Proposed Rule2022-08993
Tobacco Product Standard for Characterizing Flavors in Cigars
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 4, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 86 (Wednesday, May 4, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 86 (Wednesday, May 4, 2022)]
[Proposed Rules]
[Pages 26396-26451]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08993]
[[Page 26395]]
Vol. 87
Wednesday,
No. 86
May 4, 2022
Part II
Department of Health and Human Services
-----------------------------------------------------------------------
Food and Drug Administration
-----------------------------------------------------------------------
21 CFR Part 1166
Tobacco Product Standard for Characterizing Flavors in Cigars; Proposed
Rule
Federal Register / Vol. 87 , No. 86 / Wednesday, May 4, 2022 /
Proposed Rules
[[Page 26396]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1166
[Docket No. FDA-2021-N-1309]
RIN 0910-AI28
Tobacco Product Standard for Characterizing Flavors in Cigars
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is proposing
a tobacco product standard that would prohibit characterizing flavors
(other than tobacco) in all cigars and their components and parts.
Characterizing flavors in cigars, such as strawberry, grape, cocoa, and
fruit punch, increase appeal and make the cigars easier to use,
particularly among youth and young adults. Over a half million youth in
the United States use flavored cigars. This proposed product standard
would reduce the appeal of cigars, particularly to youth and young
adults, and thereby decrease the likelihood of experimentation,
development of nicotine dependence, and progression to regular use. FDA
is taking this action to reduce the tobacco-related death and disease
associated with cigar use. The proposed standard also is expected to
reduce tobacco-related health disparities and advance health equity.
DATES: Submit either electronic or written comments on the proposed
rule by July 5, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 5, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2021-N-1309 for ``Tobacco Product Standard for Characterizing
Flavors in Cigars.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Courtney Smith or Nathan Mease, Center
for Tobacco Products, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993-0002, 877-287-1373,
<a href="/cdn-cgi/l/email-protection#5b180f0b093e3c2e373a2f323435281b3d3f3a75333328753c342d"><span class="__cf_email__" data-cfemail="26657276744341534a47524f49485566404247084e4e5508414950">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Proposed Rule
B. Summary of the Major Provisions of the Proposed Rule
C. Legal Authority
D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms
III. Background
A. Need for the Regulation
B. Relevant Regulatory History
C. Legal Authority
D. FDA's Consideration of Health Equity
IV. Characterizing Flavors Impact Cigar Use, Particularly Among
Youth and Young Adults
A. Recent Market Trends of Flavored Cigars in the United States
B. Over Half a Million Youth, and Even More Young Adults, in the
United States Use Flavored Cigars
C. Adult Use of Flavored Cigars in the United States
D. Characterizing Flavors Increase Appeal and Make Tobacco
Products, Including Cigars, Easier To Use
E. Characterizing Flavors Increase Youth and Young Adult
Experimentation With Tobacco Products, Including Cigars, and Make
Progression to Regular Tobacco Use More Likely
F. Real-World Experiences Demonstrate That Restricting
Characterizing Flavors
[[Page 26397]]
in Tobacco Products, Including Cigars, Decreases Tobacco Use
G. Flavored Cigars Are Marketed Disproportionately in
Underserved Communities and to Vulnerable Populations
V. Cigar Use Is Common, Addictive, and Harmful
A. Prevalence of Cigar Use Among Youth, Young Adults, and Older
Adults in the United States
B. Flavored Cigar Use Exposes Users to Additional Toxicants
C. Cigar Use Is Addictive
D. Research Clearly Demonstrates a Causal Relationship Between
Cigar Smoking and Death and Disease
E. Secondhand Tobacco Smoke, Including Cigar Smoke, Increases
the Risks of Lung Cancer, Heart Disease, and Other Adverse Health
Effects in Nonsmokers
F. Disparities in Tobacco Use, Including Cigar Use, Lead to
Disparities in Tobacco-Related Morbidity and Mortality
VI. Determination That the Standard Is Appropriate for the
Protection of the Public Health
A. The Likelihood That Nonusers Would Start Using Cigars
B. The Likelihood That Existing Users Would Reduce Cigar
Consumption or Stop Cigar Smoking
C. Benefits and Risks to the Population as a Whole
D. Conclusion
VII. Additional Considerations and Requests for Comments
A. Section 907 of the FD&C Act
B. Pathways to Market
C. Considerations and Request for Comments on Scope of Products
D. Request for Comments on the Potential Racial and Social
Justice Implications of the Proposed Product Standard
VIII. Description of the Proposed Rule
A. Scope (Proposed Sec. 1166.1)
B. Definitions (Proposed Sec. 1166.3)
C. Prohibition on Use of Characterizing Flavors in Cigars
(Proposed Sec. 1166.5)
IX. Proposed Effective Date
X. Preliminary Economic Analysis of Impacts
A. Introduction
B. Summary of Costs and Benefits
XI. Analysis of Environmental Impact
XII. Paperwork Reduction Act of 1995
XIII. Federalism
XIV. Consultation and Coordination With Indian Tribal Governments
XV. References
I. Executive Summary
A. Purpose of the Proposed Rule
FDA is proposing a tobacco product standard that would prohibit
characterizing flavors (other than tobacco) in cigars manufactured or
sold in the United States. In developing this proposed rule, FDA
carefully considered the scientific evidence and complex policy issues
related to characterizing flavors in cigars.
Each year, an estimated 9,000 premature deaths are attributed to
regular cigar smoking, defined as smoking cigars on 15 or more of the
past 30 days; approximately 5,200 of these premature deaths occur in
regular cigar smokers who did not also smoke cigarettes. In 2019, not
excluding use of other tobacco products, more young adults tried a
cigar for the first time each day than tried a cigarette for the first
time (3,163 cigar vs. 2,640 cigarette initiates per day). According to
the 2020 National Youth Tobacco Survey (NYTS), an estimated 3.5 percent
(960,000) of middle and high school students, including 5 percent
(770,000) of high school students (grades 9-12) and 1.5 percent
(180,000) of middle school students (grades 6-8), had smoked a cigar
(cigar, cigarillo, or little cigar) in the preceding 30 days. Of
particular concern is the number of youth smoking cigars with
characterizing flavors. More than half (58.3 percent) of youth cigar
smokers, or approximately 550,000 youth, reported using a flavored
cigar during the past 30 days.
Researchers have found that characterizing flavors in cigars and
other tobacco products play a key role in how users and nonusers,
particularly youth, initiate, progress, and continue using tobacco
products. Characterizing flavors in tobacco products increase the
appeal of those tobacco products to youth and promote youth initiation,
resulting in an increased likelihood that youth and young adults
experimenting with flavored cigars will progress to regular cigar
smoking. This proposed product standard is expected to reduce the
appeal of cigars, particularly to youth and young adults, and thereby
decrease the likelihood of experimentation, development of nicotine
dependence, progression to regular use, and the resulting tobacco-
related disease and death. The proposed standard also is anticipated to
improve public health by increasing the likelihood of cessation among
existing cigar smokers. And it will improve health outcomes within
groups that experience disproportionate levels of tobacco use,
including certain vulnerable populations, thus advancing health equity.
For the reasons discussed in the preamble of this proposed rule, FDA
finds that the proposed tobacco product standard would be appropriate
for the protection of the public health.
B. Summary of the Major Provisions of the Proposed Rule
The proposed rule would prohibit characterizing flavors (other than
tobacco) in cigars and cigar components and parts. Under the proposed
rule, no person may manufacture, distribute, sell, or offer for
distribution or sale, within the United States a cigar or any of its
components or parts that is not in compliance with the product
standard. We also are proposing an effective date of 1 year after the
date of publication of the final rule. We seek comment on all parts of
this proposed rule.
