26454 Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 

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. 

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 tobaccorelated death and disease associated 

with menthol cigarette use. The 

proposed standard also is expected to 

reduce tobacco-related health disparities 

and advance health equity. 

DATES: Submit either electronic or 

written comments on the proposed rule 

by July 5, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

July 5, 2022. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are postmarked or the 

delivery service acceptance receipt is on 

or before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2021–N–1349 for ‘‘Tobacco Product 

Standard for Menthol in Cigarettes.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: Beth 

Buckler or Eric Mandle, Center for 

Tobacco Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

877–287–1373, CTPRegulations@

fda.hhs.gov. 

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 


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Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 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 § 1162.1) 

B. Definitions (Proposed § 1162.3) 

C. Prohibition on Use of Menthol as a 

Characterizing Flavor in Cigarettes 

(Proposed § 1162.5) 

VIII. Proposed Effective Date 

IX. Preliminary Economic Analysis of 

Impacts 

A. Introduction 

B. Summary of Costs and Benefits 

X. Analysis of Environmental Impact 

XI. Paperwork Reduction Act of 1995 

XII. Federalism 

XIII. Consultation and Coordination With 

Indian Tribal Governments 

XIV. References 

I. Executive Summary 

A. Purpose of the Proposed Rule 

FDA is proposing a tobacco product 

standard that would prohibit menthol as 

a characterizing flavor in cigarettes. In 

developing this proposed rule, FDA 

carefully considered the scientific 

evidence and complex policy issues 

related to menthol cigarettes. As 

described in the preamble of this rule, 

FDA has conducted multiple scientific 

reviews related to menthol cigarettes, 

issued two advance notices of proposed 

rulemaking (ANPRMs) to solicit data 

and information about menthol 

cigarettes, considered a citizen petition 

requesting that FDA ban menthol as a 

characterizing flavor in cigarettes, and 

sponsored research on a variety of 

menthol-related topics. 

Each year, 480,000 people die 

prematurely from a smoking-attributable 

disease, making tobacco use the leading 

cause of preventable death and disease 

in the United States. In 2009, the Family 

Smoking Prevention and Tobacco 

Control Act (Tobacco Control Act) 

banned characterizing flavors in 

cigarettes, other than tobacco or 

menthol, based on their appeal to youth, 

in order to reduce the number of 

children and adolescents who smoke 

cigarettes. As a result, menthol 

cigarettes are the only cigarettes with a 

characterizing flavor still marketed in 

the United States. 

In 2019, there were more than 18.5 

million current smokers of menthol 

cigarettes ages 12 and older in the 

United States. Although menthol 

cigarette smoking is widespread in the 

United States, menthol cigarettes are 

used at a particularly high rate by youth, 

young adults, and certain other 

vulnerable populations such as African 

American and other racial and ethnic 

groups. Menthol is a flavor compound 

added to cigarettes, which produces a 

minty taste and cooling sensation when 

inhaled. Menthol’s flavor and sensory 

effects reduce the harshness of cigarette 

smoking and make it easier for new 

users, particularly youth and young 

adults, to continue experimenting and 

progress to regular use. In addition, data 

show that menthol cigarettes contribute 

to greater nicotine dependence in youth 

and young adults than non-menthol 

cigarettes. By prohibiting menthol as a 

characterizing flavor in cigarettes, this 

proposed product standard would 

reduce the appeal of cigarettes, 

particularly to youth and young adults, 

who are more likely to try a menthol 

cigarette as their first cigarette than a 

non-menthol cigarette. And because 

almost all daily smokers started 

smoking before the age of 25, it would 

thereby decrease the likelihood that 

nonusers who would otherwise 

experiment with menthol cigarettes 

would progress to regular smoking. By 

prohibiting menthol as a characterizing 

flavor in cigarettes, FDA expects a 

significant reduction in the likelihood of 

youth and young adult initiation and 

progression to regular cigarette smoking, 

which is expected to prevent future 

cigarette-related disease and death. 

In addition, the proposed tobacco 

product standard would improve the 

health and reduce the mortality risk of 

current menthol cigarette smokers by 

substantially decreasing cigarette 

consumption and increasing the 

likelihood of cessation. Published 

modeling studies have estimated a 15.1 

percent reduction in smoking 

prevalence within 40 years if menthol 

cigarettes were no longer available in 

the United States. These studies also 

estimate that 324,000 to 654,000 

smoking attributable deaths overall 

(92,000 to 238,000 among African 

Americans) would be avoided within 40 

years. FDA expects the public health 

benefit of this rule to be particularly 

pronounced among vulnerable 

populations, including youth and young 

adults, as well as Black smokers, who 

have the highest prevalence of menthol 

cigarette smoking and experience a 

disproportionate burden of the related 

harms. For the reasons discussed in the 

preamble of this proposed rule, FDA 

finds that the proposed tobacco product 

standard would be appropriate for the 

protection of the public health. 

Additionally, this proposed product 

standard is expected to substantially 

decrease tobacco-related health 

disparities and to advance health equity 

across population groups. 

B. Summary of the Major Provisions of 

the Proposed Rule 

The proposed rule would prohibit the 

use of menthol as a characterizing flavor 

in cigarettes and cigarette components 

and parts, including those that are sold 

separately to consumers. Specifically, 

the rule would provide that a cigarette 

or any of its components or parts 

(including the tobacco, filter, wrapper, 

or paper, as applicable) shall not 

contain, as a constituent (including a 

smoke constituent) or additive, menthol 

that is a characterizing flavor of the 

tobacco product or tobacco smoke. 

Under the proposed rule, no person may 

manufacture, distribute, sell, or offer for 

distribution or sale, within the United 

States a cigarette or cigarette component 

or part that is not in compliance with 

the product standard. Among the factors 

that FDA believes are relevant in 

determining whether a cigarette has a 

characterizing flavor are: 

• The presence and amount of 

artificial or natural flavor additives, 

compounds, constituents, or 

ingredients, or any other flavoring 

ingredient in a tobacco product, 

including its components or parts; 

• The multisensory experience (i.e., 

taste, aroma, and cooling or burning 

sensations in the mouth and throat) of 

a flavor during use of a tobacco product, 

including its components or parts; 

• Flavor representations (including 

descriptors), either explicit or implicit, 

in or on the labeling (including 

packaging) or advertising of tobacco 

products; and 

• Any other means that impart flavor 

or represent that the tobacco products 

has a characterizing flavor. 

FDA is proposing that any final rule 

that may issue based on this proposed 

rule become effective 1 year after the 

date of publication of the final rule. 

Therefore, after the effective date, no 

person may manufacture, sell, or offer 

for sale or distribution within the 

United States a cigarette or any of its 

components or parts that is not in 


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26456 Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 

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 

Abbreviation/acronym What it means 

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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1Though 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). 

2Throughout 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. 

3Throughout 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. 

4Section 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. 

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 nonmenthol 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). 

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). 

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. 

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. 

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 


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26458 Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 

5As 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 tobaccorelated health disparities, such communities may 

include populations disproportionately impacted 

by marketing and promotion targeted on the basis 

of such shared characteristics. 

6 Information on specific projects supported by 

FDA is available at https://www.fda.gov/tobaccoproducts/tobacco-science-research/research (search 

‘‘menthol’’ or ‘‘flavors’’). 

7Based 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 followup’’ 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). 

8Two 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 

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 publichealth 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 nonsmokers, 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 tobaccorelated 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. 

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. 

1. Scientific Reviews 

In March 2010, FDA’s Tobacco 

Product Scientific Advisory Committee 

(TPSAC) undertook a review of the 

available evidence concerning menthol 

cigarettes and solicited and received 

input from many public commenters, 

including researchers, tobacco industry 

representatives, consultants to the 

tobacco industry, and public health 

experts. As required by section 907(e) of 

the FD&C Act, on March 23, 2011, 

TPSAC submitted its report and 

recommendation to the Secretary of 

HHS on the impact of the use of 

menthol in cigarettes on the public 

health, including use among children, 

African Americans, Hispanics, and 

other racial and ethnic populations (Ref. 

72).7 8 In addition, the nonvoting 


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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. 

industry representatives of TPSAC 

submitted a separate document 

reflecting the tobacco industry 

perspective (Ref. 73). 

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 peerreviewed, 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 


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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 nonsmokers, 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 


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Health & Human Servs., ECF No. 34 at 

8 (emphasis in original). 

On January 14, 2021, the Petitioners 

submitted a citizen petition supplement 

pursuant to 21 CFR 10.30(g) to update 

the administrative record with research 

developed since 2013 on the impact of 

menthol in cigarettes. The supplement 

identified and discussed evidence 

related to the following topics: 

Menthol’s impact on youth initiation, 

adult and youth cessation, the impact 

on non-users of menthol cigarettes 

caused by secondhand smoke exposure, 

thirdhand smoke exposure, tobacco 

waste pollution, the disproportionate 

impact that menthol has had on several 

populations (e.g., African Americans), 

evaluation data from several 

jurisdictions that have implemented 

prohibitions on menthol, technical 

achievability, and illicit trade (Ref. 82). 

On April 29, 2021, FDA issued its 

final response to the citizen petition and 

included in its response a determination 

that the Special Rule for Cigarettes 

should be changed to include menthol 

(Ref. 83). In its response, FDA stated 

that it interpreted the petition ‘‘as a 

request that the Agency engage in the 

rulemaking process by proposing a rule 

to prohibit menthol as a characterizing 

flavor in cigarettes.’’ FDA granted the 

request, stating it intends to issue a 

proposed rule to prohibit menthol as a 

characterizing flavor in cigarettes (Ref. 

83). FDA also stated that it intends to 

work with HHS to enlist and collaborate 

with other entities at the Federal, Tribal, 

State, and local levels who provide 

support to menthol smokers who quit or 

want to quit as a result of a prohibition 

of menthol as a characterizing flavor in 

cigarettes going into effect (Ref. 83). To 

reach this decision, the Agency 

considered, among other things, the 

petition, the January 2021 supplement 

filed by the Petitioners that updated the 

administrative record with research 

developed since 2013 on the impact of 

menthol cigarettes, and the comments 

submitted to the petition docket (Ref. 

83). 

C. Legal Authority 

1. Product Standard Authority Generally 

The Tobacco Control Act was enacted 

on June 22, 2009, amending the FD&C 

Act and providing FDA with the 

authority to regulate tobacco products to 

protect the public health, including 

reducing tobacco use by youth (Pub. L. 

111–31). Section 901 of the FD&C Act 

(21 U.S.C. 387a) granted FDA the 

authority to regulate the manufacture, 

marketing, and distribution of cigarettes, 

cigarette tobacco, roll-your-own (RYO) 

tobacco, and smokeless tobacco as well 

as any other tobacco product FDA 

deemed by regulation. 

Among the tobacco product 

authorities provided to FDA is the 

authority to revise or-adopt tobacco 

product standards where FDA 

determines that such standard is 

appropriate for the protection of the 

public health (section 907(a)(2) and (3) 

of the FD&C Act). This includes a 

tobacco product standard to prohibit the 

use of menthol as a characterizing 

flavor. To establish a tobacco product 

standard, section 907(a)(3)(A) and (B) of 

the FD&C Act requires that FDA find 

that the standard is appropriate for the 

protection of the public health, taking 

into consideration scientific evidence 

concerning: 

• The risks and benefits to the 

population as a whole, including users 

and nonusers of tobacco products, of the 

proposed standard; 

• The increased or decreased 

likelihood that existing users of tobacco 

products will stop using such products; 

and 

• The increased or decreased 

likelihood that those who do not use 

tobacco products will start using such 

products. 

2. Authority To Prohibit Menthol as a 

Characterizing Flavor in Cigarettes 

The Tobacco Control Act established 

the Special Rule for Cigarettes that 

prohibited cigarettes or any of its 

component parts from containing, as a 

constituent (including smoke 

constituent) or additive, an artificial or 

natural flavor or an herb or spice that is 

a characterizing flavor of the tobacco 

product or tobacco smoke (section 

907(a)(1)(A) of the FD&C Act). This rule 

exempted menthol from the prohibition 

but stated that ‘‘nothing in this 

subparagraph shall be construed to limit 

the Secretary’s authority to take action 

under this section or other sections of 

this Act applicable to menthol’’ (id.). 

Further, section 907(a)(2) states that 

FDA ‘‘may revise’’ the Special Rule in 

accordance with the rulemaking 

provisions outlined in section 907 of the 

FD&C Act. 

Section 907 of the FD&C Act 

authorizes FDA to issue tobacco product 

standards that are appropriate for the 

protection of the public health, 

including provisions that would require 

the reduction or elimination of a 

constituent (including a smoke 

constituent), or harmful component of 

tobacco products and provisions 

respecting the construction, 

components, ingredients, additives, 

constituents (including smoke 

constituents), and properties of the 

tobacco product (section 907(a)(3), 

(a)(4)(A)(ii), and (a)(4)(B)(i) of the FD&C 

Act). This includes the authority to 

issue a new product standard 

prohibiting characterizing flavors in 

tobacco products pursuant to section 

907(a)(3) and (4) and to amend or revoke 

an existing product standard pursuant 

to section 907(d)(4) of the FD&C Act. 

Section 907(a)(4)(B)(v) also authorizes 

FDA to include in a product standard a 

provision restricting the sale and 

distribution of a tobacco product to the 

extent that it may be restricted by a 

regulation under section 906(d) of the 

FD&C Act. Similar to section 

907(a)(4)(B)(v), section 906(d) of the 

FD&C Act gives FDA authority to 

require restrictions on the sale and 

distribution of tobacco products by 

regulation if the Agency determines that 

such regulation would be appropriate 

for the protection of the public health. 

Section 701 of the FD&C Act (21 U.S.C. 

371) provides FDA with the authority to 

‘‘promulgate regulations for the efficient 

enforcement of’’ the FD&C Act. 

Pursuant to section 907(a)(2) and (3) 

and (c) of the FD&C Act, FDA is 

proposing this tobacco product standard 

that would prohibit menthol as a 

characterizing flavor in cigarettes, 

because it would reduce the tobaccorelated 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 


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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 nonmenthol (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 


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Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 26463 

9Throughout the preamble of this proposed rule, 

FDA uses the terminology cited in the scientific 

studies. 

10The 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. 

11 ‘‘Living in poverty’’ was determined and 

recoded in the NSDUH public use file based on a 

person’s family income relative to poverty 

thresholds. The full definition of this variable can 

be found in the 2019 NSDUH codebook at: https:// 

www.datafiles.samhsa.gov/sites/default/files/fielduploads-protected/studies/NSDUH-2019/NSDUH2019-datasets/NSDUH-2019-DS0001/NSDUH-2019- 

DS0001-info/NSDUH-2019-DS0001-infocodebook.pdf. The U.S. Census Bureau assigns a 

poverty threshold for each combination of family 

size and number of children in the household. To 

be at 100 percent of the poverty threshold is 

equivalent to having a family income that is the 

same as the poverty threshold. A poverty level less 

than 100 percent indicates having a family income 

less than the poverty threshold and therefore 

defined by the Federal Government as living in 

poverty. A poverty level greater than 100 percent 

indicates having a family income greater than the 

poverty threshold. 

(Ref. 98). Additionally, in another study 

of trends in menthol smoking from 2004 

to 2014, the NSDUH data showed that 

women are significantly more likely to 

smoke menthol cigarettes than men (Ref. 

57). This is consistent with data from 

the 2019 NSDUH, which indicated that 

a higher proportion and number of 

female cigarette smokers smoked 

menthol (44.8 percent; 9.49 million) 

than male cigarette smokers (37.1 

percent; 9.10 million) (Ref. 44). High 

levels of menthol cigarette smoking 

have also been reported in pregnant 

smokers. An analysis of 2006 to 2015 

participant data from two racially and 

ethnically diverse cohorts of pregnant 

smokers with lower educational 

attainment and lower household income 

indicated high prevalence of menthol 

use in both cohorts (85 percent and 87 

percent) (Ref. 71). 

Study findings indicate that 

individuals who identify as lesbian, gay, 

or bisexual are more likely to report 

smoking menthol cigarettes compared to 

those who identify as heterosexual, as 

well as other disparities related to 

gender identity or sexual orientation.9 10

A study examining menthol use by 

LGBT status found a higher prevalence 

and a higher likelihood of smoking 

menthol cigarettes among LGBT 

smokers compared to heterosexual 

smokers, and that these differences in 

use were even greater among LGBT 

female respondents compared to 

heterosexual women (Ref. 69). In 

national data from the 2019 NSDUH, 

only 6.9 percent of those identifying as 

straight or heterosexual reported 

smoking menthol (15.95 million) 

compared to 14 percent of those 

identifying as lesbian, gay, or bisexual 

(2.04 million) (Ref. 44). An analysis of 

pooled data from the 2015–2019 

NSDUH indicate that compared to 

heterosexual/straight respondents, 

respondents who identified as gay 

males, lesbian/gay females, or bisexual 

females reported higher prevalence of 

past 30-day smoking (Ref. 99). 

Additionally, compared to heterosexual/ 

straight respondents, gay males, and 

bisexual males, findings indicated that 

lesbian/gay females and bisexual 

females had higher menthol preference 

(defined as past 30-day use of menthol 

cigarettes among those who smoked 

cigarettes in the past 30-days) (Ref. 99). 

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). 

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 pastmonth 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 


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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-a`-vis 

candy’’ (Ref. 112). Additionally, a 1978 

document about a traditionally mentholonly 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 mentholtreated 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 


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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 nonmenthol 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 nonmenthol smokers (Ref. 28). Similarly, 

results from Wave 2 PATH Study data 

(2014–2015) show that youth menthol 


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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 nonmenthol 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 nonmenthol 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 nonmenthol 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 nonmenthol 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 longterm (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) 


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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 nonmenthol 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 nonmenthol 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 nonmenthol 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 selfreport (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 


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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 


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reach and appeal to Black menthol 

smokers (Refs. 169, 168, 90–91). 

Over many decades, tobacco 

companies continued to employ 

marketing strategies to promote menthol 

cigarette use among youth, young 

adults, and underserved communities, 

such as low-income Black communities. 

The strategies used to target 

underserved communities included 

discounts (Ref. 170), distribution of free 

samples (Refs. 168, 171, and 172), and 

advertising in nightclubs, bars, and 

special events (Ref. 171). The tobacco 

industry also marketed menthol 

cigarettes to low-income Black 

communities and youth, including 

Black teens as young as 16 years of age, 

by selling menthol cigarettes in smaller 

package quantities to encourage trial 

and initiation, and to provide a lower 

price point (Refs. 173 and 174). 

Recent scientific evidence indicates 

that tobacco companies market menthol 

cigarettes in the retail environment to 

continually appeal to underserved 

communities. For example, menthol 

marketing is more prevalent in 

neighborhoods that have more Black 

and low-income residents (Refs. 170 and 

175). Furthermore, tobacco retailers in 

predominantly Black neighborhoods are 

more likely to advertise discount 

promotions for menthol cigarettes, and 

sell menthol cigarettes at a lower price, 

as compared to tobacco retailers in 

predominantly White neighborhoods 

(Refs. 175, 170, and 176). Menthol 

marketing is also more visible in 

neighborhoods with predominately 

Black residents as compared to 

predominately White neighborhoods, as 

well as in urban neighborhoods (Ref. 

175). A recent nationally representative 

study of tobacco retailers in the 

contiguous United States found that 

retail menthol advertising was more 

common in neighborhoods with more 

Black and low-income residents (Ref. 

177). Furthermore, price promotions for 

Newport brand menthol cigarettes were 

more common in retailers in 

neighborhoods with more Black 

residents (Ref. 177). 

Higher exposure to tobacco 

advertisements and retailing are 

associated with disparities in tobacco 

use susceptibility and tobacco use 

among youth. For example, youth who 

live or go to school in neighborhoods 

where tobacco retailers are 

disproportionately present are more 

susceptible to smoking (Refs. 178 and 

179), are more likely to experiment with 

smoking (Refs. 180 and 179), and are 

more likely to smoke currently (Ref. 

181). 

Taken together, scientific evidence 

indicates that menthol cigarettes have 

historically and continue to be 

disproportionately marketed in 

underserved communities and 

contribute to the longstanding 

disparities in menthol cigarette smoking 

and health outcomes observed in 

vulnerable populations, particularly the 

Black community. While targeted 

marketing is only one factor in the 

development and perpetuation of 

menthol cigarette use and related harms, 

this background helps to explain and 

provide critical context for the outcomes 

and disparities that undermine public 

health and are of concern to FDA. 

Addressing how these products 

disproportionately affect vulnerable 

populations supports the Agency’s 

mission of promoting public health. 

V. Determination That the Standard Is 

Appropriate for the Protection of the 

Public Health 

The Tobacco Control Act authorizes 

FDA to revise or adopt tobacco product 

standards by regulation if it finds that 

such tobacco product standards are 

appropriate for the protection of the 

public health (section 907(a)(2) and 

(a)(3)(A) of the FD&C Act). The notice of 

proposed rulemaking for such a product 

standard must set forth this finding with 

supporting justification, which FDA is 

doing here (section 907(c)(2)(A) of the 

FD&C Act). 

In order to make this finding, FDA 

must consider scientific evidence 

concerning: 

• The risks and benefits to the 

population as a whole, including users 

and nonusers of tobacco products, of the 

proposed standard; 

• The increased or decreased 

likelihood that existing users of tobacco 

products will stop using such products; 

and 

• The increased or decreased 

likelihood that those who do not use 

tobacco products will start using such 

products. 

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

FDA has considered scientific 

evidence related to all three factors. 

Based on these considerations, as 

discussed below, we find that the 

proposed standard is appropriate for the 

protection of the public health because 

the prohibition of menthol as a 

characterizing flavor in cigarettes: 

Decreases the likelihood that 

nonsmokers would experiment with 

cigarettes, develop tobacco dependence 

symptoms, and progress to regular 

cigarette smoking and/or use of other 

tobacco products, while also decreasing 

the likelihood that current smokers 

would continue to smoke cigarettes. 

Cigarettes are the most toxic consumer 

product when used as intended and 

adding menthol as a characterizing 

flavor makes cigarettes more appealing 

and easier to smoke. The proposed 

standard is anticipated to decrease the 

likelihood of menthol cigarette 

experimentation and the subsequent 

progression to regular, established 

cigarette smoking and cigarette 

consumption. Further, the proposed 

standard is anticipated to improve the 

health of current smokers of menthol 

cigarettes by increasing the likelihood of 

cessation, which would lead to lower 

disease and death in the U.S. population 

due to diminished exposure to tobacco 

smoke for both users and nonusers of 

cigarettes. Prohibiting menthol as a 

characterizing flavor in cigarettes would 

reduce the death and disease caused by 

cigarette use. 

A. The Likelihood That Nonusers Would 

Start Using Cigarettes 

Menthol in cigarettes is a significant 

contributor to youth and young adult 

initiation of cigarette smoking. In this 

section, we summarize evidence from 

multiple study designs, incorporating 

findings from longitudinal studies, 

national surveys, policy evaluations, 

and qualitative research that illustrate 

the role menthol plays in facilitating 

initiation and experimentation of 

cigarettes. We also discuss how the 

proposed prohibition on menthol as a 

characterizing flavor in cigarettes would 

decrease experimentation and thus, 

reduce progression to regular cigarette 

smoking among current nonusers. 

Menthol is a flavor compound that is 

added to cigarettes, which produces a 

minty taste and cooling sensation when 

inhaled (Ref. 2). These sensory 

properties are pleasing and drive 

smoker beliefs that menthol cigarettes 

have a better taste, are smoother and 

more refreshing, are easier to inhale, 

and are less irritating than non-menthol 

cigarettes (Refs. 3–5). These properties 

also mask the harshness of smoking for 

new smokers and facilitate repeated 

experimentation and progression to 

regular smoking of menthol cigarettes, 

particularly among youth and young 

adults (Refs. 6–7, 5, 8). 

When an individual tries a menthol 

cigarette, the sensory effects associated 

with menthol make initial and 

continued smoking experiences more 

palatable. In a focus group study 

conducted with young adult (aged 18– 

24) menthol smokers, participants 

reported that the taste of menthol made 

cigarettes as ‘‘minty’’, ‘‘cool’’, and 

‘‘refreshing’’, stating that these factors 

influenced their initial preference for 

menthol cigarettes (Ref. 5). Further, 

these young adults indicated that they 


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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 


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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 ecigarette 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. 


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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 nonflavored 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 


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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 selfreported 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 nonmenthol 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, 


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26474 Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 

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 nonmenthol 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 nonmenthol cigarettes (Ref. 4). 

Additionally, participants agreed that 

menthol cigarettes were ‘‘refreshing’’, 

‘‘soothing’’, and ‘‘smooth’’ while nonmenthol 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 nonWhite 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 matchedbrand 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 tobaccorelated 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 nonHispanic 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 

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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 nonsignificant 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. 


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For example, smokers may have 

obtained cigarettes through channels not 

included in the Ontario sales data (e.g., 

other provinces) or switched to nonrestricted 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 nonmenthol 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 


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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 shorterterm 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 longterm. 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 selfreported 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. 


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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 tobaccorelated 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 nonmenthol 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 tobaccorelated 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 


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cigarettes were unavailable following a 

menthol restriction (Refs. 214, 215, and 

217). Based on these collective findings, 

FDA anticipates that the proposed 

product standard will improve smoking 

cessation outcomes among vulnerable 

populations, in particular, Black 

smokers, leading to a reduction in 

adverse tobacco-related health effects in 

these populations. 

3. Given the Harmful Effects of Cigarette 

Smoking, Switching to a Potentially 

Less Harmful Nicotine Delivery Product 

May Reduce Death and Disease 

FDA recognizes that smokers who 

choose to switch completely to a 

potentially less harmful nicotine 

delivery product to maintain their 

nicotine dose also could, to the extent 

that those products result in less harm, 

significantly reduce their risk of 

tobacco-related death and disease (Ref. 

271). The least harmful nicotine 

delivery products available to smokers 

are the pharmaceutical nicotine 

replacement therapies already approved 

by FDA as both safe and effective 

cessation tools, many of which are 

available in a variety of flavors, 

including mint, which could appeal to 

menthol smokers. However, smokers 

may also transition to tobacco products 

which utilize other forms of nicotine 

delivery in place of smoking combusted 

cigarettes. These include smokeless 

tobacco, dissolvable products, and 

ENDS products, among others. 

In surveys, some menthol cigarette 

smokers and some dual users of 

menthol cigarettes and ENDS report 

intending to use ENDS if menthol 

cigarettes were no longer available (Refs. 

221, 272, and 222). Experimental 

marketplace studies also suggest that, in 

addition to taking other actions, some 

menthol smokers may switch partially 

or fully to ENDS in the event of a 

menthol cigarette ban (Refs. 273 and 

225). These empirical findings are 

consistent with the 2020 Surgeon 

General’s Report, titled ‘‘Smoking 

Cessation,’’ and several systematic 

reviews, which suggest that some adult 

cigarette smokers report using ENDS to 

try to reduce or quit smoking (Refs. 245, 

274–276). The literature also suggests 

that cigarette smokers who use ENDS 

more frequently (versus less frequently) 

have improved success in switching, 

however the long-term patterns of use 

remain unknown (Refs. 271, 277–279). 

