ranged from 9.1 percent to 24.8 
percent (under scenarios 1 and 3, respectively) (Ref. 45).
    In conclusion, population health models simulating menthol ban 
policies are consistent with a substantial public health benefit. The 
2021 simulation by Levy et al., using the SAVM model, estimated 
approximately 650,000 premature deaths averted and 11.3 million life-
years lost averted in the first 40 years of a menthol cigarette and 
cigar ban beginning in 2021 (Refs. 46, 211, and 291). The prevalence of 
smoking was also estimated to decline 15.1 percent in that period. 
Sensitivity analyses demonstrated that lower cessation among menthol 
smokers compared to non-menthol smokers was a notable driver of the 
public health impact of the simulated menthol ban. The overall findings 
were consistent with the 2011 simulation by Levy et al. that estimated 
324,000-634,000 premature deaths averted under a similar ban and time 
period (Ref. 45).\13\
---------------------------------------------------------------------------

    \13\ The Further Consolidated Appropriations Act, 2020, made it 
unlawful for any retailer to sell a tobacco product to any person 
younger than 21 years of age (Pub. L. 116-94, section 603 (2019)). 
The quantitative estimates of the impact of a menthol ban on 
premature mortality presented in these studies do not take into 
account the impact of T21. However, given the long lag period 
between smoking initiation and premature mortality from smoking, any 
impact of T21 on the mortality benefits described in this rule would 
not be observed for decades into the future. See section II.C.4.a of 
the Preliminary Regulatory Impact Analysis (PRIA) for a discussion 
of T21 impacts on premature smoking-attributable deaths averted 
(Ref. 292).

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[[Page 26482]]

6. Public Health Benefits Not Addressed in the Smoking and Vaping Model
    While the SAVM projections of the potential impact from a menthol 
product standard suggest a significant public health benefit to the 
United States resulting from substantial reductions in smoking 
prevalence, these analyses do not address other additional benefits.
    First, the SAVM simulation does not account for increased quality 
of life from decreased tobacco-related morbidity. The Surgeon General 
has reported that about 30 individuals will suffer from at least one 
smoking-related disease for every person that dies from smoking each 
year (Ref. 245). Researchers in one study estimated that individuals 
are living with 14 million major smoking-related conditions in the 
United States, including more than 7.4 million cases of chronic 
obstructive pulmonary disease, nearly 2.3 million heart attacks, 1.8 
million cases of diabetes, nearly 1.2 million stroke events, more than 
300,000 cases of lung cancer, and nearly 1 million cases of other 
smoking-attributable cancers (bladder, cervix, colon/rectum, kidney, 
larynx, mouth, tongue, lip, throat, pharynx, stomach) (Ref. 246). 
Another study, which examined disparities in tobacco-related cancer 
incidence and mortality, found that tobacco-related mortality decreased 
between 2004 and 2013, however tobacco-related cancer incidence and 
mortality rates remain highest among African Americans, accounting for 
more than 39,000 deaths annually between 2009 and 2013 (Ref. 293). 
Cigarette smoking, in addition to causing disease, can diminish overall 
health status, leading to higher risks for surgical complications, 
including wound healing and respiratory complications, increased 
absenteeism from work, and greater use of health care services (Ref. 
1). Increased smoking cessation, reduced cigarette consumption, and 
lower progression to regular cigarette smoking would reduce not only 
the mortality from smoking, but it also would reduce the enormous 
burden of cigarette-attributable disease in the United States.
    Second, the SAVM simulation does not account for the public health 
impacts of reduced secondhand smoke exposure. Exposure to secondhand 
smoke is a cause of cancer, respiratory, and cardiovascular disease 
(Ref. 1). Secondhand smoke exposure is currently estimated to be 
responsible for over 41,000 deaths annually in the United States (Ref. 
1). Reducing secondhand smoke exposure through increased smoking 
cessation, reduced cigarette consumption, and lower progression to 
regular cigarette smoking would reduce the more than 7,300 lung cancer 
deaths and nearly 34,000 coronary heart disease deaths annually 
attributed to secondhand smoke (Ref. 1). Exposure to secondhand smoke 
can also cause adverse health effects in infants and children. Exposure 
to cigarette smoke among children and adolescents can trigger asthma 
attacks and lead to more frequent respiratory infections compared to 
those not exposed to smoke (Ref. 1). Prenatal tobacco exposure and 
postnatal secondhand smoke exposure increase the risks of fetal deaths, 
fetal growth restriction/low birth weight, respiratory conditions, and 
SIDS (Ref. 1).
    Third, the SAVM simulation does not isolate differential effects as 
experienced by vulnerable populations. Menthol cigarette use, and the 
disease and death linked to such use, is disproportionately high among 
members of vulnerable populations such as African Americans and other 
racial and ethnic groups, those with lower household income, and those 
who identify as LGBTQ+ (Refs. 55-57, 21-24, 44). As a result, a menthol 
restriction is expected to confer larger benefits among these 
vulnerable populations by promoting improved public health outcomes. 
For example, studies have shown that after switching to non-menthol 
cigarettes, Black menthol smokers had greater reductions in cigarettes 
per day when compared to non-Black menthol smokers (Ref. 217). In 
comparison to White smokers, a higher prevalence of Black smokers 
report they would not smoke a non-mentholated cigarette if they could 
not smoke a mentholated cigarette (Ref. 214), a higher prevalence of 
Black menthol smokers reported intentions to quit following a menthol 
restriction (Refs. 219 and 215), and Black menthol smokers had lower 
odds of reporting that they would switch to a non-menthol brand (Ref. 
213). Prior modeling has shown that by 2050, following a 2011 menthol 
ban, an estimated 92,000 to 238,000 smoking attributable deaths among 
African Americans would have been prevented, comprising almost one-
third of the total deaths averted by the ban (Ref. 45). The relative 
reduction in African Americans' smoking prevalence in 2050 was also 
projected to range between 9.1 and 24.8 percent compared to the status 
quo of no menthol ban (Ref. 45).
    Finally, the analysis does not account for reductions in harms 
caused by smoking-related fires. Lower prevalence of cigarette smoking, 
and reduced cigarette consumption are likely to decrease the occurrence 
of fires caused by smoking materials, including cigarettes and other 
lighted tobacco products. Even though all states have instituted laws 
requiring fire-safety-compliant cigarette paper (adoption began in 2003 
with all states adopting these laws by 2012), smoking remained the 
second leading cause of residential fire deaths in the United States in 
2018 (Ref. 294). In 2011, an estimated 90,000 fires in the United 
States were caused by smoking materials, of which 17,600 occurred in 
the home (Ref. 295). Between 2012 and 2016, there were an average of 
18,100 home structure fires per year started by smoking material, 
accounting for around 1 in 20 of all home fires (5 percent) (Ref. 296). 
The fatality rate for smoking-related residential building fires is 
seven times greater than for nonsmoking related fires (Ref. 297). 
Moreover, smoking materials remain the leading cause of fatal home 
fires in the United States and smokers themselves are not the only 
victims (Refs. 295 and 296). One out of every four fatal victims of 
smoking-material fires were not the smoker whose cigarette initiated 
the fire (Ref. 298). Reductions in smoking as a result of the proposed 
standard are likely to have an impact on the 590 deaths and over 1,100 
injuries from smoking-attributable structure fires (Ref. 296).
    We note that, while the impact of a proposed rule prohibiting 
menthol as a characterizing flavor in cigarettes is likely to be 
sizable, there is uncertainty in precisely quantifying the effects. 
Although the exact magnitude of the effects of the proposed ban are 
uncertain, because of the sheer number of smokers currently using 
menthol cigarettes--an estimated 18.5 million persons ages 12 and older 
(Ref. 44)--even modest decreases in the percentage of the population 
initiating smoking and increases in the percentage of the population 
quitting smoking would save many lives.