Characterizing Flavor Prohibition--This proposed rule would
prohibit the use of characterizing flavors in all cigars. FDA proposes
to define ``cigar'' as a tobacco product that: (1) Is not a cigarette
and (2) is a roll of tobacco wrapped in leaf tobacco or any substance
containing tobacco. This rule would provide that a cigar or any of its
components or parts (including the tobacco, filter, or wrapper, as
applicable) must not contain, as a constituent (including a smoke
constituent) or additive, an artificial or natural flavor (other than
tobacco) or an herb or spice, including, but not limited to,
strawberry, grape, orange, clove, cinnamon, pineapple, vanilla,
coconut, licorice, cocoa, chocolate, cherry, coffee, mint, or menthol,
that is a characterizing flavor of the tobacco product or tobacco
smoke. Among the factors that FDA believes are relevant in determining
whether a cigar has a characterizing flavor are:
<bullet> The presence and amount of artificial or natural flavor
additives, compounds, constituents, or ingredients, or any other
flavoring ingredient in a tobacco product, including its components or
parts;
<bullet> The multisensory experience (i.e., taste, aroma, and
cooling or burning sensations in the mouth and throat) of a flavor
during use of a tobacco product, including its components or parts;
<bullet> Flavor representations (including descriptors), either
explicit or implicit, in or on the labeling (including packaging) or
advertising of a tobacco product; and
<bullet> Any other means that impart flavor or represent that a
tobacco product has a characterizing flavor.
However, cigars with tobacco as their characterizing flavor would
not be subject to this proposed product standard's prohibition. For
those who experiment with cigars, especially youth and young adults,
tobacco-flavored \1\ cigars do not currently appear as attractive as
cigars with other characterizing flavors. FDA is committed to
monitoring the use of cigars with tobacco as their
[[Page 26398]]
characterizing flavor through surveillance of national representative
data sources and other data to determine whether to take additional
action in the future consistent with FDA's authority.
---------------------------------------------------------------------------
\1\ Throughout this document, FDA uses the terms ``tobacco-
flavored,'' ``non-flavored,'' and ``unflavored.'' FDA relies on the
specific term used by researchers when citing to individual studies;
however, FDA generally considers a cigar that does not have a
characterizing flavor other than tobacco to be ``tobacco-flavored.''
---------------------------------------------------------------------------
Proposed Effective Date--FDA is proposing that any final rule that
may issue based on this proposed rule become effective 1 year after the
date of publication of the final rule. Therefore, after the effective
date, no person may manufacture, distribute, sell, or offer for
distribution or sale within the United States a cigar or any of its
components or parts that is not in compliance with part 1166 (21 CFR
part 1166). This regulation does not include a prohibition on
individual consumer possession or use, and FDA cannot and will not
enforce against individual consumers for possession or use of flavored
cigars. FDA's enforcement will only address manufacturers,
distributors, wholesalers, importers, and retailers. State and local
law enforcement agencies do not independently enforce the Federal Food,
Drug, and Cosmetic Act (FD&C Act). These entities do not and cannot
take enforcement actions against any violation of chapter IX of the Act
or this regulation on FDA's behalf. We recognize concerns about how
State and local law enforcement agencies enforce their own laws in a
manner that may impact equity and community safety and seek comment on
how FDA can best make clear the respective roles of FDA and State and
local law enforcement.
C. Legal Authority
This proposed rule is being issued upon FDA's authority to
establish a tobacco product standard under section 907 of the FD&C Act
(21 U.S.C. 387g), including its authority thereunder to require the
reduction or elimination of a constituent (including a smoke
constituent), or harmful component of tobacco products, and respecting
the construction, components, ingredients, additives, constituents
(including smoke constituents), and properties of the tobacco product
(section 907(a)(3), (a)(4)(A)(ii), and (a)(4)(B)(i) of the FD&C Act);
FDA's authorities related to the sale and distribution of tobacco
products under sections 907(a)(4)(B)(v) and 906(d) (21 U.S.C. 387f);
FDA's authorities related to adulterated and misbranded tobacco
products under sections 902 and 903 (21 U.S.C. 387b and 387c); FDA's
authorities related to prohibited acts and penalties under sections 301
and 303 (21 U.S.C. 331 and 333); and FDA's rulemaking authority under
section 701 of the FD&C Act (21 U.S.C. 371).
D. Costs and Benefits
The quantified benefits of this proposed rule, if finalized, come
from reduced smoking-attributable mortality that are the result of
cigar use among adult cigar smokers and reduced mortality from
secondhand smoke among non-users. The costs of this proposed rule are
those to firms to comply with the rule, to consumers impacted by the
rule, and to the Government to enforce this product standard. In
addition to benefits and costs, this rule will cause transfers from
State governments, the Federal Government, and firms to consumers in
the form of reduced revenue and tax revenue.
We estimate that the annualized benefits over a 40-year time
horizon will equal $7,024 million at a 7 percent discount rate, with a
low estimate of $3,962 million and a high estimate of $10,140 million,
and $8,575 million at a 3 percent discount rate, with a low estimate of
$4,837 million and a high estimate of $12,378 million.
Over a 40-year time horizon, we estimate that the annualized costs
will equal $112 million at a 7 percent discount rate, with a low
estimate of $9 million and a high estimate of $216 million, and $102
million at a 3 percent discount rate, with a low estimate of $5 million
and a high estimate of $200 million.
II. Table of Abbreviations/Commonly Used Acronyms
------------------------------------------------------------------------
Abbreviation/acronym What it means
------------------------------------------------------------------------
AI/ANs............................ American Indians or Alaskan Natives.
ANPRM............................. Advance notice of proposed
rulemaking.
CDC............................... Centers for Disease Control and
Prevention.
CFR............................... Code of Federal Regulations.
CO................................ Carbon monoxide.
COPD.............................. Chronic obstructive pulmonary
disease.
CPS I............................. Cancer Prevention Study I.
CPS II............................ Cancer Prevention Study II.
ENDS.............................. Electronic Nicotine Delivery
Systems.
E.O............................... Executive order.
FD&C Act.......................... Federal Food, Drug, and Cosmetic
Act.
FDA............................... Food and Drug Administration.
FR................................ Federal Register.
HHS............................... U.S. Department of Health and Human
Services.
IARC.............................. International Agency for Research on
Cancer.
IOM............................... Institute of Medicine.
LCCs.............................. Little cigars and cigarillos.
LGBTQ+............................ Lesbian, Gay, Bisexual, Transgender,
or Queer.
MI................................ Myocardial Infarction.
MSS............................... Minnesota Student Survey.
MYTS.............................. Minnesota Youth Tobacco Survey.
NATS.............................. National Adult Tobacco Survey.
NCI............................... National Cancer Institute.
NHANES............................ National Health and Nutrition
Examination Survey.
NHIS.............................. National Health Interview Survey.
NHIS-LMF.......................... National Health Interview Survey-
Linked Mortality Files.
NRC............................... National Research Council.
NSDUH............................. National Survey on Drug Use and
Health.
NYC............................... New York City.
NYTS.............................. National Youth Tobacco Survey.
OMB............................... Office of Management and Budget.
PAH............................... Polycyclic aromatic hydrocarbon.
PATH.............................. Population Assessment of Tobacco and
Health.
[[Page 26399]]
RYO............................... Roll-your-own.
SE................................ Substantial equivalence.
TPSAC............................. Tobacco Products Scientific Advisory
Committee.
TUS-CPS........................... Tobacco Use Supplement to the
Current Population Survey.
WHO............................... World Health Organization.
YPLL.............................. Years of potential life lost.
YRBS.............................. Youth Risk Behavior Survey.
------------------------------------------------------------------------
III. Background
A. Need for the Regulation
FDA is proposing to prohibit characterizing flavors \2\ (other than
tobacco) in cigars. Specifically, FDA is proposing a product standard
that would prohibit a cigar or any of its components or parts
(including the tobacco, filter, or wrapper, as applicable) from
containing, as a constituent (including a smoke constituent) or
additive, an artificial or natural flavor (other than tobacco) or an
herb or spice, including, but not limited to, strawberry, grape,
orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa,
chocolate, cherry, coffee, mint, or menthol that is a characterizing
flavor of the tobacco product or tobacco smoke.
