26396 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 1166 

[Docket No. FDA–2021–N–1309] 

RIN 0910–AI28 

Tobacco Product Standard for 

Characterizing Flavors in Cigars 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

proposing a tobacco product standard 

that would prohibit characterizing 

flavors (other than tobacco) in all cigars 

and their components and parts. 

Characterizing flavors in cigars, such as 

strawberry, grape, cocoa, and fruit 

punch, increase appeal and make the 

cigars easier to use, particularly among 

youth and young adults. Over a half 

million youth in the United States use 

flavored cigars. This proposed product 

standard would reduce the appeal of 

cigars, particularly to youth and young 

adults, and thereby decrease the 

likelihood of experimentation, 

development of nicotine dependence, 

and progression to regular use. FDA is 

taking this action to reduce the tobaccorelated death and disease associated 

with cigar use. The proposed standard 

also is expected to reduce tobaccorelated 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–1309 for ‘‘Tobacco Product 

Standard for Characterizing Flavors in 

Cigars.’’ 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: 

Courtney Smith or Nathan Mease, 

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 

III. Background 

A. Need for the Regulation 

B. Relevant Regulatory History 

C. Legal Authority 

D. FDA’s Consideration of Health Equity 

IV. Characterizing Flavors Impact Cigar Use, 

Particularly Among Youth and Young 

Adults 

A. Recent Market Trends of Flavored 

Cigars in the United States 

B. Over Half a Million Youth, and Even 

More Young Adults, in the United States 

Use Flavored Cigars 

C. Adult Use of Flavored Cigars in the 

United States 

D. Characterizing Flavors Increase Appeal 

and Make Tobacco Products, Including 

Cigars, Easier To Use 

E. Characterizing Flavors Increase Youth 

and Young Adult Experimentation With 

Tobacco Products, Including Cigars, and 

Make Progression to Regular Tobacco 

Use More Likely 

F. Real-World Experiences Demonstrate 

That Restricting Characterizing Flavors 


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Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 26397 

1Throughout this document, FDA uses the terms 

‘‘tobacco-flavored,’’ ‘‘non-flavored,’’ and 

‘‘unflavored.’’ FDA relies on the specific term used 

by researchers when citing to individual studies; 

however, FDA generally considers a cigar that does 

not have a characterizing flavor other than tobacco 

to be ‘‘tobacco-flavored.’’ 

in Tobacco Products, Including Cigars, 

Decreases Tobacco Use 

G. Flavored Cigars Are Marketed 

Disproportionately in Underserved 

Communities and to Vulnerable 

Populations 

V. Cigar Use Is Common, Addictive, and 

Harmful 

A. Prevalence of Cigar Use Among Youth, 

Young Adults, and Older Adults in the 

United States 

B. Flavored Cigar Use Exposes Users to 

Additional Toxicants 

C. Cigar Use Is Addictive 

D. Research Clearly Demonstrates a Causal 

Relationship Between Cigar Smoking 

and Death and Disease 

E. Secondhand Tobacco Smoke, Including 

Cigar Smoke, Increases the Risks of Lung 

Cancer, Heart Disease, and Other 

Adverse Health Effects in Nonsmokers 

F. Disparities in Tobacco Use, Including 

Cigar Use, Lead to Disparities in 

Tobacco-Related Morbidity and 

Mortality 

VI. Determination That the Standard Is 

Appropriate for the Protection of the 

Public Health 

A. The Likelihood That Nonusers Would 

Start Using Cigars 

B. The Likelihood That Existing Users 

Would Reduce Cigar Consumption or 

Stop Cigar Smoking 

C. Benefits and Risks to the Population as 

a Whole 

D. Conclusion 

VII. Additional Considerations and Requests 

for Comments 

A. Section 907 of the FD&C Act 

B. Pathways to Market 

C. Considerations and Request for 

Comments on Scope of Products 

D. Request for Comments on the Potential 

Racial and Social Justice Implications of 

the Proposed Product Standard 

VIII. Description of the Proposed Rule 

A. Scope (Proposed § 1166.1) 

B. Definitions (Proposed § 1166.3) 

C. Prohibition on Use of Characterizing 

Flavors in Cigars (Proposed § 1166.5) 

IX. Proposed Effective Date 

X. Preliminary Economic Analysis of Impacts 

A. Introduction 

B. Summary of Costs and Benefits 

XI. Analysis of Environmental Impact 

XII. Paperwork Reduction Act of 1995 

XIII. Federalism 

XIV. Consultation and Coordination With 

Indian Tribal Governments 

XV. References 

I. Executive Summary 

A. Purpose of the Proposed Rule 

FDA is proposing a tobacco product 

standard that would prohibit 

characterizing flavors (other than 

tobacco) in cigars manufactured or sold 

in the United States. In developing this 

proposed rule, FDA carefully 

considered the scientific evidence and 

complex policy issues related to 

characterizing flavors in cigars. 

Each year, an estimated 9,000 

premature deaths are attributed to 

regular cigar smoking, defined as 

smoking cigars on 15 or more of the past 

30 days; approximately 5,200 of these 

premature deaths occur in regular cigar 

smokers who did not also smoke 

cigarettes. In 2019, not excluding use of 

other tobacco products, more young 

adults tried a cigar for the first time each 

day than tried a cigarette for the first 

time (3,163 cigar vs. 2,640 cigarette 

initiates per day). According to the 2020 

National Youth Tobacco Survey (NYTS), 

an estimated 3.5 percent (960,000) of 

middle and high school students, 

including 5 percent (770,000) of high 

school students (grades 9–12) and 1.5 

percent (180,000) of middle school 

students (grades 6–8), had smoked a 

cigar (cigar, cigarillo, or little cigar) in 

the preceding 30 days. Of particular 

concern is the number of youth smoking 

cigars with characterizing flavors. More 

than half (58.3 percent) of youth cigar 

smokers, or approximately 550,000 

youth, reported using a flavored cigar 

during the past 30 days. 

Researchers have found that 

characterizing flavors in cigars and 

other tobacco products play a key role 

in how users and nonusers, particularly 

youth, initiate, progress, and continue 

using tobacco products. Characterizing 

flavors in tobacco products increase the 

appeal of those tobacco products to 

youth and promote youth initiation, 

resulting in an increased likelihood that 

youth and young adults experimenting 

with flavored cigars will progress to 

regular cigar smoking. This proposed 

product standard is expected to reduce 

the appeal of cigars, particularly to 

youth and young adults, and thereby 

decrease the likelihood of 

experimentation, development of 

nicotine dependence, progression to 

regular use, and the resulting tobaccorelated disease and death. The proposed 

standard also is anticipated to improve 

public health by increasing the 

likelihood of cessation among existing 

cigar smokers. And it will improve 

health outcomes within groups that 

experience disproportionate levels of 

tobacco use, including certain 

vulnerable populations, thus advancing 

health equity. 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. 

B. Summary of the Major Provisions of 

the Proposed Rule 

The proposed rule would prohibit 

characterizing flavors (other than 

tobacco) in cigars and cigar components 

and parts. Under the proposed rule, no 

person may manufacture, distribute, 

sell, or offer for distribution or sale, 

within the United States a cigar or any 

of its components or parts that is not in 

compliance with the product standard. 

We also are proposing an effective date 

of 1 year after the date of publication of 

the final rule. We seek comment on all 

parts of this proposed rule. 

Characterizing Flavor Prohibition— 

This proposed rule would prohibit the 

use of characterizing flavors in all 

cigars. FDA proposes to define ‘‘cigar’’ 

as a tobacco product that: (1) Is not a 

cigarette and (2) is a roll of tobacco 

wrapped in leaf tobacco or any 

substance containing tobacco. This rule 

would provide that a cigar or any of its 

components or parts (including the 

tobacco, filter, or wrapper, as 

applicable) must not contain, as a 

constituent (including a smoke 

constituent) or additive, an artificial or 

natural flavor (other than tobacco) or an 

herb or spice, including, but not limited 

to, strawberry, grape, orange, clove, 

cinnamon, pineapple, vanilla, coconut, 

licorice, cocoa, chocolate, cherry, coffee, 

mint, or menthol, that is a 

characterizing flavor of the tobacco 

product or tobacco smoke. Among the 

factors that FDA believes are relevant in 

determining whether a cigar 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 a tobacco 

product; and 

• Any other means that impart flavor 

or represent that a tobacco product has 

a characterizing flavor. 

However, cigars with tobacco as their 

characterizing flavor would not be 

subject to this proposed product 

standard’s prohibition. For those who 

experiment with cigars, especially youth 

and young adults, tobacco-flavored 1

cigars do not currently appear as 

attractive as cigars with other 

characterizing flavors. FDA is 

committed to monitoring the use of 

cigars with tobacco as their 


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26398 Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 

characterizing flavor through 

surveillance of national representative 

data sources and other data to determine 

whether to take additional action in the 

future consistent with FDA’s authority. 

Proposed Effective Date—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, distribute, sell, or offer for 

distribution or sale within the United 

States a cigar or any of its components 

or parts that is not in compliance with 

part 1166 (21 CFR part 1166). 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 

flavored cigars. 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 

This proposed rule is being issued 

upon FDA’s authority to establish a 

tobacco product standard under section 

907 of the FD&C Act (21 U.S.C. 387g), 

including its authority thereunder to 

require the reduction or elimination of 

a constituent (including a smoke 

constituent), or harmful component of 

tobacco products, and 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); FDA’s authorities related to the 

sale and distribution of tobacco 

products under sections 907(a)(4)(B)(v) 

and 906(d) (21 U.S.C. 387f); FDA’s 

authorities related to adulterated and 

misbranded tobacco products under 

sections 902 and 903 (21 U.S.C. 387b 

and 387c); FDA’s authorities related to 

prohibited acts and penalties under 

sections 301 and 303 (21 U.S.C. 331 and 

333); and FDA’s rulemaking authority 

under section 701 of the FD&C Act (21 

U.S.C. 371). 

D. Costs and Benefits 

The quantified benefits of this 

proposed rule, if finalized, come from 

reduced smoking-attributable mortality 

that are the result of cigar use among 

adult cigar smokers and reduced 

mortality from secondhand smoke 

among non-users. 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, the 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 $7,024 million at a 7 percent 

discount rate, with a low estimate of 

$3,962 million and a high estimate of 

$10,140 million, and $8,575 million at 

a 3 percent discount rate, with a low 

estimate of $4,837 million and a high 

estimate of $12,378 million. 

Over a 40-year time horizon, we 

estimate that the annualized costs will 

equal $112 million at a 7 percent 

discount rate, with a low estimate of $9 

million and a high estimate of $216 

million, and $102 million at a 3 percent 

discount rate, with a low estimate of $5 

million and a high estimate of $200 

million. 

II. Table of Abbreviations/Commonly 

Used Acronyms 

Abbreviation/acronym What it means 

AI/ANs ............................................. American Indians or Alaskan Natives. 

ANPRM ........................................... Advance notice of proposed rulemaking. 

CDC ................................................ Centers for Disease Control and Prevention. 

CFR ................................................. Code of Federal Regulations. 

CO ................................................... Carbon monoxide. 

COPD .............................................. Chronic obstructive pulmonary disease. 

CPS I ............................................... Cancer Prevention Study I. 

CPS II .............................................. Cancer Prevention Study II. 

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. 

HHS ................................................. U.S. Department of Health and Human Services. 

IARC ................................................ International Agency for Research on Cancer. 

IOM ................................................. Institute of Medicine. 

LCCs ............................................... Little cigars and cigarillos. 

LGBTQ+ .......................................... Lesbian, Gay, Bisexual, Transgender, or Queer. 

MI .................................................... Myocardial Infarction. 

MSS ................................................ Minnesota Student Survey. 

MYTS .............................................. Minnesota Youth Tobacco Survey. 

NATS ............................................... National Adult Tobacco Survey. 

NCI .................................................. National Cancer Institute. 

NHANES ......................................... National Health and Nutrition Examination Survey. 

NHIS ................................................ National Health Interview Survey. 

NHIS–LMF ...................................... National Health Interview Survey-Linked Mortality Files. 

NRC ................................................ National Research Council. 

NSDUH ........................................... National Survey on Drug Use and Health. 

NYC ................................................. New York City. 

NYTS ............................................... National Youth Tobacco Survey. 

OMB ................................................ Office of Management and Budget. 

PAH ................................................. Polycyclic aromatic hydrocarbon. 

PATH ............................................... Population Assessment of Tobacco and Health. 


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2For the purposes of this proposed rule, we are 

using the terms ‘‘flavoring’’ in a tobacco product, 

a tobacco product with ‘‘flavors,’’ or a ‘‘flavored 

tobacco product’’ to refer to a tobacco product with 

characterizing flavors, which is the subject of this 

proposed rule. 

3Throughout this document, FDA uses the terms 

‘‘traditional,’’ ‘‘conventional,’’ ‘‘regular,’’ ‘‘large,’’ 

‘‘little,’’ ‘‘filtered,’’ and ‘‘cigarillo’’ when discussing 

different types of cigars. FDA relies on the specific 

term used by researchers when citing a specific 

study. FDA uses the term ‘‘cigar’’ when not citing 

a specific study. 

4Throughout this document, FDA uses both the 

terms ‘‘Black’’ and ‘‘African American.’’ The term 

‘‘African American’’ is used to describe or refer to 

a person of African ancestral origins or who 

identifies as African American. ‘‘Black’’ is used to 

broadly describe or refer to a person who identifies 

with that term. Though 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. 

5Though 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. 17). 6The PATH Study is a collaboration between the 

Center for Tobacco Products, FDA and the National 

Institute on Drug Abuse, National Institutes of 

Health. It was launched in 2011 to inform FDA’s 

regulatory activities under the Tobacco Control Act. 

The PATH Study is an ongoing longitudinal cohort 

study on tobacco use behavior, attitudes and beliefs, 

and tobacco-related health outcomes. More 

information can be found at: https://www.icpsr.

umich.edu/web/NAHDAP/series/606. 

Abbreviation/acronym What it means 

RYO ................................................ Roll-your-own. 

SE ................................................... Substantial equivalence. 

TPSAC ............................................ Tobacco Products Scientific Advisory Committee. 

TUS–CPS ........................................ Tobacco Use Supplement to the Current Population Survey. 

WHO ............................................... World Health Organization. 

YPLL ............................................... Years of potential life lost. 

YRBS .............................................. Youth Risk Behavior Survey. 

III. Background 

A. Need for the Regulation 

FDA is proposing to prohibit 

characterizing flavors 2 (other than 

tobacco) in cigars. Specifically, FDA is 

proposing a product standard that 

would prohibit a cigar or any of its 

components or parts (including the 

tobacco, filter, or wrapper, as 

applicable) from containing, as a 

constituent (including a smoke 

constituent) or additive, an artificial or 

natural flavor (other than tobacco) or an 

herb or spice, including, but not limited 

to, strawberry, grape, orange, clove, 

cinnamon, pineapple, vanilla, coconut, 

licorice, cocoa, chocolate, cherry, coffee, 

mint, or menthol that is a characterizing 

flavor of the tobacco product or tobacco 

smoke. 

Use of cigars 3 overall has increased in 

recent years. Since 2000, sales of cigars 

have doubled from approximately 6.2 

billion cigars in 2000 to more than 14 

billion cigars in 2019 (Refs. 1 and 2). 

Each year, an estimated 9,000 premature 

deaths are attributed to regular cigar 

smoking (defined in the study as 

smoking cigars on 15 or more of the past 

30 days); approximately 5,200 of these 

premature deaths occur in regular cigar 

smokers who do not also smoke 

cigarettes (Ref. 3). It is estimated that 

cigar-attributable annual healthcare 

expenditures amount to $1.8 billion per 

year (Ref. 4). Analysis of 2014–2015 

data from the Tobacco Use Supplement 

to the Current Population Survey (TUS– 

CPS) found that adult flavored-cigar 

smokers had greater odds of daily cigar 

smoking and smoking within 30 

minutes of waking than non-flavored 

cigar smokers, after adjusting for age, 

sex, race/ethnicity, and multiple 

tobacco product use (Ref. 5). 

As discussed in section IV.B of this 

document, youth consumption of cigars 

is substantial, and nicotine dependence 

in cigar smokers could result from even 

a limited exposure to nicotine during 

adolescence (Ref. 6). According to the 

2020 NYTS, an estimated 960,000 

middle and high school students, 

including 5 percent (an estimated 

770,000) of high school students (grades 

9–12) and 1.5 percent (an estimated 

180,000) of middle school students 

(grades 6–8), had smoked a cigar (cigar, 

cigarillo, or little cigar) on at least 1 day 

during the past 30 days (Ref. 7). Overall, 

the prevalence of cigar smoking among 

middle and high school students is 

comparable to the prevalence of 

cigarette smoking, with 4.6 percent (an 

estimated 710,000) of high school 

students and 1.6 percent (an estimated 

190,000) of middle school students 

having smoked cigarettes on at least 1 

day during the past 30 days (Ref. 7). For 

non-Hispanic Black 4 students, cigar 

smoking prevalence (6.5 percent) is 

considerably greater than cigarette 

smoking (2.5 percent) (Ref. 7). Of 

particular concern is the number of 

youth smoking cigars with 

characterizing flavors. According to 

2020 NYTS data analyzing flavored 

cigar use among youth, 58.3 percent of 

youth cigar smokers, or approximately 

550,000 youth, reported using a flavored 

cigar during the past 30 days (Ref. 8). 

Characterizing flavors in cigars and 

other tobacco products reduce the 

harshness, bitterness, and astringency of 

tobacco during inhalation and soothe 

irritation during use (Refs. 9–11). 

Characterizing flavors thus increase the 

youth 5 appeal of those tobacco products 

and promote youth initiation, resulting 

in an increased likelihood that youth 

and young adults experimenting with 

flavored cigars will become addicted 

and progress to regular smoking (see 

sections IV.D and IV.E of this 

document). Recent evidence from an 

analysis of data from Wave 5 of the 

Population Assessment of Tobacco and 

Health (PATH) Study 6 (2018–19) 

demonstrates that over half of youth 

(aged 12–17 years) who used cigars in 

the past 30 days identified flavors as a 

reason for use (Ref. 12). In addition, 

research has shown that characterizing 

flavors in tobacco products can trigger 

reward pathways in the brain that are 

responsible for reward-related learning, 

which may increase the attractiveness of 

flavored products to consumers and the 

probability of repeated use (Refs. 13– 

15). 

FDA’s experience with manufacturers’ 

historical practices as well as the 

prohibition of characterizing flavors, 

other than menthol, in cigarettes 

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

21 U.S.C. 387g(a)(1)(A)) is instructive 

for purposes of evaluating cigars’ 

characterizing flavors and this proposed 

product standard. Reflective of the 

appeal that flavored tobacco products 

have for youth and young adults, 

internal tobacco industry documents 

attest to cigar manufacturers’ historical 

practices of adding characterizing 

flavors to diminish the harshness of 

tobacco products’ taste with specific 

intent to appeal to young consumers 

(Refs. 16 and 17). Tobacco industry 

practices reflect the fact that nontobacco flavors appear to enhance youth 

appeal (Refs. 9–11). Researchers have 

concluded that tobacco companies have 

engaged in a ‘‘calculated effort to blur 

the line between LCCs [little cigars and 


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cigarillos] to increase appeal to cigarette 

smokers, and the use of flavours 

facilitated these efforts’’ (Ref. 16). 

The Family Smoking Prevention and 

Tobacco Control Act (Tobacco Control 

Act; Pub. L. 111–31) prohibited, among 

other things, cigarettes with 

characterizing flavors other than tobacco 

or menthol. In 2009, when the Act was 

passed, national cross-sectional data 

suggested that the use of flavored 

cigarettes was most prevalent among 

younger smokers (Ref. 18), which 

caused concern that the availability of 

flavored cigarettes was contributing to 

youth tobacco use (Ref. 19). Additional 

evidence available at that time showed 

that younger tobacco users and nonusers 

had greater positive expectancies (e.g., 

beliefs that smoking will enhance 

positive affect and control weight) for 

flavored cigarettes compared to nonflavored cigarettes (Ref. 20), a finding 

that was consistent with evidence from 

internal industry documents showing 

that tobacco product manufacturers 

targeted flavored cigarettes toward 

young populations (Refs. 9, 10, and 21). 

Moreover, the Surgeon General has 

concluded that most smokers try, and 

become addicted to, cigarettes before 

adulthood (Ref. 17) and that smoking 

causes severe disease, disability, and 

death (Refs. 22 and 23). 

As with cigarettes, first cigar use often 

occurs during youth or young adulthood 

(Refs. 24 and 25). In a cross-sectional 

analysis of data collected between 2011 

and 2017 as part of a longitudinal study, 

among almost 10,000 young adult 

college students who had ever used 

cigars, the mean age of first cigar use 

was 13.6 years (Ref. 24). A longitudinal 

analysis of Waves 1–4 (2013–2017) of 

PATH Study data found the proportion 

of youth who initiate cigar use increases 

considerably between ages 15 and 20 

years (Ref. 25). Whereas only 1.5 

percent of 15-year-olds in the PATH 

Study (2013–2017) had ever used any 

cigar (i.e., cigarillo, filtered cigar, or 

traditional cigar), by age 20, 31 percent 

had ever used any cigar, with the 

greatest increase in first use between 17 

and 18 years of age (Ref. 25). Similarly, 

an analysis of harmonized data from 

five large national surveys found a 

consistent peak in cigar initiation 

among individuals aged 17–19 years 

(Ref. 26). The consistency of this age of 

initiation across all five studies 

increases the confidence in this finding 

and suggests cigar initiation extends 

into young adulthood (Ref. 26). A 

longitudinal study of Waves 1–3 (2013– 

2016) of PATH Study data found that 

9.0 percent of youth (aged 12–17 years) 

and 12.0 percent of young adults (aged 

18–24 years) started using cigars for the 

first time between Wave 1 (2013–2014) 

and Wave 3 (2015–2016) (Ref. 27). In 

comparison, 3.3 percent of adults over 

25 years old initiated cigar use in the 

same time period (Ref. 27). Study 

findings also indicate racial and ethnic 

disparities in cigar product use. NonHispanic Black youth were 47 percent 

more likely to initiate past 30-day 

cigarillo or filtered cigar use at earlier 

ages compared to non-Hispanic White 

youth (Ref. 25). 

We also know that a majority of youth 

and young adults initiate with a 

flavored cigar compared to older adults 

based on data from Wave 5 (2018–2019) 

of the PATH Study (Ref. 12) and that 

first use of flavored cigars is associated 

with continued use of these products 

(Refs. 28 and 29). In a longitudinal 

analysis of Waves 1–4 (2013–2017) 

PATH Study data, youth whose first 

cigar was either a mint or menthol cigar 

or an ‘‘other’’ flavored cigar (e.g., fruit, 

alcohol, chocolate, candy, and other 

flavor) were more likely to be a past-30- 

day cigar user at a subsequent wave 

(approximately 1 year later) compared 

to those who first used a non-flavored 

cigar. Similarly, young adults (aged 18– 

24 years) who first used a mint or 

menthol cigar or other flavored cigar 

were more likely to be a past-30-day 

cigar user at a subsequent wave 

compared to those first using a nonflavored cigar (Ref. 29). 

Similar to cigarettes with 

characterizing flavors, cigars with 

characterizing flavors expose users to 

the highly addictive chemical nicotine 

and other toxic and carcinogenic 

chemicals found in combusted tobacco 

products. Little cigars, in particular, 

deliver similar (and sometimes higher) 

levels of nicotine, as well as similar 

(and sometimes higher) levels of 

carcinogens, compared to cigarettes 

(Refs. 30 and 31). People who smoke 

cigars regularly are at increased risk for 

many of the same diseases as cigarette 

smokers, including oral, esophageal, 

laryngeal, and lung cancer; 

cardiovascular diseases; and chronic 

obstructive pulmonary disease (COPD) 

(Ref. 32). 

In particular, youth and young adult 

exposure to the nicotine in cigars can 

result in negative health effects. 

Exposure to nicotine can disrupt brain 

development, which continues through 

approximately age 25, and may lead to 

long-term adverse consequences for 

cognitive function into adulthood (Ref. 

33). Nicotine exposure in adolescence 

may have lasting implications and can 

result in decreased attention, increased 

impulsivity, and various lasting mental 

health conditions (Ref. 34). Nicotine is 

highly addictive. Using nicotine in 

adolescence may increase risk for future 

addiction to other drugs (Ref. 33). 

FDA finds that this product standard 

is appropriate for the protection of the 

public health because it would reduce 

the appeal of cigars, particularly to 

youth and young adults, by eliminating 

flavorings that increase appeal, reduce 

the harshness and bitterness of cigars, 

and make them easier to smoke, thereby 

decreasing the likelihood that both 

nonusers would experiment with cigars 

and that current experimenters would 

continue to use cigars, as further 

discussed in sections IV.D and IV.E of 

this document. Furthermore, FDA finds 

that this product standard would 

decrease the likelihood that both 

nonusers and current experimenters 

would be exposed to the toxic and 

carcinogenic chemicals in cigars, 

develop nicotine dependence, and 

progress to regular tobacco use, as 

further discussed in sections IV.E and 

V.B of this document. Additionally, as 

discussed in section VI.B of this 

document, the proposed product 

standard could improve the health of 

current flavored cigar smokers by 

increasing their likelihood of smoking 

cessation or reduction. The population 

health benefits of the proposed product 

standard are discussed in detail in 

section VI of this document. Thus, 

based on the information discussed in 

the following sections of this document, 

FDA finds that the proposed tobacco 

product standard would be appropriate 

for the protection of the public health. 

Reducing the appeal and use of cigars 

by eliminating characterizing flavors 

(other than tobacco) also is expected to 

substantially decrease tobacco-related 

health disparities and to equitably 

promote health 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 

capacity and infrastructure (e.g., 

political systems, educational 

institutions), access to resources (e.g., 

access to health services and programs), 

and environmental secondhand smoke 

exposure (Refs. 35–37). Tobacco-related 

health disparities affect those who have 

systematically experienced greater 

obstacles to health based on group 

membership due in part to the 

inequitable distribution of social, 

political, economic, and environmental 

resources (Refs. 37–39). Health equity is 

the attainment of the highest level of 

health for all people (Ref. 39). It is 

achieved by equally valuing all 


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7As defined by Executive Order (E.O.) 13895, 

‘‘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. 

8Throughout this document, 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. 

9Underserved communities are overrepresented 

in vulnerable populations. 

10Throughout this document, FDA uses the term 

‘‘LGBTQ+’’ broadly when referring to lesbian, gay, 

bisexual, transgender, and queer (and other) 

communities. When we describe findings from the 

published literature, we refer specifically to the 

groups that are studied. For example, some authors 

examine tobacco-related outcomes for members 

who identify as lesbian, gay, bisexual, or 

transgender (LGBT) only; as such, the data are 

limited to those who identify as LGBT, and authors 

interpret the findings for those specific groups. 

11 Information on specific projects supported by 

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

‘‘cigars’’ or ‘‘flavors’’). 

individuals regardless of group 

membership; removing social, 

economic, and institutional obstacles to 

health; and addressing historical and 

contemporary injustices (Refs. 39–41). 

The advancement of health equity is 

integral to the reduction and 

elimination of tobacco-related health 

disparities, which affect those who have 

been denied opportunity and access to 

economic, political, and social 

participation. Members of underserved 

communities 7 experience a 

disproportionate burden of cigar use in 

initiation, prevalence of use, current 

use, and frequency of use (see section 

V.A of this document), leading to 

observed tobacco-related health 

disparities within those communities. 

Such disparities in cigar use contribute 

to higher rates of observed tobaccorelated morbidity and mortality among 

underserved communities and 

vulnerable populations,8 9 such as youth 

and young adults, some racial and 

ethnic populations, those with lower 

household income and educational 

attainment, and individuals who 

identify as lesbian, gay, bisexual, 

transgender, or queer (LGBTQ+),10 as 

further discussed in section V.F of this 

document. This proposed product 

standard is anticipated to promote better 

public health outcomes across 

population groups. 

B. Relevant Regulatory History 

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 flavored tobacco products. 

FDA has issued an advance notice of 

proposed rulemaking (ANPRM) to 

solicit data and information about the 

roles of flavors in tobacco products, 

sponsored research on a variety of cigarand flavors-related topics through 

contracts and interagency agreements 

with Federal partners, including the 

National Institutes of Health (NIH),11

and undertaken its own scientific 

review related to the impact of 

characterizing flavors in cigar products. 

Among other things, FDA has 

considered the comments and 

information received in response to the 

ANPRM and scientific review in 

developing this proposed rule. 

1. ANPRM 

In July 2017, FDA announced a 

comprehensive approach to tobacco and 

nicotine regulation to protect youth and 

reduce tobacco-related disease and 

death (Ref. 42). 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, entitled ‘‘Illicit 

Trade in Tobacco Products after 

Implementation of a Food and Drug 

Administration Product Standard,’’ and 

sought public comment (83 FR 11754, 

March 16, 2018). This paper analyzes 

the potential for illicit trade markets to 

develop in response to a tobacco 

product standard (Ref. 43). 

The Flavors ANPRM requested data 

and information about the role that 

flavors play in tobacco products (83 FR 

12294). Specifically, the Flavors 

ANPRM requested comments, data, 

research results, or other information 

about, among other things, how flavors 

attract youth to initiate tobacco product 

use. While the Flavors ANPRM 

discussed potential product standards 

and a range of product types, it also 

specifically requested public input on 

the role of flavors in cigars. FDA 

received over 525,000 comments on the 

Flavors ANPRM, a large proportion of 

which were form letters related to 61 

different organized campaigns. Five of 

these campaigns, which included a 

combined total of approximately 

329,668 comments, were identified as 

being automatically generated ‘‘bot’’ 

comments. Some of the issues raised in 

the comments to the ANPRM are 

highlighted below. 

Comments generally in support of the 

regulation of flavors in tobacco products 

stated that a product standard 

prohibiting the use of flavors in tobacco 

products would be appropriate for the 

protection of the public health. In 

particular, many comments argued that 

such a tobacco product standard would 

be appropriate for the following reasons: 

(1) To protect youth and young adults 

from becoming tobacco product users; 

(2) to prevent widened appeal of 

tobacco product use; and (3) to 

discourage addiction to tobacco 

products. FDA received many 

comments expressing concern about the 

use of flavors to capture new users, 

particularly children, into lifelong 

nicotine addiction by making tobacco 

products more appealing and/or 

palatable. Citing internal tobacco 

industry documents that have since 

been made public, many commenters, 

including several public health 

advocacy groups, some professional 

associations, and multiple State 

attorneys general, pointed out that the 

industry has a long and well-established 

history of deliberately targeting children 

through the development and/or 

marketing of flavored tobacco products. 

FDA received many comments in 

support of the regulation of flavors in 

cigar products, specifically. These 

comments often noted that flavors are 

frequently added to cigars for the 

express purpose of making harsh 

products more palatable to new users. 

Citing national survey data trends and 

various recent studies, these 

commenters often noted that youth and 

young adults report flavors as a key 

reason for their use of cigars, including 

little cigars and cigarillos (LCCs), and 

that a substantial percentage of youth 

cigar smokers exclusively use flavored 

cigars. 

FDA also received comments from 

individuals and representatives from the 

tobacco industry generally opposing the 

regulation of flavored tobacco products. 

These comments generally stated that 

such regulation was not likely to 

decrease the appeal of such tobacco 

products to youth nor have positive 

effects for society at large. Some 

comments opposed to a tobacco product 


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standard addressing flavors in cigars, 

specifically, stated that FDA had not 

presented the scientific basis for such a 

product standard, noting what they 

characterized as gaps in the scientific 

literature regarding usage patterns and 

consumer perceptions of flavored cigars, 

particularly among youth. Other 

comments from tobacco industry 

representatives conclude that any 

tobacco product standard for flavors in 

cigars should exclude premium cigars. 

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 tobacco product standard. FDA 

also received comments in support of 

regulation suggesting that FDA define 

‘‘characterizing flavor’’ in a way that 

makes the prohibition clear to 

manufacturers and retailers, protects 

public health, and prevents 

manufacturers from evading the intent 

of the product standard. 

FDA has reviewed and closely 

considered the comments to the Flavors 

ANPRM, as well as additional evidence 

and information not available at the 

time of the Flavors ANPRM, in 

developing this proposed rule. 

2. Scientific Review 

As the body of evidence continues to 

grow, FDA recently undertook a review 

of the scientific evidence regarding the 

role characterizing flavors play in 

increasing the appeal and use of tobacco 

products, particularly cigars, among 

youth, young adults, and adults in the 

United States. This review, entitled 

‘‘Scientific Assessment of the Impact of 

Flavors in Cigar Products,’’ summarizes 

findings from the peer-reviewed, 

publicly available scientific literature 

organized around three research 

questions: (1) How does the addition of 

characterizing flavors to tobacco 

products, including cigars, impact 

product appeal and product use; (2) 

how do characterizing flavors impact 

youth and young adult experimentation 

with tobacco products, including cigars, 

and do they make progression to regular 

tobacco use more likely; and (3) what 

impact do local and national policies 

restricting the sale of flavored cigars and 

other flavored tobacco products have on 

cigar sales and use? The ‘‘Scientific 

Assessment of the Impact of Flavors in 

Cigar Products’’ has been peer reviewed 

by independent external experts. Taking 

into consideration comments from this 

peer review (Ref. 44), FDA revised the 

scientific assessment, and the final peerreviewed scientific assessment is 

available in the docket for this proposed 

rule (Ref. 45). This scientific assessment 

informed the development of this 

proposed product standard. 

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. 

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 tobacco (RYO), 

and smokeless tobacco to protect the 

public health and to reduce tobacco use 

by youth. The Tobacco Control Act also 

gave the Agency authority to conduct 

rulemaking to ‘‘deem’’ any other tobacco 

products subject to chapter IX of the 

FD&C Act. In 2016, FDA issued a final 

rule deeming products meeting the 

statutory definition of ‘‘tobacco 

product’’ (including cigars), except 

accessories of the newly deemed 

products, to be subject to chapter IX of 

the FD&C Act, as amended by the 

Tobacco Control Act (81 FR 28974) 

(deeming final rule). 

