[Federal Register Volume 87, Number 86 (Wednesday, May 4, 2022)]
[Proposed Rules]
[Pages 26396-26451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-08993]



[[Page 26395]]

Vol. 87

Wednesday,

No. 86

May 4, 2022

Part II





Department of Health and Human Services





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Food and Drug Administration





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21 CFR Part 1166





Tobacco Product Standard for Characterizing Flavors in Cigars; Proposed 
Rule

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

[[Page 26396]]


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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.

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked, and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2021-N-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.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on 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, 
<a href="/cdn-cgi/l/email-protection#5b180f0b093e3c2e373a2f323435281b3d3f3a75333328753c342d"><span class="__cf_email__" data-cfemail="26657276744341534a47524f49485566404247084e4e5508414950">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms
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

[[Page 26397]]

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 Sec.  1166.1)
    B. Definitions (Proposed Sec.  1166.3)
    C. Prohibition on Use of Characterizing Flavors in Cigars 
(Proposed Sec.  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:
    <bullet> The presence and amount of artificial or natural flavor 
additives, compounds, constituents, or ingredients, or any other 
flavoring ingredient in a tobacco product, including its components or 
parts;
    <bullet> The multisensory experience (i.e., taste, aroma, and 
cooling or burning sensations in the mouth and throat) of a flavor 
during use of a tobacco product, including its components or parts;
    <bullet> Flavor representations (including descriptors), either 
explicit or implicit, in or on the labeling (including packaging) or 
advertising of a tobacco product; and
    <bullet> 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

[[Page 26398]]

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.
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    \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.''
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    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

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       Abbreviation/acronym                     What it means
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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.

[[Page 26399]]

 
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.
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    \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.
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    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).
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    \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.
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    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).
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    \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.
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    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).
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    \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.
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    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

[[Page 26400]]

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

[[Page 26401]]

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,<SUP>8 9</SUP> 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

[[Page 26402]]

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:
    <bullet> The risks and benefits to the population as a whole, 
including users and nonusers of tobacco products, of the proposed 
standard;
    <bullet> The increased or decreased likelihood that existing users 
of tobacco products will stop using such products; and
    <bullet> The increased or decreased likelihood that those who do 
not use tobacco products will start using such products.
2. Authority To Prohibit 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.

[[Page 26403]]

    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

[[Page 26404]]

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,

[[Page 26405]]

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

[[Page 26406]]

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,

[[Page 26407]]

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,

[[Page 26408]]

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                          Key outcome
       Jurisdiction              Policy \1\           Effective or       Retailer exemptions    Study design &        Sample size      measures \2\ and
                                                    enforcement year                               reference                               findings
--------------------------------------------------------------------------------------------------------------------------------------------------------
NYC, NY...................  Restriction          2010..................  Tobacco bars with    Pre/Post Design     Youth Tobacco Use:  Sales: Flavored
                             includes all                                 >=10% gross income   (Ref. 51).          n=1708 (2010);      cigars dollar
                             flavored products                            from tobacco sales.                      n=8814 (2013).      sales declined.
                             except menthol-,                                                                                          Cigar dollar
                             mint-, and                                                                                                sales of non-
                             wintergreen-                                                                                              flavored cigars
                             flavored products.                                                                                        increased.
                             In 2020,                                                                                                 Youth (aged 13-17
                             restriction was                                                                                           years) Tobacco
                             expanded to                                                                                               Use: Youth had
                             include flavored                                                                                          lower odds of
                             Electronic                                                                                                ever trying a
                             Nicotine Delivery                                                                                         flavored tobacco
                             Systems (ENDS)                                                                                            product and of
                             products,                                                                                                 ever using
                             including menthol-                                                                                        tobacco products.
                             , mint-, and
                             wintergreen-
                             flavored ENDS
                             products.
                                                                                              Pre/Post Design     N/A...............  Sales: Overall
                                                                                               with Comparison                         cigar unit sales
                                                                                               (Ref. 108).                             declined.
                                                                                                                                       Flavored cigar
                                                                                                                                       unit sales
                                                                                                                                       declined.
                                                                                                                                       Flavored cigar
                                                                                                                                       unit sales
                                                                                                                                       increased in
                                                                                                                                       comparison
                                                                                                                                       counties.
Providence, RI............  Restriction          2013..................  All smoking bars...  Pre/Post Design     N/A...............  Sales: Decrease in
                             includes all                                                      with Comparison                         flavored cigar
                             flavored products                                                 (Ref. 109).                             unit sales.
                             except menthol,                                                                                           Decreases in
                             mint, and                                                                                                 overall cigar
                             wintergreen                                                                                               unit sales.
                             flavors.                                                                                                  Flavored cigar
                                                                                                                                       unit sales
                                                                                                                                       increased in the
                                                                                                                                       rest of the
                                                                                                                                       State.
                                                                                              Post-only Design    n=2,150 (2012);     Youth (10th and
                                                                                               (Ref. 60).          n=2,062 (2016);     12th grade
                                                                                                                   n=2,223 (2018).     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          2016..................  Adult-only (21+      Post-only Design    Lowell: Baseline    Youth (9th-12th
                             includes all                                 years old) retail    with Comparison     n=593; follow-up    grade students)
                             flavored products                            tobacco stores       (Ref. 61).          n=524.              Flavored Tobacco
                             (except menthol,                             with >=90% of                           Malden (comparison   Use: Youth
                             mint, or                                     sales from tobacco                       community):         current use of
                             wintergreen).                                products.                                baseline n=636;     any flavored
                                                                                                                   follow up n=646.    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          2016 (Attleboro); 2017  Adult-only (21+      Pre/Post Design     Attleboro:          Youth (9th-12th
                             includes all         (Salem).                years old) retail    with Comparison     Baseline n=1413;    grade students)
                             flavored products                            tobacco stores       (Ref. 110).         follow up n=1565.   Flavored Tobacco
                             (except menthol,                             with >=90% of                           Salem: Baseline      Use:
                             mint, or                                     sales from tobacco                       n=480; follow up    Statistically
                             wintergreen).                                products.                                n=620.              significantly
                                                                         All smoking bars...                      Gloucester           smaller increases
                                                                                                                   (comparison         in current use of
                                                                                                                   municipality):      Flavored in
                                                                                                                   Baseline n=539;     Attleboro and
                                                                                                                   follow up n=629.    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.

[[Page 26409]]

 
Twin Cities, MN...........  Restriction          2016..................  Minneapolis: Adult-  Pre/Post Design     Minnesota Youth     Youth (6th-12th
                             includes all                                 only (18 years and   with Comparison     Tobacco Survey:     grade students)
                             flavored products                            older) licensed      (Ref. 111).         More than 4,000     Cigar Use: Before
                             (except menthol,                             tobacco product                          students            and after the
                             mint, or                                     shops with >=90%                         participated in     2016 restriction
                             wintergreen).                                revenue from sale                        the 2017 survey     on flavored
                                                                          of tobacco.                              statewide.          tobacco products
                                                                         St. Paul: Adult-                                              (except menthol,
                                                                          only (18 years and                                           mint, and
                                                                          older) retail                                                wintergreen),
                                                                          stores with >=90%                                            cigar use did not
                                                                          revenue from sale                                            change in the
                                                                          of tobacco.                                                  Twin Cities but
                                                                                                                                       increased in the
                                                                                                                                       rest of the
                                                                                                                                       State.
                            Restriction          2018..................  Minneapolis: Sales   Pre/Post Design     Minnesota Student   Youth (8th, 9th,
                             expanded to                                  of mint-, menthol-   with Comparison     Survey (8th, 9th,   11th grade
                             include menthol,                             , and wintergreen-   (Ref. 111).         11th grade          students) Cigar
                             mint, and                                    flavored tobacco                         students): More     Use: Before and
                             wintergreen in                               products at adult                        than 170,000        after the 2018
                             2018.                                        only (21 years and                       participating       restriction on
                                                                          older) liquor                            students in 2019.   flavored tobacco
                                                                          stores.                                                      products,
                                                                         St. Paul: Sales of                                            including
                                                                          mint-, menthol-,                                             menthol, mint,
                                                                          and wintergreen-                                             and wintergreen,
                                                                          flavored tobacco                                             cigar use
                                                                          products at liquor                                           declined more in
                                                                          stores that also                                             the Twin Cities
                                                                          hold a license for                                           compared to the
                                                                          tobacco sales.                                               rest of the
                                                                                                                                       State.
San Francisco, CA.........  Restriction          2019..................  None...............  Post-only Design    n=247.............  Young Adult (aged
                             includes all                                                      (Ref. 62).                              18-24 years)
                             flavored products                                                                                         Cigar Use:
                             (including                                                                                                Statistically
                             menthol).                                                                                                 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     N/A...............  Sales:
                                                                                               with Comparison                         Statistically
                                                                                               (Ref. 52).                              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          2010..................  None...............  Pre/Post Design     N/A...............  Sales: Decreases
                             includes flavored                                                 (Ref. 112).                             in overall cigar
                             little cigars/                                                                                            and flavored
                             cigarillos (except                                                                                        cigar units sold.
                             menthol);                                                                                                 Increase in
                             unflavored                                                                                                unflavored cigar
                             cigarillos minimum                                                                                        units sold.
                             packs of 20.
                                                                                              Pre/Post Design     Over 46,000         Youth (aged 15-24
                                                                                               (Ref. 113).         observations.       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

[[Page 26410]]

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

[[Page 26411]]

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.

[[Page 26412]]

    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

[[Page 26413]]

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

[[Page 26414]]

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)

[[Page 26415]]

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

[[Page 26416]]

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

[[Page 26417]]

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
------------------------------------------------------------------------
                                Chemical reaction      Health hazard of
     Flavor ingredient               product           flavor ingredient
------------------------------------------------------------------------
Benzaldehyde...............  Benzene, Carbon          Respiratory
                              monoxide (CO) (Refs.     irritant and
                              191 and 192).            toxicant (Ref.
                                                       193).
Benzyl alcohol.............  Benzene, toluene (Refs.  Acute inhalation
                              194 and 195).            toxicant; Nose,
                                                       throat, and
                                                       respiratory tract
                                                       irritant (Ref.
                                                       196).
Ethyl maltol...............  Acetaldehyde, acrolein,  Mutagen (Ref.
                              CO, formaldehyde, 1,3-   199).
                              butadiene, acetone,
                              propionaldehyde,
                              crotonaldehyde, methyl
                              ethyl ketone (Refs.
                              197 and 198).
Ethyl vanillin.............  Benzene, naphthalene     Respiratory
                              (Ref. 200).              irritant (Ref.
                                                       201).
Hexyl acetate..............  CO (Ref. 202)..........  Respiratory
                                                       irritant (Ref.
                                                       203).
Methyl cinnamate...........  Styrene (Ref. 185).....  Sensitization
                                                       (Ref. 204).
Piperonal..................  1,3-butadieneButadiene,  Mutagenic;
                              benzene (Ref. 188).      hepatoxic in rats
                                                       (Ref. 205).
Vanillin...................  Benzene, catechol,       Respiratory
                              naphthalene, phenol,     irritant (Ref.
                              [ogr]-cresols, toluene   207).
                              (Refs. 200 and 206).
------------------------------------------------------------------------

    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,

[[Page 26418]]

such as how long the individual smokes the cigar, the number of puffs 
taken, and the degree of inhalation, a leading review of the science of 
cigar smoking concluded that ``[c]igars are capable of providing high 
levels of nicotine at a sufficiently rapid rate to produce clear 
physiological and psychological effects that lead to dependence, even 
if the smoke is not inhaled'' (Ref. 210).
    Research indicates that most cigar smokers unknowingly inhale some 
amount of smoke, including cigar smokers who report that they do not 
inhale (Ref. 211; see Ref. 212). Youth more commonly use cigarillos and 
little filtered cigars that are designed to be inhaled, which may 
increase their risk of poor health outcomes as well as addiction (Refs. 
32 and 183). Little cigars are often indistinguishable from cigarettes 
given their shape, size, filters, and packaging, and are perceived as 
being healthier than cigarettes (Refs. 48 and 49). Even if cigar 
smokers do not breathe or inhale smoke into their lungs, they are still 
subject to nicotine's addictive effects through buccal absorption of 
nicotine or nicotine absorption through the lips due to cigar tobacco's 
alkalinity (Refs. 211, 213-215). Cigar smoke dissolves in saliva and 
makes it possible for smokers to absorb sufficient amounts of nicotine 
to create dependence (Ref. 213).
    Nicotine can exist in protonated and freebase, or unprotonated, 
forms; in the freebase form, it is most addictive because it is readily 
absorbed by the buccal mucosa, respiratory tissues, skin, and the 
gastrointestinal tract (Refs. 6 and 121). Freebase, unprotonated 
nicotine amounts are generally higher in cigars than cigarettes due to 
the higher pH of cigar smoke (Ref. 183). Nicotine absorbed across the 
buccal mucosa, the mouth's membrane lining, can provide sustained 
amounts of freebase nicotine to the tobacco product user, which, along 
with the harshness of cigar smoke, may explain why cigar smokers are 
less likely to intend to inhale than cigarette smokers (Ref. 183). 
Cigars can deliver nicotine much like chewing tobacco or oral snuff, 
with nicotine extraction from the unburned tobacco absorbed directly 
through the buccal mucosa and lips (Ref. 183).
    In addition, characterizing flavors may impact the effects of 
nicotine. In particular, characterizing flavors, including menthol, can 
activate the brain's reward circuit, producing rewarding effects that, 
when added to tobacco products, can reinforce the effects of nicotine 
(Refs. 13 and 14). The use of sweet/candy and other characterizing 
flavors that appeal to youth produces a robust reinforcing effect in 
young populations (Refs. 13 and 14). One animal study found that 
flavors can enhance the reinforcing effects of low nicotine doses in 
rodents (Ref. 216). The authors of this study suggest this effect may 
influence nicotine exposure and subsequent dependence. While flavors 
can activate the brain's reward circuit and produce rewarding effects 
on their own (Ref. 14), these findings suggest that flavors and 
nicotine can interact to enhance the reinforcing effects of nicotine 
(Refs. 13, 216, and 217). Further studies demonstrate that menthol, 
like nicotine, binds to nicotinic receptors in the brain (Refs. 218 and 
219) and menthol alone can increase the number of nicotinic receptors 
in the brain (Refs. 220 and 221). Increases in nicotinic receptors can 
lead to greater withdrawal and cravings (Ref. 222). Evidence 
demonstrates that menthol's effects on nicotine in the brain are 
associated with behaviors indicative of greater addiction to nicotine 
(Refs. 220 and 223). In an analysis of 2019-2020 NYTS data, use of one 
or more flavored tobacco products, including menthol, during the past 
30 days was associated with higher odds of reporting strong cravings 
and desire to use tobacco within 30 minutes of waking compared to use 
of an unflavored tobacco product (Ref. 182).
    A cigar smoker's age is another factor that affects susceptibility 
to nicotine addiction. The Surgeon General has noted that nicotine 
dependence in cigar smokers could result from even a limited exposure 
to nicotine during adolescence (Ref. 6). Analyses of data from the 2012 
and 2019-2020 NYTS found that, although the percentage of middle and 
high school students reporting various measures of dependence was lower 
for cigars than for cigarettes, youth reported measures of nicotine 
dependence when exclusively using cigars (Refs. 181 and 182). The 
analysis of 2019-2020 NYTS data found that 14.8 percent of middle and 
high school students who only smoked cigars reported strong cravings 
for a tobacco product during the past 30 days (Ref. 182).
    Prohibiting characterizing flavors (other than tobacco) in cigars 
would reduce the appeal of cigars, particularly among youth and young 
adults, and decrease the likelihood that nonusers would experiment with 
cigars. It also would decrease the likelihood that current 
experimenters would continue to use these products. Reducing the appeal 
of cigars and experimentation is particularly important because, as 
experimenters continue to use these products, they can develop 
dependence, leading to regular use and increasing their risk of 
developing the many negative health consequences associated with 
regular cigar use.

D. Research Clearly Demonstrates a Causal Relationship Between Cigar 
Smoking and Death and Disease

    Flavored cigar smokers, like all cigar smokers, are at increased 
risk for developing cancers of the mouth and throat, lung cancer, heart 
disease, and many other adverse health consequences, with some groups 
with higher rates of use at greater risk than others. As discussed in 
section V.C of this document, those who experiment with flavored cigars 
(due to their appeal and ease of use) can develop nicotine dependence, 
placing infrequent cigar smokers at risk of progression to regular use 
and to tobacco-related disease and death. Studies demonstrate that not 
only is cigar smoking causally associated with many of the same 
diseases as cigarette smoking, but cigar smoking risks can also exceed 
those causally associated with cigarette use depending on the number of 
cigars smoked and the depth of smoke inhalation (Ref. 32).
    Cigar smoke contains many of the same harmful constituents as 
cigarette smoke, and cigar smoke may have even higher levels of several 
harmful compounds (Refs. 3, 23, and 224). For example, cigar smoke 
contains higher amounts of carcinogenic, tobacco-specific N-
nitrosamines than cigarette smoke due to the relatively high 
concentration of nitrate in cigar tobacco, which leads to formation of 
cancer-causing nitrosamines during the fermentation process (Refs. 23; 
183 at Chapter 3; and 224). Researchers have found urinary 
concentrations of NNAL (a hazardous tobacco-specific nitrosamine) 
measured in daily cigar smokers to be as high as those measured in 
daily cigarette smokers (Refs. 225 and 226). Like exposure to cigarette 
smoke, exposure to higher levels of cigar smoke for longer time periods 
increases the adverse health risks caused by cigar smoking (Ref. 6).
    Using NATS data for 2009-2010, researchers have estimated that 
regular cigar smoking caused approximately 9,000 premature deaths or 
almost 140,000 years of potential life lost among adults 35 years or 
older (Ref. 3). A study of healthcare expenditures from 2000-2015 found 
that cigar-attributable health care expenditures for adults totaled 
$1.75 billion per year, with $284 million attributed to exclusive cigar 
smoking and $1.5 billion attributed to non-exclusive cigar smoking 
(i.e., cigar plus cigarette or smokeless tobacco use) (Ref. 4). The 
overall mortality rates for cigar smokers who inhale generally