---------------------------------------------------------------------------
\2\ For the purposes of this proposed rule, we are using the
terms ``flavoring'' in a tobacco product, a tobacco product with
``flavors,'' or a ``flavored tobacco product'' to refer to a tobacco
product with characterizing flavors, which is the subject of this
proposed rule.
---------------------------------------------------------------------------
Use of cigars \3\ overall has increased in recent years. Since
2000, sales of cigars have doubled from approximately 6.2 billion
cigars in 2000 to more than 14 billion cigars in 2019 (Refs. 1 and 2).
Each year, an estimated 9,000 premature deaths are attributed to
regular cigar smoking (defined in the study as smoking cigars on 15 or
more of the past 30 days); approximately 5,200 of these premature
deaths occur in regular cigar smokers who do not also smoke cigarettes
(Ref. 3). It is estimated that cigar-attributable annual healthcare
expenditures amount to $1.8 billion per year (Ref. 4). Analysis of
2014-2015 data from the Tobacco Use Supplement to the Current
Population Survey (TUS-CPS) found that adult flavored-cigar smokers had
greater odds of daily cigar smoking and smoking within 30 minutes of
waking than non-flavored cigar smokers, after adjusting for age, sex,
race/ethnicity, and multiple tobacco product use (Ref. 5).
---------------------------------------------------------------------------
\3\ Throughout this document, FDA uses the terms
``traditional,'' ``conventional,'' ``regular,'' ``large,''
``little,'' ``filtered,'' and ``cigarillo'' when discussing
different types of cigars. FDA relies on the specific term used by
researchers when citing a specific study. FDA uses the term
``cigar'' when not citing a specific study.
---------------------------------------------------------------------------
As discussed in section IV.B of this document, youth consumption of
cigars is substantial, and nicotine dependence in cigar smokers could
result from even a limited exposure to nicotine during adolescence
(Ref. 6). According to the 2020 NYTS, an estimated 960,000 middle and
high school students, including 5 percent (an estimated 770,000) of
high school students (grades 9-12) and 1.5 percent (an estimated
180,000) of middle school students (grades 6-8), had smoked a cigar
(cigar, cigarillo, or little cigar) on at least 1 day during the past
30 days (Ref. 7). Overall, the prevalence of cigar smoking among middle
and high school students is comparable to the prevalence of cigarette
smoking, with 4.6 percent (an estimated 710,000) of high school
students and 1.6 percent (an estimated 190,000) of middle school
students having smoked cigarettes on at least 1 day during the past 30
days (Ref. 7). For non-Hispanic Black \4\ students, cigar smoking
prevalence (6.5 percent) is considerably greater than cigarette smoking
(2.5 percent) (Ref. 7). Of particular concern is the number of youth
smoking cigars with characterizing flavors. According to 2020 NYTS data
analyzing flavored cigar use among youth, 58.3 percent of youth cigar
smokers, or approximately 550,000 youth, reported using a flavored
cigar during the past 30 days (Ref. 8).
---------------------------------------------------------------------------
\4\ Throughout this document, FDA uses both the terms ``Black''
and ``African American.'' The term ``African American'' is used to
describe or refer to a person of African ancestral origins or who
identifies as African American. ``Black'' is used to broadly
describe or refer to a person who identifies with that term. Though
both of these terms may overlap, they are distinct concepts (e.g., a
Black person may not identify as African American). As a result, FDA
relies on the specific term used by researchers when citing to
specific studies. FDA uses the term ``Black'' when not citing to a
specific study.
---------------------------------------------------------------------------
Characterizing flavors in cigars and other tobacco products reduce
the harshness, bitterness, and astringency of tobacco during inhalation
and soothe irritation during use (Refs. 9-11). Characterizing flavors
thus increase the youth \5\ appeal of those tobacco products and
promote youth initiation, resulting in an increased likelihood that
youth and young adults experimenting with flavored cigars will become
addicted and progress to regular smoking (see sections IV.D and IV.E of
this document). Recent evidence from an analysis of data from Wave 5 of
the Population Assessment of Tobacco and Health (PATH) Study \6\ (2018-
19) demonstrates that over half of youth (aged 12-17 years) who used
cigars in the past 30 days identified flavors as a reason for use (Ref.
12). In addition, research has shown that characterizing flavors in
tobacco products can trigger reward pathways in the brain that are
responsible for reward-related learning, which may increase the
attractiveness of flavored products to consumers and the probability of
repeated use (Refs. 13-15).
---------------------------------------------------------------------------
\5\ Though age ranges for youth and young adults vary across
studies, in general, ``youth'' or ``adolescent'' encompasses those
11-17 years of age, while those who are 18-25 years old are
considered ``young adults'' (even though, developmentally, the
period between 18-20 years of age is often labeled late
adolescence); those 26 years of age or older are considered
``adults'' or ``older adults'' (Ref. 17).
\6\ The PATH Study is a collaboration between the Center for
Tobacco Products, FDA and the National Institute on Drug Abuse,
National Institutes of Health. It was launched in 2011 to inform
FDA's regulatory activities under the Tobacco Control Act. The PATH
Study is an ongoing longitudinal cohort study on tobacco use
behavior, attitudes and beliefs, and tobacco-related health
outcomes. More information can be found at: <a href="https://www.icpsr.umich.edu/web/NAHDAP/series/606">https://www.icpsr.umich.edu/web/NAHDAP/series/606</a>.
---------------------------------------------------------------------------
FDA's experience with manufacturers' historical practices as well
as the prohibition of characterizing flavors, other than menthol, in
cigarettes (section 907(a)(1)(A) of the FD&C Act; 21 U.S.C.
387g(a)(1)(A)) is instructive for purposes of evaluating cigars'
characterizing flavors and this proposed product standard. Reflective
of the appeal that flavored tobacco products have for youth and young
adults, internal tobacco industry documents attest to cigar
manufacturers' historical practices of adding characterizing flavors to
diminish the harshness of tobacco products' taste with specific intent
to appeal to young consumers (Refs. 16 and 17). Tobacco industry
practices reflect the fact that non-tobacco flavors appear to enhance
youth appeal (Refs. 9-11). Researchers have concluded that tobacco
companies have engaged in a ``calculated effort to blur the line
between LCCs [little cigars and
[[Page 26400]]
cigarillos] to increase appeal to cigarette smokers, and the use of
flavours facilitated these efforts'' (Ref. 16).
The Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act; Pub. L. 111-31) prohibited, among other things, cigarettes
with characterizing flavors other than tobacco or menthol. In 2009,
when the Act was passed, national cross-sectional data suggested that
the use of flavored cigarettes was most prevalent among younger smokers
(Ref. 18), which caused concern that the availability of flavored
cigarettes was contributing to youth tobacco use (Ref. 19). Additional
evidence available at that time showed that younger tobacco users and
nonusers had greater positive expectancies (e.g., beliefs that smoking
will enhance positive affect and control weight) for flavored
cigarettes compared to non-flavored cigarettes (Ref. 20), a finding
that was consistent with evidence from internal industry documents
showing that tobacco product manufacturers targeted flavored cigarettes
toward young populations (Refs. 9, 10, and 21). Moreover, the Surgeon
General has concluded that most smokers try, and become addicted to,
cigarettes before adulthood (Ref. 17) and that smoking causes severe
disease, disability, and death (Refs. 22 and 23).
