[Federal Register Volume 87, Number 86 (Wednesday, May 4, 2022)]
[Proposed Rules]
[Pages 26396-26451]
[FR Doc No: 2022-08993]

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

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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:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-N-1309 for ``Tobacco Product Standard for Characterizing
Flavors in Cigars.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     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,<PHONE_NUMBER>.

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,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms
III. Background
    A. Need for the Regulation
    B. Relevant Regulatory History
    C. Legal Authority
    D. FDA's Consideration of Health Equity
IV. Characterizing Flavors Impact Cigar Use, Particularly Among
Youth and Young Adults
    A. Recent Market Trends of Flavored Cigars in the United States
    B. Over Half a Million Youth, and Even More Young Adults, in the
United States Use Flavored Cigars
    C. Adult Use of Flavored Cigars in the United States
    D. Characterizing Flavors Increase Appeal and Make Tobacco
Products, Including Cigars, Easier To Use
    E. Characterizing Flavors Increase Youth and Young Adult
Experimentation With Tobacco Products, Including Cigars, and Make
Progression to Regular Tobacco Use More Likely
    F. Real-World Experiences Demonstrate That Restricting
Characterizing Flavors

in Tobacco Products, Including Cigars, Decreases Tobacco Use
    G. Flavored Cigars Are Marketed Disproportionately in
Underserved Communities and to Vulnerable Populations
V. Cigar Use Is Common, Addictive, and Harmful
    A. Prevalence of Cigar Use Among Youth, Young Adults, and Older
Adults in the United States
    B. Flavored Cigar Use Exposes Users to Additional Toxicants
    C. Cigar Use Is Addictive
    D. Research Clearly Demonstrates a Causal Relationship Between
Cigar Smoking and Death and Disease
    E. Secondhand Tobacco Smoke, Including Cigar Smoke, Increases
the Risks of Lung Cancer, Heart Disease, and Other Adverse Health
Effects in Nonsmokers
    F. Disparities in Tobacco Use, Including Cigar Use, Lead to
Disparities in Tobacco-Related Morbidity and Mortality
VI. Determination That the Standard Is Appropriate for the
Protection of the Public Health
    A. The Likelihood That Nonusers Would Start Using Cigars
    B. The Likelihood That Existing Users Would Reduce Cigar
Consumption or Stop Cigar Smoking
    C. Benefits and Risks to the Population as a Whole
    D. Conclusion
VII. Additional Considerations and Requests for Comments
    A. Section 907 of the FD&C Act
    B. Pathways to Market
    C. Considerations and Request for Comments on Scope of Products
    D. Request for Comments on the Potential Racial and Social
Justice Implications of the Proposed Product Standard
VIII. Description of the Proposed Rule
    A. Scope (Proposed 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:
     The presence and amount of artificial or natural flavor
additives, compounds, constituents, or ingredients, or any other
flavoring ingredient in a tobacco product, including its components or
parts;
     The multisensory experience (i.e., taste, aroma, and
cooling or burning sensations in the mouth and throat) of a flavor
during use of a tobacco product, including its components or parts;
     Flavor representations (including descriptors), either
explicit or implicit, in or on the labeling (including packaging) or
advertising of a tobacco product; and
     Any other means that impart flavor or represent that a
tobacco product has a characterizing flavor.
    However, cigars with tobacco as their characterizing flavor would
not be subject to this proposed product standard's prohibition. For
those who experiment with cigars, especially youth and young adults,
tobacco-flavored \1\ cigars do not currently appear as attractive as
cigars with other characterizing flavors. FDA is committed to
monitoring the use of cigars with tobacco as their

characterizing flavor through surveillance of national representative
data sources and other data to determine whether to take additional
action in the future consistent with FDA's authority.
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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.

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.
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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

cigarillos] to increase appeal to cigarette smokers, and the use of
flavours facilitated these efforts'' (Ref. 16).
    The Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act; Pub. L. 111-31) prohibited, among other things, cigarettes
with characterizing flavors other than tobacco or menthol. In 2009,
when the Act was passed, national cross-sectional data suggested that
the use of flavored cigarettes was most prevalent among younger smokers
(Ref. 18), which caused concern that the availability of flavored
cigarettes was contributing to youth tobacco use (Ref. 19). Additional
evidence available at that time showed that younger tobacco users and
nonusers had greater positive expectancies (e.g., beliefs that smoking
will enhance positive affect and control weight) for flavored
cigarettes compared to non-flavored cigarettes (Ref. 20), a finding
that was consistent with evidence from internal industry documents
showing that tobacco product manufacturers targeted flavored cigarettes
toward young populations (Refs. 9, 10, and 21). Moreover, the Surgeon
General has concluded that most smokers try, and become addicted to,
cigarettes before adulthood (Ref. 17) and that smoking causes severe
disease, disability, and death (Refs. 22 and 23).
    As with cigarettes, first cigar use often occurs during youth or
young adulthood (Refs. 24 and 25). In a cross-sectional analysis of
data collected between 2011 and 2017 as part of a longitudinal study,
among almost 10,000 young adult college students who had ever used
cigars, the mean age of first cigar use was 13.6 years (Ref. 24). A
longitudinal analysis of Waves 1-4 (2013-2017) of PATH Study data found
the proportion of youth who initiate cigar use increases considerably
between ages 15 and 20 years (Ref. 25). Whereas only 1.5 percent of 15-
year-olds in the PATH Study (2013-2017) had ever used any cigar (i.e.,
cigarillo, filtered cigar, or traditional cigar), by age 20, 31 percent
had ever used any cigar, with the greatest increase in first use
between 17 and 18 years of age (Ref. 25). Similarly, an analysis of
harmonized data from five large national surveys found a consistent
peak in cigar initiation among individuals aged 17-19 years (Ref. 26).
The consistency of this age of initiation across all five studies
increases the confidence in this finding and suggests cigar initiation
extends into young adulthood (Ref. 26). A longitudinal study of Waves
1-3 (2013-2016) of PATH Study data found that 9.0 percent of youth
(aged 12-17 years) and 12.0 percent of young adults (aged 18-24 years)
started using cigars for the first time between Wave 1 (2013-2014) and
Wave 3 (2015-2016) (Ref. 27). In comparison, 3.3 percent of adults over
25 years old initiated cigar use in the same time period (Ref. 27).
Study findings also indicate racial and ethnic disparities in cigar
product use. Non-Hispanic Black youth were 47 percent more likely to
initiate past 30-day cigarillo or filtered cigar use at earlier ages
compared to non-Hispanic White youth (Ref. 25).
    We also know that a majority of youth and young adults initiate
with a flavored cigar compared to older adults based on data from Wave
5 (2018-2019) of the PATH Study (Ref. 12) and that first use of
flavored cigars is associated with continued use of these products
(Refs. 28 and 29). In a longitudinal analysis of Waves 1-4 (2013-2017)
PATH Study data, youth whose first cigar was either a mint or menthol
cigar or an ``other'' flavored cigar (e.g., fruit, alcohol, chocolate,
candy, and other flavor) were more likely to be a past-30-day cigar
user at a subsequent wave (approximately 1 year later) compared to
those who first used a non-flavored cigar. Similarly, young adults
(aged 18-24 years) who first used a mint or menthol cigar or other
flavored cigar were more likely to be a past-30-day cigar user at a
subsequent wave compared to those first using a non-flavored cigar
(Ref. 29).
    Similar to cigarettes with characterizing flavors, cigars with
characterizing flavors expose users to the highly addictive chemical
nicotine and other toxic and carcinogenic chemicals found in combusted
tobacco products. Little cigars, in particular, deliver similar (and
sometimes higher) levels of nicotine, as well as similar (and sometimes
higher) levels of carcinogens, compared to cigarettes (Refs. 30 and
31). People who smoke cigars regularly are at increased risk for many
of the same diseases as cigarette smokers, including oral, esophageal,
laryngeal, and lung cancer; cardiovascular diseases; and chronic
obstructive pulmonary disease (COPD) (Ref. 32).
    In particular, youth and young adult exposure to the nicotine in
cigars can result in negative health effects. Exposure to nicotine can
disrupt brain development, which continues through approximately age
25, and may lead to long-term adverse consequences for cognitive
function into adulthood (Ref. 33). Nicotine exposure in adolescence may
have lasting implications and can result in decreased attention,
increased impulsivity, and various lasting mental health conditions
(Ref. 34). Nicotine is highly addictive. Using nicotine in adolescence
may increase risk for future addiction to other drugs (Ref. 33).
    FDA finds that this product standard is appropriate for the
protection of the public health because it would reduce the appeal of
cigars, particularly to youth and young adults, by eliminating
flavorings that increase appeal, reduce the harshness and bitterness of
cigars, and make them easier to smoke, thereby decreasing the
likelihood that both nonusers would experiment with cigars and that
current experimenters would continue to use cigars, as further
discussed in sections IV.D and IV.E of this document. Furthermore, FDA
finds that this product standard would decrease the likelihood that
both nonusers and current experimenters would be exposed to the toxic
and carcinogenic chemicals in cigars, develop nicotine dependence, and
progress to regular tobacco use, as further discussed in sections IV.E
and V.B of this document. Additionally, as discussed in section VI.B of
this document, the proposed product standard could improve the health
of current flavored cigar smokers by increasing their likelihood of
smoking cessation or reduction. The population health benefits of the
proposed product standard are discussed in detail in section VI of this
document. Thus, based on the information discussed in the following
sections of this document, FDA finds that the proposed tobacco product
standard would be appropriate for the protection of the public health.
    Reducing the appeal and use of cigars by eliminating characterizing
flavors (other than tobacco) also is expected to substantially decrease
tobacco-related health disparities and to equitably promote health
across population groups. Tobacco-related health disparities are the
differences observed in population groups regarding: the patterns
(e.g., initiation, dual or polyuse, cessation), prevention, and
treatment of tobacco use; the risk, incidence, morbidity, mortality,
and burden of tobacco-related illness; and capacity and infrastructure
(e.g., political systems, educational institutions), access to
resources (e.g., access to health services and programs), and
environmental secondhand smoke exposure (Refs. 35-37). Tobacco-related
health disparities affect those who have systematically experienced
greater obstacles to health based on group membership due in part to
the inequitable distribution of social, political, economic, and
environmental resources (Refs. 37-39). Health equity is the attainment
of the highest level of health for all people (Ref. 39). It is achieved
by equally valuing all