In an expert elicitation study 

estimating effects of a menthol ban on 

transitions in use, the panel of experts 

estimated that among menthol smokers 

aged 35 to 54 years, 55.1 percent would 

remain combustible tobacco users (a 

reduction of 20.1 percent from the status 

quo), with another 20 percent switching 

to a ‘‘novel nicotine delivery product,’’ 

defined in the study as ENDS or heated 

tobacco products (HTPs) (a 10.3 percent 

increase from the status quo), and about 

22.5 percent quitting all tobacco use (a 

10.0 percent increase from the status 

quo) (Ref. 211). Additionally, the 

experts estimated that among those aged 

12 to 24 years who would have initiated 

as menthol cigarette smokers, under the 

menthol ban, 41.1 percent would still 

initiate combustible tobacco use 

(including non-menthol cigarettes, 

cigars, or illegal menthol cigarettes), 

while 17.6 percent would instead 

initiate with a ‘‘novel nicotine delivery 

product,’’ such as ENDS or HTPs; the 

result is a 58.9 percent reduction in 

combustible tobacco initiation from the 

status quo (Ref. 211). Additional details 

of the expert elicitation study and 

resulting population model study can be 

found in section V.C.5 of this document. 

Data from the 2017 Ontario menthol 

sales restriction did not show increases 

in menthol smokers’ self-reported use of 

e-cigarettes (Ref. 280) or increases in 

retail sales of e-cigarettes (Ref. 231) 

following policy implementation. To the 

extent that this may occur following 

implementation of this product 

standard, FDA recognizes that 

completely switching from combusted 

tobacco products to ENDS has the 

potential to reduce some tobacco-related 

disease risks among individual users 

(Ref. 271). However, cessation of all 

tobacco products leads to the greatest 

reduction in tobacco-related disease and 

death (Ref. 245). 

4. Having Fewer People Smoke 

Cigarettes Will Reduce Smoking-Related 

Death and Disease Associated With 

Secondhand Smoke Exposure 

Secondhand smoke exposure is 

harmful to the health of non-smokers. 

The 2006 Surgeon General’s Report, 

‘‘The Health Consequences of 

Involuntary Exposure to Secondhand 

Smoke,’’ concluded that ‘‘secondhand 

smoke exposure causes premature death 

and disease in children and in adults 

who do not smoke’’ (Ref. 281). Exposure 

to secondhand smoke is a cause of 

cancer and respiratory and 

cardiovascular disease (Ref. 1). 

According to the 2014 Surgeon 

General’s Report, more than 437,000 

premature deaths per year are caused by 

active cigarette smoking, and an 

additional 41,280 premature deaths 

among adults aged 35 years and older 

are due to secondhand smoke (Ref. 1). 

Specifically, the 2014 Surgeon General’s 

Report estimated secondhand smoke 

causes approximately 7,330 deaths from 

lung cancer and 33,950 deaths from 

coronary heart diseases in non-smokers 

annually (Ref. 1). 

Secondhand smoke is particularly 

harmful to children. The 2014 Surgeon 

General’s Report estimated that 

secondhand smoke is associated with 

150,000 to 300,000 lower respiratory 

tract infections in infants and children 

under 18 months of age, 790,000 

doctor’s office visits related to ear 

infections per year, and 202,000 asthma 

cases each year (Refs. 282 and 1). In 

2014, the Surgeon General reported 400 

SIDS deaths related to perinatal 

smoking or exposure to secondhand 

smoke; the ‘‘Reproductive Outcomes’’ 

section describes the impact of perinatal 

smoking (Ref. 1). Children of parents 

who smoke, when compared with 

children of nonsmoking parents, have 

an increased frequency of respiratory 

infections like pneumonia and 

bronchitis (Ref. 256). Children exposed 

to tobacco smoke in the home are also 

more likely to develop acute otitis 

media (middle ear infections) and 

persistent middle ear effusions (fluid 

behind the eardrum) (Ref. 256). 

More recent data from the 2013–2014 

NHANES estimates that approximately 

58 million American non-smokers (1 in 

4) were exposed to secondhand smoke, 

including 14 million children (Ref. 283). 

Approximately half of all U.S. children 

aged 3 to 18 years are exposed to 

cigarette smoke regularly at home or 

other locations that still permit smoking 

(Ref. 1). In 2019, approximately onequarter of middle and high school 

students reported breathing in 

secondhand smoke in their homes or in 

a vehicle (Ref. 284). 

The burden of secondhand smoke 

exposure is experienced 

disproportionately among members of 

some racial or ethnic groups and lower 

income groups. Among nonsmokers age 

3 and older, findings from 2011–2018 

NHANES data indicate that nonHispanic Black persons and those living 

below the poverty level had the highest 

levels of secondhand smoke exposure 

compared to people of other races and 

those living above the poverty level, 

respectively; these disparities persisted 

across all years of the study analysis 

from 2011 to 2018 (Ref. 285). From 1999 

to 2012, the percentage of the 

nonsmoking population age 3 and older 

exposed to secondhand smoke (defined 

in the study as levels 0.05–10 ng/mL) 

declined across all racial and ethnic 

groups (Ref. 286). However, a 

significantly higher proportion of nonHispanic Black nonsmokers continued 

to have detectable serum cotinine levels, 

compared to Mexican American and 

non-Hispanic White nonsmokers. For 

example, in 2011–2012, nearly 50 


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12The Menthol Ban Scenario models a ban of 

menthol in cigarettes and cigars, but includes only 

the benefits attributed to the menthol cigarette ban. 

Cigars are covered in the model because it is 

assumed that menthol cigarette smokers could 

simply switch to menthol cigars if a menthol 

cigarette ban was put in place and if menthol cigars 

were still available. FDA’s expectation is that, even 

if menthol was not prohibited as a characterizing 

flavor in cigars, this rule would still reduce 

initiation and experimentation of cigarette smoking, 

decrease nicotine dependence and addiction, and 

increase cessation among current menthol cigarette 

smokers. However, since FDA is concurrently 

pursuing a proposed rule, published elsewhere in 

this issue of the Federal Register, that would 

prohibit characterizing flavors (other than tobacco) 

in cigars, the Menthol Ban Scenario is directly 

applicable. 

percent of non-Hispanic Black 

nonsmokers had detectable serum 

cotinine levels, compared with 22 

percent of non-Hispanic White and 24 

percent of Mexican American 

nonsmokers (Ref. 286). 

Disparities in the secondhand smoke 

exposure are found across various 

environmental settings. These 

disparities speak to the interrelated 

influences of individual factors (e.g., 

age, race and ethnicity, income) and 

existing inequities in places where 

members from underserved 

communities are likely to reside, spend 

time, and work (Ref. 49). Findings 

drawn from the 2013–2016 NHANES 

data indicate that compared to nonHispanic Whites, non-Hispanic Blacks 

had higher odds of secondhand smoke 

exposure in homes other than their own 

(Ref. 27). An analysis of NYTS data 

indicates that non-Hispanic Black and 

non-Hispanic White students both had 

higher prevalence of secondhand smoke 

exposure at home and in vehicles than 

Hispanic and non-Hispanic other 

students (Ref. 284). While secondhand 

smoke exposure in homes and vehicles 

significantly declined from 2011 to 

2018, secondhand smoke exposure in 

homes among non-Hispanic Black 

students did not change (Ref. 284). 

Home smoking bans (or household rules 

that restrict or ban smoking inside the 

home) can reduce secondhand smoke 

exposure. A study using 1995–2007 data 

from the TUS–CPS found that among 

two parent households, higher levels of 

parental educational level, higher levels 

of annual household income, and both 

parents being Hispanic, non-Hispanic, 

Other race, or other combinations of 

parents of different race/ethnicities were 

associated with the higher reporting of 

a complete home ban as compared to 

lower levels of parental educational, 

lower levels of annual household 

income, and both parents being nonHispanic White, respectively (Ref. 287). 

Such findings are consistent with a 

higher degree of autonomy over home 

environment for households with 

greater economic resources and housing 

flexibility, emphasizing the degree to 

which certain aspects of disadvantage 

(such as lower family income, lack of 

access to single-family housing, or lack 

of autonomy over the home 

environment) may compound tobaccorelated health disparities. Workplace 

secondhand smoke exposure has also 

been shown to vary across population 

groups. Data from the 2010 and 2015 

NHIS show that exposure to 

secondhand smoke in the workplace 

was disproportionately high among nonHispanic Blacks, Hispanics, and 

workers with low education and low 

income (Ref. 288). Additionally, the 

study findings indicated that ‘‘bluecollar workers’’ (defined as those who 

performed manual labor such as 

manufacturing, mining, sanitation, and 

construction) experienced higher 

prevalence of secondhand smoke 

exposure as compared to ‘‘white-collar 

workers’’ (defined as those who 

primarily work in an office, with 

computer and desk setting, and perform 

professional, managerial, or 

administrative work) (Ref. 288). The 

proposed product standard is 

anticipated to reduce smoking-related 

morbidity and mortality for these 

vulnerable populations, especially 

youth. 

FDA expects that the proposed 

menthol product standard would reduce 

the number of smokers and decrease 

non-smokers’ exposures to secondhand 

smoke. As evidenced by evaluations of 

smoke-free policies, decreasing 

exposure to secondhand smoke will 

reduce exposure to tobacco smoke 

pollution and decrease smoking-related 

death and disease (Refs. 289 and 290). 

5. Results From Simulation Models Are 

Consistent With the Findings That 

Prohibiting Menthol Cigarettes Would 

Benefit the Population’s Health 

The population health benefit of 

prohibiting menthol cigarettes has been 

examined in several simulation studies 

conducted in the past decade (Refs. 46, 

211, 291, 45). A 2021 study by Levy et 

al. simulated the future benefit of a 

menthol cigarette ban on the U.S. 

population as a whole over the 2021– 

2060 period (Ref. 46). This model 

compared a Status Quo Scenario, in 

which no menthol ban was 

implemented, to a simulated Menthol 

Ban Scenario in which a complete ban 

on menthol cigarettes and cigars was 

implemented in 2021.12 Additionally, as 

part of the model, it took into account 

the use of ENDS products (‘‘nicotine 

vaping products’’) by smokers and nonsmokers over the study period (Refs. 46, 

211, and 291). 

The simulation used the Smoking and 

Vaping Model (SAVM), a model capable 

of simulating the population health 

effects of cigarette smoking and ENDS 

use for specific birth cohorts. For this 

study, the model was extended to 

evaluate non-menthol and menthol 

cigarettes separately, with the following 

use states captured in the model 

compartments: (1) Never users, (2) 

menthol smokers, (3) non-menthol 

smokers, (4) exclusive ENDS users, (5) 

former smokers using ENDS, (6) former 

smokers, and (7) former ENDS users. 

The SAVM first utilized historical 

data from the NHIS (1965–2013) for 

estimates of smoking prevalence 

(specific model inputs can be found in 

the manuscript) (Refs. 46, 211, and 291). 

The model projected prevalence 

estimates of never, current, and former 

smoking by age and gender beginning in 

2013. The model was then recalibrated 

using 2013–2018 NHIS data to improve 

model estimates of smoking prevalence 

after ENDS products became more 

widely available around 2013. Next, 

age- and gender-specific rates of 

smoking initiation (i.e., any initiation of 

regular cigarette smoking by age 40) and 

cessation (i.e., cessation of regular 

cigarette smoking for 2 years, including 

those who temporarily use ENDS but 

ultimately quit all tobacco use), 

cigarettes-to-ENDS switching (i.e., 

cessation of regular cigarette smoking 

with initiation of regular ENDS 

smoking), and initiation of ENDS use 

(i.e., initiation of regular ENDS use 

without regular cigarette smoking) were 

modeled using PATH Study data, with 

separate rates of initiation, cessation 

and switching for menthol and nonmenthol smokers. To simplify the 

model, dual users of cigarettes and 

ENDS were not modeled separately from 

current smokers. Smokers who switched 

to ENDS before age 35 were treated the 

same as exclusive ENDS users, while 

smokers who switched to ENDS age 35 

or later were considered separately as 

former smokers using ENDS. 

Additionally, the transitions modeled 

were unidirectional; relapse (i.e., 

reinitiating regular cigarette smoking or 

ENDS use after entering any group 

containing former smokers/users) was 

not considered in the model. Although 

age- and gender-specific effects were 

modeled, other sources of population 

heterogeneity, such as race, ethnicity, 

socioeconomic status, and geographical 

location, were not simulated. 

Based on PATH Study data and other 

publications, the ratio of menthol to 

non-menthol cessation was modeled as 

0.8 and the ratio of menthol to nonVerDate Sep<11>2014 17:17 May 03, 2022 Jkt 256001 PO 00000 Frm 00028 Fmt 4701 Sfmt 4702 E:\FR\FM\04MYP3.SGM 04MYP3

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13The Further Consolidated Appropriations Act, 

2020, made it unlawful for any retailer to sell a 

Continued 

menthol switching was modeled as 0.9, 

in effect modeling menthol cigarette 

smokers as 20 percent less likely to quit 

smoking and 10 percent less likely to 

switch to ENDS than non-menthol 

smokers (Refs. 46 and 211). Based on 

PATH Study data, all cigarettes-to-ENDS 

switching was assumed to decline 10 

percent annually from 2018. The excess 

relative risk of mortality for ENDS 

products compared to cigarettes was set 

at 0.15, in effect modeling the mortality 

risk of ENDS use as 15 percent of the 

mortality risk of cigarette smoking over 

the same period. 

To estimate the specific effects of a 

menthol ban on current and future 

tobacco use, an expert elicitation (EE) 

was conducted (Ref. 211). The EE used 

a systematic approach to identify eleven 

leading academic experts on topics 

related to the impacts of menthol flavor 

bans in tobacco products. Experts 

estimated a number of behaviors under 

a menthol ban, such as continued 

(illicit) menthol product use, menthol to 

non-flavored product switching, 

switching to other nicotine products 

(e.g., ENDS, smokeless tobacco 

products), and tobacco cessation. These 

estimates were adapted to fit the simpler 

structure of the SAVM. For example, 

transitions from cigarettes to HTPs were 

treated as transitions to ENDS, while 

transitions from menthol cigarettes to 

non-menthol cigars were treated as a 

transition to non-menthol cigarettes. 

Transitions to smokeless tobacco 

products were also treated as transitions 

to non-menthol cigarettes. Experts 

estimated the effects of a menthol ban 

for youth and young adults ages 12–24 

who would otherwise have initiated 

menthol smoking by age 24 (i.e., 

counterfactual menthol smokers), which 

were used to calculate the ongoing 

initiation rates beginning with the 

simulated ban in 2021 in the Menthol 

Ban Scenario. Among menthol smokers 

in both the Status Quo Scenario and 

Menthol Ban Scenario, experts 

estimated transitions over a 2-year 

period for ages 18–24 and 35–54, which 

were modeled as mean net differences 

applied to menthol smokers up to age 30 

and over age 30, respectively. The ban 

was assumed to have no effects on nonmenthol smokers. In the expert 

elicitation study, it is likely that when 

the experts were answering survey 

questions around tobacco use behaviors 

under a future menthol ban, they 

considered the products available in the 

market at the time. The marketplace of 

products may change over time due to 

a variety of reasons, and it is possible 

that changes in the marketplace, if 

known, may impact experts’ judgements 

about how menthol smokers and nonusers at risk for initiation may act in 

response to a menthol ban. 

The model estimated smokingattributable deaths averted and lifeyears lost averted over the 2021–2060 

period (Ref. 46). Compared to the Status 

Quo Scenario, in which no menthol ban 

was implemented, under the Menthol 

Ban Scenario the estimated overall 

smoking prevalence declined 14.7 

percent by 2026 and 15.1 percent by 

2060. This overall decrease was due to 

a sharp reduction in menthol smoking 

(down 92.5 percent by 2026, and 96.5 

percent by 2060), coupled with a 

smaller increase in non-menthol 

smoking (up 47.4 percent by 2026, and 

58.0 percent by 2060) over the same 

time period. The ban was also estimated 

to increase ENDS use 22.6 percent by 

2026, up to a 26.5 percent relative 

increase by 2060. Totaling the effects, 

the model estimated 654,000 premature 

deaths and 11,300,000 life-years lost 

averted by 2060. 

The study authors also conducted 

several sensitivity analyses to determine 

which model parameters had the 

greatest influence on outcome estimates 

(Ref. 46). Increasing the ratio of menthol 

to non-menthol cessation rate from 0.8 

to 1.0, in effect making menthol 

cigarettes no harder to quit than nonmenthol cigarettes, had the greatest 

impact on the model estimates, resulting 

in decreasing deaths averted by 29.5 

percent (to 461,000) and life-years lost 

averted by 24.2 percent (to 8.58 

million). Eliminating the 10 percent 

annual declines in cigarette-to-ENDS 

switching from the model, in effect 

increasing the appeal of complete 

switching for smokers in later years of 

the model, reduced deaths averted by 

20.5 percent (to 520,000) and life-years 

lost averted by 21.9 percent (to 8.83 

million). Other sensitivity analyses 

included 10 percent absolute increases 

and decreases in the excess relative risk 

of ENDS products to cigarettes, and 10 

percent relative changes in smoking 

initiation, smoking cessation, timeindependent cigarette-to-ENDS 

switching, ENDS initiation, and ENDS 

cessation. All of these sensitivity 

analyses resulted in modest (under 10 

percent) changes to model-predicted 

deaths and life-years lost averted. 

In addition to the SAVM study, a 

2011 study by Levy et al. that simulated 

the future benefit of a menthol cigarette 

ban was also consistent with the 

findings of other studies. This study 

estimated potential impacts of a U.S. 

menthol ban on future smoking 

prevalence and smoking attributable 

mortality for the total population, and 

for African Americans specifically (Ref. 

45). The model used data from the 2003 

TUS–CPS to characterize current 

smoking status, initiation and cessation 

rates by cigarette type, various other 

sources to characterize smoking relapse 

rates, and CPS II to characterize 

mortality risks, which were treated as 

equivalent for menthol and nonmenthol smokers. The analysis 

simulated the 2010–2050 period, with a 

menthol ban going into effect in 2011. 

The study compared three menthol ban 

scenarios against a status quo scenario 

with no menthol ban: 

1. 10 percent of menthol smokers quit 

permanently and 10 percent who would 

have initiated as menthol smokers do 

not take up smoking, 

2. 20 percent of menthol smokers quit 

permanently and 20 percent who would 

have initiated as menthol smokers do 

not take up smoking, and 

3. 30 percent of menthol smokers quit 

permanently and 30 percent who would 

have initiated as menthol smokers do 

not take up smoking. 

The study estimated that by 2050, 

under these menthol ban scenarios, 

324,000 (scenario 1) to 634,000 

(scenario 3) smoking attributable deaths 

would have been averted in the United 

States overall, while relative declines in 

smoking prevalence were expected to 

range from 4.8 percent to 9.7 percent, 

under scenarios 1 and 3, respectively. 

Among African Americans, by 2050, an 

estimated 92,000 to 238,000 smoking 

attributable deaths would have been 

prevented, while relative declines in 

smoking prevalence ranged from 9.1 

percent to 24.8 percent (under scenarios 

1 and 3, respectively) (Ref. 45). 

In conclusion, population health 

models simulating menthol ban policies 

are consistent with a substantial public 

health benefit. The 2021 simulation by 

Levy et al., using the SAVM model, 

estimated approximately 650,000 

premature deaths averted and 11.3 

million life-years lost averted in the first 

40 years of a menthol cigarette and cigar 

ban beginning in 2021 (Refs. 46, 211, 

and 291). The prevalence of smoking 

was also estimated to decline 15.1 

percent in that period. Sensitivity 

analyses demonstrated that lower 

cessation among menthol smokers 

compared to non-menthol smokers was 

a notable driver of the public health 

impact of the simulated menthol ban. 

The overall findings were consistent 

with the 2011 simulation by Levy et al. 

that estimated 324,000–634,000 

premature deaths averted under a 

similar ban and time period (Ref. 45).13


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tobacco product to any person younger than 21 

years of age (Pub. L. 116–94, section 603 (2019)). 

The quantitative estimates of the impact of a 

menthol ban on premature mortality presented in 

these studies do not take into account the impact 

of T21. However, given the long lag period between 

smoking initiation and premature mortality from 

smoking, any impact of T21 on the mortality 

benefits described in this rule would not be 

observed for decades into the future. See section 

II.C.4.a of the Preliminary Regulatory Impact 

Analysis (PRIA) for a discussion of T21 impacts on 

premature smoking-attributable deaths averted (Ref. 

292). 

6. Public Health Benefits Not Addressed 

in the Smoking and Vaping Model 

While the SAVM projections of the 

potential impact from a menthol 

product standard suggest a significant 

public health benefit to the United 

States resulting from substantial 

reductions in smoking prevalence, these 

analyses do not address other additional 

benefits. 

First, the SAVM simulation does not 

account for increased quality of life 

from decreased tobacco-related 

morbidity. The Surgeon General has 

reported that about 30 individuals will 

suffer from at least one smoking-related 

disease for every person that dies from 

smoking each year (Ref. 245). 

Researchers in one study estimated that 

individuals are living with 14 million 

major smoking-related conditions in the 

United States, including more than 7.4 

million cases of chronic obstructive 

pulmonary disease, nearly 2.3 million 

heart attacks, 1.8 million cases of 

diabetes, nearly 1.2 million stroke 

events, more than 300,000 cases of lung 

cancer, and nearly 1 million cases of 

other smoking-attributable cancers 

(bladder, cervix, colon/rectum, kidney, 

larynx, mouth, tongue, lip, throat, 

pharynx, stomach) (Ref. 246). Another 

study, which examined disparities in 

tobacco-related cancer incidence and 

mortality, found that tobacco-related 

mortality decreased between 2004 and 

2013, however tobacco-related cancer 

incidence and mortality rates remain 

highest among African Americans, 

accounting for more than 39,000 deaths 

annually between 2009 and 2013 (Ref. 

293). Cigarette smoking, in addition to 

causing disease, can diminish overall 

health status, leading to higher risks for 

surgical complications, including 

wound healing and respiratory 

complications, increased absenteeism 

from work, and greater use of health 

care services (Ref. 1). Increased smoking 

cessation, reduced cigarette 

consumption, and lower progression to 

regular cigarette smoking would reduce 

not only the mortality from smoking, 

but it also would reduce the enormous 

burden of cigarette-attributable disease 

in the United States. 

Second, the SAVM simulation does 

not account for the public health 

impacts of reduced secondhand smoke 

exposure. Exposure to secondhand 

smoke is a cause of cancer, respiratory, 

and cardiovascular disease (Ref. 1). 

Secondhand smoke exposure is 

currently estimated to be responsible for 

over 41,000 deaths annually in the 

United States (Ref. 1). Reducing 

secondhand smoke exposure through 

increased smoking cessation, reduced 

cigarette consumption, and lower 

progression to regular cigarette smoking 

would reduce the more than 7,300 lung 

cancer deaths and nearly 34,000 

coronary heart disease deaths annually 

attributed to secondhand smoke (Ref. 1). 

Exposure to secondhand smoke can also 

cause adverse health effects in infants 

and children. Exposure to cigarette 

smoke among children and adolescents 

can trigger asthma attacks and lead to 

more frequent respiratory infections 

compared to those not exposed to smoke 

(Ref. 1). Prenatal tobacco exposure and 

postnatal secondhand smoke exposure 

increase the risks of fetal deaths, fetal 

growth restriction/low birth weight, 

respiratory conditions, and SIDS (Ref. 

1). 

Third, the SAVM simulation does not 

isolate differential effects as 

experienced by vulnerable populations. 

Menthol cigarette use, and the disease 

and death linked to such use, is 

disproportionately high among members 

of vulnerable populations such as 

African Americans and other racial and 

ethnic groups, those with lower 

household income, and those who 

identify as LGBTQ+ (Refs. 55–57, 21–24, 

44). As a result, a menthol restriction is 

expected to confer larger benefits among 

these vulnerable populations by 

promoting improved public health 

outcomes. For example, studies have 

shown that after switching to nonmenthol cigarettes, Black menthol 

smokers had greater reductions in 

cigarettes per day when compared to 

non-Black menthol smokers (Ref. 217). 

In comparison to White smokers, a 

higher prevalence of Black smokers 

report they would not smoke a nonmentholated cigarette if they could not 

smoke a mentholated cigarette (Ref. 

214), a higher prevalence of Black 

menthol smokers reported intentions to 

quit following a menthol restriction 

(Refs. 219 and 215), and Black menthol 

smokers had lower odds of reporting 

that they would switch to a nonmenthol brand (Ref. 213). Prior 

modeling has shown that by 2050, 

following a 2011 menthol ban, an 

estimated 92,000 to 238,000 smoking 

attributable deaths among African 

Americans would have been prevented, 

comprising almost one-third of the total 

deaths averted by the ban (Ref. 45). The 

relative reduction in African Americans’ 

smoking prevalence in 2050 was also 

projected to range between 9.1 and 24.8 

percent compared to the status quo of 

no menthol ban (Ref. 45). 

Finally, the analysis does not account 

for reductions in harms caused by 

smoking-related fires. Lower prevalence 

of cigarette smoking, and reduced 

cigarette consumption are likely to 

decrease the occurrence of fires caused 

by smoking materials, including 

cigarettes and other lighted tobacco 

products. Even though all states have 

instituted laws requiring fire-safetycompliant cigarette paper (adoption 

began in 2003 with all states adopting 

these laws by 2012), smoking remained 

the second leading cause of residential 

fire deaths in the United States in 2018 

(Ref. 294). In 2011, an estimated 90,000 

fires in the United States were caused 

by smoking materials, of which 17,600 

occurred in the home (Ref. 295). 

Between 2012 and 2016, there were an 

average of 18,100 home structure fires 

per year started by smoking material, 

accounting for around 1 in 20 of all 

home fires (5 percent) (Ref. 296). The 

fatality rate for smoking-related 

residential building fires is seven times 

greater than for nonsmoking related fires 

(Ref. 297). Moreover, smoking materials 

remain the leading cause of fatal home 

fires in the United States and smokers 

themselves are not the only victims 

(Refs. 295 and 296). One out of every 

four fatal victims of smoking-material 

fires were not the smoker whose 

cigarette initiated the fire (Ref. 298). 

Reductions in smoking as a result of the 

proposed standard are likely to have an 

impact on the 590 deaths and over 1,100 

injuries from smoking-attributable 

structure fires (Ref. 296). 

We note that, while the impact of a 

proposed rule prohibiting menthol as a 

characterizing flavor in cigarettes is 

likely to be sizable, there is uncertainty 

in precisely quantifying the effects. 

Although the exact magnitude of the 

effects of the proposed ban are 

uncertain, because of the sheer number 

of smokers currently using menthol 

cigarettes—an estimated 18.5 million 

persons ages 12 and older (Ref. 44)— 

even modest decreases in the percentage 

of the population initiating smoking and 

increases in the percentage of the 

population quitting smoking would save 

many lives. 


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14While we recognize that some smokers could 

try to add menthol e-cigarette liquids (or e-liquids) 

to non-menthol cigarettes, we believe that the 

amount of e-liquid needed to impart a menthol 

characterizing flavor would make the cigarette 

unsmokeable. 

7. Potential Risks to the Population as 

a Whole of the Proposed Menthol 

Product Standard Would Not Outweigh 

the Potential Benefits of the Proposed 

Product Standard 

There are possible countervailing 

effects that could occur from the 

proposed product standard, if finalized. 