[[Page 26419]]

approach the same mortality rates observed for cigarette smokers (Ref. 
183 at 110-112). In addition, overall mortality rates for all cigar 
smokers (i.e., those who report inhaling as well as those who report 
not inhaling cigar smoke) are higher than rates for those who have 
never smoked, although they are generally lower than the rates observed 
for cigarette smokers (Ref. 183 at 112). A recently published analysis 
using more contemporary data from the National Longitudinal Mortality 
Study, following participants for mortality from 1980 through the end 
of 2011, also found that exclusive cigar smokers had an elevated risk 
of all-cause mortality compared to never tobacco users, but lower than 
exclusive cigarette smokers (Ref. 227). Another similar analysis using 
the restricted-use National Health Interview Survey-Linked Mortality 
Files (NHIS-LMF), following participants for mortality from 2000 
through 2015, observed that current, daily cigar smokers had elevated 
risk of all-cause mortality compared to never tobacco users (Ref. 228). 
In addition, researchers studying cigar smokers in 2009 and 2010 found 
that the average cigar or pipe smoker loses approximately 15 life-years 
(Ref. 3).
    Given this causal relationship between cigar smoking and all-cause 
mortality, it is critical that FDA propose action to decrease the 
appeal and ease of cigar use, making it less likely that youth and 
young adults will experiment with cigars or progress to regular use. 
FDA also expects that the proposed product standard, if finalized, will 
cause a large number of existing cigar smokers to cease combusted 
tobacco product use (as discussed in section VI of this document) and, 
therefore, be less likely to suffer the negative health consequences of 
cigar smoking.
1. Cancers of the Mouth and Throat
    The National Cancer Institute's (NCI's) Tobacco Control Monograph 
No. 9, which provides a comprehensive, peer-reviewed analysis of the 
trends in cigar smoking and potential public health consequences, 
identified a dose-response relationship for cigar smoking and certain 
types of cancer (Ref. 183 at 120-130). Specifically, NCI's Tobacco 
Control Monograph No. 9 identified a dose-response relationship for 
cigar smoking and oral, laryngeal, pharyngeal, and esophageal cancers, 
finding an increased risk of these diseases with greater numbers of 
cigars smoked per day and deeper inhalation (Refs. 183 and 229-232). 
Likewise, a systematic review of the mortality risks associated with 
cigar smoking that identified 22 studies observed similar dose trends 
(Ref. 32).
    Cigar smoking can cause cancers of the mouth and throat even in 
smokers who report they do not inhale (Ref. 183). According to the 
NCI's Tobacco Control Monograph No. 9, the data clearly establish that 
cigar smoking is a cause of oral cancer (Ref. 183). Regular cigar 
smokers who have never smoked cigarettes, including those who report 
that they do not inhale, experience elevated risks for oral, laryngeal, 
pharyngeal, and esophageal cancers (Ref. 183). Although former 
cigarette smokers who currently smoke cigars are more likely to inhale 
more deeply than cigar smokers who never smoked cigarettes, ``the mouth 
and oral cavity are exposed to the carcinogens in smoke whether the 
smoke is inhaled or not'' (Ref. 183). The systematic review of the 
mortality risks associated with cigar smoking also noted that the 
relative mortality risk was still highly elevated for oral, esophageal, 
and laryngeal cancer among primary cigar smokers reporting no 
inhalation (Ref. 32). Cigar smokers, including those who do not inhale, 
have a similar risk of death from mouth and throat cancer as do 
cigarette smokers, with an overall risk 7 to 10 times higher than for 
those who have never smoked (Ref. 183). This similarity in risk is 
likely due to the similar doses of tobacco smoke delivered directly to 
the oral cavity and esophagus by cigars and cigarettes (Ref. 210). 
Cigar smokers are also more likely to develop mouth and throat cancer 
than those who have never smoked. In a large retrospective cohort study 
that included more than 17,000 men, researchers found that cigar 
smokers were nearly three times more likely than nonsmokers to develop 
cancer of the oropharynx and twice as likely to develop cancer of the 
upper aerodigestive tract (which includes oral cavity, pharynx, larynx, 
and esophagus) (Ref. 229). Those risks increased to roughly seven and 
five times, respectively, among those who smoked five or more cigars 
per day (Ref. 229).
    The NCI's Tobacco Control Monograph No. 9 concluded that cigar 
smoking is a cause of laryngeal and esophageal cancers (Ref. 183). The 
likelihood of cigar smokers developing laryngeal cancer is similar to 
that of cigarette smokers who smoke fewer than 20 cigarettes per day 
(Ref. 233). The relative risk (i.e., the risk of an outcome under study 
among exposed (smokers) compared to unexposed (nonsmokers)) of death 
from laryngeal cancer for those who smoke five or more cigars per day, 
or who inhale moderately or deeply, approaches the risk for cigarette 
smokers (Ref. 183). This similarity in risk is likely due to the 
similar amounts of tobacco smoke delivered directly to the oral cavity 
and esophagus by cigars and cigarettes (Ref. 210). Regardless of 
whether smoke is inhaled, the mouths and tongues of cigar smokers are 
exposed to a high level of smoke (Ref. 210). The esophagus is exposed 
to the carcinogens of tobacco smoke, which collect on the mouth's 
surface and are swallowed with saliva, rendering cigar smoking a cause 
of esophageal cancer (Ref. 210). The risk of esophageal cancer is 
several times higher for cigar smokers than for those who have never 
smoked, and the relative risk of esophageal cancer is higher for cigar 
smokers than for cigarette smokers, even when cigar smokers are 
compared to the heaviest cigarette smokers (Ref. 234).
    Several multinational research studies also have found that cigar 
smoking can cause oral and other cancers, even in those who do not 
inhale smoke. For example, the European Prospective Investigation into 
Cancer and Nutrition (EPIC) examined 102,395 men from Denmark, Germany, 
Spain, Sweden, and the United Kingdom and calculated the incidence of 
cancer in smokers who used cigars exclusively and cigar smokers who 
also smoked cigarettes (Ref. 235). According to the EPIC study 
findings, exclusive cigar smokers who report not inhaling had 
approximately a two-fold higher risk of lung, upper aerodigestive 
tract, and bladder cancers combined compared to those who never smoked 
(Ref. 235). This increased risk was raised to six- or seven-fold higher 
in cigar smokers who inhaled smoke compared to noninhalers (Ref. 235). 
This increased risk by comparison to never-smokers was lowest for 
smokers who had quit both cigarettes and cigars and higher for those 
who switched from cigarettes to only cigars, demonstrating the 
additional risk associated with cigar smoking compared to stopping 
smoking altogether (Ref. 235). Researchers confirmed a carcinogenic 
effect from cigar smoking with regard to upper aerodigestive tract 
cancers and found that the risk of these hazards increased with 
increased duration of smoking over the smoker's lifespan, increased 
intensity of use per week, and increased degree of smoke inhalation per 
episode (Ref. 235). A recently published international pooled cohort 
study found that ever cigar smokers had a non-significantly elevated 
risk of head and neck cancer and no elevated risk of esophageal cancer, 
although the numbers of cancer cases among ever cigar smokers were 
small at 12 for esophageal and 38 for head and neck cancer (Ref. 236). 
Such small sample

[[Page 26420]]

sizes, common in cancer studies given the relative rarity of the 
outcome, can limit the ability to observe a statistical association in 
the study.
    In addition, the World Health Organization (WHO) International 
Agency for Research on Cancer (IARC) published a monograph evaluating 
the carcinogenic risk to humans from tobacco smoke and involuntary 
smoke exposure. The IARC explained: ``Cigar and/or pipe smoking is 
strongly related to cancers of the oral cavity, oropharynx, 
hypopharynx, larynx, and esophagus, the magnitude of risk being similar 
to that from cigarette smoking. These risks increase with the amount of 
cigar . . . smoking and with the combination of alcohol and tobacco 
consumption'' (Ref. 224).
2. Lung Cancer
    The evidence clearly establishes that cigar smoking can cause lung 
cancer; the risk varies by number of cigars per day and level of 
exposure (Refs. 32; 183 at 119-120; and 224 at 1180). A recently 
published international pooled cohort study found that ever cigar 
smokers had a statistically significantly elevated risk of lung cancer 
(Ref. 236).
    Like the dose-response relationship between cigar smoking and mouth 
and throat cancers, the risk of death and disease from lung cancer 
increases as the number of cigars smoked per day and the depth of smoke 
inhalation increases (Refs. 32, 183, and 237-239). Overall lung cancer 
risk for cigar smokers is lower than the overall risk for cigarette 
smokers (Refs. 229 and 240-243), but the risk of death from lung cancer 
for cigar smokers may be similar to the risk of death from lung cancer 
for cigarette smokers (Refs. 32, 229, and 237-242) once the rates are 
adjusted for differences in inhalation levels and quantity of cigars 
smoked daily (Ref. 183 at 120). Cigar smokers in the Cancer Prevention 
Study I (CPS I), conducted from 1959-1972, who smoked five or more 
cigars daily with moderate inhalation had a similar risk of death from 
lung cancer as did pack-a-day cigarette smokers (Ref. 183).
    Former cigarette smokers who currently smoke cigars are more likely 
to inhale deeply than cigar smokers who have never smoked cigarettes, 
increasing their lung cancer risk (Ref. 23, citing Ref. 183). Although 
cigarette smokers who switch to smoking only cigars have lower lung 
cancer risks than they would have if they had continued smoking 
cigarettes, these risks appear to be substantially greater than for 
individuals who have quit smoking altogether (Refs. 183 at 155; 239; 
and 240).
    Likewise, according to data from the Cancer Prevention Study II 
(CPS II, a 12-year study of 1.2 million men and women, in which an 
analysis was conducted on a subset of male participants from 1982 to 
1994 who were asked about cigar use), the risk of lung cancer mortality 
was approximately five times higher for men who were current smokers of 
only cigars at the start of the followup study period compared with men 
who never smoked (Ref. 243). In an analysis of a subset of men who 
participated in the CPS II study, researchers found that men who smoked 
three or more cigars per day, who reported inhaling cigar smoke, or who 
had smoked cigars for 25 years or more experienced a statistically 
significantly greater risk of mortality from lung cancer than those men 
who reported less frequent cigar use, not inhaling, and smoking cigars 
for 25 years or less (Ref. 243). Even male cigar smokers who reported 
that they did not inhale were approximately three times more likely to 
die from lung cancer than those who never smoked (Ref. 243).
    The type of cigar used also may impact the risk of lung cancer in 
cigar smokers. One large case-control study found that lung cancer 
patients had 12.7 times greater odds of being an exclusive cigarillo 
user than controls, compared to a 5.6 times greater odds of being an 
exclusive user of cigars other than cigarillos (the study was conducted 
in Europe, where cigarillos typically weigh 1.5 to 3 grams and 
traditional cigars weigh 2 to 8 grams) (Ref. 239). This difference was 
likely due to differences in inhalation, as the researchers found that 
cigarillo users were more likely to inhale than users of other cigars, 
and inhalers were at higher risk of lung cancer than noninhalers (Ref. 
239). As cigarillo and filtered cigar use has increased (and cigarette 
use has decreased over this same period) in the United States, it is 
likely that smokers are using such products as substitutes for 
cigarettes and inhaling them as they would cigarettes (Refs. 101 and 
183). Filtered cigars, for example, share many of the design 
characteristics of cigarettes (Ref. 49). Therefore, the risk of lung 
cancer for some cigar smokers may be similar to that for cigarette 
smokers.
3. Heart Disease and Aortic Aneurysm
    Researchers have identified a pattern of elevated rates of death 
from coronary heart disease and aortic aneurysm among primary cigar 
smokers who smoke heavily or inhale deeply (Ref. 32). The CPS I (1959-
1972), which evaluated nearly one million men and women in 25 states, 
found that the rate of death from coronary heart disease increases with 
the number of cigars smoked and the depth of smoking inhalation (Refs. 
32 and 183). Researchers also identified an elevated risk of developing 
coronary heart disease in those individuals who smoked five or more 
cigars per day and exhibited moderate or deep inhalation (Refs. 32, 
183, and 244). CPS I data also suggest that cigar smokers are at an 
increased risk for aortic aneurysm, the risk rate approaching that 
observed for cigarette smokers (Refs. 32 and 183).
    Researchers analyzing CPS II data also examined death rates 
resulting from coronary heart disease related to cigar smoking. The 
1999 CPS II reviewed approximately 7,000 current cigar smokers, 7,000 
former cigar smokers, and 113,000 men who had never regularly smoked 
tobacco to determine the risk of heart disease for cigar smokers (Ref. 
210). Among men younger than 75 years old, current cigar smokers 
experienced a coronary heart disease death rate about one-third higher 
than those who had never smoked (Ref. 210).
    Additional studies provide supporting evidence that cigar smokers 
have elevated rates of developing coronary heart disease compared with 
nonsmokers (Refs. 229, 241, and 245). One large study examined primary 
(i.e., current, exclusive with no previous history of cigarette or pipe 
tobacco use) and secondary (i.e., current, exclusive with previous 
history of cigarette or pipe tobacco use) cigar smokers compared with 
never smokers (Ref. 241). It found that both primary and secondary 
cigar smokers were at increased risk of major coronary heart disease 
compared to never smokers (Ref. 242). Secondary cigar smokers also had 
a higher risk of major stroke compared with never smokers (Ref. 241). 
Primary and secondary cigar smokers had similar risks of major coronary 
heart disease and stroke and experienced outcomes similar to those who 
smoked less than a pack of cigarettes per day (Ref. 241). In the 
recently published NHIS-LMF, current, daily cigar smokers had a non-
significantly elevated risk of death due to coronary heart disease 
compared to never tobacco users (Ref. 228).
    In addition, in 2010, the Surgeon General found that for older 
adult cigar smokers, particularly those who smoke more than one cigar 
per day or inhale the smoke, the risk of heart disease is moderately 
higher than that for nonsmokers (Ref. 6). In support of the Surgeon 
General's findings, one study conducted from 1964 to 1973 involved 
17,774 men ranging in age from 30 to 85, of which 1,546 smoked cigars 
and 16,228 did not, all of whom reported

[[Page 26421]]

that they had never smoked cigarettes and did not currently smoke pipes 
(Ref. 229). This study determined that cigar smoking was associated 
with a moderate, but statistically significant, increase in the risk of 
coronary heart disease (Ref. 229).
    International researchers have reached similar conclusions about 
the impact of cigar smoking on the risk of developing heart disease. 
For example, in a study of more than 12,000 Danish people aged 30 years 
and older that looked at the risk of first acute myocardial infarction 
(MI), researchers found the risk of first acute MI escalated with 
increasing depth of smoke inhalation and with increasing number of 
cigars smoked per day (Refs. 183 and 244). Another Danish study found 
the highest rates of myocardial infarction for smokers of cheroots (a 
type of cigar with ends that do not taper that is traditionally used in 
India and Burma) to be for those individuals who smoked six or more 
cheroots per day, with a relative risk of myocardial infarction of more 
than four times the risk of individuals who had never smoked (Ref. 183, 
citing Ref. 246).
4. Other Health Outcomes
    Research studies have found that cigar smokers have approximately 
40 to 45 percent higher risk of COPD than never tobacco users. A cohort 
study of Kaiser Permanente plan members found a relative risk of COPD 
diagnosis of 1.45 for cigar (Ref. 229), and CPS I data found a similar 
elevated relative risk of COPD among primary cigar smokers of 1.42 
(Ref. 247).
    The risk of bladder cancer in CPS I data was also approximately 40 
percent higher for cigar smokers, with a relative risk of 1.38 (Ref. 
247). In a recently published study using data from the Agricultural 
Health Study, ever cigar use was statistically significantly associated 
with risk of urinary cancer (Ref. 248).
    There are other health outcomes attributable to cigar smoking that 
were not assessed using CPS I or II mortality data. For example, one 
study found statistically significant increased risks of colon and 
rectal cancers among cigar smokers in a cohort of nearly 250,000 World 
War I era veterans who were followed for mortality for 26 years (Ref. 
249). While most research has focused on cigar-attributable mortality, 
limited research has addressed cigar-attributable morbidity. Besides 
dying from cigar-attributable disease, lifelong cigar smokers may live 
many years with serious medical conditions, such as cancers (Refs. 229 
and 232), heart disease (Refs. 229 and 245), and increased airflow 
obstruction (Ref. 124) that can lead to major physical impairments, and 
substantially reduce functioning and quality of life.
5. Impact on Individuals Who Report That They Do Not Inhale Smoke
    Studies suggest that even cigar smokers who do not intend to inhale 
smoke, and who are unaware they are doing so, nonetheless inhale some 
amount of cigar smoke (Refs. 124 and 212). While inhaling cigar smoke 
poses much higher morbidity and mortality rates than not inhaling, 
substantial risks still exist for those cigar smokers who may not 
intentionally inhale smoke. Relative mortality risks for oral, 
esophageal, and laryngeal cancers are high even among those primary 
cigar smokers who reported that they do not inhale cigar smoke (Ref. 
32; see Refs. 183, 230, and 247). Researchers found that the risk of 
stomach cancer mortality was also higher among cigar users who reported 
they did not inhale smoke when compared to individuals who did not use 
tobacco products (Ref. 250). Regardless of whether cigar smokers 
inhale, they are still subject to cigars' addictive and other adverse 
health effects through absorption of nicotine and other harmful 
constituents, including those discussed in section V.B of this document 
(Refs. 212 and 250). Buccal absorption of nicotine occurs even if cigar 
smoke is not inhaled, and cigar smokers may also absorb nicotine 
through the lips due to the alkalinity of cigar tobacco (Refs. 214 and 
215). This greater nicotine yield and absorption increases the risk of 
nicotine addiction from cigar smoking.

E. Secondhand Tobacco Smoke, Including Cigar Smoke, Increases the Risks 
of Lung Cancer, Heart Disease, and Other Adverse Health Effects in 
Nonsmokers

    Tobacco smoke inhaled by nonsmokers in indoor and outdoor spaces is 
most commonly referred to today as ``secondhand smoke'' but has also 
been referred to as ``environmental tobacco smoke,'' ``passive smoke,'' 
or ``involuntary smoke.'' Extensive data exist regarding the dangers of 
involuntary exposure to tobacco smoke. It is well established that 
exposure to secondhand tobacco smoke causes premature death and disease 
in youth and adults who do not smoke (e.g., Refs. 251 and 252). 
Exposure to secondhand smoke has immediate adverse effects on the 
cardiovascular system and can cause lung cancer, coronary heart 
disease, and stroke (Ref. 251). By reducing the prevalence of cigar 
smoking, this proposed standard also has benefits for those who do not 
use cigars.
    Tobacco smoke contains over 7,000 compounds, and cigars generate 
more than 50 carcinogens in mainstream and sidestream smoke (Refs. 23, 
183, and 251). Mainstream cigar smoke is the smoke one draws into the 
mouth from the butt end or mouthpiece of a cigar; sidestream cigar 
smoke is the smoke emitted from the burning cone of a cigar during the 
interval between puffs (Ref. 183). Secondhand smoke is a combination of 
sidestream smoke and exhaled mainstream smoke.
    While the above data on secondhand smoke are related to cigarettes, 
evidence supports the conclusion that these data apply to secondhand 
cigar smoke, as well, and there is no basis to conclude that secondhand 
smoke from cigars is any less hazardous than secondhand smoke from 
cigarettes. Cigar smoke contains the same toxic substances as cigarette 
smoke, with varying concentrations of these constituents found in 
different cigar types and sizes (Ref. 183). Even though, on average, 
tobacco users smoke more cigarettes than cigars, the overall level of 
toxicants in secondhand smoke from cigars can be quantitatively higher 
than in the secondhand smoke from cigarettes (Ref. 183). Cigars also 
produce much higher levels of many indoor pollutants than cigarettes, 
which can be explained, at least in part, by the larger size of cigars 
and therefore greater amount of tobacco burned compared to cigarettes 
(Ref. 183). The smoke from one cigar can take 5 hours to dissipate, 
exposing household members to a considerable involuntary health risk 
(Ref. 183).
1. Lung Cancer and Secondhand Smoke
    Exposure of nonsmokers to secondhand tobacco smoke has been shown 
to cause a statistically significant increase in urinary levels of 
metabolites of tobacco-specific nitrosamines, which are carcinogens 
that specifically link exposure to secondhand smoke with an increased 
risk for lung cancer (Ref. 251). Studies in rodents have demonstrated 
that 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone specifically 
induces lung tumors by systemic administration, which provides support 
that nitrosamines are major factors in the development of lung cancer 
(Ref. 251). According to the Surgeon General, there is sufficient 
evidence from which to infer a causal relationship between secondhand 
tobacco smoke exposure and lung cancer among lifetime nonsmokers (Ref. 
251). Individuals living with smokers had a 20 to 30 percent increase 
in the risk of developing lung cancer from