individuals regardless of group membership; removing social, economic,
and institutional obstacles to health; and addressing historical and
contemporary injustices (Refs. 39-41). The advancement of health equity
is integral to the reduction and elimination of tobacco-related health
disparities, which affect those who have been denied opportunity and
access to economic, political, and social participation. Members of
underserved communities \7\ experience a disproportionate burden of
cigar use in initiation, prevalence of use, current use, and frequency
of use (see section V.A of this document), leading to observed tobacco-
related health disparities within those communities. Such disparities
in cigar use contribute to higher rates of observed tobacco-related
morbidity and mortality among underserved communities and vulnerable
populations,8 9 such as youth and young adults, some racial
and ethnic populations, those with lower household income and
educational attainment, and individuals who identify as lesbian, gay,
bisexual, transgender, or queer (LGBTQ+),\10\ as further discussed in
section V.F of this document. This proposed product standard is
anticipated to promote better public health outcomes across population
groups.
---------------------------------------------------------------------------

    \7\ As defined by Executive Order (E.O.) 13895, ``Advancing
Racial Equity and Support for Underserved Communities Through the
Federal Government,'' (86 FR 7009, January 25, 2021) the term
``underserved communities'' refers to populations sharing a
particular characteristic, as well as geographic communities, that
have been systematically denied a full opportunity to participate in
aspects of economic, social, and civic life. In the context of
tobacco products and tobacco-related health disparities, such
communities may include populations disproportionately impacted by
marketing and promotion targeted on the basis of such shared
characteristics.
    \8\ Throughout this document, the term ``vulnerable
populations'' refers to groups that are susceptible to tobacco
product risk and harm due to disproportionate rates of tobacco
product initiation, use, burden of tobacco-related diseases, or
decreased cessation. Examples of vulnerable populations include
those with lower household income and educational attainment,
certain racial or ethnic populations, individuals who identify as
LGBTQ+, underserved rural populations, those pregnant or trying to
become pregnant, those in the military or veterans, or those with
behavioral health conditions.
    \9\ Underserved communities are overrepresented in vulnerable
populations.
    \10\ Throughout this document, FDA uses the term ``LGBTQ+''
broadly when referring to lesbian, gay, bisexual, transgender, and
queer (and other) communities. When we describe findings from the
published literature, we refer specifically to the groups that are
studied. For example, some authors examine tobacco-related outcomes
for members who identify as lesbian, gay, bisexual, or transgender
(LGBT) only; as such, the data are limited to those who identify as
LGBT, and authors interpret the findings for those specific groups.
---------------------------------------------------------------------------

B. Relevant Regulatory History

    In its implementation of the Tobacco Control Act over the past
several years, FDA has engaged in close study and careful consideration
of the scientific evidence and complex policy issues related to
flavored tobacco products. FDA has issued an advance notice of proposed
rulemaking (ANPRM) to solicit data and information about the roles of
flavors in tobacco products, sponsored research on a variety of cigar-
and flavors-related topics through contracts and interagency agreements
with Federal partners, including the National Institutes of Health
(NIH),\11\ and undertaken its own scientific review related to the
impact of characterizing flavors in cigar products. Among other things,
FDA has considered the comments and information received in response to
the ANPRM and scientific review in developing this proposed rule.
---------------------------------------------------------------------------

    \11\ Information on specific projects supported by FDA is
available at https://www.fda.gov/tobacco-products/tobacco-science-research/research (search ``cigars'' or ``flavors'').
---------------------------------------------------------------------------