As with cigarettes, first cigar use often occurs during youth or
young adulthood (Refs. 24 and 25). In a cross-sectional analysis of
data collected between 2011 and 2017 as part of a longitudinal study,
among almost 10,000 young adult college students who had ever used
cigars, the mean age of first cigar use was 13.6 years (Ref. 24). A
longitudinal analysis of Waves 1-4 (2013-2017) of PATH Study data found
the proportion of youth who initiate cigar use increases considerably
between ages 15 and 20 years (Ref. 25). Whereas only 1.5 percent of 15-
year-olds in the PATH Study (2013-2017) had ever used any cigar (i.e.,
cigarillo, filtered cigar, or traditional cigar), by age 20, 31 percent
had ever used any cigar, with the greatest increase in first use
between 17 and 18 years of age (Ref. 25). Similarly, an analysis of
harmonized data from five large national surveys found a consistent
peak in cigar initiation among individuals aged 17-19 years (Ref. 26).
The consistency of this age of initiation across all five studies
increases the confidence in this finding and suggests cigar initiation
extends into young adulthood (Ref. 26). A longitudinal study of Waves
1-3 (2013-2016) of PATH Study data found that 9.0 percent of youth
(aged 12-17 years) and 12.0 percent of young adults (aged 18-24 years)
started using cigars for the first time between Wave 1 (2013-2014) and
Wave 3 (2015-2016) (Ref. 27). In comparison, 3.3 percent of adults over
25 years old initiated cigar use in the same time period (Ref. 27).
Study findings also indicate racial and ethnic disparities in cigar
product use. Non-Hispanic Black youth were 47 percent more likely to
initiate past 30-day cigarillo or filtered cigar use at earlier ages
compared to non-Hispanic White youth (Ref. 25).
We also know that a majority of youth and young adults initiate
with a flavored cigar compared to older adults based on data from Wave
5 (2018-2019) of the PATH Study (Ref. 12) and that first use of
flavored cigars is associated with continued use of these products
(Refs. 28 and 29). In a longitudinal analysis of Waves 1-4 (2013-2017)
PATH Study data, youth whose first cigar was either a mint or menthol
cigar or an ``other'' flavored cigar (e.g., fruit, alcohol, chocolate,
candy, and other flavor) were more likely to be a past-30-day cigar
user at a subsequent wave (approximately 1 year later) compared to
those who first used a non-flavored cigar. Similarly, young adults
(aged 18-24 years) who first used a mint or menthol cigar or other
flavored cigar were more likely to be a past-30-day cigar user at a
subsequent wave compared to those first using a non-flavored cigar
(Ref. 29).
Similar to cigarettes with characterizing flavors, cigars with
characterizing flavors expose users to the highly addictive chemical
nicotine and other toxic and carcinogenic chemicals found in combusted
tobacco products. Little cigars, in particular, deliver similar (and
sometimes higher) levels of nicotine, as well as similar (and sometimes
higher) levels of carcinogens, compared to cigarettes (Refs. 30 and
31). People who smoke cigars regularly are at increased risk for many
of the same diseases as cigarette smokers, including oral, esophageal,
laryngeal, and lung cancer; cardiovascular diseases; and chronic
obstructive pulmonary disease (COPD) (Ref. 32).
In particular, youth and young adult exposure to the nicotine in
cigars can result in negative health effects. Exposure to nicotine can
disrupt brain development, which continues through approximately age
25, and may lead to long-term adverse consequences for cognitive
function into adulthood (Ref. 33). Nicotine exposure in adolescence may
have lasting implications and can result in decreased attention,
increased impulsivity, and various lasting mental health conditions
(Ref. 34). Nicotine is highly addictive. Using nicotine in adolescence
may increase risk for future addiction to other drugs (Ref. 33).
FDA finds that this product standard is appropriate for the
protection of the public health because it would reduce the appeal of
cigars, particularly to youth and young adults, by eliminating
flavorings that increase appeal, reduce the harshness and bitterness of
cigars, and make them easier to smoke, thereby decreasing the
likelihood that both nonusers would experiment with cigars and that
current experimenters would continue to use cigars, as further
discussed in sections IV.D and IV.E of this document. Furthermore, FDA
finds that this product standard would decrease the likelihood that
both nonusers and current experimenters would be exposed to the toxic
and carcinogenic chemicals in cigars, develop nicotine dependence, and
progress to regular tobacco use, as further discussed in sections IV.E
and V.B of this document. Additionally, as discussed in section VI.B of
this document, the proposed product standard could improve the health
of current flavored cigar smokers by increasing their likelihood of
smoking cessation or reduction. The population health benefits of the
proposed product standard are discussed in detail in section VI of this
document. Thus, based on the information discussed in the following
sections of this document, FDA finds that the proposed tobacco product
standard would be appropriate for the protection of the public health.
Reducing the appeal and use of cigars by eliminating characterizing
flavors (other than tobacco) also is expected to substantially decrease
tobacco-related health disparities and to equitably promote health
across population groups. Tobacco-related health disparities are the
differences observed in population groups regarding: the patterns
(e.g., initiation, dual or polyuse, cessation), prevention, and
treatment of tobacco use; the risk, incidence, morbidity, mortality,
and burden of tobacco-related illness; and capacity and infrastructure
(e.g., political systems, educational institutions), access to
resources (e.g., access to health services and programs), and
environmental secondhand smoke exposure (Refs. 35-37). Tobacco-related
health disparities affect those who have systematically experienced
greater obstacles to health based on group membership due in part to
the inequitable distribution of social, political, economic, and
environmental resources (Refs. 37-39). Health equity is the attainment
of the highest level of health for all people (Ref. 39). It is achieved
by equally valuing all
[[Page 26401]]
individuals regardless of group membership; removing social, economic,
and institutional obstacles to health; and addressing historical and
contemporary injustices (Refs. 39-41). The advancement of health equity
is integral to the reduction and elimination of tobacco-related health
disparities, which affect those who have been denied opportunity and
access to economic, political, and social participation. Members of
underserved communities \7\ experience a disproportionate burden of
cigar use in initiation, prevalence of use, current use, and frequency
of use (see section V.A of this document), leading to observed tobacco-
related health disparities within those communities. Such disparities
in cigar use contribute to higher rates of observed tobacco-related
morbidity and mortality among underserved communities and vulnerable
populations,<SUP>8 9</SUP> such as youth and young adults, some racial
and ethnic populations, those with lower household income and
educational attainment, and individuals who identify as lesbian, gay,
bisexual, transgender, or queer (LGBTQ+),\10\ as further discussed in
section V.F of this document. This proposed product standard is
anticipated to promote better public health outcomes across population
groups.
---------------------------------------------------------------------------
\7\ As defined by Executive Order (E.O.) 13895, ``Advancing
Racial Equity and Support for Underserved Communities Through the
Federal Government,'' (86 FR 7009, January 25, 2021) the term
``underserved communities'' refers to populations sharing a
particular characteristic, as well as geographic communities, that
have been systematically denied a full opportunity to participate in
aspects of economic, social, and civic life. In the context of
tobacco products and tobacco-related health disparities, such
communities may include populations disproportionately impacted by
marketing and promotion targeted on the basis of such shared
characteristics.
\8\ Throughout this document, the term ``vulnerable
populations'' refers to groups that are susceptible to tobacco
product risk and harm due to disproportionate rates of tobacco
product initiation, use, burden of tobacco-related diseases, or
decreased cessation. Examples of vulnerable populations include
those with lower household income and educational attainment,
certain racial or ethnic populations, individuals who identify as
LGBTQ+, underserved rural populations, those pregnant or trying to
become pregnant, those in the military or veterans, or those with
behavioral health conditions.
\9\ Underserved communities are overrepresented in vulnerable
populations.
\10\ Throughout this document, FDA uses the term ``LGBTQ+''
broadly when referring to lesbian, gay, bisexual, transgender, and
queer (and other) communities. When we describe findings from the
published literature, we refer specifically to the groups that are
studied. For example, some authors examine tobacco-related outcomes
for members who identify as lesbian, gay, bisexual, or transgender
(LGBT) only; as such, the data are limited to those who identify as
LGBT, and authors interpret the findings for those specific groups.