[[Page 26422]]

secondhand smoke exposure, compared with individuals living with 
nonsmokers (Ref. 251). Based on the similarity of the toxic 
constituents in cigars and cigarettes, and the fact that cigars 
commonly share similar product design and mechanisms of smoke delivery 
as cigarettes, FDA's scientific judgment leads the Agency to expect 
that secondhand cigar smoke would produce effects similar to those 
produced by secondhand cigarette smoke. According to the World Health 
Organization's International Agency for Research on Cancer, a mass 
balance model developed for predicting secondhand tobacco smoke was 
used to obtain CO, respirable suspended particle, and PAH emission 
(Ref. 224). These observed factors demonstrated that cigars can be more 
potent sources of CO than cigarettes (Ref. 224). The study also 
demonstrated that although a single cigar may have lower emissions of 
respirable suspended particles and PAHs per gram of tobacco consumed 
than a cigarette, a cigar's larger size and longer smoking time results 
in greater total respirable suspended particles and PAH emission than a 
single cigarette (Refs. 224 and 253). Findings from the NCI Tobacco 
Control Monograph No. 9 also demonstrate that carcinogens linked to 
lung cancer would be expected to be present at comparable levels in 
cigar and cigarette smoke (Ref. 183). Little cigars with filter tips 
and regular cigars contain higher levels of certain nitrosamines in 
sidestream smoke than do filtered tip cigarettes (Ref. 183).
2. Heart Disease and Secondhand Smoke
    The evidence cited in Surgeon General's Reports supports the 
conclusion that secondhand tobacco smoke exposure can cause heart 
disease and stroke. Although the research examining the effects of 
exposure specific to secondhand cigar smoke is more limited compared to 
cigarettes, evidence from a recently published study suggests that the 
risk of experiencing negative cardiovascular effects due to secondhand 
cigar smoke exposure is similar to the risk from secondhand cigarette 
smoke exposure (Ref. 254). It is reasonable to anticipate that the 
cardiovascular risks from secondhand cigar smoke would be similar to 
those of secondhand cigarette smoke due to the similar smoke profiles 
for cigars and cigarettes, the excess risk of coronary heart disease 
associated with active cigar smoking, and the low levels of toxicant 
exposure that can cause coronary heart disease (Ref. 251).
    In a 2006 report regarding the health effects of exposure to 
secondhand tobacco smoke, the Surgeon General concluded that exposure 
to secondhand tobacco smoke had immediate adverse effects on the 
cardiovascular systems and caused coronary heart disease (Ref. 251). 
The estimated increase in coronary heart disease risk from exposure to 
secondhand tobacco smoke is 25 to 30 percent above that of unexposed 
individuals (Ref. 251). Based on these data, the Surgeon General 
concluded that ``the evidence is sufficient to infer a causal 
relationship between exposure to secondhand smoke and increased risks 
of coronary heart disease morbidity and mortality among both men and 
women'' (Ref. 251).
3. Other Health Problems
    Studies have concluded that secondhand tobacco smoke can cause 
other health problems, specifically for youth. Secondhand smoke 
exposure has been independently linked to increased inflammatory 
responses, oxidative stress, and endocrine disruption in youth (Refs. 
255-257). Children exposed to secondhand smoke are also at an increased 
risk of sudden infant death syndrome, acute respiratory infections, ear 
problems, and more severe asthma (Ref. 23). In addition, smoking by 
parents can cause respiratory symptoms and slower lung growth in their 
children as compared to the children of non-smoking parents (Ref. 23). 
It is expected that these health effects would apply to secondhand 
cigar smoke exposure specifically, given the stated similarities 
between cigar smoke and other forms of tobacco smoke.
    For all of these reasons and based on extensive evidence, it is 
clear that cigar use causes severe negative health consequences among 
users and nonusers. As discussed in section VI of this document, this 
proposed rule, if finalized, would help to prevent experimentation with 
cigars and progression to regular use, and increase cessation among 
current users, which would help to lessen the incidence of cigar-
related negative health consequences.

F. Disparities in Tobacco Use, Including Cigar Use, Lead to Disparities 
in Tobacco-Related Morbidity and Mortality

    As previously discussed, cigar smoking exposes users to the same 
toxic and carcinogenic compounds identified in cigarette smoke and is 
associated with many of the same health risks as cigarette smoking. As 
such, this section discusses the evidence to support how disparities in 
tobacco use shape disparities in tobacco-related morbidity and 
mortality. While the prevalence of cigar use has decreased over time 
for non-Hispanic White persons, data from the 2002-2016 NSDUH show that 
cigar use has remained stable for non-Hispanic Black persons (aged 12 
years and older) (Ref. 162), while 2000-2015 NHIS data show increased 
prevalence for non-Hispanic Black adults (aged 18 years and older) 
(Ref. 258). In addition, differences in cessation and quit attempts 
have been observed across population groups. Despite more attempts at 
quitting, Black cigarette smokers are less successful at quitting than 
White and Hispanic cigarette smokers (Refs. 38, 259, and 260). While 
less is known about disparities in cigar cessation, findings from 2013-
2016 PATH data indicate that non-Hispanic Black cigar users had lower 
odds of discontinuing cigar use than non-Hispanic White users (Ref. 
261). Collectively, these factors contribute to the disparities in 
tobacco-related health outcomes. While the etiology of chronic health 
conditions is multifactorial in nature, smoking has been found to be an 
important causal factor (Ref. 23) African American adults, and in 
particular African American men, experience the highest rates of 
incidence and mortality and lowest rates of survival from many tobacco-
related cancers, such as lung and bronchus cancer and head and neck 
cancer, compared to those from other racial and ethnic groups (Refs. 
262 and 263). Deaths from other tobacco-related conditions such as 
heart disease, stroke, and hypertension are higher among African 
Americans compared to other racial and ethnic groups (Refs. 264-269).
    The higher levels of flavored cigar use among non-Hispanic Black 
cigar users exacerbate already-existing health disparities experienced 
by the Black community (Refs. 163 and 270). Levels of nicotine and 
other carcinogens in cigars may be higher than those in cigarettes and 
may be at levels that lead to increased risk of morbidity and mortality 
from conditions such as cancer, cardiovascular disease, and COPD (Refs. 
3, 32, and 210).
    Additionally, American Indians or Alaskan Natives (AI/ANs) have the 
highest prevalence of overall tobacco use compared to members of other 
racial and ethnic groups (Refs. 37, 38, 68, and 271). Prevalence of 
cigar smoking among AI/ANs is lower than prevalence among Blacks, but 
higher than among Hispanics and Asians (Ref. 271). It is well 
documented that AI/ANs suffer disproportionately from both lung cancer 
and cardiovascular diseases (Refs. 272 and 273). An analysis of 2001-
2009 mortality data for people living in the Indian Health Service

[[Page 26423]]

Contract Health Service Delivery Area counties in the United States 
indicated that age-adjusted death rates, smoking-attributable 
fractions, and smoking-attributable mortality for all-cause mortality 
were statistically significantly higher among AI/AN populations than 
among Whites for adult men and women aged 35 years and older (Ref. 
274). Cigarette smoking caused 21 percent of ischemic heart disease, 15 
percent of other heart disease, and 17 percent of stroke deaths in AI/
AN men, compared with 15 percent, 10 percent, and 9 percent, 
respectively, for White men (Ref. 274). Among AI/AN women, smoking 
caused 18 percent of ischemic heart disease deaths, 13 percent of other 
heart diseases deaths, and 20 percent of stroke deaths, compared with 9 
percent, 7 percent, and 10 percent, respectively, among White women 
(Ref. 274).
    Disparities in tobacco-related morbidity and mortality have also 
been observed for other population groups that have higher levels of 
tobacco use. Those with low household income and educational attainment 
bear a disproportionate burden of heart disease and stroke incidence 
and mortality (Refs. 275 and 276). National Health and Nutrition 
Examination Survey (NHANES) data from 2007 to 2010 indicate that 
prevalence of co-occurring obesity and smoking was linearly associated 
with educational attainment as women with the lowest levels of 
education had greater likelihood of being obese smokers than women with 
the highest levels of education (Ref. 277). Research has also 
demonstrated that individuals with behavioral health conditions and 
other medical comorbidities have higher prevalence of combusted tobacco 
use compared to those without these conditions (Refs. 167 and 278) and 
have increased risk of tobacco-related morbidity and mortality (Refs. 
23, 279, and 280). Inpatient hospital admission data from 1990 to 2005 
from California indicate that approximately half of the deaths in those 
who had been hospitalized for schizophrenia, bipolar disorder, or major 
depressive disorder were due to diseases causally linked to tobacco use 
(Ref. 279) and that the majority of deaths for those hospitalized for 
opioid-related conditions were related to tobacco and alcohol, not to 
opioids (Ref. 281). In a study of 470 unhoused individuals, the 
analysis found that past 30-day use of all tobacco products was high 
and that 74.0 percent of respondents reported use of cigars and over 
half (55 percent) reported use of flavored cigars in the past 30 days 
(Ref. 166). Tobacco-related cancers are a leading cause of death among 
adults experiencing homelessness (Ref. 165).
    Additionally, the burden of secondhand smoke exposure is 
experienced disproportionately among members from some racial and 
ethnic groups and people from lower household income and educational 
attainment backgrounds. Among nonsmokers ages 3 and older, findings 
from 2011-2018 NHANES data indicate that non-Hispanic Blacks and those 
living below the poverty level had the highest levels of secondhand 
smoke exposure compared to people of other races and those living above 
the poverty level, respectively; these disparities persisted across all 
years of the study analysis from 2011 to 2018 (Ref. 282). From 1999 to 
2012, the percentage of the nonsmoking population ages 3 and older with 
detectable serum cotinine levels (defined in the study as levels >=0.05 
ng/mL to indicate secondhand smoke exposure) declined across all racial 
and ethnic groups (Ref. 283). However, a higher proportion of non-
Hispanic Black nonsmokers continued to have detectable serum cotinine 
levels, compared to Mexican American and non-Hispanic White nonsmokers. 
For example, in 2011-2012, nearly 50 percent of non-Hispanic Black 
nonsmokers had detectable serum cotinine levels, compared with 22 
percent of non-Hispanic White and 24 percent of Mexican American 
nonsmokers (Ref. 283).
    Disparities in the secondhand smoke exposure are found across 
various environmental settings. These disparities speak to the 
interrelated influences of individual factors (e.g., age, race and 
ethnicity, income) and existing inequities in places where members from 
underserved communities are likely to reside, spend time, and work 
(Ref. 183). Findings drawn from the 2013-2016 NHANES data indicate that 
compared to non-Hispanic Whites, non-Hispanic Blacks had higher odds of 
secondhand smoke exposure in homes other than their own (Ref. 284). An 
analysis of NYTS data indicates that non-Hispanic Black and non-
Hispanic White students both had higher prevalence of secondhand smoke 
exposure at home and in vehicles than Hispanic and non-Hispanic other 
students (Ref. 285). While secondhand smoke exposure in homes and 
vehicles declined from 2011 to 2018, secondhand smoke exposure in homes 
among non-Hispanic Black students did not change (Ref. 285). Home 
smoking bans (i.e., household rules that restrict or ban smoking inside 
the home) can reduce secondhand smoke exposure. A study using 1995-2007 
data from the TUS-CPS found that among two parent households, higher 
levels of parental educational level and annual household income were 
associated with the higher reporting of a complete home ban as compared 
to lower levels of parental educational and annual household income 
(Ref. 286). Such findings are consistent with a higher degree of 
autonomy over the home environment for households with greater economic 
resources and housing flexibility, emphasizing the degree to which 
certain aspects of disadvantage (such as lower family income, lack of 
access to single-family housing, or lack of autonomy over the home 
environment) may compound tobacco-related health disparities. Workplace 
secondhand smoke exposure has also been shown to vary across population 
groups. Data from the 2010 and 2015 NHIS show that exposure to 
secondhand smoke in the workplace was disproportionately high among 
non-Hispanic Blacks, Hispanics, and workers with low education and low 
income (Ref. 287). Additionally, the study findings indicated that 
``blue-collar workers'' (defined as those who performed manual labor 
such as manufacturing, mining, sanitation, and construction) 
experienced higher prevalence of secondhand smoke exposure as compared 
to ``white-collar workers'' (defined as those who primarily work in an 
office, with computer and desk setting, and perform professional, 
managerial, or administrative work) (Ref. 287).
    The disparities observed in tobacco and cigar use, as well as 
disparities in secondhand smoke exposure, contribute to the disparities 
in tobacco-related morbidity and mortality experienced by some 
population groups. This proposed product standard is anticipated to 
reduce smoking-related morbidity and mortality for these vulnerable 
populations.

VI. Determination That the Standard Is Appropriate for the Protection 
of the Public Health

    The Tobacco Control Act authorizes FDA to adopt tobacco product 
standards by regulation if it finds that a tobacco product standard is 
appropriate for the protection of the public health (section 
907(a)(3)(A) of the FD&C Act). The notice of proposed rulemaking for 
such a product standard must set forth this finding with supporting 
justification, which FDA is doing here (section 907(c)(2)(A) of the 
FD&C Act).
    In order to make this finding, FDA must consider scientific 
evidence concerning:
    <bullet> The risks and benefits to the population as a whole, 
including users

[[Page 26424]]

and nonusers of tobacco products, of the proposed standard;
    <bullet> The increased or decreased likelihood that existing users 
of tobacco products will stop using such products; and
    <bullet> The increased or decreased likelihood that those who do 
not use tobacco products will start using such products.
    Section 907(a)(3)(B)(i) of the FD&C Act.
    FDA has considered scientific evidence related to all three 
factors. Based on these considerations, as discussed below, we find 
that the proposed standard is appropriate for the protection of the 
public health because it would reduce the appeal of cigars, 
particularly to youth and young adults, thereby decreasing the 
likelihood both that nonusers would experiment with cigars and that 
current and future experimenters would continue to use cigars, develop 
an addiction to nicotine, and progress to regular use of cigars and/or 
other tobacco products. Additionally, FDA anticipates that the proposed 
standard would improve the health of some current smokers of flavored 
cigars by increasing the likelihood of cessation. Decreased 
experimentation, progression to regular use, and consumption would lead 
to lower disease and death in the U.S. population, including in certain 
populations that are disproportionately marketed to and bear a 
disparate burden of tobacco-related morbidity and mortality. In 
addition, the population as a whole would likely experience health 
benefits based on a likely decrease in morbidity and mortality 
resulting from secondhand smoke exposure.

A. The Likelihood That Nonusers Would Start Using Cigars

    Flavors are a significant driver for youth and young adults to try 
cigars. In section IV of this document, we summarize evidence from 
multiple study designs, incorporating findings from qualitative 
research, and nationally representative cross-sectional and 
longitudinal observational studies that illustrate the appeal of 
flavored cigars among young people and the role characterizing flavors 
play in experimentation and continued cigar use. In this section, we 
discuss how, given this evidence and findings from policy evaluations 
of local and national jurisdictions, FDA expects the proposed standard 
on characterizing flavors (other than tobacco) in cigars would decrease 
experimentation and progression to regular use of cigars among current 
nonusers.
    Youth and young adults consistently identify the availability of 
characterizing flavors as a leading reason for their cigar use (Refs. 
64 and 65). In 2018-2019, 50.4 percent of youth (aged 12-17 years) 
participants in the PATH Study who reported past 30-day cigar smoking 
identified flavors as a reason for use (Ref. 12). Four systematic 
reviews of the scientific literature concluded that flavored tobacco 
products attract youth to the tobacco product (Refs. 86-89). Two of the 
reviews that included discussion of cigars concluded that 
characterizing flavors were an appealing feature of tobacco products 
and that flavors influence perceptions, initiation, and progression to 
use of tobacco products, particularly among youth (Refs. 88 and 89). 
Similarly, results from qualitative research indicate that youth and 
young adults themselves acknowledge that flavorings impact their cigar 
use, making smoking flavored cigars more palatable than smoking non-
flavored cigars (Ref. 82). The appeal of flavors is also consistent 
with physiological studies assessing youth preference for flavors, 
including studies assessing the similarities between flavor chemicals 
in tobacco products with drink mixes and candy (Refs. 95 and 96). 
Overall, the literature is consistent on the appeal of flavors in 
tobacco products, including cigars (see section IV.D of this document). 
Diminishing the appeal of cigars by prohibiting the use of 
characterizing flavors (other than tobacco) is, therefore, appropriate 
for the protection of the public health, as it would decrease the 
likelihood of experimentation at younger ages and reduce the potential 
for onset of tobacco dependence during the progression to regular 
tobacco use. Furthermore, flavored cigar use exposes users to more 
toxicants than are present in non-flavored cigars and there is no 
evidence that flavored cigars present any countervailing benefits to 
public health.
    Experimentation with cigars can lead to nicotine dependence and 
regular use, as discussed in section IV.E of this document. Based on 
nationally representative Truth Longitudinal Cohort data from 2014 to 
2019, 44.7 percent of youth and young adults (aged 15-25 years) who 
initiated cigar use reported current (i.e., past-30-day) cigar use 6 
months after initiation (Ref. 100). When trying a cigar for the first 
time, the majority of youth cigar smokers report that the first cigar 
they used was flavored. Data from Wave 5 (2018-2019) of the PATH Study 
revealed that 60.4 percent of youth (aged 12-17 years) and 63.2 percent 
of young adults (aged 18-24 years) who reported ever using cigars said 
that the first cigar they used was flavored (Ref. 12).
    Using nationally representative longitudinal data from Waves 1 
(2013-2014) and 2 (2014-2015) of the PATH Study, one study found that 
first use of a flavored cigar was associated with more likely 
subsequent cigar use 1 year later compared to first use of a non-
flavored cigar in young adults (aged 18-24 years) and adults (aged 25 
years and older) (Ref. 28). This analysis was extended using Waves 1-4 
(2013-2017) of PATH Study data to assess the relationship between new 
use of a menthol- or mint-flavored cigar or other flavored (e.g., 
fruit, alcohol, chocolate, candy, and other flavor) cigar with 
subsequent use compared to first use of a non-flavored cigar. The 
analysis found that among youth (aged 12-17 years) and young adults 
(aged 18-24 years), first use of any menthol- or mint-flavored or other 
flavored cigar was associated with current past 30-day use of flavored 
cigars at a later wave compared with first use of a non-flavored (i.e., 
tobacco) cigar (Ref. 29). Specifically, youth who used a menthol/mint-
flavored cigar or other flavored cigar were 72 percent (menthol/mint) 
and 47 percent (other flavor) more likely, respectively, to be using a 
cigar a year or more later compared to those first using a non-flavored 
cigar. Similarly, young adults (aged 18-24 years) who used a menthol/
mint-flavored cigar or other flavored cigar were 71 percent (menthol/
mint) and 52 percent (other flavor) more likely to be using a cigar a 
year or more later compared to those first using a non-flavored cigar. 
For both youth and young adults, the association between the first 
flavor used and subsequent cigar use was not statistically 
significantly different for menthol- or mint-flavored compared to other 
flavored cigars. These results are consistent with the evidence that 
flavors enhance the addictive effects of nicotine and make cigars 
easier to use, as discussed previously. FDA finds that eliminating 
flavored cigar varieties likely would decrease the number of youth and 
young adults experimenting and progressing to regular, sustained use of 
cigars.
    Given that nicotine is highly addictive and present in all cigars, 
as experimenters continue to use these products, there is a risk of 
development of nicotine dependence and progression to regular use. 
Several studies found that cigars reduce craving and urge to smoke 
similar to cigarettes (Refs. 101-103). The adolescent brain is more 
vulnerable to developing nicotine