1. ANPRM
    In July 2017, FDA announced a comprehensive approach to tobacco and
nicotine regulation to protect youth and reduce tobacco-related disease
and death (Ref. 42). As part of the public dialogue on the
comprehensive approach, in March 2018, FDA issued three ANPRMs related
to the regulation of nicotine in combustible cigarettes (83 FR 11818,
March 16, 2018), flavors (including menthol) in tobacco products (83 FR
12294, March 21, 2018) (Flavors ANPRM), and premium cigars (83 FR
12901, March 26, 2018). In addition, FDA announced the availability of
a draft concept paper, entitled ``Illicit Trade in Tobacco Products
after Implementation of a Food and Drug Administration Product
Standard,'' and sought public comment (83 FR 11754, March 16, 2018).
This paper analyzes the potential for illicit trade markets to develop
in response to a tobacco product standard (Ref. 43).
    The Flavors ANPRM requested data and information about the role
that flavors play in tobacco products (83 FR 12294). Specifically, the
Flavors ANPRM requested comments, data, research results, or other
information about, among other things, how flavors attract youth to
initiate tobacco product use. While the Flavors ANPRM discussed
potential product standards and a range of product types, it also
specifically requested public input on the role of flavors in cigars.
FDA received over 525,000 comments on the Flavors ANPRM, a large
proportion of which were form letters related to 61 different organized
campaigns. Five of these campaigns, which included a combined total of
approximately 329,668 comments, were identified as being automatically
generated ``bot'' comments. Some of the issues raised in the comments
to the ANPRM are highlighted below.
    Comments generally in support of the regulation of flavors in
tobacco products stated that a product standard prohibiting the use of
flavors in tobacco products would be appropriate for the protection of
the public health. In particular, many comments argued that such a
tobacco product standard would be appropriate for the following
reasons: (1) To protect youth and young adults from becoming tobacco
product users; (2) to prevent widened appeal of tobacco product use;
and (3) to discourage addiction to tobacco products. FDA received many
comments expressing concern about the use of flavors to capture new
users, particularly children, into lifelong nicotine addiction by
making tobacco products more appealing and/or palatable. Citing
internal tobacco industry documents that have since been made public,
many commenters, including several public health advocacy groups, some
professional associations, and multiple State attorneys general,
pointed out that the industry has a long and well-established history
of deliberately targeting children through the development and/or
marketing of flavored tobacco products.
    FDA received many comments in support of the regulation of flavors
in cigar products, specifically. These comments often noted that
flavors are frequently added to cigars for the express purpose of
making harsh products more palatable to new users. Citing national
survey data trends and various recent studies, these commenters often
noted that youth and young adults report flavors as a key reason for
their use of cigars, including little cigars and cigarillos (LCCs), and
that a substantial percentage of youth cigar smokers exclusively use
flavored cigars.
    FDA also received comments from individuals and representatives
from the tobacco industry generally opposing the regulation of flavored
tobacco products. These comments generally stated that such regulation
was not likely to decrease the appeal of such tobacco products to youth
nor have positive effects for society at large. Some comments opposed
to a tobacco product

standard addressing flavors in cigars, specifically, stated that FDA
had not presented the scientific basis for such a product standard,
noting what they characterized as gaps in the scientific literature
regarding usage patterns and consumer perceptions of flavored cigars,
particularly among youth. Other comments from tobacco industry
representatives conclude that any tobacco product standard for flavors
in cigars should exclude premium cigars.
    Many comments received from industry noted concern with how FDA
would define ``characterizing flavors,'' arguing that any such
definition must use clear and science-based criteria. Some comments
argued that, without a definition for ``characterizing flavors,'' it
could be difficult for industry to comply with a tobacco product
standard. FDA also received comments in support of regulation
suggesting that FDA define ``characterizing flavor'' in a way that
makes the prohibition clear to manufacturers and retailers, protects
public health, and prevents manufacturers from evading the intent of
the product standard.
    FDA has reviewed and closely considered the comments to the Flavors
ANPRM, as well as additional evidence and information not available at
the time of the Flavors ANPRM, in developing this proposed rule.
2. Scientific Review
    As the body of evidence continues to grow, FDA recently undertook a
review of the scientific evidence regarding the role characterizing
flavors play in increasing the appeal and use of tobacco products,
particularly cigars, among youth, young adults, and adults in the
United States. This review, entitled ``Scientific Assessment of the
Impact of Flavors in Cigar Products,'' summarizes findings from the
peer-reviewed, publicly available scientific literature organized
around three research questions: (1) How does the addition of
characterizing flavors to tobacco products, including cigars, impact
product appeal and product use; (2) how do characterizing flavors
impact youth and young adult experimentation with tobacco products,
including cigars, and do they make progression to regular tobacco use
more likely; and (3) what impact do local and national policies
restricting the sale of flavored cigars and other flavored tobacco
products have on cigar sales and use? The ``Scientific Assessment of
the Impact of Flavors in Cigar Products'' has been peer reviewed by
independent external experts. Taking into consideration comments from
this peer review (Ref. 44), FDA revised the scientific assessment, and
the final peer-reviewed scientific assessment is available in the
docket for this proposed rule (Ref. 45). This scientific assessment
informed the development of this proposed product standard.

C. Legal Authority

1. Product Standard Authority Generally
    The Tobacco Control Act was enacted on June 22, 2009, amending the
FD&C Act and providing FDA with the authority to regulate tobacco
products. Section 901 of the FD&C Act (21 U.S.C. 387a) granted FDA the
authority to regulate the manufacture, marketing, and distribution of
cigarettes, cigarette tobacco, roll-your-own tobacco (RYO), and
smokeless tobacco to protect the public health and to reduce tobacco
use by youth. The Tobacco Control Act also gave the Agency authority to
conduct rulemaking to ``deem'' any other tobacco products subject to
chapter IX of the FD&C Act. In 2016, FDA issued a final rule deeming
products meeting the statutory definition of ``tobacco product''
(including cigars), except accessories of the newly deemed products, to
be subject to chapter IX of the FD&C Act, as amended by the Tobacco
Control Act (81 FR 28974) (deeming final rule).
    Among the tobacco product authorities provided to FDA is the
authority to adopt tobacco product standards where FDA determines that
such standard is appropriate for the protection of the public health
(section 907(a)(3) of the FD&C Act). To establish a tobacco product
standard, section 907(a)(3)(A) and (B) of the FD&C Act requires that
FDA find that the standard is appropriate for the protection of the
public health, taking into consideration scientific evidence
concerning:
     The risks and benefits to the population as a whole,
including users and nonusers of tobacco products, of the proposed
standard;
     The increased or decreased likelihood that existing users
of tobacco products will stop using such products; and
     The increased or decreased likelihood that those who do
not use tobacco products will start using such products.
2. Authority To Prohibit Characterizing Flavors in Cigars
    Section 907 of the FD&C Act authorizes FDA to issue tobacco product
standards that are appropriate for the protection of the public health,
including provisions that would require the reduction or elimination of
a constituent (including a smoke constituent), or harmful component of
tobacco products and provisions respecting the construction,
components, ingredients, additives, constituents (including smoke
constituents), and properties of the tobacco product (section
907(a)(3), (a)(4)(A)(ii), and (a)(4)(B)(i) of the FD&C Act). This
includes the authority to issue a new product standard prohibiting
characterizing flavors in tobacco products pursuant to section
907(a)(3) and (4) and to amend or revoke an existing product standard
pursuant to section 907(d)(4) of the FD&C Act. Section 907(a)(4)(B)(v)
also authorizes FDA to include in a product standard a provision
restricting the sale and distribution of a tobacco product to the
extent that it may be restricted by a regulation under section 906(d)
of the FD&C Act.
    Pursuant to section 907(a)(3) and (c) of the FD&C Act, FDA is
proposing this product standard that would require the elimination of
characterizing flavors (other than tobacco) from cigars, because it
would reduce the disease, disability, and death caused by tobacco use,
and FDA has found the standard to be appropriate for the protection of
the public health consistent with section 907(a)(3), (a)(4)(A)(ii), and
(a)(4)(B)(i) of the FD&C Act. In addition, this proposed rule would
prohibit the distribution, sale, and offer for distribution or sale of
cigars with characterizing flavors (other than tobacco). Because this
sale and distribution restriction would assist FDA in enforcing the
standard and would ensure that manufacturers and retailers are selling
product that complies with the standard, the Agency has found such
restriction to be appropriate for the protection of the public health
consistent with sections 907(a)(4)(B)(v) and 906(d) of the FD&C Act.
FDA's analysis showing that the proposed tobacco product standard is
appropriate for the protection of the public health is discussed in
section VI of this document.
    FDA is proposing this product standard under the authorities
discussed previously, along with section 701 of the FD&C Act, which
provides FDA with the authority to ``promulgate regulations for the
efficient enforcement of this Act.''