Potential risks to the population, 

however, would generally only occur 

among individuals currently using 

tobacco or smoking cigarettes as FDA 

concludes there are little to no risks to 

nonusers of tobacco. These potential 

risks do not offset the anticipated 

benefits of the rule. The countervailing 

effects on current tobacco users could 

include continued combusted tobacco 

product smoking, smokers seeking to 

add menthol to their combusted tobacco 

product, and the possibility of illicit 

trade. As part of this rulemaking, FDA 

is required by the Tobacco Control Act 

to consider information submitted on 

such possible countervailing effects, 

including among vulnerable 

populations and other population 

subgroups. 

With the removal of menthol 

cigarettes from the tobacco marketplace, 

some cigarette smokers may seek other 

sources of tobacco and/or nicotine. 

These could include nicotine 

replacement therapy products, nonmenthol cigarettes, other combusted 

tobacco products, or other potentially 

less harmful tobacco products. Findings 

from evaluations of menthol sales 

restrictions in Canada suggest some 

users switch to non-menthol cigarettes 

and flavored combusted tobacco 

products following a menthol sales 

restriction (Refs. 226, 231, 230, 216, 193, 

197). 

FDA acknowledges that the 

availability of flavored cigars may 

impact the public health benefits of the 

proposed rule. FDA’s expectation is 

that, even if menthol is not prohibited 

as a characterizing flavor in cigars, this 

rule would reduce initiation of and 

experimentation with cigarette smoking, 

decrease nicotine dependence and 

addiction to cigarettes, and increase the 

likelihood of cessation among current 

menthol cigarette smokers. It is also 

unlikely that all current or potential 

users of menthol cigarettes would 

switch to or initiate with menthol 

cigars. In studies assessing the potential 

impacts of banning menthol cigarettes, a 

minority of menthol smokers indicated 

that they might switch to flavored cigars 

(Refs. 219, 273, and 225). However, FDA 

is concurrently proposing a product 

standard to prohibit characterizing 

flavors (other than tobacco) in cigars, 

which would decrease the likelihood 

that menthol smokers would switch to 

cigars as a result of the proposed 

menthol cigarette standard. Working 

with others in HHS, FDA is currently 

exploring options to ensure that 

smokers who would like to quit 

cigarettes or would like to quit tobacco 

product use completely in response to 

the proposed standard will be aware of 

and have access to resources that 

provide cessation support. 

FDA recognizes that, while some 

smokers may switch to non-menthol 

flavored cigarettes, the risks of this 

won’t outweigh the benefits from 

smokers who quit smoking completely. 

FDA has no reason to believe that 

individuals switching from menthol 

cigarettes to other combusted tobacco 

products would be exposed to 

additional harm beyond their current 

exposure level. FDA requests comments 

regarding additional evidence on the 

extent and magnitude that menthol 

smokers will switch to other combusted 

tobacco products. 

With the removal of menthol 

cigarettes from the tobacco marketplace, 

some users could seek out products that 

will add menthol to non-menthol 

cigarettes (e.g., drops, capsules, filter 

tips for RYO tobacco, or cards that can 

be inserted into a cigarette pack or 

pouch of rolling tobacco) (Refs. 226, 

299, and 300),14 which would reduce 

the benefits of the proposed rule. A 

study of smokers from Ontario found 

that, before the menthol sales 

restriction, 4.4 percent of daily menthol 

smokers had previously tried flavored 

additives (including flavor cards, drops, 

oils, or other additives to add menthol 

to tobacco) (Ref. 299). One month after 

the menthol sales restriction in Ontario, 

5.1 percent of daily menthol smokers 

had tried flavored additives, 1 year after 

12.5 percent had, and 2 years after 9.5 

percent had (Ref. 299). However, 

products used to alter or affect the 

cigarette’s performance, composition, 

constituents, or characteristics are 

components and parts of the cigarette 

would also be subject to this rule. Thus, 

to the extent that flavor cards, drops, 

oils, or other additives that are 

components and parts of a cigarette 

contain menthol as a characterizing 

flavor, such products would be 

prohibited under proposed § 1162.3. 

Therefore, FDA does not anticipate a 

substantial number of individuals 

would utilize such products. 

Even if some people were to modify 

their non-menthol cigarettes in response 

to a menthol cigarette prohibition, FDA 

does not expect this behavior to result 

in significant additional harm beyond 

what menthol cigarette smokers are 

already being exposed to. Furthermore, 

with many other tobacco products 

available on the marketplace and the 

prohibition of products used to alter or 

affect the cigarette’s performance, 

composition, constituents, FDA does 

not expect that many individuals would 

attempt to modify non-menthol 

cigarettes and thus, FDA does not 

expect that this potential countervailing 

effect would significantly reduce the 

impact of the rule (Ref. 299). 

Finally, the removal of menthol 

cigarettes from the marketplace could 

result in some people seeking menthol 

cigarettes through the illicit trade 

market. FDA is considering whether 

illicit trade could occur as a result of a 

menthol product standard and potential 

implications. 

Since the enactment of the Tobacco 

Control Act, FDA has been committed to 

studying and understanding the 

potential effects of a product standard 

on the illicit tobacco market. As part of 

FDA’s consideration of possible 

regulations, the Agency asked the 

National Research Council (NRC) and 

Institute of Medicine (IOM) of the 

National Academy of Sciences to assess 

the international illicit tobacco market, 

including variations by country; the 

effects of various policy mechanisms on 

the market; and the applicability of 

international experiences to the United 

States (Ref. 301). In 2015, the NRC/IOM 

issued its final report titled 

‘‘Understanding the U.S. Illicit Tobacco 

Market: Characteristics, Policy Context, 

and Lessons from International 

Experiences’’ and concluded ‘‘[o]verall, 

the limited evidence now available 

suggests that if conventional cigarettes 

are modified by regulations, the demand 

for illicit versions of them is likely to be 

modest.’’ (Ref. 301 at 9). In addition, in 

March 2018, FDA issued a draft concept 

paper as an initial step in assessing the 

possible health effects of a tobacco 

product standard in the form of demand 

for contraband or nonconforming 

tobacco products (83 FR 11754). Among 

other things, the draft concept paper 

examined the factors that might support 

or hinder the establishment of a 

persistent illicit trade market related to 

a product standard but did not reach 

any conclusions regarding the potential 

demand that may develop due to a 

product standard (Ref. 79). 

The recent implementation of local 

menthol restrictions in the United States 

and restrictions outside of the United 


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States provides real-world experience 

regarding the potential for illicit trade of 

menthol cigarettes. Evidence from 

Canada, England, and the United States 

suggest that the impact of the proposed 

rule on the illicit market would not be 

significant (Refs. 302, 226, 224, 216, 

200, 209, 191, 303, 197). For example, 

a study evaluating a restriction on sales 

of menthol cigarettes in Nova Scotia, 

Canada found that the policy did not 

result in an increase in illicit cigarette 

seized (Ref. 302). The researchers noted 

that according to local Canadian 

authorities there were only a few small 

seizures of menthol cigarettes in the 

year following the policy (with the 

nature of the data analyzed indicating 

that seizures were from businesses only, 

not individual users, though the study 

is not clear on this point), and that there 

were no further seizures of menthol 

cigarettes after the first year (Ref. 302). 

Studies asking smokers about their 

responses to menthol sales restrictions 

in Canada find a small percentage that 

continue to use and purchase menthol 

cigarettes (Refs. 226, 224, and 216). 

When menthol smokers were asked 

where they purchased menthol 

cigarettes after menthol sales 

restrictions, a majority reported 

purchasing from First Nations Reserves 

(54.7 percent), which were generally 

exempted from the sales restrictions, 

followed by retail stores (31.0 percent); 

few reported purchasing menthol 

cigarettes online (7.5 percent) (Ref. 216). 

The study, however, was not able to 

determine the proportion of menthol 

cigarettes purchased by cigarette 

smokers post-policy that were 

contraband (Ref. 216). The authors also 

noted it is unclear how smokers were 

able to purchase menthol cigarettes at 

retail stores and hypothesized that 

smokers could be reporting the purchase 

of non-menthol cigarettes that were 

rebranded as menthol replacements 

with color on the pack or in the brand 

name to suggest menthol-like qualities 

(Ref. 216). Another study of a local 

Canadian menthol sales restriction 

found that one month following 

implementation of Ontario’s menthol 

sales restriction, 14.1 percent of smokers 

reported using menthol cigarettes 

purchased from a First Nations reserve, 

other province, other country, or online 

(Ref. 226). A study of young adult ever 

tobacco users in San Francisco found 

that a small percentage reported 

purchasing flavored tobacco products 

illegally in San Francisco (5 percent) 

and purchasing flavored tobacco 

products online (15 percent) after the 

policy; however, this was a 

retrospective study with a relatively 

small convenience sample (Ref. 191). 

These results are consistent with the 

expert elicitation study discussed 

previously (Ref. 211). In the expert 

elicitation study, 50.5 percent of 

menthol smokers were expected to 

remain combusted tobacco product 

users, with 40.3 percent becoming nonmenthol cigarette smokers, and 3.7 

percent becoming non-menthol cigar 

smokers; however, the experts also 

estimated that 6.5 percent would 

continue to use illicit menthol cigarettes 

(Ref. 211). 

Taken together, these studies provide 

evidence that a major change to the 

availability of products covered by this 

proposed rule (see section VII.A) is not 

likely to lead to a surge in illicit 

menthol cigarette use. In reaching this 

conclusion, FDA has considered several 

factors that are likely to affect the 

potential for illicit trade. For example, 

FDA anticipates that a nationwide 

standard that prohibits the manufacture 

and sale of menthol cigarettes, coupled 

with FDA’s authority to take 

enforcement actions and other steps 

regarding the sale and distribution of 

illicit tobacco products, would 

eliminate the manufacture and 

distribution of these products. FDA also 

expects that a nationwide product 

standard would eliminate the 

opportunity to easily travel to 

neighboring jurisdictions within the 

United States that do not have such 

menthol sales restrictions or use online 

retailers to purchase menthol cigarettes. 

FDA thus anticipates that the rule 

would result in much less illicit trade 

than observed in the case of a state or 

local requirement and that any such 

trade would be significantly outweighed 

by the benefits of the rule. 

If an illicit market develops after this 

proposed menthol standard is finalized, 

FDA has the authority to take 

enforcement actions and other steps 

regarding the sale and distribution of 

illicit tobacco products, including those 

imported or purchased online (see 

section VII.C of this document for 

additional information about FDA’s 

enforcement authorities). FDA conducts 

routine surveillance of sales, 

distribution, marketing, and advertising 

related to tobacco products and takes 

corrective actions when violations 

occur. After this proposed menthol 

standard is finalized and goes into 

effect, it would be illegal to import 

menthol cigarettes and such products 

would be subject to import examination 

and refusal of admission under the 

FD&C Act. Similarly, it would be illegal 

to sell or distribute menthol cigarettes, 

including those sold online, and doing 

so may result in FDA initiating 

enforcement or regulatory actions. We 

note that the Prevent All Cigarette 

Trafficking Act of 2009 (PACT Act) 

establishes restrictions that make 

cigarettes generally nonmailable 

through the U.S. Postal Service, subject 

to certain exceptions (18 U.S.C. 1716E). 

Outside of these exceptions, the U.S. 

Postal Service cannot accept or transmit 

any package that it knows, or has 

reasonable cause to believe, contains 

nonmailable cigarettes, smokeless 

tobacco, or ENDS. 

As previously noted, FDA’s 

enforcement will only address 

manufacturers, distributors, 

wholesalers, importers, and retailers. 

This regulation does not include a 

prohibition on individual consumer 

possession or use, and FDA cannot and 

will not enforce against individual 

consumers for possession or use of 

menthol cigarettes. In addition, State 

and local law enforcement agencies do 

not independently enforce the FD&C 

Act. These entities do not and cannot 

take enforcement actions against any 

violation of chapter IX of the Act or this 

regulation on FDA’s behalf. As noted 

previously, FDA recognizes concern 

about how State and local law 

enforcement agencies enforce their own 

laws in a manner that may impact 

equity and community safety and seeks 

comments on how FDA can best make 

clear the respective roles of FDA and 

State and local law enforcement. 

Based on the available evidence, FDA 

finds that, while there may be potential 

countervailing effects that could 

diminish the expected population 

health benefits of the proposed 

standard, such effects would be 

significantly outweighed by the 

potential benefits of the proposed 

menthol product standard. 

In this section, FDA has cited studies 

describing the potential countervailing 

effects of the proposed product 

standard. FDA requests additional 

information concerning the potential 

countervailing effects discussed in this 

section, as well as any other potential 

countervailing effects that could result 

from this rule, and how the potential 

countervailing effects could be 

minimized. FDA is particularly 

interested in receiving comments, 

including supporting data and research, 

regarding whether and to what extent 

this proposed rule would result in an 

increase in illicit trade in menthol 

cigarettes and how any such increase 

could impact the marketplace or public 

health. 


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D. Conclusion 

FDA has considered scientific 

evidence related to the likely impact of 

the proposed rule prohibiting use of 

menthol as a characterizing flavor in 

cigarettes on current nonusers, current 

users, and the U.S. population as a 

whole. Based on these considerations, 

we find that the proposed tobacco 

product standard is appropriate for the 

protection of the public health because 

it would reduce the appeal and ease of 

smoking cigarettes, particularly for 

young people and new users, thereby 

decreasing the likelihood that nonusers 

of cigarettes who experiment with these 

tobacco products would progress to 

regular cigarette smoking. Additionally, 

the proposed tobacco product standard 

is anticipated to improve the health of 

current smokers of menthol cigarettes by 

decreasing cigarette consumption, 

increasing the likelihood of cessation 

among this population, and decreasing 

secondhand smoke exposure among 

current smokers and non-smokers. 

These positive public health impacts 

will also address the significant health 

disparities linked to menthol cigarettes. 

Tobacco use is the leading 

preventable cause of disease and death 

in the United States (Ref. 1). As over 

18.5 million Americans ages 12 and 

older smoke menthol cigarettes (Ref. 

44), even modest reductions in the 

percentage of people initiating and 

modest increases in the percentage of 

people quitting smoking would lead to 

substantial reductions in the over 

480,000 annual deaths and 

approximately 16 million cases of 

disease attributed to combustible 

tobacco products in the United States, 

as well as the economic and societal 

costs associated with such illness and 

death. 

Each day in the United States, more 

than 1,500 youth under the age of 18 

smoke their first cigarette (Ref. 96). 

Additionally, nearly 90 percent of adult 

current daily cigarette smokers in the 

United States report having smoked 

their first cigarette by the age of 18 (Ref. 

1). Nicotine is a highly addictive 

substance, and multiple studies have 

shown that symptoms of nicotine 

dependence can arise early after youth 

start smoking cigarettes, even among 

infrequent users (Refs. 184, 137, and 

135). Menthol in cigarettes enhances 

nicotine addiction through a 

combination of its flavor, sensory 

effects, and interaction with nicotine in 

the brain, facilitating repeated 

experimentation with cigarettes and 

progression to regular cigarette smoking, 

which repeatedly exposes the brain to 

nicotine (Refs. 6 and 9). 

Evidence shows that adding menthol 

to cigarettes soothes irritation from 

nicotine and smoke inhalation, 

particularly among new smokers (Ref. 

7). Data from the 2013–2014 PATH 

Study indicate that 43 percent of youth 

(aged 12–17 years), 45 percent of young 

adults (aged 18–24 years) and 30 

percent of adults (aged 25 years and 

older) that have ever smoked a cigarette 

reported that their first tobacco product 

was mentholated (Ref. 31). Results from 

national studies also consistently show 

a preference for smoking menthol 

cigarettes among youth and young adult 

smokers, compared to older smokers, 

and existing research suggests that the 

likelihood of progressing to regular, 

established smoking is higher among 

youth who initiate with menthol 

smoking compared to those starting 

with non-menthol cigarettes (Refs. 25, 

29–31, 8). The result is that nearly half 

of youth (48.6 percent) and young adults 

(51 percent) and two in five (39 percent) 

adult smokers report smoking menthol 

cigarettes (Ref. 44). 

Prohibiting the use of menthol as a 

characterizing flavor in cigarettes would 

help to decrease future addiction, 

disease, and death among youth at risk 

of tobacco use. FDA anticipates that the 

proposed standard would produce 

substantial health benefits. Even small 

changes in initiation and cessation 

would result in a significant reduction 

in the burden of death and disease in 

the United States caused by smoking, 

including reductions in smoking-related 

morbidity and mortality, diminished 

exposure to secondhand smoke among 

non-smokers, decreased potential years 

of life lost, decreased disability, and 

improved quality of life for the current 

and future generations to come. 

While preventing initiation to regular 

cigarette smoking by even modest 

amounts carries the greatest potential 

from this proposed standard to improve 

population health in the long term, FDA 

anticipates that the proposed standard 

would produce substantial short-term 

health benefits resulting from decreased 

cigarette consumption and increased 

cessation among current menthol 

cigarette smokers. In the United States, 

there are currently over 18.5 million 

smokers of menthol cigarettes ages 12 

and older (Ref. 44). As previously 

described, the health benefits of 

smoking cessation are substantial. A 

published population modeling study 

estimated that as many as 654,000 

smoking attributable deaths would be 

avoided by the year 2060 if menthol 

cigarettes were no longer available (Ref. 

46). Beyond averted deaths, societal 

benefits would include reduced 

smoking-related morbidity and health 

disparities, diminished exposure to 

secondhand smoke among non-smokers, 

decreased potential years of life lost, 

decreased disability, and improved 

quality of life among former smokers. 

FDA’s expectation that the proposed 

product standard would be appropriate 

for the protection of the public health is 

reasonable and well-supported by 

scientific evidence. Cigarettes are the 

most toxic consumer product, when 

used as intended, and adding menthol 

as a characterizing flavor makes 

cigarettes more appealing and easier to 

smoke. Given the existing scientific 

evidence described in sections IV and V 

of this document, FDA expects that 

implementing the proposed menthol 

product standard would result in 

reduced smoking initiation and 

progression among youth and young 

adults, and increased smoking cessation 

among current cigarette smokers. Across 

the population, these changes in 

cigarette smoking behaviors would lead 

to lower disease and death in the United 

States in both the short term, and in the 

future, due to diminished exposure to 

tobacco smoke among both smokers and 

non-smokers. 

FDA anticipates the proposed product 

standard also will improve health 

outcomes among vulnerable 

populations. As previously described, 

menthol cigarette use, and the disease 

and death linked to such use, is 

disproportionately high among members 

of vulnerable populations such as 

African Americans and other racial and 

ethnic groups, those with lower 

household income, and those who 

identify as LGBTQ+ (Refs. 55–57, 21–24, 

44). For example, out of all nonHispanic Black smokers, nearly 85 

percent smoke menthol cigarettes, 

compared to 30 percent of non-Hispanic 

White smokers who smoke menthol 

cigarettes (Ref. 44). As a result, these 

population groups with the greatest 

menthol cigarette use would be 

expected to experience the greatest 

benefit from the proposed product 

standard through its impact on reducing 

youth initiation of and experimentation 

with cigarette smoking, decreasing the 

likelihood of nicotine dependence and 

addiction, and increasing the likelihood 

of cessation. Accordingly, the proposed 

product standard is anticipated to 

promote better public health outcomes 

across population groups. 

VI. Additional Considerations and 

Requests for Comments 

A. Section 907 of the FD&C Act 

FDA is required by section 907 of the 

FD&C Act to consider the following 


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15For additional information about the variability 

of tobacco products, see the Premarket Tobacco 

Product Applications and Recordkeeping 

information submitted in connection 

with a proposed product standard: 

• For a proposed product standard to 

require the reduction or elimination of 

an additive, constituent (including 

smoke constituent), or other component 

of a tobacco product because FDA has 

found that the additive, constituent 

(including a smoke constituent), or 

other component is or may be harmful, 

scientific evidence submitted by any 

party objecting to the proposed standard 

demonstrating that the proposed 

standard will not reduce or eliminate 

the risk of illness or injury (section 

907(a)(3)(B)(ii) of the FD&C Act). 

• Information submitted regarding the 

technical achievability of compliance 

with the standard, including with regard 

to any differences related to the 

technical achievability of compliance 

with such standard for products in the 

same class containing nicotine not made 

or derived from tobacco and products 

containing nicotine made or derived 

from tobacco (section 907(b)(1) of the 

FD&C Act). 

• All other information submitted, 

including information concerning the 

countervailing effects of the tobacco 

product standard on the health of 

adolescent tobacco users, adult tobacco 

users, or nontobacco users, such as the 

creation of a significant demand for 

contraband or other tobacco products 

that do not meet the requirements of 

chapter IX of the FD&C Act and the 

significance of such demand (section 

907(b)(2) of the FD&C Act). 

As required by section 907(c)(2) of the 

FD&C Act, FDA invites interested 

persons to submit a draft or proposed 

tobacco product standard for the 

Agency’s consideration (section 

907(c)(2)(B)) and information regarding 

structuring the standard so as not to 

advantage foreign-grown tobacco over 

domestically grown tobacco (section 

907(c)(2)(C)). In addition, FDA invites 

the Secretary of Agriculture to provide 

any information or analysis which the 

Secretary of Agriculture believes is 

relevant to the proposed tobacco 

product standard (section 907(c)(2)(D) of 

the FD&C Act). 

FDA is requesting all relevant 

documents and information described 

in this section with this proposed rule. 

Such documents and information may 

be submitted in accordance with the 

‘‘Instructions’’ included in the 

preliminary information section of this 

document. 

Section 907(d)(5) of the FD&C Act 

allows the Agency to refer a proposed 

regulation for the establishment of a 

tobacco product standard to TPSAC at 

the Agency’s own initiative or in 

response to a request that demonstrates 

good cause for a referral and is made 

before the expiration of the comment 

period. If FDA opts to refer this 

proposed regulation to TPSAC, the 

Agency will publish a notice in the 

Federal Register announcing the TPSAC 

meeting to discuss this proposal. 

B. Request for Comments on the 

Potential Racial and Social Justice 

Implications of the Proposed Product 

Standard 

FDA is aware of concerns raised by 

some that this proposed rule could lead 

to illicit trade in menthol cigarettes, 

increased policing, and criminal 

penalties in underserved communities, 

including Black communities, which 

tend to have higher rates of menthol 

cigarette use and experience greater 

tobacco-related morbidity and mortality. 

We reiterate that this regulation does 

not include a prohibition on individual 

consumer possession or use, and FDA 

cannot and will not enforce against 

individual consumer possession or use 

of menthol cigarettes. FDA’s 

enforcement of this proposed rule will 

only address manufacturers, 

distributors, wholesalers, importers, and 

retailers. State and local law 

enforcement agencies do not 

independently enforce the FD&C Act. 

These entities do not and cannot take 

enforcement actions against any 

violation of chapter IX of the Act or this 

regulation on FDA’s behalf. 

Recognizing concerns related to how 

State and local law enforcement 

agencies enforce their own laws in a 

manner that may impact equity and 

community safety, FDA requests 

comments, including supporting data 

and research, on any potential for this 

proposed rule to result, directly or 

indirectly, in disparate impacts within 

particular underserved communities or 

vulnerable populations. With respect to 

any potential disparate impacts, FDA 

requests comments and data on whether 

and how specific aspects of the rule, if 

finalized, might increase the likelihood 

of such outcomes beyond what would 

be expected to occur in the absence of 

the rule, and potential strategies for 

avoiding or addressing such impacts of 

the rule within the bounds of FDA’s 

authorities. FDA also requests 

comments and data related to the 

existence, nature and degree of any 

change in police activity or community 

encounters with State or local law 

enforcement within a State, locality or 

other jurisdiction following 

implementation of a prohibition of 

menthol cigarettes. Finally, FDA 

requests comment on any other policy 

considerations related to potential racial 

and social justice implications of the 

rule. 

VII. Description of the Proposed 

Regulation 

We are proposing to establish a new 

21 CFR part 1162 (part 1162) that would 

prohibit menthol as a characterizing 

flavor in cigarettes. Part 1162 would 

describe the scope of the proposed 

regulation, applicable definitions, and 

the prohibition on use of menthol as a 

characterizing flavor in cigarettes. 

A. Scope (Proposed § 1162.1) 

Proposed § 1162.1(a) would provide 

that this part sets out a tobacco product 

standard under the FD&C Act regarding 

the use of menthol as a characterizing 

flavor in cigarettes. We are proposing 

that this product standard would cover 

all products meeting the definition of 

‘‘cigarette’’ in section 900(3) of the 

FD&C Act (21 U.S.C. 387(3)) (proposed 

§ 1162.3 includes a definition of 

cigarette). This includes all types, sizes, 

nicotine strengths and formulations of 

cigarettes, cigarette tobacco and RYO 

tobacco, as well as HTPs that meet the 

definition of a cigarette in the FD&C Act 

(cigarettes that are HTPs). 

In general, as discussed in this 

document, menthol as a characterizing 

flavor in tobacco products enhances 

product appeal, usability, and 

addictiveness and has played a role in 

creating and perpetuating tobaccorelated health disparities. While these 

effects raise concerns in the context of 

any tobacco product—none of which is 

without risk—FDA recognizes that 

certain products that meet the definition 

of cigarette in the FD&C Act may 

present different considerations with 

respect to this proposed product 

standard. For example, certain cigarettes 

may produce significantly fewer or 

lower levels of toxicants or have 

significantly reduced potential for 

creating or sustaining addiction. 

Recognizing that tobacco products exist 

on a continuum of risk, with combusted 

cigarettes being the deadliest, FDA 

recognizes that certain, specific 

products meeting the definition of a 

cigarette (e.g., some that are not 

combusted or are minimally addictive) 

may pose less risk to individual users or 

to population health than other 

products meeting the definition of a 

cigarette. FDA also notes that there is 

wide variability even within certain 

types of cigarettes, such as variability in 

toxicants or youth appeal among HTPs 

or minimally addictive cigarettes.15


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Requirements (PMTA) final rule (86 FR 55300, 

October 5, 2021) available at https://www.federal

register.gov/documents/2021/10/05/2021-21011/ 

premarket-tobacco-product-applications-andrecordkeeping-requirements. 

Accordingly, FDA is considering 

options that would allow certain 

products that present different 

considerations to seek exemptions from 

the product standard on a case-by-case 

basis. 

Section 910 of the FD&C Act provides 

that those seeking to market new 

tobacco products via a premarket 

tobacco application may justify a 

deviation from a product standard to 

which it does not conform. However, no 

similar provision exists for pre-existing 

products or products that already are 

authorized under, or that seek 

authorization under, other pathways, 

i.e., the substantial equivalence pathway 

or exemption from substantial 

equivalence. FDA is considering 

whether a final product standard rule 

should include a provision for 

requesting an exemption from the 

standard for certain products within 

particular categories, on a case-by-case 

basis, consistent with the potential for 

differential public health impacts 

among products meetings the definition 

of ‘‘cigarette’’, as discussed above. 

Accordingly, we are requesting 

comments on exemptions, including: (1) 

Whether the final rule should include a 

provision that allows for firms to 

request an exemption from the standard 

for specific products of certain types 

(e.g., noncombusted, reduced nicotine), 

on a case-by-case basis; (2) for what 

types of products should firms be 

eligible to request an exemption; (3) for 

an exemption provision, how should the 

Agency evaluate exemption requests, 

and what data and information should 

firms be required to submit for this; and 

(4) if an exemption provision should 

apply to products currently on the 

market at the time of the final rule’s 

effective date, how the exemption 

process should work (e.g., require that 

any exemption request be received 

within 180 days of publication so the 

Agency has time to make a 

determination before the effective date). 