[[Page 26425]]

dependence than the adult brain. Nicotine can disrupt brain development 
and have long-term consequences, including decreasing attention and 
increasing impulsivity, which could promote the maintenance of nicotine 
use behavior (Ref. 288). Therefore, progressing to regular use during 
adolescence can have lasting consequences and signs of nicotine 
dependence are evident in young cigar users. Researchers analyzing data 
from the 2017-2018 NYTS found that 43.1 percent of middle and high 
school students using cigars in the past 30 days reported nicotine 
dependence, including feeling a strong craving to use a tobacco product 
or using a tobacco product within 30 minutes of waking (Ref. 107). Such 
results suggest that even infrequent experimentation can lead to early 
signs of dependence, which underscores the public health importance of 
decreasing the likelihood of cigar experimentation among youth and 
young adults in the United States.
    It is also important to note the role that cigars play in polyuse 
patterns, and the subsequent development of dependence, among youth 
tobacco users. As polyuse increases, youth exposure to nicotine 
increases (Ref. 17), increasing the risk of dependence among young 
people (Refs. 181 and 182). When looking at the association between 
cigar use and dependence, exclusive use of cigars among youth in the 
2017-2018 NYTS was associated with lower odds of nicotine dependence 
relative to exclusive use of another tobacco product. However, when 
youth cigar use included polyuse, which was more common for youth cigar 
users, current cigar use was associated with twice the odds of nicotine 
dependence compared to current use of any other tobacco product (Ref. 
107). See section V.A.3 of this document for additional discussion 
regarding polyuse.
    Similar to cigarette smoking, first cigar use often occurs during 
youth or young adulthood (Refs. 24 and 25). A longitudinal analysis of 
Waves 1-4 (2013-2017) of PATH Study data found an increasing 
probability of initiating cigar use between ages 15 and 20 years, with 
the greatest increase in first use between 17 and 18 years of age (Ref. 
25).
    FDA expects a substantial reduction in youth and young adult 
initiation and progression to regular use of cigars, which would 
ultimately protect many youth and young adults from a lifetime of 
addiction, disease, and death attributable to cigar smoking. There are 
multiple sources of evidence to inform the Agency's analysis of how the 
proposed standard would affect the likelihood that nonusers would start 
to experiment and continue using cigars (Refs. 28, 29, and 100). First, 
many individuals who initiate cigar use transition to more regular use. 
One analysis of data from a nationally representative cohort found that 
44.7 percent of youth and young adults who initiated cigar use became a 
regular user 6 months after first trying a cigar (Ref. 100). Next, 
several studies suggest that when individuals initiate cigar use, it is 
often with a flavored product. PATH researchers found that 60.4 percent 
of youth (aged 12-17 years) and 63.2 percent of young adults (aged 18-
24 years) who reported ever using cigars said that the first cigar they 
used was flavored (Ref. 12). Lastly, analyses of PATH data also suggest 
that initiation with a flavored cigar is associated with a greater 
likelihood of progressing to regular use compared to initiation with a 
non-flavored cigar. In a cross-sectional analysis of the PATH study, 
young adult (aged 18-24 years) and adult ever tobacco users (aged 25 
years and older) who initiated with a flavored cigar were more likely 
that those who initiated with a non-flavored cigar to be a current 
regular cigar user, after controlling for demographics, education, 
income, age at first tobacco use, substance use, and mental health 
indicators (Ref. 289). In a longitudinal analysis using Waves 1 to 4 
(2013-2017) of PATH Study data, youth and young adults who used a mint 
or menthol cigar or other flavored cigar were more likely to be past-
30-day cigar users at a subsequent wave compared to those first using a 
non-flavored cigar, after controlling for sociodemographics (Ref. 29). 
Together these study results indicate that experimentation with cigars 
is associated with progression to regular use, the majority of youth 
and young adults who initiate cigar use do so with flavored cigars, and 
initiating with flavored cigars (compared to non-flavored cigars) is 
associated with an increased risk of current and ongoing tobacco use, 
as compared to experimentation with non-flavored cigars. To the extent 
that youth and young adult cigar users using a flavored cigar on their 
first use would not otherwise initiate with non-flavored cigars or 
other tobacco products, the proposed standard would prevent future 
tobacco-related disease and death among these youth and young adults.
    In addition to longitudinal studies illustrating the role of 
flavors in youth and young adults progressing from experimenting with 
flavored cigars to regular use, policy evaluations from local 
jurisdictions throughout the United States illustrate how a flavor 
restriction can decrease youth cigar use. Section IV.F of this document 
discusses results from evaluation studies of restrictions on the sale 
of tobacco products with characterizing flavors in jurisdictions 
throughout the United States and in Canada. Studies of policies 
implemented in Providence, RI; New York, NY; Lowell, MA; Attleboro and 
Salem, MA; Minneapolis and St. Paul, MN; San Francisco, CA; and Canada 
focused on the impact of flavored tobacco sales restrictions on youth 
use of tobacco products, including cigars and are informative to FDA's 
consideration of how the proposed standard would impact the likelihood 
of tobacco use among youth.
    In Providence, RI, at 3 years and 5 years following implementation 
of the city's restriction on flavored tobacco products except menthol, 
mint, and wintergreen, youth current use of any tobacco product had 
declined, from 22.2 percent in 2016 to 12.1 percent in 2018; and 
current use of cigars/cigarillos had declined from 7.1 percent in 2016 
to 1.9 percent in 2018 (Ref. 60). Three years after implementation of a 
restriction on flavored tobacco products except menthol, mint, and 
wintergreen, in NYC in 2010, youth (13-17 years) had 37 percent lower 
odds of reporting having ever tried a flavored tobacco product, and 28 
percent lower odds of ever using tobacco products in 2013 compared to 
2010 (Ref. 51). Six months after enacting a restriction on flavored 
tobacco products except menthol in 2016, researchers in Lowell, MA, 
found that youth current use of any flavored tobacco products decreased 
in Lowell from baseline to followup (-2.4 percent), with a 
statistically significant difference between Lowell and an observed 
increase in flavored tobacco use in the comparison community (3.3. 
percent) (Ref. 61). In the Twin Cities, MN, two cross sectional studies 
were administered before and after implementation of a restriction on 
flavored tobacco products first excluding menthol, mint, and 
wintergreen in 2016 and then after the policy was expanded to include 
menthol, mint, and wintergreen in 2018 (Ref. 111). Comparing the two 
cities to the rest of the State, the study found that when the first 
policy was implemented the prevalence of cigar use did not change in 
the Twin Cities among 6th to 12th grade students, but cigar use 
increased 71.3 percent in the rest of the State. The analysis also 
found that between 2016 and 2019, when the flavor restriction also 
included menthol, cigar use among 8th, 9th, and 11th grade students 
declined more in the Twin

[[Page 26426]]

Cities compared to the rest of the State (Ref. 111). In San Francisco, 
CA, following implementation of the city's restriction on flavored 
tobacco products, including menthol, among a small convenience sample 
of young adults ages 18 to 24 years surveyed after policy 
implementation there was a statistically significant decrease in 
flavored cigar use (from 19.4 to 6.5 percent) (Ref. 62). An evaluation 
of a national flavored tobacco policy in Canada that restricted 
flavored tobacco products except menthol cigarettes and cigars under 
1.4 grams (or in any cigar that had a filter or non-spiral wrap) is 
consistent with local flavored tobacco policies in the United States 
regarding decreased use of cigars among young people and found a 
statistically significant 2.3 percentage point decrease in past 30-day 
cigarillo use among young people aged 15 to 24 years 1 year after 
policy implementation (Ref. 113). Most of these studies of local 
flavored tobacco policies in the United States describe concerns with 
compliance and enforcement of the policies, noting potential increases 
in cross-border sales and observed retail sales of flavored product in 
defiance of implemented policies. FDA anticipates that a nationwide 
standard that prohibits the manufacture and sale of flavored cigars 
would likely have a greater impact in decreasing youth cigar use 
compared to that observed from policies from limited jurisdictions, 
because a nationwide product standard would eliminate the manufacture 
of these products as well as the opportunity for youth to easily travel 
to neighboring jurisdictions that do not have a flavor prohibition or 
use online retailers to purchase flavored cigars.
    As described in section IV.B of this document, an estimated 960,000 
youth reported past 30-day use of cigars in 2020, with an estimated 
550,000 youth, reported using a flavored cigar during the past 30 days 
(Ref. 8). Given the measured decrease in youth tobacco use consistent 
across U.S. localities that have recently implemented restrictions on 
the sale of flavored tobacco, FDA expects that many of these youth 
would be discouraged from continued experimentation with cigars as a 
result of the proposed standard. In contrast to the locality 
restrictions discussed previously, FDA's proposed product standard 
would result in a comprehensive regulation restricting both the 
manufacturing and sale of cigars with characterizing flavors in the 
United States. Evaluations of retailer compliance following 
implementation of local flavor restrictions suggest that incomplete 
compliance led to availability of violative products in retail 
environments, which likely diminished the impact of the restrictions 
(Refs. 108 and 109). Unlike a restriction on sales alone, the proposed 
standard would prohibit both the manufacture and sale of cigars with 
characterizing flavors (other than tobacco), and as a result, it would 
allow for a more complete prohibition of flavored cigar products from 
the market. It is therefore likely that the impact of the FDA product 
standard on youth and young adult cigar smoking would be greater than 
that observed among the evaluation studies discussed previously.
    In summary, across varying study populations and research study 
designs, evidence shows that the presence of characterizing flavors in 
tobacco products enhances the appeal of tobacco products to young 
people and is associated with experimentation and progression to 
regular tobacco use. Characterizing flavors also can activate the 
brain's reward circuit and reinforce tobacco use. Prohibiting 
characterizing flavors (other than tobacco) in cigars would eliminate 
rewarding and reinforcing associations with the product among youth and 
would result in a marketplace that solely consists of (mostly already 
existing) cigar products that have harsher, more astringent cigar smoke 
that are likely less appealing to novice users. Evidence from five U.S. 
localities and Canada consistently indicate that prohibiting sales of 
flavored tobacco decreased youth and young adult use of tobacco, 
including cigars. In nationally representative estimates, most youth 
and young adults report initiating use with a flavored cigar (Ref. 12). 
In addition, results from a large national study observed a 
relationship between first use of a flavored cigar and regular cigar 
use in youth and young adults (Refs. 28 and 29). Therefore, a 
prohibition on characterizing flavors (other than tobacco) in cigars 
would reduce the likelihood that youth and young adults would initiate 
cigar use and also mean fewer youth and young adults progressing to 
regular cigar use. For these reasons, FDA expects that prohibiting 
characterizing flavors as described in this proposed rule would reduce 
the likelihood that youth would experiment with and continue to use 
cigars and would ultimately reduce future disease and death associated 
with long-term cigar smoking.

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

    FDA expects that the prohibition of characterizing flavors (other 
than tobacco) in cigars, as proposed, would result in changes in 
tobacco use patterns among current smokers of flavored cigars. In 
addition to the long-term public health benefits that would accrue from 
the prevention or reduction of cigar smoking among youth and young 
adults, FDA anticipates that the proposed standard would increase the 
likelihood that some existing flavored cigar smokers would find 
tobacco-flavored cigars unappealing and consequently stop smoking 
cigars altogether, yielding health benefits from smoking cessation. For 
instance, current flavored cigar smokers may quit cigar use altogether, 
transition to tobacco-flavored cigars or other combusted tobacco 
products, or switch to other potentially less harmful tobacco products. 
Given the substantial proportion of existing cigar users using flavored 
cigars, the consistently high endorsement of characterizing flavors as 
a reason for use, empirical evidence of lower tobacco sales (as a proxy 
for consumption) following a flavored tobacco product restriction in 
multiple localities, and evidence suggesting decreased cigar use among 
adult consumers following implementation of flavor restrictions in two 
studied localities, FDA expects that the proposed standard would lead 
many flavored cigar smokers to reduce or stop using cigars.
    In section IV.D of this document, we discussed how the addition of 
characterizing flavors improves the taste of tobacco and decreases the 
harshness of tobacco smoke. While the evidence shows that use of 
flavored tobacco products, including flavored cigars, is particularly 
concerning among youth and young adults, millions of adults report 
using flavored tobacco products (Ref. 63). According to Wave 5 (2018-
2019) data from the PATH Study, among young adult past 30-day cigar 
smokers 18-24 years old, 38.3 percent reported that the cigar product 
they smoked in the past 30 days was flavored (Ref. 63). Similarly, 
among adult cigar smokers aged 25 years and older, 36.0 percent 
reported past 30-day use of a flavored cigar (Ref. 63). Many adult 
cigar consumers consistently identify the availability of 
characterizing flavors as a reason for their cigar use. An analysis of 
Wave 5 (2018-2019) PATH Study data indicated that among young adults 
(aged 18-24 years) who used cigars some or every day, 54.1 percent of 
traditional cigar users, 66.5 percent of cigarillo users, and 65.1 
percent of filtered cigar users reported flavoring as a reason for 
cigar use (Ref. 12). Similarly, among adults over 25 years old who used 
cigars

[[Page 26427]]

every or some days, 54.8 percent of traditional cigar users, 69.6 
percent of cigarillo users, and 71.4 percent of filtered cigar users 
reported flavoring as a reason for cigar use (Ref. 12). There was not a 
statistically significant difference by age group in reporting flavors 
as a reason for use (Ref. 12). In totality, such data from large 
national observational studies show that the availability of flavors is 
a contributing factor to young adult and adult cigar use. In addition, 
proprietary data gathered by Euromonitor International in March 2021 
reveals that, in 2020, flavored cigars accounted for nearly half of all 
cigar sales in the United States (41.9 percent).
    Data from three U.S. localities (Providence, RI; New York, NY; and 
San Francisco, CA) \18\ as well as Canada provide real-world evidence 
of the potential behavioral impacts the proposed product standard could 
have on cigar sales as a proxy for consumption with two localities (San 
Francisco, CA, and Canada) providing additional data suggesting a 
decline in cigar use among current cigar smokers. In Providence, 
following implementation of the city's restriction on flavored tobacco 
products, except menthol, mint, and wintergreen, there was a 31 percent 
decrease in total cigar sales of flavored and unflavored cigars and a 
51 percent decrease in average weekly sales of flavored cigars in 
Providence following policy implementation (Ref. 109). Sale of explicit 
flavor-named cigars (e.g., cherry) declined after policy implementation 
while concept flavor-named cigars (e.g., ``jazz'') increased (Ref. 
109). However, the increase in sales of concept flavor-named cigars did 
not completely offset the decrease in explicit flavor-named cigars 
(Ref. 109).
---------------------------------------------------------------------------

    \18\ Study data from the Twin Cities, MN, Lowell, MA, and 
Attleboro and Salem, MA, only looked at youth use and not sales data 
and thus is not included in this aspect of the discussion.
---------------------------------------------------------------------------

    In New York, following implementation of a restriction on flavored 
tobacco products except menthol, mint, and wintergreen, in NYC in 2010, 
researchers found that the flavor restriction was associated with an 
approximate 15 percent to 20 percent reduction in total cigar sales in 
NYC, relative to the proximal area (Ref. 108). Flavored cigar sales in 
NYC declined 28 percent while sales of flavored cigars increased in the 
10 non-NYC comparison counties surrounding the city (+3.2 percent) pre-
post policy implementation (Ref. 108).
    In San Francisco, CA, following implementation of the city's 
restriction on flavored tobacco products, including menthol, sales of 
flavored tobacco products overall and of flavored cigars specifically 
decreased a statistically significant 96 percent from the pre-policy 
period and overall cigar sales decreased a statistically significant 51 
percent (Ref. 52). There was a statistically significant decrease in 
the prevalence of flavored cigar use in a small convenience sample of 
young adults aged 18 to 34 years who used tobacco products prior San 
Francisco's restriction (Ref. 62). In Canada, following implementation 
of a national flavored tobacco policy that restricted flavored tobacco 
products except menthol cigarettes and cigars under 1.4 grams (or in 
any cigar that had a filter or non-spiral wrap), cigar sales decreased 
when comparing 6 years before policy enactment to 6 years after 
enactment (Ref. 112). In addition, following Canada's restriction on 
flavored cigarillos, young people aged 15 to 24 reported a significant 
increase in past 30-day abstinence in cigarillo use among prior 
cigarillo smokers (Ref. 113).
    The findings from evaluations in these three U.S. localities and 
Canada, drawing on both changes in sales data as well as behavioral 
changes, including increased abstinence in use of cigars among previous 
smokers as discussed in this section, are applied by FDA to inform our 
conclusions about the extent to which flavored cigar smokers would quit 
smoking cigars under the proposed standard. The findings from Canada 
also, as discussed in section IV.F of this document, help to support 
these conclusions by FDA regarding the impact of the proposed standard 
on current cigar smokers. These data provide evidence of the general 
behavioral responses we would expect to see in response to the proposed 
standard; however, we acknowledge there are limitations to these 
findings. These limitations include a reliance on aggregate tobacco 
sales information as a proxy for consumption, rather than data 
concerning individual-level tobacco use behaviors; the potential that 
smokers obtained flavored cigars through alternate means (e.g., 
internet sales) or switched to non-cigar products, which may have 
resulted in an overestimation of the impacts; and evidence of 
incomplete compliance with the restriction and exemptions for some 
retail establishments (e.g., tobacco bars), which may have resulted in 
an underestimation of the impacts of the prohibition. In addition, 
evidence from the evaluations of the impact of local restrictions on 
the sale of flavored tobacco products suggest that enforcement of such 
restrictions was not complete (see Refs. 108 and 109). Therefore, the 
estimated effect of local restrictions on flavored cigars may 
underestimate the effect of the proposed flavor standard since such 
standard would apply to cigar manufacturers as well as retailers, thus 
reducing the probability that violative products would make their way 
onto store shelves. Despite these limitations in generalizing findings 
from local jurisdictions, these real-world evaluations provide 
important insight into how sales and tobacco use change in response to 
restrictions on flavored tobacco products, including cigars. These 
evaluation studies provide important insight into how the proposed 
prohibition on characterizing flavors (other than tobacco) in cigar 
products could reduce the rate of youth and young adult experimentation 
and progression to regular tobacco use and increase cessation among 
current cigar smokers.
    Additionally, the proposed product standard is anticipated to 
promote the public health by addressing the disproportionate burden of 
cigar use among current users from vulnerable populations and promoting 
better health outcomes within those groups. As described in section V.A 
of this document, compared to non-Hispanic White adults, non-Hispanic 
Black adults are more likely to report that they have ever been a 
``fairly regular'' cigar smoker and to report that they smoke cigars 
daily (Ref. 163). Hispanic adults are more likely to smoke cigars 
within 30 minutes of waking than non-Hispanic White adults (Ref. 162). 
Adults who identify as LGBTQ+ are more likely to use tobacco products 
and to meet the criteria for nicotine dependence when compared to their 
heterosexual and cisgender peers with findings being more pronounced 
for some racial and ethnic groups such as LGBTQ+ persons who are 
Hispanic and non-Hispanic Black (Refs. 68, 157, 159, 160, and 170-173). 
As described in section V.F of this document, disparities in cigar use 
likely contribute to the disproportionate burden of tobacco-related 
morbidity and mortality that are observed for some population groups. 
For example, findings from 2013-2016 PATH data indicate that non-
Hispanic Black cigar users had lower odds of discontinuing cigar use 
than non-Hispanic White users (Ref. 261); additionally, while cigar use 
has decreased over time for non-Hispanic White adults, the data 
indicate that cigar use has remained stable or increased for non-
Hispanic Black adults

[[Page 26428]]

over time (Refs. 162 and 179). African American adults experience some 
of the highest rates of morbidity and mortality from tobacco-related 
disease such as heart disease, stroke, and hypertension (Refs. 264-
269), which may be attributed to the disproportionate levels of cigar 
use observed within that population. Based on these findings, the 
proposed product standard is anticipated to benefit the population as a 
whole by addressing disparities associated with cigar use, dependence, 
cessation, and, thus, tobacco-related morbidity and mortality.
    The sum of the available evidence, including the current use of 
flavored cigars by millions of Americans, the consistently high 
acknowledgement of characterizing flavors as a reason for using cigars 
among youth and adults, and the empirical evidence of lower tobacco 
sales (as a proxy for consumption) and tobacco use prevalence data 
following flavored tobacco product restrictions in multiple U.S. 
jurisdictions as well as Canada, supports FDA's finding that the 
proposed product standard would lead many flavored cigar smokers to 
stop using combusted cigars, yielding considerable health benefits.