D. FDA's Consideration of Health Equity

    Advancing health equity is a policy priority and an important
component of fulfilling FDA's mission to protect and promote public
health. FDA and the Federal Government now recognize the advancement of
health equity as ``both a moral imperative and pragmatic policy,'' as
E.O. 13995 states.

    Considerations related to health equity helped inform FDA's
decision to prioritize this proposed product standard. In particular,
FDA took into account the disproportionate toll flavored cigars have
taken on certain population subgroups. We note that the expected health
benefits of this proposed standard are expected to be greater in these
subgroups than in the population more generally.
    This proposed product standard easily clears the threshold of being
appropriate for the protection of the public health, due to the large
health benefits from the expected reduced initiation and increased
cessation when looking at the population generally. We make this
finding even without taking into account the specific expected greater
health benefits from this product standard among certain population
subgroups.

IV. Characterizing Flavors Impact Cigar Use, Particularly Among Youth
and Young Adults

A. Recent Market Trends of Flavored Cigars in the United States

    Congress passed the Tobacco Control Act in 2009 to address the
premature death, disease, and other serious health conditions caused by
tobacco use. The Tobacco Control Act gave FDA a mandate to reduce
tobacco product dependence and use, particularly among youth (see
section 3(2) and (9) of the Tobacco Control Act). Of particular
importance for this proposed product standard, the Tobacco Control Act
established a ban on characterizing flavors (other than tobacco or
menthol) in cigarettes (section 907(a)(1)(A) of the FD&C Act). The
legislative history of the Tobacco Control Act reflects that the goal
of the Act's cigarette characterizing flavor ban was to eliminate one
emerging group of tobacco products that was particularly appealing to
youth (Ref. 46 at 37-38). Congress determined that banning cigarettes
with characterizing flavors would benefit youth because flavored
cigarettes were typically used by individuals experimenting with
tobacco products, such as youth, and noted that such products were not
typically used by regular adult smokers (Ref. 46 at 37-38). In 2009,
FDA issued guidance on the statutory provision (see General Questions
and Answers on the Ban of Cigarettes that Contain Certain
Characterizing Flavors (Edition 2), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-questions-and-answers-ban-cigarettes-contain-certain-characterizing-flavors-edition-2), noting that ``flavored products make it easier for new
smokers to start smoking by masking the unpleasant flavor of tobacco''
and that ``[r]emoving these flavored products from the market is
important because it removes an avenue that young people can use to
begin regular tobacco use.'' Research and data concerning the impact of
Congress's decision to ban flavored cigarettes are instructive for
purposes of evaluating cigars' characterizing flavors and this proposed
product standard.
    After the ban on characterizing flavors in cigarettes became
effective, researchers noted that certain products previously marketed
as cigarettes likely were modified or rebranded as ``cigars'' so that
they could remain on the market in flavored varieties (e.g., Ref. 47).
Little cigars are often indistinguishable from cigarettes given their
shape, size, filters, and packaging (Refs. 48 and 49). An analysis of
NYTS data from middle and high school students between 1999 and 2013
found that cigar use rose 34.4 percent following the ban on
characterizing flavors in cigarettes (Ref. 50). The analysis found an
overall decrease of 17 percent in the prevalence of youth cigarette
smoking, fewer cigarettes smoked per month, and, despite the rise in
cigar use, an overall reduction of 6 percent in the probability of
using any type of tobacco (Ref. 50). A review of publicly available
internal documents from a clove cigarette company found that the
company started to develop a clove cigar product in 2007 in
anticipation of the Tobacco Control Act and its ban on cigarettes with
characterizing flavors, including clove-flavored cigarettes (Ref. 47).
According to these documents, the goal was to be prepared for a product
transition to allow for continual marketing of a clove-flavored
combusted tobacco product (Ref. 47). Immediately following the
prohibition on cigarette characterizing flavors, sales of clove cigars
increased more than 1,400 percent between 2009 and 2012 (Ref. 47),
strongly suggesting that users of clove cigarettes switched to clove
cigars on the basis of flavor availability.
    A similar trend in modifying or rebranding of products has been
seen in several U.S. jurisdictions \12\ where laws have been enacted to
further restrict the sale of flavored tobacco products, including
cigars. Subsequent to these restrictions on the sale of flavored
tobacco products, researchers have noted the emergence of ``concept''
flavored named products that include ambiguous names that imply flavor
but do not explicitly indicate any particular flavor on the products
labeling or packaging (e.g., purple, tropical sunset) (Refs. 51 and
52). Sales of concept flavors (e.g., sweet, jazz) increased from 2.2
percent of U.S. flavored cigar sales in 2009 to 21.4 percent of U.S.
flavored cigar sales in 2020, a 33 percent average annual percentage
change (Ref. 53).
---------------------------------------------------------------------------

    \12\ For more information on U.S. localities and the
implementation of flavored tobacco product restrictions, see section
IV.F of this document.
---------------------------------------------------------------------------