[[Page 26483]]

7. Potential Risks to the Population as a Whole of the Proposed Menthol 
Product Standard Would Not Outweigh the Potential Benefits of the 
Proposed Product Standard
    There are possible countervailing effects that could occur from the 
proposed product standard, if finalized. Potential risks to the 
population, however, would generally only occur among individuals 
currently using tobacco or smoking cigarettes as FDA concludes there 
are little to no risks to nonusers of tobacco. These potential risks do 
not offset the anticipated benefits of the rule. The countervailing 
effects on current tobacco users could include continued combusted 
tobacco product smoking, smokers seeking to add menthol to their 
combusted tobacco product, and the possibility of illicit trade. As 
part of this rulemaking, FDA is required by the Tobacco Control Act to 
consider information submitted on such possible countervailing effects, 
including among vulnerable populations and other population subgroups.
    With the removal of menthol cigarettes from the tobacco 
marketplace, some cigarette smokers may seek other sources of tobacco 
and/or nicotine. These could include nicotine replacement therapy 
products, non-menthol cigarettes, other combusted tobacco products, or 
other potentially less harmful tobacco products. Findings from 
evaluations of menthol sales restrictions in Canada suggest some users 
switch to non-menthol cigarettes and flavored combusted tobacco 
products following a menthol sales restriction (Refs. 226, 231, 230, 
216, 193, 197).
    FDA acknowledges that the availability of flavored cigars may 
impact the public health benefits of the proposed rule. FDA's 
expectation is that, even if menthol is not prohibited as a 
characterizing flavor in cigars, this rule would reduce initiation of 
and experimentation with cigarette smoking, decrease nicotine 
dependence and addiction to cigarettes, and increase the likelihood of 
cessation among current menthol cigarette smokers. It is also unlikely 
that all current or potential users of menthol cigarettes would switch 
to or initiate with menthol cigars. In studies assessing the potential 
impacts of banning menthol cigarettes, a minority of menthol smokers 
indicated that they might switch to flavored cigars (Refs. 219, 273, 
and 225). However, FDA is concurrently proposing a product standard to 
prohibit characterizing flavors (other than tobacco) in cigars, which 
would decrease the likelihood that menthol smokers would switch to 
cigars as a result of the proposed menthol cigarette standard. Working 
with others in HHS, FDA is currently exploring options to ensure that 
smokers who would like to quit cigarettes or would like to quit tobacco 
product use completely in response to the proposed standard will be 
aware of and have access to resources that provide cessation support.
    FDA recognizes that, while some smokers may switch to non-menthol 
flavored cigarettes, the risks of this won't outweigh the benefits from 
smokers who quit smoking completely. FDA has no reason to believe that 
individuals switching from menthol cigarettes to other combusted 
tobacco products would be exposed to additional harm beyond their 
current exposure level. FDA requests comments regarding additional 
evidence on the extent and magnitude that menthol smokers will switch 
to other combusted tobacco products.
    With the removal of menthol cigarettes from the tobacco 
marketplace, some users could seek out products that will add menthol 
to non-menthol cigarettes (e.g., drops, capsules, filter tips for RYO 
tobacco, or cards that can be inserted into a cigarette pack or pouch 
of rolling tobacco) (Refs. 226, 299, and 300),\14\ which would reduce 
the benefits of the proposed rule. A study of smokers from Ontario 
found that, before the menthol sales restriction, 4.4 percent of daily 
menthol smokers had previously tried flavored additives (including 
flavor cards, drops, oils, or other additives to add menthol to 
tobacco) (Ref. 299). One month after the menthol sales restriction in 
Ontario, 5.1 percent of daily menthol smokers had tried flavored 
additives, 1 year after 12.5 percent had, and 2 years after 9.5 percent 
had (Ref. 299). However, products used to alter or affect the 
cigarette's performance, composition, constituents, or characteristics 
are components and parts of the cigarette would also be subject to this 
rule. Thus, to the extent that flavor cards, drops, oils, or other 
additives that are components and parts of a cigarette contain menthol 
as a characterizing flavor, such products would be prohibited under 
proposed Sec.  1162.3. Therefore, FDA does not anticipate a substantial 
number of individuals would utilize such products.
---------------------------------------------------------------------------

    \14\ While we recognize that some smokers could try to add 
menthol e-cigarette liquids (or e-liquids) to non-menthol 
cigarettes, we believe that the amount of e-liquid needed to impart 
a menthol characterizing flavor would make the cigarette 
unsmokeable.
---------------------------------------------------------------------------

    Even if some people were to modify their non-menthol cigarettes in 
response to a menthol cigarette prohibition, FDA does not expect this 
behavior to result in significant additional harm beyond what menthol 
cigarette smokers are already being exposed to. Furthermore, with many 
other tobacco products available on the marketplace and the prohibition 
of products used to alter or affect the cigarette's performance, 
composition, constituents, FDA does not expect that many individuals 
would attempt to modify non-menthol cigarettes and thus, FDA does not 
expect that this potential countervailing effect would significantly 
reduce the impact of the rule (Ref. 299).
    Finally, the removal of menthol cigarettes from the marketplace 
could result in some people seeking menthol cigarettes through the 
illicit trade market. FDA is considering whether illicit trade could 
occur as a result of a menthol product standard and potential 
implications.
    Since the enactment of the Tobacco Control Act, FDA has been 
committed to studying and understanding the potential effects of a 
product standard on the illicit tobacco market. As part of FDA's 
consideration of possible regulations, the Agency asked the National 
Research Council (NRC) and Institute of Medicine (IOM) of the National 
Academy of Sciences to assess the international illicit tobacco market, 
including variations by country; the effects of various policy 
mechanisms on the market; and the applicability of international 
experiences to the United States (Ref. 301). In 2015, the NRC/IOM 
issued its final report titled ``Understanding the U.S. Illicit Tobacco 
Market: Characteristics, Policy Context, and Lessons from International 
Experiences'' and concluded ``[o]verall, the limited evidence now 
available suggests that if conventional cigarettes are modified by 
regulations, the demand for illicit versions of them is likely to be 
modest.'' (Ref. 301 at 9). In addition, in March 2018, FDA issued a 
draft concept paper as an initial step in assessing the possible health 
effects of a tobacco product standard in the form of demand for 
contraband or nonconforming tobacco products (83 FR 11754). Among other 
things, the draft concept paper examined the factors that might support 
or hinder the establishment of a persistent illicit trade market 
related to a product standard but did not reach any conclusions 
regarding the potential demand that may develop due to a product 
standard (Ref. 79).
    The recent implementation of local menthol restrictions in the 
United States and restrictions outside of the United

[[Page 26484]]