Among the tobacco product 

authorities provided to FDA is the 

authority to adopt tobacco product 

standards where FDA determines that 

such standard is appropriate for the 

protection of the public health (section 

907(a)(3) of the FD&C Act). To establish 

a tobacco product standard, section 

907(a)(3)(A) and (B) of the FD&C Act 

requires that FDA find that the standard 

is appropriate for the protection of the 

public health, taking into consideration 

scientific evidence concerning: 

• 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 Characterizing 

Flavors in Cigars 

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. 

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

of the FD&C Act, FDA is proposing this 

product standard that would require the 

elimination of characterizing flavors 

(other than tobacco) from cigars, 

because it would reduce the disease, 

disability, and death caused by tobacco 

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) of 

the FD&C Act. In addition, this 

proposed rule would prohibit the 

distribution, sale, and offer for 

distribution or sale of cigars with 

characterizing flavors (other than 

tobacco). Because this sale and 

distribution restriction would assist 

FDA in enforcing the standard and 

would ensure that manufacturers and 

retailers are selling product that 

complies with the standard, 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 VI 

of this document. 

FDA is proposing this product 

standard under the authorities 

discussed previously, along with section 

701 of the FD&C Act, which provides 

FDA with the authority to ‘‘promulgate 

regulations for the efficient enforcement 

of this Act.’’ 

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. 


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12For more information on U.S. localities and the 

implementation of flavored tobacco product 

restrictions, see section IV.F of this document. 

Considerations related to health 

equity helped inform FDA’s decision to 

prioritize this proposed product 

standard. In particular, FDA took into 

account the disproportionate toll 

flavored cigars 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. Characterizing Flavors Impact Cigar 

Use, Particularly Among Youth and 

Young Adults 

A. Recent Market Trends of Flavored 

Cigars in the United States 

Congress passed the Tobacco Control 

Act in 2009 to address the premature 

death, disease, and other serious health 

conditions caused by tobacco use. The 

Tobacco Control Act gave FDA a 

mandate to reduce tobacco product 

dependence and use, particularly among 

youth (see section 3(2) and (9) of the 

Tobacco Control Act). Of particular 

importance for this proposed product 

standard, the Tobacco Control Act 

established a ban on characterizing 

flavors (other than tobacco or menthol) 

in cigarettes (section 907(a)(1)(A) of the 

FD&C Act). The legislative history of the 

Tobacco Control Act reflects that the 

goal of the Act’s cigarette characterizing 

flavor ban was to eliminate one 

emerging group of tobacco products that 

was particularly appealing to youth 

(Ref. 46 at 37–38). Congress determined 

that banning cigarettes with 

characterizing flavors would benefit 

youth because flavored cigarettes were 

typically used by individuals 

experimenting with tobacco products, 

such as youth, and noted that such 

products were not typically used by 

regular adult smokers (Ref. 46 at 37–38). 

In 2009, FDA issued guidance on the 

statutory provision (see General 

Questions and Answers on the Ban of 

Cigarettes that Contain Certain 

Characterizing Flavors (Edition 2), 

available at https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/general-questionsand-answers-ban-cigarettes-containcertain-characterizing-flavors-edition-2), 

noting that ‘‘flavored products make it 

easier for new smokers to start smoking 

by masking the unpleasant flavor of 

tobacco’’ and that ‘‘[r]emoving these 

flavored products from the market is 

important because it removes an avenue 

that young people can use to begin 

regular tobacco use.’’ Research and data 

concerning the impact of Congress’s 

decision to ban flavored cigarettes are 

instructive for purposes of evaluating 

cigars’ characterizing flavors and this 

proposed product standard. 

After the ban on characterizing flavors 

in cigarettes became effective, 

researchers noted that certain products 

previously marketed as cigarettes likely 

were modified or rebranded as ‘‘cigars’’ 

so that they could remain on the market 

in flavored varieties (e.g., Ref. 47). Little 

cigars are often indistinguishable from 

cigarettes given their shape, size, filters, 

and packaging (Refs. 48 and 49). An 

analysis of NYTS data from middle and 

high school students between 1999 and 

2013 found that cigar use rose 34.4 

percent following the ban on 

characterizing flavors in cigarettes (Ref. 

50). The analysis found an overall 

decrease of 17 percent in the prevalence 

of youth cigarette smoking, fewer 

cigarettes smoked per month, and, 

despite the rise in cigar use, an overall 

reduction of 6 percent in the probability 

of using any type of tobacco (Ref. 50). 

A review of publicly available internal 

documents from a clove cigarette 

company found that the company 

started to develop a clove cigar product 

in 2007 in anticipation of the Tobacco 

Control Act and its ban on cigarettes 

with characterizing flavors, including 

clove-flavored cigarettes (Ref. 47). 

According to these documents, the goal 

was to be prepared for a product 

transition to allow for continual 

marketing of a clove-flavored combusted 

tobacco product (Ref. 47). Immediately 

following the prohibition on cigarette 

characterizing flavors, sales of clove 

cigars increased more than 1,400 

percent between 2009 and 2012 (Ref. 

47), strongly suggesting that users of 

clove cigarettes switched to clove cigars 

on the basis of flavor availability. 

A similar trend in modifying or 

rebranding of products has been seen in 

several U.S. jurisdictions 12 where laws 

have been enacted to further restrict the 

sale of flavored tobacco products, 

including cigars. Subsequent to these 

restrictions on the sale of flavored 

tobacco products, researchers have 

noted the emergence of ‘‘concept’’ 

flavored named products that include 

ambiguous names that imply flavor but 

do not explicitly indicate any particular 

flavor on the products labeling or 

packaging (e.g., purple, tropical sunset) 

(Refs. 51 and 52). Sales of concept 

flavors (e.g., sweet, jazz) increased from 

2.2 percent of U.S. flavored cigar sales 

in 2009 to 21.4 percent of U.S. flavored 

cigar sales in 2020, a 33 percent average 

annual percentage change (Ref. 53). 

Flavored cigars continue to maintain 

a substantial share of the cigar market. 

Researchers analyzing Nielsen data 

trends found that cigar dollar and unit 

sales in convenience stores increased by 

23 percent and 50 percent, respectively, 

between 2008 and 2015, and that 

flavored cigar dollar sales—including, 

for example, those with characterizing 

flavors such as chocolate, mint, or 

rum—increased by 46.5 percent (Refs. 

54 and 55). A more recent study also 

found that flavored cigar sales increased 

substantially between 2009 and 2020, 

while non-flavored cigar sales did not 

change (Ref. 53). Another study 

analyzing trends in cigars using Nielsen 

data found that during January 2016 to 

June 2020, monthly cigarillo unit sales, 

which represented 94.2 percent of total 

cigar unit sales during the study period, 

increased from about 131 million to 190 

million (Ref. 56). Additionally, 

proprietary data gathered by 

Euromonitor International in March 

2021 reveals that, in 2020, flavored 

cigars, including flavored cigarillos, 

accounted for approximately 19.1 

percent of all cigar U.S. dollar sales and 

41.9 percent of all cigar unit sales, 

suggesting that the average price of a 

single unit of flavored cigar was lower 

than that of a single unit of tobaccoflavored cigar in 2020. 

Data suggest that due to both 

Congress’s prohibition on cigarettes 

with characterizing flavors and the 

pressure placed on price-sensitive 

smokers (i.e., those smokers whose 

smoking behaviors change based on the 

cost of tobacco products) by increased 

taxation of cigarettes resulting from the 

2009 Children’s Health Insurance 

Program Reauthorization Act (Pub. L. 

111–3), some price-sensitive cigarette 

smokers smoke cigars as a flavored, less 

expensive alternative to cigarettes (Ref. 

57). In addition, the popularity of cigar 

products among young adults may be 

due to their lower price relative to 

cigarettes, lack of minimum pack size 

requirements, and exclusion from the 

advertising restrictions of the Tobacco 

Master Settlement Agreement (Ref. 54). 

Findings from a survey study indicated 

that affordability and flavors were the 

most commonly cited reasons for little 

cigar and cigarillo use among White and 


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13The 2020 NYTS is a survey that was conducted 

after the Federal law went into effect prohibiting 

sales of tobacco products to those under the age of 

21 (Further Consolidated Appropriations Act, 2020, 

Public Law 116–94, section 906(d) of the FD&C 

Act), thus potentially capturing some of the impacts 

of the new law. 

Black young adult ever users and past 

30-day users (Ref. 58). 

Given the current market share of 

flavored cigar products, research 

demonstrating how sales of flavored 

cigars increased in the years following 

the removal of flavored cigarettes, and 

how industry contributed to these shifts 

by marketing clove-flavored cigars 

nationally and introducing concept 

flavors, FDA is proposing to prohibit 

characterizing flavors (other than 

tobacco) in cigars to prevent youth and 

young adults from entering the market 

and progressing from experimentation 

to regular use of these products, and to 

promote cessation among existing users 

of these products. 

B. Over Half a Million Youth, and Even 

More Young Adults, in the United States 

Use Flavored Cigars 

Widespread use of flavored cigars by 

youth supports FDA’s determination 

that this proposed rule would have a 

considerable positive impact on public 

health. Using NYTS 2020 13 data, 

researchers estimated that 

approximately 960,000 U.S. middle and 

high school students had smoked a cigar 

in the prior month (Ref. 7). Overall, the 

prevalence of cigar smoking among 

middle and high school students is 

comparable to cigarette smoking, and for 

non-Hispanic Black students, cigar 

smoking prevalence (6.5 percent) is 

considerably greater than cigarette 

smoking (2.5 percent) (Ref. 7). In 2019, 

not excluding use of other tobacco 

products, more young adults tried a 

cigar for the first time each day than 

tried a cigarette for the first time (3,163 

cigar vs. 2,640 cigarette) (Ref. 59 at 

Table A.3A). As discussed throughout 

this proposed rule, evidence is well 

documented of broad youth and young 

adult use of cigars and the reasons cited 

for their use. In addition, local policy 

evaluation studies of restrictions on the 

sale of flavored tobacco products, 

including cigars, found a decrease in 

overall tobacco use by youth (Refs. 51 

and 60–62), further supporting the 

conclusion that prohibiting the use of 

characterizing flavors (other than 

tobacco) in cigars is likely to result in 

less cigar use and less tobacco product 

use overall, especially among youth and 

young adults. 

Studies indicate that a substantial 

percentage of youth cigar users smoke 

flavored cigars. Data from Wave 5 

(2018–2019) of the PATH Study indicate 

that among youth (aged 12–17 years) 

44.0 percent of past 30-day cigar 

smokers reported using flavored cigars 

(i.e., 33.9 percent of youth traditional 

cigar smokers, 46 percent of youth 

cigarillo users, and 50.2 percent of 

youth filtered cigar users reported past 

30-day use of a flavored cigar) (Ref. 63). 

Data from the 2020 NYTS indicate that 

58.3 percent of middle and high school 

students who smoke cigars (or 

approximately 550,000 youth), reported 

using a flavored cigar during the past 30 

days (Ref. 8). The majority of youth 

cigar smokers identify the availability of 

cigar flavors as a leading reason for their 

cigar use (Refs. 64 and 65). 

The data indicate a similar preference 

for flavors among young adults. 

According to Wave 5 (2018–2019) data 

from the PATH Study, approximately 

630,000 young adults aged 18 to 24 

years reported past month flavored cigar 

smoking (Ref. 63). An analysis of Wave 

5 (2018–2019) PATH Study data 

indicated that among young adults (aged 

18–24 years) who used cigars some or 

every day, 54.1 percent of traditional 

cigar users, 66.5 percent of cigarillo 

users, and 65.1 percent of filtered cigar 

users reported flavoring as a reason for 

cigar use (Ref. 12). Among young adult 

past 30-day cigar smokers 18–24 years 

old, 38.3 percent reported that the cigar 

product they smoked in the past 30 days 

was flavored (i.e., 17.7 percent of young 

adult traditional cigar smokers, 46 

percent of young adult cigarillo users, 

and 41 percent of young adult filtered 

cigar users reported past 30 day use of 

a flavored cigar) (Ref. 63). Since the 

brain continues development into an 

individual’s mid-twenties, cigar use in 

both youth and young adulthood can 

harm the developing brain (Ref. 33). As 

discussed in section V.C of this 

document, nicotine can disrupt brain 

development and have long term 

consequences. 

Studies illustrate some disparities in 

young adult flavored cigar use across 

population groups. Among a sample of 

college students aged 18–29 who used 

cigars in the past 30 days (n=523), 

Black, Asian, and Hispanic young adults 

were all significantly more likely to 

have used flavored cigars than White 

young adults (Ref. 66). Participants aged 

18–24 years also had greater odds of 

using flavored cigars compared to 

participants aged 25–29 years (Ref. 66). 

Lastly, young adults who identified as 

lesbian, gay, or bisexual had higher 

odds of reporting past 30-day flavored 

large cigar and LCC use compared to 

respondents who identified as straight/ 

heterosexual (Ref. 67). 

The data also show that a substantial 

percentage of youth and young adult 

cigar users initiate with flavored cigars. 

Data from Wave 5 (2018–2019) of the 

PATH Study revealed that 60.4 percent 

of the youth participants (aged 12–17 

years) and 63.2 percent of young adults 

(aged 18–24 years) who reported ever 

using cigars said that the first cigar they 

used was flavored, statistically 

significantly higher than the 41.9 

percent of adults (aged 25 years and 

older) who have ever used cigars (Ref. 

12). 

C. Adult Use of Flavored Cigars in the 

United States 

While the evidence is clear that youth 

and young adults use flavored cigars, it 

is important to note that older adults 

also use them. According to Wave 5 data 

(2018–2019) from the PATH Study, 36.0 

percent of adult cigar smokers (adults 

aged 25 years and older who used cigars 

in the past 30 days), or over 3 million 

adults, reported use of a flavored cigar 

in one or more of the past 30 days (Ref. 

63). When considering the type of cigar, 

reported use of a flavored cigar in the 

past 30 days occurred less frequently for 

adult traditional cigar smokers (19.7 

percent) compared with adult smokers 

of all other cigar types (46.5 percent for 

cigarillos and 48.7 percent for filtered 

cigars) (Refs. 63). 

Many adult cigar consumers also 

identify the availability of 

characterizing flavors as a reason for 

their cigar use. Among adults over 25 

years old who used cigars every or some 

days, 54.8 percent of traditional cigar 

users, 69.6 percent of cigarillo users, 

and 71.4 percent of filtered cigar users 

reported flavoring as a reason for cigar 

use (Ref. 12). Among adults, studies 

suggest males are more likely than 

females to use cigars, with some 

differences across cigar types (Refs. 63, 

66, 68, and 69). However, among cigar 

users, females are more likely to use 

flavored cigars. For example, a study of 

college students aged 18–29 years who 

had used cigars in the past 30 days 

found that 60.5 percent of cigar users 

were male, but, among cigar users, 

males were statistically significantly 

less likely to have used flavored cigars 

than females (Ref. 66). Likewise, in 

every wave of the PATH Study, adult 

males were more likely to use any cigar 

in the past 30 days, but among past-30- 

day cigar users, females were 

statistically significantly more likely to 

have used flavored cigar products (Ref. 

63). 

Furthermore, there are differences in 

adult use of flavored cigars across 

population groups. Among adults who 

were past-30-day users of any cigar type, 


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non-Hispanic Black adults were 

statistically significantly more likely to 

have used a flavored cigar in the past 30 

days compared to non-Hispanic White 

adults at every survey wave of the 

PATH Study (2013–2019) (Ref. 63). 

Likewise, at every wave of the PATH 

Study, among adults aged 25 years and 

older who had smoked cigars in the past 

30 days, individuals with a college 

degree were statistically significantly 

less likely to use a flavored cigar (20.0 

percent) than individuals categorized as 

having less than a high school diploma 

(44.9 percent), a high school diploma 

(37.4 percent), or some college (42.9 

percent) (Ref. 63). Using 2009–2010 

National Adult Tobacco Survey (NATS) 

data, adults who identified as lesbian, 

gay, bisexual, or transgender were also 

more likely to use flavored cigars (8.2 

percent) compared to the national 

prevalence (2.8 percent) (Ref. 70). 

This proposed rule, if finalized, could 

lead adult flavored cigar smokers to 

cease tobacco use, reduce tobacco use, 

or encourage them to switch to other, 

potentially less harmful tobacco 

products. 

D. Characterizing Flavors Increase 

Appeal and Make Tobacco Products, 

Including Cigars, Easier To Use 

Characterizing flavors increase the 

appeal of cigars and make them easier 

to use. Characterizing flavors are added 

to tobacco products, including cigars, 

for numerous reasons that relate to 

product appeal, such as to ensure 

pleasant flavor and taste; to reduce the 

harshness, bitterness, and astringency of 

tobacco during inhalation; and to soothe 

irritation during product use (Refs. 9– 

11). As documented by the Surgeon 

General, tobacco product manufacturers 

have historically added characterizing 

flavors to products with lower levels of 

free-nicotine content (i.e., those 

products that have lower amounts of 

nicotine easily absorbed by the user) 

intended for use as ‘‘starter products’’ 

for new tobacco users (Ref. 17). 

In particular, the addition of menthol 

as a characterizing flavor in combusted 

tobacco products, including cigars, can 

soothe irritation and increase appeal. 

Menthol is a flavor compound that 

when added to combusted tobacco 

products produces a minty taste and 

cooling sensation when inhaled (Ref. 

71). Smokers report that mentholated 

products have a better taste, are 

smoother and more refreshing (Refs. 72– 

74). Menthol’s flavor and sensory effects 

reduce the harshness of smoking among 

new users and facilitates product use, 

particularly among youth and young 

adults (Refs. 29 and 74–76). 

While much of the evidence on the 

role of flavors in increasing appeal 

focuses on cigarettes and tobacco 

products overall, internal industry 

documents also specifically discuss the 

role of flavors in cigars (Ref. 16). 

Internal tobacco industry documents 

illustrate cigar manufacturers’ historical 

practices of adding characterizing 

flavors to diminish the harshness of 

tobacco products’ taste with specific 

intent to appeal to young consumers 

(Refs. 16 and 17). A review of the Truth 

Tobacco Industry Documents, an 

archive of tobacco industry documents, 

showed that some flavors in cigars (e.g., 

vanilla bean, peach, apricot, licorice, 

cocoa) may mask the bitterness of 

tobacco leaves, throat burn, and heavy 

taste, thereby facilitating inhalation, 

making smoking more tolerable for 

current users, and increasing 

palatability for new users. These 

documents illustrate that the effect of 

characterizing flavors in the appeal of 

other tobacco products is applicable to 

the effect of characterizing flavors in the 

appeal of cigar products. These 

documents also illustrate that the 

tobacco industry added flavors and 

changed some design characteristics of 

little cigars and cigarillos to facilitate 

inhalation and make smoking more 

tolerable for current smokers, as well as 

more palatable for new users, including 

youth (Refs. 16 and 77–79). 

Flavors play an important role in 

attracting youth to tobacco products, 

including cigars (Refs. 55, 80, and 81). 

In survey and qualitative research, 

youth report that flavors in cigars are a 

leading reason for use. In 2018–2019 

PATH Study data, 50.4 percent of youth 

participants (aged 12–17 years) who 

reported past 30-day cigar smoking 

identified flavors as a reason for use 

(Ref. 12). Results from qualitative 

research indicate that youth themselves 

acknowledge that flavorings impact 

their cigar use (Ref. 82). Similarly, some 

young adult participants mentioned that 

the flavors of little flavored cigars and 

cigarillos were particularly appealing, 

with one stating: ‘‘They taste basically 

like a strawberry. And I like the 

Tropical Fusion cause it’s like a 

coconut.’’ In a qualitative study 

involving focus groups of youth and 

young adults who used cigars (Ref. 83), 

the most appealing component of cigar 

packaging were aspects that indicated 

the flavor (e.g., a flavor name or image), 

which was identified by nearly half of 

all participants, and participants 

indicated that the words describing the 

flavor (e.g., ‘‘sweet’’) were a reason to 

buy the product. In a qualitative study 

of adolescents (aged 15–18 years) (Ref. 

84), both users of tobacco products 

(including users of cigars/cigarillos) and 

nonusers indicated flavors make tobacco 

products appealing and are a reason to 

use tobacco products. Participants 

indicated that both the taste and smell 

of flavored products were appealing 

(specifically mentioning minty, sweet, 

and fruit flavors) and noted that the 

smell of flavors could obscure the smell 

of tobacco. 

Both younger and older adults 

similarly report flavors as a leading 

reason for cigar use. Among young 

adults (aged 18–24 years) in the PATH 

Study (2018–2019) who used cigars 

regularly and currently used cigars 

every or someday, 54.1 percent of 

current traditional cigar users, 66.5 

percent of current cigarillo users, and 

65.1 percent of current filtered cigar 

users reported flavoring as a reason for 

cigar use (Ref. 12). Likewise, adults aged 

25 years and older report flavors as a 

leading reason for cigar use. Among 

adults aged 25 years and older in the 

PATH Study, 54.8 percent of current 

traditional cigar smokers, 69.6 percent 

of current cigarillo smokers, and 71.4 

percent of current filtered cigar smokers 

reported flavoring as a reason for cigar 

use. There was not a statistically 

significant difference by age group in 

reporting flavors as a reason for use (Ref. 

12). 

Characterizing flavors increase 

susceptibility to use (a measure of how 

much individuals report being open or 

willing to use a tobacco product) in 

nonsmoking young adults, as 

documented in a 2020 study that tested 

cigarillo pack images containing the 

most popular characterizing flavors. 

Susceptibility to cigarillo use was 

statistically significantly greater among 

participants exposed to the packs with 

characterizing flavors (Ref. 85). Results 

from focus groups and semistructured 

interviews with 90 young adult past 30- 

day LCC-only, cigarette-only, and dual 

cigarette and LCC smokers provide 

insight about the appeal of 

characterizing flavors in certain cigars to 

youth and young adults (Ref. 82). 

Among study participants, the average 

age of initiation of LCC was 16.1 years, 

and nearly two-thirds of the participants 

reported first using an LCC that was 

flavored (Ref. 82). Participants 

frequently reported that smoking 

flavored LCCs relieved stress and that 

flavored LCC use sometimes depended 

on mood and was associated with 

boosted mood and gratification (Ref. 82). 

Participants frequently mentioned that 

flavored tobacco made smoking LCCs 

more palatable than smoking unflavored 

(or regular flavor) cigars (Ref. 82). For 

many participants, seeing or hearing the 


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phrase ‘‘little cigars or cigarillos’’ 

evoked thoughts about their favorite 

flavors (Ref. 82). In addition, for many 

participants, peers played an important 

role in continued experimentation 

because friends would often suggest 

flavors to one another (Ref. 82). 

Moreover, many participants stated that 

the appeal of the variety of available 

flavored LCCs on the market influenced 

their decision to try LCCs (Ref. 82). 

These studies indicate that flavors are 

an important factor in initiation and use 

of cigars among young adults. 

Four systematic reviews of the 

scientific literature concluded that 

flavored tobacco products attract youth 

to the tobacco product (Refs. 86–89). 

Two of the systematic reviews included 

cigars and assessed studies on use and 

attitudes related to non-menthol 

flavored tobacco products (Refs. 88 and 

89). The two reviews concluded that 

characterizing flavors were an appealing 

feature of tobacco products and that 

flavors influence perceptions, initiation, 

and progression to use of tobacco 

products, particularly among youth 

(Refs. 88 and 89). 

The appeal of flavors in tobacco 

products, including cigars, is not only 

consistent across the literature on 

tobacco products, but is also consistent 

with the food literature. Physiologically, 

scientists have described how youth 

have a heightened preference for sweet 

food tastes and greater rejection of bitter 

food tastes; these preferences diminish 

with age (Refs. 90–93). 

An FDA-funded scientific review of 

474 articles published between 1931 

and 2015 conducted to understand how 

youth and adults differ with respect to 

their preferences for characterizing 

flavors, primarily in food, concluded 

that preference for sweetness and 

saltiness is generally higher for children 

than it is for adults; and the level of 

sugar selected as most preferred in 

clinical experiments decreased between 

adolescence and adulthood (Ref. 94). 

The researchers hypothesized that the 

higher caloric needs of youth to sustain 

growth likely account for the more 

pronounced preference for sweetness in 

youth (Ref. 94). 

Laboratory research has confirmed 

that the chemical-specific flavor sensory 

cues associated with fruit flavors in 

tobacco products are often the same as 

those found in popular candies (Refs. 95 

and 96). While inhaling flavored 

chemicals is in many ways very 

different than ingesting flavored foods, 

researchers reviewed the levels of flavor 

chemicals in several brands of candy 

and Kool-Aid drink mix and concluded 

that the chemical amounts and 

combinations largely overlapped with 

similarly labeled ‘‘cherry,’’ ‘‘grape,’’ 

‘‘apple,’’ ‘‘peach,’’ and ‘‘berry’’ cigar and 

other tobacco products (Refs. 95 and 

96). 

Overall, FDA finds that evidence 

regarding the role of flavors in 

increasing appeal of cigars to youth and 

young adults, promoting progression to 

regular use, and increasing the 

addiction potential indicates that 

removing flavors from cigars would 

reduce initiation and use of such 

products, especially among youth and 

young adults. As a majority of adult 

regular tobacco users become dependent 

on or addicted to nicotine as youth and 

young adults, reducing initiation and 

use of cigar products in youth would 

reduce the likelihood that youth 

progress to nicotine dependence and 

regular use, as well as subsequent 

tobacco-related illness and death. 

Therefore, FDA anticipates that 

removing flavors from cigars would 

substantially reduce tobacco-related 

disease and death as a result of averted 

youth initiation. 

E. Characterizing Flavors Increase 

Youth and Young Adult 

Experimentation With Tobacco 

Products, Including Cigars, and Make 

Progression to Regular Tobacco Use 

More Likely 

Cigars are more commonly used 

among youth and young adults relative 

to other combusted tobacco products, 

including cigarettes. An analysis of 

PATH Study data found that new cigar 

use (i.e., initiation since a prior wave of 

data collection) at Waves 2, 3, or 4 

(2014–2017) was more common (14.5 

percent youth, 19.7 percent young 

adults, 6.3 percent adults aged 25 and 

older) relative to new cigarette use (i.e., 

initiation since a prior wave) (14.0 

percent youth, 7.1 percent young adults, 

1.1 percent adults aged 25 and older) 

(Ref. 29). Data from the 2019 National 

Survey on Drug Use and Health 

(NSDUH) found that each day 1,210 

youth 12–17 years and 3,163 young 

adults aged 18 to 25 years tried a cigar 

for the first time (Ref. 59 at Table A.3A). 

In 2019, prevalence of past 30-day cigar 

use surpassed that of past 30-day 

cigarette use among U.S. high school 

students for the first time (Ref. 97). 

Flavors make tobacco products, 

including cigars, easier to use and 

reinforce tobacco use among youth and 

young adults. FDA finds that 

eliminating characterizing flavors (other 

than tobacco) in cigars would decrease 

the number of first-time users of cigars 

who progress to regular use. 

The process of becoming a regular 

cigar smoker includes stages of 

experimentation, development of 

nicotine dependence, and progression to 

regular use (Refs. 98 and 99). FDA finds 

that eliminating flavored cigar varieties 

would decrease the number of youth 

experimenting and the likelihood that 

youth will progress to regular, sustained 

use of tobacco products, and, thus, 

would reduce the risk of tobacco-related 

death and disease. 

Experimentation with cigars can lead 

to nicotine dependence and regular use 

in less than one year. Longitudinal data 

from the nationally representative Truth 

Longitudinal Cohort (2014–2019) were 

used to examine the progression from 

cigar initiation to regular use among 

youth and young adults aged 15 to 25 

years (Ref. 100). Nearly half (44.7 

percent) of participants who initiated 

cigar use reported current (i.e., past-30- 

day) cigar use 6 months after initiation 

(Ref. 100). Compared to participants 

who did not become past-30-day users 

6 months after initiation, those who 

were past-30-day users engaged in a 

higher frequency of cigar use during the 

initial 6-month period, were younger, 

non-Hispanic African American, and 

were more likely to use other tobacco 

products. For example, non-Hispanic 

African American participants (relative 

to non-Hispanic White participants) had 

over twice the odds of past-30-day cigar 

use and had a higher average frequency 

of use (2.21 days/month vs. 1.34 days/ 

month, respectively) 6 months after 

initiation of cigar use (Ref. 100). 

Experimentation with flavored cigar 

use is associated with subsequent use. 

Another study used longitudinal data 

from Waves 1 (2013–2014) and 2 (2014– 

2015) of the PATH Study to assess 

whether there is a prospective 

association between first flavored use of 

a tobacco product and subsequent use of 

that specific product (Ref. 28). This 

analysis found that first use of any 

flavored cigar or first use of flavored 

cigarillos and filtered cigars (including 

menthol) at Wave 1 (2013–2014) of the 

nationally representative PATH Study 

was subsequently associated with daily 

or nondaily use of these products in 

young adults (aged 18–24 years) and 

adults (aged 25 years and older) 1 year 

later (2014–2015) compared with first 

non-flavored use (Ref. 28). 

Studies have shown that menthol’s 

flavor and sensory effects reduce the 

harshness of smoking among new users 

and facilitate experimentation and 

progression to regular smoking of 

menthol products, particularly among 

youth and young adults (Refs. 29 and 

74–76). A subsequent analysis using 

Waves 1–4 (2013–2017) of PATH Study 

data assessed the relationship between 

new use of a menthol/mint-flavored or 

other flavored (e.g., fruit, alcohol, 


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chocolate, candy, and other flavor) cigar 

at Wave 2 or 3 with cigar use at a 

subsequent wave (Wave 3 or 4) 

compared to first use of a non-flavored 

cigar (Ref. 29). The analysis found that 

among youth (aged 12–17 years) and 

young adults (aged 18–24 years), first 

use of any menthol/mint-flavored or 

other flavored cigar (e.g., fruit, alcohol, 

chocolate, candy, and other flavor) was 

associated with greater odds of past 30- 

day use of these products at the 

subsequent wave compared with first 

use of a non-flavored (i.e., tobacco) 

cigar, even after controlling for 

sociodemographic variables (Ref. 29). 

Youth who first used a menthol/mintflavored cigar or other flavored cigar 

were 72 percent (menthol/mint) and 47 

percent (other flavor) more likely to be 

past-30-day cigar users at a subsequent 

wave (1 or more years later) compared 

to those first using a non-flavored cigar. 

Similarly, young adults (aged 18–24 

years) who first used a menthol/mintflavored cigar or other flavored cigar 

were 71 percent and 52 percent more 

likely to be past-30-day cigar users at a 

subsequent wave compared to those first 

using a non-flavored cigar (Ref. 29). For 

both youth and young adults, the 

association between the first flavor used 

and subsequent cigar use was not 

statistically significantly different for 

menthol/mint-flavored compared to 

other flavored cigars. Among adults (25 

years and older), first use of an ‘‘other’’ 

flavored cigar (e.g., fruit, alcohol, 

chocolate, candy, and other flavor) was 

also associated with higher likelihood of 

subsequent past 30-day cigar use (Ref. 

29). Overall, this study extends findings 

from the Wave 1 (2013–2014) to Wave 

2 (2014–2015) PATH Study analysis 

(Ref. 28) finding that among youth and 

young adults newly using cigars, first 

use of any menthol/mint-flavored cigar 

or other flavored cigar is associated with 

greater continued use of these products 

at the subsequent wave compared with 

first use of non-flavored cigars (Ref. 29). 

Several studies examining nicotine 

dependence found that smoking cigars 

fosters addiction by reducing cravings 

and the urge to smoke to a similar 

magnitude as cigarettes (Refs. 101–103). 

Cigars, like cigarettes, have also been 

shown to decrease acute nicotine 

withdrawal symptoms (e.g., craving, 

anxiousness) (Ref. 104). Available 

scientific data on nicotine’s 

addictiveness demonstrate that the 

adolescent brain is more vulnerable to 

developing nicotine dependence than 

the adult brain (Ref. 17). Exposure to 

substances such as nicotine can disrupt 

brain development and may lead to 

long-term consequences for cognitive 

function (Refs. 105 and 106). Exposure 

to nicotine from cigarette smoking in 

adolescence is associated with changes 

in the brain that could increase the 

likelihood for addiction and 

dependence as adults (Ref. 34). 

Furthermore, nicotine exposure in 

adolescence may have lasting effects; it 

has been associated with decreased 

attention, increased impulsivity, and 

various lasting mental health conditions 

in adult smokers (Ref. 34). While 

research is not yet able to fully 

disentangle whether the association of 

nicotine with changes in attention and 

impulsivity are primarily a result of 

nicotine exposure or partially due to 

pre-existing vulnerability to changes in 

attention and impulsivity (Ref. 34), 

considerable research shows that 

exposure to nicotine in adolescence 

causes long-term changes in the brain, 

with implications for nicotine 

dependence, attention, and impulsivity, 

as well as other areas of cognitive 

function and substance use (Refs. 17 

and 34). Researchers analyzing data 

from the 2017–2018 NYTS found that 

43.1 percent of middle and high school 

students using cigars in the past 30 days 

reported nicotine dependence, 

including feeling a strong craving to use 

a tobacco product or using a tobacco 

product within 30 minutes of waking 

(Ref. 107). An analysis of Waves 1–4 

(2013–2017) PATH data did not find a 

longitudinal association between first 

use of a menthol- or mint-flavored cigar 

and nicotine dependence scores (Ref. 

29). Similarly, a cross-sectional analysis 

of 2017–2018 NYTS data found that 

exclusive use of cigars was associated 

with lower odds of reporting 

dependence compared to exclusive use 

of another product (Ref. 107). However, 

frequent cigar use (use on 20 or more 

days in the past 30 days) as well as 

current cigar use including both 

exclusive and polyuse of cigars was 

associated with increased odds of youth 

reporting nicotine dependence (Ref. 