    Flavored cigars continue to maintain a substantial share of the
cigar market. Researchers analyzing Nielsen data trends found that
cigar dollar and unit sales in convenience stores increased by 23
percent and 50 percent, respectively, between 2008 and 2015, and that
flavored cigar dollar sales--including, for example, those with
characterizing flavors such as chocolate, mint, or rum--increased by
46.5 percent (Refs. 54 and 55). A more recent study also found that
flavored cigar sales increased substantially between 2009 and 2020,
while non-flavored cigar sales did not change (Ref. 53). Another study
analyzing trends in cigars using Nielsen data found that during January
2016 to June 2020, monthly cigarillo unit sales, which represented 94.2
percent of total cigar unit sales during the study period, increased
from about 131 million to 190 million (Ref. 56). Additionally,
proprietary data gathered by Euromonitor International in March 2021
reveals that, in 2020, flavored cigars, including flavored cigarillos,
accounted for approximately 19.1 percent of all cigar U.S. dollar sales
and 41.9 percent of all cigar unit sales, suggesting that the average
price of a single unit of flavored cigar was lower than that of a
single unit of tobacco-flavored cigar in 2020.
    Data suggest that due to both Congress's prohibition on cigarettes
with characterizing flavors and the pressure placed on price-sensitive
smokers (i.e., those smokers whose smoking behaviors change based on
the cost of tobacco products) by increased taxation of cigarettes
resulting from the 2009 Children's Health Insurance Program
Reauthorization Act (Pub. L. 111-3), some price-sensitive cigarette
smokers smoke cigars as a flavored, less expensive alternative to
cigarettes (Ref. 57). In addition, the popularity of cigar products
among young adults may be due to their lower price relative to
cigarettes, lack of minimum pack size requirements, and exclusion from
the advertising restrictions of the Tobacco Master Settlement Agreement
(Ref. 54). Findings from a survey study indicated that affordability
and flavors were the most commonly cited reasons for little cigar and
cigarillo use among White and

Black young adult ever users and past 30-day users (Ref. 58).
    Given the current market share of flavored cigar products, research
demonstrating how sales of flavored cigars increased in the years
following the removal of flavored cigarettes, and how industry
contributed to these shifts by marketing clove-flavored cigars
nationally and introducing concept flavors, FDA is proposing to
prohibit characterizing flavors (other than tobacco) in cigars to
prevent youth and young adults from entering the market and progressing
from experimentation to regular use of these products, and to promote
cessation among existing users of these products.

B. Over Half a Million Youth, and Even More Young Adults, in the United
States Use Flavored Cigars

    Widespread use of flavored cigars by youth supports FDA's
determination that this proposed rule would have a considerable
positive impact on public health. Using NYTS 2020 \13\ data,
researchers estimated that approximately 960,000 U.S. middle and high
school students had smoked a cigar in the prior month (Ref. 7).
Overall, the prevalence of cigar smoking among middle and high school
students is comparable to cigarette smoking, and for non-Hispanic Black
students, cigar smoking prevalence (6.5 percent) is considerably
greater than cigarette smoking (2.5 percent) (Ref. 7). In 2019, not
excluding use of other tobacco products, more young adults tried a
cigar for the first time each day than tried a cigarette for the first
time (3,163 cigar vs. 2,640 cigarette) (Ref. 59 at Table A.3A). As
discussed throughout this proposed rule, evidence is well documented of
broad youth and young adult use of cigars and the reasons cited for
their use. In addition, local policy evaluation studies of restrictions
on the sale of flavored tobacco products, including cigars, found a
decrease in overall tobacco use by youth (Refs. 51 and 60-62), further
supporting the conclusion that prohibiting the use of characterizing
flavors (other than tobacco) in cigars is likely to result in less
cigar use and less tobacco product use overall, especially among youth
and young adults.
---------------------------------------------------------------------------

    \13\ The 2020 NYTS is a survey that was conducted after the
Federal law went into effect prohibiting sales of tobacco products
to those under the age of 21 (Further Consolidated Appropriations
Act, 2020, Public Law 116-94, section 906(d) of the FD&C Act), thus
potentially capturing some of the impacts of the new law.
---------------------------------------------------------------------------

    Studies indicate that a substantial percentage of youth cigar users
smoke flavored cigars. Data from Wave 5 (2018-2019) of the PATH Study
indicate that among youth (aged 12-17 years) 44.0 percent of past 30-
day cigar smokers reported using flavored cigars (i.e., 33.9 percent of
youth traditional cigar smokers, 46 percent of youth cigarillo users,
and 50.2 percent of youth filtered cigar users reported past 30-day use
of a flavored cigar) (Ref. 63). Data from the 2020 NYTS indicate that
58.3 percent of middle and high school students who smoke cigars (or
approximately 550,000 youth), reported using a flavored cigar during
the past 30 days (Ref. 8). The majority of youth cigar smokers identify
the availability of cigar flavors as a leading reason for their cigar
use (Refs. 64 and 65).
    The data indicate a similar preference for flavors among young
adults. According to Wave 5 (2018-2019) data from the PATH Study,
approximately 630,000 young adults aged 18 to 24 years reported past
month flavored cigar smoking (Ref. 63). An analysis of Wave 5 (2018-
2019) PATH Study data indicated that among young adults (aged 18-24
years) who used cigars some or every day, 54.1 percent of traditional
cigar users, 66.5 percent of cigarillo users, and 65.1 percent of
filtered cigar users reported flavoring as a reason for cigar use (Ref.
12). Among young adult past 30-day cigar smokers 18-24 years old, 38.3
percent reported that the cigar product they smoked in the past 30 days
was flavored (i.e., 17.7 percent of young adult traditional cigar
smokers, 46 percent of young adult cigarillo users, and 41 percent of
young adult filtered cigar users reported past 30 day use of a flavored
cigar) (Ref. 63). Since the brain continues development into an
individual's mid-twenties, cigar use in both youth and young adulthood
can harm the developing brain (Ref. 33). As discussed in section V.C of
this document, nicotine can disrupt brain development and have long
term consequences.
    Studies illustrate some disparities in young adult flavored cigar
use across population groups. Among a sample of college students aged
18-29 who used cigars in the past 30 days (n=523), Black, Asian, and
Hispanic young adults were all significantly more likely to have used
flavored cigars than White young adults (Ref. 66). Participants aged
18-24 years also had greater odds of using flavored cigars compared to
participants aged 25-29 years (Ref. 66). Lastly, young adults who
identified as lesbian, gay, or bisexual had higher odds of reporting
past 30-day flavored large cigar and LCC use compared to respondents
who identified as straight/heterosexual (Ref. 67).
    The data also show that a substantial percentage of youth and young
adult cigar users initiate with flavored cigars. Data from Wave 5
(2018-2019) of the PATH Study revealed that 60.4 percent of the youth
participants (aged 12-17 years) and 63.2 percent of young adults (aged
18-24 years) who reported ever using cigars said that the first cigar
they used was flavored, statistically significantly higher than the
41.9 percent of adults (aged 25 years and older) who have ever used
cigars (Ref. 12).