C. Benefits and Risks to the Population as a Whole

    As discussed in section IV.D of this document, the presence of 
characterizing flavors enhances the appeal and ease of cigar use among 
youth and young adults. We expect that the proposed product standard, 
if finalized, would reduce tobacco-related harms by reducing this 
appeal and ease of use. Anticipated reductions in population harm would 
be realized through both long-term health benefits resulting from 
prevention of cigar uptake among youth and young adults as described in 
section VI.A of this document, as well as more immediate health 
benefits (e.g., improved breathing) resulting from increased cessation 
of cigar use among current flavored cigar smokers, as described in 
section VI.B of this document. In this section, we summarize the health 
effects of cigar smoking and describe analyses used to demonstrate 
anticipated population health benefits from the proposed standard in 
terms of decreased initiation and progression to regular use and 
decreased mortality attributable to cigar smoking in the United States.
    Additionally, the proposed product standard is anticipated to 
improve health outcomes in populations that have historically 
experienced tobacco-related health disparities related to flavored 
tobacco product use and, specifically, flavored cigar use. As described 
in section IV.G of this document, tobacco companies have strategically 
marketed flavored cigars to underserved communities over many decades. 
The tobacco industry continues to target these populations with 
tailored cigar marketing practices that contribute to and reinforce 
these longstanding and entrenched cigar disparities. As described in 
section V.A of this document, prevalence of cigar use is 
disproportionately high among certain population groups such as non-
Hispanic Black youth (Ref. 7), youth who identify as lesbian, gay, 
bisexual, or transgender (Refs. 7, 157, and 158), and youth with 
disabilities (Ref. 161). After initiating cigar use, members of these 
vulnerable populations are more likely to progress to regular cigar use 
or display patterns of more frequent use (Ref. 100). Because nonusers, 
particularly youth, from vulnerable populations are more likely to 
experience adverse effects from prior cigar use, the proposed product 
standard is anticipated to promote improved health outcomes within 
these population groups.
1. Flavored Cigar Smoking and Adverse Health Effects
    As described in section V.D of this document, cigar smoking, 
including flavored cigar smoking, causes many of the same serious 
health conditions as cigarette smoking (Ref. 32). As also noted, FDA 
has conducted and published a systematic review of cigar smoking-
attributable mortality risks and estimates of regular cigar smoking-
attributable mortality for the U.S. population (Refs. 3 and 32). NCI 
previously reviewed the studies that were available on cigar smoking 
mortality risks and reached similar general conclusions (Ref. 183). 
Both reviews found that cigar smoking causes oral, esophageal, 
pancreatic, laryngeal, and lung cancers, as well as coronary heart 
disease and aortic aneurysm (Refs. 32 and 183). These conclusions were 
based primarily on statistically significant risk estimates for primary 
cigar smokers who had never regularly used other tobacco products such 
as cigarettes that were calculated from American Cancer Society's CPS I 
and II data. The CPS I and II were large longitudinal cohort studies of 
cancer risk factors in the U.S. population that each enrolled at least 
one million participants (Ref. 290). The CPS I began in 1959 and the 
CPS II in 1982 (Ref. 290). Researchers assessed the mortality followup 
for participants through followup visits or linkage with the National 
Death Index (Refs. 243 and 290). Numerous studies have been published 
that analyze and quantify tobacco-attributable mortality risks using 
CPS I and II data, including studies of cigar smoking-attributable 
mortality risks (Refs. 243, 247, and 291). While findings using CPS I 
and CPS II data are representative of historical cohorts of U.S. 
residents, a more recent analysis was conducted using data from 
participants in the TUS-CPS from 1992 to 2011 in the National 
Longitudinal Mortality Study, following participants for mortality 
through the end of 2011 (Ref. 227). Results from this study regarding 
elevated risk of all-cause and cause-specific mortality among exclusive 
current cigar smokers compared to never tobacco users were generally 
consistent with estimates from CPS I and II (Ref. 227).
    Research studies have found that cigar smokers have approximately 
40 to 45 percent higher risk of COPD than never tobacco users (Refs. 
229 and 247). Similarly, the risk of bladder cancer in CPS I data was 
also approximately 40 percent higher for cigar smokers (Ref. 247).
    There may be other health outcomes attributable to cigar smoking 
that were not assessed using CPS I or II mortality data. For example, 
Heineman et al. found statistically significant increased risks of 
colon and rectal cancers among cigar smokers in a cohort of nearly 
250,000 World War I era veterans who were followed for mortality for 26 
years (Ref. 249). Patterns of flavored cigar use may have also changed 
over time and could contribute to health risks. While most research has 
focused on cigar-attributable mortality, limited research has addressed 
cigar-attributable morbidity. Besides dying from cigar-attributable 
disease, lifelong cigar smokers may live many years with serious 
medical conditions, such as cancers (Refs. 229 and 232), heart disease 
(Refs. 229 and 245), and increased airflow obstruction (Ref. 124) that 
can lead to major physical impairments, reduce functioning and quality 
of life, and produce appreciable health care costs and medical 
expenditures.
2. Estimated Impacts of the Proposed Standard on Cigar Smoking 
Initiation and Progression to Regular Use
    As described throughout this document, the proposed standard is 
expected to have substantial public health benefits. Significant 
benefits are expected to come from the prevention of cigar smoking 
initiation and progression to regular use among youth and youth adults, 
resulting in reduced morbidity and premature mortality. To estimate

[[Page 26429]]

these benefits, we have updated an analysis published by Rostron et al. 
in 2019 that examined the potential effects of the product standard on 
each cohort of 18-year-olds in the United States (Ref. 292). Beginning 
with the 4.26 million 18-year-olds in 2019 (Ref. 293), we estimate that 
3.9 percent of these individuals were current cigar users at that age, 
based on PATH Study Wave 5 data of self-reported every day or someday 
cigar use (Ref. 12). We also use PATH data to estimate that 63.6 
percent of these cigar smokers initiated cigar use with a flavored 
product, resulting in approximately 106,000 18-year-olds who currently 
use cigars and had initiated cigar use with a flavored product (Ref. 
12).
    We then estimate the proportion of these cigar users who would have 
initiated cigar smoking with non-flavored cigars in the absence of 
flavored cigars. Consistent with Rostron et al., we assume that the 
lower bound would be 35 percent, equal to the proportion of cigar users 
who currently initiate with non-flavored products, and that the upper 
bound would be 100 percent, which reflects complete substitution with 
non-flavored cigars. We use the midpoint of these values, 67.5 percent, 
as our main estimate, so 32.5 percent of those currently initiating 
with flavored cigars would be deterred from trying cigars, and we 
estimate that approximately 34,000 (106,000 x 32.5 percent) cigar 
smoking initiates would be prevented by the product standard from 
initiating cigar use in this model. We also considered the possibility 
that flavored cigar initiates are more likely to continue cigar use 
than those who initiate with non-flavored products. PATH Study data 
from Waves 1 (2013-2014) and 2 (2014-2015) show that adult ever cigar 
users who initiated with flavored cigars are more likely to be current 
regular cigar users than ever users who initiated with non-flavored 
cigars, controlling for other relevant factors related to cigar use 
(Ref. 28). Similar estimates were obtained from analysis of Waves 2-4 
(2014-2017) PATH Study data, although results were presented separately 
for mint- or menthol-flavored cigars and other flavored cigars (Ref. 
29). We therefore estimate that approximately 26,000 [106,000 x (1.0-
32.5 percent) x (1.0-(1.0/1.56 \19\))] cigar smokers would be prevented 
from continuing to regular use by the product standard for a total 
reduction of 60,000 current cigar smokers in each cohort of 18-year-
olds.
---------------------------------------------------------------------------

    \19\ This estimate is based on Reference 28 in which the 
adjusted prevalence ratio = 1.56, meaning that, after accounting for 
other factors in the model, such as demographics, individuals who 
initiated with flavored cigars were 56 percent more likely to 
currently use them.
---------------------------------------------------------------------------

    Consistent with the prior analysis (Ref. 292), we account for the 
uncertainty inherent in estimating the impact of the proposed policy 
based on these data and conducted Monte Carlo simulations using @RISK 
statistical software to assess the effects of varying key data inputs. 
We conducted 1,000 simulations, with reductions in cigar initiation 
ranging from 0 to 65 percent and reductions in continuing use ranging 
from 22.5 percent (1.0-1.0/1.29) to 46.5 percent (1.0-1.0/1.87), among 
those who would have otherwise initiated cigar use with flavored 
cigars. Ninety percent of the resulting estimates were between 42,000 
and 75,000 cigar users prevented in each cohort.
3. Estimated Impacts of the Proposed Standard on Mortality
    In the preceding section, we describe the longer-term benefits of 
the proposed standard that would include prevention of disease and 
premature death among youth and young adults who are discouraged from 
taking up cigar smoking in the absence of access to the flavored cigars 
covered by the proposed standard. Over a shorter term, health benefits 
would come from decreased tobacco product use including cessation among 
those who currently use flavored cigars. In this section, our 
estimation of public health impacts focuses on the reduction in cigar-
attributable deaths that would occur if such flavored cigars were 
removed from the market. To be clear, these estimates significantly 
understate the public health benefits because they do not include lives 
saved of youth and young adults who, as the result of the product 
standard, do not begin to smoke.
    To estimate the potential impact of the proposed standard on 
mortality, we again updated a previously published analysis (Ref. 292), 
which began with an estimate of the current number of deaths that are 
attributable to regular cigar smoking in the United States on an annual 
basis. We then removed deaths due to dual cigar and cigarette use to 
specifically estimate mortality due to exclusive cigar smoking given 
that dual users may continue to use combusted tobacco products. 
Mortality estimates are not available for other combinations of 
polytobacco use involving cigars, but over 90 percent of cigar users 
who are polytobacco users use cigarettes (Ref. 294). Consistent with 
the prior analysis (Ref. 292), we applied a range of estimates for the 
reduction in total cigar consumption that reflects behavioral evidence 
from multiple localities' flavored tobacco restrictions as well as 
information on the size of the flavored U.S. cigar market. These 
estimates were then translated to potential behavior change to estimate 
the number of deaths in the United States that would be prevented each 
year among exclusive regular cigar smokers as a result of the proposed 
standard.
    We based our estimate of the annual mortality attributable to cigar 
smoking in the United States on a previously published analysis (Ref. 
3). This analysis modified the Smoking-Attributable Mortality, 
Morbidity, and Economic Costs methodology, used by the CDC to estimate 
cigarette smoking-attributable mortality, to quantify the mortality 
burden of regular cigar smoking in the United States in 2010 for adults 
aged 35 years or older (Ref. 3). The analysis estimated that regular 
cigar smoking (defined in the study as smoking cigars on 15 or more of 
the past 30 days) was responsible for approximately 9,000 premature 
deaths annually and that 5,200 of these deaths occurred among regular 
cigar smokers who did not also currently smoke cigarettes (hereafter 
referred to as exclusive cigar smokers) (Ref. 3). Because it is 
possible that some dual cigarette and cigar smokers might replace their 
cigar use with cigarette use if flavored cigars were prohibited, our 
analysis used the latter estimate of 5,200 deaths as the basis for 
quantifying the benefits of the proposed standard. This is a 
conservative approach because it does not account for any health 
benefits among dual users who quit tobacco or cigar use as a result of 
the proposed standard. As data from the NHIS from 2000-2019 has shown 
relatively stable cigar use prevalence estimates among adults, this 
estimate of 5,200 premature deaths also serves as a general measure of 
the effects of exclusive regular cigar smoking (i.e., non-dual) on 
mortality in the United States in subsequent years (Ref. 3). Although 
youth cigar smoking has declined in recent years, the long-term 
implications for regular cigar smoking in this population are unclear. 
These estimates are based on an expectation that the number of 
premature deaths from cigar use would remain constant over time in the 
absence of regulatory action. Conceivably, the number of cigar-
attributable premature deaths could rise due to population growth even 
if cigar smoking rates remained constant, or the number could fall if 
cigar-smoking rates fell by more than the population growth.
    We then estimated the fraction of deaths that would be avoided if 
the proposed standard were in effect as proposed. As discussed in 
section IV.F of this document, real-world experience

[[Page 26430]]

regarding the impact of flavored tobacco restrictions across U.S. 
jurisdictions suggests that the removal of flavored cigars from the 
U.S. market would lead consumers who now smoke flavored cigars to alter 
their behavior and some of these individuals would reduce their use of 
cigars or quit smoking cigars completely, others would product switch 
entirely to other tobacco products. We used data from the Providence, 
NYC, and San Francisco areas because these cities' restrictions on the 
sale of flavored tobacco products provide the best available U.S. data 
on the effect of real-world, implemented restrictions on cigar sales, 
and thus consumption.\20\ Several studies conducted analyses using 
Nielsen retail scanner data to assess changes in the number of cigars 
sold (both flavored and non-flavored) in Providence, NYC, and San 
Francisco before and after the flavor restrictions went into effect 
(Refs. 52, 108, and 109). For comparison, they also examined sales over 
the same timeframe in the rest of Rhode Island in the Providence 
analysis, in nine counties proximal to NYC, as well as sales in the 
United States overall, in the NYC analysis, and in San Diego and San 
Jose in the San Francisco analysis. Using a times series analysis, the 
study of Providence estimated the effect of the flavor restriction to 
be a 31 percent reduction in overall cigar sales (Ref. 109). This 
analysis also found that the restriction was associated with an 
approximate 15 percent to 20 percent reduction in overall NYC cigar 
sales, relative to the proximal area or the United States overall. The 
study of San Francisco found that the flavor restriction was associated 
with a 51 percent reduction in overall cigar sales (Ref. 52). 
Importantly, these decreases in overall cigar sales indicate that 
consumers did not completely substitute non-flavored cigars for 
flavored cigars because of the restriction (Ref. 108). The data also 
suggest that cross-border purchasing of flavored cigars was limited. 
For example, the NYC study found that flavored cigar sales in the ten-
county area surrounding NYC declined after the implementation of NYC's 
flavor restriction, although the change was not statistically 
significant (Ref. 108).
---------------------------------------------------------------------------

    \20\ Study data from Lowell, MA, and Attleboro and Salem, MA, 
only looked at youth use and not sales data and thus is not included 
in this aspect of the discussion.
---------------------------------------------------------------------------

    We note that the decline in flavored and overall cigar sales 
occurred despite incomplete compliance in some localities, such as the 
NYC ordinance (Ref. 108). The NYC study found that flavored cigars, 
specifically, continued to be sold at persistently high levels in NYC 
in violation of the restriction. FDA anticipates the proposed product 
standard would have a greater impact on public health than the NYC 
flavor sales restrictions. Unlike a restriction on sales alone, the 
proposed standard would prohibit both the manufacture and sale of 
cigars with characterizing flavors (other than tobacco), and as a 
result, it would allow for a more complete prohibition of flavored 
cigar products from the market. Moreover, FDA anticipates that this 
nationwide product standard would eliminate the opportunity for 
consumers to travel to local neighboring U.S.-based jurisdictions that 
do not have a flavor prohibition or use online retailers to purchase 
flavored cigars.
    In our analysis, cigar sales are used as a proxy for consumption, 
given we expect sales and consumption to be highly correlated. We start 
with a 30 percent relative decrease in total cigar sales as our main 
estimate in the analysis, using a rounded estimate of 31 percent 
reduction in overall cigar sales observed in Providence, which provided 
the midrange of estimates from the three evaluation studies. For the 
reasons described in this section, FDA considers the impacts of the NYC 
flavor restriction on total cigar sales (i.e., 15-20 percent reduction 
in overall cigar sales in NYC) to be a conservative estimate of what 
the reduction in total cigar consumption in the United States overall 
would be if the proposed standard were implemented. We therefore use an 
estimated 15 percent relative decline in total cigar sales as a lower 
bound of the impact of this proposed product standard as a conservative 
estimate, which would suggest some substitution with non-flavored 
cigars.
    An alternate scenario is one in which the proposed flavored tobacco 
products are removed from the U.S. market after implementation of the 
proposed standard and no substitution of non-flavored cigars occurs 
among consumers. In this case, the impact of the proposed standard on 
total cigar consumption would be equivalent to the fraction of the 
total U.S. cigar market comprised of flavored cigars. Proprietary data 
gathered by Euromonitor International in March 2021 reveals that 
approximately 41.9 percent of 2020 cigar (including cigarillo) unit 
sales in the United States were for flavored varieties. In this 
alternative scenario, if there is no switching from flavored to non-
flavored cigar varieties, then overall cigar sales, and subsequently 
consumption, would decrease by 41.9 percent. We use this figure as the 
upper bound for the decrease in total cigar sales following 
implementation of the product standard. As noted, the reduction in 
cigar sales observed in San Francisco following implementation of a 
flavored tobacco product restriction was consistent with such a 
decrease at 51 percent (Ref. 52).
    Next, we estimate the mortality effects of these reductions in 
cigar consumption. The proposed standard is expected to result in some 
consumers quitting smoking cigars entirely, others cutting back on 
cigar smoking. To estimate how reductions in consumption at the 
population-level may be distributed across individual consumer 
behaviors, we use data from studies of other tobacco control policies. 
These studies can inform estimates of potential effects of the proposed 
standard on cigar use. A robust evidence base exists to characterize 
the impact of tobacco taxes on consumption and behavior. Data from 
studies on the impacts of cigarette tax increases on smoking behaviors 
suggest that approximately half of observed reductions in cigarette 
sales are due to smokers quitting, while the remainder are due to 
reducing or cutting back on the number of cigarettes smoked (Ref. 295). 
For this analysis, we assume that, among exclusive cigar smokers who 
would change their smoking behavior due to the standard, approximately 
50 percent would quit smoking entirely, while the other 50 percent 
would cut back. To be conservative, we assume there are no benefits in 
avoided mortality among those who cut back and avoided mortality is 
only counted among those who quit smoking entirely. This estimate may 
be somewhat conservative because some studies have found some health 
and mortality benefits from substantial reductions in cigarette 
consumption, although these benefits are less than those from complete 
smoking cessation (Refs. 296 and 297).
    We use these inputs in our analysis. By multiplying the estimated 
5,200 annual exclusive cigar attributable deaths previously described 
by 30 percent due to decline in cigar sales, and then reducing that 
value by 50 percent to reflect benefits only for those who quit 
entirely, we estimate that the proposed standard would result in 
approximately 800 annual averted deaths.\21\ We again conducted Monte 
Carlo simulations using @RISK statistical software to assess the effect 
of varying key data inputs. We ran 1,000