107). In this analysis, use of cigars in 

combination with other tobacco 

products was common: 76.1 percent of 

youth past 30-day cigar users used 

cigars in combination with one or two 

additional tobacco products (Ref. 107). 

Given the role of frequent use and 

polyuse in the relationship between 

cigar use among youth and dependence, 

the authors noted ‘‘the importance of 

examining behaviors related to use, as 

they can affect and/or exacerbate the 

risk of nicotine dependence’’ (Ref. 107). 

Given that nicotine is highly addictive 

and present in all cigars, as youth 

experimenters continue to use these 

products, there is a risk of nicotine 

dependence and progression to regular 

use, resulting in an increased risk of 

developing the many negative health 

consequences associated with regular 

cigar use. Based on the totality of the 

evidence, prohibiting characterizing 

flavors (other than tobacco) in cigars 

would reduce the appeal and ease of use 

of such products and is an important 

step toward reducing the likelihood of 

nicotine dependence, experimentation, 

and progression to regular use. 

F. Real-World Experiences Demonstrate 

That Restricting Characterizing Flavors 

in Tobacco Products, Including Cigars, 

Decreases Tobacco Use 

As previously discussed in section 

IV.A of this document, Congress passed 

the Tobacco Control Act in 2009 to 

address the premature death, disease, 

and other serious health conditions 

caused by tobacco use. To address the 

appeal and use of flavored combusted 

tobacco products among the Nation’s 

youth, in 2009, the Tobacco Control Act 

prohibited cigarettes with characterizing 

flavors other than tobacco or menthol. 

Researchers analyzed repeated crosssectional data from the NYTS and 

concluded that the ban was associated 

with a 17 percent reduction in the 

probability of being a cigarette smoker 

and a 6 percent reduction in the 

probability of any tobacco use (i.e., 

cigarette, cigars, smokeless tobacco, or 

pipe tobacco) in the past 30 days among 

U.S. middle and high school students 

(Ref. 50). While cigarette smoking 

decreased among the Nation’s youth 

following implementation of the 

Tobacco Control Act, researchers noted 

that youth use of cigars and pipe 

tobacco, which remained available in 

flavored varieties, rose after 

implementation of the ban on 

characterizing flavors in cigarettes (Ref. 

50). 

While the prior analysis (Ref. 50) was 

limited in its ability to attribute changes 

in tobacco use, particularly flavored use, 

directly to the Federal restriction (as the 

NYTS was not designed to evaluate 

such a policy), recent evaluation studies 

implementing pre-post study designs 

with geographic comparisons provide 

real-world examples of how tobacco 

product use changes as a result of a 

sales restriction on characterizing 

flavors in tobacco products, including 

cigars. Such recent evaluations of 

restrictions on the sale of tobacco 

products with characterizing flavors in 

U.S. localities include studies of New 

York, NY (NYC); Providence, RI; Lowell, 

MA; Attleboro and Salem, MA; San 

Francisco, CA; Minneapolis and St. 

Paul, MN (Twin Cities); as well as 

Canada (See table 1, below, 


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summarizing the evaluation studies). 

Taken in totality, the real-world 

experience of state and local 

jurisdictions implementing sales 

restrictions on flavored tobacco 

products provide insight into the likely 

responses of youth and young adults as 

well as current cigar smokers to a 

proposed product standard restricting 

characterizing flavors (other than 

tobacco) in cigar products, including 

decreases in youth cigar use and cigar 

consumption among current cigar 

smokers. 

TABLE 1—SUMMARY OF EVALUATION STUDIES ON SALES RESTRICTIONS INCLUDING FLAVORED CIGARS

Jurisdiction Policy 1

Effective or 

enforcement 

year 

Retailer 

exemptions 

Study design 

& reference Sample size Key outcome measures 2

and findings 

NYC, NY .................. Restriction includes all flavored products except 

menthol-, mint-, and wintergreen-flavored products. In 2020, restriction 

was expanded to include 

flavored Electronic Nicotine Delivery Systems 

(ENDS) products, including menthol-, mint-, and 

wintergreen-flavored 

ENDS products.

2010 .................. Tobacco bars with 

≥10% gross income from tobacco sales.

Pre/Post Design 

(Ref. 51).

Youth Tobacco 

Use: n=1708 

(2010); n=8814 

(2013).

Sales: Flavored cigars dollar sales declined. Cigar 

dollar sales of non-flavored cigars increased. 

Youth (aged 13–17 years) 

Tobacco Use: Youth had 

lower odds of ever trying 

a flavored tobacco product and of ever using tobacco products. 

Pre/Post Design 

with Comparison 

(Ref. 108).

N/A ....................... Sales: Overall cigar unit 

sales declined. Flavored 

cigar unit sales declined. 

Flavored cigar unit sales 

increased in comparison 

counties. 

Providence, RI ......... Restriction includes all flavored products except 

menthol, mint, and wintergreen flavors.

2013 .................. All smoking bars .. Pre/Post Design 

with Comparison 

(Ref. 109).

N/A ....................... Sales: Decrease in flavored 

cigar unit sales. Decreases in overall cigar 

unit sales. Flavored cigar 

unit sales increased in 

the rest of the State. 

Post-only Design 

(Ref. 60).

n=2,150 (2012); 

n=2,062 (2016); 

n=2,223 (2018).

Youth (10th and 12th grade 

students) Tobacco Use: 

Youth current use of any 

tobacco product declined. 

Youth (10th and 12th grade 

students) Cigar Use: 

Youth current use of cigars/cigarillos declined. 

Lowell, MA ............... Restriction includes all flavored products (except 

menthol, mint, or wintergreen).

2016 .................. Adult-only (21+ 

years old) retail 

tobacco stores 

with ≥90% of 

sales from tobacco products.

Post-only Design 

with Comparison 

(Ref. 61).

Lowell: Baseline 

n=593; follow-up 

n=524.

Malden (comparison community): 

baseline n=636; 

follow up n=646.

Youth (9th–12th grade students) Flavored Tobacco 

Use: Youth current use of 

any flavored tobacco 

products decreased in 

Lowell and increased in 

the comparison community, a statistically significant difference. 

Youth (9th–12th grade students) Non-Flavored Tobacco Use: Youth current 

use of any non-flavored 

tobacco products also decreased in Lowell and increased in the comparison community, a statistically significant difference. 

Attleboro & Salem, 

MA.

Restriction includes all flavored products (except 

menthol, mint, or wintergreen).

2016 (Attleboro); 

2017 (Salem).

Adult-only (21+ 

years old) retail 

tobacco stores 

with ≥90% of 

sales from tobacco products.

All smoking bars ..

Pre/Post Design 

with Comparison 

(Ref. 110).

Attleboro: Baseline 

n=1413; follow 

up n=1565.

Salem: Baseline 

n=480; follow up 

n=620.

Gloucester (comparison municipality): Baseline 

n=539; follow up 

n=629.

Youth (9th–12th grade students) Flavored Tobacco 

Use: Statistically significantly smaller increases 

in current use of Flavored 

in Attleboro and Salem 

than in the comparison 

municipality. 

Youth (9th–12th grade students) Non-Flavored Tobacco Use: Significantly 

smaller increases in current use of non-flavored 

or menthol tobacco in Attleboro and Salem than in 

the comparison municipality. 


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TABLE 1—SUMMARY OF EVALUATION STUDIES ON SALES RESTRICTIONS INCLUDING FLAVORED CIGARS—Continued 

Jurisdiction Policy 1

Effective or 

enforcement 

year 

Retailer 

exemptions 

Study design 

& reference Sample size Key outcome measures 2

and findings 

Twin Cities, MN ....... Restriction includes all flavored products (except 

menthol, mint, or wintergreen).

2016 .................. Minneapolis: 

Adult-only (18 

years and older) 

licensed tobacco 

product shops 

with ≥90% revenue from sale 

of tobacco.

St. Paul: Adultonly (18 years 

and older) retail 

stores with 

≥90% revenue 

from sale of tobacco.

Pre/Post Design 

with Comparison 

(Ref. 111).

Minnesota Youth 

Tobacco Survey: More than 

4,000 students 

participated in 

the 2017 survey 

statewide.

Youth (6th–12th grade students) Cigar Use: Before 

and after the 2016 restriction on flavored tobacco 

products (except menthol, 

mint, and wintergreen), 

cigar use did not change 

in the Twin Cities but increased in the rest of the 

State. 

Restriction expanded to include menthol, mint, and 

wintergreen in 2018.

2018 .................. Minneapolis: Sales 

of mint-, menthol-, and wintergreen-flavored tobacco 

products at adult 

only (21 years 

and older) liquor 

stores.

St. Paul: Sales of 

mint-, menthol-, 

and wintergreen-flavored 

tobacco products at liquor 

stores that also 

hold a license 

for tobacco 

sales.

Pre/Post Design 

with Comparison 

(Ref. 111).

Minnesota Student 

Survey (8th, 9th, 

11th grade students): More 

than 170,000 

participating students in 2019.

Youth (8th, 9th, 11th grade 

students) Cigar Use: Before and after the 2018 

restriction on flavored tobacco products, including 

menthol, mint, and wintergreen, cigar use declined 

more in the Twin Cities 

compared to the rest of 

the State. 

San Francisco, CA .. Restriction includes all flavored products (including 

menthol).

2019 .................. None .................... Post-only Design 

(Ref. 62).

n=247 ................... Young Adult (aged 18–24 

years) Cigar Use: Statistically significant decrease in flavored cigar 

use. Decrease in overall 

cigar use, but the decline 

was not statistically significant. 

Young Adult (aged 25–34 

years) Cigar Use: Decreases in overall cigar 

use and flavored cigar 

use, but the declines 

were not statistically significant. 

Pre/Post Design 

with Comparison 

(Ref. 52).

N/A ....................... Sales: Statistically significant decreases in overall 

tobacco and flavored tobacco unit sales. Statistically significant decreases in overall cigar 

and flavored cigar unit 

sales. The comparison 

cities had more modest 

decreases or no statistically significant change. 

Canada .................... Restriction includes flavored 

little cigars/cigarillos (except menthol); unflavored 

cigarillos minimum packs 

of 20.

2010 .................. None .................... Pre/Post Design 

(Ref. 112).

N/A ....................... Sales: Decreases in overall 

cigar and flavored cigar 

units sold. Increase in 

unflavored cigar units 

sold. 

Pre/Post Design 

(Ref. 113).

Over 46,000 observations.Youth (aged 15–24 years) 

Cigarillo Use: Decreases 

in past 30-day cigarillo 

use. 

1Tobacco products covered under flavored tobacco restrictions differed across jurisdictions, particularly in regard to menthol status and inclusion of ENDS. 

2Outcome measures differed across studies, with some focused specifically on sales data, whereas others measured tobacco use (cigar specific and/or all tobacco 

use), across differing age groups. 

In November 2010, NYC began 

enforcing a restriction on sales of 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 on total cigar sales of NYC’s 

flavor restriction found a considerable 


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reduction in overall sales, a proxy for 

overall consumption, after controlling 

for temporal trends in sales and the 

potential for purchases across the city 

border (Ref. 108). This evaluation used 

retail scanner data to assess changes in 

total cigar units sold before and after the 

NYC flavor restriction went into effect. 

For comparison, the analysis also 

examined sales in nine counties in New 

York and New Jersey proximal to NYC, 

as well as sales in the United States 

overall, over the same timeframe. In 

NYC, sales of all flavored tobacco 

products combined declined 27.1 

percent, and sales of flavored cigars 

declined 22.3 percent at policy 

implementation. The NYC flavor 

restriction was associated with a 

statistically significant 11.6 percent 

decrease in total cigar sales in NYC 

immediately following policy 

implementation, while cigar sales in the 

comparison area and nationally did not 

statistically significantly change. The 

decrease in overall cigar sales observed 

in NYC suggests that consumers did not 

completely substitute non-flavored 

cigars for flavored cigars because of the 

restriction (Ref. 108). This study showed 

that the concurrent decrease in unit 

sales of flavored tobacco products and 

flavored cigars observed in NYC was not 

offset by an increase in non-flavored 

cigars or tobacco products not included 

in the restriction. Furthermore, these 

findings were similar to results from an 

earlier analysis of the NYC policy that 

used more limited data (Ref. 51). This 

more limited study analyzed data from 

stores with overall sales of at least $2 

million per year in NYC and found that 

the restriction was associated with an 86 

percent decrease in flavored cigar dollar 

sales and only a 5 percent increase in 

unflavored cigar dollar sales (Ref. 51). 

An evaluation of the impact of the 

NYC flavored tobacco restriction on 

youth tobacco 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 

went into effect compared to youth in 

2010. Similarly, in 2013, youth had 28 

percent lower odds of ever using any 

tobacco product compared to youth 

before the policy went into effect (Ref. 

51), suggesting that the decreases in 

overall sales and consumption of 

flavored tobacco products, including 

cigars, was also reflected in declines in 

youth tobacco experimentation. This 

study illustrated that youth tobacco use 

declined following the NYC sales 

restriction. 

Providence, RI, implemented a sales 

restriction on tobacco products with 

characterizing flavors other than 

menthol, mint, or wintergreen in 

January 2013 (Ref. 109). An evaluation 

in Providence, similar to the analysis in 

NYC, used retail scanner data to assess 

changes in total cigar units (both 

flavored and not flavored, including 

menthol, mint, and wintergreen flavors) 

sold before and after the Providence 

flavor restriction went into effect (Ref. 

109). For comparison, the analysis also 

examined sales over the same time 

period in the rest of Rhode Island (Ref. 

109). Sale of explicit flavor-named 

cigars (e.g., ‘‘cherry’’) in Providence 

declined 93 percent, while ‘‘concept’’ 

flavor-named cigars (e.g., ‘‘jazz’’) 

increased 74 percent after policy 

implementation compared to before 

policy implementation. Despite the 

increase in ‘‘concept’’ flavor-named 

cigar sales, flavored cigar sales 

decreased overall, suggesting that 

‘‘concept’’ flavor-named cigar 

consumption did not entirely replace 

explicit flavored-named cigar 

consumption after the policy. The 

analysis found that average weekly sales 

of all flavored cigars decreased 51 

percent following policy 

implementation in Providence 

compared to before policy 

implementation and increased 10 

percent across the rest of the state 

during the same time period (Ref. 109). 

Average weekly sales of all cigars 

decreased 31 percent following policy 

implementation in Providence and 

decreased 6 percent across the rest of 

the state during the same time period 

(Ref. 109). This study illustrated that 

flavored cigar use decreased following 

policy implementation alongside an 

increase in sales in the rest of the state. 

While concept-flavored cigar sales 

increased in Providence and the rest of 

the State, the overall decline in flavored 

sales suggests that flavored cigar use 

was only partially offset by an increase 

in concept-flavored use. 

Another evaluation of the Providence 

restrictions examined youth tobacco use 

including cigar use through a schoolbased survey of over 2,000 10th and 

12th grade students at two time points 

after Providence’s sales restriction was 

in effect: 2016 (3 years post-restriction) 

and 2018 (5 years post-restriction) (Ref. 

60). This analysis found that youth 

current use of any tobacco product 

declined, from 22.2 percent in 2016 to 

12.1 percent in 2018; and current use of 

cigars/cigarillos declined from 7.1 

percent in 2016 to 1.9 percent in 2018 

(Ref. 60). This study illustrates a decline 

in youth cigar use after increased 

enforcement of the policy in 

Providence, which is consistent with 

the analysis of sales data in Providence 

(Ref. 109). 

Lowell, MA, enacted a restriction on 

flavored tobacco except for menthol-, 

mint-, or wintergreen-flavored tobacco 

products in October 2016. One study 

assessed short-term (6-month) impact of 

the Lowell, MA, sales restriction on 

youth use of flavored tobacco using prepost design with a comparison 

community (Malden, MA). The 

comparison community of Malden, MA, 

did not have a sales restriction and was 

similar to Lowell, MA, in demographics, 

retailer characteristics, and other pointof-sale policies (Ref. 61). The analysis 

evaluated youth use of flavored tobacco 

products in Lowell and Malden at 

baseline (November 2016-January 2017 

in Lowell; September 2016 in Malden) 

and followup approximately 6 months 

later (May 2017 in Lowell; April 2017 in 

Malden). Youth current use of any 

flavored tobacco products decreased 2.4 

percent in Lowell from baseline to 

followup periods and increased 3.1 

percent in the comparison community 

without a sales restriction (Malden, MA) 

for a statistically significant estimated 

difference of ¥5.7 percent between the 

communities (Ref. 61). When 

considering the change in specific 

product use, ever use of flavored cigars 

and current use of flavored cigars 

decreased in Lowell and increased in 

the comparison community, although 

the changes were not statistically 

significant. In general, there were no 

statistically significant changes in youth 

use by specific tobacco products in 

Lowell, in the comparison city, or in the 

difference estimate between the 

communities when the models were 

adjusted for age, gender, and race and 

ethnicity (Ref. 61). Youth current use of 

any non-flavored tobacco products also 

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. 61). This study 

showed that youth use of flavored 

tobacco products declined potentially in 

response to a sales restriction in a 

Massachusetts community compared to 

a similar community without a sales 

restriction. 

Another study evaluated the impact of 

flavored tobacco sales restrictions 

(excluding menthol, mint, and 

wintergreen) in Attleboro and Salem, 

MA, on tobacco use among high school 

students (Ref. 110). While youth tobacco 

use increased from baseline to followup 

in Attleboro and Salem and in the 

comparison municipality of Gloucester, 

MA, the increases in flavored tobacco 

use and non-flavored, mint, or menthol 

tobacco use were statistically 


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14Although enforcement of this policy was slated 

to begin in January 2019, compliance inspections 

with penalties did not commence until April 2019. 

significantly smaller in Attleboro and 

Salem than the comparison 

municipality, suggesting that the policy 

mitigated increases in tobacco use (Ref. 

110). This study found that youth 

tobacco use increased at a lower rate 

within the two municipalities covered 

by sales restrictions compared to the 

municipality without a restriction. 

Therefore, the study findings suggest 

that the flavored tobacco restriction may 

have prevented increases in tobacco use. 

In 2016, Minneapolis and St. Paul, 

Minnesota, commonly referred to as the 

Twin Cities, also implemented sales 

restrictions that included all flavored 

tobacco products, including ENDS but 

excluded menthol, mint, and 

wintergreen flavors. These sales 

restrictions exempted adult-only (18 

years and older) licensed tobacco 

product shops with at least 90 percent 

or greater revenue from sales of tobacco 

in Minneapolis and adult-only (18 years 

and older) retail stores with at least 90 

percent or greater revenue from sales of 

tobacco in St. Paul. In 2018, the Twin 

Cities expanded the restrictions to 

include mint-, menthol-, and 

wintergreen-flavored tobacco products. 

However, sales of mint-, menthol-, and 

wintergreen-flavored tobacco products 

were permitted in adult-only (aged 21 

years and older) liquor stores in 

Minneapolis and liquor stores that also 

hold a license for tobacco sales in St. 

Paul. An analysis of the Minnesota 

restrictions examined youth tobacco use 

prevalence in the seven-county Twin 

Cities metropolitan area, including 

Minneapolis and St. Paul, and 

compared it to the rest of the State of 

Minnesota using data from two crosssectional surveys: The Minnesota Youth 

Tobacco Survey (MYTS) and the 

Minnesota Student Survey (MSS) (Ref. 

111). The analysis used MYTS data from 

students in grades 6–12 to estimate 

tobacco use before (2014) and after 

(2017) the Twin Cities implemented 

flavor policies in 2016 that included all 

tobacco products but excluded menthol, 

mint, and wintergreen flavors. The 

analysis used MSS data from students in 

grades 8, 9, and 11 to assess changes in 

tobacco use before (2016) and after 

(2019) when the flavor restrictions were 

expanded to include mint, menthol, and 

wintergreen flavors. Using the MYTS 

data to assess youth tobacco use while 

the 2016 flavor restriction (excluding 

menthol, mint, and wintergreen) was in 

effect, the prevalence of tobacco product 

use overall and cigar use did not change 

in the Twin Cities among 6–12th 

graders; however, e-cigarette use 

increased 34.1 percent. In contrast, 

tobacco use prevalence overall, cigar 

use, and e-cigarette use increased at 

greater rates in the rest of the state 

(+26.6 percent, +71.3 percent, and +114 

percent, respectively). Using the MSS 

data to assess youth tobacco use after 

the 2019 flavor restriction (including 

menthol, mint, and wintergreen) was 

implemented, tobacco use and ecigarette use among students in grades 

8, 9, and 11 increased in the Twin 

Cities; however, the increase was 

smaller than the rest of the state (34.6 

percent vs. 44.6 percent tobacco use 

increase; 49.5 percent vs. 88.9 percent ecigarette increase). Cigar use declined 

more in the Twin Cities compared to the 

rest of the state (¥42.4 percent and 

¥23.7 percent, respectively). Cigarette 

use decreased more in the Twin Cities 

relative to the rest of the State (¥40.5 

percent and ¥22.6 percent, 

respectively). Use of any menthol or 

mint tobacco product decreased in both 

areas (¥5.9 percent Twin Cities and 

¥15.7 percent rest of state), and use of 

non-cigarette tobacco products (e.g., 

cigars, smokeless tobacco, e-cigarettes, 

hookah) with flavors other than mint or 

menthol increased in both areas (+5 

percent Twin Cities and +10.2 percent 

rest of state) (Ref. 111). 

Given the differences in survey items, 

timing of data collection, and that the 

MYTS and MSS data included all seven 

counties of the Twin Cities metropolitan 

area, including some counties not 

implementing flavor restrictions, the 

observed prevalence changes may 

reflect contextual factors beyond the 

restrictions in the cities of Minneapolis 

and St. Paul. For example, the 2019 

MSS data collection was shortly after 

the policies including mint, menthol, 

and wintergreen went into effect; 

therefore, the study may underestimate 

the effect of the policy on youth 

behavior change. However, the study 

observed stable and decreasing cigar use 

among youth across the surveys in the 

Twin Cities relative to the rest of the 

state, which suggests the sales 

restriction slowed youth cigar use. 

In 2018, San Francisco, CA, enacted 

restrictions on flavored tobacco 

products. Changes following the 2018 

San Francisco restriction on all flavored 

(including menthol) tobacco product 

sales were evaluated and compared with 

sales in two California comparison cities 

without such sales restrictions: San Jose 

and San Diego (Ref. 52). The analysis 

used Nielsen retail scanner sales data to 

estimate within-city changes in average 

weekly unit sales of tobacco products 

for San Francisco and comparison cities 

for three time periods: Pre-policy (June 

2015–July 2018; pre-policy); policy 

enactment (July 2018–January 2019) and 

policy enforcement (January 2019– 

December 2019).14 Sales of flavored 

tobacco products overall and of flavored 

cigars specifically decreased a 

statistically significant 96 percent from 

the pre-policy period through the 

enforcement period in San Francisco 

(Ref. 52). In the comparison cities, 

average weekly sales of flavored tobacco 

products either decreased more 

modestly, yet still statistically 

significantly (e.g., 10 percent for all 

flavored products and 13 percent for 

flavored cigars in San Diego), or did not 

have a statistically significant change 

from pre-policy to policy enforcement, 

with the exception of flavored ENDS 

(which statistically significantly 

increased by 195 percent in San Jose 

and 118 percent in San Diego) and 

flavored smokeless tobacco (which 

statistically significantly increased by 3 

percent in San Diego). Predicted average 

weekly total cigar sales decreased by 51 

percent in San Francisco from prepolicy to policy enforcement, suggesting 

that there was not complete substitution 

of flavored cigars for non-flavored cigars 

(Ref. 52). This study observed a decline 

in overall tobacco product sales and 

flavored tobacco product sales, 

suggesting that there was not complete 

substitution of tobacco or non-flavored 

products for flavored products following 

the flavor restriction in San Francisco. 

Another study evaluated the impact of 

the San Francisco restriction on all 

flavored (including menthol) tobacco 

products on use of cigars among a small 

convenience sample (n=247) of young 

adults aged 18–34 years who used 

tobacco products prior to the restriction 

(Ref. 62). After implementation of the 

flavor restriction in San Francisco, 

among young adults aged 18–24 years, 

there was a statistically significant 

decrease in use of flavored cigars (from 

19.4 percent to 6.5 percent) and 

decrease in cigar use overall that was 

not statistically significant (Ref. 62). 

There were decreases in the prevalence 

of cigar use overall and use of flavored 

cigars among 25–34-year-old 

respondents, but the declines were not 

statistically significant. Among the 25– 

34 age group, there was a statistically 

significant decrease in flavored ecigarette use (from 56.2 percent to 48.1 

percent) and dual use of e-cigarettes 

with cigars (from 14.1 percent to 9.7 

percent). This study showed among 

young adults, flavored cigar use may 

have declined following the San 

Francisco sales restriction, and the 

decrease was not offset by an increase 

in non-flavored cigar use. 


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One study of San Francisco’s flavored 

tobacco policy using 2019 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. 114). 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. 115). As noted above, 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. 52). 

In addition to the local U.S. 

jurisdictions discussed previously, a 

study of local level restrictions across 

Massachusetts from 2011–2017 found 

that counties with 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 high school students 

smoked cigarettes in the past 30 days 

and a decrease in the likelihood of their 

e-cigarette use (Ref. 116). This study 

illustrates the potential for flavor 

restrictions to reduce youth tobacco use. 

Evaluations of a national flavored 

tobacco policy in Canada reinforce 

trends observed in jurisdictions that 

enacted flavored tobacco policies in the 

United States, including a decrease in 

cigar sales and a decrease in use of 

cigars among young people. In 2009, the 

government of Canada prohibited the 

use of characterizing flavors (excluding 

menthol) in cigarettes and cigars under 

1.4 grams, or in any cigar that had a 

filter or non-spiral wrap. Using 

wholesale sales volumes, one evaluation 

examined trends in sales of flavored 

cigars during the 2004–2016 period, 

with equal periods of 6 years before and 

6 years after enactment of the 2009 

restriction (Ref. 112). The analysis 

found that overall cigar sales decreased 

49.6 million units and sales of flavored 

cigars decreased 59 million units in the 

quarter immediately following policy 

enactment (i.e., first quarter of 2010). 

Sales of cigars with no flavor descriptors 

increased 9.6 million units in the 

quarter immediately after policy 

implementation (Ref. 112). Another 

evaluation assessed the impact of 

Canada’s 2010 ban on the sale of 

flavored cigarillos (Ref. 113). This 

evaluation analyzed data from the 2007 

to 2011 Canadian Tobacco Use 

Monitoring Survey and found that the 

policy was associated with a statistically 

significant 2.3 percentage point decrease 

in past 30-day cigarillo use and a 

statistically significant 4.3 percentage 

point increase in past 30-day 

abstinence, defined as no cigar use in 

the prior 30 days among previous 

cigarillo users among young people aged 

15 to 24 years. Cigarillo use declined in 

the older age group, 25 to 65 years, but 

the decline was not statistically 

significant. The study noted that there 

was some evidence of a small increase 

in use of cigars other than cigarillos or 

little cigars that were not included in 

the policy, and the analysis did not 

distinguish flavored cigarillo from 

unflavored cigarillos (Ref. 113). 

Taken in totality, these studies of the 

impact of real-world restrictions on 

flavored tobacco products provide 

insight into the likely responses of 

youth and young adults as well as 

current cigar smokers to the proposed 

standard, including decreases in youth 

and adult cigar use. However, we 

acknowledge there are limitations to the 

application of these findings. One 

limitation includes the timing of data 

collection on cigar use. Some of the 

evaluation studies rely on data 

collection only after the policy with 

retrospective recall of cigar use prior to 

policy implementation. Furthermore, 

the duration of followup time varied 

between studies, and those with shorter 

followup times (e.g., Refs. 61 and 62) 

may have underestimated the impact on 

cigar use. Limitations also include that 

some studies rely on aggregate tobacco 

sales information as a proxy for 

consumption, rather than data 

concerning individual-level tobacco use 

behaviors. Certain analyses used cigar 

sales as a proxy for consumption, given 

that sales and consumption tend to be 

highly correlated (Refs. 117–119). 

Furthermore, a number of noted studies 

used state or nationally representative 

surveys of youth and young adults to 

assess differences in tobacco use before 

and after policy implementation. Some 

of these studies were able to assess 

changes in cigar use specifically, while 

others assessed changes in overall 

tobacco use or flavored tobacco use 

more broadly. Lastly, smokers may have 

obtained flavored cigars through 

alternate means (e.g., internet sales) that 

would not have been captured in sales 

data in these studies, or smokers may 

have switched to tobacco products not 

subject to restrictions, which may have 

resulted in an overestimation of the 

impacts of the restrictions, unless 

changes in overall tobacco use was 

accounted for. Despite these limitations, 

these real-world evaluations provide 

important insight into how sales and 

tobacco use change in response to 

restrictions on flavored tobacco 

products, including cigars. These 

evaluation studies further demonstrate 

that the proposed prohibition on 

characterizing flavors (other than 

tobacco) in cigar products would reduce 

the rate of youth and young adult 

experimentation and progression to 

regular tobacco use and increase 

cessation among current cigar smokers. 

Section VI of this document draws on 

such findings to estimate the impact of 

the proposed rule on population health, 

including the likelihood that existing 

cigar smokers would stop smoking as 

well as the likelihood that nonusers 

would start smoking cigars. 

G. Flavored Cigars 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 companies and 

their products among youth, young 

adults, and other vulnerable 

populations (Refs. 37, 120, and 121). 

With regard to cigars, decades of 

targeted marketing activities have 

helped make cigars more appealing and 

affordable and contributed to the 

pervasive and enduring nature of 

disparities in cigar use in vulnerable 

populations. 

A robust body of scientific evidence 

shows that tobacco is disproportionately 

marketed in underserved communities 

and to vulnerable populations, such as 

youth and young adults, some racial and 

ethnic populations, individuals who 

identify as LGBTQ+, pregnant persons, 

those with lower household income and 

educational attainment, and individuals 

with behavioral health conditions. 

Storefront and outdoor tobacco 

marketing as well as point-of-sale 

marketing are all disproportionately 

present in African American/Black, 

Hispanic/Latino, and low-income 

communities (Refs. 122–129). 

Additionally, tobacco companies have 

historically targeted African Americans, 

LGBTQ+ communities, and low-income 

populations by using strategies such as 

offering coupons and other price 

promotions to entice these groups to use 

tobacco products (Refs. 122 and 130). 

This evidence holds true for combusted 

tobacco products, including cigar and 

flavored cigar products. 

Industry documents reveal that 

tobacco companies have for many 


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decades strategically marketed flavored 

cigars to encourage trial and initiation 

among vulnerable populations. For 

example, a 1969 industry report noted 

the introduction of new flavored cigar 

products ‘‘aimed directly at youth,’’ as 

well as marketing campaigns targeting 

youth by including special offers, such 

as record albums (Refs. 16 and 79). 

Similarly, a 1972 report on the findings 

of an industry consumer research study 

concluded that adding menthol and 

mint flavor to little cigars was appealing 

to young (not defined) study 

participants and recommended 

marketing this flavored cigar product at 

a lower price point than cigarettes in 

order to attract young users (Refs. 16 

and 131). Industry documents also 

disclose that tobacco companies 

targeted Black consumers, including by 

offering sampling and distribution 

opportunities as well as publishing 

advertisements in Black-only 

newspapers (Refs. 16, 132, and 133). 

Furthermore, hip-hop artists, DJs, and 

music events are all avenues tobacco 

companies have used to attract African 

Americans to use flavored little cigars 

and cigarillos (Ref. 16). Industry market 

research also studied how to increase 

cigar use among young women, 

including the addition of flavors to 

improve palatability and mildness and 

thereby promote product trial. Segments 

of the industry used this information to 

inform marketing and product 

development targeted at women such as 

adding appealing flavors, reducing cigar 

size so they could fit into purses or 

pockets, and including celebrities in 

advertisements (Refs. 16 and 131). 

The tobacco industry’s historic 

practice of marketing to vulnerable 

populations has resulted in long-term 

consequences for these communities. 

Scientific evidence indicates that 

tobacco marketing influences social 

norms around tobacco use, making 

tobacco use more socially acceptable 

and increasing the likelihood of tobacco 

use (Refs. 134–137). In underserved 

communities where the tobacco 

industry has disproportionately 

marketed over decades, these social 

norms are transferred through social 

networks of peers and generations of 

families, thereby contributing to 

present-day tobacco-related health 

disparities in these populations (Refs. 

134, 135, 138, and 139). Furthermore, 

recent scientific evidence indicates that 

tobacco companies continue to target 

populations from underserved 

communities with cigar marketing, 

including flavored cigar marketing (see, 

e.g., Refs. 140–146). Across diverse 

marketing platforms, ranging from 

traditional print media to online 

platforms, populations from 

underserved communities are 

disproportionately exposed to cigar 

advertisements. 

Brick-and-mortar tobacco retailers are 

present in disproportionate numbers in 

neighborhoods of underserved 

communities, particularly in Black 

communities. Studies have found that 

the more Black residents there are in a 

census tract, the more tobacco retailers 

there are in that census tract, with a 

statistically significant positive 

association between tobacco retailer 

density and the proportion of residents 

who are Black (Refs. 124–127). Two 

systematic reviews and several studies 

found that tobacco retailers in 

predominately African American/Black 

neighborhoods were statistically 

significantly more likely to sell cigars 

and cigarillos, were statistically 

significantly more likely to have exterior 

advertisements for cigars and cigarillos, 

and were statistically significantly more 

likely to sell cigars and cigarillos at a 

lower price, as compared to tobacco 

retailers in other neighborhoods (Refs. 

125, 127, and 146–149). Furthermore, 

two nationally representative studies 

found that retailers in Black 

neighborhoods were more likely to 

place interior advertisements at or 

below 3 feet off the floor, at a point 

where cigar advertisements are more 

visible to youth, compared to tobacco 

retailers in predominately non-Hispanic 

White neighborhoods (Refs. 143 and 

144). 