---------------------------------------------------------------------------
B. Relevant Regulatory History
In its implementation of the Tobacco Control Act over the past
several years, FDA has engaged in close study and careful consideration
of the scientific evidence and complex policy issues related to
flavored tobacco products. FDA has issued an advance notice of proposed
rulemaking (ANPRM) to solicit data and information about the roles of
flavors in tobacco products, sponsored research on a variety of cigar-
and flavors-related topics through contracts and interagency agreements
with Federal partners, including the National Institutes of Health
(NIH),\11\ and undertaken its own scientific review related to the
impact of characterizing flavors in cigar products. Among other things,
FDA has considered the comments and information received in response to
the ANPRM and scientific review in developing this proposed rule.
---------------------------------------------------------------------------
\11\ Information on specific projects supported by FDA is
available at <a href="https://www.fda.gov/tobacco-products/tobacco-science-research/research">https://www.fda.gov/tobacco-products/tobacco-science-research/research</a> (search ``cigars'' or ``flavors'').
---------------------------------------------------------------------------
1. ANPRM
In July 2017, FDA announced a comprehensive approach to tobacco and
nicotine regulation to protect youth and reduce tobacco-related disease
and death (Ref. 42). As part of the public dialogue on the
comprehensive approach, in March 2018, FDA issued three ANPRMs related
to the regulation of nicotine in combustible cigarettes (83 FR 11818,
March 16, 2018), flavors (including menthol) in tobacco products (83 FR
12294, March 21, 2018) (Flavors ANPRM), and premium cigars (83 FR
12901, March 26, 2018). In addition, FDA announced the availability of
a draft concept paper, entitled ``Illicit Trade in Tobacco Products
after Implementation of a Food and Drug Administration Product
Standard,'' and sought public comment (83 FR 11754, March 16, 2018).
This paper analyzes the potential for illicit trade markets to develop
in response to a tobacco product standard (Ref. 43).
The Flavors ANPRM requested data and information about the role
that flavors play in tobacco products (83 FR 12294). Specifically, the
Flavors ANPRM requested comments, data, research results, or other
information about, among other things, how flavors attract youth to
initiate tobacco product use. While the Flavors ANPRM discussed
potential product standards and a range of product types, it also
specifically requested public input on the role of flavors in cigars.
FDA received over 525,000 comments on the Flavors ANPRM, a large
proportion of which were form letters related to 61 different organized
campaigns. Five of these campaigns, which included a combined total of
approximately 329,668 comments, were identified as being automatically
generated ``bot'' comments. Some of the issues raised in the comments
to the ANPRM are highlighted below.
Comments generally in support of the regulation of flavors in
tobacco products stated that a product standard prohibiting the use of
flavors in tobacco products would be appropriate for the protection of
the public health. In particular, many comments argued that such a
tobacco product standard would be appropriate for the following
reasons: (1) To protect youth and young adults from becoming tobacco
product users; (2) to prevent widened appeal of tobacco product use;
and (3) to discourage addiction to tobacco products. FDA received many
comments expressing concern about the use of flavors to capture new
users, particularly children, into lifelong nicotine addiction by
making tobacco products more appealing and/or palatable. Citing
internal tobacco industry documents that have since been made public,
many commenters, including several public health advocacy groups, some
professional associations, and multiple State attorneys general,
pointed out that the industry has a long and well-established history
of deliberately targeting children through the development and/or
marketing of flavored tobacco products.
FDA received many comments in support of the regulation of flavors
in cigar products, specifically. These comments often noted that
flavors are frequently added to cigars for the express purpose of
making harsh products more palatable to new users. Citing national
survey data trends and various recent studies, these commenters often
noted that youth and young adults report flavors as a key reason for
their use of cigars, including little cigars and cigarillos (LCCs), and
that a substantial percentage of youth cigar smokers exclusively use
flavored cigars.
FDA also received comments from individuals and representatives
from the tobacco industry generally opposing the regulation of flavored
tobacco products. These comments generally stated that such regulation
was not likely to decrease the appeal of such tobacco products to youth
nor have positive effects for society at large. Some comments opposed
to a tobacco product
[[Page 26402]]
standard addressing flavors in cigars, specifically, stated that FDA
had not presented the scientific basis for such a product standard,
noting what they characterized as gaps in the scientific literature
regarding usage patterns and consumer perceptions of flavored cigars,
particularly among youth. Other comments from tobacco industry
representatives conclude that any tobacco product standard for flavors
in cigars should exclude premium cigars.
Many comments received from industry noted concern with how FDA
would define ``characterizing flavors,'' arguing that any such
definition must use clear and science-based criteria. Some comments
argued that, without a definition for ``characterizing flavors,'' it
could be difficult for industry to comply with a tobacco product
standard. FDA also received comments in support of regulation
suggesting that FDA define ``characterizing flavor'' in a way that
makes the prohibition clear to manufacturers and retailers, protects
public health, and prevents manufacturers from evading the intent of
the product standard.
FDA has reviewed and closely considered the comments to the Flavors
ANPRM, as well as additional evidence and information not available at
the time of the Flavors ANPRM, in developing this proposed rule.
2. Scientific Review
As the body of evidence continues to grow, FDA recently undertook a
review of the scientific evidence regarding the role characterizing
flavors play in increasing the appeal and use of tobacco products,
particularly cigars, among youth, young adults, and adults in the
United States. This review, entitled ``Scientific Assessment of the
Impact of Flavors in Cigar Products,'' summarizes findings from the
peer-reviewed, publicly available scientific literature organized
around three research questions: (1) How does the addition of
characterizing flavors to tobacco products, including cigars, impact
product appeal and product use; (2) how do characterizing flavors
impact youth and young adult experimentation with tobacco products,
including cigars, and do they make progression to regular tobacco use
more likely; and (3) what impact do local and national policies
restricting the sale of flavored cigars and other flavored tobacco
products have on cigar sales and use? The ``Scientific Assessment of
the Impact of Flavors in Cigar Products'' has been peer reviewed by
independent external experts. Taking into consideration comments from
this peer review (Ref. 44), FDA revised the scientific assessment, and
the final peer-reviewed scientific assessment is available in the
docket for this proposed rule (Ref. 45). This scientific assessment
informed the development of this proposed product standard.
C. Legal Authority
1. Product Standard Authority Generally
The Tobacco Control Act was enacted on June 22, 2009, amending the
FD&C Act and providing FDA with the authority to regulate tobacco
products. Section 901 of the FD&C Act (21 U.S.C. 387a) granted FDA the
authority to regulate the manufacture, marketing, and distribution of
cigarettes, cigarette tobacco, roll-your-own tobacco (RYO), and
smokeless tobacco to protect the public health and to reduce tobacco
use by youth. The Tobacco Control Act also gave the Agency authority to
conduct rulemaking to ``deem'' any other tobacco products subject to
chapter IX of the FD&C Act. In 2016, FDA issued a final rule deeming
products meeting the statutory definition of ``tobacco product''
(including cigars), except accessories of the newly deemed products, to
be subject to chapter IX of the FD&C Act, as amended by the Tobacco
Control Act (81 FR 28974) (deeming final rule).
Among the tobacco product authorities provided to FDA is the
authority to adopt tobacco product standards where FDA determines that
such standard is appropriate for the protection of the public health
(section 907(a)(3) of the FD&C Act). To establish a tobacco product
standard, section 907(a)(3)(A) and (B) of the FD&C Act requires that
FDA find that the standard is appropriate for the protection of the
public health, taking into consideration scientific evidence
concerning:
<bullet> The risks and benefits to the population as a whole,
including users and nonusers of tobacco products, of the proposed
standard;
<bullet> The increased or decreased likelihood that existing users
of tobacco products will stop using such products; and
<bullet> The increased or decreased likelihood that those who do
not use tobacco products will start using such products.