C. Adult Use of Flavored Cigars in the United States

    While the evidence is clear that youth and young adults use
flavored cigars, it is important to note that older adults also use
them. According to Wave 5 data (2018-2019) from the PATH Study, 36.0
percent of adult cigar smokers (adults aged 25 years and older who used
cigars in the past 30 days), or over 3 million adults, reported use of
a flavored cigar in one or more of the past 30 days (Ref. 63). When
considering the type of cigar, reported use of a flavored cigar in the
past 30 days occurred less frequently for adult traditional cigar
smokers (19.7 percent) compared with adult smokers of all other cigar
types (46.5 percent for cigarillos and 48.7 percent for filtered
cigars) (Refs. 63).
    Many adult cigar consumers also identify the availability of
characterizing flavors as a reason for their cigar use. Among adults
over 25 years old who used cigars every or some days, 54.8 percent of
traditional cigar users, 69.6 percent of cigarillo users, and 71.4
percent of filtered cigar users reported flavoring as a reason for
cigar use (Ref. 12). Among adults, studies suggest males are more
likely than females to use cigars, with some differences across cigar
types (Refs. 63, 66, 68, and 69). However, among cigar users, females
are more likely to use flavored cigars. For example, a study of college
students aged 18-29 years who had used cigars in the past 30 days found
that 60.5 percent of cigar users were male, but, among cigar users,
males were statistically significantly less likely to have used
flavored cigars than females (Ref. 66). Likewise, in every wave of the
PATH Study, adult males were more likely to use any cigar in the past
30 days, but among past-30-day cigar users, females were statistically
significantly more likely to have used flavored cigar products (Ref.
63).
    Furthermore, there are differences in adult use of flavored cigars
across population groups. Among adults who were past-30-day users of
any cigar type,

non-Hispanic Black adults were statistically significantly more likely
to have used a flavored cigar in the past 30 days compared to non-
Hispanic White adults at every survey wave of the PATH Study (2013-
2019) (Ref. 63). Likewise, at every wave of the PATH Study, among
adults aged 25 years and older who had smoked cigars in the past 30
days, individuals with a college degree were statistically
significantly less likely to use a flavored cigar (20.0 percent) than
individuals categorized as having less than a high school diploma (44.9
percent), a high school diploma (37.4 percent), or some college (42.9
percent) (Ref. 63). Using 2009-2010 National Adult Tobacco Survey
(NATS) data, adults who identified as lesbian, gay, bisexual, or
transgender were also more likely to use flavored cigars (8.2 percent)
compared to the national prevalence (2.8 percent) (Ref. 70).
    This proposed rule, if finalized, could lead adult flavored cigar
smokers to cease tobacco use, reduce tobacco use, or encourage them to
switch to other, potentially less harmful tobacco products.

D. Characterizing Flavors Increase Appeal and Make Tobacco Products,
Including Cigars, Easier To Use

    Characterizing flavors increase the appeal of cigars and make them
easier to use. Characterizing flavors are added to tobacco products,
including cigars, for numerous reasons that relate to product appeal,
such as to ensure pleasant flavor and taste; to reduce the harshness,
bitterness, and astringency of tobacco during inhalation; and to soothe
irritation during product use (Refs. 9-11). As documented by the
Surgeon General, tobacco product manufacturers have historically added
characterizing flavors to products with lower levels of free-nicotine
content (i.e., those products that have lower amounts of nicotine
easily absorbed by the user) intended for use as ``starter products''
for new tobacco users (Ref. 17).
    In particular, the addition of menthol as a characterizing flavor
in combusted tobacco products, including cigars, can soothe irritation
and increase appeal. Menthol is a flavor compound that when added to
combusted tobacco products produces a minty taste and cooling sensation
when inhaled (Ref. 71). Smokers report that mentholated products have a
better taste, are smoother and more refreshing (Refs. 72-74). Menthol's
flavor and sensory effects reduce the harshness of smoking among new
users and facilitates product use, particularly among youth and young
adults (Refs. 29 and 74-76).
    While much of the evidence on the role of flavors in increasing
appeal focuses on cigarettes and tobacco products overall, internal
industry documents also specifically discuss the role of flavors in
cigars (Ref. 16). Internal tobacco industry documents illustrate cigar
manufacturers' historical practices of adding characterizing flavors to
diminish the harshness of tobacco products' taste with specific intent
to appeal to young consumers (Refs. 16 and 17). A review of the Truth
Tobacco Industry Documents, an archive of tobacco industry documents,
showed that some flavors in cigars (e.g., vanilla bean, peach, apricot,
licorice, cocoa) may mask the bitterness of tobacco leaves, throat
burn, and heavy taste, thereby facilitating inhalation, making smoking
more tolerable for current users, and increasing palatability for new
users. These documents illustrate that the effect of characterizing
flavors in the appeal of other tobacco products is applicable to the
effect of characterizing flavors in the appeal of cigar products. These
documents also illustrate that the tobacco industry added flavors and
changed some design characteristics of little cigars and cigarillos to
facilitate inhalation and make smoking more tolerable for current
smokers, as well as more palatable for new users, including youth
(Refs. 16 and 77-79).
    Flavors play an important role in attracting youth to tobacco
products, including cigars (Refs. 55, 80, and 81). In survey and
qualitative research, youth report that flavors in cigars are a leading
reason for use. In 2018-2019 PATH Study data, 50.4 percent of youth
participants (aged 12-17 years) who reported past 30-day cigar smoking
identified flavors as a reason for use (Ref. 12). Results from
qualitative research indicate that youth themselves acknowledge that
flavorings impact their cigar use (Ref. 82). Similarly, some young
adult participants mentioned that the flavors of little flavored cigars
and cigarillos were particularly appealing, with one stating: ``They
taste basically like a strawberry. And I like the Tropical Fusion cause
it's like a coconut.'' In a qualitative study involving focus groups of
youth and young adults who used cigars (Ref. 83), the most appealing
component of cigar packaging were aspects that indicated the flavor
(e.g., a flavor name or image), which was identified by nearly half of
all participants, and participants indicated that the words describing
the flavor (e.g., ``sweet'') were a reason to buy the product. In a
qualitative study of adolescents (aged 15-18 years) (Ref. 84), both
users of tobacco products (including users of cigars/cigarillos) and
nonusers indicated flavors make tobacco products appealing and are a
reason to use tobacco products. Participants indicated that both the
taste and smell of flavored products were appealing (specifically
mentioning minty, sweet, and fruit flavors) and noted that the smell of
flavors could obscure the smell of tobacco.
    Both younger and older adults similarly report flavors as a leading
reason for cigar use. Among young adults (aged 18-24 years) in the PATH
Study (2018-2019) who used cigars regularly and currently used cigars
every or someday, 54.1 percent of current traditional cigar users, 66.5
percent of current cigarillo users, and 65.1 percent of current
filtered cigar users reported flavoring as a reason for cigar use (Ref.
12). Likewise, adults aged 25 years and older report flavors as a
leading reason for cigar use. Among adults aged 25 years and older in
the PATH Study, 54.8 percent of current traditional cigar smokers, 69.6
percent of current cigarillo smokers, and 71.4 percent of current
filtered cigar smokers reported flavoring as a reason for cigar use.
There was not a statistically significant difference by age group in
reporting flavors as a reason for use (Ref. 12).
    Characterizing flavors increase susceptibility to use (a measure of
how much individuals report being open or willing to use a tobacco
product) in nonsmoking young adults, as documented in a 2020 study that
tested cigarillo pack images containing the most popular characterizing
flavors. Susceptibility to cigarillo use was statistically
significantly greater among participants exposed to the packs with
characterizing flavors (Ref. 85). Results from focus groups and
semistructured interviews with 90 young adult past 30-day LCC-only,
cigarette-only, and dual cigarette and LCC smokers provide insight
about the appeal of characterizing flavors in certain cigars to youth
and young adults (Ref. 82). Among study participants, the average age
of initiation of LCC was 16.1 years, and nearly two-thirds of the
participants reported first using an LCC that was flavored (Ref. 82).
Participants frequently reported that smoking flavored LCCs relieved
stress and that flavored LCC use sometimes depended on mood and was
associated with boosted mood and gratification (Ref. 82). Participants
frequently mentioned that flavored tobacco made smoking LCCs more
palatable than smoking unflavored (or regular flavor) cigars (Ref. 82).
For many participants, seeing or hearing the