Higher exposure to tobacco 

advertisements and retailing are 

associated with disparities in tobacco 

use susceptibility and tobacco use 

among youth. For example, a nationally 

representative study of youth found that 

exposure to cigar advertisements at the 

point-of-sale was statistically 

significantly associated with high 

curiosity about using cigars, with nonHispanic Black (14.8 percent) and 

Hispanic youth (11.9 percent) being 

statistically significantly more likely to 

be highly curious about cigars as 

compared to non-Hispanic White youth 

(7.6 percent). This finding raises 

concern because curiosity about using 

tobacco products predicts tobacco use 

susceptibility, tobacco use initiation, 

and progression to regular tobacco use 

among youth (Ref. 150). Similarly, a 

longitudinal study of middle and high 

school students found that recall of 

tobacco advertisements and products at 

the point-of-sale at baseline predicted 

current cigar use at a 6-month followup 

(Ref. 151). Additionally, one crosssectional study found that youth who 

reported going to a corner, convenience, 

or other retail store on the way to or 

from school frequently had statistically 

significantly higher odds of current use 

of cigars, little cigars, and cigarillos (Ref. 

152). 

Taken together, scientific evidence 

indicates that cigars and flavored cigars 

historically have been and continue to 

be disproportionately marketed in 

underserved communities and that the 

presence of flavors in cigars is intended 

to encourage trial and initiation and 

deter tobacco cessation. The differences 

found in exposure to flavored cigar 

marketing contribute to observed 

disparities in tobacco use and associated 

tobacco-related health disparities and 

health outcomes among vulnerable 

populations, as further discussed in 

section V.F of this document. While 

targeted marketing is only one factor in 

the development and perpetuation of 

flavored cigar 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 great concern to FDA. 

FDA remains committed to improving 

health outcomes across the population 

as a whole, including within groups that 

experience disproportionate levels of 

tobacco use, such as the vulnerable 

populations discussed in this section. 

V. Cigar Use Is Common, Addictive, 

and Harmful 

A. Prevalence of Cigar Use Among 

Youth, Young Adults, and Older Adults 

in the United States 

Patterns of cigar use differ markedly 

by age group, race and ethnicity, 

household income and educational 

attainment, and among others who have 

systematically experienced greater 

obstacles to health based due to the 

inequitable distribution of social, 

political, economic, and environmental 

resources, such as individuals who 

identify as LGBTQ+ and persons with 

disabilities. 

1. Cigar Use Prevalence in Youth and 

Young Adults 

Evidence from national surveys, 

including the Monitoring the Future 

study of 8th, 10th, and 12th grade 

students and the NYTS of middle and 

high school students, has suggested that, 

similar to cigarettes, cigar use has been 

on the decline among U.S. youth in 

recent years (Refs. 153 and 154). 

However, in 2020, cigars were the most 

commonly reported combusted tobacco 

product used by youth (Ref. 7). 

Nationwide, in 2020, nearly 1 million 

youth had smoked a cigar on at least 1 

day during the past 30 days (Ref. 7). 

According to the 2020 NYTS, an 


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15FDA acknowledges that sexual orientation is 

distinct from gender identity and that discussion 

and consideration of these factors in the context of 

public health should recognize and account for that 

distinction. However, the relevant scientific studies 

cited herein do not provide data separated by 

sexual orientation and gender identity. Due to these 

study limitations, we discuss sexual orientation and 

gender identity in a combined manner, despite their 

important distinctions. 

estimated 960,000 middle and high 

school students (3.5 percent), including 

5.0 percent (770,000) of high school 

students (grades 9–12) and 1.5 percent 

(180,000) of middle school students 

(grades 6–8), had smoked a cigar (cigar, 

cigarillo, or little cigar) in the preceding 

30 days (Ref. 7). The most recent NYTS 

data also found that, of those youth who 

use cigars, the largest proportion use 

cigarillos (44.1 percent), followed by 

regular cigars (33.1 percent), and little 

cigars (22.6 percent) (Ref. 8). Of note, 

21.8 percent of youth who are current 

users report not knowing which cigar 

type they use (Ref. 8). 

While there has been an overall 

downward trend in cigar use among 

youth in general, cigar use—particularly 

flavored cigar use—remains significant, 

and this decrease has not been equitably 

experienced as the popularity of cigar 

use remains disproportionately high 

among non-Hispanic Black youth (Ref. 

7). Tobacco-related health disparities 

result, in part, from inequitable 

practices and denial of opportunities 

that prevent some communities from 

fully participating in aspects of 

economic, social, and civic life. These 

inequities influence vulnerabilities that 

some populations experience across the 

continuum of tobacco use. For example, 

disparities in initiation and prevalence 

of cigar use that are connected to 

inequitable treatment and opportunities 

likely contribute to and reinforce the 

continued tobacco-related 

vulnerabilities of Black youth as 

subsequent disparities are observed 

along the continuum of tobacco use for 

these youth. The 2020 NYTS data show 

that the popularity of cigars is especially 

high among non-Hispanic Black middle 

and high school students, as 6.5 percent 

reported past 30-day cigar use compared 

to 2.8 percent of non-Hispanic White 

students (Ref. 7). Additionally, the 

findings show that cigar use was 

statistically significantly higher than 

cigarette use among non-Hispanic Black 

high school students in 2020, with 9.2 

percent reporting having smoked cigars 

during the past 30 days, compared with 

2.8 percent reporting having smoked 

cigarettes (Ref. 7). Data also indicate that 

non-Hispanic Black youth have a higher 

risk than White youth of initiating cigar 

use at earlier ages. An analysis of 2013– 

2017 PATH Study youth (aged 12–17 

years) data indicated that, when 

compared to non-Hispanic White youth, 

non-Hispanic Black youth were 47 

percent more likely to initiate past 30- 

day cigarillo or filtered cigar use and 

111 percent more likely to be ‘‘fairly 

regular’’ users of these products (Ref. 

25). These observed disparities in cigar 

use initiation are associated with higher 

levels of current cigar use and frequency 

of cigar use among Black youth and 

young adults. An analysis of data from 

a longitudinal cohort study found that 

once Non-Hispanic African American 

youth and young adults had initiated 

cigar use, they had twice the odds of 

current cigar use within 6 months 

relative to non-Hispanic Whites (Ref. 

100). Also, within 6 months of 

initiation, the average frequency of use 

and days per month used was higher for 

non-Hispanic African Americans 

compared to non-Hispanic Whites (Ref. 

100). Findings from the 2013 Cuyahoga 

County Youth Risk Behavior Survey 

indicate that non-Hispanic Black youth 

had statistically significantly higher 

odds of using cigars as compared to 

non-Hispanic White youth (Ref. 155). 

Disparities in cigar use among Black 

youth may also pose additional 

concerns due to the increased risk 

associated with polyuse with other 

combusted tobacco products. Cigarette 

smoking being perceived as harmful 

reduced the likelihood of cigar use 

among all racial and ethnic categories of 

youth except for non-Hispanic Black 

youth, who were statistically 

significantly more likely to be current 

cigar users if they perceived smoking 

cigarettes as harmful (Ref. 155). 

Moreover, use of cigars among Black 

youth disproportionately leads to 

cigarette smoking. In a nationally 

representative longitudinal study of 

youth, ever cigar use statistically 

significantly increased the odds of 

subsequent past-30-day cigarette use 

among non-Hispanic Black youth (Ref. 

156). However, ever cigar use did not 

increase the odds of subsequent past 30- 

day cigarette use among non-Hispanic 

White youth (Ref. 156). This study 

found that 9.1 percent of cigarette 

initiation among non-Hispanic Black 

youth was directly attributable to cigar 

use, compared with only 3.9 percent 

among non-Hispanic White youth (Ref. 

156). 

Youth and young adults who identify 

as LGBTQ+ also face tobacco-related 

health disparities when compared with 

non-LGBTQ+ counterparts, including 

higher prevalence of tobacco product 

use as well as cigar use.15 In 2020, 

NYTS analysis found that past 30-day 

use of any tobacco product was higher 

among youth identifying as lesbian, gay, 

or bisexual than heterosexual youth 

(25.5 percent vs. 15.1 percent) (Ref. 7). 

Past 30-day cigar use was nearly twice 

as prevalent among youth identifying as 

lesbian, gay, or bisexual than 

heterosexual youth (6.0 percent vs. 3.1 

percent) (Ref. 7). Findings from an 

analysis of Wave 3 PATH Study data 

(2015–2016) indicated that, similar to 

patterns among adults, lesbian and 

bisexual girls have even higher 

disparities and are more than twice as 

likely than their heterosexual peers to 

report ever using cigars (11.3 percent vs. 

5.2 percent) and to have used cigars in 

the past 30 days (3.2 percent vs. 1.0 

percent) (Ref. 157). An analysis of the 

2015 YRBS data found that lesbian and 

bisexual girls have statistically 

significantly higher current use 

prevalence of cigars than their 

heterosexual peers (16.4 percent for 

lesbian girls, 10.2 percent for bisexual 

girls, 5.4 percent for heterosexual girls), 

as do gay and bisexual boys (20.0 

percent for gay boys, 16.9 percent for 

bisexual boys, and 13.5 percent for 

heterosexual boys) (Ref. 158). Findings 

from a nationally representative cohort 

study indicated that young adults who 

identified as homosexual reported 

higher ever cigar use compared to young 

adults who identified as heterosexual 

(Ref. 159). Transgender youth also are 

statistically significantly more likely 

than non-transgender youth to report 

ever using any tobacco product (53.6 

percent vs. 31.5 percent) including 

cigars (16.1 percent vs. 7.5 percent) and 

past 30-day use of more than one 

tobacco product, including cigars (10.2 

percent vs. 3.5 percent) (Ref. 157). Study 

findings from a young adult cohort 

study indicated that past 30-day little 

cigars/cigarillos/bidis use was greater 

for young adults who identified as 

LGBT in comparison to those who did 

not identify as LGBT (Ref. 160). 

Youth with disabilities also have 

higher rates of cigar use than their 

nondisabled peers. In one study of more 

than 20,000 11th graders in Oregon that 

controlled for sociodemographic risk 

factors of tobacco use, the proportion of 

little cigar use among students with at 

least one reported disability (7.0 

percent) was statistically significantly 

higher than among students without a 

disability (5.4 percent) (Ref. 161). 

2. Cigar Use in Adults 

Cigars are also a popular tobacco 

product among adults. In the 2019 

National Health Interview Survey 

(NHIS), 3.6 percent of adults 18 or older 

reported currently using cigars some or 

every day, behind cigarettes (14 percent) 


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and e-cigarettes (4.5 percent) (Ref. 68). 

Comparing 2011 to 2019, while past 

month cigarette smoking and cigar use 

were both statistically significantly 

lower in young adults (aged 18–25 

years), the absolute decline in cigar use 

was less than the decline in cigarette 

use (33.5 percent in 2011 to 17.5 percent 

in 2019 for cigarettes; 10.9 percent in 

2011 to 7.7 percent in 2019 for cigars) 

(Ref. 59). For adults (aged 26 years or 

older), cigarette use in 2011 was 

statistically significantly higher 

compared to in 2019; however, cigar use 

remained relatively stable and did not 

significantly change (21.9 percent in 

2011 to 18.2 percent in 2019 for 

cigarettes; 4.2 percent in 2011 to 4.0 

percent in 2019 for cigars) (Ref. 59). The 

2019 NSDUH found that among adults 

aged 26 or older in 2019, 1,420 

individuals initiated cigar use each day, 

considerably more than the 247 who 

initiated cigarette smoking each day in 

that year (Ref. 59). 

Prevalence of cigar smoking, however, 

varied by the type of cigar smoked. 

Analysis of Wave 5 (2018–2019) data 

from the PATH Study found that, 4.8 

percent of young adults (aged 18–24 

years) used traditional cigars; 7.9 

percent used cigarillos, and 2.4 percent 

used filtered cigars in the past 30 days 

(Ref. 63). According to the most recent 

data from the PATH Study (2018–2019), 

3.5 percent of adults (aged 25 years and 

older) used traditional cigars, 3.3 

percent used cigarillos, and 1.6 percent 

used filtered cigars in the past 30 days 

(Ref. 63). 

Similar to youth and young adults, 

adults (aged 25 years and older) 

reported use of flavored cigars and are 

expected to benefit from the proposed 

product standard if finalized. Wave 5 

(2018–2019) data from the PATH Study 

showed that 36.0 percent of adult cigar 

smokers (aged 25 years and older) 

reported past 30-day use of flavored 

cigar from 2018–2019 (Ref. 63). Among 

adult cigar smokers, a statistically 

significantly greater proportion of adult 

traditional cigar smokers (19.7 percent) 

reported use of a flavored cigar in the 

past 30 days compared with adult 

smokers of all other cigar types (46.5 

percent for cigarillos and 48.7 percent 

for filtered cigars) (Ref. 63). The 

proportion of adults using flavored 

cigars within each of the cigar types did 

not differ over time across recent PATH 

Waves 4–5 (2016–2019) (Ref. 63). 

A disproportionate proportion of cigar 

smoking occurs among vulnerable 

populations; this burden has grown over 

the past two decades. In the 2019 NHIS, 

4.4 percent of non-Hispanic Black, 3.8 

percent of non-Hispanic White, and 3.0 

percent of Hispanic adults reported 

some or everyday cigar use (Ref. 68). In 

an analysis of 2002–2016 NSDUH data 

for individuals aged 12 and older, nonHispanic Black individuals were 

statistically significantly more likely 

than all other racial and ethnic groups 

to have used cigars in the past 30 days 

(Ref. 162). Decreases in prevalence of 

cigar use have not been observed in 

non-Hispanic Black adults as they have 

for other racial and ethnic groups (Ref. 

162). There were no statistically 

significant changes in past 30-day use 

prevalence between 2002–2016 in the 

NSDUH data among non-Hispanic Black 

and non-Hispanic other/mixed race 

adults while there were decreases 

among both non-Hispanic White and 

Hispanic adults. Further, over this same 

time period, cigar use decreased among 

non-Hispanic White men and stayed the 

same among non-Hispanic White 

women, but it increased among nonHispanic Black women and remained 

the same among non-Hispanic Black 

men (Ref. 162). When considering more 

recent NSDUH data, these racial and 

ethnic disparities have persisted, with 

the prevalence of past 30-day cigar 

smoking remaining statistically 

significantly higher among nonHispanic Blacks compared to nonHispanic Whites through 2019 (Ref. 59). 

A recent analysis of PATH Study data 

from Wave 3 (2015–2016) showed 

differences in daily cigar smoking by 

racial and ethnic group (Ref. 163). NonHispanic Black individuals are 

statistically significantly more likely to 

report that they have ever been a ‘‘fairly 

regular’’ cigar smoker (5.4 percent) than 

non-Hispanic White cigar smokers (2.5 

percent) and to report that they smoke 

cigars daily (1.9 percent), compared to 

non-Hispanic White cigar smokers (0.5 

percent), with these differences being 

most pronounced for cigarillos (3.7 

percent vs. 0.9 percent) (Ref. 163). 

Hispanic adults were more likely to 

smoke cigars within 30 minutes of 

waking, when compared with nonHispanic Whites (Ref. 163). The analysis 

found a consistently higher prevalence 

of use for non-Hispanic Blacks, 

compared with non-Hispanic Whites for 

three cigar-smoking outcomes (past 30- 

day use, daily use, and established use) 

across all the cigar types (Ref. 163). 

Differences in prevalence have been 

observed across cigar type and in the 

use of flavors across racial and ethnic 

populations. In the PATH Study, past 

30-day cigarillo use was statistically 

significantly higher among nonHispanic Black young adults (aged 18– 

24 years) and adults (aged 25 years and 

older) compared with non-Hispanic 

Whites and Hispanics at all waves 

(2013–2019) (Ref. 63). Past 30-day use of 

flavored traditional cigars was 

statistically significantly higher among 

non-Hispanic Black older adults (aged 

25 years and older) compared to nonHispanic White adults at Waves 2–5 

(2014–2019) and compared to Hispanic 

adults at Waves 2–3 (2014–2016) and 

Wave 5 (2018–2019) (Ref. 63). An 

analysis of survey data on college 

students indicated that Black young 

adults were three times more likely to 

smoke flavored cigars than White young 

adults (Ref. 66). Hispanic and Asian 

participants were also more likely to use 

flavored cigars over non-flavored cigars 

compared to non-Hispanic White 

participants (Ref. 66). Younger 

participants (aged 18–24 years) had 

greater odds of using flavored cigars 

when compared to older participants 

(aged 25–29 years) (Ref. 66). 

Differences in prevalence of cigar use 

have also been observed across other 

population groups. Research indicates 

social gradient effects (where higher 

levels of household income and 

educational attainment are linked to 

better health outcomes and lower levels 

of household income and educational 

attainment are linked to poorer health 

outcomes) for cigar use. Data from the 

2012–2013 NATS show that higher 

educational levels and higher annual 

household income generally were 

associated with lower prevalence of 

usual use of cigarillos, other mass 

market cigars, and of little filtered cigars 

(Ref. 164). Data from the PATH Study in 

2018–2019 show that there was a 

statistically significant difference in past 

30-day cigar use by education level as 

7.3 percent of adults (aged 25 years and 

older) with less than a high school 

diploma smoked cigars in the past 30 

days, compared to 3.8 percent of adults 

with a college degree or higher (Ref. 63). 

Among adults who used any cigar in the 

past 30 days, individuals with a college 

degree were statistically significantly 

less likely to use a flavored cigar (20.0 

percent) than individuals categorized as 

having less than a high school diploma 

(44.9 percent), a high school diploma 

(37.4 percent), or some college (42.9 

percent) (Ref. 63). 

Tobacco-related cancers are a leading 

cause of death among adults 

experiencing homelessness (Ref. 165). In 

a study of 470 unhoused individuals, 

the analysis found that past 30-day use 

of all tobacco products was high and 

that 74.0 percent of respondents 

reported use of cigars and over half (55 

percent) reported use of flavored cigars 

in the past 30 days (Ref. 166). 

Adults over 18 with at least one 

chronic health condition (e.g., heart 

disease, hypertension, stroke, diabetes, 

asthma, lung cancer, hepatitis, human 


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16See, e.g., E.O. 13988, ‘‘Preventing and 

Combating Discrimination on the Basis of Gender 

Identity or Sexual Orientation’’ (86 FR 7023, 

January 25, 2021). 

immunodeficiency virus infection, 

anxiety, depression, substance abuse) 

have been shown in one study to be 

more than one and a half times more 

likely than those without a chronic 

health condition to use cigars, with no 

statistically significant changes over 

time (Ref. 167). In particular, adults who 

have anxiety, depression, or substance 

use disorders have cigar use rates 

statistically significantly greater than 

those with no chronic health conditions 

(Ref. 167). This association holds for 

mentholated tobacco products, 

including cigars, which are used 

disproportionately by young adults 

(aged 18–34 years) who report mental 

health disorders, with past 30-day 

menthol tobacco product use being 

associated with greater odds of anxiety 

and depression when controlling for 

other tobacco and mental health risk 

factors (Ref. 168). Likewise, using 

Waves 1–4 (2013–2017) of PATH Study 

data, adults who reported past-year 

severe internalizing problems were 

more likely to have initiated use of 

flavored cigarillos since the prior PATH 

wave, and were also more likely to be 

past-30-day users of flavored cigarillos 

(Ref. 169). 

Adults who identify as LGBTQ+ are 

more likely to use tobacco products, 

including cigars, and to meet the criteria 

for nicotine dependence when 

compared to their heterosexual and 

cisgender peers, with these associations 

being stronger for some racial and 

ethnic populations (Refs. 68, 157, 159, 

160, and 170–173). For example, while 

adults who identified as gay/lesbian, 

bisexual, and ‘‘conflicting’’ (defined by 

study authors as those who identified as 

‘‘heterosexual, had engaged in either no 

sexual behavior or exclusively 

heterosexual behavior, but reported 

some levels of same-sex attraction’’) are 

more likely than their heterosexual 

peers to use tobacco and meet tobacco 

use disorder criteria, Hispanic and nonHispanic Black bisexual adults have 

even stronger associations for current 

tobacco use than do their White 

bisexual peers (Ref. 172). Overlapping 

forms of disadvantage can interact to 

create and exacerbate tobacco-related 

health disparities. For example, 

discrimination experienced on the basis 

of gender identity or sexual orientation 

often overlaps with discrimination 

experienced on the basis of race or 

disability.16 As discussed in section 

IV.G of this document, the tobacco 

industry disproportionately targets its 

marketing to those who identify as 

LGBTQ+ and some racial and ethnic 

populations. For example, adults who 

identify as lesbian, gay, bisexual, or 

transgender report higher rates of 

tobacco media exposure compared to 

their peers who do not identify as 

lesbian, gay, bisexual, or transgender 

(Ref. 141), which can lead to use of 

tobacco products, including cigars (Refs. 

141 and 172). 

Generally, findings indicate that 

adults who identify as lesbian, gay, 

bisexual, or transgender have a higher 

prevalence of experimental and current 

cigar use compared to their heterosexual 

peers (Refs. 159 and 173–175). Findings 

from an analysis of the 2012–2013 

NATS data indicated that among 

women who identified as lesbian or gay, 

bisexual, or ‘‘something else’’ (an option 

provided in the study), cigar use was 

more than triple the rate of heterosexual 

women (Ref. 176). Data from the 2015– 

2017 NSDUH, indicate that lesbian and 

bisexual women had more than twice 

the odds of using cigars in the past year 

relative to heterosexual women (Ref. 

170). These findings are consistent with 

those from a 2013 cross-sectional survey 

study showing that lesbian and bisexual 

women had more than twice the odds of 

current cigar use relative to heterosexual 

women (Ref. 173). 

Adults who identify as transgender 

are more likely to use tobacco products, 

including cigars, than their cisgender 

peers. In a national cross-sectional 

online survey, transgender adults 

reported higher current (past 30-day) 

use of any cigarette/e-cigarette/cigar 

product (39.7 percent vs. 25.1 percent) 

(Ref. 177). This study also found that 

transgender adults had higher current 

use of cigars (26.8 percent vs. 9.3 

percent), specifically, when compared 

with cisgender adults as well as 

statistically significantly higher odds of 

past 30-day tobacco product use for any 

cigarette/e-cigarette/cigar product and 

for cigars, compared to cisgender adults 

(Ref. 177). 

These disparities also exist for 

flavored cigar use, as data from the 

2009–2010 NATS indicated that adults 

who identify as lesbian, gay, bisexual, or 

transgender have a higher prevalence of 

flavored cigar use (8.2 percent) 

compared to the national prevalence 

(2.8 percent) and when compared to 

cigar users nationally (42.9 percent) 

(Ref. 70). Data from the 2011–2015 

Truth Initiative Young Adult Cohort 

Study showed that respondents who 

identified lesbian, gay, or bisexual had 

higher odds of reporting past 30-day 

flavored large cigar and LCC use 

compared to respondents who identified 

as straight/heterosexual (Ref. 67). 

3. Polyuse of Tobacco and Cigar 

Prevalence 

FDA finds that recent trends toward 

polyuse of tobacco (i.e., the use of two 

or more tobacco products) also support 

the Agency’s conclusion that this 

proposed rule would have positive 

impacts on public health. Polyuse 

increases exposure to nicotine (Ref. 178) 

and other harmful constituents of 

tobacco products and tobacco smoke. 

Using data from the 2017–2018 NYTS 

survey, one study found that 40.8 

percent of middle and high school aged 

youth past 30-day tobacco users were 

using two or more tobacco products in 

the past month (Ref. 107). Among youth 

using cigars in the past 30 days, a 

majority, 76.1 percent, used cigars in 

combination with one or two additional 

tobacco products (Ref. 107). Among 

youth in the 2017–2018 NYTS data, 

cigarettes and e-cigarettes were the most 

common products used alongside cigars 

(Ref. 107). 

The cumulative exposure from 

polyuse can sustain and may increase 

levels of tobacco dependence. A 2017– 

2018 analysis of NYTS data found that 

43.1 percent of youth current cigar 

smokers, including polyusers, reported 

nicotine dependence, including feeling 

strong craving to use a tobacco product 

or using a tobacco product within 30 

minutes of waking (Ref. 107). When 

looking at the association between cigar 

use and dependence, frequent cigar use 

(i.e., use on 20 to 30 days in the past 30 

days) was associated with increased 

odds of nicotine dependence as 

compared to less frequent users (Ref. 

107). Exclusive use of cigars was 

associated with lower odds of 

dependence relative to exclusive use of 

another tobacco product. However, most 

youth cigar users in the study used 

cigars and one or more other tobacco 

products. When cigar use included 

polyuse and exclusive use, youth cigar 

use was associated with twice the odds 

of nicotine dependence (Ref. 107). 

Given the role of frequent and polyuse 

in the relationship between cigar use 

among youth and dependence, the 

authors note ‘‘. . . the importance of 

examining behaviors related to use, as 

they can affect and/or exacerbate the 

risk of nicotine dependence’’ (Ref. 107). 

An analysis of tobacco dependence 

among daily cigarette, cigar, and ecigarette users in the United States, 

using data from the 2012–2013 NATS, 

found that compared to cigarette-only 

smokers, dual cigarette and cigar 

smokers exhibited greater dependence, 

with a higher average number of 

cigarettes smoked per day (17.3 vs. 

15.8), shorter times to first tobacco use 


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17FDA is not aware of additional analyses that 

examine dependence in youth in NYTS data using 

2013–2018 data. 

after waking (21.4 minutes vs. 25.9 

minutes), and more frequent reporting 

of withdrawal and craving symptoms 

compared to exclusive cigarette smokers 

(Ref. 179). In addition, data from Wave 

1 (2013–2014) of the PATH Study 

demonstrates that high nicotine 

dependence is two to three times more 

likely among poly users compared to 

dual and single product users (Ref. 180). 

Data from the 2012 and 2019–2020 

NYTS also noted that reports of 

dependence were consistently 

associated with polyuse (Refs. 181 and 

182).17 FDA anticipates this proposed 

product standard would help to reduce 

the number of cigar users and, therefore, 

the number of tobacco users who are 

poly users and likely even more tobacco 

dependent. 

B. Flavored Cigar Use Exposes Users to 

Additional Toxicants 

All cigar users, including flavored 

cigar users, are exposed to toxicants, 

including more than 50 carcinogens in 

mainstream and sidestream cigar smoke 

(Ref. 183). In flavored combustible 

tobacco products, including cigars, 

additional toxicity can result from the 

chemicals formed when flavors are 

heated or burned (Refs. 184–187). For 

example, acetaldehyde, formaldehyde, 

and benzene were found during 

pyrolysis (i.e., thermal decomposition or 

the process of breaking down a product 

under the presence of heat) of 18 

different cigarette flavor additives, and 

various polycyclic aromatic 

hydrocarbons (PAHs) were also detected 

during pyrolysis of cocoa (Ref. 188). 

Similar results would be expected for 

cigar flavor additives (Ref. 189). A study 

conducted by the Centers for Disease 

Control and Prevention (CDC) identified 

benzyl alcohol, piperonal, methyl 

cinnamate, and vanillin in strawberry 

cigar filler (Ref. 190). The table below 

summarizes examples of known 

respiratory and other relevant toxicities 

associated with these ingredients (and 

subcomponents) and their potential 

pyrolysis products. 

TABLE 2—FLAVOR INGREDIENT PYROLYSIS AND POTENTIAL HEALTH HAZARDS

Flavor ingredient Chemical reaction product Health hazard of flavor ingredient 

Benzaldehyde ......... Benzene, Carbon monoxide (CO) (Refs. 191 and 192) ...................... Respiratory irritant and toxicant (Ref. 193). 

Benzyl alcohol ........ Benzene, toluene (Refs. 194 and 195) ............................................... Acute inhalation toxicant; Nose, throat, and respiratory tract irritant (Ref. 196). 

Ethyl maltol ............. Acetaldehyde, acrolein, CO, formaldehyde, 1,3-butadiene, acetone, 

propionaldehyde, crotonaldehyde, methyl ethyl ketone (Refs. 197 

and 198).

Mutagen (Ref. 199). 

Ethyl vanillin ........... Benzene, naphthalene (Ref. 200) ........................................................ Respiratory irritant (Ref. 201). 

Hexyl acetate ......... CO (Ref. 202) ...................................................................................... Respiratory irritant (Ref. 203). 

Methyl cinnamate ... Styrene (Ref. 185) ............................................................................... Sensitization (Ref. 204). 

Piperonal ................ 1,3-butadieneButadiene, benzene (Ref. 188) ...................................... Mutagenic; hepatoxic in rats (Ref. 205). 

Vanillin .................... Benzene, catechol, naphthalene, phenol, o-cresols, toluene (Refs. 

200 and 206).

Respiratory irritant (Ref. 207). 

FDA expects that the proposed 

product standard, if finalized, would 

result in reduction or removal of such 

flavoring ingredients in cigars. Reducing 

flavoring ingredients in cigars and, 

thereby, reducing these toxicant levels 

in such products would reduce 

consumer exposure to these toxicants 

and help to protect consumers from the 

health effects of these toxicants. 

C. Cigar Use Is Addictive 

Through cigar smoke, nicotine can be 

absorbed by inhalation (like cigarettes) 

or through the oral mucosa (like 

smokeless tobacco). Multiple studies 

found that cigar smokers inhale (as 

evidenced by CO levels), and plasma 

nicotine levels are similar to those of 

cigarette smokers (Refs. 101–104 and 

208). 

All cigars contain nicotine, a highly 

addictive chemical. The Surgeon 

General has long recognized that the 

addictive nature of tobacco products is 

due to the presence of highly addictive 

nicotine that can be absorbed into the 

bloodstream and pass into the brain 

(e.g., Ref. 121). Nicotine is ‘‘one of the 

most addictive substances used by 

humans’’ (Ref. 209). Given that nicotine 

is highly addictive and present in all 

cigars, as experimenters continue to use 

these products, there is a risk of nicotine 

dependence and progression to regular 

use, resulting in an increased risk of 

developing the many negative health 

consequences associated with regular 

cigar use. Prohibiting characterizing 

flavors (other than tobacco) in cigars is 

an important step toward reducing 

experimentation and progression to 

regular use since it can reduce the 

appeal and ease of use of such products 

and, consequently, the likelihood of 

nicotine addiction. 

The amount of nicotine delivered, and 

the means through which it is delivered, 

can either reduce or enhance nicotine’s 

potential for abuse and physiological 

effects (Ref. 6). Generally, the quicker 

the nicotine delivery, rate of absorption, 

and attainment of peak concentrations, 

the greater the potential that an 

individual will become addicted to 

nicotine (Ref. 6). Research has found 

that little cigars deliver nicotine levels 

that are similar to cigarettes and also 

reduce users’ urge to smoke cigarettes 

(Ref. 6). Large cigars can deliver as 

much as ten times the nicotine of a 

filtered cigarette (Ref. 183). Factors 

determinative of cigars’ ability to deliver 

nicotine at a level capable of producing 

dependence include the age of 

initiation, the rate of nicotine 

absorption, the duration of exposure, 

the degree of cigar smoke inhalation, 

and the development of tolerance to 

nicotine (Ref. 210). 

Cigar smoke contains many of the 

same harmful constituents as cigarette 

smoke—including nicotine (Ref. 183). A 

single cigar can contain as much 

tobacco as an entire pack of cigarettes, 

and nicotine yields from smoke from a 

cigar can be up to roughly eight times 

higher than yields from smoke from a 

non-filtered cigarette in machine 

smoking regimens—with delivery of 1.7 

milligrams (mg) in non-filtered 

cigarettes compared to 3.8 mg in little 

cigars, 9.8 mg in cigarillos/other mass 

market cigars, and 13.3 mg in 

‘‘premium’’ cigars (Ref. 183). Although 

the amount of nicotine taken in by a 

cigar user depends on various factors, 


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such as how long the individual smokes 

the cigar, the number of puffs taken, and 

the degree of inhalation, a leading 

review of the science of cigar smoking 

concluded that ‘‘[c]igars are capable of 

providing high levels of nicotine at a 

sufficiently rapid rate to produce clear 

physiological and psychological effects 

that lead to dependence, even if the 

smoke is not inhaled’’ (Ref. 210). 

Research indicates that most cigar 

smokers unknowingly inhale some 

amount of smoke, including cigar 

smokers who report that they do not 

inhale (Ref. 211; see Ref. 212). Youth 

more commonly use cigarillos and little 

filtered cigars that are designed to be 

inhaled, which may increase their risk 

of poor health outcomes as well as 

addiction (Refs. 32 and 183). Little 

cigars are often indistinguishable from 

cigarettes given their shape, size, filters, 

and packaging, and are perceived as 

being healthier than cigarettes (Refs. 48 

and 49). Even if cigar smokers do not 

breathe or inhale smoke into their lungs, 

they are still subject to nicotine’s 

addictive effects through buccal 

absorption of nicotine or nicotine 

absorption through the lips due to cigar 

tobacco’s alkalinity (Refs. 211, 213– 

215). Cigar smoke dissolves in saliva 

and makes it possible for smokers to 

absorb sufficient amounts of nicotine to 

create dependence (Ref. 213). 

Nicotine can exist in protonated and 

freebase, or unprotonated, forms; in the 

freebase form, it is most addictive 

because it is readily absorbed by the 

buccal mucosa, respiratory tissues, skin, 

and the gastrointestinal tract (Refs. 6 

and 121). Freebase, unprotonated 

nicotine amounts are generally higher in 

cigars than cigarettes due to the higher 

pH of cigar smoke (Ref. 183). Nicotine 

absorbed across the buccal mucosa, the 

mouth’s membrane lining, can provide 

sustained amounts of freebase nicotine 

to the tobacco product user, which, 

along with the harshness of cigar smoke, 

may explain why cigar smokers are less 

likely to intend to inhale than cigarette 

smokers (Ref. 183). Cigars can deliver 

nicotine much like chewing tobacco or 

oral snuff, with nicotine extraction from 

the unburned tobacco absorbed directly 

through the buccal mucosa and lips 

(Ref. 183). 