As part of this, comments could address 

or account for impact on industry, 

impact on the Agency’s use of resources 

and the Agency’s ability to protect 

public health, as well as situations 

where the commenter believes an 

exemption would or would not be 

appropriate. 

Proposed § 1162.1(b) would prohibit 

the manufacture, distribution, sale, or 

offering for distribution or sale, in the 

United States of a cigarette or any of its 

components or parts that is not in 

compliance with the tobacco product 

standard. This provision is not intended 

to restrict the manufacture of cigarettes 

with menthol as a characterizing flavor 

intended for export. Consistent with 

section 801(e)(1) of the FD&C Act (21 

U.S.C. 381(e)(1)), a tobacco product 

intended for export shall not be deemed 

to be in violation of section 907 of the 

FD&C Act or this product standard, if it 

meets the criteria enumerated in section 

801(e)(1), including not being sold or 

offered for sale in domestic commerce. 

B. Definitions (Proposed § 1162.3) 

Proposed § 1162.3 provides the 

definitions for the terms used in the 

proposed rule. Several of these 

definitions are included in the FD&C 

Act or are used in other regulations. 

• Accessory: FDA defined 

‘‘accessory’’ in the deeming final rule 

(81 FR 28974, May 10, 2016; codified at 

§ 1100.3 (21 CFR 1100.3)). We are 

proposing to use that definition here as 

it applies to cigarettes to provide further 

understanding as to the scope of the 

proposed standard. Therefore, FDA 

proposes to define ‘‘accessory’’ in the 

context of part 1162 to mean any 

product that is intended or reasonably 

expected to be used with or for the 

human consumption of a cigarette; does 

not contain tobacco or nicotine from any 

source, and is not made or derived from 

tobacco; and meets either of the 

following: (1) Is not intended or 

reasonably expected to affect or alter the 

performance, composition, constituents, 

or characteristics of a cigarette; or (2) is 

intended or reasonably expected to 

affect or maintain the performance, 

composition, constituents, or 

characteristics of a cigarette but (i) 

solely controls moisture and/or 

temperature of a stored cigarette; or (ii) 

solely provides an external heat source 

to initiate but not maintain combustion 

of a cigarette. An example of a cigarette 

‘‘accessory’’ is an ashtray. 

• Cigarette: As defined in section 

900(3) of the FD&C Act, the term 

‘‘cigarette’’: (1) Means a product that: (i) 

Is a tobacco product and (ii) meets the 

definition of the term ‘‘cigarette’’ in 

section 3(1) of the Federal Cigarette 

Labeling and Advertising Act (15 U.S.C. 

1332(1)) and (2) includes tobacco, in 

any form, that is functional in the 

product, which, because of its 

appearance, the type of tobacco used in 

the filler, or its packaging and labeling, 

is likely to be offered to, or purchased 

by, consumers as a cigarette or as RYO 

tobacco. 

• Cigarette tobacco: As defined in 

section 900(4) of the FD&C Act, the term 

‘‘cigarette tobacco’’ means any product 

that consists of loose tobacco that is 

intended for use by consumers in a 

cigarette. Unless otherwise stated, the 

requirements applicable to cigarettes 

under 21 CFR chapter I also apply to 

cigarette tobacco. 

• Component or part: FDA defined 

‘‘component or part’’ in the deeming 

final rule (§ 1100.3). We are proposing 

to use that definition here as it applies 

to cigarettes. Therefore, FDA proposes 

to define ‘‘component or part’’ in the 

context of part 1162 to mean any 

software or assembly of materials 

intended or reasonably expected: (1) To 

alter or affect the cigarette’s 

performance, composition, constituents 

or characteristics or (2) to be used with 

or for the human consumption of a 

cigarette. The term excludes anything 

that is an accessory of a cigarette. 

Examples of cigarette components or 

parts that would be subject to this 

proposed product standard include 

cigarette paper, filters, and flavor 

additives. With respect to these 

definitions, FDA notes that 

‘‘component’’ and ‘‘part’’ are separate 

and distinct terms within chapter IX of 

the FD&C Act. However, for purposes of 

this rule, FDA is using the terms 

‘‘component’’ and ‘‘part’’ 

interchangeably and without 

emphasizing a distinction between the 

terms. FDA may clarify the distinctions 

between ‘‘component’’ and ‘‘part’’ in the 

future. 

• Person: As defined in section 201(e) 

of the FD&C Act (21 U.S.C. 321(e)), the 

term ‘‘person’’ includes an individual, 

partnership, corporation, and 

association. 

• Roll-your-own tobacco: As defined 

in section 900(15) of the FD&C Act, the 

term ‘‘roll-your-own tobacco’’ means 

any tobacco product which, because of 

its appearance, type, packaging, or 

labeling, is suitable for use and likely to 

be offered to, or purchased by, 

consumers as tobacco for making 

cigarettes. 

• Tobacco product: As defined in 

section 201(rr) of the FD&C Act, the 

term ‘‘tobacco product’’ is defined as 

any product that is made or derived 

from tobacco, or containing nicotine 

from any source, that is intended for 

human consumption, including any 

component, part, or accessory of a 

tobacco product (except for raw 

materials other than tobacco used in 

manufacturing a component, part, or 

accessory of a tobacco product). The 

term ‘‘tobacco product’’ does not mean 

an article that is: A drug under section 

201(g)(1); a device under section 201(h); 

a combination product described in 

section 503(g) of the FD&C Act (21 

U.S.C. 353(g)); or a food under section 

201(f) if such article contains no 


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16We note that the language in section 

907(a)(1)(A) of the FD&C Act states that the Special 

Rule for Cigarettes applies to cigarettes or ‘‘any of 

its component parts.’’ For purposes of this standard, 

we have used the phrase ‘‘any of its components or 

parts’’ and have defined ‘‘component or part’’ for 

clarity and consistency with the deeming final rule 

(81 FR 28974 at 28975). 

17 If a cigarette has a characterizing flavor (other 

than tobacco), but its labeling or advertising 

represents that it does not, then the product may 

be, among other things, misbranded under section 

903 of the FD&C Act because its labeling or 

advertising is false or misleading. Similarly, if a 

product does not have a characterizing flavor, but 

its labeling or advertising represents that it does, 

then the product may be misbranded under section 

903 of the FD&C Act because its labeling or 

advertising is false or misleading. 

18Section 907(d)(2) of the FD&C Act states that 

a regulation establishing a tobacco product standard 

shall set forth the date or dates upon which the 

standard shall take effect, but no such regulation 

may take effect before 1 year after the date of its 

publication unless the Secretary determines that an 

earlier effective date is necessary for the protection 

of the public health. 

nicotine, or no more than trace amounts 

of naturally occurring nicotine. 

• United States: As defined in section 

900(22) of the FD&C Act, the term 

‘‘United States’’ means the 50 States of 

the United States of America and the 

District of Columbia, the 

Commonwealth of Puerto Rico, Guam, 

the Virgin Islands, American Samoa, 

Wake Island, Midways Islands, 

Kingman Reef, Johnston Atoll, the 

Northern Mariana Islands, and any other 

trust territory or possession of the 

United States. 

C. Prohibition on Use of Menthol as a 

Characterizing Flavor in Cigarettes 

(Proposed § 1162.5) 

Proposed § 1162.5 would establish a 

tobacco product standard prohibiting 

the use of menthol as a characterizing 

flavor in cigarettes. Specifically, 

proposed § 1162.5 would state that a 

cigarette or any of its components or 

parts (including the tobacco, filter, 

wrapper, or paper, as applicable) shall 

not contain, as a constituent (including 

a smoke constituent) or additive, 

menthol that is a characterizing flavor of 

the tobacco product or tobacco smoke.16

This proposal takes into consideration, 

among other information, the comments 

received by FDA on the ANPRMs and 

citizen petition, including comments 

urging FDA to ban menthol as a 

characterizing flavor in cigarettes, 

comments arguing for a total ban on 

menthol in cigarettes, comments 

recommending that any product 

standard for menthol also cover 

additives and components which 

convey menthol flavoring, and 

comments opposing any product 

standard for menthol in cigarettes. As 

discussed in section V of this document, 

FDA finds that this proposed product 

standard, which would prohibit 

menthol as a characterizing flavor in 

cigarettes, would be appropriate for the 

protection of the public health. 

FDA would enforce the requirements 

of this proposed product standard under 

various sections of the FD&C Act, 

including sections 301, 303, 902, and 

903. Section 907(a)(4)(B)(v) of the FD&C 

Act states that product standards must, 

where appropriate for the protection of 

the public health, include provisions 

requiring that the sale and distribution 

of the tobacco products be restricted but 

only to the extent that the sale and 

distribution of a tobacco product may be 

restricted under section 906(d). Similar 

to section 907(a)(4)(B)(v), section 906(d) 

of the FD&C Act gives FDA authority to 

require restrictions on the sale and 

distribution of tobacco products by 

regulation if the Agency determines that 

such regulation would be appropriate 

for the protection of the public health. 

Because this sale and distribution 

restriction of menthol cigarettes would 

also assist FDA in enforcing the 

standard and would ensure that 

manufacturers, distributors, and 

retailers are selling product that 

complies with the standard, the Agency 

has found the restriction to be 

appropriate for the protection of the 

public health consistent with sections 

907(a)(4)(B)(v) and 906(d) of the FD&C 

Act. 

Failure to comply with any 

requirements prescribed by this product 

standard may result in FDA initiating 

enforcement or regulatory actions, 

including, but not limited to, warning 

letters, civil money penalties, notobacco-sale orders, criminal 

prosecution, seizure, and/or injunction. 

In addition, adulterated or misbranded 

tobacco products offered for import into 

the United States are subject to 

detention and refusal of admission. As 

previously discussed, FDA’s 

enforcement will only address 

manufacturers, distributors, 

wholesalers, importers, and retailers. 

FDA cannot and will not enforce against 

individual consumer possession or use 

of menthol cigarettes. 

Among the factors that FDA believes 

are relevant in determining whether a 

cigarette has a characterizing flavor are: 

• The presence and amount of 

artificial or natural flavor additives, 

compounds, constituents, or 

ingredients, or any other flavoring 

ingredient in a tobacco product, 

including its components or parts; 

• The multisensory experience (i.e., 

taste, aroma, and cooling or burning 

sensations in the mouth and throat) of 

a flavor during use of a tobacco product, 

including its components or parts; 

• Flavor representations (including 

descriptors), either explicit or implicit, 

in or on the labeling (including 

packaging) or advertising of tobacco 

products; 17 and 

• Any other means that impart flavor 

or represent that the tobacco product 

has a characterizing flavor. 

FDA expects that the approach 

proposed in this rule—relying on 

specific, flexible factors to make a caseby-case determination as to a 

characterizing flavor of menthol—would 

provide important clarity for FDA, 

regulated industry, and other 

stakeholders while also ensuring critical 

flexibility and enforceability to achieve 

the public health goals of this rule. FDA 

requests comments regarding these 

factors and other potential factors that 

the Agency might consider in 

determining whether a cigarette has 

menthol as a characterizing flavor. 

FDA also requests comments, 

including supporting data and research, 

regarding any alternatives to prohibiting 

menthol as a characterizing flavor (e.g., 

prohibiting all menthol flavor additives, 

compounds, constituents, or 

ingredients). 

We note that this prohibition also 

would cover menthol flavoring that is 

separate from the cigarette. For example, 

menthol can be added to non-menthol 

cigarettes via drops, capsules, filter tips 

for RYO tobacco, or cards that can be 

inserted into a cigarette pack or pouch 

of rolling tobacco (Refs. 299 and 300). 

Such menthol flavorings would be 

considered components or parts of 

cigarettes under proposed § 1162.3, as 

they could be intended or reasonably 

expected to: (1) Alter or affect the 

cigarette’s performance, composition, 

constituents, or characteristics or (2) be 

used with or for the human 

consumption of a cigarette, and they 

would not be accessories of cigarettes. 

Therefore, the manufacture, 

distribution, sale, or offer for 

distribution or sale of such products 

would be prohibited should this 

proposed rule be finalized. 

VIII. Proposed Effective Date 

In accordance with section 907(d)(2) 

of the FD&C Act,18 FDA proposes that 

any final rule that may issue based on 

this proposal become effective 1 year 

after the date of publication of the final 

rule. Therefore, after the effective date, 

no person may manufacture, sell, or 

offer for sale or distribution within the 

United States a cigarette or any of its 

components or parts that is not in 

compliance with part 1162. This 


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regulation does not include a 

prohibition on individual consumer 

possession or use. 

FDA finds this proposed standard 

appropriate for the protection of the 

public health because it would reduce 

the ease of smoking cigarettes, 

particularly for young people and new 

users, thereby decreasing the likelihood 

that nonusers who experiment with 

these products would progress to 

regular smoking. In addition, the 

proposed tobacco product standard 

would improve the health of current 

menthol cigarette smokers by decreasing 

cigarette consumption and increasing 

the likelihood of cessation. Additional 

delay, past 1 year, would only increase 

the numbers of youth and young adults 

who experiment with menthol cigarettes 

and become regular smokers, delay 

cessation by current smokers, and 

exacerbate tobacco-related health 

disparities. 

FDA also finds that a 1-year effective 

date will ‘‘minimize, consistent with the 

public health, economic loss to, and 

disruption or dislocation of, domestic 

and international trade’’ pursuant to 

section 907(d)(2) of the FD&C Act. As 

discussed in the preliminary economic 

analysis (Ref. 292), FDA believes that 

most currently marketed menthol 

cigarettes are available for purchase in 

currently marketed non-menthol 

versions. Therefore, FDA does not 

expect that this rule, if finalized, would 

result in many new tobacco product 

applications. For these reasons, FDA 

believes that the availability of currently 

marketed non-menthol versions of 

currently marketed menthol cigarettes 

would minimize the economic loss to, 

and disruption of, domestic and 

international trade. 

We also note that the Tobacco Control 

Act banned characterizing flavors in 

cigarettes with a 90-day effective date 

(section 907(a)(1)(A) of the FD&C Act). 

FDA is proposing a longer effective date 

here in accordance with section 

907(d)(2) of the FD&C Act. FDA requests 

comments as to whether a shorter 

effective date, such as 90 days, would be 

necessary for the protection of the 

public health. In setting the effective 

date, FDA will consider information 

submitted in connection with this 

proposal by interested parties, including 

manufacturers and tobacco growers, 

regarding the technical achievability of 

compliance with the standard, and 

including information concerning the 

existence of patents that make it 

impossible to comply in the proposed 1- 

year timeframe. 

FDA is aware of retailers’ concerns 

regarding unsold inventory when any 

final rule goes into effect. FDA requests 

comments, including supportive data 

and research, regarding a sell-off period 

(e.g., 30 days after the effective date of 

a final rule) for retailers to sell through 

their current inventory of menthol 

cigarettes. 

IX. Preliminary Economic Analysis of 

Impacts 

A. Introduction 

We have examined the impacts of the 

proposed rule under Executive Order 

(E.O.) 12866, E.O. 13563, the Regulatory 

Flexibility Act (5 U.S.C. 601–612), and 

the Unfunded Mandates Reform Act of 

1995 (Pub. L. 104–4). E.O.s 12866 and 

13563 direct us to assess all costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity). We believe that 

this proposed rule is an economically 

significant regulatory action as defined 

by E.O. 12866. As such, it has been 

reviewed by the Office of Information 

and Regulatory Affairs. 

The Regulatory Flexibility Act 

requires us to analyze regulatory options 

that would minimize any significant 

impact of a rule on small entities. 

Because a portion of business revenues 

may revert back to consumers who 

currently purchase menthol cigarettes, 

we find that the rule may have a 

significant economic impact on a 

substantial number of small entities. 

The Unfunded Mandates Reform Act 

of 1995 (section 202(a)) requires us to 

prepare a written statement, which 

includes an assessment of anticipated 

costs and benefits, before proposing 

‘‘any rule that includes any Federal 

mandate that may result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000 or more 

(adjusted annually for inflation) in any 

one year.’’ The current threshold after 

adjustment for inflation is $158 million, 

using the most current (2020) Implicit 

Price Deflator for the Gross Domestic 

Product. This proposed rule, if 

finalized, would result in expenditures 

that meet or exceed this amount. 

B. Summary of Costs and Benefits 

The summary of benefits and costs is 

presented in Table 1. The proposed rule, 

if finalized, would establish a tobacco 

product standard prohibiting the use of 

menthol as a characterizing flavor in 

cigarettes. The quantified benefits of 

this proposed rule come from lower 

smoking-attributable mortality in the 

U.S. population due to diminished 

exposure to tobacco smoke for both 

users and nonusers of cigarettes. 

Qualitative benefits include: decreased 

illness and associated reductions in 

medical costs (both publicly and 

privately funded), decreased 

productivity loss, and improved healthrelated quality of life for menthol 

smokers and non-smokers; reductions in 

smoking-related fires; and reductions in 

cigarette butt litter and associated harms 

to the environment. We estimate that 

the present value of the monetized 

benefits over a 40-year time horizon 

ranges between $2,529 billion and 

$8,253 billion (primary estimate of 

$5,428 billion) at a 3 percent discount 

rate, and range between $1,369 billion 

and $4,470 billion (primary estimate of 

$2,941 billion) at a 7 percent discount 

rate. The primary annualized benefits 

equal $232 billion at a 3 percent 

discount rate and $220 billion at a 7 

percent discount rate. Unquantified 

benefits are expected to provide 

additional benefits beyond those 

amounts and additional health and 

related benefits are expected to occur 

outside the time horizon used in this 

analysis. 

The proposed rule, if finalized, would 

also create costs for firms, consumers 

and the Federal Government. Firms face 

one-time costs to read and review the 

rule (undiscounted primary estimate of 

$186.6 million with a range of $56.0 

million to $349.9 million), and may face 

one-time costs for reallocation, friction, 

and adjustment in the cigarette product 

market (undiscounted primary estimate 

of $235.9 million with a range of $0.2 

million to $471.9 million). Firms may 

also face costs due to producer surplus 

loss over the 40 year time horizon 

(undiscounted primary estimate of 

$10,628 million with a range of $0 to 

$21,256). Consumers may face one-time 

search costs of $359.3 million 

(undiscounted, range of $179.7 million 

to $539.0 million) to find substitute 

tobacco products as a replacement for 

menthol cigarettes. The FDA may face 

annual costs associated with 

enforcement of the proposed product 

standard (undiscounted range from $0 

to $1.3 million, primary estimate $0.7 

million per year). Qualitative costs may 

include changes in consumer surplus 

for some menthol cigarette product 

users, including potential utility 

changes for smokers of menthol 

cigarette products who switch from 

menthol to non-menthol cigarette 

products. We estimate that the present 

value of monetized costs over a 40-year 

time horizon ranges between $223.0 

million and $13,421.6 million (primary 


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26490 Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 

estimate of $6,805.9 million) for a 3 

percent discount rate, and between 

$208.0 million and $8,051.3 million 

(primary estimate of $4,113.2 million) at 

a 7 percent discount rate. The primary 

estimates for the annualized cost are 

$291 million at a 3 percent discount rate 

and $307 million at a 7 percent discount 

rate. In addition to benefits and costs, 

this rule, if finalized, will create 

significant transfers from State 

governments, Federal Government, and 

firms to consumers in the form of 

reduced revenue and tax revenue. The 

primary estimates for annualized 

transfers related to Federal taxes are 

$2.0 billion at a 3 percent discount rate 

and $2.0 billion at a 7 percent discount 

rate. The primary estimates for the 

annualized transfers related to State 

taxes are $3.7 billion at a 3 percent 

discount rate and $3.7 billion at a 7 

percent discount rate. The primary 

estimates for the annualized transfers 

between cigarette product 

manufacturers and consumers are $13.3 

billion at a 3 percent discount rate and 

$13.0 billion at a 7 percent discount 

rate. Benefits, costs, and transfers are 

summarized in Table 1. 

TABLE 1—SUMMARY OF BENEFITS, COSTS, AND DISTRIBUTIONAL EFFECTS OF PROPOSED RULE

[$ Millions of 2020 dollars over a 40 year time horizon] 

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

dollars 

Discount 

rate 

(%) 

Period 

covered 

Benefits: 

Annualized Monetized ($m/year) ......................... $220,000 

232,000 

$102,000 

108,000 

$334,000 

353,000 

2020 

2020 

7 

3 

40 

40 

Annualized Quantified .......................................... .................. .................. .................. .................. .................. ..................

Qualitative ............................................................ Qualitative benefits include: Decreased illness and associated reductions in 

medical costs (both publicly and privately funded), decreased productivity 

loss, and improved health-related quality of life for menthol smokers and 

non-smokers; reductions in smoking-related fires; and reductions in cigarette 

butt litter and associated harms to the environment. 

Costs: 

Annualized Monetized ($m/year) ......................... 307 

291 

16 

9 

601 

573 

2020 

2020 

7 

3 

40 

40 

Annualized Quantified .......................................... .................. .................. .................. .................. .................. ..................

Qualitative ............................................................ Changes in consumer surplus may occur for some menthol smokers. 

Transfers: 

Federal Annualized Monetized ($m/year) ........... 2,000 

2,000 

1,000 

1,000 

2,000 

2,000 

2020 

2020 

7 

3 

40 

40 

From: Federal Government To: Consumers 

State Annualized Monetized ($m/year) ............... 4,000 

4,000 

3,000 

3,000 

4,000 

4,000 

2020 

2020 

7 

3 

40 

40 

From: State Government To: Consumers 

Other Annualized Monetized ($m/year) ............... 13,000 

13,000 

9,000 

9,000 

15,000 

15,000 

2020 

2020 

7 

3 

40 

40 

From: Cigarette Product 

Manufacturers 

To: Consumers and Manufacturers of 

Other Tobacco Products 

Effects: 

State, Local, or Tribal Government: See transfers for estimated State excise tax impacts. See distributional effects for discussions of impacts to tribally-affiliated 

manufacturers and/or manufacturers operating on tribal lands. 

Small Business: Small menthol cigarette manufacturers are expected to face one-time costs for reading and understanding the rule and for planning and implementing reallocation procedures for menthol cigarette production lines. Small menthol cigarette manufacturers would also face revenue transfers as consumers cease purchasing menthol cigarette products. 

Wages: No effect. 

Growth: No effect. 

We have developed a comprehensive 

Preliminary Economic Analysis of 

Impacts that assesses the impacts of the 

proposed rule. The full analysis of 

economic impacts is available in the 

docket for this proposed rule (see Ref. 

292) and at https://www.fda.gov/aboutfda/reports/economic-impact-analysesfda-regulations. 

X. Analysis of Environmental Impact 

The Agency has carefully considered 

the potential environmental effects of 

this action. FDA has concluded that the 

action will not have a significant impact 

on the human environment, and that an 

environmental impact statement is not 

required. The Agency’s finding of no 

significant impact and the evidence 

supporting that finding is available in 

the docket for this proposed rule (see 

Refs. 304 and 305) and may be seen in 

the Dockets Management Staff (see 

ADDRESSES) between 9 a.m. and 4 p.m., 

Monday through Friday; it is also 

available electronically at https://

www.regulations.gov. Under FDA’s 

regulations implementing the National 

Environmental Policy Act (21 CFR part 

25), an action of this type would require 

an environmental assessment under 21 

CFR 25.20. 

XI. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

proposed rule contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3521) is not required. 


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Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 26491 

XII. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in E.O. 13132. Section 4(a) of the 

Executive order requires Agencies to 

‘‘construe . . . a Federal statute to 

preempt State law only where the 

statute contains an express preemption 

provision or there is some other clear 

evidence that the Congress intended 

preemption of State law, or where the 

exercise of State authority conflicts with 

the exercise of Federal authority under 

the Federal statute.’’ We have 

determined that the proposed rule, if 

finalized, would not contain policies 

that have substantial direct effects on 

the States, on the relationship between 

the National Government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government. Accordingly, the 

Agency tentatively concludes that the 

rule does not contain policies that have 

federalism implications as defined in 

the E.O. and, consequently, a federalism 

summary impact statement is not 

required. 

This rule is being issued under 

section 907 of the FD&C Act, which 

enables FDA to prescribe regulations 

relating to tobacco product standards, 

and the sale and distribution restriction 

in this rule is also being issued under 

section 906(d) of the FD&C Act, which 

enables FDA to prescribe regulations 

restricting the sale and distribution of a 

tobacco product. If this proposed rule is 

made final, the final rule would create 

requirements whose preemptive effect 

would be governed by section 916 of the 

FD&C Act, entitled ‘‘Preservation of 

State and Local Authority.’’ 

Section 916 broadly preserves the 

authority of states and localities to 

protect the public against the harms of 

tobacco use. Specifically, section 

916(a)(1) establishes a general 

presumption that FDA requirements do 

not preempt or otherwise limit the 

authority of States, localities, or tribes 

to, among other things, enact and 

enforce laws regarding tobacco products 

that relate to certain activities (e.g., sale, 

distribution) and that are in addition to 

or more stringent than requirements 

established under chapter IX of the 

FD&C Act. 

Section 916(a)(2)(A) of the FD&C Act 

is an express preemption provision that 

establishes an exception to the 

preservation of State and local 

governmental authority over tobacco 

products established in section 

916(a)(1). Specifically, section 

916(a)(2)(A) of the FD&C Act provides 

that ‘‘[n]o State or political subdivision 

of a State may establish or continue in 

effect with respect to a tobacco product 

any requirement which is different 

from, or in addition to, any requirement 

under the provisions of this chapter 

relating to tobacco product standards 

. . . .’’ 

However, section 916(a)(2)(B) of the 

FD&C Act limits the applicability of 

section 916(a)(2)(A), narrowing the 

scope of state and local requirements 

that are subject to express preemption. 

In particular, paragraph (a)(2)(B) 

provides that preemption under 

paragraph (a)(2)(A) does not apply to 

State or local ‘‘requirements relating to 

the sale, distribution, possession, 

information reporting to the State, 

exposure to, access to, the advertising 

and promotion of, or use of, tobacco 

products by individuals of any age, or 

relating to fire safety standards for 

tobacco products.’’ 

If this proposed rule is finalized as 

proposed, the final rule would create 

requirements that fall within the scope 

of section 916(a)(2)(A) because they are 

‘‘requirements under the provisions of 

the chapter relating to tobacco product 

standards.’’ Accordingly, the 

preemptive effect of those requirements 

on any state or local requirement would 

be determined by the nature of the state 

or local requirement at issue— 

specifically, whether the state or local 

requirement is preserved under section 

916(a)(1), and/or excepted under section 

916(a)(2)(B) (such as if it relates to the 

‘‘sale, distribution, possession, 

information reporting to the State, 

exposure to, access to, the advertising 

and promotion of, or use of, tobacco 

products’’). State and local prohibitions 

on the sale and distribution of flavored 

tobacco products, such as menthol 

cigarettes, would not be preempted by 

this rule, if finalized, because such 

prohibitions would be preserved by 

FD&C Act section 916(a)(1) or, as 

applicable, excepted from express 

preemption by FD&C Act section 

916(a)(2)(B). FDA invites comments on 

how State or local laws may be 

implicated if this proposed rule is 

finalized. 

XIII. Consultation and Coordination 

With Indian Tribal Governments 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in E.O. 13175. We have tentatively 

determined that the rule does not 

contain policies that would have a 

substantial direct effect on one or more 

Indian Tribes, on the relationship 

between the Federal Government and 

Indian Tribes, or on the distribution of 

power and responsibilities between the 

Federal Government and Indian Tribes. 