2. Authority To Prohibit Characterizing Flavors in Cigars
Section 907 of the FD&C Act authorizes FDA to issue tobacco product
standards that are appropriate for the protection of the public health,
including provisions that would require the reduction or elimination of
a constituent (including a smoke constituent), or harmful component of
tobacco products and provisions respecting the construction,
components, ingredients, additives, constituents (including smoke
constituents), and properties of the tobacco product (section
907(a)(3), (a)(4)(A)(ii), and (a)(4)(B)(i) of the FD&C Act). This
includes the authority to issue a new product standard prohibiting
characterizing flavors in tobacco products pursuant to section
907(a)(3) and (4) and to amend or revoke an existing product standard
pursuant to section 907(d)(4) of the FD&C Act. Section 907(a)(4)(B)(v)
also authorizes FDA to include in a product standard a provision
restricting the sale and distribution of a tobacco product to the
extent that it may be restricted by a regulation under section 906(d)
of the FD&C Act.
Pursuant to section 907(a)(3) and (c) of the FD&C Act, FDA is
proposing this product standard that would require the elimination of
characterizing flavors (other than tobacco) from cigars, because it
would reduce the disease, disability, and death caused by tobacco use,
and FDA has found the standard to be appropriate for the protection of
the public health consistent with section 907(a)(3), (a)(4)(A)(ii), and
(a)(4)(B)(i) of the FD&C Act. In addition, this proposed rule would
prohibit the distribution, sale, and offer for distribution or sale of
cigars with characterizing flavors (other than tobacco). Because this
sale and distribution restriction would assist FDA in enforcing the
standard and would ensure that manufacturers and retailers are selling
product that complies with the standard, the Agency has found such
restriction to be appropriate for the protection of the public health
consistent with sections 907(a)(4)(B)(v) and 906(d) of the FD&C Act.
FDA's analysis showing that the proposed tobacco product standard is
appropriate for the protection of the public health is discussed in
section VI of this document.
FDA is proposing this product standard under the authorities
discussed previously, along with section 701 of the FD&C Act, which
provides FDA with the authority to ``promulgate regulations for the
efficient enforcement of this Act.''
D. FDA's Consideration of Health Equity
Advancing health equity is a policy priority and an important
component of fulfilling FDA's mission to protect and promote public
health. FDA and the Federal Government now recognize the advancement of
health equity as ``both a moral imperative and pragmatic policy,'' as
E.O. 13995 states.
[[Page 26403]]
Considerations related to health equity helped inform FDA's
decision to prioritize this proposed product standard. In particular,
FDA took into account the disproportionate toll flavored cigars have
taken on certain population subgroups. We note that the expected health
benefits of this proposed standard are expected to be greater in these
subgroups than in the population more generally.
This proposed product standard easily clears the threshold of being
appropriate for the protection of the public health, due to the large
health benefits from the expected reduced initiation and increased
cessation when looking at the population generally. We make this
finding even without taking into account the specific expected greater
health benefits from this product standard among certain population
subgroups.
IV. Characterizing Flavors Impact Cigar Use, Particularly Among Youth
and Young Adults
A. Recent Market Trends of Flavored Cigars in the United States
Congress passed the Tobacco Control Act in 2009 to address the
premature death, disease, and other serious health conditions caused by
tobacco use. The Tobacco Control Act gave FDA a mandate to reduce
tobacco product dependence and use, particularly among youth (see
section 3(2) and (9) of the Tobacco Control Act). Of particular
importance for this proposed product standard, the Tobacco Control Act
established a ban on characterizing flavors (other than tobacco or
menthol) in cigarettes (section 907(a)(1)(A) of the FD&C Act). The
legislative history of the Tobacco Control Act reflects that the goal
of the Act's cigarette characterizing flavor ban was to eliminate one
emerging group of tobacco products that was particularly appealing to
youth (Ref. 46 at 37-38). Congress determined that banning cigarettes
with characterizing flavors would benefit youth because flavored
cigarettes were typically used by individuals experimenting with
tobacco products, such as youth, and noted that such products were not
typically used by regular adult smokers (Ref. 46 at 37-38). In 2009,
FDA issued guidance on the statutory provision (see General Questions
and Answers on the Ban of Cigarettes that Contain Certain
Characterizing Flavors (Edition 2), available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-questions-and-answers-ban-cigarettes-contain-certain-characterizing-flavors-edition-2">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-questions-and-answers-ban-cigarettes-contain-certain-characterizing-flavors-edition-2</a>), noting that ``flavored products make it easier for new
smokers to start smoking by masking the unpleasant flavor of tobacco''
and that ``[r]emoving these flavored products from the market is
important because it removes an avenue that young people can use to
begin regular tobacco use.'' Research and data concerning the impact of
Congress's decision to ban flavored cigarettes are instructive for
purposes of evaluating cigars' characterizing flavors and this proposed
product standard.
After the ban on characterizing flavors in cigarettes became
effective, researchers noted that certain products previously marketed
as cigarettes likely were modified or rebranded as ``cigars'' so that
they could remain on the market in flavored varieties (e.g., Ref. 47).
Little cigars are often indistinguishable from cigarettes given their
shape, size, filters, and packaging (Refs. 48 and 49). An analysis of
NYTS data from middle and high school students between 1999 and 2013
found that cigar use rose 34.4 percent following the ban on
characterizing flavors in cigarettes (Ref. 50). The analysis found an
overall decrease of 17 percent in the prevalence of youth cigarette
smoking, fewer cigarettes smoked per month, and, despite the rise in
cigar use, an overall reduction of 6 percent in the probability of
using any type of tobacco (Ref. 50). A review of publicly available
internal documents from a clove cigarette company found that the
company started to develop a clove cigar product in 2007 in
anticipation of the Tobacco Control Act and its ban on cigarettes with
characterizing flavors, including clove-flavored cigarettes (Ref. 47).
According to these documents, the goal was to be prepared for a product
transition to allow for continual marketing of a clove-flavored
combusted tobacco product (Ref. 47). Immediately following the
prohibition on cigarette characterizing flavors, sales of clove cigars
increased more than 1,400 percent between 2009 and 2012 (Ref. 47),
strongly suggesting that users of clove cigarettes switched to clove
cigars on the basis of flavor availability.
A similar trend in modifying or rebranding of products has been
seen in several U.S. jurisdictions \12\ where laws have been enacted to
further restrict the sale of flavored tobacco products, including
cigars. Subsequent to these restrictions on the sale of flavored
tobacco products, researchers have noted the emergence of ``concept''
flavored named products that include ambiguous names that imply flavor
but do not explicitly indicate any particular flavor on the products
labeling or packaging (e.g., purple, tropical sunset) (Refs. 51 and
52). Sales of concept flavors (e.g., sweet, jazz) increased from 2.2
percent of U.S. flavored cigar sales in 2009 to 21.4 percent of U.S.
flavored cigar sales in 2020, a 33 percent average annual percentage
change (Ref. 53).
---------------------------------------------------------------------------
\12\ For more information on U.S. localities and the
implementation of flavored tobacco product restrictions, see section
IV.F of this document.
---------------------------------------------------------------------------
Flavored cigars continue to maintain a substantial share of the
cigar market. Researchers analyzing Nielsen data trends found that
cigar dollar and unit sales in convenience stores increased by 23
percent and 50 percent, respectively, between 2008 and 2015, and that
flavored cigar dollar sales--including, for example, those with
characterizing flavors such as chocolate, mint, or rum--increased by
46.5 percent (Refs. 54 and 55). A more recent study also found that
flavored cigar sales increased substantially between 2009 and 2020,
while non-flavored cigar sales did not change (Ref. 53). Another study
analyzing trends in cigars using Nielsen data found that during January
2016 to June 2020, monthly cigarillo unit sales, which represented 94.2
percent of total cigar unit sales during the study period, increased
from about 131 million to 190 million (Ref. 56). Additionally,
proprietary data gathered by Euromonitor International in March 2021
reveals that, in 2020, flavored cigars, including flavored cigarillos,
accounted for approximately 19.1 percent of all cigar U.S. dollar sales
and 41.9 percent of all cigar unit sales, suggesting that the average
price of a single unit of flavored cigar was lower than that of a
single unit of tobacco-flavored cigar in 2020.