States provides real-world experience regarding the potential for 
illicit trade of menthol cigarettes. Evidence from Canada, England, and 
the United States suggest that the impact of the proposed rule on the 
illicit market would not be significant (Refs. 302, 226, 224, 216, 200, 
209, 191, 303, 197). For example, a study evaluating a restriction on 
sales of menthol cigarettes in Nova Scotia, Canada found that the 
policy did not result in an increase in illicit cigarette seized (Ref. 
302). The researchers noted that according to local Canadian 
authorities there were only a few small seizures of menthol cigarettes 
in the year following the policy (with the nature of the data analyzed 
indicating that seizures were from businesses only, not individual 
users, though the study is not clear on this point), and that there 
were no further seizures of menthol cigarettes after the first year 
(Ref. 302). Studies asking smokers about their responses to menthol 
sales restrictions in Canada find a small percentage that continue to 
use and purchase menthol cigarettes (Refs. 226, 224, and 216). When 
menthol smokers were asked where they purchased menthol cigarettes 
after menthol sales restrictions, a majority reported purchasing from 
First Nations Reserves (54.7 percent), which were generally exempted 
from the sales restrictions, followed by retail stores (31.0 percent); 
few reported purchasing menthol cigarettes online (7.5 percent) (Ref. 
216). The study, however, was not able to determine the proportion of 
menthol cigarettes purchased by cigarette smokers post-policy that were 
contraband (Ref. 216). The authors also noted it is unclear how smokers 
were able to purchase menthol cigarettes at retail stores and 
hypothesized that smokers could be reporting the purchase of non-
menthol cigarettes that were rebranded as menthol replacements with 
color on the pack or in the brand name to suggest menthol-like 
qualities (Ref. 216). Another study of a local Canadian menthol sales 
restriction found that one month following implementation of Ontario's 
menthol sales restriction, 14.1 percent of smokers reported using 
menthol cigarettes purchased from a First Nations reserve, other 
province, other country, or online (Ref. 226). A study of young adult 
ever tobacco users in San Francisco found that a small percentage 
reported purchasing flavored tobacco products illegally in San 
Francisco (5 percent) and purchasing flavored tobacco products online 
(15 percent) after the policy; however, this was a retrospective study 
with a relatively small convenience sample (Ref. 191).
    These results are consistent with the expert elicitation study 
discussed previously (Ref. 211). In the expert elicitation study, 50.5 
percent of menthol smokers were expected to remain combusted tobacco 
product users, with 40.3 percent becoming non-menthol cigarette 
smokers, and 3.7 percent becoming non-menthol cigar smokers; however, 
the experts also estimated that 6.5 percent would continue to use 
illicit menthol cigarettes (Ref. 211).
    Taken together, these studies provide evidence that a major change 
to the availability of products covered by this proposed rule (see 
section VII.A) is not likely to lead to a surge in illicit menthol 
cigarette use. In reaching this conclusion, FDA has considered several 
factors that are likely to affect the potential for illicit trade. For 
example, FDA anticipates that a nationwide standard that prohibits the 
manufacture and sale of menthol cigarettes, coupled with FDA's 
authority to take enforcement actions and other steps regarding the 
sale and distribution of illicit tobacco products, would eliminate the 
manufacture and distribution of these products. FDA also expects that a 
nationwide product standard would eliminate the opportunity to easily 
travel to neighboring jurisdictions within the United States that do 
not have such menthol sales restrictions or use online retailers to 
purchase menthol cigarettes. FDA thus anticipates that the rule would 
result in much less illicit trade than observed in the case of a state 
or local requirement and that any such trade would be significantly 
outweighed by the benefits of the rule.
    If an illicit market develops after this proposed menthol standard 
is finalized, FDA has the authority to take enforcement actions and 
other steps regarding the sale and distribution of illicit tobacco 
products, including those imported or purchased online (see section 
VII.C of this document for additional information about FDA's 
enforcement authorities). FDA conducts routine surveillance of sales, 
distribution, marketing, and advertising related to tobacco products 
and takes corrective actions when violations occur. After this proposed 
menthol standard is finalized and goes into effect, it would be illegal 
to import menthol cigarettes and such products would be subject to 
import examination and refusal of admission under the FD&C Act. 
Similarly, it would be illegal to sell or distribute menthol 
cigarettes, including those sold online, and doing so may result in FDA 
initiating enforcement or regulatory actions. We note that the Prevent 
All Cigarette Trafficking Act of 2009 (PACT Act) establishes 
restrictions that make cigarettes generally nonmailable through the 
U.S. Postal Service, subject to certain exceptions (18 U.S.C. 1716E). 
Outside of these exceptions, the U.S. Postal Service cannot accept or 
transmit any package that it knows, or has reasonable cause to believe, 
contains nonmailable cigarettes, smokeless tobacco, or ENDS.
    As previously noted, FDA's enforcement will only address 
manufacturers, distributors, wholesalers, importers, and retailers. 
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. In 
addition, State and local law enforcement agencies do not independently 
enforce the 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. As noted previously, FDA recognizes concern 
about how State and local law enforcement agencies enforce their own 
laws in a manner that may impact equity and community safety and seeks 
comments on how FDA can best make clear the respective roles of FDA and 
State and local law enforcement.
    Based on the available evidence, FDA finds that, while there may be 
potential countervailing effects that could diminish the expected 
population health benefits of the proposed standard, such effects would 
be significantly outweighed by the potential benefits of the proposed 
menthol product standard.
    In this section, FDA has cited studies describing the potential 
countervailing effects of the proposed product standard. FDA requests 
additional information concerning the potential countervailing effects 
discussed in this section, as well as any other potential 
countervailing effects that could result from this rule, and how the 
potential countervailing effects could be minimized. FDA is 
particularly interested in receiving comments, including supporting 
data and research, regarding whether and to what extent this proposed 
rule would result in an increase in illicit trade in menthol cigarettes 
and how any such increase could impact the marketplace or public 
health.

[[Page 26485]]

D. Conclusion

    FDA has considered scientific evidence related to the likely impact 
of the proposed rule prohibiting use of menthol as a characterizing 
flavor in cigarettes on current nonusers, current users, and the U.S. 
population as a whole. Based on these considerations, we find that the 
proposed tobacco product standard is appropriate for the protection of 
the public health because it would reduce the appeal and ease of 
smoking cigarettes, particularly for young people and new users, 
thereby decreasing 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, increasing the 
likelihood of cessation among this population, and decreasing 
secondhand smoke exposure among current smokers and non-smokers. These 
positive public health impacts will also address the significant health 
disparities linked to menthol cigarettes.
    Tobacco use is the leading preventable cause of disease and death 
in the United States (Ref. 1). As over 18.5 million Americans ages 12 
and older smoke menthol cigarettes (Ref. 44), even modest reductions in 
the percentage of people initiating and modest increases in the 
percentage of people quitting smoking would lead to substantial 
reductions in the over 480,000 annual deaths and approximately 16 
million cases of disease attributed to combustible tobacco products in 
the United States, as well as the economic and societal costs 
associated with such illness and death.
    Each day in the United States, more than 1,500 youth under the age 
of 18 smoke their first cigarette (Ref. 96). Additionally, nearly 90 
percent of adult current daily cigarette smokers in the United States 
report having smoked their first cigarette by the age of 18 (Ref. 1). 
Nicotine is a highly addictive substance, and multiple studies have 
shown that symptoms of nicotine dependence can arise early after youth 
start smoking cigarettes, even among infrequent users (Refs. 184, 137, 
and 135). Menthol in cigarettes enhances nicotine addiction through a 
combination of its flavor, sensory effects, and interaction with 
nicotine in the brain, facilitating repeated experimentation with 
cigarettes and progression to regular cigarette smoking, which 
repeatedly exposes the brain to nicotine (Refs. 6 and 9).
    Evidence shows that adding menthol to cigarettes soothes irritation 
from nicotine and smoke inhalation, particularly among new smokers 
(Ref. 7). Data from the 2013-2014 PATH Study indicate that 43 percent 
of youth (aged 12-17 years), 45 percent of young adults (aged 18-24 
years) and 30 percent of adults (aged 25 years and older) that have 
ever smoked a cigarette reported that their first tobacco product was 
mentholated (Ref. 31). Results from national studies also consistently 
show a preference for smoking menthol cigarettes among youth and young 
adult smokers, compared to older smokers, and existing research 
suggests that the likelihood of progressing to regular, established 
smoking is higher among youth who initiate with menthol smoking 
compared to those starting with non-menthol cigarettes (Refs. 25, 29-
31, 8). The result is that nearly half of youth (48.6 percent) and 
young adults (51 percent) and two in five (39 percent) adult smokers 
report smoking menthol cigarettes (Ref. 44).
    Prohibiting the use of menthol as a characterizing flavor in 
cigarettes would help to decrease future addiction, disease, and death 
among youth at risk of tobacco use. FDA anticipates that the proposed 
standard would produce substantial health benefits. Even small changes 
in initiation and cessation would result in a significant reduction in 
the burden of death and disease in the United States caused by smoking, 
including reductions in smoking-related morbidity and mortality, 
diminished exposure to secondhand smoke among non-smokers, decreased 
potential years of life lost, decreased disability, and improved 
quality of life for the current and future generations to come.
    While preventing initiation to regular cigarette smoking by even 
modest amounts carries the greatest potential from this proposed 
standard to improve population health in the long term, FDA anticipates 
that the proposed standard would produce substantial short-term health 
benefits resulting from decreased cigarette consumption and increased 
cessation among current menthol cigarette smokers. In the United 
States, there are currently over 18.5 million smokers of menthol 
cigarettes ages 12 and older (Ref. 44). As previously described, the 
health benefits of smoking cessation are substantial. A published 
population modeling study estimated that as many as 654,000 smoking 
attributable deaths would be avoided by the year 2060 if menthol 
cigarettes were no longer available (Ref. 46). 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's expectation that the proposed product standard would be 
appropriate for the protection of the public health is reasonable and 
well-supported by scientific evidence. 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. Given the existing scientific evidence described in sections IV 
and V of this document, FDA expects that implementing the proposed 
menthol product standard would result in reduced smoking initiation and 
progression among youth and young adults, and increased smoking 
cessation among current cigarette smokers. Across the population, these 
changes in cigarette smoking behaviors would lead to lower disease and 
death in the United States in both the short term, and in the future, 
due to diminished exposure to tobacco smoke among both smokers and non-
smokers.
    FDA anticipates the proposed product standard also will improve 
health outcomes among vulnerable populations. As previously described, 
menthol cigarette use, and the disease and death linked to such use, is 
disproportionately high among members of vulnerable populations such as 
African Americans and other racial and ethnic groups, those with lower 
household income, and those who identify as LGBTQ+ (Refs. 55-57, 21-24, 
44). For example, out of all non-Hispanic Black smokers, nearly 85 
percent smoke menthol cigarettes, compared to 30 percent of non-
Hispanic White smokers who smoke menthol cigarettes (Ref. 44). As a 
result, these population groups with the greatest menthol cigarette use 
would be expected to experience the greatest benefit from the proposed 
product standard through its impact on reducing youth initiation of and 
experimentation with cigarette smoking, decreasing the likelihood of 
nicotine dependence and addiction, and increasing the likelihood of 
cessation. Accordingly, the proposed product standard is anticipated to 
promote better public health outcomes across population groups.