In addition, characterizing flavors 

may impact the effects of nicotine. In 

particular, characterizing flavors, 

including menthol, can activate the 

brain’s reward circuit, producing 

rewarding effects that, when added to 

tobacco products, can reinforce the 

effects of nicotine (Refs. 13 and 14). The 

use of sweet/candy and other 

characterizing flavors that appeal to 

youth produces a robust reinforcing 

effect in young populations (Refs. 13 

and 14). One animal study found that 

flavors can enhance the reinforcing 

effects of low nicotine doses in rodents 

(Ref. 216). The authors of this study 

suggest this effect may influence 

nicotine exposure and subsequent 

dependence. While flavors can activate 

the brain’s reward circuit and produce 

rewarding effects on their own (Ref. 14), 

these findings suggest that flavors and 

nicotine can interact to enhance the 

reinforcing effects of nicotine (Refs. 13, 

216, and 217). Further studies 

demonstrate that menthol, like nicotine, 

binds to nicotinic receptors in the brain 

(Refs. 218 and 219) and menthol alone 

can increase the number of nicotinic 

receptors in the brain (Refs. 220 and 

221). Increases in nicotinic receptors 

can lead to greater withdrawal and 

cravings (Ref. 222). Evidence 

demonstrates that menthol’s effects on 

nicotine in the brain are associated with 

behaviors indicative of greater addiction 

to nicotine (Refs. 220 and 223). In an 

analysis of 2019–2020 NYTS data, use 

of one or more flavored tobacco 

products, including menthol, during the 

past 30 days was associated with higher 

odds of reporting strong cravings and 

desire to use tobacco within 30 minutes 

of waking compared to use of an 

unflavored tobacco product (Ref. 182). 

A cigar smoker’s age is another factor 

that affects susceptibility to nicotine 

addiction. The Surgeon General has 

noted that nicotine dependence in cigar 

smokers could result from even a 

limited exposure to nicotine during 

adolescence (Ref. 6). Analyses of data 

from the 2012 and 2019–2020 NYTS 

found that, although the percentage of 

middle and high school students 

reporting various measures of 

dependence was lower for cigars than 

for cigarettes, youth reported measures 

of nicotine dependence when 

exclusively using cigars (Refs. 181 and 

182). The analysis of 2019–2020 NYTS 

data found that 14.8 percent of middle 

and high school students who only 

smoked cigars reported strong cravings 

for a tobacco product during the past 30 

days (Ref. 182). 

Prohibiting characterizing flavors 

(other than tobacco) in cigars would 

reduce the appeal of cigars, particularly 

among youth and young adults, and 

decrease the likelihood that nonusers 

would experiment with cigars. It also 

would decrease the likelihood that 

current experimenters would continue 

to use these products. Reducing the 

appeal of cigars and experimentation is 

particularly important because, as 

experimenters continue to use these 

products, they can develop dependence, 

leading to regular use and increasing 

their risk of developing the many 

negative health consequences associated 

with regular cigar use. 

D. Research Clearly Demonstrates a 

Causal Relationship Between Cigar 

Smoking and Death and Disease 

Flavored cigar smokers, like all cigar 

smokers, are at increased risk for 

developing cancers of the mouth and 

throat, lung cancer, heart disease, and 

many other adverse health 

consequences, with some groups with 

higher rates of use at greater risk than 

others. As discussed in section V.C of 

this document, those who experiment 

with flavored cigars (due to their appeal 

and ease of use) can develop nicotine 

dependence, placing infrequent cigar 

smokers at risk of progression to regular 

use and to tobacco-related disease and 

death. Studies demonstrate that not only 

is cigar smoking causally associated 

with many of the same diseases as 

cigarette smoking, but cigar smoking 

risks can also exceed those causally 

associated with cigarette use depending 

on the number of cigars smoked and the 

depth of smoke inhalation (Ref. 32). 

Cigar smoke contains many of the 

same harmful constituents as cigarette 

smoke, and cigar smoke may have even 

higher levels of several harmful 

compounds (Refs. 3, 23, and 224). For 

example, cigar smoke contains higher 

amounts of carcinogenic, tobaccospecific N-nitrosamines than cigarette 

smoke due to the relatively high 

concentration of nitrate in cigar tobacco, 

which leads to formation of cancercausing nitrosamines during the 

fermentation process (Refs. 23; 183 at 

Chapter 3; and 224). Researchers have 

found urinary concentrations of NNAL 

(a hazardous tobacco-specific 

nitrosamine) measured in daily cigar 

smokers to be as high as those measured 

in daily cigarette smokers (Refs. 225 and 

226). Like exposure to cigarette smoke, 

exposure to higher levels of cigar smoke 

for longer time periods increases the 

adverse health risks caused by cigar 

smoking (Ref. 6). 

Using NATS data for 2009–2010, 

researchers have estimated that regular 

cigar smoking caused approximately 

9,000 premature deaths or almost 

140,000 years of potential life lost 

among adults 35 years or older (Ref. 3). 

A study of healthcare expenditures from 

2000–2015 found that cigar-attributable 

health care expenditures for adults 

totaled $1.75 billion per year, with $284 

million attributed to exclusive cigar 

smoking and $1.5 billion attributed to 

non-exclusive cigar smoking (i.e., cigar 

plus cigarette or smokeless tobacco use) 

(Ref. 4). The overall mortality rates for 

cigar smokers who inhale generally 


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approach the same mortality rates 

observed for cigarette smokers (Ref. 183 

at 110–112). In addition, overall 

mortality rates for all cigar smokers (i.e., 

those who report inhaling as well as 

those who report not inhaling cigar 

smoke) are higher than rates for those 

who have never smoked, although they 

are generally lower than the rates 

observed for cigarette smokers (Ref. 183 

at 112). A recently published analysis 

using more contemporary data from the 

National Longitudinal Mortality Study, 

following participants for mortality from 

1980 through the end of 2011, also 

found that exclusive cigar smokers had 

an elevated risk of all-cause mortality 

compared to never tobacco users, but 

lower than exclusive cigarette smokers 

(Ref. 227). Another similar analysis 

using the restricted-use National Health 

Interview Survey-Linked Mortality Files 

(NHIS–LMF), following participants for 

mortality from 2000 through 2015, 

observed that current, daily cigar 

smokers had elevated risk of all-cause 

mortality compared to never tobacco 

users (Ref. 228). In addition, researchers 

studying cigar smokers in 2009 and 

2010 found that the average cigar or 

pipe smoker loses approximately 15 lifeyears (Ref. 3). 

Given this causal relationship 

between cigar smoking and all-cause 

mortality, it is critical that FDA propose 

action to decrease the appeal and ease 

of cigar use, making it less likely that 

youth and young adults will experiment 

with cigars or progress to regular use. 

FDA also expects that the proposed 

product standard, if finalized, will cause 

a large number of existing cigar smokers 

to cease combusted tobacco product use 

(as discussed in section VI of this 

document) and, therefore, be less likely 

to suffer the negative health 

consequences of cigar smoking. 

1. Cancers of the Mouth and Throat 

The National Cancer Institute’s 

(NCI’s) Tobacco Control Monograph No. 

9, which provides a comprehensive, 

peer-reviewed analysis of the trends in 

cigar smoking and potential public 

health consequences, identified a doseresponse relationship for cigar smoking 

and certain types of cancer (Ref. 183 at 

120–130). Specifically, NCI’s Tobacco 

Control Monograph No. 9 identified a 

dose-response relationship for cigar 

smoking and oral, laryngeal, pharyngeal, 

and esophageal cancers, finding an 

increased risk of these diseases with 

greater numbers of cigars smoked per 

day and deeper inhalation (Refs. 183 

and 229–232). Likewise, a systematic 

review of the mortality risks associated 

with cigar smoking that identified 22 

studies observed similar dose trends 

(Ref. 32). 

Cigar smoking can cause cancers of 

the mouth and throat even in smokers 

who report they do not inhale (Ref. 183). 

According to the NCI’s Tobacco Control 

Monograph No. 9, the data clearly 

establish that cigar smoking is a cause 

of oral cancer (Ref. 183). Regular cigar 

smokers who have never smoked 

cigarettes, including those who report 

that they do not inhale, experience 

elevated risks for oral, laryngeal, 

pharyngeal, and esophageal cancers 

(Ref. 183). Although former cigarette 

smokers who currently smoke cigars are 

more likely to inhale more deeply than 

cigar smokers who never smoked 

cigarettes, ‘‘the mouth and oral cavity 

are exposed to the carcinogens in smoke 

whether the smoke is inhaled or not’’ 

(Ref. 183). The systematic review of the 

mortality risks associated with cigar 

smoking also noted that the relative 

mortality risk was still highly elevated 

for oral, esophageal, and laryngeal 

cancer among primary cigar smokers 

reporting no inhalation (Ref. 32). Cigar 

smokers, including those who do not 

inhale, have a similar risk of death from 

mouth and throat cancer as do cigarette 

smokers, with an overall risk 7 to 10 

times higher than for those who have 

never smoked (Ref. 183). This similarity 

in risk is likely due to the similar doses 

of tobacco smoke delivered directly to 

the oral cavity and esophagus by cigars 

and cigarettes (Ref. 210). Cigar smokers 

are also more likely to develop mouth 

and throat cancer than those who have 

never smoked. In a large retrospective 

cohort study that included more than 

17,000 men, researchers found that cigar 

smokers were nearly three times more 

likely than nonsmokers to develop 

cancer of the oropharynx and twice as 

likely to develop cancer of the upper 

aerodigestive tract (which includes oral 

cavity, pharynx, larynx, and esophagus) 

(Ref. 229). Those risks increased to 

roughly seven and five times, 

respectively, among those who smoked 

five or more cigars per day (Ref. 229). 

The NCI’s Tobacco Control 

Monograph No. 9 concluded that cigar 

smoking is a cause of laryngeal and 

esophageal cancers (Ref. 183). The 

likelihood of cigar smokers developing 

laryngeal cancer is similar to that of 

cigarette smokers who smoke fewer than 

20 cigarettes per day (Ref. 233). The 

relative risk (i.e., the risk of an outcome 

under study among exposed (smokers) 

compared to unexposed (nonsmokers)) 

of death from laryngeal cancer for those 

who smoke five or more cigars per day, 

or who inhale moderately or deeply, 

approaches the risk for cigarette 

smokers (Ref. 183). This similarity in 

risk is likely due to the similar amounts 

of tobacco smoke delivered directly to 

the oral cavity and esophagus by cigars 

and cigarettes (Ref. 210). Regardless of 

whether smoke is inhaled, the mouths 

and tongues of cigar smokers are 

exposed to a high level of smoke (Ref. 

210). The esophagus is exposed to the 

carcinogens of tobacco smoke, which 

collect on the mouth’s surface and are 

swallowed with saliva, rendering cigar 

smoking a cause of esophageal cancer 

(Ref. 210). The risk of esophageal cancer 

is several times higher for cigar smokers 

than for those who have never smoked, 

and the relative risk of esophageal 

cancer is higher for cigar smokers than 

for cigarette smokers, even when cigar 

smokers are compared to the heaviest 

cigarette smokers (Ref. 234). 

Several multinational research studies 

also have found that cigar smoking can 

cause oral and other cancers, even in 

those who do not inhale smoke. For 

example, the European Prospective 

Investigation into Cancer and Nutrition 

(EPIC) examined 102,395 men from 

Denmark, Germany, Spain, Sweden, and 

the United Kingdom and calculated the 

incidence of cancer in smokers who 

used cigars exclusively and cigar 

smokers who also smoked cigarettes 

(Ref. 235). According to the EPIC study 

findings, exclusive cigar smokers who 

report not inhaling had approximately a 

two-fold higher risk of lung, upper 

aerodigestive tract, and bladder cancers 

combined compared to those who never 

smoked (Ref. 235). This increased risk 

was raised to six- or seven-fold higher 

in cigar smokers who inhaled smoke 

compared to noninhalers (Ref. 235). 

This increased risk by comparison to 

never-smokers was lowest for smokers 

who had quit both cigarettes and cigars 

and higher for those who switched from 

cigarettes to only cigars, demonstrating 

the additional risk associated with cigar 

smoking compared to stopping smoking 

altogether (Ref. 235). Researchers 

confirmed a carcinogenic effect from 

cigar smoking with regard to upper 

aerodigestive tract cancers and found 

that the risk of these hazards increased 

with increased duration of smoking over 

the smoker’s lifespan, increased 

intensity of use per week, and increased 

degree of smoke inhalation per episode 

(Ref. 235). A recently published 

international pooled cohort study found 

that ever cigar smokers had a nonsignificantly elevated risk of head and 

neck cancer and no elevated risk of 

esophageal cancer, although the 

numbers of cancer cases among ever 

cigar smokers were small at 12 for 

esophageal and 38 for head and neck 

cancer (Ref. 236). Such small sample 


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sizes, common in cancer studies given 

the relative rarity of the outcome, can 

limit the ability to observe a statistical 

association in the study. 

In addition, the World Health 

Organization (WHO) International 

Agency for Research on Cancer (IARC) 

published a monograph evaluating the 

carcinogenic risk to humans from 

tobacco smoke and involuntary smoke 

exposure. The IARC explained: ‘‘Cigar 

and/or pipe smoking is strongly related 

to cancers of the oral cavity, 

oropharynx, hypopharynx, larynx, and 

esophagus, the magnitude of risk being 

similar to that from cigarette smoking. 

These risks increase with the amount of 

cigar . . . smoking and with the 

combination of alcohol and tobacco 

consumption’’ (Ref. 224). 

2. Lung Cancer 

The evidence clearly establishes that 

cigar smoking can cause lung cancer; 

the risk varies by number of cigars per 

day and level of exposure (Refs. 32; 183 

at 119–120; and 224 at 1180). A recently 

published international pooled cohort 

study found that ever cigar smokers had 

a statistically significantly elevated risk 

of lung cancer (Ref. 236). 

Like the dose-response relationship 

between cigar smoking and mouth and 

throat cancers, the risk of death and 

disease from lung cancer increases as 

the number of cigars smoked per day 

and the depth of smoke inhalation 

increases (Refs. 32, 183, and 237–239). 

Overall lung cancer risk for cigar 

smokers is lower than the overall risk 

for cigarette smokers (Refs. 229 and 

240–243), but the risk of death from 

lung cancer for cigar smokers may be 

similar to the risk of death from lung 

cancer for cigarette smokers (Refs. 32, 

229, and 237–242) once the rates are 

adjusted for differences in inhalation 

levels and quantity of cigars smoked 

daily (Ref. 183 at 120). Cigar smokers in 

the Cancer Prevention Study I (CPS I), 

conducted from 1959–1972, who 

smoked five or more cigars daily with 

moderate inhalation had a similar risk 

of death from lung cancer as did packa-day cigarette smokers (Ref. 183). 

Former cigarette smokers who 

currently smoke cigars are more likely 

to inhale deeply than cigar smokers who 

have never smoked cigarettes, 

increasing their lung cancer risk (Ref. 

23, citing Ref. 183). Although cigarette 

smokers who switch to smoking only 

cigars have lower lung cancer risks than 

they would have if they had continued 

smoking cigarettes, these risks appear to 

be substantially greater than for 

individuals who have quit smoking 

altogether (Refs. 183 at 155; 239; and 

240). 

Likewise, according to data from the 

Cancer Prevention Study II (CPS II, a 12- 

year study of 1.2 million men and 

women, in which an analysis was 

conducted on a subset of male 

participants from 1982 to 1994 who 

were asked about cigar use), the risk of 

lung cancer mortality was 

approximately five times higher for men 

who were current smokers of only cigars 

at the start of the followup study period 

compared with men who never smoked 

(Ref. 243). In an analysis of a subset of 

men who participated in the CPS II 

study, researchers found that men who 

smoked three or more cigars per day, 

who reported inhaling cigar smoke, or 

who had smoked cigars for 25 years or 

more experienced a statistically 

significantly greater risk of mortality 

from lung cancer than those men who 

reported less frequent cigar use, not 

inhaling, and smoking cigars for 25 

years or less (Ref. 243). Even male cigar 

smokers who reported that they did not 

inhale were approximately three times 

more likely to die from lung cancer than 

those who never smoked (Ref. 243). 

The type of cigar used also may 

impact the risk of lung cancer in cigar 

smokers. One large case-control study 

found that lung cancer patients had 12.7 

times greater odds of being an exclusive 

cigarillo user than controls, compared to 

a 5.6 times greater odds of being an 

exclusive user of cigars other than 

cigarillos (the study was conducted in 

Europe, where cigarillos typically weigh 

1.5 to 3 grams and traditional cigars 

weigh 2 to 8 grams) (Ref. 239). This 

difference was likely due to differences 

in inhalation, as the researchers found 

that cigarillo users were more likely to 

inhale than users of other cigars, and 

inhalers were at higher risk of lung 

cancer than noninhalers (Ref. 239). As 

cigarillo and filtered cigar use has 

increased (and cigarette use has 

decreased over this same period) in the 

United States, it is likely that smokers 

are using such products as substitutes 

for cigarettes and inhaling them as they 

would cigarettes (Refs. 101 and 183). 

Filtered cigars, for example, share many 

of the design characteristics of cigarettes 

(Ref. 49). Therefore, the risk of lung 

cancer for some cigar smokers may be 

similar to that for cigarette smokers. 

3. Heart Disease and Aortic Aneurysm 

Researchers have identified a pattern 

of elevated rates of death from coronary 

heart disease and aortic aneurysm 

among primary cigar smokers who 

smoke heavily or inhale deeply (Ref. 

32). The CPS I (1959–1972), which 

evaluated nearly one million men and 

women in 25 states, found that the rate 

of death from coronary heart disease 

increases with the number of cigars 

smoked and the depth of smoking 

inhalation (Refs. 32 and 183). 

Researchers also identified an elevated 

risk of developing coronary heart 

disease in those individuals who 

smoked five or more cigars per day and 

exhibited moderate or deep inhalation 

(Refs. 32, 183, and 244). CPS I data also 

suggest that cigar smokers are at an 

increased risk for aortic aneurysm, the 

risk rate approaching that observed for 

cigarette smokers (Refs. 32 and 183). 

Researchers analyzing CPS II data also 

examined death rates resulting from 

coronary heart disease related to cigar 

smoking. The 1999 CPS II reviewed 

approximately 7,000 current cigar 

smokers, 7,000 former cigar smokers, 

and 113,000 men who had never 

regularly smoked tobacco to determine 

the risk of heart disease for cigar 

smokers (Ref. 210). Among men younger 

than 75 years old, current cigar smokers 

experienced a coronary heart disease 

death rate about one-third higher than 

those who had never smoked (Ref. 210). 

Additional studies provide supporting 

evidence that cigar smokers have 

elevated rates of developing coronary 

heart disease compared with 

nonsmokers (Refs. 229, 241, and 245). 

One large study examined primary (i.e., 

current, exclusive with no previous 

history of cigarette or pipe tobacco use) 

and secondary (i.e., current, exclusive 

with previous history of cigarette or 

pipe tobacco use) cigar smokers 

compared with never smokers (Ref. 

241). It found that both primary and 

secondary cigar smokers were at 

increased risk of major coronary heart 

disease compared to never smokers (Ref. 

242). Secondary cigar smokers also had 

a higher risk of major stroke compared 

with never smokers (Ref. 241). Primary 

and secondary cigar smokers had 

similar risks of major coronary heart 

disease and stroke and experienced 

outcomes similar to those who smoked 

less than a pack of cigarettes per day 

(Ref. 241). In the recently published 

NHIS–LMF, current, daily cigar smokers 

had a non-significantly elevated risk of 

death due to coronary heart disease 

compared to never tobacco users (Ref. 

228). 

In addition, in 2010, the Surgeon 

General found that for older adult cigar 

smokers, particularly those who smoke 

more than one cigar per day or inhale 

the smoke, the risk of heart disease is 

moderately higher than that for 

nonsmokers (Ref. 6). In support of the 

Surgeon General’s findings, one study 

conducted from 1964 to 1973 involved 

17,774 men ranging in age from 30 to 

85, of which 1,546 smoked cigars and 

16,228 did not, all of whom reported 


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that they had never smoked cigarettes 

and did not currently smoke pipes (Ref. 

229). This study determined that cigar 

smoking was associated with a 

moderate, but statistically significant, 

increase in the risk of coronary heart 

disease (Ref. 229). 

International researchers have 

reached similar conclusions about the 

impact of cigar smoking on the risk of 

developing heart disease. For example, 

in a study of more than 12,000 Danish 

people aged 30 years and older that 

looked at the risk of first acute 

myocardial infarction (MI), researchers 

found the risk of first acute MI escalated 

with increasing depth of smoke 

inhalation and with increasing number 

of cigars smoked per day (Refs. 183 and 

244). Another Danish study found the 

highest rates of myocardial infarction 

for smokers of cheroots (a type of cigar 

with ends that do not taper that is 

traditionally used in India and Burma) 

to be for those individuals who smoked 

six or more cheroots per day, with a 

relative risk of myocardial infarction of 

more than four times the risk of 

individuals who had never smoked (Ref. 

183, citing Ref. 246). 

4. Other Health Outcomes 

Research studies have found that cigar 

smokers have approximately 40 to 45 

percent higher risk of COPD than never 

tobacco users. A cohort study of Kaiser 

Permanente plan members found a 

relative risk of COPD diagnosis of 1.45 

for cigar (Ref. 229), and CPS I data 

found a similar elevated relative risk of 

COPD among primary cigar smokers of 

1.42 (Ref. 247). 

The risk of bladder cancer in CPS I 

data was also approximately 40 percent 

higher for cigar smokers, with a relative 

risk of 1.38 (Ref. 247). In a recently 

published study using data from the 

Agricultural Health Study, ever cigar 

use was statistically significantly 

associated with risk of urinary cancer 

(Ref. 248). 

There are other health outcomes 

attributable to cigar smoking that were 

not assessed using CPS I or II mortality 

data. For example, one study found 

statistically significant increased risks of 

colon and rectal cancers among cigar 

smokers in a cohort of nearly 250,000 

World War I era veterans who were 

followed for mortality for 26 years (Ref. 

249). While most research has focused 

on cigar-attributable mortality, limited 

research has addressed cigar-attributable 

morbidity. Besides dying from cigarattributable disease, lifelong cigar 

smokers may live many years with 

serious medical conditions, such as 

cancers (Refs. 229 and 232), heart 

disease (Refs. 229 and 245), and 

increased airflow obstruction (Ref. 124) 

that can lead to major physical 

impairments, and substantially reduce 

functioning and quality of life. 

5. Impact on Individuals Who Report 

That They Do Not Inhale Smoke 

Studies suggest that even cigar 

smokers who do not intend to inhale 

smoke, and who are unaware they are 

doing so, nonetheless inhale some 

amount of cigar smoke (Refs. 124 and 

212). While inhaling cigar smoke poses 

much higher morbidity and mortality 

rates than not inhaling, substantial risks 

still exist for those cigar smokers who 

may not intentionally inhale smoke. 

Relative mortality risks for oral, 

esophageal, and laryngeal cancers are 

high even among those primary cigar 

smokers who reported that they do not 

inhale cigar smoke (Ref. 32; see Refs. 

183, 230, and 247). Researchers found 

that the risk of stomach cancer mortality 

was also higher among cigar users who 

reported they did not inhale smoke 

when compared to individuals who did 

not use tobacco products (Ref. 250). 

Regardless of whether cigar smokers 

inhale, they are still subject to cigars’ 

addictive and other adverse health 

effects through absorption of nicotine 

and other harmful constituents, 

including those discussed in section V.B 

of this document (Refs. 212 and 250). 

Buccal absorption of nicotine occurs 

even if cigar smoke is not inhaled, and 

cigar smokers may also absorb nicotine 

through the lips due to the alkalinity of 

cigar tobacco (Refs. 214 and 215). This 

greater nicotine yield and absorption 

increases the risk of nicotine addiction 

from cigar smoking. 

E. Secondhand Tobacco Smoke, 

Including Cigar Smoke, Increases the 

Risks of Lung Cancer, Heart Disease, 

and Other Adverse Health Effects in 

Nonsmokers 

Tobacco smoke inhaled by 

nonsmokers in indoor and outdoor 

spaces is most commonly referred to 

today as ‘‘secondhand smoke’’ but has 

also been referred to as ‘‘environmental 

tobacco smoke,’’ ‘‘passive smoke,’’ or 

‘‘involuntary smoke.’’ Extensive data 

exist regarding the dangers of 

involuntary exposure to tobacco smoke. 

It is well established that exposure to 

secondhand tobacco smoke causes 

premature death and disease in youth 

and adults who do not smoke (e.g., Refs. 

251 and 252). Exposure to secondhand 

smoke has immediate adverse effects on 

the cardiovascular system and can cause 

lung cancer, coronary heart disease, and 

stroke (Ref. 251). By reducing the 

prevalence of cigar smoking, this 

proposed standard also has benefits for 

those who do not use cigars. 

Tobacco smoke contains over 7,000 

compounds, and cigars generate more 

than 50 carcinogens in mainstream and 

sidestream smoke (Refs. 23, 183, and 

251). Mainstream cigar smoke is the 

smoke one draws into the mouth from 

the butt end or mouthpiece of a cigar; 

sidestream cigar smoke is the smoke 

emitted from the burning cone of a cigar 

during the interval between puffs (Ref. 

183). Secondhand smoke is a 

combination of sidestream smoke and 

exhaled mainstream smoke. 

While the above data on secondhand 

smoke are related to cigarettes, evidence 

supports the conclusion that these data 

apply to secondhand cigar smoke, as 

well, and there is no basis to conclude 

that secondhand smoke from cigars is 

any less hazardous than secondhand 

smoke from cigarettes. Cigar smoke 

contains the same toxic substances as 

cigarette smoke, with varying 

concentrations of these constituents 

found in different cigar types and sizes 

(Ref. 183). Even though, on average, 

tobacco users smoke more cigarettes 

than cigars, the overall level of toxicants 

in secondhand smoke from cigars can be 

quantitatively higher than in the 

secondhand smoke from cigarettes (Ref. 

183). Cigars also produce much higher 

levels of many indoor pollutants than 

cigarettes, which can be explained, at 

least in part, by the larger size of cigars 

and therefore greater amount of tobacco 

burned compared to cigarettes (Ref. 

183). The smoke from one cigar can take 

5 hours to dissipate, exposing 

household members to a considerable 

involuntary health risk (Ref. 183). 

1. Lung Cancer and Secondhand Smoke 

Exposure of nonsmokers to 

secondhand tobacco smoke has been 

shown to cause a statistically significant 

increase in urinary levels of metabolites 

of tobacco-specific nitrosamines, which 

are carcinogens that specifically link 

exposure to secondhand smoke with an 

increased risk for lung cancer (Ref. 251). 

Studies in rodents have demonstrated 

that 4-(methylnitrosamino)-1-(3- 

pyridyl)-1-butanone specifically induces 

lung tumors by systemic administration, 

which provides support that 

nitrosamines are major factors in the 

development of lung cancer (Ref. 251). 

According to the Surgeon General, there 

is sufficient evidence from which to 

infer a causal relationship between 

secondhand tobacco smoke exposure 

and lung cancer among lifetime 

nonsmokers (Ref. 251). Individuals 

living with smokers had a 20 to 30 

percent increase in the risk of 

developing lung cancer from 


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secondhand smoke exposure, compared 

with individuals living with 

nonsmokers (Ref. 251). Based on the 

similarity of the toxic constituents in 

cigars and cigarettes, and the fact that 

cigars commonly share similar product 

design and mechanisms of smoke 

delivery as cigarettes, FDA’s scientific 

judgment leads the Agency to expect 

that secondhand cigar smoke would 

produce effects similar to those 

produced by secondhand cigarette 

smoke. According to the World Health 

Organization’s International Agency for 

Research on Cancer, a mass balance 

model developed for predicting 

secondhand tobacco smoke was used to 

obtain CO, respirable suspended 

particle, and PAH emission (Ref. 224). 

These observed factors demonstrated 

that cigars can be more potent sources 

of CO than cigarettes (Ref. 224). The 

study also demonstrated that although a 

single cigar may have lower emissions 

of respirable suspended particles and 

PAHs per gram of tobacco consumed 

than a cigarette, a cigar’s larger size and 

longer smoking time results in greater 

total respirable suspended particles and 

PAH emission than a single cigarette 

(Refs. 224 and 253). Findings from the 

NCI Tobacco Control Monograph No. 9 

also demonstrate that carcinogens 

linked to lung cancer would be expected 

to be present at comparable levels in 

cigar and cigarette smoke (Ref. 183). 

Little cigars with filter tips and regular 

cigars contain higher levels of certain 

nitrosamines in sidestream smoke than 

do filtered tip cigarettes (Ref. 183). 

2. Heart Disease and Secondhand 

Smoke 

The evidence cited in Surgeon 

General’s Reports supports the 

conclusion that secondhand tobacco 

smoke exposure can cause heart disease 

and stroke. Although the research 

examining the effects of exposure 

specific to secondhand cigar smoke is 

more limited compared to cigarettes, 

evidence from a recently published 

study suggests that the risk of 

experiencing negative cardiovascular 

effects due to secondhand cigar smoke 

exposure is similar to the risk from 

secondhand cigarette smoke exposure 

(Ref. 254). It is reasonable to anticipate 

that the cardiovascular risks from 

secondhand cigar smoke would be 

similar to those of secondhand cigarette 

smoke due to the similar smoke profiles 

for cigars and cigarettes, the excess risk 

of coronary heart disease associated 

with active cigar smoking, and the low 

levels of toxicant exposure that can 

cause coronary heart disease (Ref. 251). 

In a 2006 report regarding the health 

effects of exposure to secondhand 

tobacco smoke, the Surgeon General 

concluded that exposure to secondhand 

tobacco smoke had immediate adverse 

effects on the cardiovascular systems 

and caused coronary heart disease (Ref. 

251). The estimated increase in coronary 

heart disease risk from exposure to 

secondhand tobacco smoke is 25 to 30 

percent above that of unexposed 

individuals (Ref. 251). Based on these 

data, the Surgeon General concluded 

that ‘‘the evidence is sufficient to infer 

a causal relationship between exposure 

to secondhand smoke and increased 

risks of coronary heart disease 

morbidity and mortality among both 

men and women’’ (Ref. 251). 

3. Other Health Problems 

Studies have concluded that 

secondhand tobacco smoke can cause 

other health problems, specifically for 

youth. Secondhand smoke exposure has 

been independently linked to increased 

inflammatory responses, oxidative 

stress, and endocrine disruption in 

youth (Refs. 255–257). Children exposed 

to secondhand smoke are also at an 

increased risk of sudden infant death 

syndrome, acute respiratory infections, 

ear problems, and more severe asthma 

(Ref. 23). In addition, smoking by 

parents can cause respiratory symptoms 

and slower lung growth in their 

children as compared to the children of 

non-smoking parents (Ref. 23). It is 

expected that these health effects would 

apply to secondhand cigar smoke 

exposure specifically, given the stated 

similarities between cigar smoke and 

other forms of tobacco smoke. 

For all of these reasons and based on 

extensive evidence, it is clear that cigar 

use causes severe negative health 

consequences among users and 

nonusers. As discussed in section VI of 

this document, this proposed rule, if 

finalized, would help to prevent 

experimentation with cigars and 

progression to regular use, and increase 

cessation among current users, which 

would help to lessen the incidence of 

cigar-related negative health 

consequences. 

F. Disparities in Tobacco Use, Including 

Cigar Use, Lead to Disparities in 

Tobacco-Related Morbidity and 

Mortality 

As previously discussed, cigar 

smoking exposes users to the same toxic 

and carcinogenic compounds identified 

in cigarette smoke and is associated 

with many of the same health risks as 

cigarette smoking. As such, this section 

discusses the evidence to support how 

disparities in tobacco use shape 

disparities in tobacco-related morbidity 

and mortality. While the prevalence of 

cigar use has decreased over time for 

non-Hispanic White persons, data from 

the 2002–2016 NSDUH show that cigar 

use has remained stable for nonHispanic Black persons (aged 12 years 

and older) (Ref. 162), while 2000–2015 

NHIS data show increased prevalence 

for non-Hispanic Black adults (aged 18 

years and older) (Ref. 258). In addition, 

differences in cessation and quit 

attempts have been observed across 

population groups. Despite more 

attempts at quitting, Black cigarette 

smokers are less successful at quitting 

than White and Hispanic cigarette 

smokers (Refs. 38, 259, and 260). While 

less is known about disparities in cigar 

cessation, findings from 2013–2016 

PATH data indicate that non-Hispanic 

Black cigar users had lower odds of 

discontinuing cigar use than nonHispanic White users (Ref. 261). 

Collectively, these factors contribute to 

the disparities in tobacco-related health 

outcomes. While the etiology of chronic 

health conditions is multifactorial in 

nature, smoking has been found to be an 

important causal factor (Ref. 23) African 

American adults, and in particular 

African American men, experience the 

highest rates of incidence and mortality 

and lowest rates of survival from many 

tobacco-related cancers, such as lung 

and bronchus cancer and head and neck 

cancer, compared to those from other 

racial and ethnic groups (Refs. 262 and 

263). Deaths from other tobacco-related 

conditions such as heart disease, stroke, 

and hypertension are higher among 

African Americans compared to other 

racial and ethnic groups (Refs. 264– 

269). 

The higher levels of flavored cigar use 

among non-Hispanic Black cigar users 

exacerbate already-existing health 

disparities experienced by the Black 

community (Refs. 163 and 270). Levels 

of nicotine and other carcinogens in 

cigars may be higher than those in 

cigarettes and may be at levels that lead 

to increased risk of morbidity and 

mortality from conditions such as 

cancer, cardiovascular disease, and 

COPD (Refs. 3, 32, and 210). 