The Agency solicits comments from 

tribal officials on any potential impact 

on Indian Tribes from this proposed 

action. 

XIV. References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff (see 

ADDRESSES) and are available for 

viewing by interested persons between 

9 a.m. and 4 p.m., Monday through 

Friday; they also are available 

electronically at https://

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. FDA 

has verified the website addresses, as of 

the date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 

1. *HHS. ‘‘The Health Consequences of 

Smoking—50 Years of Progress: A Report 

of the Surgeon General.’’ Atlanta, GA: 

HHS, CDC, National Center for Chronic 

Disease Prevention and Health 

Promotion, Office on Smoking and 

Health, 2014. Available at https://

www.ncbi.nlm.nih.gov/books/ 

NBK179276/pdf/Bookshelf_

NBK179276.pdf. 

2. Kamatou, G.P, I. Vermaak, A.M. Viljoen, et 

al. ‘‘Menthol: A Simple Monoterpene 

with Remarkable Biological Properties.’’ 

Phytochemistry, 96:15–25, 2013. 

Available at https://doi.org/10.1016/ 

j.phytochem.2013.08.005. 

3. Wiseman, E.J. and D.E. McMillan. 

‘‘Rationale for Cigarette Smoking and for 

Mentholation Preference in Cocaine- and 

Nicotine-Dependent Outpatients.’’ 

Comprehensive Psychiatry, 39(6):358– 

363, 1998. Available at https://doi.org/ 

10.1016/s0010-440x(98)90048-7. 

4. Richter, P., D. Beistle, L. Pederson, et al. 

‘‘Small-Group Discussions on Menthol 

Cigarettes: Listening to Adult African 

American Smokers in Atlanta, Georgia.’’ 

Ethnicity & Health, 13(2):171–182, 2008. 

Available at https://doi.org/10.1080/ 

13557850701784694. 

5. Wackowski, O.A., K.R. Evans, M.B. 

Harrell, et al. ‘‘In Their Own Words: 

Young Adults’ Menthol Cigarette 

Initiation, Perceptions, Experiences and 

Regulation Perspectives.’’ Nicotine & 

Tobacco Research, 20(9):1076–1084, 

2018. Available at https://doi.org/ 

10.1093/ntr/ntx048. 

6. Kreslake, J.M., G.F. Wayne, H.R. Alpert, et 

al. ‘‘Tobacco Industry Control of Menthol 

in Cigarettes and Targeting of 

Adolescents and Young Adults.’’ 

American Journal of Public Health, 

98:1685–1692, 2008. Available at https:// 

doi.org/10.2105/AJPH.2007.125542. 

7. *Klausner, K. ‘‘Menthol Cigarettes and 

Smoking Initiation: A Tobacco Industry 

Perspective.’’ Tobacco Control, 20(Suppl 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
26492 Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 

2) ii12-ii19, 2011. Available at https://

doi.org/10.1136/tc.2010.041954. 

8. Villanti, A.C., A.L. Johnson, M. Halenar, et 

al. ‘‘Menthol and Mint Cigarettes and 

Cigars: Initiation and Progression in 

Youth, Young Adults and Adults in 

Waves 1–4 of the PATH Study, 2013– 

2017.’’ Nicotine & Tobacco Research, 

23(8): 1318–1326, 2021. Available at 

https://doi.org/10.1093/ntr/ntaa224. 

9. Benowitz, N.L. ‘‘Nicotine Addiction.’’ The 

New England Journal of Medicine, 

362(24):2295–2303, 2010. Available at 

https://doi.org/10.1056/NEJMra0809890. 

10. * Alsharari, S.D., J.R. King, J.C. Nordman, 

et al. ‘‘Effects of Menthol on Nicotine 

Pharmacokinetic, Pharmacology and 

Dependence in Mice.’’ PLoS ONE, 

10(9):e0137070, 2015. Available at 

https://doi.org/10.1371/journal.pone.

0137070. 

11. * Henderson, B.J., T.R. Wall, B.M. Henley, 

et al. ‘‘Menthol Alone Upregulates 

Midbrain Nachrs, Alters Nachr Subtype 

Stoichiometry, Alters Dopamine Neuron 

Firing Frequency, and Prevents Nicotine 

Reward.’’ The Journal of Neuroscience, 

36(10):2957–2974, 2016. Available at 

https://doi.org/10.1523/ 

JNEUROSCI.4194-15.2016. 

12. * Henderson, B.J., T.R. Wall, B.M. Henley, 

et al. ‘‘Menthol Enhances Nicotine 

Reward-Related Behavior by Potentiating 

Nicotine-Induced Changes in Nachr 

Function, Nachr Upregulation, and Da 

Neuron Excitability.’’ 

Neuropsychopharmacology, 42:2285– 

2291, 2017. Available at https://doi.org/ 

10.1038/npp.2017.72. 

13. Zhang, M., E. Harrison, L. Biswas, et al. 

‘‘Menthol Facilitates DopamineReleasing Effect of Nicotine in Rat 

Nucleus Accumbens.’’ Pharmacology, 

Biochemistry and Behavior, 175:47–52, 

2018. Available at https://doi.org/ 

10.1016/j.pbb.2018.09.004. 

14. Brody, A.L., A.G. Mukhin, J.L. Charite, et 

al. ‘‘Up-Regulation of Nicotinic 

Acetylcholine Receptors in Menthol 

Cigarette Smokers.’’ International Journal 

of Neuropsychopharmacology, 

16(5):957–966, 2013. Available at https:// 

doi.org/10.1017/S1461145712001022. 

15. * Wickham, R.J. ‘‘The Biological Impact of 

Menthol on Tobacco Dependence.’’ 

Nicotine & Tobacco Research, 

22(10):1676–1684, 2020. Available at 

https://doi.org/10.1093/ntr/ntz239. 

16. Shahoei, R. and E. Tajkhorshid. ‘‘Menthol 

Binding to the Human A4B2 Nicotinic 

Acetylcholine Receptor Facilitated by Its 

Strong Partitioning in The Membrane.’’ 

Journal of Physical Chemistry, 

124(10):1866¥1880, 2020. Available at 

https://doi.org/10.1021/ 

acs.jpcb.9b10092. 

17. * Goriounova, N.A. and H.D. Mansvelder. 

‘‘Short- and Long-Term Consequences of 

Nicotine Exposure During Adolescence 

for Prefrontal Cortex Neuronal Network 

Function.’’ Cold Spring Harbor 

Perspectives in Medicine, 2:a012120, 

2012. Available at https://doi.org/ 

10.1101/cshperspect.a012120. 

18. * Yuan, M., S.J. Cross, SE Loughlin, et al. 

‘‘Nicotine and the Adolescent Brain.’’ 

The Journal of Physiology, 593(16):3397– 

3412, 2015. Available at https://doi.org/ 

10.1113/JP270492. 

19. * HHS. ‘‘E-Cigarette Use Among Youth 

and Young Adults: A Report of the 

Surgeon General.’’ Atlanta, GA: HHS, 

CDC, National Center for Chronic 

Disease Prevention and Health 

Promotion, Office on Smoking and 

Health, 2016. Available at https://

www.cdc.gov/tobacco/data_statistics/ 

sgr/e-cigarettes/pdfs/2016_sgr_entire_

report_508.pdf. 

20. Collins, C.C. and E.T. Moolchan. ‘‘Shorter 

Time to First Cigarette of the Day in 

Menthol Adolescent Cigarette Smokers.’’ 

Addictive Behaviors, 31(8):1460–1464, 

2006. Available at https://doi.org/ 

10.1016/j.addbeh.2005.10.001. 

21. Hersey, J.C., SW Ng, J.M. Nonnemaker, et 

al. ‘‘Are Menthol Cigarettes a Starter 

Product for Youth?’’ Nicotine & Tobacco 

Research, 8(3):403–413, 2006. Available 

at https://doi.org/10.1080/ 

14622200600670389. 

22. Wackowski, O. and C.D. Delnevo. 

‘‘Menthol Cigarettes and Indicators of 

Tobacco Dependence Among 

Adolescents.’’ Addictive Behaviors, 

32(9):1964–1969, 2007. Available at 

https://doi.org/10.1016/ 

j.addbeh.2006.12.023. 

23. Muilenburg, J.L. and J.S. Legge. ‘‘African 

American Adolescents and Menthol 

Cigarettes: Smoking Behavior Among 

Secondary School Students.’’ Journal of 

Adolescent Health, 43(6):570–575, 2008. 

Available at https://doi.org/10.1016/ 

j.jadohealth.2008.08.017. 

24. Hersey, J., J. Nonnemaker, and G. Homsi. 

‘‘Menthol Cigarettes Contribute to the 

Appeal and Addiction Potential of 

Smoking for Youth.’’ Nicotine & Tobacco 

Research, 12(2):S136–S146, 2010. 

Available at https://doi.org/10.1093/ntr/ 

ntq173. 

25. Nonnemaker J., J. Hersey, G. Homsi, et al. 

‘‘Initiation with Menthol Cigarettes and 

Youth Smoking Uptake.’’ Addiction, 

108(1):171–8, 2013. Available at https:// 

doi.org/10.1111/j.1360- 

0443.2012.04045.x. 

26. Cwalina, S.N., A. Majmundar, J.B. Unger, 

et al. ‘‘Adolescent Menthol Cigarette Use 

and Risk of Nicotine Dependence: 

Findings from the National Population 

Assessment on Tobacco and Health 

(PATH) Study.’’ Drug and Alcohol 

Dependence, 206:107715, 2020. 

Available at https://doi.org/10.1016/ 

j.drugalcdep.2019.107715. 

27. Azagba, S., J. King, L. Shan, et al. 

‘‘Cigarette Smoking Behavior Among 

Menthol and Nonmenthol Adolescent 

Smokers.’’ Journal of Adolescent Health, 

66(5):545–550, 2020. Available at https:// 

doi.org/10.1016/ 

j.jadohealth.2019.11.307. 

28. Mantey, D.S., O.G. Chido-Amajuoyi, O. 

Omega-Njemnobi, et al. ‘‘Cigarette 

Smoking Frequency, Quantity, 

Dependence, and Quit Intentions During 

Adolescence: Comparison of Menthol 

and Non-Menthol Smokers (National 

Youth Tobacco Survey 2017–2020).’’ 

Addictive Behaviors 121:106986, 2021. 

Available at https://doi.org/10.1016/ 

j.addbeh.2021.106986. 

29. Delnevo, C.D., A.C. Villanti, O.A. 

Wackowski, et al. ‘‘The Influence of 

Menthol, E-Cigarettes and Other Tobacco 

Products on Young Adults’ Self-Reported 

Changes in Past Year Smoking.’’ Tobacco 

Control, 25:571–574, 2016. Available at 

https://doi.org/10.1136/tobaccocontrol2015-052325. 

30. Nonnemaker, J., S.P. Feirman, A. 

MacMonegle, et al. ‘‘Examining the Role 

of Menthol Cigarettes in Progression to 

Established Smoking Among Youth.’’ 

Addictive Behaviors, 98(2019):106045, 

2019. Available at https://doi.org/ 

10.1016/j.addbeh.2019.106045. 

31. *‘‘Villanti, A.C., A.L. Johnson, A.M. 

Glasser, et al. ‘‘Association of Flavored 

Tobacco Use with Tobacco Initiation and 

Subsequent Use Among US Youth and 

Adults, 2013–2015.’’ JAMA Network 

Open, 2(10):e1913804, 2019. Available at 

https://doi.org/10.1001/jamanet

workopen.2019.13804. 

32. * HHS. ‘‘Preventing Tobacco Use Among 

Youth and Young Adults: A Report of 

the Surgeon General.’’ Atlanta, GA: HHS, 

CDC, National Center for Chronic 

Disease Prevention and Health 

Promotion, Office on Smoking and 

Health, 2012. Available at https://

www.ncbi.nlm.nih.gov/books/ 

NBK99237/pdf/Bookshelf_

NBK99237.pdf. 

33. D’Silva, J., A.M. Cohn, A.L. Johnson, et 

al. ‘‘Differences in Subjective 

Experiences to First Use of Menthol and 

Nonmenthol Cigarettes in a National 

Sample of Young Adult Cigarette 

Smokers.’’ Nicotine & Tobacco Research, 

20(9):1062–1068, 2018. Available at 

https://doi.org/10.1093/ntr/ntx181. 

34. Gundersen, D.A., C.D. Delnevo, and O. 

Wackowski ‘‘Exploring the Relationship 

Between Race/Ethnicity, Menthol 

Smoking, and Cessation, in a Nationally 

Representative Sample of Adults.’’ 

Preventive Medicine, 49(6):553–557, 

2009. Available at https://doi.org/ 

10.1016/j.ypmed.2009.10.003. 

35. * Stahre, M., K.S. Okuyemi, A.M. Joseph, 

et al. ‘‘Racial/Ethnic Differences in 

Menthol Cigarette Smoking, Population 

Quit Ratios and Utilization of EvidenceBased Tobacco Cessation Treatments.’’ 

Addiction, 105(Suppl. 1):75–83, 2010. 

Available at https://doi.org/10.1111/ 

j.1360-0443.2010.03200.x. 

36. Delnevo, C.D., D.A. Gundersen, M. 

Hrywna, et al. ‘‘Smoking-Cessation 

Prevalence Among U.S. Smokers of 

Menthol Versus Non-Menthol 

Cigarettes.’’ American Journal of 

Preventive Medicine, 41(4):357–365, 

2011. Available at https://doi.org/ 

10.1016/j.amepre.2011.06.039. 

37. Levy, D.T., K. Blackman, J. Tauras, et al. 

‘‘Quit attempts and Quit Rates Among 

Menthol and Nonmenthol Smokers in 

the United States.’’ American Journal of 

Public Health, 101:1241–1247, 2011. 

Available at https://doi.org/10.2105/ 

AJPH.2011.300178. 

38. * Sulsky, S.I., W.G. Fuller, C. Van 

Landingham, et al. ‘‘Evaluating the 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 26493 

Association Between Menthol Cigarette 

Use and the Likelihood of Being A 

Former Versus Current Smoker.’’ 

Regulatory Toxicology and 

Pharmacology, 70(1):231–241, 2014. 

Available at https://doi.org/10.1016/ 

j.yrtph.2014.07.009. 

39. * Sanders, E., R. Weitkunat, and R. 

Dempsey. ‘‘Menthol Cigarettes, Time to 

First Cigarette, and Smoking Cessation.’’ 

Contributions to Tobacco Research, 

27(5):4–32, 2017. Available at https://

doi.org/10.1515/cttr-2017-0003. 

40. Mills, S.D., Y. Hao, K. Ribisl, et al. ‘‘The 

Relationship Between Menthol Cigarette 

Use, Smoking Cessation, and Relapse: 

Findings from Waves 1 to 4 of the 

Population Assessment of Tobacco and 

Health Study.’’ Nicotine & Tobacco 

Research, 23(6):966–975, 2021. Available 

at https://doi.org/10.1093/ntr/ntaa212. 

41. * Smith, P.H., B. Assefa, S. Kainth, et al. 

‘‘Use of Mentholated Cigarettes and 

Likelihood of Smoking Cessation in the 

United States: A Meta-Analysis.’’ 

Nicotine & Tobacco Research, 22(3):307– 

316, 2020. Available at https://doi.org/ 

10.1093/ntr/ntz067. 

42. * Trinidad, D.R., E. Pe ́rez-Stable, K. 

Messer, et al. ‘‘Menthol Cigarettes and 

Smoking Cessation Among Racial/Ethnic 

Groups in the United States.’’ Addiction, 

105(1): 84–94, 2010. Available at https:// 

dx.doi.org/10.1111%2Fj.1360-0443.2010.

03187.x. 

43. * Leas, E.C., T. Benmarhnia, D.R. Strong, 

et al. ‘‘Effects of Menthol Use and 

Transitions in Use on Short-Term and 

Long-Term Cessation from Cigarettes 

Among US Smokers.’’ Tobacco Control, 

0:1–6, 2021. Available at https://doi.org/ 

10.1136/tobaccocontrol-2021-056596. 

44. * FDA, ‘‘Memorandum of Summary of 

Internal Analyses Using Data From the 

2019 National Survey on Drug Use and 

Health on Menthol Cigarette Smoking.’’ 

Silver Spring, MD: HHS, FDA, Center for 

Tobacco Products, 2022. 

45. Levy, D.T., J. Pearson, A. Villanti, et al. 

‘‘Modeling the Future Effects of a 

Menthol Ban on Smoking Prevalence and 

Smoking-Attributable Deaths in the 

United States.’’ American Journal of 

Public Health, 101:1236–1240, 2011. 

Available at https://doi.org/10.2105/ 

AJPH.2011.300179. 

46. Levy, D.T., R. Meza, Z. Yuan, et al. 

‘‘Public Health Impact of a US Ban on 

Menthol in Cigarettes and Cigars: A 

Simulation Study.’’ Tobacco Control, 

2021. Available at https://doi.org/ 

10.1136/tobaccocontrol-2021-056604. 

47. Fagan, P., G. King, D. Lawrence, et al. 

‘‘Eliminating Tobacco-Related Health 

Disparities: Directions for Future 

Research.’’ Am J Public Health, 

94(2):211–217, 2004. Available at https:// 

doi.org/10.2105/ajph.94.2.211. 

48. * Fagan, P., E.T. Moolchan, D. Lawrence, 

et al. ‘‘Identifying Health Disparities 

Across the Tobacco Continuum.’’ 

Addiction, 102 Suppl. 2:5–29, 2007. 

Available at https://doi.org/10.1111/ 

j.1360-0443.2007.01952.x. 

49. * National Cancer Institute. ‘‘A 

Socioecological Approach to Addressing 

Tobacco-Related Health Disparities. 

National Cancer Institute Tobacco 

Control Monograph 22.’’ Bethesda, MD: 

U.S. Department of Health and Human 

Services, National Institutes of Health, 

National Cancer Institute. NIH 

Publication No. 17–CA–8035A, 2017. 

Available at https://cancercontrol.

cancer.gov/brp/tcrb/monographs/ 

monograph-22. 

50. * HHS. ‘‘Tobacco Use Among U.S. Racial/ 

Ethnic Minority Groups: A Report of the 

Surgeon General.’’ Atlanta, GA: HHS, 

CDC, National Center for Chronic 

Disease Prevention and Health 

Promotion, Office on Smoking and 

Health, 1998. Available at https://

www.cdc.gov/tobacco/data_statistics/ 

sgr/1998/complete_report/pdfs/ 

complete_report.pdf. 

51. * HHS. ‘‘Healthy People 2020: 

Disparities.’’ HHS, Office of Disease 

Prevention and Health Promotion. 

HealthyPeople.gov. Accessed November 

12, 2021. Available at https://

www.healthypeople.gov/2020/about/ 

foundation-health-measures/Disparities. 

52. * Braveman, P., E. Arkin, T. Orleans, et 

al. ‘‘What is Health Equity?’’ Behavioral 

Science & Policy, 4(1):1–14, 2018. 

Available at https://behavioralpolicy.org/ 

wp-content/uploads/2018/12/What-isHealth-Equity.pdf. 

53. * Peterson, A., V. Charles, D. Yeung, et al. 

‘‘The Health Equity Framework: A 

Science and Justice-Based Model for 

Public Health Researchers and 

Practitioners.’’ Health Promotion 

Practice, 1–6, 2020. Available at https:// 

doi.org/10.1177/1524839920950730. 

54. * Centers for Disease Control and 

Prevention. ‘‘Best Practices for 

Comprehensive Tobacco Control 

Programs.’’ CDC, National Center for 

Chronic Disease Prevention and Health 

Promotion, Office on Smoking and 

Health, 2014. Available at https://

www.cdc.gov/tobacco/stateand

community/guides/pdfs/2014/ 

comprehensive.pdf. 

55. * Caraballo, R.S. and K. Asman. 

‘‘Epidemiology of Menthol Cigarette Use 

in the United States.’’ Tobacco Induced 

Diseases, 9(Suppl. 1):S1, 2011. Available 

at https://doi.org/10.1186/1617-9625-9- 

S1-S1. 

56. * Sawdey, M.D., J.T. Chang, K.A. Cullen, 

et al. ‘‘Trends and Associations of 

Menthol Cigarette Smoking Among US 

Middle and High School Students— 

National Youth Tobacco Survey, 2011– 

2018.’’ Nicotine & Tobacco Research, 

22(10):1726–1735, 2020. Available at 

https://doi.org/10.1093/ntr/ntaa054. 

57. * Villanti, A., P.D. Mowery, C.D. Delnevo, 

et al. ‘‘Changes in the Prevalence and 

Correlates of Menthol Cigarette Use in 

the USA, 2004–2014.’’ Tobacco Control, 

25:ii14-ii20, 2016. Available at https://

doi.org/10.1136/tobaccocontrol-2016- 

053329. 

58. Weinberger, A.H., D.P. Giovenco, J. Zhu, 

et al. ‘‘Racial/Ethnic Differences in Daily, 

Nondaily, and Menthol Cigarette Use 

and Smoking Quit Ratios in the United 

States: 2002 to 2016.’’ Preventive 

Medicine, 125:32–39, 2019. Available at 

https://doi.org/10.1016/ 

j.ypmed.2019.04.009. 

59. * Delnevo, C.D., O. Ganz, R.D. Goodwin, 

et al. ‘‘Banning Menthol Cigarettes: A 

Social Justice Issue Long Overdue.’’ 

Nicotine & Tobacco Research, 22(10) 

1673–1675, 2020. Available at https://

doi.org/10.1093/ntr/ntaa152. 

60. Alexander, L.A., D.R. Trinidad, K.K. 

Sakuma, et al. ‘‘Why We Must Continue 

to Investigate Menthol’s Role in the 

African American Smoking Paradox.’’ 

Nicotine & Tobacco Research, 18(Suppl. 

1):S91–S101, 2016. Available at https:// 

doi.org/10.1093/ntr/ntv209. 

61. Benowitz, N.L., E.J. Pe ́rez-Stable, B. 

Herrera, et al. ‘‘Slower Metabolism and 

Reduced Intake of Nicotine from 

Cigarette Smoking in ChineseAmericans.’’ Journal of the National 

Cancer Institute, 94(2):108–15, Jan. 16, 

2002. Available at https://pubmed.ncbi.

nlm.nih.gov/11792749/. 

62. Garten, S. and R.V. Falkner. ‘‘Role of 

Mentholated Cigarettes in Increased 

Nicotine Dependence and Greater Risk 

Tobacco-Attributable Disease.’’ 

Preventive Medicine 38 793–798, 2004. 

Available at https://doi.org/10.1016/ 

j.ypmed.2004.01.019. 

63. Hooper, M., W. Zhao, M. Byrne, et al. 

‘‘Menthol Cigarette Smoking and Health, 

Florida 2007 BRFSS.’’ American Journal 

of Health Behavior, 35(1):3–14, 2011. 

Available at https://doi.org/10.5993/ 

AJHB.35.1.1. 

64. * Fagan, P., E.T. Moolchan, A. Hart, et al. 

‘‘Nicotine Dependence and Quitting 

Behaviors Among Menthol and NonMenthol Smokers with Similar 

Consumptive Patterns.’’ Addiction, 

105(Suppl. 1):55–74, 2010. Available at 

https://doi.org/10.1111/j.1360- 

0443.2010.03190.x. 

65. * Fernander, A., M. Rayens, M. Zhang, et 

al. ‘‘Are Age of Smoking Initiation and 

Purchasing Patterns Associated with 

Menthol Smoking?’’ Addiction, 

105(Suppl. 1):39–45, 2010. Available at 

https://doi.org/10.1111/j.1360- 

0443.2010.03188.x. 

66. * Lawrence, D., A. Rose, P. Fagan, et al. 

‘‘National Patterns and Correlates of 

Mentholated Cigarette Use in the United 

States.’’ Addiction, 105(Suppl. 1), 13–31, 

2010. Available at https://doi.org/ 

10.1111/j.1360-0443.2010.03203.x. 

67. * Cubbin, C., M. Soobader, and F.B. 

LeClere. ‘‘The Intersection of Gender and 

Race/Ethnicity in Smoking Behaviors 

Among Menthol and Non-Menthol 

Smokers in the United States.’’ 

Addiction, 105(Suppl. 1):32–38, 2010. 

Available at https://doi.org/10.1111/ 

j.1360-0443.2010.03191.x. 

68. Hickman, N.J., K.L. Delucchi, and J.J. 

Prochaska. ‘‘Menthol Use Among 

Smokers with Psychological Distress: 

Findings from the 2008 and 2009 

National Survey on Drug Use and 

Health.’’ Tobacco Control, 23:7–13, 2014. 

Available at https://doi.org/10.1136/ 

tobaccocontrol-2012-050479. 

69. Fallin, A., A.J. Goodin, B. King. ‘‘Menthol 

Cigarette Smoking Among Lesbian, Gay, 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
26494 Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 

Bisexual, and Transgender Adults.’’ Am 

J Prev Med., 48(1):93–97, 2015. Available 

at https://doi.org/10.1016/ 

j.amepre.2014.07.044. 

70. * Mattingly, D.T., J.L. Hirschtick, R. Meza, 

et al. ‘‘Trends in Prevalence and 

Sociodemographic and Geographic 

Patterns of Current Menthol Cigarette 

Use Among U.S. Adults, 2005–2015.’’ 

Preventive Medicine Reports, 20:101227, 

2020. Available at https://doi.org/ 

10.1016/j.pmedr.2020.101227. 

71. Stroud, L.R., C. Vergara-Lopez, M. 

McCallum, et al. ‘‘High Rates of Menthol 

Cigarette Use among Pregnant Smokers: 

Preliminary Findings and Call for Future 

Research.’’ Nicotine & Tobacco Research, 

22(10):1711–1717, 2020. Available at 

https://doi.org/10.1093/ntr/ntz142. 

72. * FDA Tobacco Products Scientific 

Advisory Committee. ‘‘Menthol 

Cigarettes and Public Health: Review of 

the Scientific Evidence and 

Recommendations.’’ Silver Spring, MD. 

HHS, FDA, Center for Tobacco Products, 

Tobacco Products Scientific Advisory 

Committee, 2011. Available at https://

wayback.archive-it.org/7993/ 

20170405201731/https://www.fda.gov/ 

downloads/AdvisoryCommittees/ 

CommitteesMeetingMaterials/Tobacco

ProductsScientificAdvisoryCommittee/ 

UCM269697.pdf. 

73. * Non-Voting Industry Representatives on 

TPSAC and Other Tobacco Industry 

Stakeholders. ‘‘Menthol Cigarettes: No 

Disproportionate Impact on Public 

Health.’’ The Industry Menthol Report, 

2011. Available at https://

wayback.archive-it.org/7993/ 

20170406091740/https://www.fda.gov/ 

downloads/AdvisoryCommittees/ 

CommitteesMeetingMaterials/Tobacco

ProductsScientificAdvisoryCommittee/ 

UCM249320.pdf. 

74. * FDA. ‘‘Preliminary Scientific Evaluation 

of the Possible Public Health Effects of 

Menthol versus Nonmenthol Cigarettes.’’ 

Silver Spring, MD: HHS, FDA, Center for 

Tobacco Products, 2013. Available at 

https://www.fda.gov/media/86497/ 

download. 