VI. Additional Considerations and Requests for Comments

A. Section 907 of the FD&C Act

    FDA is required by section 907 of the FD&C Act to consider the 
following

[[Page 26486]]

information submitted in connection with a proposed product standard:
     For a proposed product standard to require the reduction 
or elimination of an additive, constituent (including smoke 
constituent), or other component of a tobacco product because FDA has 
found that the additive, constituent (including a smoke constituent), 
or other component is or may be harmful, scientific evidence submitted 
by any party objecting to the proposed standard demonstrating that the 
proposed standard will not reduce or eliminate the risk of illness or 
injury (section 907(a)(3)(B)(ii) of the FD&C Act).
     Information submitted regarding the technical 
achievability of compliance with the standard, including with regard to 
any differences related to the technical achievability of compliance 
with such standard for products in the same class containing nicotine 
not made or derived from tobacco and products containing nicotine made 
or derived from tobacco (section 907(b)(1) of the FD&C Act).
     All other information submitted, including information 
concerning the countervailing effects of the tobacco product standard 
on the health of adolescent tobacco users, adult tobacco users, or 
nontobacco users, such as the creation of a significant demand for 
contraband or other tobacco products that do not meet the requirements 
of chapter IX of the FD&C Act and the significance of such demand 
(section 907(b)(2) of the FD&C Act).
    As required by section 907(c)(2) of the FD&C Act, FDA invites 
interested persons to submit a draft or proposed tobacco product 
standard for the Agency's consideration (section 907(c)(2)(B)) and 
information regarding structuring the standard so as not to advantage 
foreign-grown tobacco over domestically grown tobacco (section 
907(c)(2)(C)). In addition, FDA invites the Secretary of Agriculture to 
provide any information or analysis which the Secretary of Agriculture 
believes is relevant to the proposed tobacco product standard (section 
907(c)(2)(D) of the FD&C Act).
    FDA is requesting all relevant documents and information described 
in this section with this proposed rule. Such documents and information 
may be submitted in accordance with the ``Instructions'' included in 
the preliminary information section of this document.
    Section 907(d)(5) of the FD&C Act allows the Agency to refer a 
proposed regulation for the establishment of a tobacco product standard 
to TPSAC at the Agency's own initiative or in response to a request 
that demonstrates good cause for a referral and is made before the 
expiration of the comment period. If FDA opts to refer this proposed 
regulation to TPSAC, the Agency will publish a notice in the Federal 
Register announcing the TPSAC meeting to discuss this proposal.

B. Request for Comments on the Potential Racial and Social Justice 
Implications of the Proposed Product Standard

    FDA is aware of concerns raised by some that this proposed rule 
could lead to illicit trade in menthol cigarettes, increased policing, 
and criminal penalties in underserved communities, including Black 
communities, which tend to have higher rates of menthol cigarette use 
and experience greater tobacco-related morbidity and mortality. We 
reiterate that this regulation does not include a prohibition on 
individual consumer possession or use, and FDA cannot and will not 
enforce against individual consumer possession or use of menthol 
cigarettes. FDA's enforcement of this proposed rule will only address 
manufacturers, distributors, wholesalers, importers, and retailers. 
State and local law enforcement agencies do not independently enforce 
the 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.
    Recognizing concerns related to how State and local law enforcement 
agencies enforce their own laws in a manner that may impact equity and 
community safety, FDA requests comments, including supporting data and 
research, on any potential for this proposed rule to result, directly 
or indirectly, in disparate impacts within particular underserved 
communities or vulnerable populations. With respect to any potential 
disparate impacts, FDA requests comments and data on whether and how 
specific aspects of the rule, if finalized, might increase the 
likelihood of such outcomes beyond what would be expected to occur in 
the absence of the rule, and potential strategies for avoiding or 
addressing such impacts of the rule within the bounds of FDA's 
authorities. FDA also requests comments and data related to the 
existence, nature and degree of any change in police activity or 
community encounters with State or local law enforcement within a 
State, locality or other jurisdiction following implementation of a 
prohibition of menthol cigarettes. Finally, FDA requests comment on any 
other policy considerations related to potential racial and social 
justice implications of the rule.

VII. Description of the Proposed Regulation

    We are proposing to establish a new 21 CFR part 1162 (part 1162) 
that would prohibit menthol as a characterizing flavor in cigarettes. 
Part 1162 would describe the scope of the proposed regulation, 
applicable definitions, and the prohibition on use of menthol as a 
characterizing flavor in cigarettes.