Additionally, American Indians or 

Alaskan Natives (AI/ANs) have the 

highest prevalence of overall tobacco 

use compared to members of other racial 

and ethnic groups (Refs. 37, 38, 68, and 

271). Prevalence of cigar smoking 

among AI/ANs is lower than prevalence 

among Blacks, but higher than among 

Hispanics and Asians (Ref. 271). It is 

well documented that AI/ANs suffer 

disproportionately from both lung 

cancer and cardiovascular diseases 

(Refs. 272 and 273). An analysis of 

2001–2009 mortality data for people 

living in the Indian Health Service 


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Contract Health Service Delivery Area 

counties in the United States indicated 

that age-adjusted death rates, smokingattributable fractions, and smokingattributable mortality for all-cause 

mortality were statistically significantly 

higher among AI/AN populations than 

among Whites for adult men and 

women aged 35 years and older (Ref. 

274). Cigarette smoking caused 21 

percent of ischemic heart disease, 15 

percent of other heart disease, and 17 

percent of stroke deaths in AI/AN men, 

compared with 15 percent, 10 percent, 

and 9 percent, respectively, for White 

men (Ref. 274). Among AI/AN women, 

smoking caused 18 percent of ischemic 

heart disease deaths, 13 percent of other 

heart diseases deaths, and 20 percent of 

stroke deaths, compared with 9 percent, 

7 percent, and 10 percent, respectively, 

among White women (Ref. 274). 

Disparities in tobacco-related 

morbidity and mortality have also been 

observed for other population groups 

that have higher levels of tobacco use. 

Those with low household income and 

educational attainment bear a 

disproportionate burden of heart disease 

and stroke incidence and mortality 

(Refs. 275 and 276). National Health and 

Nutrition Examination Survey 

(NHANES) data from 2007 to 2010 

indicate that prevalence of co-occurring 

obesity and smoking was linearly 

associated with educational attainment 

as women with the lowest levels of 

education had greater likelihood of 

being obese smokers than women with 

the highest levels of education (Ref. 

277). Research has also demonstrated 

that individuals with behavioral health 

conditions and other medical 

comorbidities have higher prevalence of 

combusted tobacco use compared to 

those without these conditions (Refs. 

167 and 278) and have increased risk of 

tobacco-related morbidity and mortality 

(Refs. 23, 279, and 280). Inpatient 

hospital admission data from 1990 to 

2005 from California indicate that 

approximately half of the deaths in 

those who had been hospitalized for 

schizophrenia, bipolar disorder, or 

major depressive disorder were due to 

diseases causally linked to tobacco use 

(Ref. 279) and that the majority of 

deaths for those hospitalized for opioidrelated conditions were related to 

tobacco and alcohol, not to opioids (Ref. 

281). In a study of 470 unhoused 

individuals, the analysis found that past 

30-day use of all tobacco products was 

high and that 74.0 percent of 

respondents reported use of cigars and 

over half (55 percent) reported use of 

flavored cigars in the past 30 days (Ref. 

166). Tobacco-related cancers are a 

leading cause of death among adults 

experiencing homelessness (Ref. 165). 

Additionally, the burden of 

secondhand smoke exposure is 

experienced disproportionately among 

members from some racial and ethnic 

groups and people from lower 

household income and educational 

attainment backgrounds. Among 

nonsmokers ages 3 and older, findings 

from 2011–2018 NHANES data indicate 

that non-Hispanic Blacks 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. 282). 

From 1999 to 2012, the percentage of 

the nonsmoking population ages 3 and 

older with detectable serum cotinine 

levels (defined in the study as levels 

≥0.05 ng/mL to indicate secondhand 

smoke exposure) declined across all 

racial and ethnic groups (Ref. 283). 

However, a 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 

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. 283). 

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. 183). 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. 284). 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. 285). While secondhand 

smoke exposure in homes and vehicles 

declined from 2011 to 2018, 

secondhand smoke exposure in homes 

among non-Hispanic Black students did 

not change (Ref. 285). Home smoking 

bans (i.e., 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 and annual household 

income were associated with the higher 

reporting of a complete home ban as 

compared to lower levels of parental 

educational and annual household 

income (Ref. 286). Such findings are 

consistent with a higher degree of 

autonomy over the 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 singlefamily housing, or lack of autonomy 

over the home environment) may 

compound tobacco-related health 

disparities. Workplace secondhand 

smoke exposure has also been shown to 

vary across population groups. Data 

from the 2010 and 2015 NHIS show that 

exposure to secondhand smoke in the 

workplace was disproportionately high 

among non-Hispanic Blacks, Hispanics, 

and workers with low education and 

low income (Ref. 287). 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. 287). 

The disparities observed in tobacco 

and cigar use, as well as disparities in 

secondhand smoke exposure, contribute 

to the disparities in tobacco-related 

morbidity and mortality experienced by 

some population groups. This proposed 

product standard is anticipated to 

reduce smoking-related morbidity and 

mortality for these vulnerable 

populations. 

VI. Determination That the Standard Is 

Appropriate for the Protection of the 

Public Health 

The Tobacco Control Act authorizes 

FDA to adopt tobacco product standards 

by regulation if it finds that a tobacco 

product standard is appropriate for the 

protection of the public health (section 

907(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 


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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 

it would reduce the appeal of cigars, 

particularly to youth and young adults, 

thereby decreasing the likelihood both 

that nonusers would experiment with 

cigars and that current and future 

experimenters would continue to use 

cigars, develop an addiction to nicotine, 

and progress to regular use of cigars 

and/or other tobacco products. 

Additionally, FDA anticipates that the 

proposed standard would improve the 

health of some current smokers of 

flavored cigars by increasing the 

likelihood of cessation. Decreased 

experimentation, progression to regular 

use, and consumption would lead to 

lower disease and death in the U.S. 

population, including in certain 

populations that are disproportionately 

marketed to and bear a disparate burden 

of tobacco-related morbidity and 

mortality. In addition, the population as 

a whole would likely experience health 

benefits based on a likely decrease in 

morbidity and mortality resulting from 

secondhand smoke exposure. 

A. The Likelihood That Nonusers Would 

Start Using Cigars 

Flavors are a significant driver for 

youth and young adults to try cigars. In 

section IV of this document, we 

summarize evidence from multiple 

study designs, incorporating findings 

from qualitative research, and nationally 

representative cross-sectional and 

longitudinal observational studies that 

illustrate the appeal of flavored cigars 

among young people and the role 

characterizing flavors play in 

experimentation and continued cigar 

use. In this section, we discuss how, 

given this evidence and findings from 

policy evaluations of local and national 

jurisdictions, FDA expects the proposed 

standard on characterizing flavors (other 

than tobacco) in cigars would decrease 

experimentation and progression to 

regular use of cigars among current 

nonusers. 

Youth and young adults consistently 

identify the availability of 

characterizing flavors as a leading 

reason for their cigar use (Refs. 64 and 

65). In 2018–2019, 50.4 percent of youth 

(aged 12–17 years) participants in the 

PATH Study who reported past 30-day 

cigar smoking identified flavors as a 

reason for use (Ref. 12). Four systematic 

reviews of the scientific literature 

concluded that flavored tobacco 

products attract youth to the tobacco 

product (Refs. 86–89). Two of the 

reviews that included discussion of 

cigars concluded that characterizing 

flavors were an appealing feature of 

tobacco products and that flavors 

influence perceptions, initiation, and 

progression to use of tobacco products, 

particularly among youth (Refs. 88 and 

89). Similarly, results from qualitative 

research indicate that youth and young 

adults themselves acknowledge that 

flavorings impact their cigar use, 

making smoking flavored cigars more 

palatable than smoking non-flavored 

cigars (Ref. 82). The appeal of flavors is 

also consistent with physiological 

studies assessing youth preference for 

flavors, including studies assessing the 

similarities between flavor chemicals in 

tobacco products with drink mixes and 

candy (Refs. 95 and 96). Overall, the 

literature is consistent on the appeal of 

flavors in tobacco products, including 

cigars (see section IV.D of this 

document). Diminishing the appeal of 

cigars by prohibiting the use of 

characterizing flavors (other than 

tobacco) is, therefore, appropriate for 

the protection of the public health, as it 

would decrease the likelihood of 

experimentation at younger ages and 

reduce the potential for onset of tobacco 

dependence during the progression to 

regular tobacco use. Furthermore, 

flavored cigar use exposes users to more 

toxicants than are present in nonflavored cigars and there is no evidence 

that flavored cigars present any 

countervailing benefits to public health. 

Experimentation with cigars can lead 

to nicotine dependence and regular use, 

as discussed in section IV.E of this 

document. Based on nationally 

representative Truth Longitudinal 

Cohort data from 2014 to 2019, 44.7 

percent of youth and young adults (aged 

15–25 years) who initiated cigar use 

reported current (i.e., past-30-day) cigar 

use 6 months after initiation (Ref. 100). 

When trying a cigar for the first time, 

the majority of youth cigar smokers 

report that the first cigar they used was 

flavored. Data from Wave 5 (2018–2019) 

of the PATH Study revealed that 60.4 

percent of youth (aged 12–17 years) and 

63.2 percent of young adults (aged 18– 

24 years) who reported ever using cigars 

said that the first cigar they used was 

flavored (Ref. 12). 

Using nationally representative 

longitudinal data from Waves 1 (2013– 

2014) and 2 (2014–2015) of the PATH 

Study, one study found that first use of 

a flavored cigar was associated with 

more likely subsequent cigar use 1 year 

later compared to first use of a nonflavored cigar in young adults (aged 18– 

24 years) and adults (aged 25 years and 

older) (Ref. 28). This analysis was 

extended using Waves 1–4 (2013–2017) 

of PATH Study data to assess the 

relationship between new use of a 

menthol- or mint-flavored cigar or other 

flavored (e.g., fruit, alcohol, chocolate, 

candy, and other flavor) cigar with 

subsequent use compared to first use of 

a non-flavored cigar. The analysis found 

that among youth (aged 12–17 years) 

and young adults (aged 18–24 years), 

first use of any menthol- or mintflavored or other flavored cigar was 

associated with current past 30-day use 

of flavored cigars at a later wave 

compared with first use of a nonflavored (i.e., tobacco) cigar (Ref. 29). 

Specifically, youth who used a menthol/ 

mint-flavored cigar or other flavored 

cigar were 72 percent (menthol/mint) 

and 47 percent (other flavor) more 

likely, respectively, to be using a cigar 

a year or more later compared to those 

first using a non-flavored cigar. 

Similarly, young adults (aged 18–24 

years) who used a menthol/mintflavored cigar or other flavored cigar 

were 71 percent (menthol/mint) and 52 

percent (other flavor) more likely to be 

using a cigar a year or more later 

compared to those first using a nonflavored cigar. For both youth and 

young adults, the association between 

the first flavor used and subsequent 

cigar use was not statistically 

significantly different for menthol- or 

mint-flavored compared to other 

flavored cigars. These results are 

consistent with the evidence that flavors 

enhance the addictive effects of nicotine 

and make cigars easier to use, as 

discussed previously. FDA finds that 

eliminating flavored cigar varieties 

likely would decrease the number of 

youth and young adults experimenting 

and progressing to regular, sustained 

use of cigars. 

Given that nicotine is highly addictive 

and present in all cigars, as 

experimenters continue to use these 

products, there is a risk of development 

of nicotine dependence and progression 

to regular use. Several studies found 

that cigars reduce craving and urge to 

smoke similar to cigarettes (Refs. 101– 

103). The adolescent brain is more 

vulnerable to developing nicotine 


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dependence than the adult brain. 

Nicotine can disrupt brain development 

and have long-term consequences, 

including decreasing attention and 

increasing impulsivity, which could 

promote the maintenance of nicotine 

use behavior (Ref. 288). Therefore, 

progressing to regular use during 

adolescence can have lasting 

consequences and signs of nicotine 

dependence are evident in young cigar 

users. Researchers analyzing data from 

the 2017–2018 NYTS found that 43.1 

percent of middle and high school 

students using cigars in the past 30 days 

reported nicotine dependence, 

including feeling a strong craving to use 

a tobacco product or using a tobacco 

product within 30 minutes of waking 

(Ref. 107). 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 cigar experimentation among youth 

and young adults in the United States. 

It is also important to note the role 

that cigars play in polyuse patterns, and 

the subsequent development of 

dependence, among youth tobacco 

users. As polyuse increases, youth 

exposure to nicotine increases (Ref. 17), 

increasing the risk of dependence 

among young people (Refs. 181 and 

182). When looking at the association 

between cigar use and dependence, 

exclusive use of cigars among youth in 

the 2017–2018 NYTS was associated 

with lower odds of nicotine dependence 

relative to exclusive use of another 

tobacco product. However, when youth 

cigar use included polyuse, which was 

more common for youth cigar users, 

current cigar use was associated with 

twice the odds of nicotine dependence 

compared to current use of any other 

tobacco product (Ref. 107). See section 

V.A.3 of this document for additional 

discussion regarding polyuse. 

Similar to cigarette smoking, first 

cigar use often occurs during youth or 

young adulthood (Refs. 24 and 25). A 

longitudinal analysis of Waves 1–4 

(2013–2017) of PATH Study data found 

an increasing probability of initiating 

cigar use between ages 15 and 20 years, 

with the greatest increase in first use 

between 17 and 18 years of age (Ref. 25). 

FDA expects a substantial reduction 

in youth and young adult initiation and 

progression to regular use of cigars, 

which would ultimately protect many 

youth and young adults from a lifetime 

of addiction, disease, and death 

attributable to cigar smoking. There are 

multiple sources of evidence to inform 

the Agency’s analysis of how the 

proposed standard would affect the 

likelihood that nonusers would start to 

experiment and continue using cigars 

(Refs. 28, 29, and 100). First, many 

individuals who initiate cigar use 

transition to more regular use. One 

analysis of data from a nationally 

representative cohort found that 44.7 

percent of youth and young adults who 

initiated cigar use became a regular user 

6 months after first trying a cigar (Ref. 

100). Next, several studies suggest that 

when individuals initiate cigar use, it is 

often with a flavored product. PATH 

researchers found that 60.4 percent of 

youth (aged 12–17 years) and 63.2 

percent of young adults (aged 18–24 

years) who reported ever using cigars 

said that the first cigar they used was 

flavored (Ref. 12). Lastly, analyses of 

PATH data also suggest that initiation 

with a flavored cigar is associated with 

a greater likelihood of progressing to 

regular use compared to initiation with 

a non-flavored cigar. In a cross-sectional 

analysis of the PATH study, young adult 

(aged 18–24 years) and adult ever 

tobacco users (aged 25 years and older) 

who initiated with a flavored cigar were 

more likely that those who initiated 

with a non-flavored cigar to be a current 

regular cigar user, after controlling for 

demographics, education, income, age at 

first tobacco use, substance use, and 

mental health indicators (Ref. 289). In a 

longitudinal analysis using Waves 1 to 

4 (2013–2017) of PATH Study data, 

youth and young adults who used a 

mint or menthol cigar or other flavored 

cigar were more likely to be past-30-day 

cigar users at a subsequent wave 

compared to those first using a nonflavored cigar, after controlling for 

sociodemographics (Ref. 29). Together 

these study results indicate that 

experimentation with cigars is 

associated with progression to regular 

use, the majority of youth and young 

adults who initiate cigar use do so with 

flavored cigars, and initiating with 

flavored cigars (compared to nonflavored cigars) is associated with an 

increased risk of current and ongoing 

tobacco use, as compared to 

experimentation with non-flavored 

cigars. To the extent that youth and 

young adult cigar users using a flavored 

cigar on their first use would not 

otherwise initiate with non-flavored 

cigars or other tobacco products, the 

proposed standard would prevent future 

tobacco-related disease and death 

among these youth and young adults. 

In addition to longitudinal studies 

illustrating the role of flavors in youth 

and young adults progressing from 

experimenting with flavored cigars to 

regular use, policy evaluations from 

local jurisdictions throughout the 

United States illustrate how a flavor 

restriction can decrease youth cigar use. 

Section IV.F of this document discusses 

results from evaluation studies of 

restrictions on the sale of tobacco 

products with characterizing flavors in 

jurisdictions throughout the United 

States and in Canada. Studies of policies 

implemented in Providence, RI; New 

York, NY; Lowell, MA; Attleboro and 

Salem, MA; Minneapolis and St. Paul, 

MN; San Francisco, CA; and Canada 

focused on the impact of flavored 

tobacco sales restrictions on youth use 

of tobacco products, including cigars 

and are informative to FDA’s 

consideration of how the proposed 

standard would impact the likelihood of 

tobacco use among youth. 

In Providence, RI, at 3 years and 5 

years following implementation of the 

city’s restriction on flavored tobacco 

products except menthol, mint, and 

wintergreen, youth current use of any 

tobacco product had declined, from 22.2 

percent in 2016 to 12.1 percent in 2018; 

and current use of cigars/cigarillos had 

declined from 7.1 percent in 2016 to 1.9 

percent in 2018 (Ref. 60). Three years 

after implementation of a restriction on 

flavored tobacco products except 

menthol, mint, and wintergreen, in NYC 

in 2010, youth (13–17 years) had 37 

percent lower odds of reporting having 

ever tried a flavored tobacco product, 

and 28 percent lower odds of ever using 

tobacco products in 2013 compared to 

2010 (Ref. 51). Six months after enacting 

a restriction on flavored tobacco 

products except menthol in 2016, 

researchers in Lowell, MA, found that 

youth current use of any flavored 

tobacco products decreased in Lowell 

from baseline to followup (¥2.4 

percent), with a statistically significant 

difference between Lowell and an 

observed increase in flavored tobacco 

use in the comparison community (3.3. 

percent) (Ref. 61). In the Twin Cities, 

MN, two cross sectional studies were 

administered before and after 

implementation of a restriction on 

flavored tobacco products first 

excluding menthol, mint, and 

wintergreen in 2016 and then after the 

policy was expanded to include 

menthol, mint, and wintergreen in 2018 

(Ref. 111). Comparing the two cities to 

the rest of the State, the study found 

that when the first policy was 

implemented the prevalence of cigar use 

did not change in the Twin Cities 

among 6th to 12th grade students, but 

cigar use increased 71.3 percent in the 

rest of the State. The analysis also found 

that between 2016 and 2019, when the 

flavor restriction also included menthol, 

cigar use among 8th, 9th, and 11th grade 

students declined more in the Twin 


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Cities compared to the rest of the State 

(Ref. 111). In San Francisco, CA, 

following implementation of the city’s 

restriction on flavored tobacco products, 

including menthol, among a small 

convenience sample of young adults 

ages 18 to 24 years surveyed after policy 

implementation there was a statistically 

significant decrease in flavored cigar use 

(from 19.4 to 6.5 percent) (Ref. 62). An 

evaluation of a national flavored tobacco 

policy in Canada that restricted flavored 

tobacco products except menthol 

cigarettes and cigars under 1.4 grams (or 

in any cigar that had a filter or nonspiral wrap) is consistent with local 

flavored tobacco policies in the United 

States regarding decreased use of cigars 

among young people and found a 

statistically significant 2.3 percentage 

point decrease in past 30-day cigarillo 

use among young people aged 15 to 24 

years 1 year after policy implementation 

(Ref. 113). Most of these studies of local 

flavored tobacco policies in the United 

States describe concerns with 

compliance and enforcement of the 

policies, noting potential increases in 

cross-border sales and observed retail 

sales of flavored product in defiance of 

implemented policies. FDA anticipates 

that a nationwide standard that 

prohibits the manufacture and sale of 

flavored cigars would likely have a 

greater impact in decreasing youth cigar 

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 for youth to easily travel to 

neighboring jurisdictions that do not 

have a flavor prohibition or use online 

retailers to purchase flavored cigars. 

As described in section IV.B of this 

document, an estimated 960,000 youth 

reported past 30-day use of cigars in 

2020, with an estimated 550,000 youth, 

reported using a flavored cigar during 

the past 30 days (Ref. 8). Given the 

measured decrease in youth tobacco use 

consistent across U.S. localities that 

have recently implemented restrictions 

on the sale of flavored tobacco, FDA 

expects that many of these youth would 

be discouraged from continued 

experimentation with cigars as a result 

of the proposed standard. In contrast to 

the locality restrictions discussed 

previously, FDA’s proposed product 

standard would result in a 

comprehensive regulation restricting 

both the manufacturing and sale of 

cigars with characterizing flavors in the 

United States. Evaluations of retailer 

compliance following implementation 

of local flavor restrictions suggest that 

incomplete compliance led to 

availability of violative products in 

retail environments, which likely 

diminished the impact of the 

restrictions (Refs. 108 and 109). Unlike 

a restriction on sales alone, the 

proposed standard would prohibit both 

the manufacture and sale of cigars with 

characterizing flavors (other than 

tobacco), and as a result, it would allow 

for a more complete prohibition of 

flavored cigar products from the market. 

It is therefore likely that the impact of 

the FDA product standard on youth and 

young adult cigar smoking would be 

greater than that observed among the 

evaluation studies discussed previously. 

In summary, across varying study 

populations and research study designs, 

evidence shows that the presence of 

characterizing flavors in tobacco 

products enhances the appeal of tobacco 

products to young people and is 

associated with experimentation and 

progression to regular tobacco use. 

Characterizing flavors also can activate 

the brain’s reward circuit and reinforce 

tobacco use. Prohibiting characterizing 

flavors (other than tobacco) in cigars 

would eliminate rewarding and 

reinforcing associations with the 

product among youth and would result 

in a marketplace that solely consists of 

(mostly already existing) cigar products 

that have harsher, more astringent cigar 

smoke that are likely less appealing to 

novice users. Evidence from five U.S. 

localities and Canada consistently 

indicate that prohibiting sales of 

flavored tobacco decreased youth and 

young adult use of tobacco, including 

cigars. In nationally representative 

estimates, most youth and young adults 

report initiating use with a flavored 

cigar (Ref. 12). In addition, results from 

a large national study observed a 

relationship between first use of a 

flavored cigar and regular cigar use in 

youth and young adults (Refs. 28 and 

29). Therefore, a prohibition on 

characterizing flavors (other than 

tobacco) in cigars would reduce the 

likelihood that youth and young adults 

would initiate cigar use and also mean 

fewer youth and young adults 

progressing to regular cigar use. For 

these reasons, FDA expects that 

prohibiting characterizing flavors as 

described in this proposed rule would 

reduce the likelihood that youth would 

experiment with and continue to use 

cigars and would ultimately reduce 

future disease and death associated with 

long-term cigar smoking. 

B. The Likelihood That Existing Users 

Would Reduce Cigar Consumption or 

Stop Cigar Smoking 

FDA expects that the prohibition of 

characterizing flavors (other than 

tobacco) in cigars, as proposed, would 

result in changes in tobacco use patterns 

among current smokers of flavored 

cigars. In addition to the long-term 

public health benefits that would accrue 

from the prevention or reduction of 

cigar smoking among youth and young 

adults, FDA anticipates that the 

proposed standard would increase the 

likelihood that some existing flavored 

cigar smokers would find tobaccoflavored cigars unappealing and 

consequently stop smoking cigars 

altogether, yielding health benefits from 

smoking cessation. For instance, current 

flavored cigar smokers may quit cigar 

use altogether, transition to tobaccoflavored cigars or other combusted 

tobacco products, or switch to other 

potentially less harmful tobacco 

products. Given the substantial 

proportion of existing cigar users using 

flavored cigars, the consistently high 

endorsement of characterizing flavors as 

a reason for use, empirical evidence of 

lower tobacco sales (as a proxy for 

consumption) following a flavored 

tobacco product restriction in multiple 

localities, and evidence suggesting 

decreased cigar use among adult 

consumers following implementation of 

flavor restrictions in two studied 

localities, FDA expects that the 

proposed standard would lead many 

flavored cigar smokers to reduce or stop 

using cigars. 

In section IV.D of this document, we 

discussed how the addition of 

characterizing flavors improves the taste 

of tobacco and decreases the harshness 

of tobacco smoke. While the evidence 

shows that use of flavored tobacco 

products, including flavored cigars, is 

particularly concerning among youth 

and young adults, millions of adults 

report using flavored tobacco products 

(Ref. 63). According to Wave 5 (2018– 

2019) data from the PATH Study, among 

young adult past 30-day cigar smokers 

18–24 years old, 38.3 percent reported 

that the cigar product they smoked in 

the past 30 days was flavored (Ref. 63). 

Similarly, among adult cigar smokers 

aged 25 years and older, 36.0 percent 

reported past 30-day use of a flavored 

cigar (Ref. 63). Many adult cigar 

consumers consistently identify the 

availability of characterizing flavors as a 

reason for their cigar use. An analysis of 

Wave 5 (2018–2019) PATH Study data 

indicated that among young adults (aged 

18–24 years) who used cigars some or 

every day, 54.1 percent of traditional 

cigar users, 66.5 percent of cigarillo 

users, and 65.1 percent of filtered cigar 

users reported flavoring as a reason for 

cigar use (Ref. 12). Similarly, among 

adults over 25 years old who used cigars 


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18Study data from the Twin Cities, MN, Lowell, 

MA, and Attleboro and Salem, MA, only looked at 

youth use and not sales data and thus is not 

included in this aspect of the discussion. 

every or some days, 54.8 percent of 

traditional cigar users, 69.6 percent of 

cigarillo users, and 71.4 percent of 

filtered cigar users reported flavoring as 

a reason for cigar use (Ref. 12). There 

was not a statistically significant 

difference by age group in reporting 

flavors as a reason for use (Ref. 12). In 

totality, such data from large national 

observational studies show that the 

availability of flavors is a contributing 

factor to young adult and adult cigar 

use. In addition, proprietary data 

gathered by Euromonitor International 

in March 2021 reveals that, in 2020, 

flavored cigars accounted for nearly half 

of all cigar sales in the United States 

(41.9 percent). 

Data from three U.S. localities 

(Providence, RI; New York, NY; and San 

Francisco, CA) 18 as well as Canada 

provide real-world evidence of the 

potential behavioral impacts the 

proposed product standard could have 

on cigar sales as a proxy for 

consumption with two localities (San 

Francisco, CA, and Canada) providing 

additional data suggesting a decline in 

cigar use among current cigar smokers. 

In Providence, following 

implementation of the city’s restriction 

on flavored tobacco products, except 

menthol, mint, and wintergreen, there 

was a 31 percent decrease in total cigar 

sales of flavored and unflavored cigars 

and a 51 percent decrease in average 

weekly sales of flavored cigars in 

Providence following policy 

implementation (Ref. 109). Sale of 

explicit flavor-named cigars (e.g., 

cherry) declined after policy 

implementation while concept flavornamed cigars (e.g., ‘‘jazz’’) increased 

(Ref. 109). However, the increase in 

sales of concept flavor-named cigars did 

not completely offset the decrease in 

explicit flavor-named cigars (Ref. 109). 

In New York, following 

implementation of a restriction on 

flavored tobacco products except 

menthol, mint, and wintergreen, in NYC 

in 2010, researchers found that the 

flavor restriction was associated with an 

approximate 15 percent to 20 percent 

reduction in total cigar sales in NYC, 

relative to the proximal area (Ref. 108). 

Flavored cigar sales in NYC declined 28 

percent while sales of flavored cigars 

increased in the 10 non-NYC 

comparison counties surrounding the 

city (+3.2 percent) pre-post policy 

implementation (Ref. 108). 

In San Francisco, CA, following 

implementation of the city’s restriction 

on flavored tobacco products, including 

menthol, sales of flavored tobacco 

products overall and of flavored cigars 

specifically decreased a statistically 

significant 96 percent from the prepolicy period and overall cigar sales 

decreased a statistically significant 51 

percent (Ref. 52). There was a 

statistically significant decrease in the 

prevalence of flavored cigar use in a 

small convenience sample of young 

adults aged 18 to 34 years who used 

tobacco products prior San Francisco’s 

restriction (Ref. 62). In Canada, 

following implementation of a national 

flavored tobacco policy that restricted 

flavored tobacco products except 

menthol cigarettes and cigars under 1.4 

grams (or in any cigar that had a filter 

or non-spiral wrap), cigar sales 

decreased when comparing 6 years 

before policy enactment to 6 years after 

enactment (Ref. 112). In addition, 

following Canada’s restriction on 

flavored cigarillos, young people aged 

15 to 24 reported a significant increase 

in past 30-day abstinence in cigarillo 

use among prior cigarillo smokers (Ref. 

113). 

The findings from evaluations in 

these three U.S. localities and Canada, 

drawing on both changes in sales data 

as well as behavioral changes, including 

increased abstinence in use of cigars 

among previous smokers as discussed in 

this section, are applied by FDA to 

inform our conclusions about the extent 

to which flavored cigar smokers would 

quit smoking cigars under the proposed 

standard. The findings from Canada 

also, as discussed in section IV.F of this 

document, help to support these 

conclusions by FDA regarding the 

impact of the proposed standard on 

current cigar smokers. These data 

provide evidence of the general 

behavioral responses we would expect 

to see in response to the proposed 

standard; however, we acknowledge 

there are limitations to these findings. 

These limitations include a reliance on 

aggregate tobacco sales information as a 

proxy for consumption, rather than data 

concerning individual-level tobacco use 

behaviors; the potential that smokers 

obtained flavored cigars through 

alternate means (e.g., internet sales) or 

switched to non-cigar products, which 

may have resulted in an overestimation 

of the impacts; and evidence of 

incomplete compliance with the 

restriction and exemptions for some 

retail establishments (e.g., tobacco bars), 

which may have resulted in an 

underestimation of the impacts of the 

prohibition. In addition, evidence from 

the evaluations of the impact of local 

restrictions on the sale of flavored 

tobacco products suggest that 

enforcement of such restrictions was not 

complete (see Refs. 108 and 109). 

Therefore, the estimated effect of local 

restrictions on flavored cigars may 

underestimate the effect of the proposed 

flavor standard since such standard 

would apply to cigar manufacturers as 

well as retailers, thus reducing the 

probability that violative products 

would make their way onto store 

shelves. Despite these limitations in 

generalizing findings from local 

jurisdictions, these real-world 

evaluations provide important insight 

into how sales and tobacco use change 

in response to restrictions on flavored 

tobacco products, including cigars. 

These evaluation studies provide 

important insight into how the proposed 

prohibition on characterizing flavors 

(other than tobacco) in cigar products 

could reduce the rate of youth and 

young adult experimentation and 

progression to regular tobacco use and 

increase cessation among current cigar 

smokers. 

Additionally, the proposed product 

standard is anticipated to promote the 

public health by addressing the 

disproportionate burden of cigar use 

among current users from vulnerable 

populations and promoting better health 

outcomes within those groups. As 

described in section V.A of this 

document, compared to non-Hispanic 

White adults, non-Hispanic Black adults 

are more likely to report that they have 

ever been a ‘‘fairly regular’’ cigar smoker 

and to report that they smoke cigars 

daily (Ref. 163). Hispanic adults are 

more likely to smoke cigars within 30 

minutes of waking than non-Hispanic 

White adults (Ref. 162). Adults who 

identify as LGBTQ+ are more likely to 

use tobacco products and to meet the 

criteria for nicotine dependence when 

compared to their heterosexual and 

cisgender peers with findings being 

more pronounced for some racial and 

ethnic groups such as LGBTQ+ persons 

who are Hispanic and non-Hispanic 

Black (Refs. 68, 157, 159, 160, and 170– 

173). As described in section V.F of this 

document, disparities in cigar use likely 

contribute to the disproportionate 

burden of tobacco-related morbidity and 

mortality that are observed for some 

population groups. For example, 

findings from 2013–2016 PATH data 

indicate that non-Hispanic Black cigar 

users had lower odds of discontinuing 

cigar use than non-Hispanic White users 

(Ref. 261); additionally, while cigar use 

has decreased over time for nonHispanic White adults, the data indicate 

that cigar use has remained stable or 

increased for non-Hispanic Black adults 


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over time (Refs. 162 and 179). African 

American adults experience some of the 

highest rates of morbidity and mortality 

from tobacco-related disease such as 

heart disease, stroke, and hypertension 

(Refs. 264–269), which may be 

attributed to the disproportionate levels 

of cigar use observed within that 

population. Based on these findings, the 

proposed product standard is 

anticipated to benefit the population as 

a whole by addressing disparities 

associated with cigar use, dependence, 

cessation, and, thus, tobacco-related 

morbidity and mortality. 

The sum of the available evidence, 

including the current use of flavored 

cigars by millions of Americans, the 

consistently high acknowledgement of 

characterizing flavors as a reason for 

using cigars among youth and adults, 

and the empirical evidence of lower 

tobacco sales (as a proxy for 

consumption) and tobacco use 

prevalence data following flavored 

tobacco product restrictions in multiple 

U.S. jurisdictions as well as Canada, 

supports FDA’s finding that the 

proposed product standard would lead 

many flavored cigar smokers to stop 

using combusted cigars, yielding 

considerable health benefits. 

C. Benefits and Risks to the Population 

as a Whole 

As discussed in section IV.D of this 

document, the presence of 

characterizing flavors enhances the 

appeal and ease of cigar use among 

youth and young adults. We expect that 

the proposed product standard, if 

finalized, would reduce tobacco-related 

harms by reducing this appeal and ease 

of use. Anticipated reductions in 

population harm would be realized 

through both long-term health benefits 

resulting from prevention of cigar 

uptake among youth and young adults 

as described in section VI.A of this 

document, as well as more immediate 

health benefits (e.g., improved 

breathing) resulting from increased 

cessation of cigar use among current 

flavored cigar smokers, as described in 

section VI.B of this document. In this 

section, we summarize the health effects 

of cigar smoking and describe analyses 

used to demonstrate anticipated 

population health benefits from the 

proposed standard in terms of decreased 

initiation and progression to regular use 

and decreased mortality attributable to 

cigar smoking in the United States. 