75. * FDA. ‘‘Scientific Review of the Effects 

of Menthol in Cigarettes on Tobacco 

Addiction: 1980–2021.’’ Silver Spring, 

MD: HHS, FDA, Center for Tobacco 

Products, 2022. Available at https://

www.fda.gov/media/157642/download. 

76. * FDA. ‘‘Peer Review Summary Report: 

External Peer Review of the FDA 

Scientific Evaluation of the Possible 

Health Effects of Menthol Versus 

Nonmenthol Cigarettes.’’ 2011. Available 

at https://www.fda.gov/media/86018/ 

download. 

77. * FDA. ‘‘Review of Studies Assessing the 

Potential Impact of Prohibiting Menthol 

as a Characterizing Flavor in Cigarettes.’’ 

Silver Spring, MD: HHS, FDA, Center for 

Tobacco Products, 2022. Available at 

https://www.fda.gov/media/157643/ 

download. 

78. * FDA. ‘‘FDA Announces Comprehensive 

Regulatory Plan to Shift Trajectory of 

Tobacco-Related Disease, Death.’’ 

FDA.gov. July 27, 2017. Available at 

https://www.fda.gov/news-events/pressannouncements/fda-announcescomprehensive-regulatory-plan-shifttrajectory-tobacco-related-disease-death. 

79. * FDA. ‘‘Illicit Trade in Tobacco Products 

after Implementation of an FDA Product 

Standard.’’ 2018. Available at https://

www.fda.gov/files/tobacco%20products/ 

published/Illicit-Trade-in-TobaccoProducts-After-Implementation-of-anFDA-Product-Standard.pdf. 

80. * Tobacco Control Legal Consortium et al. 

‘‘Citizen Petition to the FDA Related to 

Prohibiting Menthol as a Characterizing 

Flavor in Cigarettes.’’ April 12, 2013 

(Docket No. FDA–2013–P–0435–0001). 

Available at https://

www.regulations.gov/docket/FDA-2013- 

P-0435/document. 

81. * FDA. Letter, FDA/CTP Response to 

Tobacco Control Legal Consortium et al. 

October 7, 2013 (Docket No. FDA–2013– 

P–0435–0088). Available at https://

www.regulations.gov/docket/FDA-2013- 

P-0435/document. 

82. * Tobacco Control Legal Consortium, et 

al. ‘‘Supplement to Citizen Petition: 

‘Prohibit Menthol as a Characterizing 

Flavor of Cigarettes and Cigarette 

Smoke.’’ January 14, 2021 (Docket No. 

FDA–2013–P–0435–0001). Available at 

https://www.regulations.gov/document/ 

FDA-2013-P-0435-0106. 

83. * FDA. Letter, FDA Response to Menthol 

Citizen Petition. April 29, 2021 (Docket 

No. FDA–2013–P–0435–0106). Available 

at https://www.regulations.gov/docket/ 

FDA-2013-P-0435/document. 

84. World Health Organization. ‘‘Banning 

Menthol in Tobacco Products.’’ Geneva, 

Switzerland: World Health Organization 

Study Group on Tobacco Product 

Regulation, 2016. 

85. Perfetti, T.A. and H.H. Gordin. ‘‘Just 

Noticeable Differences Studies with 

Menthol and Non-Menthol.’’ Tobacco 

Science, 29:57–66, 1985. 

86. * Borschke, A. J. ‘‘Review of Technologies 

Relating to Menthol Use in Cigarettes.’’ 

Philip Morris Records; Master Settlement 

Agreement, 1993. Available at https://

www.industrydocuments.ucsf.edu/docs/ 

tncy0002. 

87. * Ai, J., K.M. Taylor, J.G. Lisko, et al. 

‘‘Menthol Content in US Marketed 

Cigarettes.’’ Nicotine & Tobacco 

Research, 18(7):1575–1580, 2016. 

Available at https://doi.org/ 

10.1093%2Fntr%2Fntv162. 

88. Giovino, G.A., S. Sidney, J.C. Gfroerer, et 

al. ‘‘Epidemiology of Menthol Cigarette 

Use.’’ Nicotine & Tobacco Research, 6(1), 

2004. Available at https://doi.org/ 

10.1080/14622203710001649696. 

89. Henningfield, J., N. Benowitz, K. 

Ahijevych, et al. ‘‘Does menthol enhance 

the addictiveness of cigarettes? An 

agenda for research.’’ Nicotine & Tobacco 

Research, 5(1):9–11, 2003. Available at 

https://doi.org/10.1080/ 

1462220031000070543. 

90. Gardiner, P.S. ‘‘The African 

Americanization of Menthol Cigarette 

Use in the United States.’’ Nicotine & 

Tobacco Research, 6(1) S55–S65, 2004. 

Available at https://doi.org/10.1080/ 

14622200310001649478. 

91. Sutton, C.D. and R.G. Robinson. ‘‘The 

Marketing of Menthol Cigarettes in the 

United States: Populations, Messages, 

and Channels.’’ Nicotine & Tobacco 

Research, 6(Suppl. 1) S82–S91, 2004. 

Available at https://doi.org/10.1080/ 

14622203310001649504. 

92. * Federal Trade Commission. Cigarette 

Report for 2019. Washington, DC. 

Federal Trade Commission, 2021. 

Available at https://www.ftc.gov/reports/ 

federal-trade-commission-cigarettereport-2019-smokeless-tobacco-report2019. 

93. * Kuiper, N., D. Gammon, B. Loomis, et 

al. ‘‘Trends in Sales of Flavored and 

Menthol Tobacco Products in the United 

States During 2011–2015.’’ Nicotine & 

Tobacco Research, 20(6):698–706, 2018. 

Available at https://doi.org/10.1093/ntr/ 

ntx123. 

94. * Delnevo, C.D., D.P. Giovenco, and A.C. 

Villanti. ‘‘Assessment of Menthol and 

Nonmenthol Cigarette Consumption in 

the US, 2000 to 2018.’’ JAMA Network 

Open, 3(8):e2013601, 2020. Available at 

https://doi.org/10.1001/jamanet

workopen.2020.13601. 

95. * Wang, T., A. Gentzke, M. Creamer, et al. 

‘‘Tobacco Product Use and Associated 

Factors Among Middle and High School 

Students—United States, 2019.’’ 

Morbidity and Mortality Weekly Report, 

68(12):1–22, 2019. Available at https://

www.cdc.gov/mmwr/volumes/68/ss/ 

ss6812a1.htm. 

96. * Substance Abuse and Mental Health 

Services Administration. ‘‘Key Substance 

Use and Mental Health Indicators in the 

United States: Results from the 2019 

National Survey on Drug Use and Health 

(HHS Publication No. PEP20–07–01–001, 

NSDUH Series H–55).’’ Rockville, MD: 

Center for Behavioral Health Statistics 

and Quality, 2020. Available at https:// 

nsduhweb.rti.org/respweb/ 

homepage.cfm. 

97. Rose, S.W., A. Johnson, A.M. Glasser, et 

al. ‘‘Flavour Types Used by Youth and 

Adult Tobacco Users in Wave 2 of The 

Population Assessment of Tobacco and 

Health (Path) Study 2014–2015.’’ 

Tobacco Control, 29(4):432–446, 2020. 

Available at https://doi.org/10.1136/ 

tobaccocontrol-2018-054852. 

98. Smith, P.H., E. Akpara, R. Haq, et al. 

‘‘Gender and Menthol Cigarette Use in 

the United States: A Systematic Review 

of the Recent Literature (2011–May 

2017).’’ Current Addiction Reports, 

4(4):431–438, 2017. Available at https:// 

doi.org/10.1007/s40429-017-0175-6. 

99. Ganz, O. and C.D. Delnevo. ‘‘Cigarette 

Smoking and the Role of Menthol in 

Tobacco Use Inequalities for Sexual 

Minorities.’’ Nicotine & Tobacco 

Research, 23(11) 1942–1946, 2021. 

Available at https://doi.org/10.1093/ntr/ 

ntab101. 

100. *Cohn, A.M., A.L. Johnson, E. Hair, et 

al. ‘‘Menthol Tobacco Use Is Correlated 

with Mental Health Symptoms in a 

National Sample of Young Adults: 

Implications for Future Health Risks and 

Policy Recommendations.’’ Tobacco 

Induced Diseases, 14(1), 2016. Available 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 26495 

at https://doi.org/10.1186/s12971-015- 

0066-3. 

101. Brunette, M.F., J.C. Ferron, P. Geiger, et 

al. ‘‘Menthol Cigarette Use in Young 

Adult Smokers with Severe Mental 

Illnesses.’’ Nicotine & Tobacco Research, 

21(5):691–694, 2019. Available at https:// 

doi.org/10.1093/ntr/nty064. 

102. * Willis, D.N., B. Liu, M.A. Ha, et al. 

‘‘Menthol Attenuates Respiratory 

Irritation Responses to Multiple Cigarette 

Smoke Irritants.’’ The Federation of 

American Societies for Experimental 

Biology Journal, 25(12):4434–4444, 2011. 

Available at https://doi.org/10.1096/ 

fj.11-188383. 

103. * Ha, M.A., G.J. Smith, J.A. Cichock, et 

al. ‘‘Menthol Attenuates Respiratory 

Irritation and Elevates Blood Cotinine in 

Cigarette Smoke Exposed Mice.’’ PLOS 

ONE, 2015. Available at https://doi.org/ 

10.1371/journal.pone.0117128. 

104. Wise, P., P. Breslin, and P. Dalton. 

‘‘Sweet Taste and Menthol Increase 

Cough Reflex Thresholds.’’ Pulmonary 

Pharmacology & Therapeutics, 25 236– 

241, 2012. Available at https://doi.org/ 

10.1016/j.pupt.2012.03.005. 

105. * Plevkova, J.M., M. Kollarik, I. Poliacek, 

et al. ‘‘The Role of Trigeminal Nasal 

Trpm8—Expressing Afferent Neurons in 

the Antitussive Effects of Menthol.’’ 

Journal of Applied Physiology, 115: 268– 

274, 2013. Available at https://doi.org/ 

10.1152/japplphysiol.01144.2012. 

106. Liu, B., L. Fan, S. Balakrishna, et al. 

‘‘TRPM8 is the Principal Mediator of 

Menthol-Induced Analgesia of Acute and 

Inflammatory Pain.’’ PAIN, 

154(10):2169–2177, 2013. Available at 

https://doi.org/10.1016/j.pain.2013.

06.043. 

107. Cohn, A.M., S.W. Rose, J. D’Silva, et al. 

‘‘Menthol Smoking Patterns and 

Smoking Perceptions Among Youth: 

Findings from the Population 

Assessment of Tobacco and Health 

Study.’’ American Journal of Preventive 

Medicine, 56(4):e107–e116, 2019. 

Available at https://doi.org/10.1016/ 

j.amepre.2018.11.027. 

108. Cohn, A.M., O. Ganz, A.A. Dennhardt, 

et al. ‘‘Menthol Cigarette Smoking is 

Associated with Greater Subjective 

Reward, Satisfaction, and ‘‘Throat Hit,’’ 

But Not Greater Behavioral Economic 

Demand.’’ Addictive Behaviors, 

101(2020):106108, 2020. Available at 

https://doi.org/10.1016/j.addbeh.

2019.106108. 

109. Villanti, A.C., A.L. Johnson, B. Ambrose, 

et al. ‘‘Flavored Tobacco Product Use in 

Youth and Adults: Findings from the 

First Wave of the Path Study (2013– 

2014).’’ American Journal of Preventive 

Medicine, 53(2):139–151, 2017. 

Available at https://doi.org/10.1016/ 

j.amepre.2017.01.026. 

110. Cohn, A. and J. D’Silva. ‘‘Menthol 

Smoking and Subjective Response to the 

First Cigarette Smoked.’’ Tobacco 

Regulatory Science, 5(6):554–566, 2019. 

Available at https://doi.org/10.18001/ 

TRS.5.6.7. 

111. D’Silva, J., E. O’Gara, C.S. Fryer, et al. 

‘‘Because There’s Just Something About 

That Menthol’’: Exploring African 

American Smokers’ Perspectives on 

Menthol Smoking and Local Menthol 

Sales Restrictions.’’ Nicotine & Tobacco 

Research, 23(2):357–363, 2021. Available 

at https://doi.org/10.1093/ntr/ntaa164. 

112. * Cantrell, Dan V. ‘‘U.S. Exhibit 30,792, 

Report, ‘Kool Isn’t Getting the Starters/ 

236’ DAN V. CANTRELL, BROWN & 

WILLIAMSON TOBACCO CORP., 

February 17, 1987.’’ Depositions and 

Trial Testimony (DATTA); RICO 

Privilege Downgrades Collection. 1987. 

Available at https://www.industry

documents.ucsf.edu/docs/xskv0035. 

113. * Achey, Ted L. ‘‘U.S Exhibit 22,357, 

Memo, ‘Product Information’ TED L. 

ACHEY, LORILLARD INC., August 30, 

1978.’’ Depositions and Trial Testimony 

(DATTA); RICO Privilege Downgrades 

Collection. 1978. Available at https://

www.industrydocuments.ucsf.edu/docs/ 

fhhv0035. 

114. * HHS. ‘‘The Health Consequences of 

Smoking: Nicotine Addiction: A Report 

of the Surgeon General.’’ Atlanta, GA: 

HHS, CDC, Office on Smoking and 

Health, 1988. Available at https://

collections.nlm.nih.gov/ext/document/ 

101584932X423/PDF/ 

101584932X423.pdf. 

115. * Dani, J.A. and S. Heinemann. 

‘‘Molecular and Cellular Aspects of 

Nicotine Abuse.’’ Neuron, 16(5):905–908, 

1996. Available at https://doi.org/ 

10.1016/S0896-6273(00)80112-9. 

116. * Dani, J.A., D. Jenson, J.I. Broussard, et 

al. ‘‘Neurophysiology of Nicotine 

Addiction.’’ Journal of Addiction 

Research & Therapy, 20(Suppl. 1), 2011. 

Available at https://doi.org/10.4172/ 

2155-6105.S1-001. 

117. Gotti, C., M. Moretti, A. Gaimarri, et al. 

‘‘Heterogeneity and Complexity of Native 

Brain Nicotinic Receptors.’’ Biochemical 

Pharmacology, 74(8):1102–1111, 2007. 

Available at https://doi.org/10.1016/ 

j.bcp.2007.05.023. 

118. O’Dell, L.E. and T.V. Khroyan. ‘‘Rodent 

Models of Nicotine Reward: What Do 

They Tell Us About Tobacco Abuse in 

Humans?’’ Pharmacology Biochemistry 

and Behavior, 91(4):481–488, 2009. 

Available at https://doi.org/10.1016/ 

j.pbb.2008.12.011. 

119. Malin, D., and P. Goyarzu ‘‘Rodent 

Models of Nicotine Withdrawal 

Syndrome.’’ Nicotine 

Psychopharmacology, 402–427, 2009. 

Available at https://doi.org/10.1007/978- 

3-540-69248-5_14. 

120. * HHS. ‘‘Preventing Tobacco Use Among 

Young People: A Report of the Surgeon 

General.’’ Atlanta, GA: HHS, CDC, 

National Center for Chronic Disease 

Prevention and Health Promotion, Office 

on Smoking and Health, 1994. 

121. Torres, O.V., H.A. Tejeda, L.E. 

Natividad, et al. ‘‘Enhanced 

Vulnerability to the Rewarding Effects of 

Nicotine During the Adolescent Period of 

Development.’’ Pharmacology 

Biochemistry and Behavior, 90(4):658– 

663, 2008. Available at https://doi.org/ 

10.1016/j.pbb.2008.05.009. 

122. Levin, E.D., S.S. Slade, C. Wells, et al. 

‘‘Threshold of Adulthood for the Onset 

of Nicotine Self-Administration in Male 

and Female Rats.’’ Behavioural Brain 

Research, 225(2):473–481, 2011. 

Available at https://doi.org/10.1016/ 

j.bbr.2011.08.005. 

123. de la Pena, J.B., H.M. Ahsan, C.J. 

Botanas, et al. ‘‘Adolescent Nicotine Or 

Cigarette Smoke Exposure Changes 

Subsequent Response to Nicotine 

Conditioned Place Preference And SelfAdministration.’’ Behavioral Brain 

Research, 272(1):156–164, 2014. 

Available at https://doi.org/10.1016/ 

j.bbr.2014.06.044. 

124. Dannenhoffer, C.A. and L.P. Spear. ‘‘Age 

Differences in Conditioned Place 

Preferences and Taste Aversions to 

Nicotine.’’ Developmental 

Psychobiology, 58(5):660–666, 2016. 

Available at https://doi.org/10.1002/ 

dev.21400. 

125. Adriani, W., S. Macri, R. Pacifici, et al. 

‘‘Peculiar Vulnerability to Nicotine Oral 

Self-Administration in Mice During 

Early Adolescence.’’ 

Neuropsychopharmacology, 27(2):212– 

224, 2002. Available at https://doi.org/ 

10.1016/S0893-133X(02)00295-6. 

126. Kota, D., S.E. Robinson, and M.I. Damaj. 

‘‘Enhanced Nicotine Reward in 

Adulthood After Exposure to Nicotine 

During Early Adolescence in Mice.’’ 

Biochemical Pharmacology, 78(7):873– 

879, 2009. Available at https://doi.org/ 

10.1016/j.bcp.2009.06.099. 

127. Cao, J., J.D. Bulluzzi, S.E. Loughlin, et 

al. ‘‘Locomotor and Stress Responses to 

Nicotine Differ in Adolescent and Adult 

Rats.’’ Pharmacology Biochemistry and 

Behavior, 96(1):82–90, 2010. Available at 

https://doi.org/10.1016/ 

j.pbb.2010.04.010. 

128. Trauth, J., F. Seidler, S. Ali, et al. 

‘‘Adolescent Nicotine Exposure Produces 

Immediate and Long-Term Changes in 

CNS Noradrenergic and Dopaminergic 

Function.’’ Brain Research, 892:269–280, 

2001. Available at https://doi.org/ 

10.1016/s0006-8993(00)03227-3. 

129. *Counotte, D.S., N.A. Goriounova, M. 

Moretti, et al. ‘‘Adolescent Nicotine 

Exposure Transiently Increases HighAffinity Nicotinic Receptors and 

Modulates Inhibitory Synaptic 

Transmission in Rat Medial Prefrontal 

Cortex.’’ FASEB Journal, 26(5):1810– 

1820, 2012. Available at https://doi.org/ 

10.1096/fj.11-198994. 

130. McDonald, C.G., A.K. Eppolito, J.M. 

Brielmaier, et al. ‘‘Evidence for Elevated 

Nicotine-Induced Structural Plasticity in 

Nucleus Accumbens of Adolescent 

Rats.’’ Brain Research, 1151:211–218, 

2007. Available at https://doi.org/ 

10.1016/j.brainres.2007.03.019. 

131. Schochet, T., A. Kelley, and C. Landry. 

‘‘Differential Expression of Arc MRNA 

and Other Plasticity-Related Genes 

Induced By Nicotine in Adolescent Rat 

Forebrain.’’ Neuroscience, 135(1): 285– 

297, 2005. Available at https://doi.org/ 

10.1016/j.neuroscience.2005.05.057. 

132. Trauth, J., F. Seidler, E. McCook, et al. 

‘‘Adolescent Nicotine Exposure Causes 

Persistent Upregulation of Nicotinic 

Cholinergic Receptors in Rat Brain 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
26496 Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 

Regions.’’ Brain Research, 851:9–19, 

1999. Available at https://doi.org/ 

10.1016/s0006-8993(99)01994-0. 

133. Doura, M.B., T.V. Luu, N. Lee, et al. 

‘‘Persistent Gene Expression Changes in 

Ventral Tegmental Area of Adolescent 

But Not Adult Rats in Response to 

Chronic Nicotine.’’ Neuroscience, 

170(2):503–513, 2010. Available at 

https://doi.org/10.1016/j.neuroscience.

2010.06.071. 

134. * Sharapova, S., C. Reyes-Guzman, T. 

Singh, et al. ‘‘Age of Tobacco Use 

Initiation and Association with Current 

Use and Nicotine Dependence Among 

US Middle and High School Students, 

2014–2016.’’ Tobacco Control, 29(1):49– 

54, 2020. Available at https://doi.org/ 

10.1136/tobaccocontrol-2018-054593. 

135. * Apelberg, B.J., C.G. Corey, A.C. 

Hoffman, et al. ‘‘Symptoms of Tobacco 

Dependence Among Middle and High 

School Tobacco Users: Results from the 

2012 National Youth Tobacco Survey.’’ 

American Journal of Preventive 

Medicine, 47(2, Suppl. 1):S4–S14, 2014. 

Available at https://doi.org/10.1016/ 

j.amepre.2014.04.013. 

136. * Dierker, L.D., J.S. Swendsen, J.R. Rose, 

et al. ‘‘Transitions to Regular Smoking 

and Nicotine Dependence in the 

Adolescent National Comorbidity Survey 

(NCS–A).’’ Annals of Behavioral 

Medicine, 43:394–401, 2012. Available at 

https://doi.org/10.1007/s12160-011- 

9330-9. 

137. * DiFranza, J.R., J.A. Savageau, K. 

Fletcher, et al. ‘‘Symptoms of Tobacco 

Dependence After Brief Intermittent Use: 

The Development and Assessment of 

Nicotine Dependence in Youth-2 Study.’’ 

JAMA, 161(7):704–710, 2007. Available 

at https://jamanetwork.com/journals/ 

jamapediatrics/fullarticle/570706. 

138. O’Loughlin, J., J. DiFranza, R.F. Tyndale, 

et al. ‘‘Nicotine-Dependence Symptoms 

Are Associated with Smoking Frequency 

in Adolescents.’’ American Journal of 

Preventive Medicine, 25(3):0749–3797, 

2003. Available at https://doi.org/ 

10.1016/S0749-3797(03)00198-3. 

139. Rose J.S., L.C. Dierker, E. Donny. 

‘‘Nicotine Dependence Symptoms 

Among Recent Onset Adolescent 

Smokers.’’ Drug and Alcohol 

Dependence, 106(2–3):126–32, 2010. 

Available at https://doi.org/10.1016/ 

j.drugalcdep.2009.08.012. 

140. DiFranza, J.R., J.A. Savageau, K. 

Fletcher, et al. ‘‘Recollections and 

Repercussions of the First Inhaled 

Cigarette.’’ Addictive Behaviors, 29:261– 

272, 2004. Available at https://doi.org/ 

10.1016/j.addbeh.2003.08.002. 

141. * Curtin, G.M., S.I. Sulsky, C.V. 

Landingham, et al. ‘‘Primary Measures of 

Dependence Among Menthol Compared 

to Non-Menthol Cigarette Smokers in the 

United States.’’ Regulatory Toxicology 

and Pharmacology, 69(3):451–466, 2014. 

Available at https://doi.org/10.1016/ 

j.yrtph.2014.05.011. 

142. * Pletcher, M.J., B.J. Hulley, T. Houston, 

et al. ‘‘Menthol Cigarettes, Smoking 

Cessation, Atherosclerosis, and 

Pulmonary Function.’’ Archives of 

Internal Medicine, 166:1915–1922, 2006. 

Available at https://doi.org/10.1001/ 

archinte.166.17.1915. 

143. Reitzel, L.R., E. Cromley, Y. Li, et al. 

‘‘The Effect of Tobacco Outlet Density 

and Proximity on Smoking Cessation.’’ 

American Journal of Public Health, 

101(2):315–320, 2011. Available at 

https://dx.doi.org/10.2105%2FAJPH.

2010.191676. 

144. * Reitzel, L.R., Y. Li, D.W. Stewart, et al. 

‘‘Race Moderates the Effect of Menthol 

Cigarette Use on Short-Term Smoking 

Abstinence.’’ Nicotine & Tobacco 

Research, 15(5):883–889, 2013. Available 

at https://doi.org/10.1093/ntr/nts335. 

145. Rojewski, A.M., B.A. Toll, and S. 

O’Malley. ‘‘Menthol Cigarette Use 

Predicts Treatment Outcomes of WeightConcerned Smokers.’’ Nicotine & 

Tobacco Research, 16(1):115–119, 2014. 

Available at https://doi.org/10.1093/ntr/ 

ntt137. 

146. Smith, S.S., M.C. Fiore, and T.B. Baker. 

‘‘Smoking Cessation in Smokers Who 

Smoke Menthol and Non-Menthol 

Cigarettes.’’ Addiction, 109(12):2107– 

2117, 2014. Available at https://doi.org/ 

10.1111/add.12661. 

147. Muench, C. and L.M. Juliano. 

‘‘Predictors of Smoking Lapse During a 

48-Hour Laboratory Analogue Smoking 

Cessation Attempt.’’ Psychology of 

Addictive Behaviors, 31(4):415–422, 

2017. Available at https://doi.org/ 

10.1037/adb0000246. 

148. Bover, M.T., J. Foulds, M.B. Steinberg, 

et al. ‘‘Waking at Night to Smoke as a 

Marker for Tobacco Dependence: Patient 

Characteristics and Relationship to 

Treatment Outcome.’’ International 

Journal of Clinical Practice, 62(2):182– 

190, 2008. Available at https://doi.org/ 

10.1111/j.1742-1241.2007.01653.x. 

149. Okuyemi, K.S., J.S. Ahluwalia, M. 

Ebersole-Robinson, et al. ‘‘Does Menthol 

Attenuate the Effect of Bupropion 

Among African American Smokers?’’ 

Addiction, 98:1387–1393, 2003. 

Available at https://doi.org/10.1046/ 

j.1360-0443.2003.00443.x. 

150. Okuyemi, K.S., B. Faseru, L.S. Cox, et 

al. ‘‘Relationship Between Menthol 

Cigarettes and Smoking Cessation 

Among African American Light 

Smokers.’’ Addiction, 102(12):1979– 

1986, 2007. Available at https://doi.org/ 

10.1111/j.1360-0443.2007.02010.x. 

151. Gandhi, K., J. Foulds, M. Steinberg, et 

al. ‘‘Lower Quit Rates Among African 

American and Latino Menthol Cigarette 

Smokers at a Tobacco Treatment Clinic.’’ 

International Journal of Clinical Practice, 

63(3): 360–367, 2009. Available at 

https://doi.org/10.1111/j.1742-1241.

2008.01969.x. 

152. Faseru, B., N.L. Nollen, M.S. Mayo, et 

al. ‘‘Predictors of Cessation in African 

American Light Smokers Enrolled in a 

Bupropion Clinical Trial.’’ Addictive 

Behaviors, 38:1796–1803, 2013. 

Available at https://doi.org/10.1016/ 

j.addbeh.2012.11.010. 

153. Keeler, C., W. Max, V. Yerger, et al. ‘‘The 

Association of Menthol Cigarette Use 

with Quit Attempts, Successful 

Cessation, and Intention to Quit Across 

Racial/Ethnic Groups in the United 

States.’’ Nicotine & Tobacco Research, 

19(12):1450–1464, 2017. Available at 

https://doi.org/10.1093/ntr/ntw215. 

154. Keeler, C., W. Max, V. Yerger, et al. 

‘‘Effects of Cigarette Prices on Intention 

to Quit, Quit Attempts, and Successful 

Cessation Among African American 

Smokers.’’ Nicotine & Tobacco Research, 

22(4)1–10, 2018. Available at https://

doi.org/10.1093/ntr/nty149. 

155. Kingsbury, J.H., K. Mehrotra, J. D’Silva, 

et al. ‘‘Perceptions of Menthol Cigarettes 

and Reasons for Unsuccessful Quits in 

An African American Community 

Sample.’’ Journal of Immigrant and 

Minority Health, 23:137–144, 2021. 