[[Page 26431]]

simulations using 15 percent and 42 percent as the lower and upper 
bound of decreases in total cigar consumption and 25 percent and 75 
percent as the lower and upper bound for the proportion of decreased 
consumption due to complete cessation, and 90 percent of the resulting 
estimates fell within a range of approximately 400 to 1,100 deaths 
averted annually.
---------------------------------------------------------------------------

    \21\ All estimates are rounded to the nearest 100. See FDA's 
Preliminary Regulatory Impact Analysis (Ref. 298) for unrounded 
estimates.
---------------------------------------------------------------------------

    FDA anticipates that a reduction in deaths attributable to cigar 
use would begin to accrue soon after implementation of the proposed 
standard (see Ref. 298 at section II.F). It would take time to fully 
realize the mortality benefit of the proposed standard, given that some 
cigar smokers may still die of a smoking-related disease due to 
previous use, even if they quit cigar use after the proposed standard 
is implemented. Given that lung cancer has been estimated to be 
responsible for the majority of deaths attributable to cigar smoking 
(Ref. 3), we base the timeframe for reduction in risk on this cause. 
Estimates from contemporary cohort data have found that full reductions 
in lung cancer risk after smoking cessation can take an extended time 
period; consequently, we used a time period of 30 years (Ref. 299). 
Reductions in risk from other causes such as cardiovascular disease are 
expected to be realized more quickly (Refs. 300 and 301). Benefits from 
reductions in cigar-related morbidity would also be expected to accrue 
more quickly.
    We also estimate the years of life that would be gained due to the 
product standard. Nonnemaker et al. estimated that the approximately 
9,000 annual deaths that are attributable to regular cigar smoking 
correspond to nearly 140,000 years of potential life lost (YPLL) (Ref. 
3). This represents an average of 15.1 years of life lost per death. We 
multiply the approximately 774 deaths annually averted by the product 
standard by the 15.1 average years of life lost per attributable death 
and estimate that approximately 11,687 YPLLs are associated with the 
premature mortality that would be prevented by the product standard 
each year.
    This analysis has concentrated on mortality effects, given the 
availability of specific estimates for cigar smoking-attributable 
mortality and mortality risks, but we also anticipate reductions in 
cigar smoking-attributable morbidity due to the product standard. It 
has been estimated that regular cigar smoking is directly responsible 
for approximately 9,000 deaths among U.S. adults annually (Ref. 3) and 
that cigarette smoking is directly responsible for approximately 
437,000 deaths annually among U.S. adults (Ref. 23 at 659). It has also 
been estimated that U.S. adults suffer from approximately 14 million 
major medical conditions due to cigarette smoking (Ref. 302). These 
figures suggest that current and former cigarette smokers are living 
with approximately 30 major medical conditions due to cigarette smoking 
for every premature death that occurs each year. Since regular cigar 
smoking causes premature death from some of the same conditions as 
cigarette smoking, we would expect a considerable disease burden 
attributable to cigar smoking among U.S. adults, along with reduction 
in this burden as a result of the proposed standard.
    In addition, the population would experience health benefits based 
on a decrease in morbidity and mortality resulting from secondhand 
smoke exposure. According to the Surgeon General, there is sufficient 
evidence from which to infer a causal relationship between secondhand 
tobacco smoke exposure and lung cancer, as well as increased risks of 
coronary heart disease morbidity and mortality, among lifetime 
nonsmokers (Ref. 251 at 15). Individuals living with smokers had a 20 
to 30 percent increase in the risk of developing lung cancer from 
secondhand smoke exposure (Ref. 251 at 15). Likewise, the estimated 
increase in coronary heart disease risk from exposure to secondhand 
tobacco smoke is 25 to 30 percent above that of unexposed individuals 
(Ref. 251 at 519). Based on the similarity of the toxic constituents in 
cigars and cigarettes, and the fact that cigars commonly share similar 
product design and mechanisms of smoke delivery as cigarettes, FDA's 
scientific judgment leads the Agency to expect that secondhand cigar 
smoke would produce effects similar to those produced by secondhand 
cigarette smoke, meaning that the proposed rule, if finalized, would 
decrease morbidity and mortality caused by secondhand exposure to cigar 
smoke.
    These sections have focused on the potential benefit to the U.S. 
population as a whole from the proposed product standard, accounting 
for the potential decreased experimentation and progression to regular 
use among nonusers that would be prevented from trying flavored cigars, 
as well as potential decreased consumption or increased cessation among 
current flavored cigar smokers. Thus, we anticipate the proposed 
product standard would continue to produce reductions in morbidity and 
mortality over the long term, due in large part to the reduction in 
eventual adverse health effects from cigars due to reduced initiation 
and use among young people.
    One additional potential health benefit to continuing users of 
cigars that could result from the proposed product standard would be 
decreased exposure to potentially toxic flavor compounds, as discussed 
in section V.B of this document. In combusted tobacco products, such as 
cigarettes and cigars, toxicity can result from the chemicals formed 
when flavors are heated or burned (Refs. 184-187). For example, a study 
conducted by the CDC identified benzyl alcohol, piperonal, methyl 
cinnamate, and vanillin in strawberry cigar filler (Ref. 190) (see 
table 2 in this document for potential health hazards of these 
ingredients). While some flavoring compounds naturally occur in tobacco 
and the resulting standard may not fully eliminate such toxic 
exposures, reducing toxicant levels in these products would reduce 
consumer exposure and could protect consumers from the health effects 
of these toxicants, particularly from adverse respiratory effects.
4. Potential Risks to the Population as a Whole of the Proposed Cigar 
Flavors Product Standard Would Not Outweigh the Potential Benefits of 
the Proposed Product Standard
    There are possible countervailing effects that could occur from the 
proposed product standard, if finalized. Possible countervailing 
effects on current tobacco users could include continued combusted 
tobacco product smoking and the possibility of illicit trade. As part 
of this rulemaking, FDA is required by the Tobacco Control Act to 
consider information submitted on such possible countervailing effects, 
including among vulnerable populations such as adolescent tobacco users 
and other population subgroups.
    With the removal of characterizing flavors (other than tobacco) in 
cigar products, some cigar smokers may seek other sources of tobacco 
and/or nicotine. These could include nicotine replacement therapy 
products, which are products authorized by FDA to help people quit 
using tobacco products. However, some smokers may also transition to 
tobacco-flavored cigars, other combusted tobacco products, or other 
potentially less harmful tobacco products. As discussed in section VI.B 
of this document, if youth experimenters or users of flavored cigars 
were to switch to cigarettes or to other tobacco products as a result 
of flavored cigars no longer being available, it is possible that the 
benefits of the rule would be reduced. The availability of menthol 
cigarettes, if it continues after

[[Page 26432]]

flavored cigars are no longer available, may make this switch more 
likely and diminish the benefits. However, the proposed rule would not 
be expected to increase risks to individual or public health, since 
cigar and cigarette smokers suffer many of the same adverse health 
outcomes attributed to combusted tobacco use. In addition, FDA has 
considered the possibility that youth or adults will form a 
misperception that non-flavored cigars are safe or pose no substantial 
health risks (and that this misperception would impact behavior) 
because FDA has not similarly prohibited their continued availability. 
However, FDA is not aware of any evidence suggesting such 
misperceptions would or would not occur and will monitor for any such 
effects if this product standard is finalized. Should the Agency find 
evidence of such misperceptions, FDA would direct public education 
efforts toward such misperceptions and would consider taking other 
action as appropriate.
    FDA recognizes that, while some flavored cigar users may switch to 
tobacco-flavored cigars, this potential countervailing effect would not 
outweigh the benefits from cigar users who quit smoking completely. FDA 
has no reason to believe that individuals switching from flavored 
(other than tobacco-flavored) cigars to other combusted tobacco 
products would be exposed to additional harm beyond their current 
exposure level. There is no available data to suggest, for example, 
that the prohibition of characterizing flavors (other than tobacco) in 
cigars would increase the frequency or depth of smoke inhalation of 
tobacco-flavored cigars, make tobacco-flavored cigars more toxic to 
individual users or those who inhale secondhand smoke, lead to 
increased initiation, or make it more difficult for current tobacco 
users to quit. As explained elsewhere in this document, it is 
anticipated that the toxicity of flavored cigars could likely be 
diminished if this proposed rule is finalized. FDA requests comments 
regarding additional evidence on the extent and magnitude that flavored 
cigar users could potentially switch to other tobacco products, 
including tobacco-flavored cigars.
    In addition, FDA is considering whether illicit trade could occur 
as a result of a cigar flavor product standard and potential 
implications. Since the enactment of the Tobacco Control Act, FDA has 
been committed to studying and understanding the potential effects of a 
product standard on the illicit tobacco market. As part of FDA's 
consideration of possible regulations, the Agency asked the National 
Research Council (NRC) and Institute of Medicine (IOM) of the National 
Academy of Sciences to assess the international illicit tobacco market, 
including variations by country; the effects of various policy 
mechanisms on the market; and the applicability of international 
experiences to the United States (Ref. 303). In 2015, the NRC/IOM 
issued its final report entitled ``Understanding the U.S. Illicit 
Tobacco Market: Characteristics, Policy Context, and Lessons from 
International Experiences'' and concluded that ``[o]verall, the limited 
evidence now available suggests that if conventional cigarettes are 
modified by regulations, the demand for illicit versions of them is 
likely to be modest'' (Ref. 303 at 9). In addition, in March 2018, FDA 
issued a draft concept paper as an initial step in assessing the 
possible health effects of a tobacco product standard in the form of 
demand for contraband or nonconforming tobacco products (83 FR 11754, 
March 16, 2018). Among other things, the draft concept paper examined 
the factors that might support or hinder the establishment of a 
persistent illicit trade market related to a product standard but did 
not reach any conclusions regarding the potential demand that may 
develop due to a product standard (Ref. 43).
    A study regarding a restriction on menthol cigarettes in Canada is 
instructive here. Researchers studied the effects of the first ever 
complete sales restriction of menthol cigarettes, which was issued in 
the Canadian province of Nova Scotia (Ref. 304). The researchers found 
that the menthol restriction did not result in an increase in illicit 
cigarettes seized (Ref. 304). The Nova Scotia tax authorities estimated 
that the ``prevalence of illegal tobacco in the province had actually 
decreased, from 30 percent of all tobacco consumed in 2006-2007 to less 
than 10 percent in 2016-2017'' (Ref. 304). This is evidence that a 
major change to the availability of certain tobacco products is not 
likely to lead to a surge in illicit tobacco product use.
    FDA requests comments regarding whether and to what extent this 
proposed rule would result in an increase in illicit trade in flavored 
cigars and how any such increase could impact the marketplace or public 
health. If an illicit market develops after this proposed product 
standard is finalized, FDA has the authority to take enforcement 
actions and other steps regarding the sale and distribution of illicit 
tobacco products, including those imported or purchased online (see 
section VIII.C of this document for additional information about FDA's 
enforcement authorities). FDA conducts routine surveillance of sales, 
distribution, marketing, and advertising related to tobacco products 
and takes corrective actions when violations occur. After this proposed 
product standard is finalized and goes into effect, it would be illegal 
to import cigars with characterizing flavors (other than tobacco), and 
such products would be subject to import examination and refusal of 
admission under the FD&C Act. Similarly, it would be illegal to sell or 
distribute flavored cigars, including those sold online, and doing so 
may result in FDA initiating enforcement or regulatory actions.
    As previously noted, FDA's enforcement will only address 
manufacturers, distributors, wholesalers, importers, and retailers. 
This regulation does not include a prohibition on individual consumer 
possession or use, and FDA cannot and will not enforce against 
individual consumers for possession or use of flavored cigars. In 
addition, State and local law enforcement agencies do not independently 
enforce the FD&C Act. These entities do not and cannot take enforcement 
actions against any violation of chapter IX of the Act or this 
regulation on FDA's behalf. As noted previously, FDA recognizes 
concerns about how State and local law enforcement agencies enforce 
their own laws in a manner that may impact equity and community safety 
and seeks comments on how FDA can best make clear the respective roles 
of FDA and State and local law enforcement.
    Based on the available evidence, FDA finds that, while there may be 
potential countervailing effects that could diminish the expected 
population health benefits of the proposed standard, such effects would 
be minimal. Therefore, these potential effects would not outweigh the 
potential benefits of the proposed product standard.
    FDA requests additional information concerning the potential 
countervailing effects discussed in this section, as well as any other 
potential countervailing effects that could result from this rule, and 
how the potential countervailing effects could be minimized.

D. Conclusion

    In this section, we have reviewed multiple lines of evidence to 
assess the likely impact of the proposed prohibition on characterizing 
flavors (other than tobacco) in cigars on current nonusers, tobacco 
users, and the U.S. population as a whole. With respect to the impact 
on nonusers, the Agency

[[Page 26433]]

anticipates prevention of initiation and progression to regular tobacco 
use among youth and young adults, as well as reductions in exposure to 
secondhand cigar smoke, although this population health benefit is not 
quantified in our calculations. With respect to youth initiation and 
use, the Agency anticipates that prohibiting characterizing flavors 
(other than tobacco) in cigars as proposed would eliminate the 
availability of products that are more appealing to novice users and 
avoid rewarding and reinforcing associations with the characterizing 
flavor among youth. In addition to decreased experimentation, this is 
expected to lead to decreased use. The best available evidence 
regarding the role of flavored cigars and progression to regular use 
suggests that youth initiating with flavored cigars are more likely to 
progress to regular use. Policy evaluations from local jurisdictions 
throughout the United States (NYC, NY; Providence, RI; Lowell, MA; Twin 
Cities, MN; and San Francisco, CA) showed that youth and young adult 
tobacco use decreased when flavored cigars were removed from the 
market. In order to prevent future addiction, disease, and death 
associated with long-term cigar smoking, FDA proposes to prohibit 
characterizing flavors (other than tobacco) in cigars.
    FDA also anticipates that the proposed product standard would 
increase the likelihood that some of the estimated 3 million adult 
flavored cigar smokers would reduce the number of cigars they smoke or 
quit smoking cigars entirely instead of completely substituting non-
flavored cigars for flavored cigars. Evidence shows that flavor 
availability is consistently a highly endorsed reason for cigar use 
among youth, young adult, and adult cigar smokers (Refs. 12 and 28). 
Characterizing flavors in tobacco products ensure pleasant flavor and 
taste, reduces the harshness, bitterness, and astringency of tobacco 
during inhalation and soothes irritation during cigar smoking. When 
flavored cigar products were removed from the market in NYC, 
Providence, San Francisco, and Canada analyses showed subsequent 
reductions in total cigar sales. Taken together, this suggests the 
proposed standard would lead some flavored cigar smokers to smoke fewer 
cigars or quit cigar use entirely, decreasing total cigar consumption 
notwithstanding any substitution with non-flavored cigars. Cigar 
smoking causes many of the same diseases as cigarette smoking, 
including oral, esophageal, pancreatic, laryngeal and lung cancers, as 
well as coronary heart disease and aortic aneurysm (Refs. 32 and 183). 
Our evidence review indicates that, by increasing cessation among cigar 
smokers who would otherwise use a flavored tobacco product, the 
proposed standard would reduce cigar-attributable deaths and disease in 
the United States and would not result in any increase in deaths or 
disease from the use of other tobacco products. In addition to 
reductions in premature death, cigar smokers who quit would gain 
improved quality of life from the reduced risk or prevention of major 
medical conditions attributable to cigar smoking.
    Additionally, FDA anticipates that the proposed tobacco standard 
will improve health outcomes within groups that experience 
disproportionate levels of tobacco use, including certain vulnerable 
populations. Longstanding disparities in cigar use are the result of 
decades of cigar marketing targeted at underserved communities and the 
role of flavors in nicotine addiction and dependence. FDA anticipates 
that the prohibition of characterizing flavors in cigars will reduce 
initiation and experimentation with cigar smoking (particularly by 
youth and young adults), decrease the likelihood of nicotine dependence 
and addiction, and increase the likelihood of cessation. These public 
health benefits are expected to be particularly pronounced among 
vulnerable populations who experience the disproportionate impact of 
cigar use.
    In total, this evidence supports the conclusion that a prohibition 
on characterizing flavors (other than tobacco) in cigars would be 
appropriate for the protection of the public health. The Agency 
anticipates the proposed standard would result in decreased 
experimentation and progression to regular use among youth and young 
adults, and increased cessation among current cigar smokers, would lead 
to lower disease and death in the U.S. population in both the short 
term and long term, due to diminished exposure to tobacco smoke among 
both users and nonusers of cigars.

VII. Additional Considerations and Requests for Comments

A. Section 907 of the FD&C Act

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

[[Page 26434]]

B. Pathways to Market

    To legally market a new tobacco product \22\ in the United States, 
a tobacco product must receive authorization from FDA permitting the 
marketing of the new tobacco product under one of three pathways: (1) 
The applicant obtains an order under section 910(c)(1)(A)(i) of the 
FD&C Act (21 U.S.C. 387j(c)(1)(A)(i)) (order after review of a 
premarket tobacco product application under section 910(b)); (2) the 
applicant obtains an order finding the new tobacco product 
substantially equivalent to a predicate tobacco product and in 
compliance with the requirements of the FD&C Act under section 
910(a)(2)(A)(i) (order after review of a substantial equivalence (SE) 
report submitted under section 905(j) of the FD&C Act); or (3) the 
applicant makes a request under 21 CFR 1107.1 and obtains an exemption 
from the requirements related to SE (section 905(j)(3)(A)) (21 U.S.C. 
387e(j)(3)(A)), and at least 90 days before commercially marketing the 
product, submits a report under section 905(j) including the 
information required in section 905(j)(1)(A)(ii) and (B) of the FD&C 
Act.
---------------------------------------------------------------------------

    \22\ Products that were commercially marketed in the United 
States as of February 15, 2007 (referred to as ``pre-existing 
tobacco products,'' previously referred to as ``grandfathered 
products''), are not considered new tobacco products and do not 
require prior authorization to be legally marketed (section 910(a) 
of the FD&C Act).
---------------------------------------------------------------------------

    Applicants may be able to use the SE exemption pathway for products 
seeking to comply with this proposed standard by making a minor 
modification to an additive in their product, if FDA finds, among other 
things, that: (1) The modification is ``minor''; (2) an SE Report is 
not necessary to ensure that permitting the product to be marketed 
would be appropriate for the protection of the public health; and (3) 
an exemption is otherwise appropriate (section 905(j)(3)(A) of the FD&C 
Act). For example, FDA has previously issued exemption orders for 
tobacco products where there was deletion of casing flavor or L-menthol 
from a combusted cigarette. However, to the extent manufacturers change 
their flavored cigars to comply with this rule, FDA requests comments 
regarding how they might satisfy the premarket review requirements of 
the Tobacco Control Act.