Additionally, the proposed product 

standard is anticipated to improve 

health outcomes in populations that 

have historically experienced tobaccorelated health disparities related to 

flavored tobacco product use and, 

specifically, flavored cigar use. As 

described in section IV.G of this 

document, tobacco companies have 

strategically marketed flavored cigars to 

underserved communities over many 

decades. The tobacco industry 

continues to target these populations 

with tailored cigar marketing practices 

that contribute to and reinforce these 

longstanding and entrenched cigar 

disparities. As described in section V.A 

of this document, prevalence of cigar 

use is disproportionately high among 

certain population groups such as nonHispanic Black youth (Ref. 7), youth 

who identify as lesbian, gay, bisexual, or 

transgender (Refs. 7, 157, and 158), and 

youth with disabilities (Ref. 161). After 

initiating cigar use, members of these 

vulnerable populations are more likely 

to progress to regular cigar use or 

display patterns of more frequent use 

(Ref. 100). Because nonusers, 

particularly youth, from vulnerable 

populations are more likely to 

experience adverse effects from prior 

cigar use, the proposed product 

standard is anticipated to promote 

improved health outcomes within these 

population groups. 

1. Flavored Cigar Smoking and Adverse 

Health Effects 

As described in section V.D of this 

document, cigar smoking, including 

flavored cigar smoking, causes many of 

the same serious health conditions as 

cigarette smoking (Ref. 32). As also 

noted, FDA has conducted and 

published a systematic review of cigar 

smoking-attributable mortality risks and 

estimates of regular cigar smokingattributable mortality for the U.S. 

population (Refs. 3 and 32). NCI 

previously reviewed the studies that 

were available on cigar smoking 

mortality risks and reached similar 

general conclusions (Ref. 183). Both 

reviews found that cigar smoking causes 

oral, esophageal, pancreatic, laryngeal, 

and lung cancers, as well as coronary 

heart disease and aortic aneurysm (Refs. 

32 and 183). These conclusions were 

based primarily on statistically 

significant risk estimates for primary 

cigar smokers who had never regularly 

used other tobacco products such as 

cigarettes that were calculated from 

American Cancer Society’s CPS I and II 

data. The CPS I and II were large 

longitudinal cohort studies of cancer 

risk factors in the U.S. population that 

each enrolled at least one million 

participants (Ref. 290). The CPS I began 

in 1959 and the CPS II in 1982 (Ref. 

290). Researchers assessed the mortality 

followup for participants through 

followup visits or linkage with the 

National Death Index (Refs. 243 and 

290). Numerous studies have been 

published that analyze and quantify 

tobacco-attributable mortality risks 

using CPS I and II data, including 

studies of cigar smoking-attributable 

mortality risks (Refs. 243, 247, and 291). 

While findings using CPS I and CPS II 

data are representative of historical 

cohorts of U.S. residents, a more recent 

analysis was conducted using data from 

participants in the TUS–CPS from 1992 

to 2011 in the National Longitudinal 

Mortality Study, following participants 

for mortality through the end of 2011 

(Ref. 227). Results from this study 

regarding elevated risk of all-cause and 

cause-specific mortality among 

exclusive current cigar smokers 

compared to never tobacco users were 

generally consistent with estimates from 

CPS I and II (Ref. 227). 

Research studies have found that cigar 

smokers have approximately 40 to 45 

percent higher risk of COPD than never 

tobacco users (Refs. 229 and 247). 

Similarly, the risk of bladder cancer in 

CPS I data was also approximately 40 

percent higher for cigar smokers (Ref. 

247). 

There may be other health outcomes 

attributable to cigar smoking that were 

not assessed using CPS I or II mortality 

data. For example, Heineman et al. 

found statistically significant increased 

risks of colon and rectal cancers among 

cigar smokers in a cohort of nearly 

250,000 World War I era veterans who 

were followed for mortality for 26 years 

(Ref. 249). Patterns of flavored cigar use 

may have also changed over time and 

could contribute to health risks. While 

most research has focused on cigarattributable mortality, limited research 

has addressed cigar-attributable 

morbidity. Besides dying from cigarattributable disease, lifelong cigar 

smokers may live many years with 

serious medical conditions, such as 

cancers (Refs. 229 and 232), heart 

disease (Refs. 229 and 245), and 

increased airflow obstruction (Ref. 124) 

that can lead to major physical 

impairments, reduce functioning and 

quality of life, and produce appreciable 

health care costs and medical 

expenditures. 

2. Estimated Impacts of the Proposed 

Standard on Cigar Smoking Initiation 

and Progression to Regular Use 

As described throughout this 

document, the proposed standard is 

expected to have substantial public 

health benefits. Significant benefits are 

expected to come from the prevention of 

cigar smoking initiation and progression 

to regular use among youth and youth 

adults, resulting in reduced morbidity 

and premature mortality. To estimate 


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19This estimate is based on Reference 28 in 

which the adjusted prevalence ratio = 1.56, 

meaning that, after accounting for other factors in 

the model, such as demographics, individuals who 

initiated with flavored cigars were 56 percent more 

likely to currently use them. 

these benefits, we have updated an 

analysis published by Rostron et al. in 

2019 that examined the potential effects 

of the product standard on each cohort 

of 18-year-olds in the United States (Ref. 

292). Beginning with the 4.26 million 

18-year-olds in 2019 (Ref. 293), we 

estimate that 3.9 percent of these 

individuals were current cigar users at 

that age, based on PATH Study Wave 5 

data of self-reported every day or 

someday cigar use (Ref. 12). We also use 

PATH data to estimate that 63.6 percent 

of these cigar smokers initiated cigar use 

with a flavored product, resulting in 

approximately 106,000 18-year-olds 

who currently use cigars and had 

initiated cigar use with a flavored 

product (Ref. 12). 

We then estimate the proportion of 

these cigar users who would have 

initiated cigar smoking with nonflavored cigars in the absence of 

flavored cigars. Consistent with Rostron 

et al., we assume that the lower bound 

would be 35 percent, equal to the 

proportion of cigar users who currently 

initiate with non-flavored products, and 

that the upper bound would be 100 

percent, which reflects complete 

substitution with non-flavored cigars. 

We use the midpoint of these values, 

67.5 percent, as our main estimate, so 

32.5 percent of those currently initiating 

with flavored cigars would be deterred 

from trying cigars, and we estimate that 

approximately 34,000 (106,000 × 32.5 

percent) cigar smoking initiates would 

be prevented by the product standard 

from initiating cigar use in this model. 

We also considered the possibility that 

flavored cigar initiates are more likely to 

continue cigar use than those who 

initiate with non-flavored products. 

PATH Study data from Waves 1 (2013– 

2014) and 2 (2014–2015) show that 

adult ever cigar users who initiated with 

flavored cigars are more likely to be 

current regular cigar users than ever 

users who initiated with non-flavored 

cigars, controlling for other relevant 

factors related to cigar use (Ref. 28). 

Similar estimates were obtained from 

analysis of Waves 2–4 (2014–2017) 

PATH Study data, although results were 

presented separately for mint- or 

menthol-flavored cigars and other 

flavored cigars (Ref. 29). We therefore 

estimate that approximately 26,000 

[106,000 × (1.0¥32.5 percent) × 

(1.0¥(1.0/1.56 19))] cigar smokers would 

be prevented from continuing to regular 

use by the product standard for a total 

reduction of 60,000 current cigar 

smokers in each cohort of 18-year-olds. 

Consistent with the prior analysis 

(Ref. 292), we account for the 

uncertainty inherent in estimating the 

impact of the proposed policy based on 

these data and conducted Monte Carlo 

simulations using @RISK statistical 

software to assess the effects of varying 

key data inputs. We conducted 1,000 

simulations, with reductions in cigar 

initiation ranging from 0 to 65 percent 

and reductions in continuing use 

ranging from 22.5 percent (1.0¥1.0/ 

1.29) to 46.5 percent (1.0¥1.0/1.87), 

among those who would have otherwise 

initiated cigar use with flavored cigars. 

Ninety percent of the resulting estimates 

were between 42,000 and 75,000 cigar 

users prevented in each cohort. 

3. Estimated Impacts of the Proposed 

Standard on Mortality 

In the preceding section, we describe 

the longer-term benefits of the proposed 

standard that would include prevention 

of disease and premature death among 

youth and young adults who are 

discouraged from taking up cigar 

smoking in the absence of access to the 

flavored cigars covered by the proposed 

standard. Over a shorter term, health 

benefits would come from decreased 

tobacco product use including cessation 

among those who currently use flavored 

cigars. In this section, our estimation of 

public health impacts focuses on the 

reduction in cigar-attributable deaths 

that would occur if such flavored cigars 

were removed from the market. To be 

clear, these estimates significantly 

understate the public health benefits 

because they do not include lives saved 

of youth and young adults who, as the 

result of the product standard, do not 

begin to smoke. 

To estimate the potential impact of 

the proposed standard on mortality, we 

again updated a previously published 

analysis (Ref. 292), which began with an 

estimate of the current number of deaths 

that are attributable to regular cigar 

smoking in the United States on an 

annual basis. We then removed deaths 

due to dual cigar and cigarette use to 

specifically estimate mortality due to 

exclusive cigar smoking given that dual 

users may continue to use combusted 

tobacco products. Mortality estimates 

are not available for other combinations 

of polytobacco use involving cigars, but 

over 90 percent of cigar users who are 

polytobacco users use cigarettes (Ref. 

294). Consistent with the prior analysis 

(Ref. 292), we applied a range of 

estimates for the reduction in total cigar 

consumption that reflects behavioral 

evidence from multiple localities’ 

flavored tobacco restrictions as well as 

information on the size of the flavored 

U.S. cigar market. These estimates were 

then translated to potential behavior 

change to estimate the number of deaths 

in the United States that would be 

prevented each year among exclusive 

regular cigar smokers as a result of the 

proposed standard. 

We based our estimate of the annual 

mortality attributable to cigar smoking 

in the United States on a previously 

published analysis (Ref. 3). This 

analysis modified the SmokingAttributable Mortality, Morbidity, and 

Economic Costs methodology, used by 

the CDC to estimate cigarette smokingattributable mortality, to quantify the 

mortality burden of regular cigar 

smoking in the United States in 2010 for 

adults aged 35 years or older (Ref. 3). 

The analysis estimated that regular cigar 

smoking (defined in the study as 

smoking cigars on 15 or more of the past 

30 days) was responsible for 

approximately 9,000 premature deaths 

annually and that 5,200 of these deaths 

occurred among regular cigar smokers 

who did not also currently smoke 

cigarettes (hereafter referred to as 

exclusive cigar smokers) (Ref. 3). 

Because it is possible that some dual 

cigarette and cigar smokers might 

replace their cigar use with cigarette use 

if flavored cigars were prohibited, our 

analysis used the latter estimate of 5,200 

deaths as the basis for quantifying the 

benefits of the proposed standard. This 

is a conservative approach because it 

does not account for any health benefits 

among dual users who quit tobacco or 

cigar use as a result of the proposed 

standard. As data from the NHIS from 

2000–2019 has shown relatively stable 

cigar use prevalence estimates among 

adults, this estimate of 5,200 premature 

deaths also serves as a general measure 

of the effects of exclusive regular cigar 

smoking (i.e., non-dual) on mortality in 

the United States in subsequent years 

(Ref. 3). Although youth cigar smoking 

has declined in recent years, the longterm implications for regular cigar 

smoking in this population are unclear. 

These estimates are based on an 

expectation that the number of 

premature deaths from cigar use would 

remain constant over time in the 

absence of regulatory action. 

Conceivably, the number of cigarattributable premature deaths could rise 

due to population growth even if cigar 

smoking rates remained constant, or the 

number could fall if cigar-smoking rates 

fell by more than the population growth. 

We then estimated the fraction of 

deaths that would be avoided if the 

proposed standard were in effect as 

proposed. As discussed in section IV.F 

of this document, real-world experience 


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20Study data from Lowell, MA, and Attleboro and 

Salem, MA, only looked at youth use and not sales 

data and thus is not included in this aspect of the 

discussion. 

21All estimates are rounded to the nearest 100. 

See FDA’s Preliminary Regulatory Impact Analysis 

(Ref. 298) for unrounded estimates. 

regarding the impact of flavored tobacco 

restrictions across U.S. jurisdictions 

suggests that the removal of flavored 

cigars from the U.S. market would lead 

consumers who now smoke flavored 

cigars to alter their behavior and some 

of these individuals would reduce their 

use of cigars or quit smoking cigars 

completely, others would product 

switch entirely to other tobacco 

products. We used data from the 

Providence, NYC, and San Francisco 

areas because these cities’ restrictions 

on the sale of flavored tobacco products 

provide the best available U.S. data on 

the effect of real-world, implemented 

restrictions on cigar sales, and thus 

consumption.20 Several studies 

conducted analyses using Nielsen retail 

scanner data to assess changes in the 

number of cigars sold (both flavored and 

non-flavored) in Providence, NYC, and 

San Francisco before and after the flavor 

restrictions went into effect (Refs. 52, 

108, and 109). For comparison, they also 

examined sales over the same timeframe 

in the rest of Rhode Island in the 

Providence analysis, in nine counties 

proximal to NYC, as well as sales in the 

United States overall, in the NYC 

analysis, and in San Diego and San Jose 

in the San Francisco analysis. Using a 

times series analysis, the study of 

Providence estimated the effect of the 

flavor restriction to be a 31 percent 

reduction in overall cigar sales (Ref. 

109). This analysis also found that the 

restriction was associated with an 

approximate 15 percent to 20 percent 

reduction in overall NYC cigar sales, 

relative to the proximal area or the 

United States overall. The study of San 

Francisco found that the flavor 

restriction was associated with a 51 

percent reduction in overall cigar sales 

(Ref. 52). Importantly, these decreases in 

overall cigar sales indicate that 

consumers did not completely 

substitute non-flavored cigars for 

flavored cigars because of the restriction 

(Ref. 108). The data also suggest that 

cross-border purchasing of flavored 

cigars was limited. For example, the 

NYC study found that flavored cigar 

sales in the ten-county area surrounding 

NYC declined after the implementation 

of NYC’s flavor restriction, although the 

change was not statistically significant 

(Ref. 108). 

We note that the decline in flavored 

and overall cigar sales occurred despite 

incomplete compliance in some 

localities, such as the NYC ordinance 

(Ref. 108). The NYC study found that 

flavored cigars, specifically, continued 

to be sold at persistently high levels in 

NYC in violation of the restriction. FDA 

anticipates the proposed product 

standard would have a greater impact 

on public health than the NYC flavor 

sales restrictions. Unlike a restriction on 

sales alone, the proposed standard 

would prohibit both the manufacture 

and sale of cigars with characterizing 

flavors (other than tobacco), and as a 

result, it would allow for a more 

complete prohibition of flavored cigar 

products from the market. Moreover, 

FDA anticipates that this nationwide 

product standard would eliminate the 

opportunity for consumers to travel to 

local neighboring U.S.-based 

jurisdictions that do not have a flavor 

prohibition or use online retailers to 

purchase flavored cigars. 

In our analysis, cigar sales are used as 

a proxy for consumption, given we 

expect sales and consumption to be 

highly correlated. We start with a 30 

percent relative decrease in total cigar 

sales as our main estimate in the 

analysis, using a rounded estimate of 31 

percent reduction in overall cigar sales 

observed in Providence, which provided 

the midrange of estimates from the three 

evaluation studies. For the reasons 

described in this section, FDA considers 

the impacts of the NYC flavor restriction 

on total cigar sales (i.e., 15–20 percent 

reduction in overall cigar sales in NYC) 

to be a conservative estimate of what the 

reduction in total cigar consumption in 

the United States overall would be if the 

proposed standard were implemented. 

We therefore use an estimated 15 

percent relative decline in total cigar 

sales as a lower bound of the impact of 

this proposed product standard as a 

conservative estimate, which would 

suggest some substitution with nonflavored cigars. 

An alternate scenario is one in which 

the proposed flavored tobacco products 

are removed from the U.S. market after 

implementation of the proposed 

standard and no substitution of nonflavored cigars occurs among 

consumers. In this case, the impact of 

the proposed standard on total cigar 

consumption would be equivalent to the 

fraction of the total U.S. cigar market 

comprised of flavored cigars. 

Proprietary data gathered by 

Euromonitor International in March 

2021 reveals that approximately 41.9 

percent of 2020 cigar (including 

cigarillo) unit sales in the United States 

were for flavored varieties. In this 

alternative scenario, if there is no 

switching from flavored to non-flavored 

cigar varieties, then overall cigar sales, 

and subsequently consumption, would 

decrease by 41.9 percent. We use this 

figure as the upper bound for the 

decrease in total cigar sales following 

implementation of the product standard. 

As noted, the reduction in cigar sales 

observed in San Francisco following 

implementation of a flavored tobacco 

product restriction was consistent with 

such a decrease at 51 percent (Ref. 52). 

Next, we estimate the mortality effects 

of these reductions in cigar 

consumption. The proposed standard is 

expected to result in some consumers 

quitting smoking cigars entirely, others 

cutting back on cigar smoking. To 

estimate how reductions in 

consumption at the population-level 

may be distributed across individual 

consumer behaviors, we use data from 

studies of other tobacco control policies. 

These studies can inform estimates of 

potential effects of the proposed 

standard on cigar use. A robust evidence 

base exists to characterize the impact of 

tobacco taxes on consumption and 

behavior. Data from studies on the 

impacts of cigarette tax increases on 

smoking behaviors suggest that 

approximately half of observed 

reductions in cigarette sales are due to 

smokers quitting, while the remainder 

are due to reducing or cutting back on 

the number of cigarettes smoked (Ref. 

295). For this analysis, we assume that, 

among exclusive cigar smokers who 

would change their smoking behavior 

due to the standard, approximately 50 

percent would quit smoking entirely, 

while the other 50 percent would cut 

back. To be conservative, we assume 

there are no benefits in avoided 

mortality among those who cut back and 

avoided mortality is only counted 

among those who quit smoking entirely. 

This estimate may be somewhat 

conservative because some studies have 

found some health and mortality 

benefits from substantial reductions in 

cigarette consumption, although these 

benefits are less than those from 

complete smoking cessation (Refs. 296 

and 297). 

We use these inputs in our analysis. 

By multiplying the estimated 5,200 

annual exclusive cigar attributable 

deaths previously described by 30 

percent due to decline in cigar sales, 

and then reducing that value by 50 

percent to reflect benefits only for those 

who quit entirely, we estimate that the 

proposed standard would result in 

approximately 800 annual averted 

deaths.21 We again conducted Monte 

Carlo simulations using @RISK 

statistical software to assess the effect of 

varying key data inputs. We ran 1,000 


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simulations using 15 percent and 42 

percent as the lower and upper bound 

of decreases in total cigar consumption 

and 25 percent and 75 percent as the 

lower and upper bound for the 

proportion of decreased consumption 

due to complete cessation, and 90 

percent of the resulting estimates fell 

within a range of approximately 400 to 

1,100 deaths averted annually. 

FDA anticipates that a reduction in 

deaths attributable to cigar use would 

begin to accrue soon after 

implementation of the proposed 

standard (see Ref. 298 at section II.F). It 

would take time to fully realize the 

mortality benefit of the proposed 

standard, given that some cigar smokers 

may still die of a smoking-related 

disease due to previous use, even if they 

quit cigar use after the proposed 

standard is implemented. Given that 

lung cancer has been estimated to be 

responsible for the majority of deaths 

attributable to cigar smoking (Ref. 3), we 

base the timeframe for reduction in risk 

on this cause. Estimates from 

contemporary cohort data have found 

that full reductions in lung cancer risk 

after smoking cessation can take an 

extended time period; consequently, we 

used a time period of 30 years (Ref. 

299). Reductions in risk from other 

causes such as cardiovascular disease 

are expected to be realized more quickly 

(Refs. 300 and 301). Benefits from 

reductions in cigar-related morbidity 

would also be expected to accrue more 

quickly. 

We also estimate the years of life that 

would be gained due to the product 

standard. Nonnemaker et al. estimated 

that the approximately 9,000 annual 

deaths that are attributable to regular 

cigar smoking correspond to nearly 

140,000 years of potential life lost 

(YPLL) (Ref. 3). This represents an 

average of 15.1 years of life lost per 

death. We multiply the approximately 

774 deaths annually averted by the 

product standard by the 15.1 average 

years of life lost per attributable death 

and estimate that approximately 11,687 

YPLLs are associated with the 

premature mortality that would be 

prevented by the product standard each 

year. 

This analysis has concentrated on 

mortality effects, given the availability 

of specific estimates for cigar smokingattributable mortality and mortality 

risks, but we also anticipate reductions 

in cigar smoking-attributable morbidity 

due to the product standard. It has been 

estimated that regular cigar smoking is 

directly responsible for approximately 

9,000 deaths among U.S. adults 

annually (Ref. 3) and that cigarette 

smoking is directly responsible for 

approximately 437,000 deaths annually 

among U.S. adults (Ref. 23 at 659). It has 

also been estimated that U.S. adults 

suffer from approximately 14 million 

major medical conditions due to 

cigarette smoking (Ref. 302). These 

figures suggest that current and former 

cigarette smokers are living with 

approximately 30 major medical 

conditions due to cigarette smoking for 

every premature death that occurs each 

year. Since regular cigar smoking causes 

premature death from some of the same 

conditions as cigarette smoking, we 

would expect a considerable disease 

burden attributable to cigar smoking 

among U.S. adults, along with reduction 

in this burden as a result of the 

proposed standard. 

In addition, the population would 

experience health benefits based on a 

decrease in morbidity and mortality 

resulting from secondhand smoke 

exposure. According to the Surgeon 

General, there is sufficient evidence 

from which to infer a causal 

relationship between secondhand 

tobacco smoke exposure and lung 

cancer, as well as increased risks of 

coronary heart disease morbidity and 

mortality, among lifetime nonsmokers 

(Ref. 251 at 15). Individuals living with 

smokers had a 20 to 30 percent increase 

in the risk of developing lung cancer 

from secondhand smoke exposure (Ref. 

251 at 15). Likewise, the estimated 

increase in coronary heart disease risk 

from exposure to secondhand tobacco 

smoke is 25 to 30 percent above that of 

unexposed individuals (Ref. 251 at 519). 

Based on the similarity of the toxic 

constituents in cigars and cigarettes, and 

the fact that cigars commonly share 

similar product design and mechanisms 

of smoke delivery as cigarettes, FDA’s 

scientific judgment leads the Agency to 

expect that secondhand cigar smoke 

would produce effects similar to those 

produced by secondhand cigarette 

smoke, meaning that the proposed rule, 

if finalized, would decrease morbidity 

and mortality caused by secondhand 

exposure to cigar smoke. 

These sections have focused on the 

potential benefit to the U.S. population 

as a whole from the proposed product 

standard, accounting for the potential 

decreased experimentation and 

progression to regular use among 

nonusers that would be prevented from 

trying flavored cigars, as well as 

potential decreased consumption or 

increased cessation among current 

flavored cigar smokers. Thus, we 

anticipate the proposed product 

standard would continue to produce 

reductions in morbidity and mortality 

over the long term, due in large part to 

the reduction in eventual adverse health 

effects from cigars due to reduced 

initiation and use among young people. 

One additional potential health 

benefit to continuing users of cigars that 

could result from the proposed product 

standard would be decreased exposure 

to potentially toxic flavor compounds, 

as discussed in section V.B of this 

document. In combusted tobacco 

products, such as cigarettes and cigars, 

toxicity can result from the chemicals 

formed when flavors are heated or 

burned (Refs. 184–187). For example, a 

study conducted by the CDC identified 

benzyl alcohol, piperonal, methyl 

cinnamate, and vanillin in strawberry 

cigar filler (Ref. 190) (see table 2 in this 

document for potential health hazards 

of these ingredients). While some 

flavoring compounds naturally occur in 

tobacco and the resulting standard may 

not fully eliminate such toxic 

exposures, reducing toxicant levels in 

these products would reduce consumer 

exposure and could protect consumers 

from the health effects of these 

toxicants, particularly from adverse 

respiratory effects. 

4. Potential Risks to the Population as 

a Whole of the Proposed Cigar Flavors 

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. 

Possible countervailing effects on 

current tobacco users could include 

continued combusted tobacco product 

smoking 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 such as adolescent tobacco 

users and other population subgroups. 

With the removal of characterizing 

flavors (other than tobacco) in cigar 

products, some cigar smokers may seek 

other sources of tobacco and/or 

nicotine. These could include nicotine 

replacement therapy products, which 

are products authorized by FDA to help 

people quit using tobacco products. 

However, some smokers may also 

transition to tobacco-flavored cigars, 

other combusted tobacco products, or 

other potentially less harmful tobacco 

products. As discussed in section VI.B 

of this document, if youth 

experimenters or users of flavored cigars 

were to switch to cigarettes or to other 

tobacco products as a result of flavored 

cigars no longer being available, it is 

possible that the benefits of the rule 

would be reduced. The availability of 

menthol cigarettes, if it continues after 


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flavored cigars are no longer available, 

may make this switch more likely and 

diminish the benefits. However, the 

proposed rule would not be expected to 

increase risks to individual or public 

health, since cigar and cigarette smokers 

suffer many of the same adverse health 

outcomes attributed to combusted 

tobacco use. In addition, FDA has 

considered the possibility that youth or 

adults will form a misperception that 

non-flavored cigars are safe or pose no 

substantial health risks (and that this 

misperception would impact behavior) 

because FDA has not similarly 

prohibited their continued availability. 

However, FDA is not aware of any 

evidence suggesting such 

misperceptions would or would not 

occur and will monitor for any such 

effects if this product standard is 

finalized. Should the Agency find 

evidence of such misperceptions, FDA 

would direct public education efforts 

toward such misperceptions and would 

consider taking other action as 

appropriate. 

FDA recognizes that, while some 

flavored cigar users may switch to 

tobacco-flavored cigars, this potential 

countervailing effect would not 

outweigh the benefits from cigar users 

who quit smoking completely. FDA has 

no reason to believe that individuals 

switching from flavored (other than 

tobacco-flavored) cigars to other 

combusted tobacco products would be 

exposed to additional harm beyond 

their current exposure level. There is no 

available data to suggest, for example, 

that the prohibition of characterizing 

flavors (other than tobacco) in cigars 

would increase the frequency or depth 

of smoke inhalation of tobacco-flavored 

cigars, make tobacco-flavored cigars 

more toxic to individual users or those 

who inhale secondhand smoke, lead to 

increased initiation, or make it more 

difficult for current tobacco users to 

quit. As explained elsewhere in this 

document, it is anticipated that the 

toxicity of flavored cigars could likely 

be diminished if this proposed rule is 

finalized. FDA requests comments 

regarding additional evidence on the 

extent and magnitude that flavored cigar 

users could potentially switch to other 

tobacco products, including tobaccoflavored cigars. 

In addition, FDA is considering 

whether illicit trade could occur as a 

result of a cigar flavor 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. 303). In 2015, the NRC/IOM 

issued its final report entitled 

‘‘Understanding the U.S. Illicit Tobacco 

Market: Characteristics, Policy Context, 

and Lessons from International 

Experiences’’ and concluded that 

‘‘[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. 303 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, March 16, 2018). 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. 43). 

A study regarding a restriction on 

menthol cigarettes in Canada is 

instructive here. Researchers studied the 

effects of the first ever complete sales 

restriction of menthol cigarettes, which 

was issued in the Canadian province of 

Nova Scotia (Ref. 304). The researchers 

found that the menthol restriction did 

not result in an increase in illicit 

cigarettes seized (Ref. 304). The Nova 

Scotia tax authorities estimated that the 

‘‘prevalence of illegal tobacco in the 

province had actually decreased, from 

30 percent of all tobacco consumed in 

2006–2007 to less than 10 percent in 

2016–2017’’ (Ref. 304). This is evidence 

that a major change to the availability of 

certain tobacco products is not likely to 

lead to a surge in illicit tobacco product 

use. 

FDA requests comments regarding 

whether and to what extent this 

proposed rule would result in an 

increase in illicit trade in flavored cigars 

and how any such increase could 

impact the marketplace or public health. 

If an illicit market develops after this 

proposed product 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 VIII.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 product 

standard is finalized and goes into 

effect, it would be illegal to import 

cigars with characterizing flavors (other 

than tobacco), 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 flavored cigars, including 

those sold online, and doing so may 

result in FDA initiating enforcement or 

regulatory actions. 

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 

flavored cigars. 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 concerns 

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 

minimal. Therefore, these potential 

effects would not outweigh the potential 

benefits 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. 

D. Conclusion 

In this section, we have reviewed 

multiple lines of evidence to assess the 

likely impact of the proposed 

prohibition on characterizing flavors 

(other than tobacco) in cigars on current 

nonusers, tobacco users, and the U.S. 

population as a whole. With respect to 

the impact on nonusers, the Agency 


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anticipates prevention of initiation and 

progression to regular tobacco use 

among youth and young adults, as well 

as reductions in exposure to 

secondhand cigar smoke, although this 

population health benefit is not 

quantified in our calculations. With 

respect to youth initiation and use, the 

Agency anticipates that prohibiting 

characterizing flavors (other than 

tobacco) in cigars as proposed would 

eliminate the availability of products 

that are more appealing to novice users 

and avoid rewarding and reinforcing 

associations with the characterizing 

flavor among youth. In addition to 

decreased experimentation, this is 

expected to lead to decreased use. The 

best available evidence regarding the 

role of flavored cigars and progression 

to regular use suggests that youth 

initiating with flavored cigars are more 

likely to progress to regular use. Policy 

evaluations from local jurisdictions 

throughout the United States (NYC, NY; 

Providence, RI; Lowell, MA; Twin 

Cities, MN; and San Francisco, CA) 

showed that youth and young adult 

tobacco use decreased when flavored 

cigars were removed from the market. In 

order to prevent future addiction, 

disease, and death associated with longterm cigar smoking, FDA proposes to 

prohibit characterizing flavors (other 

than tobacco) in cigars. 

FDA also anticipates that the 

proposed product standard would 

increase the likelihood that some of the 

estimated 3 million adult flavored cigar 

smokers would reduce the number of 

cigars they smoke or quit smoking cigars 

entirely instead of completely 

substituting non-flavored cigars for 

flavored cigars. Evidence shows that 

flavor availability is consistently a 

highly endorsed reason for cigar use 

among youth, young adult, and adult 

cigar smokers (Refs. 12 and 28). 

Characterizing flavors in tobacco 

products ensure pleasant flavor and 

taste, reduces the harshness, bitterness, 

and astringency of tobacco during 

inhalation and soothes irritation during 

cigar smoking. When flavored cigar 

products were removed from the market 

in NYC, Providence, San Francisco, and 

Canada analyses showed subsequent 

reductions in total cigar sales. Taken 

together, this suggests the proposed 

standard would lead some flavored cigar 

smokers to smoke fewer cigars or quit 

cigar use entirely, decreasing total cigar 

consumption notwithstanding any 

substitution with non-flavored cigars. 

Cigar smoking causes many of the same 

diseases as cigarette smoking, including 

oral, esophageal, pancreatic, laryngeal 

and lung cancers, as well as coronary 

heart disease and aortic aneurysm (Refs. 

32 and 183). Our evidence review 

indicates that, by increasing cessation 

among cigar smokers who would 

otherwise use a flavored tobacco 

product, the proposed standard would 

reduce cigar-attributable deaths and 

disease in the United States and would 

not result in any increase in deaths or 

disease from the use of other tobacco 

products. In addition to reductions in 

premature death, cigar smokers who 

quit would gain improved quality of life 

from the reduced risk or prevention of 

major medical conditions attributable to 

cigar smoking. 

Additionally, FDA anticipates that the 

proposed tobacco standard will improve 

health outcomes within groups that 

experience disproportionate levels of 

tobacco use, including certain 

vulnerable populations. Longstanding 

disparities in cigar use are the result of 

decades of cigar marketing targeted at 

underserved communities and the role 

of flavors in nicotine addiction and 

dependence. FDA anticipates that the 

prohibition of characterizing flavors in 

cigars will reduce initiation and 

experimentation with cigar smoking 

(particularly by youth and young 

adults), decrease the likelihood of 

nicotine dependence and addiction, and 

increase the likelihood of cessation. 

These public health benefits are 

expected to be particularly pronounced 

among vulnerable populations who 

experience the disproportionate impact 

of cigar use. 

In total, this evidence supports the 

conclusion that a prohibition on 

characterizing flavors (other than 

tobacco) in cigars would be appropriate 

for the protection of the public health. 

The Agency anticipates the proposed 

standard would result in decreased 

experimentation and progression to 

regular use among youth and young 

adults, and increased cessation among 

current cigar smokers, would lead to 

lower disease and death in the U.S. 

population in both the short term and 

long term, due to diminished exposure 

to tobacco smoke among both users and 

nonusers of cigars. 

VII. 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 

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 a 

smoke constituent), or other component 

of a tobacco product because FDA has 

found that the additive, 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 

parties 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 the Tobacco 

Products Scientific Advisory Committee 

(TPSAC) at the Agency’s own initiative 

or in response to a request for good 

cause 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. 


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26434 Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 

22Products that were commercially marketed in 

the United States as of February 15, 2007 (referred 

to as ‘‘pre-existing tobacco products,’’ previously 

referred to as ‘‘grandfathered products’’), are not 

considered new tobacco products and do not 

require prior authorization to be legally marketed 

(section 910(a) of the FD&C Act). 

23A product is ‘‘handmade or hand rolled’’ if no 

machinery was used apart from simple tools, such 

as a scissors to cut the tobacco prior to rolling. 