phrase ``little cigars or cigarillos'' evoked thoughts about their
favorite flavors (Ref. 82). In addition, for many participants, peers
played an important role in continued experimentation because friends
would often suggest flavors to one another (Ref. 82). Moreover, many
participants stated that the appeal of the variety of available
flavored LCCs on the market influenced their decision to try LCCs (Ref.
82). These studies indicate that flavors are an important factor in
initiation and use of cigars among young adults.
    Four systematic reviews of the scientific literature concluded that
flavored tobacco products attract youth to the tobacco product (Refs.
86-89). Two of the systematic reviews included cigars and assessed
studies on use and attitudes related to non-menthol flavored tobacco
products (Refs. 88 and 89). The two reviews concluded that
characterizing flavors were an appealing feature of tobacco products
and that flavors influence perceptions, initiation, and progression to
use of tobacco products, particularly among youth (Refs. 88 and 89).
    The appeal of flavors in tobacco products, including cigars, is not
only consistent across the literature on tobacco products, but is also
consistent with the food literature. Physiologically, scientists have
described how youth have a heightened preference for sweet food tastes
and greater rejection of bitter food tastes; these preferences diminish
with age (Refs. 90-93).
    An FDA-funded scientific review of 474 articles published between
1931 and 2015 conducted to understand how youth and adults differ with
respect to their preferences for characterizing flavors, primarily in
food, concluded that preference for sweetness and saltiness is
generally higher for children than it is for adults; and the level of
sugar selected as most preferred in clinical experiments decreased
between adolescence and adulthood (Ref. 94). The researchers
hypothesized that the higher caloric needs of youth to sustain growth
likely account for the more pronounced preference for sweetness in
youth (Ref. 94).
    Laboratory research has confirmed that the chemical-specific flavor
sensory cues associated with fruit flavors in tobacco products are
often the same as those found in popular candies (Refs. 95 and 96).
While inhaling flavored chemicals is in many ways very different than
ingesting flavored foods, researchers reviewed the levels of flavor
chemicals in several brands of candy and Kool-Aid drink mix and
concluded that the chemical amounts and combinations largely overlapped
with similarly labeled ``cherry,'' ``grape,'' ``apple,'' ``peach,'' and
``berry'' cigar and other tobacco products (Refs. 95 and 96).
    Overall, FDA finds that evidence regarding the role of flavors in
increasing appeal of cigars to youth and young adults, promoting
progression to regular use, and increasing the addiction potential
indicates that removing flavors from cigars would reduce initiation and
use of such products, especially among youth and young adults. As a
majority of adult regular tobacco users become dependent on or addicted
to nicotine as youth and young adults, reducing initiation and use of
cigar products in youth would reduce the likelihood that youth progress
to nicotine dependence and regular use, as well as subsequent tobacco-
related illness and death. Therefore, FDA anticipates that removing
flavors from cigars would substantially reduce tobacco-related disease
and death as a result of averted youth initiation.

E. Characterizing Flavors Increase Youth and Young Adult
Experimentation With Tobacco Products, Including Cigars, and Make
Progression to Regular Tobacco Use More Likely

    Cigars are more commonly used among youth and young adults relative
to other combusted tobacco products, including cigarettes. An analysis
of PATH Study data found that new cigar use (i.e., initiation since a
prior wave of data collection) at Waves 2, 3, or 4 (2014-2017) was more
common (14.5 percent youth, 19.7 percent young adults, 6.3 percent
adults aged 25 and older) relative to new cigarette use (i.e.,
initiation since a prior wave) (14.0 percent youth, 7.1 percent young
adults, 1.1 percent adults aged 25 and older) (Ref. 29). Data from the
2019 National Survey on Drug Use and Health (NSDUH) found that each day
1,210 youth 12-17 years and 3,163 young adults aged 18 to 25 years
tried a cigar for the first time (Ref. 59 at Table A.3A). In 2019,
prevalence of past 30-day cigar use surpassed that of past 30-day
cigarette use among U.S. high school students for the first time (Ref.
97). Flavors make tobacco products, including cigars, easier to use and
reinforce tobacco use among youth and young adults. FDA finds that
eliminating characterizing flavors (other than tobacco) in cigars would
decrease the number of first-time users of cigars who progress to
regular use.
    The process of becoming a regular cigar smoker includes stages of
experimentation, development of nicotine dependence, and progression to
regular use (Refs. 98 and 99). FDA finds that eliminating flavored
cigar varieties would decrease the number of youth experimenting and
the likelihood that youth will progress to regular, sustained use of
tobacco products, and, thus, would reduce the risk of tobacco-related
death and disease.
    Experimentation with cigars can lead to nicotine dependence and
regular use in less than one year. Longitudinal data from the
nationally representative Truth Longitudinal Cohort (2014-2019) were
used to examine the progression from cigar initiation to regular use
among youth and young adults aged 15 to 25 years (Ref. 100). Nearly
half (44.7 percent) of participants who initiated cigar use reported
current (i.e., past-30-day) cigar use 6 months after initiation (Ref.
100). Compared to participants who did not become past-30-day users 6
months after initiation, those who were past-30-day users engaged in a
higher frequency of cigar use during the initial 6-month period, were
younger, non-Hispanic African American, and were more likely to use
other tobacco products. For example, non-Hispanic African American
participants (relative to non-Hispanic White participants) had over
twice the odds of past-30-day cigar use and had a higher average
frequency of use (2.21 days/month vs. 1.34 days/month, respectively) 6
months after initiation of cigar use (Ref. 100).
    Experimentation with flavored cigar use is associated with
subsequent use. Another study used longitudinal data from Waves 1
(2013-2014) and 2 (2014-2015) of the PATH Study to assess whether there
is a prospective association between first flavored use of a tobacco
product and subsequent use of that specific product (Ref. 28). This
analysis found that first use of any flavored cigar or first use of
flavored cigarillos and filtered cigars (including menthol) at Wave 1
(2013-2014) of the nationally representative PATH Study was
subsequently associated with daily or nondaily use of these products in
young adults (aged 18-24 years) and adults (aged 25 years and older) 1
year later (2014-2015) compared with first non-flavored use (Ref. 28).
    Studies have shown that menthol's flavor and sensory effects reduce
the harshness of smoking among new users and facilitate experimentation
and progression to regular smoking of menthol products, particularly
among youth and young adults (Refs. 29 and 74-76). A subsequent
analysis using Waves 1-4 (2013-2017) of PATH Study data assessed the
relationship between new use of a menthol/mint-flavored or other
flavored (e.g., fruit, alcohol,