A. Scope (Proposed Sec.  1162.1)

    Proposed Sec.  1162.1(a) would provide that this part sets out a 
tobacco product standard under the FD&C Act regarding the use of 
menthol as a characterizing flavor in cigarettes. We are proposing that 
this product standard would cover all products meeting the definition 
of ``cigarette'' in section 900(3) of the FD&C Act (21 U.S.C. 387(3)) 
(proposed Sec.  1162.3 includes a definition of cigarette). This 
includes all types, sizes, nicotine strengths and formulations of 
cigarettes, cigarette tobacco and RYO tobacco, as well as HTPs that 
meet the definition of a cigarette in the FD&C Act (cigarettes that are 
HTPs).
    In general, as discussed in this document, menthol as a 
characterizing flavor in tobacco products enhances product appeal, 
usability, and addictiveness and has played a role in creating and 
perpetuating tobacco-related health disparities. While these effects 
raise concerns in the context of any tobacco product--none of which is 
without risk--FDA recognizes that certain products that meet the 
definition of cigarette in the FD&C Act may present different 
considerations with respect to this proposed product standard. For 
example, certain cigarettes may produce significantly fewer or lower 
levels of toxicants or have significantly reduced potential for 
creating or sustaining addiction. Recognizing that tobacco products 
exist on a continuum of risk, with combusted cigarettes being the 
deadliest, FDA recognizes that certain, specific products meeting the 
definition of a cigarette (e.g., some that are not combusted or are 
minimally addictive) may pose less risk to individual users or to 
population health than other products meeting the definition of a 
cigarette. FDA also notes that there is wide variability even within 
certain types of cigarettes, such as variability in toxicants or youth 
appeal among HTPs or minimally addictive cigarettes.\15\

[[Page 26487]]

Accordingly, FDA is considering options that would allow certain 
products that present different considerations to seek exemptions from 
the product standard on a case-by-case basis.
---------------------------------------------------------------------------

    \15\ For additional information about the variability of tobacco 
products, see the Premarket Tobacco Product Applications and 
Recordkeeping Requirements (PMTA) final rule (86 FR 55300, October 
5, 2021) available at https://www.federalregister.gov/documents/2021/10/05/2021-21011/premarket-tobacco-product-applications-and-recordkeeping-requirements.
---------------------------------------------------------------------------

    Section 910 of the FD&C Act provides that those seeking to market 
new tobacco products via a premarket tobacco application may justify a 
deviation from a product standard to which it does not conform. 
However, no similar provision exists for pre-existing products or 
products that already are authorized under, or that seek authorization 
under, other pathways, i.e., the substantial equivalence pathway or 
exemption from substantial equivalence. FDA is considering whether a 
final product standard rule should include a provision for requesting 
an exemption from the standard for certain products within particular 
categories, on a case-by-case basis, consistent with the potential for 
differential public health impacts among products meetings the 
definition of ``cigarette'', as discussed above.
    Accordingly, we are requesting comments on exemptions, including: 
(1) Whether the final rule should include a provision that allows for 
firms to request an exemption from the standard for specific products 
of certain types (e.g., noncombusted, reduced nicotine), on a case-by-
case basis; (2) for what types of products should firms be eligible to 
request an exemption; (3) for an exemption provision, how should the 
Agency evaluate exemption requests, and what data and information 
should firms be required to submit for this; and (4) if an exemption 
provision should apply to products currently on the market at the time 
of the final rule's effective date, how the exemption process should 
work (e.g., require that any exemption request be received within 180 
days of publication so the Agency has time to make a determination 
before the effective date). As part of this, comments could address or 
account for impact on industry, impact on the Agency's use of resources 
and the Agency's ability to protect public health, as well as 
situations where the commenter believes an exemption would or would not 
be appropriate.
    Proposed Sec.  1162.1(b) would prohibit the manufacture, 
distribution, sale, or offering for distribution or sale, in the United 
States of a cigarette or any of its components or parts that is not in 
compliance with the tobacco product standard. This provision is not 
intended to restrict the manufacture of cigarettes with menthol as a 
characterizing flavor intended for export. Consistent with section 
801(e)(1) of the FD&C Act (21 U.S.C. 381(e)(1)), a tobacco product 
intended for export shall not be deemed to be in violation of section 
907 of the FD&C Act or this product standard, if it meets the criteria 
enumerated in section 801(e)(1), including not being sold or offered 
for sale in domestic commerce.

B. Definitions (Proposed Sec.  1162.3)

    Proposed Sec.  1162.3 provides the definitions for the terms used 
in the proposed rule. Several of these definitions are included in the 
FD&C Act or are used in other regulations.
     Accessory: FDA defined ``accessory'' in the deeming final 
rule (81 FR 28974, May 10, 2016; codified at Sec.  1100.3 (21 CFR 
1100.3)). We are proposing to use that definition here as it applies to 
cigarettes to provide further understanding as to the scope of the 
proposed standard. Therefore, FDA proposes to define ``accessory'' in 
the context of part 1162 to mean any product that is intended or 
reasonably expected to be used with or for the human consumption of a 
cigarette; does not contain tobacco or nicotine from any source, and is 
not made or derived from tobacco; and meets either of the following: 
(1) Is not intended or reasonably expected to affect or alter the 
performance, composition, constituents, or characteristics of a 
cigarette; or (2) is intended or reasonably expected to affect or 
maintain the performance, composition, constituents, or characteristics 
of a cigarette but (i) solely controls moisture and/or temperature of a 
stored cigarette; or (ii) solely provides an external heat source to 
initiate but not maintain combustion of a cigarette. An example of a 
cigarette ``accessory'' is an ashtray.
     Cigarette: As defined in section 900(3) of the FD&C Act, 
the term ``cigarette'': (1) Means a product that: (i) Is a tobacco 
product and (ii) meets the definition of the term ``cigarette'' in 
section 3(1) of the Federal Cigarette Labeling and Advertising Act (15 
U.S.C. 1332(1)) and (2) includes tobacco, in any form, that is 
functional in the product, which, because of its appearance, the type 
of tobacco used in the filler, or its packaging and labeling, is likely 
to be offered to, or purchased by, consumers as a cigarette or as RYO 
tobacco.
     Cigarette tobacco: As defined in section 900(4) of the 
FD&C Act, the term ``cigarette tobacco'' means any product that 
consists of loose tobacco that is intended for use by consumers in a 
cigarette. Unless otherwise stated, the requirements applicable to 
cigarettes under 21 CFR chapter I also apply to cigarette tobacco.
     Component or part: FDA defined ``component or part'' in 
the deeming final rule (Sec.  1100.3). We are proposing to use that 
definition here as it applies to cigarettes. Therefore, FDA proposes to 
define ``component or part'' in the context of part 1162 to mean any 
software or assembly of materials intended or reasonably expected: (1) 
To alter or affect the cigarette's performance, composition, 
constituents or characteristics or (2) to be used with or for the human 
consumption of a cigarette. The term excludes anything that is an 
accessory of a cigarette. Examples of cigarette components or parts 
that would be subject to this proposed product standard include 
cigarette paper, filters, and flavor additives. With respect to these 
definitions, FDA notes that ``component'' and ``part'' are separate and 
distinct terms within chapter IX of the FD&C Act. However, for purposes 
of this rule, FDA is using the terms ``component'' and ``part'' 
interchangeably and without emphasizing a distinction between the 
terms. FDA may clarify the distinctions between ``component'' and 
``part'' in the future.
     Person: As defined in section 201(e) of the FD&C Act (21 
U.S.C. 321(e)), the term ``person'' includes an individual, 
partnership, corporation, and association.
     Roll-your-own tobacco: As defined in section 900(15) of 
the FD&C Act, the term ``roll-your-own tobacco'' means any tobacco 
product which, because of its appearance, type, packaging, or labeling, 
is suitable for use and likely to be offered to, or purchased by, 
consumers as tobacco for making cigarettes.
     Tobacco product: As defined in section 201(rr) of the FD&C 
Act, the term ``tobacco product'' is defined as any product that is 
made or derived from tobacco, or containing nicotine from any source, 
that is intended for human consumption, including any component, part, 
or accessory of a tobacco product (except for raw materials other than 
tobacco used in manufacturing a component, part, or accessory of a 
tobacco product). The term ``tobacco product'' does not mean an article 
that is: A drug under section 201(g)(1); a device under section 201(h); 
a combination product described in section 503(g) of the FD&C Act (21 
U.S.C. 353(g)); or a food under section 201(f) if such article contains 
no

[[Page 26488]]

nicotine, or no more than trace amounts of naturally occurring 
nicotine.
     United States: As defined in section 900(22) of the FD&C 
Act, the term ``United States'' means the 50 States of the United 
States of America and the District of Columbia, the Commonwealth of 
Puerto Rico, Guam, the Virgin Islands, American Samoa, Wake Island, 
Midways Islands, Kingman Reef, Johnston Atoll, the Northern Mariana 
Islands, and any other trust territory or possession of the United 
States.