Data suggest that due to both Congress's prohibition on cigarettes
with characterizing flavors and the pressure placed on price-sensitive
smokers (i.e., those smokers whose smoking behaviors change based on
the cost of tobacco products) by increased taxation of cigarettes
resulting from the 2009 Children's Health Insurance Program
Reauthorization Act (Pub. L. 111-3), some price-sensitive cigarette
smokers smoke cigars as a flavored, less expensive alternative to
cigarettes (Ref. 57). In addition, the popularity of cigar products
among young adults may be due to their lower price relative to
cigarettes, lack of minimum pack size requirements, and exclusion from
the advertising restrictions of the Tobacco Master Settlement Agreement
(Ref. 54). Findings from a survey study indicated that affordability
and flavors were the most commonly cited reasons for little cigar and
cigarillo use among White and
[[Page 26404]]
Black young adult ever users and past 30-day users (Ref. 58).
Given the current market share of flavored cigar products, research
demonstrating how sales of flavored cigars increased in the years
following the removal of flavored cigarettes, and how industry
contributed to these shifts by marketing clove-flavored cigars
nationally and introducing concept flavors, FDA is proposing to
prohibit characterizing flavors (other than tobacco) in cigars to
prevent youth and young adults from entering the market and progressing
from experimentation to regular use of these products, and to promote
cessation among existing users of these products.
B. Over Half a Million Youth, and Even More Young Adults, in the United
States Use Flavored Cigars
Widespread use of flavored cigars by youth supports FDA's
determination that this proposed rule would have a considerable
positive impact on public health. Using NYTS 2020 \13\ data,
researchers estimated that approximately 960,000 U.S. middle and high
school students had smoked a cigar in the prior month (Ref. 7).
Overall, the prevalence of cigar smoking among middle and high school
students is comparable to cigarette smoking, and for non-Hispanic Black
students, cigar smoking prevalence (6.5 percent) is considerably
greater than cigarette smoking (2.5 percent) (Ref. 7). In 2019, not
excluding use of other tobacco products, more young adults tried a
cigar for the first time each day than tried a cigarette for the first
time (3,163 cigar vs. 2,640 cigarette) (Ref. 59 at Table A.3A). As
discussed throughout this proposed rule, evidence is well documented of
broad youth and young adult use of cigars and the reasons cited for
their use. In addition, local policy evaluation studies of restrictions
on the sale of flavored tobacco products, including cigars, found a
decrease in overall tobacco use by youth (Refs. 51 and 60-62), further
supporting the conclusion that prohibiting the use of characterizing
flavors (other than tobacco) in cigars is likely to result in less
cigar use and less tobacco product use overall, especially among youth
and young adults.
---------------------------------------------------------------------------
\13\ The 2020 NYTS is a survey that was conducted after the
Federal law went into effect prohibiting sales of tobacco products
to those under the age of 21 (Further Consolidated Appropriations
Act, 2020, Public Law 116-94, section 906(d) of the FD&C Act), thus
potentially capturing some of the impacts of the new law.
---------------------------------------------------------------------------
Studies indicate that a substantial percentage of youth cigar users
smoke flavored cigars. Data from Wave 5 (2018-2019) of the PATH Study
indicate that among youth (aged 12-17 years) 44.0 percent of past 30-
day cigar smokers reported using flavored cigars (i.e., 33.9 percent of
youth traditional cigar smokers, 46 percent of youth cigarillo users,
and 50.2 percent of youth filtered cigar users reported past 30-day use
of a flavored cigar) (Ref. 63). Data from the 2020 NYTS indicate that
58.3 percent of middle and high school students who smoke cigars (or
approximately 550,000 youth), reported using a flavored cigar during
the past 30 days (Ref. 8). The majority of youth cigar smokers identify
the availability of cigar flavors as a leading reason for their cigar
use (Refs. 64 and 65).
The data indicate a similar preference for flavors among young
adults. According to Wave 5 (2018-2019) data from the PATH Study,
approximately 630,000 young adults aged 18 to 24 years reported past
month flavored cigar smoking (Ref. 63). An analysis of Wave 5 (2018-
2019) PATH Study data indicated that among young adults (aged 18-24
years) who used cigars some or every day, 54.1 percent of traditional
cigar users, 66.5 percent of cigarillo users, and 65.1 percent of
filtered cigar users reported flavoring as a reason for cigar use (Ref.
12). Among young adult past 30-day cigar smokers 18-24 years old, 38.3
percent reported that the cigar product they smoked in the past 30 days
was flavored (i.e., 17.7 percent of young adult traditional cigar
smokers, 46 percent of young adult cigarillo users, and 41 percent of
young adult filtered cigar users reported past 30 day use of a flavored
cigar) (Ref. 63). Since the brain continues development into an
individual's mid-twenties, cigar use in both youth and young adulthood
can harm the developing brain (Ref. 33). As discussed in section V.C of
this document, nicotine can disrupt brain development and have long
term consequences.
Studies illustrate some disparities in young adult flavored cigar
use across population groups. Among a sample of college students aged
18-29 who used cigars in the past 30 days (n=523), Black, Asian, and
Hispanic young adults were all significantly more likely to have used
flavored cigars than White young adults (Ref. 66). Participants aged
18-24 years also had greater odds of using flavored cigars compared to
participants aged 25-29 years (Ref. 66). Lastly, young adults who
identified as lesbian, gay, or bisexual had higher odds of reporting
past 30-day flavored large cigar and LCC use compared to respondents
who identified as straight/heterosexual (Ref. 67).
The data also show that a substantial percentage of youth and young
adult cigar users initiate with flavored cigars. Data from Wave 5
(2018-2019) of the PATH Study revealed that 60.4 percent of the youth
participants (aged 12-17 years) and 63.2 percent of young adults (aged
18-24 years) who reported ever using cigars said that the first cigar
they used was flavored, statistically significantly higher than the
41.9 percent of adults (aged 25 years and older) who have ever used
cigars (Ref. 12).
C. Adult Use of Flavored Cigars in the United States
While the evidence is clear that youth and young adults use
flavored cigars, it is important to note that older adults also use
them. According to Wave 5 data (2018-2019) from the PATH Study, 36.0
percent of adult cigar smokers (adults aged 25 years and older who used
cigars in the past 30 days), or over 3 million adults, reported use of
a flavored cigar in one or more of the past 30 days (Ref. 63). When
considering the type of cigar, reported use of a flavored cigar in the
past 30 days occurred less frequently for adult traditional cigar
smokers (19.7 percent) compared with adult smokers of all other cigar
types (46.5 percent for cigarillos and 48.7 percent for filtered
cigars) (Refs. 63).
Many adult cigar consumers also identify the availability of
characterizing flavors as a reason for their cigar use. Among adults
over 25 years old who used cigars every or some days, 54.8 percent of
traditional cigar users, 69.6 percent of cigarillo users, and 71.4
percent of filtered cigar users reported flavoring as a reason for
cigar use (Ref. 12). Among adults, studies suggest males are more
likely than females to use cigars, with some differences across cigar
types (Refs. 63, 66, 68, and 69). However, among cigar users, females
are more likely to use flavored cigars. For example, a study of college
students aged 18-29 years who had used cigars in the past 30 days found
that 60.5 percent of cigar users were male, but, among cigar users,
males were statistically significantly less likely to have used
flavored cigars than females (Ref. 66). Likewise, in every wave of the
PATH Study, adult males were more likely to use any cigar in the past
30 days, but among past-30-day cigar users, females were statistically
significantly more likely to have used flavored cigar products (Ref.
63).