Available at https://doi.org/10.1007/ 

s10903-020-01028-z. 

156. * Hyland, A., S. Garten, G. Giovino, et 

al. ‘‘Mentholated Cigarettes and Smoking 

Cessation: Findings from COMMIT.’’ 

Tobacco Control, 11:135–139, 2002. 

Available at https://doi.org/10.1136/ 

tc.11.2.135. 

157. Murray, R.P., J.E. Connett, M.A. Skeans, 

et al. ‘‘Menthol Cigarettes and Health 

Risks in Lung Health Study Data.’’ 

Nicotine & Tobacco Research, 9(1):101– 

107, 2007. Available at https://doi.org/ 

10.1080/14622200601078418. 

158. Fu, S.S., K.S. Okuyemi, M.R. Partin, et 

al. ‘‘Menthol Cigarettes and Smoking 

Cessation During an Aided Quit 

attempt.’’ Nicotine & Tobacco Research, 

10(3):457–462, 2008. Available at https:// 

doi.org/10.1080/14622200801901914. 

159. Blot, W.J., S.S. Cohen, M. Aldrich, et al. 

‘‘Lung Cancer Risk Among Smokers of 

Menthol Cigarettes.’’ Journal of the 

National Cancer Institute, 103(10):810– 

816, 2011. Available at https://doi.org/ 

10.1093/jnci/djr102. 

160. D’Silva, J., R.G. Boyle, R.L. Lien, et al. 

‘‘Cessation Outcomes Among TreatmentSeeking Menthol and Nonmenthol 

Smokers.’’ American Journal of 

Preventive Medicine, 43(5S3):S242– 

S248, 2012. Available at https://doi.org/ 

10.1016/j.amepre.2012.07.033. 

161. Jao, N.C., A.K. Veluz-Wilkins, M.J. 

Smith, et al. ‘‘Does Menthol Cigarette 

Use Moderate the Effect of Nicotine 

Metabolism on Short-Term Smoking 

Cessation?’’ Experimental and Clinical 

Psychopharmacology, 25(3):216–222, 

2017. Available at https://doi.org/ 

10.1037/pha0000124. 

162. Tanner, N.T., N.A. Thomas, R. Ward, et 

al. ‘‘Association of Cigarette Type and 

Nicotine Dependence in Patients 

Presenting for Lung Cancer Screening.’’ 

Chest Journal, 158(5):2184–2191, 2020. 

Available at https://doi.org/10.1016/ 

j.chest.2020.05.608. 

163. Schneller, L.M., M. Bansal-Travers, M.C. 

Mahoney, et al. ‘‘Menthol Cigarettes and 

Smoking Cessation among Adult 

Smokers in the US.’’ American Journal of 

Health Behavior, 44(2): 252–256, 2020. 

Available at https://doi.org/10.5993/ 

AJHB.44.2.12. 

164. * Villanti, A.C., L.K. Collins, R.S. 

Niaura, et al. ‘‘Menthol Cigarettes and 

the Public Health Standard: A 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 26497 

Systematic Review.’’ BMC Public Health, 

17:983, 2017. Available at https://

doi.org/10.1186/s12889-017-4987-z. 

165. * Hilberink, S., J.E. Jacobs, S. Opstal, et 

al. ‘‘Validation of Smoking Cessation 

Self-Reported By Patients with Chronic 

Obstructive Pulmonary Disease.’’ 

International Journal of General 

Medicine, 4:85–90, 2011. Available at 

https://doi.org/10.2147/IJGM.S15231. 

166. Brody, A.L., A.G. Mukhin, M.S. 

Mamoun, et al. ‘‘Brain Nicotinic 

Acetylcholine Receptor Availability and 

Response to Smoking Cessation 

Treatment: A Randomized Trial.’’ JAMA 

Psychiatry, 71(7):797–805, 2014. 

Available at https://doi.org/10.1001/ 

jamapsychiatry.2014.138. 

167. * National Cancer Institute. ‘‘The Role of 

the Media in Promoting and Reducing 

Tobacco Use. Tobacco Control 

Monograph No. 19.’’ Bethesda, MD: U.S. 

Department of Health and Human 

Services, National Institutes of Health, 

National Cancer Institute. NIH Pub. No. 

07–6242, June 2008. Available at https:// 

cancercontrol.cancer.gov/brp/tcrb/ 

monographs/monograph-19. 

168. Cruz, T.B., L.T. Wright, and G. 

Crawford. ‘‘The Menthol Marketing Mix: 

Targeted Promotions for Focus 

Communities in the United States.’’ 

Nicotine & Tobacco Research, 12(Suppl. 

2):S147–S153, 2010. Available at https:// 

doi.org/10.1093/ntr/ntq201. 

169. Balbach, E.D., R.J. Gasior, and E.M. 

Barbeau. ‘‘R.J. Reynolds’ Targeting of 

African Americans: 1988–2000.’’ 

American Journal of Public Health, 

93(5):822–827, 2003. Available at https:// 

doi.org/10.2105%2Fajph.93.5.822. 

170. * Cruz, T.B., S.W. Rose, B.A. Lienemann, 

et al. ‘‘Pro-Tobacco Marketing and AntiTobacco Campaigns Aimed at Vulnerable 

Populations: A Review of the Literature.’’ 

Tobacco Induced Diseases, 17:68, 2019. 

Available at https://doi.org/10.18332/tid/ 

111397. 

171. Yerger, V.B., J. Przewoznik, and R.E. 

Malone. ‘‘Racialized Geography, 

Corporate Activity, and Health 

Disparities: Tobacco Industry Targeting 

of Inner Cities.’’ Journal of Health Care 

for the Poor and Underserved, 18(4):10– 

18, 2007. Available at https://doi.org/ 

10.1353/hpu.2007.0120. 

172. * Phillip Morris. ‘‘Benson & Hedges PartTime Inner City Sampling Program.’’ 

Philip Morris Records; Master Settlement 

Agreement, 1985. Available at https://

www.industrydocuments.ucsf.edu/docs/ 

xqxx0111. 

173. * Gravely, L. ‘‘Black Smoker Likelihood 

of Buying Ten (10) Cigarette Package 

Size of Kool.’’ Marketing to Minorities, 

Military, and Gays MSA Collection, 

1985. Available at https://www.industry

documents.ucsf.edu/docs/kmlk0045. 

174. * Persoskie, A., E.A. Donaldson, and C. 

Ryant. ‘‘How Tobacco Companies Have 

Used Package Quantity for Consumer 

Targeting.’’ BMJ, 28(4):9, 2018. Available 

at: https://tobaccocontrol.bmj.com/ 

content/28/4/365. 

175. Lee, J.G., L. Henriksen, SW Rose, et al. 

‘‘A Systematic Review of Neighborhood 

Disparities in Point-Of-Sale Tobacco 

Marketing.’’ American Journal of Public 

Health, 105:e8–e18, 2015. Available at 

https://doi.org/10.2105/ 

AJPH.2015.302777. 

176. Kephart, L., G. Song, P. Henley, et al. 

‘‘The Association Between 

Neighborhood Racial Composition and 

Menthol Cigarette Pricing in Boston, 

MA.’’ Health & Place, 58:102144, 2019. 

Available at https://doi.org/10.1016/ 

j.healthplace.2019.102144. 

177. Mills, S.D., L. Henriksen, S.D. Golden, 

et al. ‘‘Disparities in Retail Marketing for 

Menthol Cigarettes in the United States, 

2015.’’ Health & Place, 53:62–70, 2018. 

Available at https://doi.org/10.1016/ 

j.healthplace.2018.06.011. 

178. Mennis J. and M. Mason. ‘‘Tobacco 

Outlet Density and Attitudes Towards 

Smoking Among Urban Adolescent 

Smokers.’’ Substance Abuse, 37(4):521– 

525, 2016. Available at https://doi.org/ 

10.1080/08897077.2016.1181135. 

179. Robertson L., C. Cameron, R. McGee, et 

al. ‘‘Point-of-Sale Tobacco Promotion 

and Youth Smoking: A Meta-Analysis.’’ 

Tobacco Control, 25(e2):e83–e89, 2016. 

Available at https://doi.org/10.1136/ 

tobaccocontrol-2015-052586. 

180. McCarthy, M., M. Siahpush, R.A. 

Shaikh, et al. ‘‘Social Disparities in 

Unaided Quit Attempts Among Daily 

Current and Former Smokers: Results 

From the 2010–2011 Tobacco Use 

Supplement to the Current Population 

Survey.’’ Nicotine & Tobacco Research, 

18(8):1705–1710, 2016. Available at 

https://doi.org/10.1093/ntr/ntw007. 

181. Henriksen, L., N.C. Schleicher, A.L. 

Dauphinee, et al. ‘‘Targeted Advertising, 

Promotion, and Price for Menthol 

Cigarettes in California High School 

Neighborhoods.’’ Nicotine & Tobacco 

Research, 14(1):116–21, 2012. Available 

at https://doi.org/10.1093/ntr/ntr122. 

182. Rock, V., S. Davis, S. Thorne, et al. 

‘‘Menthol Cigarette Use among Racial 

and Ethnic Groups in the United States, 

2004–2008.’’ Nicotine & Tobacco 

Research, S117–S124, 2010. Available at 

https://doi.org/10.1093/ntr/ntq204. 

183. * Giovino, G.A., A.C. Villanti, P.D. 

Mowert, et al. ‘‘Differential Trends in 

Cigarette Smoking in the USA: Is 

Menthol Slowing Progress?’’ Tobacco 

Control, 24:28–37, 2015. Available at 

https://doi.org/10.1136/tobaccocontrol2013-051159. 

184. Kandel, D., M.C. Hu, P. Griesler, et al. 

‘‘On the Development of Nicotine 

Dependence in Adolescence.’’ Drug and 

Alcohol Dependence, 91(1):26–39., 2007. 

Available at https://dx.doi.org/ 

10.1016%2Fj.drugalcdep.2007.04.011. 

185. Gomez, Y., M. Creamer, K.F. Trivers, et 

al. ‘‘Patterns of Tobacco Use and 

Nicotine Dependence Among Youth, 

United States, 2017–2018.’’ Preventive 

Medicine, 141 106284, 2020. Available at 

https://doi.org/10.1016/ 

j.ypmed.2020.106284. 

186. Sledjeski, E.M., L.C. Dierker, D. Costello, 

et al. ‘‘Predictive Validity of Four 

Nicotine Dependence Measures in a 

College Sample.’’ Drug and Alcohol 

Dependence, 87(1):10–19, 2007. 

Available at https://doi.org/10.1016/ 

j.drugalcdep.2006.07.005. 

187. Walker, J.F. and P.D. Loprinzi. 

‘‘Longitudinal Examination of Predictors 

of Smoking Cessation in a National 

Sample of U.S. Adolescent and Young 

Adult Smokers.’’ Nicotine & Tobacco 

Research, 16(6):820–827, 2014. Available 

at https://doi.org/10.1093/ntr/ntu005. 

188. Rossheim, M.E., M.D. Livingston, J.R. 

Krall, et al. ‘‘Cigarette Use Before and 

After the 2009 Flavored Cigarette Ban.’’ 

Journal of Adolescent Health, 67(3):432– 

437, 2020. Available at https://doi.org/ 

10.1016/j.jadohealth.2020.06.022. 

189. Courtemanche, C.J., M.K. Palmer, and 

M.F. Pesko. ‘‘Influence of the Flavored 

Cigarette Ban on Adolescent Tobacco 

Use.’’ American Journal of Preventive 

Medicine, 52(5):e139–e146, 2017. 

Available at https://doi.org/10.1016/ 

j.amepre.2016.11.019. 

190. Gammon, D.G., T. Rogers, J. Gaber, et al. 

‘‘Implementation of a Comprehensive 

Flavoured Tobacco Product Sales 

Restriction and Retail Tobacco Sales.’’ 

Tobacco Control, 0:1–7, 2021. Available 

at https://doi.org/10.1136/ 

tobaccocontrol-2021-056494. 

191. * Yang, Y., E.N. Lindblom, R.G. Salloum, 

et al. ‘‘The Impact of a Comprehensive 

Tobacco Product Flavor Ban in San 

Francisco Among Young Adults.’’ 

Addictive Behaviors Reports, 11:100273, 

2020. Available at https://doi.org/ 

10.1016/j.abrep.2020.100273. 

192. Olson, L.T., E.M. Coats, T. Rogers, et al. 

‘‘Youth Tobacco Use Before and After 

Local Sales Restrictions on Flavored and 

Menthol Tobacco Products in 

Minnesota.’’ Journal of Adolescent 

Health, 2022. Available at https://

doi.org/10.1016/j.jadohealth.

2022.01.129. 

193. Asare S., M.A., J.L. Westmaas, et al. 

‘‘Association of Cigarette Sales with 

Comprehensive Menthol Flavor Ban in 

Massachusetts.’’ JAMA Internal 

Medicine 182(2):231–234, 2022. 

Available at https://doi:10.1001/ 

jamainternmed.2021.7333. 

194. Vyas, P., P. Ling, B. Gordon, et al. 

‘‘Compliance with San Francisco’s 

Flavoured Tobacco Sales Prohibition.’’ 

Tobacco Control, 30:227–230, 2021. 

Available at https://doi.org/10.1136/ 

tobaccocontrol-2019-055549. 

195. * Friedman, A.S. ‘‘A Difference-InDifferences Analysis of Youth Smoking 

and a Ban on Sales of Flavored Tobacco 

Products in San Francisco, California.’’ 

JAMA Pediatrics, 175(8):863–865, 2021. 

Available at https://dx.doi.org/ 

10.1001%2Fjamapediatrics.2021.0922. 

196. Liu, J., A.S.L. Tan, J.P. Winickoff, et al. 

‘‘Youth Tobacco Use Before and After 

Flavoured Tobacco Sales Restrictions in 

Oakland, California and San Francisco, 

California.’’ Tobacco Control, Published 

Online First, 17 March 2022. Available at 

http://dx.doi.org/10.1136/ 

tobaccocontrol-2021-057135. 

197. Carpenter, C.S., & Nguyen, H.V. 

‘‘Intended and unintended effects of 

banning menthol cigarettes.’’ The Journal 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
26498 Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 

of Law and Economics, 64(3), 629–650, 

2021. Available at https://doi.org/ 

10.1086/713978. 

198. * Campaign for Tobacco-Free Kids.

‘‘States and Localities That Have

Restricted The Sale of Flavored Tobacco

Products.’’ January 6, 2022. Available at

https://www.tobaccofreekids.org/assets/

factsheets/0398.pdf.

199. Farley, S.M. and M. Johns. ‘‘New York

City Flavoured Tobacco Product Sales

Ban Evaluation.’’ Tobacco Control,

26:78–84, 2017. Available at https://

doi.org/10.1136/tobaccocontrol-2015-

052418.

200. Rogers, T., E.M. Brown, T.M. McCrae, et

al. ‘‘Compliance with A Sales Policy on

Flavored Non-Cigarette Tobacco

Products.’’ Tobacco Regulatory Science,

3(Suppl 1):84–93, 2017. Available at

https://doi.org/10.18001/

TRS.3.2(Suppl1).9.

201. Kingsley, M., C.M. Setodji, J.D. Pane, et

al. ‘‘Short-Term Impact of a Flavored

Tobacco Restriction: Changes in Youth

Tobacco Use in a Massachusetts

Community.’’ American Journal of

Preventive Medicine, 57(6):741–748,

2019. Available at https://doi.org/

10.1016/j.amepre.2019.07.024.

202. * Pearlman, D.N., J.A. Arnold, G.A.

Guardino, et al. ‘‘Advancing Tobacco

Control Through Point of Sale Policies,

Providence, Rhode Island.’’ Preventing

Chronic Disease, 16:180614, 2019.

Available at https://doi.org/10.5888/

pcd16.180614.

203. * Hawkins, S.S., C. Kruzik, M. O’Brien,

et al. ‘‘Flavoured Tobacco Product

Restrictions in Massachusetts Associated

with Reductions in Adolescent Cigarette

and E-Cigarette Use.’’ Tobacco Control,

0:1–4, 2021. Available at https://doi.org/

10.1136/tobaccocontrol-2020-056159.

204. Kingsley, M., C.M. Setodji, J.D. Pane, et

al. ‘‘Longer-Term Impact of the Flavored

Tobacco Restriction in Two

Massachusetts Communities: A MixedMethods Study,’’ Nicotine & Tobacco

Research, 23(11): 1928–1935, 2021.

Available at https://doi.org/10.1093/ntr/

ntab115.

205. Liu, S.T., K. Snyder, M.A. Tynan, et al.

‘‘Youth Access to Tobacco Products in

the United States, 2016–2018.’’ Tobacco

Regulatory Science, 5(6):491–501, 2019.

Available at https://doi.org/10.18001/

TRS.5.6.2.

206. * Cotti, C., E. Nesson, and N. Tefft

(2016). ‘‘The effects of tobacco control

policies on tobacco products, tar, and

nicotine purchases among adults:

Evidence from household panel data’’.

American Economic Journal: Economic

Policy, 8(4), 103–23, 2016. Available at

http://dx.doi.org/10.1257/pol.20150268.

207. Zheng, Y., C. Zhen, J. Nonnemaker, J.,

et al. ‘‘Advertising, habit formation, and

US tobacco product demand.’’ American

Journal of Agricultural Economics, 98(4),

1038–1054, 2016. Available at https://

doi.org/10.1093/ajae/aaw024.

208. Zheng, Y., C. Zhen, D. Dench, D., et al.

‘‘US demand for tobacco products in a

system framework.’’ Health Economics,

26(8), 1067–1086, 2017. Available at

https://doi.org/10.1002/hec.3384.

209. Rogers, T., A. Feld, D.G. Gammon, et al.

‘‘Changes in Cigar Sales Following

Implementation of a Local Policy

Restricting Sales of Flavoured NonCigarette Tobacco Products.’’ Tobacco

Control, 29(4):412–419, 2020. Available

at https://doi.org/10.1136/

tobaccocontrol-2019-055004.

210. * Babb, S., A. Malarcher, G. Schauer, et

al. ‘‘Quitting Smoking Among Adults—

United States, 2000–2015.’’ Morbidity

and Mortality Weekly Report,

65(52):1457–1464, 2017. Available at

https://doi.org/10.15585/

mmwr.mm6552a1.

211. Levy, D.T., C.J. Cadham, L.M. SanchezRomero, et al. ‘‘An Expert Elicitation on

the Effects of a Ban on Menthol

Cigarettes and Cigars in the United

States.’’ Nicotine & Tobacco Research,

23(11): 1911–1920, 2021. Available at

https://doi.org/10.1093/ntr/ntab121.

212. * Czaplicki, L., B. Schillo, S.W. Rose, et

al. ‘‘National Support for a Menthol

Cigarette Sales Ban.’’ Public Health

Reports, 136(2):183–191, 2021. Available

at https://doi.org/

10.1177%2F0033354920966004.

213. Pearson, J.L., D.B. Abrams, R.S. Niaura,

et al. ‘‘A Ban on Menthol Cigarettes:

Impact on Public Opinion and Smokers’

Intention to Quit.’’ American Journal of

Public Health, 102:e107–e114, 2012.

Available at https://doi.org/10.2105/

AJPH.2012.300804.

214. Hymowitz, N., C. Mouton, and H.

Edkholdt. ‘‘Menthol Cigarette Smoking

in African Americans and Whites.’’

Tobacco Control, 4(2):194–195, 1995.

Available at http://dx.doi.org/10.1136/

tc.4.2.194b.

215. Rose, S.W., O. Ganz, Y. Zhou, et al.

‘‘Longitudinal Response to Restrictions

on Menthol Cigarettes Among Young

Adult US Menthol Smokers, 2011–

2016.’’ American Journal of Public

Health, 109:1400–1403, 2019. Available

at https://doi.org/10.2105/

AJPH.2019.305207.

216. * Chung-Hall, J., G.T. Fong, G. Meng, et

al. ‘‘Evaluating the Impact of Menthol

Cigarette Bans on Cessation and Smoking

Behaviours in Canada: Longitudinal

Findings from the Canadian Arm of the

2016–2018 ITC Four Country Smoking

and Vaping Surveys.’’ Tobacco Control,

0:1–8, 2021. Available at https://doi.org/

10.1136/tobaccocontrol-2020-056259.

217. Bold, K.W., P. Jatlow, L.M. Fucito, et al.

‘‘Evaluating the Effect of Switching to

Non-Menthol Cigarettes Among Current

Menthol Smokers: An Empirical Study of

a Potential Ban of Characterising

Menthol Flavour in Cigarettes.’’ Tobacco

Control, 29:624–630, 2020. Available at

https://doi.org/10.1136/tobaccocontrol2019-055154.

218. * Cadham, C.J., L.M. Sanchez-Romero,

N.L. Fleicher, et al. ‘‘The Actual and

Anticipated Effects of a Menthol

Cigarette Ban: A Scoping Review.’’ BMC

Public Health, 20:1055, 2020. Available

at https://doi.org/10.1186/s12889-020-

09055-z.

219. O’Connor, R.J., M. Bansal-Travers, L.P.

Carter, et al. ‘‘What Would Menthol

Smokers Do If Menthol in Cigarettes 

Were Banned? Behavioral Intentions and 

Simulated Demand.’’ Addiction, 

107:1330–1338, 2012. Available at 

https://doi.org/10.1111/j.1360-0443.

2012.03822.x. 

220. Wackowski, O.A., M.T. Manderski, and

C.D. Delnevo. ‘‘Young Adults’ Behavioral

Intentions Surrounding a Potential

Menthol Cigarette Ban.’’ Nicotine &

Tobacco Research, 16(6):876–880, 2014.

Available at https://doi.org/10.1093/ntr/

ntu003.

221. * D’Silva, J., M.S. Amato, R.G. Boyle, et

al. ‘‘Quitting and Switching: Menthol

Smokers’ Responses to a Menthol Ban.’’

Tobacco Regulatory Science, 1(1):54–60,

2015. Available at https://doi.org/

10.18001/TRS.1.1.6.

222. * Wackowski, O.A., C.D. Delnevo, and

J.L. Pearson. ‘‘Switching to E-Cigarettes

in the Event of a Menthol Cigarette Ban.’’

Nicotine & Tobacco Research,

17(10):1286–1287, 2015. Available at

https://doi.org/10.1093/ntr/ntv021.

223. * Hartman, A. ‘‘What Menthol Smokers

Report They Would Do If Menthol

Cigarettes Were No Longer Sold.’’

Presentation to FDA Tobacco Products

Scientific Advisory Committee Meeting,

Silver Spring, MD, January 10–11, 2011.

Available at https://wayback.archiveit.org/7993/20170113150718/http://

www.fda.gov/downloads/Advisory

Committees/CommitteesMeeting

Materials/TobaccoProductsScientific

AdvisoryCommittee/UCM240176.pdf.

224. Chaiton, M.O., I. Nicolau, R. Schwartz,

et al. ‘‘Ban on Menthol-Flavoured

Tobacco Products Predicts Cigarette

Cessation at 1 Year: A Population Cohort

Study.’’ Tobacco Control, 29:341–347,

2020. Available at https://doi.org/

10.1136/tobaccocontrol-2018-054841.

225. Guillory, J., A.E. Kim, J.M. Nonnemaker,

et al. ‘‘Effect of Menthol Cigarette and

Other Menthol Tobacco Product Bans on

Tobacco Purchases in the RTI iShoppe

Virtual Convenience Store.’’ Tobacco

Control, 29(4):452–459, 2020. Available

at https://doi.org/10.1136/

tobaccocontrol-2019-054997.

226. Chaiton, M.O., R. Schwartz, J.E. Cohen,

et al. ‘‘Association of Ontario’s Ban on

Menthol Cigarettes with Smoking

Behavior 1 Month After

Implementation.’’ JAMA Internal

Medicine, 178(5):710–711, 2018.

Available at https://doi.org/10.1001/

jamainternmed.2017.8650.

227. Chaiton, M.O., R. Schwartz, J.E. Cohen,

et al. ‘‘Prior Daily Menthol Smokers

More Likely to Quit 2 Years After a

Menthol Ban Than Non-Menthol

Smokers: A Population Cohort Study.’’

Nicotine & Tobacco Research,

23(9):1584–1589, 2021. Available at

https://doi.org/10.1093/ntr/ntab042.

228. * Ontario Tobacco Research Unit.

Smoke-Free Ontario Strategy Monitoring

Report. Toronto, Canada: Ontario

Tobacco Research Unit, Special Report,

March 2017. Available at https://

www.otru.org/documents/2017-smokefree-ontario-strategy-monitoring-report/.

229. * Creamer, M.R, T.W. Wang, S. Babb, et

al. ‘‘Tobacco Product Use and Cessation


khammond on DSKJM1Z7X2PROD with PROPOSALS3
Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 26499 

Indicators Among Adults—United 

States, 2018.’’ Morbidity and Mortality 

Weekly Report, 68(45):1013–1019, 2019. 

Available at https://doi.org/10.15585/ 

mmwr.mm6845a2. 

230. * Chaiton, M.O., R. Schwartz, J.

Shuldiner, et al. ‘‘Evaluating a Real

World Ban on Menthol Cigarettes: An

Interrupted Time-Series Analysis of

Sales.’’ Nicotine & Tobacco Research,

22(4):576–579, 2020. Available at https://

doi.org/10.1093/ntr/ntz041.

231. Brown, E.M., D.G. Gammon, T. Rogers,

et al. ‘‘Changes in Retail Sales in

Tobacco Products in Ontario After a

Menthol Sales Restriction.’’ Tobacco

Control, tobaccocontrol–2021–056489,

2021. Available at https://doi.org/

10.1136/tobaccocontrol-2021-056489.

232. * Chaiton M.O., R. Schwartz, A. Kundu,

et al. ‘‘Analysis of Wholesale Cigarette

Sales in Canada After Menthol Cigarette

Bans.’’ JAMA Network Open,

4(11):e2133673, 2021. Available at

https://doi:10.1001/

jamanetworkopen.2021.33673.

233. * Guydish, J.R., E.R. Straus, T. Le, et al.

‘‘Menthol Cigarette Use in Substance Use

Disorder Treatment Before and After

Implementation of a County-Wide

Flavoured Tobacco Ban.’’ Tobacco

Control, 30:616–622, 2021. Available at

https://doi.org/10.1136/tobaccocontrol2020-056000.

234. Guydish, J., E. Passalacqua, B. Tajima,

et al. ‘‘Smoking Prevalence in Addiction

Treatment: A Review.’’ Nicotine &

Tobacco Research, 13(6):401–411, 2011.

Available at https://doi.org/10.1093/ntr/

ntr048.

235. Guydish, J., E. Passalacqua, A. Pagano,

et al. ‘‘An International Systematic

Review of Smoking Prevalence in

Addiction Treatment.’’ Addiction,

111(2):220–230, 2016. Available at

https://doi.org/10.1111/add.13099.

236. McClure, E.A., S.P. Acquavita, K.E.

Dunn, et al. ‘‘Characterizing Smoking,

Cessation Services, and Quit Interest

Across Outpatient Substance Abuse

Treatment Modalities.’’ Substance Abuse

& Treatment, 46(2), 2014. Available at

https://doi.org/10.1016/

j.jsat.2013.07.009.