C. Prohibition on Use of Menthol as a Characterizing Flavor in 
Cigarettes (Proposed Sec.  1162.5)

    Proposed Sec.  1162.5 would establish a tobacco product standard 
prohibiting the use of menthol as a characterizing flavor in 
cigarettes. Specifically, proposed Sec.  1162.5 would state 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.\16\ 
This proposal takes into consideration, among other information, the 
comments received by FDA on the ANPRMs and citizen petition, including 
comments urging FDA to ban menthol as a characterizing flavor in 
cigarettes, comments arguing for a total ban on menthol in cigarettes, 
comments recommending that any product standard for menthol also cover 
additives and components which convey menthol flavoring, and comments 
opposing any product standard for menthol in cigarettes. As discussed 
in section V of this document, FDA finds that this proposed product 
standard, which would prohibit menthol as a characterizing flavor in 
cigarettes, would be appropriate for the protection of the public 
health.
---------------------------------------------------------------------------

    \16\ We note that the language in section 907(a)(1)(A) of the 
FD&C Act states that the Special Rule for Cigarettes applies to 
cigarettes or ``any of its component parts.'' For purposes of this 
standard, we have used the phrase ``any of its components or parts'' 
and have defined ``component or part'' for clarity and consistency 
with the deeming final rule (81 FR 28974 at 28975).
---------------------------------------------------------------------------

    FDA would enforce the requirements of this proposed product 
standard under various sections of the FD&C Act, including sections 
301, 303, 902, and 903. Section 907(a)(4)(B)(v) of the FD&C Act states 
that product standards must, where appropriate for the protection of 
the public health, include provisions requiring that the sale and 
distribution of the tobacco products be restricted but only to the 
extent that the sale and distribution of a tobacco product may be 
restricted under section 906(d). 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. Because this sale 
and distribution restriction of menthol cigarettes would also assist 
FDA in enforcing the standard and would ensure that manufacturers, 
distributors, and retailers are selling product that complies with the 
standard, the Agency has found the 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.
    Failure to comply with any requirements prescribed by this product 
standard may result in FDA initiating enforcement or regulatory 
actions, including, but not limited to, warning letters, civil money 
penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/
or injunction. In addition, adulterated or misbranded tobacco products 
offered for import into the United States are subject to detention and 
refusal of admission. As previously discussed, FDA's enforcement will 
only address manufacturers, distributors, wholesalers, importers, and 
retailers. FDA cannot and will not enforce against individual consumer 
possession or use of menthol cigarettes.
    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; \17\ and
---------------------------------------------------------------------------

    \17\ If a cigarette has a characterizing flavor (other than 
tobacco), but its labeling or advertising represents that it does 
not, then the product may be, among other things, misbranded under 
section 903 of the FD&C Act because its labeling or advertising is 
false or misleading. Similarly, if a product does not have a 
characterizing flavor, but its labeling or advertising represents 
that it does, then the product may be misbranded under section 903 
of the FD&C Act because its labeling or advertising is false or 
misleading.
---------------------------------------------------------------------------

     Any other means that impart flavor or represent that the 
tobacco product has a characterizing flavor.
    FDA expects that the approach proposed in this rule--relying on 
specific, flexible factors to make a case-by-case determination as to a 
characterizing flavor of menthol--would provide important clarity for 
FDA, regulated industry, and other stakeholders while also ensuring 
critical flexibility and enforceability to achieve the public health 
goals of this rule. FDA requests comments regarding these factors and 
other potential factors that the Agency might consider in determining 
whether a cigarette has menthol as a characterizing flavor.
    FDA also requests comments, including supporting data and research, 
regarding any alternatives to prohibiting menthol as a characterizing 
flavor (e.g., prohibiting all menthol flavor additives, compounds, 
constituents, or ingredients).
    We note that this prohibition also would cover menthol flavoring 
that is separate from the cigarette. For example, menthol can be added 
to non-menthol cigarettes via drops, capsules, filter tips for RYO 
tobacco, or cards that can be inserted into a cigarette pack or pouch 
of rolling tobacco (Refs. 299 and 300). Such menthol flavorings would 
be considered components or parts of cigarettes under proposed Sec.  
1162.3, as they could be intended or reasonably expected to: (1) Alter 
or affect the cigarette's performance, composition, constituents, or 
characteristics or (2) be used with or for the human consumption of a 
cigarette, and they would not be accessories of cigarettes. Therefore, 
the manufacture, distribution, sale, or offer for distribution or sale 
of such products would be prohibited should this proposed rule be 
finalized.

VIII. Proposed Effective Date

    In accordance with section 907(d)(2) of the FD&C Act,\18\ FDA 
proposes that any final rule that may issue based on this proposal 
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

[[Page 26489]]

regulation does not include a prohibition on individual consumer 
possession or use.
---------------------------------------------------------------------------

    \18\ Section 907(d)(2) of the FD&C Act states that a regulation 
establishing a tobacco product standard shall set forth the date or 
dates upon which the standard shall take effect, but no such 
regulation may take effect before 1 year after the date of its 
publication unless the Secretary determines that an earlier 
effective date is necessary for the protection of the public health.
---------------------------------------------------------------------------

    FDA finds this proposed standard appropriate for the protection of 
the public health because it would reduce the ease of smoking 
cigarettes, particularly for young people and new users, thereby 
decreasing the likelihood that nonusers who experiment with these 
products would progress to regular smoking. In addition, the proposed 
tobacco product standard would improve the health of current menthol 
cigarette smokers by decreasing cigarette consumption and increasing 
the likelihood of cessation. Additional delay, past 1 year, would only 
increase the numbers of youth and young adults who experiment with 
menthol cigarettes and become regular smokers, delay cessation by 
current smokers, and exacerbate tobacco-related health disparities.
    FDA also finds that a 1-year effective date will ``minimize, 
consistent with the public health, economic loss to, and disruption or 
dislocation of, domestic and international trade'' pursuant to section 
907(d)(2) of the FD&C Act. As discussed in the preliminary economic 
analysis (Ref. 292), FDA believes that most currently marketed menthol 
cigarettes are available for purchase in currently marketed non-menthol 
versions. Therefore, FDA does not expect that this rule, if finalized, 
would result in many new tobacco product applications. For these 
reasons, FDA believes that the availability of currently marketed non-
menthol versions of currently marketed menthol cigarettes would 
minimize the economic loss to, and disruption of, domestic and 
international trade.
    We also note that the Tobacco Control Act banned characterizing 
flavors in cigarettes with a 90-day effective date (section 
907(a)(1)(A) of the FD&C Act). FDA is proposing a longer effective date 
here in accordance with section 907(d)(2) of the FD&C Act. FDA requests 
comments as to whether a shorter effective date, such as 90 days, would 
be necessary for the protection of the public health. In setting the 
effective date, FDA will consider information submitted in connection 
with this proposal by interested parties, including manufacturers and 
tobacco growers, regarding the technical achievability of compliance 
with the standard, and including information concerning the existence 
of patents that make it impossible to comply in the proposed 1-year 
timeframe.
    FDA is aware of retailers' concerns regarding unsold inventory when 
any final rule goes into effect. FDA requests comments, including 
supportive data and research, regarding a sell-off period (e.g., 30 
days after the effective date of a final rule) for retailers to sell 
through their current inventory of menthol cigarettes.