chocolate, candy, and other flavor) cigar at Wave 2 or 3 with cigar use
at a subsequent wave (Wave 3 or 4) compared to first use of a non-
flavored cigar (Ref. 29). The analysis found that among youth (aged 12-
17 years) and young adults (aged 18-24 years), first use of any
menthol/mint-flavored or other flavored cigar (e.g., fruit, alcohol,
chocolate, candy, and other flavor) was associated with greater odds of
past 30-day use of these products at the subsequent wave compared with
first use of a non-flavored (i.e., tobacco) cigar, even after
controlling for sociodemographic variables (Ref. 29). Youth who first
used a menthol/mint-flavored cigar or other flavored cigar were 72
percent (menthol/mint) and 47 percent (other flavor) more likely to be
past-30-day cigar users at a subsequent wave (1 or more years later)
compared to those first using a non-flavored cigar. Similarly, young
adults (aged 18-24 years) who first used a menthol/mint-flavored cigar
or other flavored cigar were 71 percent and 52 percent more likely to
be past-30-day cigar users at a subsequent wave compared to those first
using a non-flavored cigar (Ref. 29). For both youth and young adults,
the association between the first flavor used and subsequent cigar use
was not statistically significantly different for menthol/mint-flavored
compared to other flavored cigars. Among adults (25 years and older),
first use of an ``other'' flavored cigar (e.g., fruit, alcohol,
chocolate, candy, and other flavor) was also associated with higher
likelihood of subsequent past 30-day cigar use (Ref. 29). Overall, this
study extends findings from the Wave 1 (2013-2014) to Wave 2 (2014-
2015) PATH Study analysis (Ref. 28) finding that among youth and young
adults newly using cigars, first use of any menthol/mint-flavored cigar
or other flavored cigar is associated with greater continued use of
these products at the subsequent wave compared with first use of non-
flavored cigars (Ref. 29).
    Several studies examining nicotine dependence found that smoking
cigars fosters addiction by reducing cravings and the urge to smoke to
a similar magnitude as cigarettes (Refs. 101-103). Cigars, like
cigarettes, have also been shown to decrease acute nicotine withdrawal
symptoms (e.g., craving, anxiousness) (Ref. 104). Available scientific
data on nicotine's addictiveness demonstrate that the adolescent brain
is more vulnerable to developing nicotine dependence than the adult
brain (Ref. 17). Exposure to substances such as nicotine can disrupt
brain development and may lead to long-term consequences for cognitive
function (Refs. 105 and 106). Exposure to nicotine from cigarette
smoking in adolescence is associated with changes in the brain that
could increase the likelihood for addiction and dependence as adults
(Ref. 34). Furthermore, nicotine exposure in adolescence may have
lasting effects; it has been associated with decreased attention,
increased impulsivity, and various lasting mental health conditions in
adult smokers (Ref. 34). While research is not yet able to fully
disentangle whether the association of nicotine with changes in
attention and impulsivity are primarily a result of nicotine exposure
or partially due to pre-existing vulnerability to changes in attention
and impulsivity (Ref. 34), considerable research shows that exposure to
nicotine in adolescence causes long-term changes in the brain, with
implications for nicotine dependence, attention, and impulsivity, as
well as other areas of cognitive function and substance use (Refs. 17
and 34). Researchers analyzing data from the 2017-2018 NYTS found that
43.1 percent of middle and high school students using cigars in the
past 30 days reported nicotine dependence, including feeling a strong
craving to use a tobacco product or using a tobacco product within 30
minutes of waking (Ref. 107). An analysis of Waves 1-4 (2013-2017) PATH
data did not find a longitudinal association between first use of a
menthol- or mint-flavored cigar and nicotine dependence scores (Ref.
29). Similarly, a cross-sectional analysis of 2017-2018 NYTS data found
that exclusive use of cigars was associated with lower odds of
reporting dependence compared to exclusive use of another product (Ref.
107). However, frequent cigar use (use on 20 or more days in the past
30 days) as well as current cigar use including both exclusive and
polyuse of cigars was associated with increased odds of youth reporting
nicotine dependence (Ref. 107). In this analysis, use of cigars in
combination with other tobacco products was common: 76.1 percent of
youth past 30-day cigar users used cigars in combination with one or
two additional tobacco products (Ref. 107). Given the role of frequent
use and polyuse in the relationship between cigar use among youth and
dependence, the authors noted ``the importance of examining behaviors
related to use, as they can affect and/or exacerbate the risk of
nicotine dependence'' (Ref. 107).
    Given that nicotine is highly addictive and present in all cigars,
as youth experimenters continue to use these products, there is a risk
of nicotine dependence and progression to regular use, resulting in an
increased risk of developing the many negative health consequences
associated with regular cigar use. Based on the totality of the
evidence, prohibiting characterizing flavors (other than tobacco) in
cigars would reduce the appeal and ease of use of such products and is
an important step toward reducing the likelihood of nicotine
dependence, experimentation, and progression to regular use.

F. Real-World Experiences Demonstrate That Restricting Characterizing
Flavors in Tobacco Products, Including Cigars, Decreases Tobacco Use

    As previously discussed in section IV.A of this document, Congress
passed the Tobacco Control Act in 2009 to address the premature death,
disease, and other serious health conditions caused by tobacco use. To
address the appeal and use of flavored combusted tobacco products among
the Nation's youth, in 2009, the Tobacco Control Act prohibited
cigarettes with characterizing flavors other than tobacco or menthol.
Researchers analyzed repeated cross-sectional data from the NYTS and
concluded that the ban was associated with a 17 percent reduction in
the probability of being a cigarette smoker and a 6 percent reduction
in the probability of any tobacco use (i.e., cigarette, cigars,
smokeless tobacco, or pipe tobacco) in the past 30 days among U.S.
middle and high school students (Ref. 50). While cigarette smoking
decreased among the Nation's youth following implementation of the
Tobacco Control Act, researchers noted that youth use of cigars and
pipe tobacco, which remained available in flavored varieties, rose
after implementation of the ban on characterizing flavors in cigarettes
(Ref. 50).
    While the prior analysis (Ref. 50) was limited in its ability to
attribute changes in tobacco use, particularly flavored use, directly
to the Federal restriction (as the NYTS was not designed to evaluate
such a policy), recent evaluation studies implementing pre-post study
designs with geographic comparisons provide real-world examples of how
tobacco product use changes as a result of a sales restriction on
characterizing flavors in tobacco products, including cigars. Such
recent evaluations of restrictions on the sale of tobacco products with
characterizing flavors in U.S. localities include studies of New York,
NY (NYC); Providence, RI; Lowell, MA; Attleboro and Salem, MA; San
Francisco, CA; Minneapolis and St. Paul, MN (Twin Cities); as well as
Canada (See table 1, below,

summarizing the evaluation studies). Taken in totality, the real-world
experience of state and local jurisdictions implementing sales
restrictions on flavored tobacco products provide insight into the
likely responses of youth and young adults as well as current cigar
smokers to a proposed product standard restricting characterizing
flavors (other than tobacco) in cigar products, including decreases in
youth cigar use and cigar consumption among current cigar smokers.

                                 Table 1--Summary of Evaluation Studies on Sales Restrictions Including Flavored Cigars
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                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.

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

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