B. Pathways to Market 

To legally market a new tobacco 

product 22 in the United States, a 

tobacco product must receive 

authorization from FDA permitting the 

marketing of the new tobacco product 

under one of three pathways: (1) The 

applicant obtains an order under section 

910(c)(1)(A)(i) of the FD&C Act (21 

U.S.C. 387j(c)(1)(A)(i)) (order after 

review of a premarket tobacco product 

application under section 910(b)); (2) 

the applicant obtains an order finding 

the new tobacco product substantially 

equivalent to a predicate tobacco 

product and in compliance with the 

requirements of the FD&C Act under 

section 910(a)(2)(A)(i) (order after 

review of a substantial equivalence (SE) 

report submitted under section 905(j) of 

the FD&C Act); or (3) the applicant 

makes a request under 21 CFR 1107.1 

and obtains an exemption from the 

requirements related to SE (section 

905(j)(3)(A)) (21 U.S.C. 387e(j)(3)(A)), 

and at least 90 days before commercially 

marketing the product, submits a report 

under section 905(j) including the 

information required in section 

905(j)(1)(A)(ii) and (B) of the FD&C Act. 

Applicants may be able to use the SE 

exemption pathway for products 

seeking to comply with this proposed 

standard by making a minor 

modification to an additive in their 

product, if FDA finds, among other 

things, that: (1) The modification is 

‘‘minor’’; (2) an SE Report is not 

necessary to ensure that permitting the 

product to be marketed would be 

appropriate for the protection of the 

public health; and (3) an exemption is 

otherwise appropriate (section 

905(j)(3)(A) of the FD&C Act). For 

example, FDA has previously issued 

exemption orders for tobacco products 

where there was deletion of casing 

flavor or L-menthol from a combusted 

cigarette. However, to the extent 

manufacturers change their flavored 

cigars to comply with this rule, FDA 

requests comments regarding how they 

might satisfy the premarket review 

requirements of the Tobacco Control 

Act. 

C. Considerations and Request for 

Comments on Scope of Products 

As indicated throughout this 

document, FDA has determined that the 

proposed standard, which would apply 

to all flavored cigars (other than 

tobacco) and their components or parts, 

is appropriate for the protection of the 

public health. The proposed scope of 

this rule—applying to all cigars, rather 

than only a subset of cigars—is 

important to protect public health and 

is justified by existing evidence. All 

cigars are combusted tobacco products 

that may be used by youth and that 

expose users to nicotine, a highly 

addictive substance, and many other 

toxic chemical constituents. Cigars are 

not a safe alternative to other tobacco 

products, including other combusted 

products such as cigarettes. In addition, 

these products pose no potential for 

positive net public health impact by 

means of reduced risk or harm. 

Cigars may vary in size, from smaller 

cigars which may resemble cigarettes in 

size and shape, such as little cigars or 

cigarillos, to larger ones, such as cigars 

referred to as ‘‘premium’’ cigars. In 

August 2020, as part of its decision in 

Cigar Association of America, et al. v. 

Food and Drug Administration, et al. 

(Cigar Association case), the U.S. 

District Court for the District of 

Columbia ‘‘remand[ed] the [deeming 

final rule] to the FDA to consider 

developing a streamlined substantial 

equivalence process for premium 

cigars’’ and ‘‘enjoin[ed] the FDA from 

enforcing the premarket review 

requirements against premium cigars 

. . . until the agency has completed its 

review.’’ Under the terms of, and for the 

purposes of, the court’s order, a 

premium cigar is defined as a cigar that 

meets all of the following eight criteria: 

1. Is wrapped in whole tobacco leaf; 

2. contains a 100 percent leaf tobacco 

binder; 

3. contains at least 50 percent (of the 

filler by weight) long filler tobacco (i.e., 

whole tobacco leaves that run the length 

of the cigar); 

4. is handmade or hand rolled; 23

5. has no filter, nontobacco tip, or 

nontobacco mouthpiece; 

6. does not have a characterizing 

flavor other than tobacco; 

7. contains only tobacco, water, and 

vegetable gum with no other ingredients 

or additives; and 

8. weighs more than 6 pounds per 

1,000 units. 

While products subject to this court’s 

order meet the definition of ‘‘cigar’’ as 

set out in this proposed rule, they do 

not contain a characterizing flavor other 

than tobacco and contain no ingredients 

or additives outside of tobacco, water, 

and vegetable gum. As discussed, the 

proposed rule would prohibit the use of 

characterizing flavors other than tobacco 

in all cigars. Therefore, products that 

meet this court order’s definition of 

‘‘premium’’ cigar would not be affected 

by the proposed rule. All cigar products, 

regardless of shape and size, including 

those that are marketed as ‘‘premium’’ 

cigars, that include a characterizing 

flavor other than tobacco, would be 

prohibited by this proposed product 

standard. 

FDA is also considering action to 

limit characterizing flavors in other 

tobacco products (see FDA’s ANPRM 

regarding the role flavors play in 

tobacco products (79 FR 12294, March 

21, 2018) and FDA’s proposed rule 

prohibiting menthol as a characterizing 

flavor in cigarette products, published 

elsewhere in this issue of the Federal 

Register). FDA is proposing to limit the 

scope of this proposed standard to 

cigars, given their well-documented 

harms and the fact that flavored cigars 

clearly appeal to youth and young 

adults in large numbers, while 

undertaking additional efforts to 

evaluate and determine whether to 

prohibit or otherwise limit 

characterizing flavors in other tobacco 

products. Research also does not 

indicate any countervailing public 

health benefit impacts from 

characterizing flavors in cigars that 

might be affected by eliminating their 

use, in potential contrast to some noncombusted tobacco products. We 

request comments, data, and research 

regarding the proposed scope of this 

rule. 

FDA considered including waterpipe 

tobacco products within the scope of 

this proposed product standard based 

on the fact that they are combusted 

tobacco products with a strong appeal to 

youth. According to the 2020 NYTS, 2.7 

percent of high school students (or 

approximately 420,000 students) 

reported using waterpipe tobacco within 

the previous 30 days and 1.3 percent of 

middle school students (or 

approximately 160,000 students) 

reported waterpipe tobacco use in the 

prior month (Ref. 7). In addition, 

waterpipe tobacco use exposes users to 

nicotine and many toxic chemical 

constituents. The WHO study group on 

tobacco regulation has found that a 

waterpipe session, which typically lasts 

20 to 80 minutes, can be the equivalent 

of smoking more than 100 cigarettes 

(Ref. 305, citing Ref. 306). However, at 

this time due to limited data— 

specifically limited data on how 

waterpipe tobacco might be used in the 

absence of non-tobacco characterizing 

flavors—FDA is not proposing to 

include waterpipe tobacco within the 

scope of this proposed product 


khammond on DSKJM1Z7X2PROD with PROPOSALS2
Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 26435 

standard. FDA requests information and 

data on how waterpipe tobacco might be 

used in the absence of non-tobacco 

characterizing flavors. FDA is 

continuing to study the health effects 

associated with waterpipe tobacco use, 

as well as use patterns generally, to 

evaluate and determine whether to 

prohibit characterizing flavors in 

waterpipe tobacco. 

Similarly, FDA is aware of the 

dangers of pipe tobacco (excluding 

waterpipe tobacco) and considered 

including pipe tobacco in the proposed 

rule. However, FDA considered youth 

and young adult usage as a primary 

concern in determining the scope of this 

proposed product standard, and at this 

time the data is limited and appears to 

suggest that youth and young adults 

have a much lower prevalence of pipe 

tobacco use compared to cigar use. 

According to the 2020 NYTS, 0.7 

percent of high school students (or 

approximately 110,000 students) 

reported using pipe tobacco within the 

previous 30 days and 0.4 percent of 

middle school students (or 

approximately 40,000 students) reported 

pipe tobacco use in the prior 30 days 

(Ref. 7). FDA is concerned that current 

data may underestimate the number of 

smokers who use pipe tobacco to roll 

their own cigarettes or cigars, but the 

lack of data on RYO tobacco use and the 

limitations in how national surveys 

assess loose pipe tobacco use impact our 

ability to draw conclusions regarding 

appeal of loose pipe tobacco among 

youth and adults at this time. Given the 

inherent differences in features of use of 

loose pipe tobacco compared to a prerolled cigar, FDA does not anticipate 

that flavored pipe tobacco would be a 

ready substitution for youth seeking to 

use flavored cigars. The current best 

available evidence indicates pipe 

tobacco is comparatively unpopular 

with youth, and findings from the few 

studies that looked at changes in pipe 

tobacco use following restrictions on 

flavors in other tobacco products were 

mixed (Refs. 50, 51, and 111). While 

youth use of any tobacco product is of 

concern, we are not proposing to 

include pipe tobacco at this time. FDA 

requests information and data to further 

inform the above considerations. We 

also note that FDA has issued Warning 

Letters to retailers illegally selling 

flavored tobacco products that bear the 

package description ‘‘pipe tobacco’’ but 

which, based on their overall 

presentation, meet the statutory 

definition of cigarette tobacco and/or 

RYO tobacco. 

FDA is not including non-combusted 

tobacco products, such as ENDS and 

smokeless tobacco products, in the 

scope of this proposed standard. As 

discussed previously, characterizing 

flavors in a variety of tobacco products 

have appealing effects, particularly 

among youth and young adults. And 

youth and young adult use of any 

tobacco product remains a significant 

concern for FDA. However, at this time, 

FDA is focusing this proposed rule on 

characterizing flavors in cigars because 

this action would help to prevent youth 

and young adults’ use of combusted 

tobacco products. Combusted tobacco 

products are responsible for the majority 

of death and disease due to tobacco use. 

Accordingly, as part of its overall 

request for comments, FDA requests 

comments, including supporting data 

and research, regarding the following 

issues: 

• Should this product standard cover 

waterpipe and/or pipe tobacco, in 

addition to cigars? Is there additional 

data or information that would support 

inclusion of waterpipe and/or pipe 

tobacco in this product standard? 

• What are the advantages and/or 

disadvantages of covering other 

combusted tobacco products with this 

product standard? What evidence would 

support covering all combusted tobacco 

products? How should FDA define 

‘‘combusted tobacco products’’ if the 

scope of the final product standard were 

expanded to include all combusted 

tobacco products? 

• Is there a significant risk that, if 

FDA limits this standard to cigars, 

consumers would substitute and/or 

migrate to other combusted tobacco 

products, thereby undermining the 

public health benefits of this rule? What 

changes, if any, should FDA make to 

this proposal to protect against or 

minimize substitution and/or migration? 

D. Request for Comments on the 

Potential Racial and Social Justice 

Implications of the Proposed Product 

Standard 

FDA is aware of concerns by some 

that this proposed rule could lead to 

illicit trade in flavored cigars, increased 

policing, and criminal penalties in 

underserved communities. 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 flavored 

cigars. FDA’s enforcement of this 

proposed rule, if finalized, 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 

flavored cigars. Finally, FDA requests 

comment on any other policy 

considerations related to potential racial 

and social justice implications of the 

rule. 

VIII. Description of the Proposed Rule 

This proposed rule would establish a 

new part 1166 that would prohibit 

characterizing flavors (other than 

tobacco) in cigars. Part 1166 would 

describe the scope of the proposed 

regulation, applicable definitions, and 

the prohibition on use of characterizing 

flavors (other than tobacco) in cigars. 

A. Scope (Proposed § 1166.1) 

Proposed § 1166.1(a) would provide 

that this part sets out a tobacco product 

standard under the FD&C Act regarding 

the use of characterizing flavors in 

cigars. 

Proposed § 1166.1(b) would prohibit 

the manufacture, distribution, sale, or 

offering for distribution or sale, within 

the United States of a cigar 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 cigars 

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 or this 

product standard, if it meets the criteria 

enumerated in section 801(e)(1) of the 

FD&C Act, including not being sold or 

offered for sale in domestic commerce. 


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26436 Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 

24Section 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 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. 

25We note that the language in section 

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

characterizing flavor ban for cigarettes applies to 

cigarettes or ‘‘any of its component parts.’’ For 

purposes of this proposed product 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). 

This proposed rule would prohibit the 

importation for sale or distribution in 

the United States of a finished cigar that 

violates this standard. As stated in 

section VII.C of this document, FDA is 

specifically requesting comment 

regarding the scope of this proposed 

rule. 

B. Definitions (Proposed § 1166.3) 

Proposed § 1166.3 provides the 

definitions for the terms used in the 

proposed rule. Several of these 

definitions are included in the FD&C 

Act or have been used in other 

regulatory documents. 

• Accessory: FDA defined 

‘‘accessory’’ in the final deeming final 

rule (81 FR 28974; codified at 21 CFR 

1100.3). We are proposing to use that 

definition here as it applies to cigars to 

provide further understanding as to the 

scope of the proposed standard. 

Therefore, FDA proposes to define 

‘‘accessory’’ in the context of part 1166 

to mean any product that is intended or 

reasonably expected to be used with or 

for the human consumption of a cigar; 

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 cigar or (2) is 

intended or reasonably expected to 

affect or maintain the performance, 

composition, constituents, or 

characteristics of a cigar but (i) solely 

controls moisture and/or temperature of 

a stored cigar or (ii) solely provides an 

external heat source to initiate but not 

maintain combustion of a cigar. A cigar 

‘‘accessory’’ is not subject to chapter IX 

of the FD&C Act or to this proposed 

standard. Examples of cigar accessories 

include a humidor that solely controls 

the moisture and/or temperature of a 

stored product, as well as cigar tip 

cutters, holders, ashtrays, and cases. We 

note that a humidor that does more than 

solely control the moisture and/or 

temperature of a stored product (e.g., 

imparts a mint characterizing flavor to 

the stored product) could meet the 

definition of a ‘‘component’’ or ‘‘part’’ 

in proposed § 1166.3 and, therefore, 

would be covered under this proposed 

standard. 

• Cigar: FDA proposes to define 

‘‘cigar’’ as a tobacco product that: (1) Is 

not a cigarette and (2) is a roll of tobacco 

wrapped in leaf tobacco or any 

substance containing tobacco. This 

definition was used in the seven 

consent orders that the Federal Trade 

Commission (FTC) entered into with the 

largest mass marketers of cigars (see, 

e.g., In re Swisher International, Inc., 

Docket No. C–3964 (FTC August 18, 

2000)) and also is codified at 21 CFR 

1143.1. 

• Component or part: FDA defined 

‘‘component or part’’ in the deeming 

final rule. We have reiterated that 

definition here as it applies to cigars. 

Therefore, FDA proposes to define 

‘‘component or part’’ in the context of 

part 1166 to mean any software or 

assembly of materials intended or 

reasonably expected: (1) To alter or 

affect the cigar’s performance, 

composition, constituents, or 

characteristics or (2) to be used with or 

for the human consumption of a cigar. 

The term excludes anything that is an 

accessory of a cigar. Examples of cigar 

components or parts that would be 

subject to this proposed product 

standard include liquids intended to 

add flavor, cigar blunt wraps, removable 

tips, mouthpieces, and filters. 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. 

• Tobacco product: As defined in 

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

term ‘‘tobacco product’’ is defined as 

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 is: A drug under section 

201(g)(1) (21 U.S.C. 321(g)); a device 

under section 201(h) (21 U.S.C. 321(h)); 

a combination product described in 

section 503(g) (21 U.S.C. 353(g)); or a 

food under section 201(f) of the FD&C 

Act (21 U.S.C. 321(f)) if such article 

contains no 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 Characterizing 

Flavors in Cigars (Proposed § 1166.5) 

Proposed § 1166.5 would establish a 

product standard prohibiting the use of 

characterizing flavors (other than 

tobacco) in cigars, similar to section 

907(a)(1)(A) of the FD&C Act.24

Specifically, proposed § 1166.5 would 

state that a cigar or any of its 

components or parts (including the 

tobacco, filter, or wrapper, as 

applicable) shall not contain, as a 

constituent (including a smoke 

constituent) or additive, an artificial or 

natural flavor (other than tobacco) or an 

herb or spice, including, but not limited 

to, strawberry, grape, orange, clove, 

cinnamon, pineapple, vanilla, coconut, 

licorice, cocoa, chocolate, cherry, coffee, 

mint, or menthol, that is a 

characterizing flavor of the tobacco 

product or tobacco smoke.25 As 

discussed in section VI of this 

document, FDA finds that this proposed 

product standard would be appropriate 

for the protection of the public health. 

FDA is proposing an effective date 1 

year after the date of publication of the 

final rule, as discussed in section IX of 

this document. 

We note that this proposed rule 

would prohibit the use of menthol as a 

characterizing flavor in cigars, whereas 

the statutory characterizing flavor ban 

for cigarettes excluded menthol from the 

prohibition. The sensory properties of 

menthol makes its addition to cigars 

concerning. Menthol is a flavor 

compound that when added to 

combusted tobacco products produces a 

minty taste and cooling sensation when 


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26 If a cigar 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 cigar 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. 

27Section 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. 

inhaled (Ref. 71). Adding menthol to 

combusted tobacco products makes the 

products easier to inhale and less 

irritating. Smokers report that 

mentholated products have a better 

taste, are smoother and more refreshing 

(Refs. 72–74). Menthol’s flavor and 

sensory effects reduce the harshness of 

smoking among new users and facilitate 

experimentation and progression to 

regular smoking of menthol products, 

particularly among youth and young 

adults (Refs. 29 and 74–76). As a result, 

the brain is repeatedly exposed to 

nicotine and susceptible to nicotine 

addiction (Ref. 222). Studies further 

demonstrate that menthol, like nicotine, 

binds to nicotinic receptors in the brain 

(Refs. 218 and 219) and menthol alone 

can increase the number of nicotinic 

receptors in the brain (Refs. 220 and 

221). Increases in nicotinic receptors 

can lead to greater withdrawal and 

cravings (Ref. 222). Evidence 

demonstrates that menthol’s effects on 

nicotine in the brain are associated with 

behaviors indicative of greater addiction 

to nicotine (Refs. 220 and 223). 

For this proposed product standard, 

FDA also is concerned that a 

characterizing flavors prohibition that 

does not include menthol would shift 

the flavored cigar market to mentholflavored cigars. FDA is addressing the 

use of menthol in cigarettes in its 

separate proposed tobacco product 

standard to prohibit the use of menthol 

as a characterizing flavor in cigarettes, 

published elsewhere in this issue of the 

Federal Register. We believe that 

including menthol within the scope of 

this proposed standard prohibition of 

characterizing flavors in cigar products 

would be appropriate for the protection 

of the public health regardless of 

whether a similar prohibition of 

menthol as a characterizing flavor in 

cigarettes is in place when this rule is 

finalized. 

FDA would enforce the requirements 

of this proposed product standard under 

various sections of the FD&C Act, 

including sections 301, 303, 701(a), 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) of the FD&C Act. Similar to 

section 907, section 906(d) of the FD&C 

Act gives FDA authority to require 

restrictions on the sale and distribution 

of tobacco products by regulation if the 

Agency determines that such regulation 

would be appropriate for the protection 

of the public health. 

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 consumers possession or use 

of flavored cigars. 

Among the factors that FDA believes 

are relevant in determining whether a 

cigar product 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 a tobacco 

product; 26 and 

• Any other means that impart flavor 

or represent that a 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 

characterizing flavor—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 cigar has a characterizing flavor. 

FDA also requests comments, 

including supporting data and research, 

regarding potential alternatives to 

prohibiting characterizing flavors (e.g., 

prohibiting all flavor additives, 

compounds, constituents, or 

ingredients). 

This proposed product standard 

would not prohibit tobacco-flavored 

cigars. Flavored tobacco products may 

differ in youth appeal—as discussed 

previously in this document, for those 

who experiment with cigars, tobaccoflavored cigars do not currently appear 

as attractive as cigars with other 

characterizing flavors. FDA expects that 

the tobacco flavor in a cigar, or its 

components or parts, need not be 

naturally inherent to the product to be 

considered ‘‘tobacco flavored’’ but 

rather may result from the addition of 

ingredients or other measures by the 

manufacturer to produce the presence of 

tobacco as its characterizing flavor. 

Further, we note that this prohibition 

also would cover flavors that are 

separate from the cigar (e.g., liquid 

flavors), including menthol, intended or 

reasonably expected to be added to 

cigars. For example, menthol can be 

added to the packaging of cigarettes to 

produce menthol cigarettes (and this 

can be done for cigars as well). Such 

flavors would be considered 

components or parts of cigars under 

§ 1166.3, as they could be intended or 

reasonably expected: (1) Alter or affect 

the cigar’s performance, composition, 

constituents, or characteristics or (2) be 

used with or for the human 

consumption of a cigar, and they would 

not be accessories of cigars. Therefore, 

the manufacture, distribution, sale, or 

offer for distribution or sale of such 

flavored products would be prohibited 

should this proposed rule be finalized. 

IX. Proposed Effective Date 

In accordance with section 907(d)(2) 

of the FD&C Act,27 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, distribute, 

sell, or offer for distribution or sale 

within the United States a cigar or any 

of its components or parts that is not in 

compliance with part 1166. This 

regulation does not include a 


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prohibition on individual consumer 

possession or use. 

FDA finds this proposed standard 

appropriate for the protection of the 

public health because characterizing 

flavors in cigars increase appeal and 

makes them easier to use, which leads 

to an increased likelihood that youth 

and young adults will experiment with 

them and that those experimenting with 

cigars will become addicted and 

progress to regular smoking. Additional 

delay, past 1 year, would only increase 

the numbers of youth and young adults 

who experiment with and become 

regular smokers after experimenting 

with flavored cigars, would delay 

cessation by current smokers, and 

would 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. Some 

cigar manufacturers of currently 

marketed flavored cigars have tobaccoflavored versions that are either preexisting tobacco products or new 

tobacco products that are required to 

obtain premarket authorization. FDA 

does not expect that this rule, if 

finalized, would result in many new 

tobacco products or would require 

extensive changes to manufacturing. 

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, 

including information concerning the 

existence of patents that make it 

impossible to comply in the proposed 1- 

year time frame. While FDA does not 

expect that the proposed product 

standard would prompt extensive 

changes to manufacturing (given the 

likely compliance method of ending the 

addition of flavoring additives to cigar 

products), FDA requests comments and 

data regarding whether 1 year is 

sufficient to comply with this rule or 

whether this compliance period should 

be extended to provide additional time. 

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 cigars with 

characterizing flavors (other than 

tobacco). 

X. Preliminary Economic Analysis of 

Impacts 

A. Introduction 

We have examined the impacts of the 

proposed rule under 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 businesses would incur costs to 

reallocate resources to products other 

than flavored cigars, we tentatively find 

that the proposed rule would 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 would 

result in an expenditure in at least 1 

year that meets or exceeds this amount. 

B. Summary of Costs and Benefits 

The summary of costs and benefits is 

presented in table 3. The main 

quantified benefits of this proposed 

rule, if finalized, come from reduced 

smoking-attributable mortality that is 

the result of cigar use among adult cigar 

smokers, and reduced mortality from 

secondhand smoke among non-users. 

Additional unquantified benefits 

include reduced smoking-attributable 

mortality among youth who are deterred 

from initiating under the proposed rule. 

Unquantified benefits also include 

medical cost savings, productivity loss 

savings, improved quality of life, and 

environmental impacts. These benefits 

occur because the proposed rule, if 

finalized, would discourage non-users 

from initiating flavored cigars, as well as 

decrease consumption and/or increase 

cessation among current flavored cigar 

users, and thus reduce the health 

consequences associated with such use. 

Reduced exposure to secondhand smoke 

would also produce such benefits 

among non-users. We estimate that the 

present value of the quantified benefits 

over a 40-year time horizon ranges 

between $111,807 million and $286,124 

million, with a primary estimate of 

$198,203 million at a 3 percent discount 

rate, and between $52,827 million and 

$135,188 million with a primary 

estimate of $93,647 million at a 7 

percent discount rate. The primary 

annualized quantifiable benefits equal 

$8,575 million at a 3 percent discount 

rate and $7,024 million at a 7 percent 

discount rate. Unquantified benefits are 

expected to provide additional benefits 

beyond those amounts. 

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, in a form not 

necessarily reflected in budgets, to 

enforce this product standard. Retailers, 

manufacturers, and wholesalers face a 

one-time cost of $239.9 (range of $80.0 

million to $399.8 million) million to 

read and understand the rule and 

manufacturers face a one-time 

adjustment, or friction cost, of $21.5 

million (range of $0.3 million to $43.7 

million) to reallocate productive 

resources currently devoted to the 

manufacture of flavored cigars to other 

tobacco products. Consumers who 

continue to use tobacco products will 

face a one-time search cost of $61.7 

million (range of $30.8 million to $92.5 

million) to find new tobacco products as 

a replacement for the banned flavored 

cigar products. In addition, producers 

face annual lost producer surplus of $88 

million (range of $0 million to $175 

million). Additional unquantified costs 

include the costs to consumers who 

switch from flavored to tobacco-flavored 

cigars and consumer surplus losses. The 

present value of the costs over a 40-year 

time horizon ranges between $126 

million and $4,612 million with a 


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primary estimate of $2,368 million for a 

3 percent discount rate, and between 

$118 million and $2,883 million with a 

primary estimate of $1,500 million at a 

7 percent discount rate. The primary 

estimates for the annualized cost are 

$102 million at a 3 percent discount rate 

and $112 million at a 7 percent discount 

rate. 

In addition to benefits and costs, this 

rule, if finalized, will cause transfers 

from state governments, Federal 

Government, and firms to consumers in 

the form of reduced revenue and tax 

revenue. The primary estimate for the 

annualized transfers from the Federal 

Government to consumers, in the form 

of reduced excise tax, is $85 million. 

The primary estimate for the annualized 

transfers from state governments to 

consumers, in the form of reduced 

excise tax, is $129 million. The primary 

estimate for the annualized transfers 

from the firms to consumers, in the form 

of reduced revenue, is $1,979 million. 

Transfers are summarized in table 3. 

TABLE 3—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 $/year .............................. $7,024 

8,575 

$3,962 

4,837 

$10,140 

12,378 

2020 

2020 

7 

3 

40 

40 

Reduced mortality among 

adult cigar smokers and 

non-users. 

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

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

Qualitative ............................................................ Medical cost savings, productivity loss savings and improved quality of life, environmental impacts. 

Costs: 

Annualized Monetized $/year .............................. 112 

102 

9 

5 

216 

200 

2020 

2020 

7 

3 

40 

40 

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

..................

..................

..................

..................

..................

..................

..................

7 

3 

..................

..................

Qualitative ............................................................ Changes in consumer surplus for some flavored cigar smokers, including potential utility changes for 

consumers who switch from flavored to non-flavored cigars. 

Transfers: 

Federal Annualized Monetized $/year ................. 85 

85 

42 

42 

119 

119 

2020 

2020 

7 

3 

..................

..................

From/To ............................................................... From: Federal Government To: Consumers 

Other Annualized Monetized $/year .................... 129 

129 

64 

64 

180 

180 

2020 

2020 

7 

3 

40 

40 

From/To ............................................................... From: State Governments To: Consumers 

Other Annualized Monetized $/year .................... 1,979 

1,979 

1,033 

1,033 

2,717 

2,717 

2020 

2020 

7 

3 

40 

40 

From/To ............................................................... From: Firms To: Consumers 

Effects: 

State, Local or Tribal Government: States would transfer some cigar excise tax revenue back to consumers. We are not aware of any cigar manufacturers that 

are tribally-affiliated and/or operate on tribal land. 

Small Business: There are about 50 small businesses. Each small business would experience about $1.9 million in annual costs at both a 3 and 7% discount 

rate. 

Wages: No effect. 

Growth: No effect. 

We have developed a comprehensive 

Preliminary Regulatory Impact Analysis 

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. 

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

XI. 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. 307 and 308) and may be seen in 

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. 

XII. 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 

(OMB) under the Paperwork Reduction 

Act of 1995 is not required. This 

proposed rule refers to previously 

approved collections of information. 

The collections of information in 21 

CFR part 1114 have been approved 

under OMB control number 0910–0879 

(expires December 31, 2024); the 

collections of information in 21 CFR 

part 1107 have been approved under 

OMB control number 0910–0684 


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26440 Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 

(expires September 30, 2022); the 

collections of information in section 

905(j) of the FD&C Act have been 

approved under OMB control number 

0910–0673 (expires November 30, 

2024); and the collections in FDA’s 

guidance entitled ‘‘Guidance for 

Industry on Establishing That a Tobacco 

Product Was Commercially Marketed in 

the United States As of February 15, 

2007,’’ have been approved under OMB 

control number 0910–0775 (expires 

August 31, 2022). 

XIII. 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 Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

This rule is being issued under 

section 907(a) 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 of the FD&C Act broadly 

preserves the authority of states and 

localities to protect the public against 

the harms of tobacco use. Specifically, 

section 916(a)(1) of the FD&C Act 

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) limits 

the applicability of section 916(a)(2)(A) 

of the FD&C Act, 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) of the FD&C Act 

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) of the 

FD&C Act, and/or excepted under 

section 916(a)(2)(B) of the FD&C Act 

(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, including flavored cigars, 

would not be preempted by this rule, if 

finalized, because such prohibitions 

would be preserved by section 916(a)(1) 

of the FD&C Act or, as applicable, 

excepted from express preemption by 

section 916(a)(2)(B) of the FD&C Act. 

FDA invites comments on how state or 

local laws may be implicated if this 

proposed rule is finalized. 

XIV. 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. 

XV. 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. Tynan, M.A., T. McAffee, G. Promoff, et 

al., ‘‘Consumption of Cigarettes and 

Combustible Tobacco—United States, 

2000–2011.’’ Morbidity and Mortality 

Weekly Report, 61(30):565–569, 2012. 

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

preview/mmwrhtml/mm6130a1.htm. 

2. Euromonitor International, ‘‘Passport: 

Cigars, Cigarillos and Smoking Tobacco 

in the US.’’ 2020. Available at https://

www.euromonitor.com/cigars-cigarillosand-smoking-tobacco-in-the-us/report. 

3. Nonnemaker, J., B. Rostron, P. Hall, et al., 

‘‘Mortality and Economic Costs from 

Regular Cigar Use in the United States, 

2010.’’ American Journal of Public 

Health, 104(9):e86–e91, 2014. Available 

at https://doi.org/10.2105/ 

AJPH.2014.301991. 

4. Wang, Y., H. Sung, T. Yao, et al., ‘‘Health 

Care Utilization and Expenditures 

Attributable to Cigar Smoking Among US 

Adults, 2000–2015.’’ Public Health 

Reports, 133(3):329–337, 2018. Available 

at https://doi.org/10.1177/ 

0033354918769873. 

*5. Odani, S., B. Armour, I.T. Agaku, 

‘‘Flavored Tobacco Product Use and Its 

Association with Indicators of Tobacco 

Dependence Among US Adults, 2014– 

2015.’’ Nicotine & Tobacco Research, 


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Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 26441 

22(6):1004–1015, 2020. Available at 

https://doi.org/10.1093/ntr/ntz092. 

*6. HHS, How Tobacco Smoke Causes 

Disease: The Biology and Behavioral 

Basis for Smoking-Attributable Disease: 

A Report of the Surgeon General. 

Atlanta, GA: HHS, CDC, National Center 

for Chronic Disease Prevention and 

Health Promotion, Office on Smoking 

and Health, 2010. 

*7. Gentzke, A.S., T.W. Wang, A. Jamal, et 

al., ‘‘Tobacco Product Use Among 

Middle and High School Students— 

United States, 2020.’’ Morbidity and 

Mortality Weekly Report, 69(50):1881– 

1888, 2020. Available at http://

dx.doi.org/10.15585/mmwr.mm6950a1. 

8. Parms, T.A., S.K. Head, M.D. Sawdey, et 

al., ‘‘Characteristics of Past 30-Day Cigar 

Smoking, U.S. Adolescents, 2020.’’ 

American Journal of Preventive 

Medicine, 62(1):e39–e44, 2022. Available 

at https://doi.org/10.1016/ 

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List of Subjects in 21 CFR Part 1166 

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 1166 to subchapter K to 

read as follows: 

PART 1166—PRODUCT STANDARD: 

FLAVORS IN CIGARS 

Subpart A—General Provisions 

Sec. 

1166.1 Scope. 

1166.3 Definitions. 

Subpart B—Tobacco Product Standard for 

Flavors in Cigars 

1166.5 Prohibition on use of characterizing 

flavors in cigars. 

Authority: 21 U.S.C. 331, 333, 371(a), 

387b, 387c, 387f(d), 387g(a). 

Subpart A—General Provisions 

§ 1166.1 Scope. 

(a) This part sets out a tobacco 

product standard under the Federal 

Food, Drug, and Cosmetic Act regarding 

the use of characterizing flavors in 

cigars. 

(b) No person may manufacture, 

distribute, sell, or offer for distribution 

or sale, within the United States a cigar 

or any of its components or parts that 

is not in compliance with this part. 

§ 1166.3 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 cigar; 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 cigar; or 

(2) Is intended or reasonably expected 

to affect or maintain the performance, 

composition, constituents, or 

characteristics of a cigar; but 

(i) Solely controls moisture and/or 

temperature of a stored cigar; or 

(ii) Solely provides an external heat 

source to initiate but not maintain 

combustion of a cigar. 

Cigar means a tobacco product that: 

(1) Is not a cigarette; and 

(2) Is a roll of tobacco wrapped in leaf 

tobacco or any substance containing 

tobacco. 

Component or part means any 

software or assembly of materials 

intended or reasonably expected: 

(1) To alter or affect the cigar’s 

performance, composition, constituents, 

or characteristics; or 

(2) To be used with or for the human 

consumption of a cigar. The term 

excludes anything that is an accessory 

of a cigar. 

Person includes an individual, 

partnership, corporation, and 

association. 

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 


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Federal Register / Vol. 87, No. 86 / Wednesday, May 4, 2022 / Proposed Rules 26451 

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. 

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—Tobacco Product Standard 

for Flavors in Cigars 

§ 1166.5 Prohibition on use of 

characterizing flavors in cigars. 

A cigar or any of its components or 

parts (including the tobacco, filter, or 

wrapper, as applicable) shall not 

contain, as a constituent (including a 

smoke constituent) or additive, an 

artificial or natural flavor (other than 

tobacco) or an herb or spice, including, 

but not limited to, strawberry, grape, 

orange, clove, cinnamon, pineapple, 

vanilla, coconut, licorice, cocoa, 

chocolate, cherry, coffee, mint, or 

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. 2022–08993 Filed 4–28–22; 11:15 am] 

BILLING CODE 4164–01–P 


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