C. Considerations and Request for Comments on Scope of Products

    As indicated throughout this document, FDA has determined that the 
proposed standard, which would apply to all flavored cigars (other than 
tobacco) and their components or parts, is appropriate for the 
protection of the public health. The proposed scope of this rule--
applying to all cigars, rather than only a subset of cigars--is 
important to protect public health and is justified by existing 
evidence. All cigars are combusted tobacco products that may be used by 
youth and that expose users to nicotine, a highly addictive substance, 
and many other toxic chemical constituents. Cigars are not a safe 
alternative to other tobacco products, including other combusted 
products such as cigarettes. In addition, these products pose no 
potential for positive net public health impact by means of reduced 
risk or harm.
    Cigars may vary in size, from smaller cigars which may resemble 
cigarettes in size and shape, such as little cigars or cigarillos, to 
larger ones, such as cigars referred to as ``premium'' cigars. In 
August 2020, as part of its decision in Cigar Association of America, 
et al. v. Food and Drug Administration, et al. (Cigar Association 
case), the U.S. District Court for the District of Columbia 
``remand[ed] the [deeming final rule] to the FDA to consider developing 
a streamlined substantial equivalence process for premium cigars'' and 
``enjoin[ed] the FDA from enforcing the premarket review requirements 
against premium cigars . . . until the agency has completed its 
review.'' Under the terms of, and for the purposes of, the court's 
order, a premium cigar is defined as a cigar that meets all of the 
following eight criteria:
    1. Is wrapped in whole tobacco leaf;
    2. contains a 100 percent leaf tobacco binder;
    3. contains at least 50 percent (of the filler by weight) long 
filler tobacco (i.e., whole tobacco leaves that run the length of the 
cigar);
    4. is handmade or hand rolled; \23\
---------------------------------------------------------------------------

    \23\ A product is ``handmade or hand rolled'' if no machinery 
was used apart from simple tools, such as a scissors to cut the 
tobacco prior to rolling.
---------------------------------------------------------------------------

    5. has no filter, nontobacco tip, or nontobacco mouthpiece;
    6. does not have a characterizing flavor other than tobacco;
    7. contains only tobacco, water, and vegetable gum with no other 
ingredients or additives; and
    8. weighs more than 6 pounds per 1,000 units.
    While products subject to this court's order meet the definition of 
``cigar'' as set out in this proposed rule, they do not contain a 
characterizing flavor other than tobacco and contain no ingredients or 
additives outside of tobacco, water, and vegetable gum. As discussed, 
the proposed rule would prohibit the use of characterizing flavors 
other than tobacco in all cigars. Therefore, products that meet this 
court order's definition of ``premium'' cigar would not be affected by 
the proposed rule. All cigar products, regardless of shape and size, 
including those that are marketed as ``premium'' cigars, that include a 
characterizing flavor other than tobacco, would be prohibited by this 
proposed product standard.
    FDA is also considering action to limit characterizing flavors in 
other tobacco products (see FDA's ANPRM regarding the role flavors play 
in tobacco products (79 FR 12294, March 21, 2018) and FDA's proposed 
rule prohibiting menthol as a characterizing flavor in cigarette 
products, published elsewhere in this issue of the Federal Register). 
FDA is proposing to limit the scope of this proposed standard to 
cigars, given their well-documented harms and the fact that flavored 
cigars clearly appeal to youth and young adults in large numbers, while 
undertaking additional efforts to evaluate and determine whether to 
prohibit or otherwise limit characterizing flavors in other tobacco 
products. Research also does not indicate any countervailing public 
health benefit impacts from characterizing flavors in cigars that might 
be affected by eliminating their use, in potential contrast to some 
non-combusted tobacco products. We request comments, data, and research 
regarding the proposed scope of this rule.
    FDA considered including waterpipe tobacco products within the 
scope of this proposed product standard based on the fact that they are 
combusted tobacco products with a strong appeal to youth. According to 
the 2020 NYTS, 2.7 percent of high school students (or approximately 
420,000 students) reported using waterpipe tobacco within the previous 
30 days and 1.3 percent of middle school students (or approximately 
160,000 students) reported waterpipe tobacco use in the prior month 
(Ref. 7). In addition, waterpipe tobacco use exposes users to nicotine 
and many toxic chemical constituents. The WHO study group on tobacco 
regulation has found that a waterpipe session, which typically lasts 20 
to 80 minutes, can be the equivalent of smoking more than 100 
cigarettes (Ref. 305, citing Ref. 306). However, at this time due to 
limited data--specifically limited data on how waterpipe tobacco might 
be used in the absence of non-tobacco characterizing flavors--FDA is 
not proposing to include waterpipe tobacco within the scope of this 
proposed product

[[Page 26435]]

standard. FDA requests information and data on how waterpipe tobacco 
might be used in the absence of non-tobacco characterizing flavors. FDA 
is continuing to study the health effects associated with waterpipe 
tobacco use, as well as use patterns generally, to evaluate and 
determine whether to prohibit characterizing flavors in waterpipe 
tobacco.
    Similarly, FDA is aware of the dangers of pipe tobacco (excluding 
waterpipe tobacco) and considered including pipe tobacco in the 
proposed rule. However, FDA considered youth and young adult usage as a 
primary concern in determining the scope of this proposed product 
standard, and at this time the data is limited and appears to suggest 
that youth and young adults have a much lower prevalence of pipe 
tobacco use compared to cigar use. According to the 2020 NYTS, 0.7 
percent of high school students (or approximately 110,000 students) 
reported using pipe tobacco within the previous 30 days and 0.4 percent 
of middle school students (or approximately 40,000 students) reported 
pipe tobacco use in the prior 30 days (Ref. 7). FDA is concerned that 
current data may underestimate the number of smokers who use pipe 
tobacco to roll their own cigarettes or cigars, but the lack of data on 
RYO tobacco use and the limitations in how national surveys assess 
loose pipe tobacco use impact our ability to draw conclusions regarding 
appeal of loose pipe tobacco among youth and adults at this time. Given 
the inherent differences in features of use of loose pipe tobacco 
compared to a pre-rolled cigar, FDA does not anticipate that flavored 
pipe tobacco would be a ready substitution for youth seeking to use 
flavored cigars. The current best available evidence indicates pipe 
tobacco is comparatively unpopular with youth, and findings from the 
few studies that looked at changes in pipe tobacco use following 
restrictions on flavors in other tobacco products were mixed (Refs. 50, 
51, and 111). While youth use of any tobacco product is of concern, we 
are not proposing to include pipe tobacco at this time. FDA requests 
information and data to further inform the above considerations. We 
also note that FDA has issued Warning Letters to retailers illegally 
selling flavored tobacco products that bear the package description 
``pipe tobacco'' but which, based on their overall presentation, meet 
the statutory definition of cigarette tobacco and/or RYO tobacco.
    FDA is not including non-combusted tobacco products, such as ENDS 
and smokeless tobacco products, in the scope of this proposed standard. 
As discussed previously, characterizing flavors in a variety of tobacco 
products have appealing effects, particularly among youth and young 
adults. And youth and young adult use of any tobacco product remains a 
significant concern for FDA. However, at this time, FDA is focusing 
this proposed rule on characterizing flavors in cigars because this 
action would help to prevent youth and young adults' use of combusted 
tobacco products. Combusted tobacco products are responsible for the 
majority of death and disease due to tobacco use.
    Accordingly, as part of its overall request for comments, FDA 
requests comments, including supporting data and research, regarding 
the following issues:
    <bullet> Should this product standard cover waterpipe and/or pipe 
tobacco, in addition to cigars? Is there additional data or information 
that would support inclusion of waterpipe and/or pipe tobacco in this 
product standard?
    <bullet> What are the advantages and/or disadvantages of covering 
other combusted tobacco products with this product standard? What 
evidence would support covering all combusted tobacco products? How 
should FDA define ``combusted tobacco products'' if the scope of the 
final product standard were expanded to include all combusted tobacco 
products?
    <bullet> Is there a significant risk that, if FDA limits this 
standard to cigars, consumers would substitute and/or migrate to other 
combusted tobacco products, thereby undermining the public health 
benefits of this rule? What changes, if any, should FDA make to this 
proposal to protect against or minimize substitution and/or migration?

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

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

VIII. Description of the Proposed Rule

    This proposed rule would establish a new part 1166 that would 
prohibit characterizing flavors (other than tobacco) in cigars. Part 
1166 would describe the scope of the proposed regulation, applicable 
definitions, and the prohibition on use of characterizing flavors 
(other than tobacco) in cigars.

A. Scope (Proposed Sec.  1166.1)

    Proposed Sec.  1166.1(a) would provide that this part sets out a 
tobacco product standard under the FD&C Act regarding the use of 
characterizing flavors in cigars.
    Proposed Sec.  1166.1(b) would prohibit the manufacture, 
distribution, sale, or offering for distribution or sale, within the 
United States of a cigar or any of its components or parts that is not 
in compliance with the tobacco product standard. This provision is not 
intended to restrict the manufacture of cigars intended for export. 
Consistent with section 801(e)(1) of the FD&C Act (21 U.S.C. 
381(e)(1)), a tobacco product intended for export shall not be deemed 
to be in violation of section 907 or this product standard, if it meets 
the criteria enumerated in section 801(e)(1) of the FD&C Act, including 
not being sold or offered for sale in domestic commerce.

[[Page 26436]]

This proposed rule would prohibit the importation for sale or 
distribution in the United States of a finished cigar that violates 
this standard. As stated in section VII.C of this document, FDA is 
specifically requesting comment regarding the scope of this proposed 
rule.

B. Definitions (Proposed Sec.  1166.3)

    Proposed Sec.  1166.3 provides the definitions for the terms used 
in the proposed rule. Several of these definitions are included in the 
FD&C Act or have been used in other regulatory documents.
    <bullet> Accessory: FDA defined ``accessory'' in the final deeming 
final rule (81 FR 28974; codified at 21 CFR 1100.3). We are proposing 
to use that definition here as it applies to cigars to provide further 
understanding as to the scope of the proposed standard. Therefore, FDA 
proposes to define ``accessory'' in the context of part 1166 to mean 
any product that is intended or reasonably expected to be used with or 
for the human consumption of a cigar; does not contain tobacco or 
nicotine from any source and is not made or derived from tobacco; and 
meets either of the following: (1) Is not intended or reasonably 
expected to affect or alter the performance, composition, constituents, 
or characteristics of a cigar or (2) is intended or reasonably expected 
to affect or maintain the performance, composition, constituents, or 
characteristics of a cigar but (i) solely controls moisture and/or 
temperature of a stored cigar or (ii) solely provides an external heat 
source to initiate but not maintain combustion of a cigar. A cigar 
``accessory'' is not subject to chapter IX of the FD&C Act or to this 
proposed standard. Examples of cigar accessories include a humidor that 
solely controls the moisture and/or temperature of a stored product, as 
well as cigar tip cutters, holders, ashtrays, and cases. We note that a 
humidor that does more than solely control the moisture and/or 
temperature of a stored product (e.g., imparts a mint characterizing 
flavor to the stored product) could meet the definition of a 
``component'' or ``part'' in proposed Sec.  1166.3 and, therefore, 
would be covered under this proposed standard.
    <bullet> Cigar: FDA proposes to define ``cigar'' as a tobacco 
product that: (1) Is not a cigarette and (2) is a roll of tobacco 
wrapped in leaf tobacco or any substance containing tobacco. This 
definition was used in the seven consent orders that the Federal Trade 
Commission (FTC) entered into with the largest mass marketers of cigars 
(see, e.g., In re Swisher International, Inc., Docket No. C-3964 (FTC 
August 18, 2000)) and also is codified at 21 CFR 1143.1.
    <bullet> Component or part: FDA defined ``component or part'' in 
the deeming final rule. We have reiterated that definition here as it 
applies to cigars. Therefore, FDA proposes to define ``component or 
part'' in the context of part 1166 to mean any software or assembly of 
materials intended or reasonably expected: (1) To alter or affect the 
cigar's performance, composition, constituents, or characteristics or 
(2) to be used with or for the human consumption of a cigar. The term 
excludes anything that is an accessory of a cigar. Examples of cigar 
components or parts that would be subject to this proposed product 
standard include liquids intended to add flavor, cigar blunt wraps, 
removable tips, mouthpieces, and filters. With respect to these 
definitions, FDA notes that ``component'' and ``part'' are separate and 
distinct terms within chapter IX of the FD&C Act. However, for purposes 
of this rule, FDA is using the terms ``component'' and ``part'' 
interchangeably and without emphasizing a distinction between the 
terms. FDA may clarify the distinctions between ``component'' and 
``part'' in the future.
    <bullet> Person: As defined in section 201(e) of the FD&C Act (21 
U.S.C. 321(e)), the term ``person'' includes an individual, 
partnership, corporation, and association.
    <bullet> Tobacco product: As defined in section 201(rr) of the FD&C 
Act, the term ``tobacco product'' is defined as any product made or 
derived from tobacco, or containing nicotine from any source, that is 
intended for human consumption, including any component, part, or 
accessory of a tobacco product (except for raw materials other than 
tobacco used in manufacturing a component, part, or accessory of a 
tobacco product). The term ``tobacco product'' does not mean an article 
that is: A drug under section 201(g)(1) (21 U.S.C. 321(g)); a device 
under section 201(h) (21 U.S.C. 321(h)); a combination product 
described in section 503(g) (21 U.S.C. 353(g)); or a food under section 
201(f) of the FD&C Act (21 U.S.C. 321(f)) if such article contains no 
nicotine, or no more than trace amounts of naturally occurring 
nicotine.
    <bullet> United States: As defined in section 900(22) of the FD&C 
Act, the term ``United States'' means the 50 States of the United 
States of America and the District of Columbia, the Commonwealth of 
Puerto Rico, Guam, the Virgin Islands, American Samoa, Wake Island, 
Midways Islands, Kingman Reef, Johnston Atoll, the Northern Mariana 
Islands, and any other trust territory or possession of the United 
States.

C. Prohibition on Use of Characterizing Flavors in Cigars (Proposed 
Sec.  1166.5)

    Proposed Sec.  1166.5 would establish a product standard 
prohibiting the use of characterizing flavors (other than tobacco) in 
cigars, similar to section 907(a)(1)(A) of the FD&C Act.\24\ 
Specifically, proposed Sec.  1166.5 would state that a cigar or any of 
its components or parts (including the tobacco, filter, or wrapper, as 
applicable) shall not contain, as a constituent (including a smoke 
constituent) or additive, an artificial or natural flavor (other than 
tobacco) or an herb or spice, including, but not limited to, 
strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, 
coconut, licorice, cocoa, chocolate, cherry, coffee, mint, or menthol, 
that is a characterizing flavor of the tobacco product or tobacco 
smoke.\25\ As discussed in section VI of this document, FDA finds that 
this proposed product standard would be appropriate for the protection 
of the public health. FDA is proposing an effective date 1 year after 
the date of publication of the final rule, as discussed in section IX 
of this document.
---------------------------------------------------------------------------

    \24\ Section 907(a)(1)(A) of the FD&C Act states that beginning 
3 months after the date of enactment of the Tobacco Control Act, a 
cigarette or any of its component parts (including the tobacco, 
filter, or paper) shall not contain, as a constituent (including a 
smoke constituent) or additive, an artificial or natural flavor 
(other than tobacco or menthol) or an herb or spice, including 
strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, 
coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a 
characterizing flavor of the tobacco product or tobacco smoke. 
Nothing in section 907(a)(1)(A) of the Tobacco Control Act shall be 
construed to limit the Secretary of HHS's authority to take action 
under this section or other sections of this Act applicable to 
menthol or any artificial or natural flavor, herb, or spice not 
specified in this section.
    \25\ We note that the language in section 907(a)(1)(A) of the 
FD&C Act states that the characterizing flavor ban for cigarettes 
applies to cigarettes or ``any of its component parts.'' For 
purposes of this proposed product standard, we have used the phrase 
``any of its components or parts'' and have defined ``component or 
part'' for clarity and consistency with the deeming final rule (81 
FR 28974 at 28975).
---------------------------------------------------------------------------

    We note that this proposed rule would prohibit the use of menthol 
as a characterizing flavor in cigars, whereas the statutory 
characterizing flavor ban for cigarettes excluded menthol from the 
prohibition. The sensory properties of menthol makes its addition to 
cigars concerning. Menthol is a flavor compound that when added to 
combusted tobacco products produces a minty taste and cooling sensation 
when

[[Page 26437]]

inhaled (Ref. 71). Adding menthol to combusted tobacco products makes 
the products easier to inhale and less irritating. Smokers report that 
mentholated products have a better taste, are smoother and more 
refreshing (Refs. 72-74). Menthol's flavor and sensory effects reduce 
the harshness of smoking among new users and facilitate experimentation 
and progression to regular smoking of menthol products, particularly 
among youth and young adults (Refs. 29 and 74-76). As a result, the 
brain is repeatedly exposed to nicotine and susceptible to nicotine 
addiction (Ref. 222). Studies further demonstrate that menthol, like 
nicotine, binds to nicotinic receptors in the brain (Refs. 218 and 219) 
and menthol alone can increase the number of nicotinic receptors in the 
brain (Refs. 220 and 221). Increases in nicotinic receptors can lead to 
greater withdrawal and cravings (Ref. 222). Evidence demonstrates that 
menthol's effects on nicotine in the brain are associated with 
behaviors indicative of greater addiction to nicotine (Refs. 220 and 
223).
    For this proposed product standard, FDA also is concerned that a 
characterizing flavors prohibition that does not include menthol would 
shift the flavored cigar market to menthol-flavored cigars. FDA is 
addressing the use of menthol in cigarettes in its separate proposed 
tobacco product standard to prohibit the use of menthol as a 
characterizing flavor in cigarettes, published elsewhere in this issue 
of the Federal Register. We believe that including menthol within the 
scope of this proposed standard prohibition of characterizing flavors 
in cigar products would be appropriate for the protection of the public 
health regardless of whether a similar prohibition of menthol as a 
characterizing flavor in cigarettes is in place when this rule is 
finalized.
    FDA would enforce the requirements of this proposed product 
standard under various sections of the FD&C Act, including sections 
301, 303, 701(a), 902, and 903. Section 907(a)(4)(B)(v) of the FD&C Act 
states that product standards must, where appropriate for the 
protection of the public health, include provisions requiring that the 
sale and distribution of the tobacco products be restricted but only to 
the extent that the sale and distribution of a tobacco product may be 
restricted under section 906(d) of the FD&C Act. Similar to section 
907, section 906(d) of the FD&C Act gives FDA authority to require 
restrictions on the sale and distribution of tobacco products by 
regulation if the Agency determines that such regulation would be 
appropriate for the protection of the public health.
    Failure to comply with any requirements prescribed by this product 
standard may result in FDA initiating enforcement or regulatory 
actions, including, but not limited to, warning letters, civil money 
penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/
or injunction. In addition, adulterated or misbranded tobacco products 
offered for import into the United States are subject to detention and 
refusal of admission. As previously discussed, FDA's enforcement will 
only address manufacturers, distributors, wholesalers, importers, and 
retailers. FDA cannot and will not enforce against individual consumers 
possession or use of flavored cigars.
    Among the factors that FDA believes are relevant in determining 
whether a cigar product has a characterizing flavor are:
    <bullet> The presence and amount of artificial or natural flavor 
additives, compounds, constituents, or ingredients, or any other 
flavoring ingredient in a tobacco product, including its components or 
parts;
    <bullet> The multisensory experience (i.e., taste, aroma, and 
cooling or burning sensations in the mouth and throat) of a flavor 
during use of a tobacco product, including its components or parts;
    <bullet> Flavor representations (including descriptors), either 
explicit or implicit, in or on the labeling (including packaging) or 
advertising of a tobacco product; \26\ and
---------------------------------------------------------------------------

    \26\ If a cigar has a characterizing flavor (other than 
tobacco), but its labeling or advertising represents that it does 
not, then the product may be, among other things, misbranded under 
section 903 of the FD&C Act because its labeling or advertising is 
false or misleading. Similarly, if a cigar does not have a 
characterizing flavor, but its labeling or advertising represents 
that it does, then the product may be misbranded under section 903 
of the FD&C Act because its labeling or advertising is false or 
misleading.
---------------------------------------------------------------------------

    <bullet> Any other means that impart flavor or represent that a 
tobacco product has a characterizing flavor.
    FDA expects that the approach proposed in this rule--relying on 
specific, flexible factors to make a case-by-case determination as to 
characterizing flavor--would provide important clarity for FDA, 
regulated industry, and other stakeholders while also ensuring critical 
flexibility and enforceability to achieve the public health goals of 
this rule. FDA requests comments regarding these factors and other 
potential factors that the Agency might consider in determining whether 
a cigar has a characterizing flavor.
    FDA also requests comments, including supporting data and research, 
regarding potential alternatives to prohibiting characterizing flavors 
(e.g., prohibiting all flavor additives, compounds, constituents, or 
ingredients).
    This proposed product standard would not prohibit tobacco-flavored 
cigars. Flavored tobacco products may differ in youth appeal--as 
discussed previously in this document, for those who experiment with 
cigars, tobacco-flavored cigars do not currently appear as attractive 
as cigars with other characterizing flavors. FDA expects that the 
tobacco flavor in a cigar, or its components or parts, need not be 
naturally inherent to the product to be considered ``tobacco flavored'' 
but rather may result from the addition of ingredients or other 
measures by the manufacturer to produce the presence of tobacco as its 
characterizing flavor.
    Further, we note that this prohibition also would cover flavors 
that are separate from the cigar (e.g., liquid flavors), including 
menthol, intended or reasonably expected to be added to cigars. For 
example, menthol can be added to the packaging of cigarettes to produce 
menthol cigarettes (and this can be done for cigars as well). Such 
flavors would be considered components or parts of cigars under Sec.  
1166.3, as they could be intended or reasonably expected: (1) Alter or 
affect the cigar's performance, composition, constituents, or 
characteristics or (2) be used with or for the human consumption of a 
cigar, and they would not be accessories of cigars. Therefore, the 
manufacture, distribution, sale, or offer for distribution or sale of 
such flavored products would be prohibited should this proposed rule be 
finalized.

