Tobacco Product Standard for Characterizing Flavors in Cigars

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 tobacco-related death and disease associated with cigar use. The proposed standard also is expected to reduce tobacco-related health disparities and advance health equity.

DATES:

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

ADDRESSES:

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The

https://www.regulations.gov

electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 5, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:

•

Federal eRulemaking Portal:

https://www.regulations.gov.

Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to

https://www.regulations.gov

will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on

https://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

•

Mail/Hand Delivery/Courier (for written/paper submissions):

Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked, and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions:

All submissions received must include the Docket No. FDA-2021-N-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

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 tobacco-related 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

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.

1

Throughout 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.”

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.

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.

2

For 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.

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).

3

Throughout 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.

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).

4

Throughout 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.

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).

5

Though age ranges for youth and young adults vary across studies, in general, “youth” or “adolescent” encompasses those 11-17 years of age, while those who are 18-25 years old are considered “young adults” (even though, developmentally, the period between 18-20 years of age is often labeled late adolescence); those 26 years of age or older are considered “adults” or “older adults” (Ref. 17).

6

The 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.

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 non-tobacco 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

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 non-flavored 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. Non-Hispanic 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 non-flavored 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

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 tobacco-related 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.

7

As 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 tobacco-related health disparities, such communities may include populations disproportionately impacted by marketing and promotion targeted on the basis of such shared characteristics.

8

Throughout 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.

9

Underserved communities are overrepresented in vulnerable populations.

10

Throughout 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.

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 cigar- and 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.

11

Information on specific projects supported by FDA is available at

https://www.fda.gov/tobacco-products/tobacco-science-research/research

(search “cigars” or “flavors”).

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

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 peer-reviewed 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.

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-fda-guidance-documents/general-questions-and-answers-ban-cigarettes-contain-certain-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).

12

For more information on U.S. localities and the implementation of flavored tobacco product restrictions, see section IV.F of this document.

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 tobacco-flavored 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

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.

13

The 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.

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,

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

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,

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/mint-flavored 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/mint-flavored 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 cross-sectional 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,

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.

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: Adult-only (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.

1

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

2

Outcome 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

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 school-based 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 pre-post 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 point-of-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

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 cross-sectional 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 e-cigarette 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 e-cigarette 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 pre-policy 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.

14

Although enforcement of this policy was slated to begin in January 2019, compliance inspections with penalties did not commence until April 2019.

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 e-cigarette 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.

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

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 non-Hispanic 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 cross-sectional 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

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).

15

FDA 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.

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)

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, non-Hispanic 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 non-Hispanic 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 non-Hispanic Blacks compared to non-Hispanic 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). Non-Hispanic 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 non-Hispanic 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 non-Hispanic 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 non-Hispanic 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

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 non-Hispanic 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).

16

See,

e.g.,

E.O. 13988, “Preventing and Combating Discrimination on the Basis of Gender Identity or Sexual Orientation” (86 FR 7023, January 25, 2021).

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 e-cigarette 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

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.

17

FDA is not aware of additional analyses that examine dependence in youth in NYTS data using 2013-2018 data.

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, ο-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,

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 decre

This text is long and has been trimmed here. Open the source document for the complete record.