IX. Preliminary Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the proposed rule under Executive 
Order (E.O.) 12866, E.O. 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). E.O.s 12866 and 13563 direct us to assess all costs and 
benefits of available regulatory alternatives and, when regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety, 
and other advantages; distributive impacts; and equity). We believe 
that this proposed rule is an economically significant regulatory 
action as defined by E.O. 12866. As such, it has been reviewed by the 
Office of Information and Regulatory Affairs.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because a portion of business revenues may revert back to 
consumers who currently purchase menthol cigarettes, we find that the 
rule may have a significant economic impact on a substantial number of 
small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $158 million, using the most current (2020) Implicit 
Price Deflator for the Gross Domestic Product. This proposed rule, if 
finalized, would result in expenditures that meet or exceed this 
amount.

B. Summary of Costs and Benefits

    The summary of benefits and costs is presented in Table 1. The 
proposed rule, if finalized, would establish a tobacco product standard 
prohibiting the use of menthol as a characterizing flavor in 
cigarettes. 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. Qualitative benefits include: decreased illness and 
associated reductions in medical costs (both publicly and privately 
funded), decreased productivity loss, and improved health-related 
quality of life for menthol smokers and non-smokers; reductions in 
smoking-related fires; and reductions in cigarette butt litter and 
associated harms to the environment. We estimate that the present value 
of the monetized benefits over a 40-year time horizon ranges between 
$2,529 billion and $8,253 billion (primary estimate of $5,428 billion) 
at a 3 percent discount rate, and range between $1,369 billion and 
$4,470 billion (primary estimate of $2,941 billion) at a 7 percent 
discount rate. The primary annualized benefits equal $232 billion at a 
3 percent discount rate and $220 billion at a 7 percent discount rate. 
Unquantified benefits are expected to provide additional benefits 
beyond those amounts and additional health and related benefits are 
expected to occur outside the time horizon used in this analysis.
    The proposed rule, if finalized, would also create costs for firms, 
consumers and the Federal Government. Firms face one-time costs to read 
and review the rule (undiscounted primary estimate of $186.6 million 
with a range of $56.0 million to $349.9 million), and may face one-time 
costs for reallocation, friction, and adjustment in the cigarette 
product market (undiscounted primary estimate of $235.9 million with a 
range of $0.2 million to $471.9 million). Firms may also face costs due 
to producer surplus loss over the 40 year time horizon (undiscounted 
primary estimate of $10,628 million with a range of $0 to $21,256). 
Consumers may face one-time search costs of $359.3 million 
(undiscounted, range of $179.7 million to $539.0 million) to find 
substitute tobacco products as a replacement for menthol cigarettes. 
The FDA may face annual costs associated with enforcement of the 
proposed product standard (undiscounted range from $0 to $1.3 million, 
primary estimate $0.7 million per year). Qualitative costs may include 
changes in consumer surplus for some menthol cigarette product users, 
including potential utility changes for smokers of menthol cigarette 
products who switch from menthol to non-menthol cigarette products. We 
estimate that the present value of monetized costs over a 40-year time 
horizon ranges between $223.0 million and $13,421.6 million (primary

[[Page 26490]]

estimate of $6,805.9 million) for a 3 percent discount rate, and 
between $208.0 million and $8,051.3 million (primary estimate of 
$4,113.2 million) at a 7 percent discount rate. The primary estimates 
for the annualized cost are $291 million at a 3 percent discount rate 
and $307 million at a 7 percent discount rate. In addition to benefits 
and costs, this rule, if finalized, will create significant transfers 
from State governments, Federal Government, and firms to consumers in 
the form of reduced revenue and tax revenue. The primary estimates for 
annualized transfers related to Federal taxes are $2.0 billion at a 3 
percent discount rate and $2.0 billion at a 7 percent discount rate. 
The primary estimates for the annualized transfers related to State 
taxes are $3.7 billion at a 3 percent discount rate and $3.7 billion at 
a 7 percent discount rate. The primary estimates for the annualized 
transfers between cigarette product manufacturers and consumers are 
$13.3 billion at a 3 percent discount rate and $13.0 billion at a 7 
percent discount rate. Benefits, costs, and transfers are summarized in 
Table 1.

                                    Table 1--Summary of Benefits, Costs, and Distributional Effects of Proposed Rule
                                                [$ Millions of 2020 dollars over a 40 year time horizon]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           Units
                                          Primary       Low        High    ------------------------------------
               Category                  estimate    estimate    estimate      Year      Discount     Period                      Notes
                                                                              dollars    rate (%)     covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized ($m/year)....    $220,000    $102,000    $334,000        2020           7          40  ........................................
                                           232,000     108,000     353,000        2020           3          40
    Annualized Quantified.............  ..........  ..........  ..........  ..........  ..........  ..........
                                       ------------------------------------------------------------------------
    Qualitative.......................      Qualitative benefits include: Decreased illness and associated
                                           reductions in medical costs (both publicly and privately funded),
                                          decreased productivity loss, and improved health-related quality of
                                           life for menthol smokers and non-smokers; reductions in smoking-
                                         related fires; and reductions in cigarette butt litter and associated
                                                               harms to the environment.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized ($m/year)....         307          16         601        2020           7          40
                                               291           9         573        2020           3          40
    Annualized Quantified.............  ..........  ..........  ..........  ..........  ..........  ..........
                                       ------------------------------------------------------------------------
    Qualitative.......................  Changes in consumer surplus may occur for some menthol smokers.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized ($m/        2,000       1,000       2,000        2020           7          40  ........................................
     year).                                  2,000       1,000       2,000        2020           3          40
                                       ------------------------------------------------------------------------
                                        From: Federal Government
                                        To: Consumers
                                       ------------------------------------------------------------------------
    State Annualized Monetized ($m/          4,000       3,000       4,000        2020           7          40  ........................................
     year).                                  4,000       3,000       4,000        2020           3          40
                                       ------------------------------------------------------------------------
                                        From: State Government
                                        To: Consumers
                                       ------------------------------------------------------------------------
    Other Annualized Monetized ($m/         13,000       9,000      15,000        2020           7          40  ........................................
     year).                                 13,000       9,000      15,000        2020           3          40
                                       ------------------------------------------------------------------------
                                        From: Cigarette Product
                                        Manufacturers
                                        To: Consumers and Manufacturers of
                                        Other Tobacco Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local, or Tribal Government: See transfers for estimated State excise tax impacts. See distributional effects for discussions of impacts to
     tribally-affiliated manufacturers and/or manufacturers operating on tribal lands..
    Small Business: Small menthol cigarette manufacturers are expected to face one-time costs for reading and understanding the rule and for planning
     and implementing reallocation procedures for menthol cigarette production lines. Small menthol cigarette manufacturers would also face revenue
     transfers as consumers cease purchasing menthol cigarette products..
    Wages: No effect....................................................................................................................................
    Growth: No effect...................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Preliminary Economic Analysis of 
Impacts that assesses the impacts of the proposed rule. The full 
analysis of economic impacts is available in the docket for this 
proposed rule (see Ref. 292) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

X. Analysis of Environmental Impact

    The Agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The Agency's finding of 
no significant impact and the evidence supporting that finding is 
available in the docket for this proposed rule (see Refs. 304 and 305) 
and may be seen in the Dockets Management Staff (see ADDRESSES) between 
9 a.m. and 4 p.m., Monday through Friday; it is also available 
electronically at https://www.regulations.gov. Under FDA's regulations 
implementing the National Environmental Policy Act (21 CFR part 25), an 
action of this type would require an environmental assessment under 21 
CFR 25.20.

XI. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3521) is not required.