IX. Proposed Effective Date

    In accordance with section 907(d)(2) of the FD&C Act,\27\ FDA 
proposes that any final rule that may issue based on this proposal 
become effective 1 year after the date of publication of the final 
rule. Therefore, after the effective date, no person may manufacture, 
distribute, sell, or offer for distribution or sale within the United 
States a cigar or any of its components or parts that is not in 
compliance with part 1166. This regulation does not include a

[[Page 26438]]

prohibition on individual consumer possession or use.
---------------------------------------------------------------------------

    \27\ Section 907(d)(2) of the FD&C Act states that a regulation 
establishing a tobacco product standard shall set forth the date or 
dates upon which the standard shall take effect, but no such 
regulation may take effect before 1 year after the date of its 
publication unless the Secretary determines that an earlier 
effective date is necessary for the protection of the public health.
---------------------------------------------------------------------------

    FDA finds this proposed standard appropriate for the protection of 
the public health because characterizing flavors in cigars increase 
appeal and makes them easier to use, which leads to an increased 
likelihood that youth and young adults will experiment with them and 
that those experimenting with cigars will become addicted and progress 
to regular smoking. Additional delay, past 1 year, would only increase 
the numbers of youth and young adults who experiment with and become 
regular smokers after experimenting with flavored cigars, would delay 
cessation by current smokers, and would exacerbate tobacco-related 
health disparities.
    FDA also finds that a 1-year effective date will ``minimize, 
consistent with the public health, economic loss to, and disruption or 
dislocation of, domestic and international trade'' pursuant to section 
907(d)(2) of the FD&C Act. Some cigar manufacturers of currently 
marketed flavored cigars have tobacco-flavored versions that are either 
pre-existing tobacco products or new tobacco products that are required 
to obtain premarket authorization. FDA does not expect that this rule, 
if finalized, would result in many new tobacco products or would 
require extensive changes to manufacturing.
    We also note that the Tobacco Control Act banned characterizing 
flavors in cigarettes with a 90-day effective date (section 
907(a)(1)(A) of the FD&C Act). FDA is proposing a longer effective date 
here in accordance with section 907(d)(2) of the FD&C Act. FDA requests 
comments as to whether a shorter effective date, such as 90 days, would 
be necessary for the protection of the public health.
    In setting the effective date, FDA will consider information 
submitted in connection with this proposal by interested parties, 
including manufacturers and tobacco growers, regarding the technical 
achievability of compliance with the standard, including information 
concerning the existence of patents that make it impossible to comply 
in the proposed 1-year time frame. While FDA does not expect that the 
proposed product standard would prompt extensive changes to 
manufacturing (given the likely compliance method of ending the 
addition of flavoring additives to cigar products), FDA requests 
comments and data regarding whether 1 year is sufficient to comply with 
this rule or whether this compliance period should be extended to 
provide additional time.
    FDA is aware of retailers' concerns regarding unsold inventory when 
any final rule goes into effect. FDA requests comments, including 
supportive data and research, regarding a sell-off period (e.g., 30 
days after the effective date of a final rule) for retailers to sell 
through their current inventory of cigars with characterizing flavors 
(other than tobacco).

X. Preliminary Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the proposed rule under E.O. 12866, 
E.O. 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). E.O.s 12866 and 
13563 direct us to assess all costs and benefits of available 
regulatory alternatives and, when regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). We believe that this 
proposed rule is an economically significant regulatory action as 
defined by E.O. 12866. As such, it has been reviewed by the Office of 
Information and Regulatory Affairs.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because businesses would incur costs to reallocate resources 
to products other than flavored cigars, we tentatively find that the 
proposed rule would have a significant economic impact on a substantial 
number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $158 million, using the most current (2020) Implicit 
Price Deflator for the Gross Domestic Product. This proposed rule would 
result in an expenditure in at least 1 year that meets or exceeds this 
amount.

B. Summary of Costs and Benefits

    The summary of costs and benefits is presented in table 3. The main 
quantified benefits of this proposed rule, if finalized, come from 
reduced smoking-attributable mortality that is the result of cigar use 
among adult cigar smokers, and reduced mortality from secondhand smoke 
among non-users. Additional unquantified benefits include reduced 
smoking-attributable mortality among youth who are deterred from 
initiating under the proposed rule. Unquantified benefits also include 
medical cost savings, productivity loss savings, improved quality of 
life, and environmental impacts. These benefits occur because the 
proposed rule, if finalized, would discourage non-users from initiating 
flavored cigars, as well as decrease consumption and/or increase 
cessation among current flavored cigar users, and thus reduce the 
health consequences associated with such use. Reduced exposure to 
secondhand smoke would also produce such benefits among non-users. We 
estimate that the present value of the quantified benefits over a 40-
year time horizon ranges between $111,807 million and $286,124 million, 
with a primary estimate of $198,203 million at a 3 percent discount 
rate, and between $52,827 million and $135,188 million with a primary 
estimate of $93,647 million at a 7 percent discount rate. The primary 
annualized quantifiable benefits equal $8,575 million at a 3 percent 
discount rate and $7,024 million at a 7 percent discount rate. 
Unquantified benefits are expected to provide additional benefits 
beyond those amounts.
    The costs of this proposed rule are those to firms to comply with 
the rule, to consumers impacted by the rule, and to the government, in 
a form not necessarily reflected in budgets, to enforce this product 
standard. Retailers, manufacturers, and wholesalers face a one-time 
cost of $239.9 (range of $80.0 million to $399.8 million) million to 
read and understand the rule and manufacturers face a one-time 
adjustment, or friction cost, of $21.5 million (range of $0.3 million 
to $43.7 million) to reallocate productive resources currently devoted 
to the manufacture of flavored cigars to other tobacco products. 
Consumers who continue to use tobacco products will face a one-time 
search cost of $61.7 million (range of $30.8 million to $92.5 million) 
to find new tobacco products as a replacement for the banned flavored 
cigar products. In addition, producers face annual lost producer 
surplus of $88 million (range of $0 million to $175 million). 
Additional unquantified costs include the costs to consumers who switch 
from flavored to tobacco-flavored cigars and consumer surplus losses. 
The present value of the costs over a 40-year time horizon ranges 
between $126 million and $4,612 million with a

[[Page 26439]]

primary estimate of $2,368 million for a 3 percent discount rate, and 
between $118 million and $2,883 million with a primary estimate of 
$1,500 million at a 7 percent discount rate. The primary estimates for 
the annualized cost are $102 million at a 3 percent discount rate and 
$112 million at a 7 percent discount rate.
    In addition to benefits and costs, this rule, if finalized, will 
cause transfers from state governments, Federal Government, and firms 
to consumers in the form of reduced revenue and tax revenue. The 
primary estimate for the annualized transfers from the Federal 
Government to consumers, in the form of reduced excise tax, is $85 
million. The primary estimate for the annualized transfers from state 
governments to consumers, in the form of reduced excise tax, is $129 
million. The primary estimate for the annualized transfers from the 
firms to consumers, in the form of reduced revenue, is $1,979 million. 
Transfers are summarized in table 3.

                                    Table 3--Summary of Benefits, Costs, and Distributional Effects of Proposed Rule
                                                 [Millions of 2020 dollars over a 40-year time horizon]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           Units
                                          Primary       Low        High    ------------------------------------
               Category                  estimate    estimate    estimate      Year      Discount     Period                      Notes
                                                                              dollars    rate (%)     covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $/year.......      $7,024      $3,962     $10,140        2020           7          40  Reduced mortality among adult cigar
                                             8,575       4,837      12,378        2020           3          40   smokers and non-users.
    Annualized Quantified.............  ..........  ..........  ..........  ..........           7  ..........
                                        ..........  ..........  ..........  ..........           3  ..........
                                       -----------------------------------------------------------------------------------------------------------------
    Qualitative.......................  Medical cost savings, productivity loss savings and improved quality of life, environmental impacts.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $/year.......         112           9         216        2020           7          40
                                               102           5         200        2020           3          40
    Annualized Quantified.............  ..........  ..........  ..........  ..........           7  ..........
                                        ..........  ..........  ..........  ..........           3  ..........
                                       -----------------------------------------------------------------------------------------------------------------
    Qualitative.......................  Changes in consumer surplus for some flavored cigar smokers, including potential utility changes for consumers
                                        who switch from flavored to non-flavored cigars.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized $/             85          42         119        2020           7  ..........
     year.                                      85          42         119        2020           3  ..........
                                       -----------------------------------------------------------------------------------------------------------------
    From/To...........................  From: Federal Government
                                        To: Consumers
                                       -----------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized $/year.         129          64         180        2020           7          40
                                               129          64         180        2020           3          40
                                       -----------------------------------------------------------------------------------------------------------------
    From/To...........................  From: State Governments
                                        To: Consumers
                                       -----------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized $/year.       1,979       1,033       2,717        2020           7          40
                                             1,979       1,033       2,717        2020           3          40
--------------------------------------------------------------------------------------------------------------------------------------------------------
    From/To...........................  From: Firms
                                        To: Consumers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government: States would transfer some cigar excise tax revenue back to consumers. We are not aware of any cigar
     manufacturers that are tribally-affiliated and/or operate on tribal land..
    Small Business: There are about 50 small businesses. Each small business would experience about $1.9 million in annual costs at both a 3 and 7%
     discount rate..
    Wages: No effect....................................................................................................................................
    Growth: No effect...................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Preliminary Regulatory Impact 
Analysis that assesses the impacts of the proposed rule. The full 
analysis of economic impacts is available in the docket for this 
proposed rule (see Ref. 298) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

XI. Analysis of Environmental Impact

    The Agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The Agency's finding of 
no significant impact and the evidence supporting that finding is 
available in the docket for this proposed rule (see Refs. 307 and 308) 
and may be seen in Dockets Management Staff (see ADDRESSES) between 9 
a.m. and 4 p.m., Monday through Friday; it is also available 
electronically at https://www.regulations.gov. Under FDA's regulations 
implementing the National Environmental Policy Act (21 CFR part 25), an 
action of this type would require an environmental assessment under 21 
CFR 25.20.

XII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
is not required. This proposed rule refers to previously approved 
collections of information. The collections of information in 21 CFR 
part 1114 have been approved under OMB control number 0910-0879 
(expires December 31, 2024); the collections of information in 21 CFR 
part 1107 have been approved under OMB control number 0910-0684

[[Page 26440]]

(expires September 30, 2022); the collections of information in section 
905(j) of the FD&C Act have been approved under OMB control number 
0910-0673 (expires November 30, 2024); and the collections in FDA's 
guidance entitled ``Guidance for Industry on Establishing That a 
Tobacco Product Was Commercially Marketed in the United States As of 
February 15, 2007,'' have been approved under OMB control number 0910-
0775 (expires August 31, 2022).

XIII. Federalism

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

XIV. Consultation and Coordination With Indian Tribal Governments

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

XV. References

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

*1. Tynan, M.A., T. McAffee, G. Promoff, et al., ``Consumption of 
Cigarettes and Combustible Tobacco--United States, 2000-2011.'' 
Morbidity and Mortality Weekly Report, 61(30):565-569, 2012. 
Available at https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6130a1.htm.
2. Euromonitor International, ``Passport: Cigars, Cigarillos and 
Smoking Tobacco in the US.'' 2020. Available at https://www.euromonitor.com/cigars-cigarillos-and-smoking-tobacco-in-the-us/report.
3. Nonnemaker, J., B. Rostron, P. Hall, et al., ``Mortality and 
Economic Costs from Regular Cigar Use in the United States, 2010.'' 
American Journal of Public Health, 104(9):e86-e91, 2014. Available 
at https://doi.org/10.2105/AJPH.2014.301991.
4. Wang, Y., H. Sung, T. Yao, et al., ``Health Care Utilization and 
Expenditures Attributable to Cigar Smoking Among US Adults, 2000-
2015.'' Public Health Reports, 133(3):329-337, 2018. Available at 
https://doi.org/10.1177/0033354918769873.
*5. Odani, S., B. Armour, I.T. Agaku, ``Flavored Tobacco Product Use 
and Its Association with Indicators of Tobacco Dependence Among US 
Adults, 2014-2015.'' Nicotine & Tobacco Research,

[[Page 26441]]

22(6):1004-1015, 2020. Available at https://doi.org/10.1093/ntr/ntz092.
*6. HHS, How Tobacco Smoke Causes Disease: The Biology and 
Behavioral Basis for Smoking-Attributable Disease: A Report of the 
Surgeon General. Atlanta, GA: HHS, CDC, National Center for Chronic 
Disease Prevention and Health Promotion, Office on Smoking and 
Health, 2010.
*7. Gentzke, A.S., T.W. Wang, A. Jamal, et al., ``Tobacco Product 
Use Among Middle and High School Students--United States, 2020.'' 
Morbidity and Mortality Weekly Report, 69(50):1881-1888, 2020. 
Available at http://dx.doi.org/10.15585/mmwr.mm6950a1.
8. Parms, T.A., S.K. Head, M.D. Sawdey, et al., ``Characteristics of 
Past 30-Day Cigar Smoking, U.S. Adolescents, 2020.'' American 
Journal of Preventive Medicine, 62(1):e39-e44, 2022. Available at 
https://doi.org/10.1016/j.amepre.2021.06.011.
9. Carpenter, C.M., G.F. Wayne, J.L. Pauly, et al., ``New Cigarette 
Brands with Flavors that Appeal to Youth: Tobacco Marketing 
Strategies.'' Health Affairs, 24(6):1601-1610, 2005. Available at 
https://doi.org/10.1377/hlthaff.24.6.1601.
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List of Subjects in 21 CFR Part 1166

    Labeling, Smoke, Smoking, Tobacco, Tobacco products.


0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that chapter I of title 21 of the Code of Federal Regulations 
be amended by adding part 1166 to subchapter K to read as follows:

PART 1166--PRODUCT STANDARD: FLAVORS IN CIGARS

Subpart A--General Provisions
Sec.
1166.1 Scope.
1166.3 Definitions.
Subpart B--Tobacco Product Standard for Flavors in Cigars
1166.5 Prohibition on use of characterizing flavors in cigars.

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

Subpart A--General Provisions


Sec.  1166.1   Scope.

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


Sec.  1166.3   Definitions.

    For purposes of this part:
    Accessory means any product that is intended or reasonably expected 
to be used with or for the human consumption of a cigar; does not 
contain tobacco or nicotine from any source and is not made or derived 
from tobacco; and meets either of the following:
    (1) Is not intended or reasonably expected to affect or alter the 
performance, composition, constituents, or characteristics of a cigar; 
or
    (2) Is intended or reasonably expected to affect or maintain the 
performance, composition, constituents, or characteristics of a cigar; 
but
    (i) Solely controls moisture and/or temperature of a stored cigar; 
or
    (ii) Solely provides an external heat source to initiate but not 
maintain combustion of a cigar.
    Cigar means a tobacco product that:
    (1) Is not a cigarette; and
    (2) Is a roll of tobacco wrapped in leaf tobacco or any substance 
containing tobacco.
    Component or part means any software or assembly of materials 
intended or reasonably expected:
    (1) To alter or affect the cigar's performance, composition, 
constituents, or characteristics; or
    (2) To be used with or for the human consumption of a cigar. The 
term excludes anything that is an accessory of a cigar.
    Person includes an individual, partnership, corporation, and 
association.
    Tobacco product means any product made or derived from tobacco, or 
containing nicotine from any source, that is intended for human 
consumption, including any component, part, or accessory of a tobacco 
product (except for raw materials other than tobacco used in

[[Page 26451]]

manufacturing a component, part, or accessory of a tobacco product). 
The term ``tobacco product'' does not mean an article that under the 
Federal Food, Drug, and Cosmetic Act is: A drug (section 201(g)(1)); a 
device (section 201(h)); a combination product (section 503(g)); or a 
food under section 201(f) if such article contains no nicotine, or no 
more than trace amounts of naturally occurring nicotine.
    United States means the 50 States of the United States of America 
and the District of Columbia, the Commonwealth of Puerto Rico, Guam, 
the Virgin Islands, American Samoa, Wake Island, Midway Islands, 
Kingman Reef, Johnston Atoll, the Northern Mariana Islands, and any 
other trust territory or possession of the United States.

Subpart B--Tobacco Product Standard for Flavors in Cigars


Sec.  1166.5   Prohibition on use of characterizing flavors in cigars.

    A cigar or any of its components or parts (including the tobacco, 
filter, or wrapper, as applicable) shall not contain, as a constituent 
(including a smoke constituent) or additive, an artificial or natural 
flavor (other than tobacco) or an herb or spice, including, but not 
limited to, strawberry, grape, orange, clove, cinnamon, pineapple, 
vanilla, coconut, licorice, cocoa, chocolate, cherry, coffee, mint, or 
menthol, that is a characterizing flavor of the tobacco product or 
tobacco smoke.

    Dated: April 22, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022-08993 Filed 4-28-22; 11:15 am]
BILLING CODE 4164-01-P


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