237. Parker, M.A., S. Sigmon, and A. Villanti.

‘‘Higher Smoking Prevalence Among

United States Adults with Co-Occurring

Affective and Drug Use Diagnosis.’’

Addictive Behaviors, 99:106112, 2019.

Available at https://doi.org/10.1016/

j.addbeh.2019.106112.

238. Parker, M.A, J.M. Streck, and S.C.

Sigmon. ‘‘Associations Between Opioid

and Nicotine Dependence in Nationally

Representative Samples of United States

Adult Daily Smokers.’’ Drug and Alcohol

Dependence, 186(2018):167–170, 2018.

Available at https://doi.org/10.1016/

j.drugalcdep.2018.01.024.

239. Richter, K., C. Gibson, J. Ahluwalia, et

al. ‘‘Tobacco Use and Quit Attempts

Among Methadone Maintenance

Clients.’’ American Journal of Public

Health, 91:296–299, 2001. Available at

https://dx.doi.org/10.2105%2Fajph.

91.2.296.

240. Richter, K.P., H.K. Ahluwalia, M.C.

Mosier, et al. ‘‘A Population-Based Study

of Cigarette Smoking among Illicit Drug

Users in The United States.’’ Addiction,

97, 861–869, 2002. Available at https://

doi.org/10.1046/j.1360-

0443.2002.00162.x.

241. Chait, L.D. and R.R. Griffiths. ‘‘Effects of

Methadone on Human Cigarette Smoking

and Subjective Ratings.’’ The Journal of

Pharmacology and Experimental

Therapeutics, 229(3):636–640, 1984.

Available at https://jpet.aspetjournals.

org/content/229/3/636.

242. Henningfield, J. and R. Griffiths.

‘‘Cigarette Smoking and Subjective

Response: Effects of D-Amphetamine.’’

Clin. Pharmacol. Ther., 30(4):497–505,

1981. Available at https://doi.org/

10.1038/clpt.1981.194.

243. Schmitz, J., J. Grabowski, and H.

Rhoades. ‘‘The Effects of High and Low

Doses of Methadone on Cigarette

Smoking.’’ Drug and Alcohol

Dependence, 34:237–242, 1994.

Available at https://doi.org/10.1016/

0376-8716(94)90162-7.

244. Spiga, R., J. Schmitz, and J. Day. ‘‘Effects

of Nicotine on Methadone SelfAdministration in Humans.’’ Drug and

Alcohol Dependence, 50(2):157–165,

1998. Available at https://doi.org/

10.1016/S0376-8716(98)00020-9.

245. * HHS. ‘‘Smoking Cessation: A Report of

the Surgeon General.’’ Atlanta, GA: HHS,

CDC, National Center for Chronic

Disease Prevention and Health

Promotion, Office on Smoking and

Health, 2020. Available at https://

www.hhs.gov/sites/default/files/2020-

cessation-sgr-full-report.pdf.

246. * Rostron, B.L., C.M. Chang, and T.F.

Pechacek. ‘‘Estimation of Cigarette

Smoking-Attributable Morbidity in the

United States.’’ JAMA Internal Medicine,

174(12):1922–1928, 2014. Available at

https://doi.org/10.1001/

jamainternmed.2014.5219.

247. Christensen, C.H., B. Rostron, C.

Cosgrove, et al. ‘‘Association of Cigarette,

Cigar, and Pipe Use with Mortality Risk

in the US Population.’’ JAMA Internal

Medicine, 178(4):469–476, 2018.

Available at https://doi.org/10.1001/

jamainternmed.2017.8625.

248. Jha, P., C. Ramasundarahettige, V.

Landsman, et al. ‘‘21St-Century Hazards

of Smoking and Benefits of Cessation in

The United States.’’ The New England

Journal of Medicine, 368:341–50, 2013.

Available at https://doi.org/10.1056/

NEJMsa1211128.

249. Inoue-Choi, M., T.S. McNeel, P. Hartge,

et al. ‘‘Non-Daily Cigarette Smokers:

Mortality Risks in The United States.’’

American Journal of Preventive

Medicine, 56(1):27–37, 2019. Available

at https://doi.org/10.1016/j.amepre.

2018.06.025.

250. * HHS. ‘‘The Health Consequences of

Smoking: A Report of the Surgeon

General.’’ Atlanta, GA: HHS, CDC,

National Center for Chronic Disease

Prevention and Health Promotion, Office

on Smoking and Health, 2004. Available

at https://www.cdc.gov/tobacco/data_

statistics/sgr/2004/complete_report/ 

index.htm. 

251. Thun M., B. Carter, D. Feskanich, et al.

‘‘50-Year Trends in Smoking-Related

Mortality in the United States.’’ The New

England Journal of Medicine.

368(4):351–364, 2013. Available at

https://doi.org/10.1056/NEJMsa1211127.

252. * World Health Organization. ‘‘Tobacco:

Health Benefits of Smoking Cessation.’’

February, 25, 2020. Accessed November

3, 2021. https://www.who.int/newsroom/questions-and-answers/item/

tobacco-health-benefits-of-smokingcessation.

253. * McBride, C. and J. Ostroff. ‘‘Teachable

Moments for Promoting Smoking

Cessation: The Context of Cancer Care

and Survivorship.’’ Cancer Control,

10(4):325–333, 2003. Available at https://

doi.org/10.1177/107327480301000407.

254. * Travis, L.B., C.S. Rabkin, L.M. Brown,

et al. ‘‘Cancer Survivorship—Genetic

Susceptibility and Second Primary

Cancers: Research Strategies and

Recommendations.’’ Journal of the

National Cancer Institute, 98(1):15–25,

2006. Available at https://doi.org/

10.1093/jnci/djj001.

255. * Parsons, A., A. Daley, R. Begh, et al.

‘‘Influence of Smoking Cessation After

Diagnosis of Early Stage Lung Cancer on

Prognosis: Systematic Review of

Observational Studies with MetaAnalysis.’’ BMJ, 340:b5569, 2010.

Available at https://doi.org/10.1136/

bmj.b5569.

256. * HHS. ‘‘The Health Benefits of Smoking

Cessation: A Report of the Surgeon

General.’’ Atlanta, GA: HHS, CDC,

National Center for Chronic Disease

Prevention and Health Promotion, Office

on Smoking and Health, 1990. Available

at https://www.google.com/books/

edition/The_Health_Benefits_of_

Smoking_Cessation/

9bkJtXVCkdMC?hl=en&

gbpv=1&printsec=frontcover.

257. Sheikh, M., A. Mukeriya, O. Shangina,

et al. ‘‘Postdiagnosis Smoking Cessation

and Reduced Risk for Lung Cancer

Progression and Mortality: A Prospective

Cohort Study.’’ Annals of Internal

Medicine, 174(9):1232–1239, 2021.

Available at https://doi.org/10.7326/

M21-0252.

258. * Kaiser, E.G., J.J. Prochaska, and M.S.

Kendra. ‘‘Tobacco Cessation in Oncology

Care.’’ Oncology, 95:129–137, 2018.

Available at: https://doi.org/10.1159/

000489266.

259. * Rosoff, D.B., J. Yoo, and F.W. Lohoff.

‘‘Smoking is Significantly Associated

with Increased Risk of COVID–19 and

Other Respiratory Infections.’’

Communications Biology, 4(1230), 2021.

Available at https://doi.org/10.1038/

s42003-021-02685-y.

260. * Taylor, D., V. Hasselblad, J. Henley, et

al. ‘‘Benefits of Smoking Cessation for

Longevity.’’ American Journal of Public

Health, 92(6):990–996, 2002.

261. Peto, R., S. Darby, H. Deo, et al.

‘‘Smoking, Smoking Cessation, and Lung

Cancer in the UK since 1950:

Combination of National Statistics with


khammond on DSKJM1Z7X2PROD with PROPOSALS3
26500 Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 

Two Case-Control Studies.’’ BMJ, 

321:323–9, 2000. Available at https://

doi.org/10.1136/bmj.321.7257.323. 

262. Doll, R., R. Peto, J. Boreham, et al. 

‘‘Mortality in Relation to Smoking: 50 

Years’ Observations on Male British 

Doctors.’’ BMJ Online First, 2004. 

Available at https://doi.org/10.1136/ 

bmj.38142.554479.AE. 

263. * Schabath, M., W. Cress, and T. Mun ̃ ozAntonia. ‘‘Racial and Ethnic Differences 

in the Epidemiology of Lung Cancer and 

the Lung Cancer Genome.’’ Cancer 

Control, 23(4): 338–346, 2016. Available 

at https://doi.org/10.1177/ 

107327481602300405. 

264. * National Cancer Institute. ‘‘SEER 

Cancer Statistics Factsheets: Cancer 

Disparities.’’ National Cancer Institute. 

Bethesda, MD: U.S. Department of 

Health and Human Services, National 

Institutes of Health, National Cancer 

Institute, Surveillance, Epidemiology, 

and End Results Program. Accessed July 

7, 2021. Available at https://

seer.cancer.gov/statfacts/html/ 

disparities.html. 

265. * Keenan N.L. and K.M. Shaw. 

‘‘Coronary heart disease and stroke 

deaths—United States, 2006.’’ Morbidity 

and Mortality Supplement, 60(1):62–6, 

Jan. 14, 2011. Available at https://

www.cdc.gov/mmwr/preview/ 

mmwrhtml/su6001a13.htm. 

266. * Safford, M., T. Brown, P. Muntner, et 

al. ‘‘Association of Race and Sex with 

Risk of Incident Acute Coronary Heart 

Disease Events.’’ Journal of American 

Medical Association, 308(17), 2012. 

Available at https://doi.org/10.1001/ 

jama.2012.14306. 

267. * Singh, G., M. Siahpush, R. Azuine, et 

al. ‘‘Widening Socioeconomic and Racial 

Disparities in Cardiovascular Disease 

Mortality in The United States, 1969– 

2013.’’ International Journal of MCH and 

AIDS, 3(2):106–118, 2015. 

268. * HHS. ‘‘Health, United States, 2019.’’ 

Hyattsville, MD: HHS, CDC, National 

Center for Health Statistics. Health, 

United States, 2019. Available at https:// 

www.cdc.gov/nchs/hus/index.htm?CDC_

AA_refVal=https%3A%2F%2Fwww.

cdc.gov%2Fnchs%2Fhus.htm. 

269. * Van Dyke, M., S. Greer, E. Odom, et 

al. ‘‘Heart Disease Death Rates Among 

Blacks and Whites Aged ≥35 Years— 

United States, 1968–2015.’’ Morbidity 

and Mortality Weekly Report, 67(5), 

2018. Available at http://dx.doi.org/ 

10.15585/mmwr.ss6705a1. 

270. * Centers for Disease Control and 

Prevention. ‘‘Vital Signs: Avoidable 

Deaths from Heart Disease, Stroke, and 

Hypertensive Disease—United States, 

2001–2010.’’ Morbidity and Mortality 

Weekly Report, 62(35):721–727, 2013. 

Available at https://www.cdc.gov/mmwr/ 

preview/mmwrhtml/mm6235a4.htm. 

271. National Academies of Sciences, 

Engineering, and Medicine. ‘‘Public 

Health Consequences of E-Cigarettes.’’ 

Washington, DC: The National 

Academies Press, 2018. Available at 

https://doi.org/10.17226/24952. 

272. Pacek, L.R., O. Rass, M.M. Sweitzer, et 

al. ‘‘Young Adult Dual Combusted 

Cigarette and E-cigarette Users’ 

Anticipated Responses to Hypothetical 

E-cigarette Market Restrictions.’’ 

Substance Use & Misuse, 54(12):2033– 

2042, 2019. Available at https://doi.org/ 

10.1080/10826084.2019.1626435. 

273. Denlinger-Apte, R.L., R.N. Cassidy, K.B. 

Carey et al. ‘‘The Impact of Menthol 

Flavoring in Combusted Tobacco on 

Alternative Product Purchasing: A Pilot 

Study Using the Experimental Tobacco 

Marketplace.’’ Drug and Alcohol 

Dependence, 218:108390, 2021. 

Available at https://doi.org/10.1016/ 

j.drugalcdep.2020.108390. 

274. Wang, R.J., S. Bhadriraju, and S.A. 

Glantz. ‘‘E-Cigarette Use and Adult 

Cigarette Smoking Cessation: A MetaAnalysis.’’ Research and Analysis, 

111(2), 2021. Available at https://

dx.doi.org/10.2105%2FAJPH.

2020.305999. 

275. Hartmann-Boyce, J., H. McRobbie, N. 

Lindson, et al. ‘‘Electronic Cigarettes for 

Smoking Cessation (Review).’’ Cochrane 

Database of Systematic Reviews, 

9:CD010216, 2021. Available at https://

doi.org/10.1002/14651858.

CD010216.pub6. 

276. * El Dib, R., E.A. Suzumura, E.A. Aki, 

et al. ‘‘Electronic Nicotine Delivery 

Systems and/or Electronic Non-nicotine 

Delivery Systems for Tobacco Smoking 

Cessation or Reduction: A Systematic 

Review and Meta-analysis.’’ BMJ, 

7:e012680, 2017. Available at: https://

doi.org/10.1136/bmjopen-2016-012680. 

277. Coleman, B., B. Rostron, S.E. Johnson, 

et al. ‘‘Transitions in electronic cigarette 

use among adults in the Population 

Assessment of Tobacco and Health 

(PATH) Study, Waves 1 and 2 (2013– 

2015).’’ Tobacco Control, 28:50–59, 2019. 

Available at http://dx.doi.org/10.1136/ 

tobaccocontrol-2017-054174. 

278. Levy, D.T., Z. Yuan, Y. Luo, et al. ‘‘The 

Relationship of E-Cigarette Use to 

Cigarette Quit Attempts and Cessation: 

Insights from a Large, Nationally 

Representative U.S. Survey.’’ Nicotine 

Tobacco Research, 20(8):931–939, 2018. 

Available at https://doi.org/10.1093/ntr/ 

ntx166. 

279. Giovenco, D.P. and C.D. Delnevo. 

‘‘Prevalence of Population Smoking 

Cessation by Electronic Cigarette Use 

Status in a National Sample of Recent 

Smokers.’’ Addictive Behaviors, 76:129– 

134, 2018. Available at https://doi.org/ 

10.1016/j.addbeh.2017.08.002. 

280. Chaiton, M.O., I. Papadhima, R. 

Schwartz, et al. ‘‘Product Substitution 

After a Real World Menthol Ban: A 

Cohort Study.’’ Tobacco Regulatory 

Science, 6(3):205–212, 2020. Available at 

https://doi.org/10.18001/TRS.6.3.5. 

281. * HHS. ‘‘The Health Consequences of 

Involuntary Exposure to Tobacco Smoke: 

A Report of the Surgeon General.’’ 

Atlanta, GA: HHS, CDC, National Center 

for Chronic Disease Prevention and 

Health Promotion, Office on Smoking 

and Health, 2006. Available at https://

www.ncbi.nlm.nih.gov/books/ 

NBK44324/pdf/Bookshelf_

NBK44324.pdf. 

282. * California Environmental Protection 

Agency. ‘‘Proposed Identification of 

Environmental Tobacco Smoke as a 

Toxic Air Contaminant.’’ CEPA, Air 

Resources Board, Office of 

Environmental Health Hazard 

Assessment, 2005. Available at https://

escholarship.org/uc/item/8hk6960q. 

283. * Tsai, J., D. Homa, A. Gentzke, et al. 

‘‘Exposure to Secondhand Smoke Among 

Nonsmokers—United States, 1988– 

2014.’’ Morbidity and Mortality Weekly 

Report, 67(48):1342–1346, 2018. 

Available at http://dx.doi.org/10.15585/ 

mmwr.mm6748a3. 

284. * Walton, K., A. Gentzke, B. Kenemer, et 

al. ‘‘Exposure to Secondhand Smoke in 

Homes and Vehicles Among US Youths, 

United States, 2011–2019.’’ Preventing 

Chronic Disease, 17:200107, 2020. 

Available at http://dx.doi.org/10.5888/ 

pcd17.200107. 

285. * Shastri, S., R. Talluri, S. Shete. 

‘‘Disparities in Secondhand Smoke 

Exposure in the United States: National 

Health and Nutrition Examination 

Survey 2011–2018.’’ JAMA Internal 

Medicine, 181(1):134–137, 2021. 

Available at https://doi.org/10.1001/ 

jamainternmed.2020.3975. 

286. * Homa, D., L. Neff, B. King, et al. ‘‘Vital 

Signs: Disparities in Nonsmokers’ 

Exposure to Secondhand Smoke—United 

States, 1999–2012.’’ Morbidity and 

Mortality Weekly Report, 64(4), 2015. 

Available at https://www.cdc.gov/mmwr/ 

preview/mmwrhtml/mm6404a7.htm. 

287. Zhang, X., N. Jones, D. Kuo, et al. 

‘‘Trends in Home Smoking Bans in the 

USA, 1995–2007: Prevalence, 

Discrepancies, and Disparities.’’ Tobacco 

Control, 21:330–336, 2012. Available at 

http://dx.doi.org/10.1136/ 

tc.2011.043802. 

288. Dai, H. and Jianqiang Hao. ‘‘Prevalence 

of Exposure to Workplace Secondhand 

Smoke in the United States: 2010 to 

2015.’’ Nicotine & Tobacco Research, 

19(11):1300–1307, 2016. Available at 

https://doi.org/10.1093/ntr/ntw306. 

289. International Agency for Research and 

Cancer. ‘‘Evaluating the Effectiveness of 

Smoke-Free Policies.’’ IARC Handbooks 

of Cancer Prevention, Tobacco Control, 

Vol. 13. Lyon (FR): IARC, 2009. 

Available at https://publications.iarc.fr/ 

Book-And-Report-Series/IarcHandbooks-Of-Cancer-Prevention/ 

Evaluating-The-Effectiveness-Of-Smokefree-Policies-2009. 

290. * Centers for Disease Control and 

Prevention. ‘‘The Community Guide: 

Tobacco Use: Smoke Free Policies.’’ 

Available at https://www.thecommunity

guide.org/findings/tobacco-use-andsecondhand-smoke-exposure-smokefree-policies. 

291. * Levy, D.T., J. Tam, L.M. SanchezRomero, et al. ‘‘Public Health 

Implications of Vaping in the USA: The 

Smoking and Vaping Simulation 

Model.’’ Population Health Metrics, 

19:19, 2021. Available at https://doi.org/ 

10.1186/s12963-021-00250-7. 

292. * FDA. Preliminary Regulatory Impact 

Analysis; Initial Regulatory Flexibility 


khammond on DSKJM1Z7X2PROD with PROPOSALS3
Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 26501 

Analysis; Unfunded Mandates Reform 

Act Analysis, Tobacco Product Standard 

for Menthol in Cigarettes; Proposed Rule. 

293. * Henley, S., C. Thomas, S. Sharapova, 

et al. ‘‘Vital Signs: Disparities in 

Tobacco-Related Cancer Incidence and 

Mortality—United States, 2004–2013.’’ 

Morbidity and Mortality Weekly Report, 

65(44), 2016. Available at http://

dx.doi.org/10.15585/mmwr.mm6544a3. 

294. * U.S. Fire Administration. ‘‘Fire 

Estimate Summary: Residential Building 

Fire Trends (2009–2018).’’ Emmitsburg, 

MD. Federal Emergency Management 

Agency, U.S. Fire Administration, 

National Fire Data Center, March 2020. 

Available at https://www.usfa.fema.gov/ 

downloads/pdf/statistics/res_bldg_fire_

estimates.pdf. 

295. * Hall, J. ‘‘Smoking-Material Fire 

Problem Fact Sheet.’’ NFPA Fire 

Analysis & Research, 2013. Available at 

https://www.nfpa.org/-/media/Files/ 

News-and-Research/Fire-statistics-andreports/Fact-sheets/ 

smokingfactsheet.ashx. 

296. * Ahrens, M. ‘‘Home Fires Started by 

Smoking.’’ National Fire Protection 

Association Research, 2019. Available at 

https://www.nfpa.org/News-andResearch/Data-research-and-tools/USFire-Problem/Smoking-Materials. 

297. * U.S. Fire Administration. ‘‘SmokingRelated Fires in Residential Buildings 

(2008–2010).’’ Topical Fire Report 

Series, 13(6), 2012. Available at https:// 

www.usfa.fema.gov/downloads/pdf/ 

statistics/v13i6.pdf. 

298. Hall, J. ‘‘U.S. Smoking-Material Fire 

Problem.’’ NFPA Fire Analysis & 

Research, 2008. Available at https://

library.nfpa.org/GeniePLUS/GeniePLUS/ 

Portal/Public.aspx. 

299. Chaiton, M.O., R. Schwartz, J.E. Cohen, 

et al. ‘‘The Use of Flavour Cards and 

Other Additives After a Menthol Ban in 

Canada.’’ Tobacco Control, 30:601–602, 

2020. Available at https://doi.org/ 

10.1136/tobaccocontrol-2020-055698. 

300. * Hiscock, R., K. Silver, Mateusz 

Zaton ́ ski, et al. ‘‘Tobacco Industry 

Tactics to Circumvent and Undermine 

the Menthol Cigarette Ban in the UK.’’ 

Tobacco Control, 29:e138–e142, 2020. 

Available at http://dx.doi.org/10.1136/ 

tobaccocontrol-2020-055769. 

301. National Research Council and Institute 

of Medicine of the National Academies. 

‘‘Understanding the U.S. Illicit Tobacco 

Market: Characteristics, Policy Context, 

and Lessons from International 

Experiences.’’ Washington, DC: The 

National Academies Press, 2015. 

Available at https://doi.org/10.17226/ 

19016. 

302. Stoklosa, M. ‘‘No Surge in Illicit 

Cigarettes After Implementation of 

Menthol Ban in Nova Scotia.’’ Tobacco 

Control, 28:701–703, 2019. Available at 

https://doi.org/10.1136/tobaccocontrol2018-054552. 

303. Kock, L., L. Shahab, I. Bogdanovica, et 

al. ‘‘Profile of Menthol Cigarette Smokers 

in the Months Following the Removal of 

These Products From the Market: A 

Cross-Sectional Population Survey in 

England.’’ Tobacco Control, Published 

Online First: 17 November 2021. 

Available at http://dx.doi.org/10.1136/ 

tobaccocontrol-2021-057005. 

304. * FDA. ‘‘Finding of No Significant 

Impact: Tobacco Product Standard for 

Menthol in Cigarettes.’’ Silver Spring, 

MD: HHS, FDA, Center for Tobacco 

Products, 2022. 

305. * FDA. ‘‘Environmental Assessment of 

the Tobacco Product Standard for 

Menthol in Cigarettes.’’ Silver Spring, 

MD: HHS, FDA, Center for Tobacco 

Products, 2022. 

List of Subjects in 21 CFR Part 1162 

Labeling, Smoke, Smoking, Tobacco, 

Tobacco products. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, it is proposed that 

chapter I of title 21 of the Code of 

Federal Regulations be amended by 

adding part 1162 to subchapter K to 

read as follows: 

PART 1162—PRODUCT STANDARD: 

MENTHOL IN CIGARETTES 

Subpart A—General Provisions 

Sec. 

1162.1 Scope. 

1162.3 Definitions. 

Subpart B—Product Standard for Menthol 

in Cigarettes 

1162.5 Prohibition on use of menthol as a 

characterizing flavor in cigarettes. 

Authority: 21 U.S.C. 331, 333, 371(a), 

387b, 387c, 387f(d), 387g. 

Subpart A—General Provisions 

§ 1162.1 Scope. 

(a) This part sets out a tobacco 

product standard under the Federal 

Food, Drug, and Cosmetic Act regarding 

the use of menthol as a characterizing 

flavor in cigarettes. 

(b) No person may manufacture, 

distribute, sell, or offer for distribution 

or sale, within the United States a 

cigarette or any of its components or 

parts that is not in compliance with this 

part. 

§ 1162.3 Definitions. 

For purposes of this part: 

Accessory means any product that is 

intended or reasonably expected to be 

used with or for the human 

consumption of a cigarette; does not 

contain tobacco or nicotine from any 

source, and is not made or derived from 

tobacco; and meets either of the 

following: 

(1) Is not intended or reasonably 

expected to affect or alter the 

performance, composition, constituents, 

or characteristics of a cigarette; or 

(2) Is intended or reasonably expected 

to affect or maintain the performance, 

composition, constituents, or 

characteristics of a cigarette; but 

(i) Solely controls moisture and/or 

temperature of a stored cigarette; or 

(ii) Solely provides an external heat 

source to initiate but not maintain 

combustion of a cigarette. 

Cigarette, as used in this part: 

(1) Means a product that: 

(i) Is a tobacco product; and 

(ii) Meets the definition of the term 

‘‘cigarette’’ in section 3(1) of the Federal 

Cigarette Labeling and Advertising Act 

(15 U.S.C. 1332(1)); and 

(2) Includes tobacco, in any form, that 

is functional in the product, which, 

because of its appearance, the type of 

tobacco used in the filler, or its 

packaging and labeling, is likely to be 

offered to, or purchased by, consumers 

as a cigarette or as roll-your-own 

tobacco. 

Cigarette tobacco means any product 

that consists of loose tobacco that is 

intended for use by consumers in a 

cigarette. Unless otherwise stated, the 

requirements applicable to cigarettes 

under this chapter also apply to 

cigarette tobacco. 

Component or part means any 

software or assembly of materials 

intended or reasonably expected: 

(1) To alter or affect the cigarette’s 

performance, composition, constituents, 

or characteristics; or 

(2) To be used with or for the human 

consumption of a cigarette. The term 

excludes anything that is an accessory 

of a cigarette. 

Person includes an individual, 

partnership, corporation, or association. 

Roll-your-own tobacco means any 

tobacco product which, because of its 

appearance, type, packaging, or labeling, 

is suitable for use and likely to be 

offered to, or purchased by, consumers 

as tobacco for making cigarettes. 

Tobacco product means any product 

made or derived from tobacco, or 

containing nicotine from any source, 

that is intended for human 

consumption, including any 

component, part, or accessory of a 

tobacco product (except for raw 

materials other than tobacco used in 

manufacturing a component, part, or 

accessory of a tobacco product). The 

term ‘‘tobacco product’’ does not mean 

an article that under the Federal Food, 

Drug, and Cosmetic Act is: A drug 

(section 201(g)(1)); a device (section 

201(h)); a combination product (section 

503(g)); or a food under section 201(f) if 

such article contains no nicotine, or no 

more than trace amounts of naturally 

occurring nicotine. 


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26502 Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 

United States means the 50 States of 

the United States of America and the 

District of Columbia, the 

Commonwealth of Puerto Rico, Guam, 

the Virgin Islands, American Samoa, 

Wake Island, Midway Islands, Kingman 

Reef, Johnston Atoll, the Northern 

Mariana Islands, and any other trust 

territory or possession of the United 

States. 

Subpart B—Product Standard for 

Menthol in Cigarettes 

§ 1162.5 Prohibition on use of menthol as 

a characterizing flavor in cigarettes. 

A cigarette or any of its components 

or parts (including the tobacco, filter, 

wrapper, or paper, as applicable) shall 

not contain, as a constituent (including 

a smoke constituent) or additive, 

menthol that is a characterizing flavor of 

the tobacco product or tobacco smoke. 

Dated: April 22, 2022. 

Robert M. Califf, 

Commissioner of Food and Drugs. 

[FR Doc. 2022–08994 Filed 4–28–22; 11:15 am] 

BILLING CODE 4164–01–P 


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