[[Page 26491]]

XII. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in E.O. 13132. Section 4(a) of the Executive order 
requires Agencies to ``construe . . . a Federal statute to preempt 
State law only where the statute contains an express preemption 
provision or there is some other clear evidence that the Congress 
intended preemption of State law, or where the exercise of State 
authority conflicts with the exercise of Federal authority under the 
Federal statute.'' We have determined that the proposed rule, if 
finalized, would not contain policies that have substantial direct 
effects on the States, on the relationship between the National 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Accordingly, 
the Agency tentatively concludes that the rule does not contain 
policies that have federalism implications as defined in the E.O. and, 
consequently, a federalism summary impact statement is not required.
    This rule is being issued under section 907 of the FD&C Act, which 
enables FDA to prescribe regulations relating to tobacco product 
standards, and the sale and distribution restriction in this rule is 
also being issued under section 906(d) of the FD&C Act, which enables 
FDA to prescribe regulations restricting the sale and distribution of a 
tobacco product. If this proposed rule is made final, the final rule 
would create requirements whose preemptive effect would be governed by 
section 916 of the FD&C Act, entitled ``Preservation of State and Local 
Authority.''
    Section 916 broadly preserves the authority of states and 
localities to protect the public against the harms of tobacco use. 
Specifically, section 916(a)(1) establishes a general presumption that 
FDA requirements do not preempt or otherwise limit the authority of 
States, localities, or tribes to, among other things, enact and enforce 
laws regarding tobacco products that relate to certain activities 
(e.g., sale, distribution) and that are in addition to or more 
stringent than requirements established under chapter IX of the FD&C 
Act.
    Section 916(a)(2)(A) of the FD&C Act is an express preemption 
provision that establishes an exception to the preservation of State 
and local governmental authority over tobacco products established in 
section 916(a)(1). Specifically, section 916(a)(2)(A) of the FD&C Act 
provides that ``[n]o State or political subdivision of a State may 
establish or continue in effect with respect to a tobacco product any 
requirement which is different from, or in addition to, any requirement 
under the provisions of this chapter relating to tobacco product 
standards . . . .''
    However, section 916(a)(2)(B) of the FD&C Act limits the 
applicability of section 916(a)(2)(A), narrowing the scope of state and 
local requirements that are subject to express preemption. In 
particular, paragraph (a)(2)(B) provides that preemption under 
paragraph (a)(2)(A) does not apply to State or local ``requirements 
relating to the sale, distribution, possession, information reporting 
to the State, exposure to, access to, the advertising and promotion of, 
or use of, tobacco products by individuals of any age, or relating to 
fire safety standards for tobacco products.''
    If this proposed rule is finalized as proposed, the final rule 
would create requirements that fall within the scope of section 
916(a)(2)(A) because they are ``requirements under the provisions of 
the chapter relating to tobacco product standards.'' Accordingly, the 
preemptive effect of those requirements on any state or local 
requirement would be determined by the nature of the state or local 
requirement at issue--specifically, whether the state or local 
requirement is preserved under section 916(a)(1), and/or excepted under 
section 916(a)(2)(B) (such as if it relates to the ``sale, 
distribution, possession, information reporting to the State, exposure 
to, access to, the advertising and promotion of, or use of, tobacco 
products''). State and local prohibitions on the sale and distribution 
of flavored tobacco products, such as menthol cigarettes, would not be 
preempted by this rule, if finalized, because such prohibitions would 
be preserved by FD&C Act section 916(a)(1) or, as applicable, excepted 
from express preemption by FD&C Act section 916(a)(2)(B). FDA invites 
comments on how State or local laws may be implicated if this proposed 
rule is finalized.

XIII. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the 
principles set forth in E.O. 13175. We have tentatively determined that 
the rule does not contain policies that would have a substantial direct 
effect on one or more Indian Tribes, on the relationship between the 
Federal Government and Indian Tribes, or on the distribution of power 
and responsibilities between the Federal Government and Indian Tribes. 
The Agency solicits comments from tribal officials on any potential 
impact on Indian Tribes from this proposed action.

XIV. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. FDA has verified the website addresses, as of 
the date this document publishes in the Federal Register, but websites 
are subject to change over time.

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[[Page 26493]]

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List of Subjects in 21 CFR Part 1162

    Labeling, Smoke, Smoking, Tobacco, Tobacco products.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that chapter I of title 21 of the Code of Federal Regulations 
be amended by adding part 1162 to subchapter K to read as follows:

PART 1162--PRODUCT STANDARD: MENTHOL IN CIGARETTES

Subpart A--General Provisions
Sec.
1162.1 Scope.
1162.3 Definitions.
Subpart B--Product Standard for Menthol in Cigarettes
1162.5 Prohibition on use of menthol as a characterizing flavor in 
cigarettes.

    Authority:  21 U.S.C. 331, 333, 371(a), 387b, 387c, 387f(d), 
387g.

Subpart A--General Provisions

Sec.  1162.1  Scope.

    (a) This part sets out a tobacco product standard under the Federal 
Food, Drug, and Cosmetic Act regarding the use of menthol as a 
characterizing flavor in cigarettes.
    (b) No person may manufacture, distribute, sell, or offer for 
distribution or sale, within the United States a cigarette or any of 
its components or parts that is not in compliance with this part.

Sec.  1162.3  Definitions.

    For purposes of this part:
    Accessory means any product that is intended or reasonably expected 
to be used with or for the human consumption of a cigarette; does not 
contain tobacco or nicotine from any source, and is not made or derived 
from tobacco; and meets either of the following:
    (1) Is not intended or reasonably expected to affect or alter the 
performance, composition, constituents, or characteristics of a 
cigarette; or
    (2) Is intended or reasonably expected to affect or maintain the 
performance, composition, constituents, or characteristics of a 
cigarette; but
    (i) Solely controls moisture and/or temperature of a stored 
cigarette; or
    (ii) Solely provides an external heat source to initiate but not 
maintain combustion of a cigarette.
    Cigarette, as used in this part:
    (1) Means a product that:
    (i) Is a tobacco product; and
    (ii) Meets the definition of the term ``cigarette'' in section 3(1) 
of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 
1332(1)); and
    (2) Includes tobacco, in any form, that is functional in the 
product, which, because of its appearance, the type of tobacco used in 
the filler, or its packaging and labeling, is likely to be offered to, 
or purchased by, consumers as a cigarette or as roll-your-own tobacco.
    Cigarette tobacco means any product that consists of loose tobacco 
that is intended for use by consumers in a cigarette. Unless otherwise 
stated, the requirements applicable to cigarettes under this chapter 
also apply to cigarette tobacco.
    Component or part means any software or assembly of materials 
intended or reasonably expected:
    (1) To alter or affect the cigarette's performance, composition, 
constituents, or characteristics; or
    (2) To be used with or for the human consumption of a cigarette. 
The term excludes anything that is an accessory of a cigarette.
    Person includes an individual, partnership, corporation, or 
association.
    Roll-your-own tobacco means any tobacco product which, because of 
its appearance, type, packaging, or labeling, is suitable for use and 
likely to be offered to, or purchased by, consumers as tobacco for 
making cigarettes.
    Tobacco product means any product made or derived from tobacco, or 
containing nicotine from any source, that is intended for human 
consumption, including any component, part, or accessory of a tobacco 
product (except for raw materials other than tobacco used in 
manufacturing a component, part, or accessory of a tobacco product). 
The term ``tobacco product'' does not mean an article that under the 
Federal Food, Drug, and Cosmetic Act is: A drug (section 201(g)(1)); a 
device (section 201(h)); a combination product (section 503(g)); or a 
food under section 201(f) if such article contains no nicotine, or no 
more than trace amounts of naturally occurring nicotine.

[[Page 26502]]

    United States means the 50 States of the United States of America 
and the District of Columbia, the Commonwealth of Puerto Rico, Guam, 
the Virgin Islands, American Samoa, Wake Island, Midway Islands, 
Kingman Reef, Johnston Atoll, the Northern Mariana Islands, and any 
other trust territory or possession of the United States.

Subpart B--Product Standard for Menthol in Cigarettes

Sec.  1162.5  Prohibition on use of menthol as a characterizing flavor 
in cigarettes.

    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.

    Dated: April 22, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022-08994 Filed 4-28-22; 11:15 am]
BILLING CODE 4164-01-P