Proposed Rule2022-08994
Tobacco Product Standard for Menthol in Cigarettes
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Published
May 4, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is proposing a tobacco product standard that would 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.
Full Text
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
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,
<a href="/cdn-cgi/l/email-protection#95d6c1c5c7f0f2e0f9f4e1fcfafbe6d5f3f1f4bbfdfde6bbf2fae3"><span class="__cf_email__" data-cfemail="37746367655250425b56435e58594477515356195f5f4419505841">[email protected]</span></a>.
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:
<bullet> 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;
<bullet> 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;
<bullet> Flavor representations (including descriptors), either
explicit or implicit, in or on the labeling (including packaging) or
advertising of tobacco products; and
<bullet> 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.
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[[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.
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In 2009, the Tobacco Control Act established the ``Special Rule for
Cigarettes'' (section 907(a)(1)(A) of the FD&C Act (Special Rule for
Cigarettes).\4\ The Special Rule for Cigarettes banned characterizing
flavors in cigarettes, other than tobacco or menthol, based on their
appeal to youth, in order to reduce the number of children and
adolescents who smoke cigarettes (see H.R. Rep. No. 111-58, pt. 1, at
37 (2009)). As a result, menthol cigarettes are the only cigarettes
with a characterizing flavor still marketed in the United States.
---------------------------------------------------------------------------
\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 <a href="https://www.fda.gov/tobacco-products/tobacco-science-research/research">https://www.fda.gov/tobacco-products/tobacco-science-research/research</a> (search ``menthol'' or ``flavors'').
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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).<SUP>7 8</SUP> 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:
<bullet> The risks and benefits to the population as a whole,
including users and nonusers of tobacco products, of the proposed
standard;
<bullet> The increased or decreased likelihood that existing users
of tobacco products will stop using such products; and
<bullet> The increased or decreased likelihood that those who do
not use tobacco products will start using such products.
2. Authority To 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.<SUP>9 10</SUP> 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: <a href="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">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</a>. 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:
<bullet> The risks and benefits to the population as a whole,
including users and nonusers of tobacco products, of the proposed
standard;
<bullet> The increased or decreased likelihood that existing users
of tobacco products will stop using such products; and
<bullet> The increased or decreased likelihood that those who do
not use tobacco products will start using such products.
(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 toba
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