Furthermore, there are differences in adult use of flavored cigars
across population groups. Among adults who were past-30-day users of
any cigar type,
[[Page 26405]]
non-Hispanic Black adults were statistically significantly more likely
to have used a flavored cigar in the past 30 days compared to non-
Hispanic White adults at every survey wave of the PATH Study (2013-
2019) (Ref. 63). Likewise, at every wave of the PATH Study, among
adults aged 25 years and older who had smoked cigars in the past 30
days, individuals with a college degree were statistically
significantly less likely to use a flavored cigar (20.0 percent) than
individuals categorized as having less than a high school diploma (44.9
percent), a high school diploma (37.4 percent), or some college (42.9
percent) (Ref. 63). Using 2009-2010 National Adult Tobacco Survey
(NATS) data, adults who identified as lesbian, gay, bisexual, or
transgender were also more likely to use flavored cigars (8.2 percent)
compared to the national prevalence (2.8 percent) (Ref. 70).
This proposed rule, if finalized, could lead adult flavored cigar
smokers to cease tobacco use, reduce tobacco use, or encourage them to
switch to other, potentially less harmful tobacco products.
D. Characterizing Flavors Increase Appeal and Make Tobacco Products,
Including Cigars, Easier To Use
Characterizing flavors increase the appeal of cigars and make them
easier to use. Characterizing flavors are added to tobacco products,
including cigars, for numerous reasons that relate to product appeal,
such as to ensure pleasant flavor and taste; to reduce the harshness,
bitterness, and astringency of tobacco during inhalation; and to soothe
irritation during product use (Refs. 9-11). As documented by the
Surgeon General, tobacco product manufacturers have historically added
characterizing flavors to products with lower levels of free-nicotine
content (i.e., those products that have lower amounts of nicotine
easily absorbed by the user) intended for use as ``starter products''
for new tobacco users (Ref. 17).
In particular, the addition of menthol as a characterizing flavor
in combusted tobacco products, including cigars, can soothe irritation
and increase appeal. Menthol is a flavor compound that when added to
combusted tobacco products produces a minty taste and cooling sensation
when inhaled (Ref. 71). Smokers report that mentholated products have a
better taste, are smoother and more refreshing (Refs. 72-74). Menthol's
flavor and sensory effects reduce the harshness of smoking among new
users and facilitates product use, particularly among youth and young
adults (Refs. 29 and 74-76).
While much of the evidence on the role of flavors in increasing
appeal focuses on cigarettes and tobacco products overall, internal
industry documents also specifically discuss the role of flavors in
cigars (Ref. 16). Internal tobacco industry documents illustrate cigar
manufacturers' historical practices of adding characterizing flavors to
diminish the harshness of tobacco products' taste with specific intent
to appeal to young consumers (Refs. 16 and 17). A review of the Truth
Tobacco Industry Documents, an archive of tobacco industry documents,
showed that some flavors in cigars (e.g., vanilla bean, peach, apricot,
licorice, cocoa) may mask the bitterness of tobacco leaves, throat
burn, and heavy taste, thereby facilitating inhalation, making smoking
more tolerable for current users, and increasing palatability for new
users. These documents illustrate that the effect of characterizing
flavors in the appeal of other tobacco products is applicable to the
effect of characterizing flavors in the appeal of cigar products. These
documents also illustrate that the tobacco industry added flavors and
changed some design characteristics of little cigars and cigarillos to
facilitate inhalation and make smoking more tolerable for current
smokers, as well as more palatable for new users, including youth
(Refs. 16 and 77-79).
Flavors play an important role in attracting youth to tobacco
products, including cigars (Refs. 55, 80, and 81). In survey and
qualitative research, youth report that flavors in cigars are a leading
reason for use. In 2018-2019 PATH Study data, 50.4 percent of youth
participants (aged 12-17 years) who reported past 30-day cigar smoking
identified flavors as a reason for use (Ref. 12). Results from
qualitative research indicate that youth themselves acknowledge that
flavorings impact their cigar use (Ref. 82). Similarly, some young
adult participants mentioned that the flavors of little flavored cigars
and cigarillos were particularly appealing, with one stating: ``They
taste basically like a strawberry. And I like the Tropical Fusion cause
it's like a coconut.'' In a qualitative study involving focus groups of
youth and young adults who used cigars (Ref. 83), the most appealing
component of cigar packaging were aspects that indicated the flavor
(e.g., a flavor name or image), which was identified by nearly half of
all participants, and participants indicated that the words describing
the flavor (e.g., ``sweet'') were a reason to buy the product. In a
qualitative study of adolescents (aged 15-18 years) (Ref. 84), both
users of tobacco products (including users of cigars/cigarillos) and
nonusers indicated flavors make tobacco products appealing and are a
reason to use tobacco products. Participants indicated that both the
taste and smell of flavored products were appealing (specifically
mentioning minty, sweet, and fruit flavors) and noted that the smell of
flavors could obscure the smell of tobacco.
Both younger and older adults similarly report flavors as a leading
reason for cigar use. Among young adults (aged 18-24 years) in the PATH
Study (2018-2019) who used cigars regularly and currently used cigars
every or someday, 54.1 percent of current traditional cigar users, 66.5
percent of current cigarillo users, and 65.1 percent of current
filtered cigar users reported flavoring as a reason for cigar use (Ref.
12). Likewise, adults aged 25 years and older report flavors as a
leading reason for cigar use. Among adults aged 25 years and older in
the PATH Study, 54.8 percent of current traditional cigar smokers, 69.6
percent of current cigarillo smokers, and 71.4 percent of current
filtered cigar smokers reported flavoring as a reason for cigar use.
There was not a statistically significant difference by age group in
reporting flavors as a reason for use (Ref. 12).
Characterizing flavors increase susceptibility to use (a measure of
how much individuals report being open or willing to use a tobacco
product) in nonsmoking young adults, as documented in a 2020 study that
tested cigarillo pack images containing the most popular characterizing
flavors. Susceptibility to cigarillo use was statistically
significantly greater among participants exposed to the packs with
characterizing flavors (Ref. 85). Results from focus groups and
semistructured interviews with 90 young adult past 30-day LCC-only,
cigarette-only, and dual cigarette and LCC smokers provide insight
about the appeal of characterizing flavors in certain cigars to youth
and young adults (Ref. 82). Among study participants, the average age
of initiation of LCC was 16.1 years, and nearly two-thirds of the
participants reported first using an LCC that was flavored (Ref. 82).
Participants frequently reported that smoking flavored LCCs relieved
stress and that flavored LCC use sometimes depended on mood and was
associated with boosted mood and gratification (Ref. 82). Participants
frequently mentioned that flavored tobacco made smoking LCCs more
palatable than smoking unflavored (or regular flavor) cigars (Ref. 82).
For many participants, seeing or hearing the
[[Page 26406]]
phrase ``little cigars or cigarillos'' evoked thoughts about their
favorite flavors (Ref. 82). In addition, for many participants, peers
played an important role in continued experimentation because friends
would often suggest flavors to one another (Ref. 82). Moreover, many
participants stated that the appeal of the variety of available
flavored LCCs on the market influenced their decision to try LCCs (Ref.
82). These studies indicate that flavors are an important factor in
initiation and use of cigars among young adults.
Four systematic reviews of the scientific literature concluded that
flavored tobacco products attract youth to the tobacco product (Refs.
86-89). Two of the systematic reviews included cigars and assessed
studies on use and attitudes related to non-menthol flavored tobacco
products (Refs. 88 and 89). The two reviews concluded that
characterizing flavors were an appealing feature of tobacco products
and that flavors influence perceptions, initiation, and progression to
use of tobacco products, particularly among youth (Refs. 88 and 89).
The appeal of flavors in tobacco products, including cigars, is not
only consistent across the literature on tobacco products, but is also
consistent with the food literature. Physiologically, scientists have
described how youth have a heightened preference for sweet food tastes
and greater rejection of bitter food tastes; these preferences diminish
with age (Refs. 90-93).
An FDA-funded scientific review of 474 articles published between
1931 and 2015 conducted to understand how youth and adults differ with
respect to their preferences for characterizing flavors, primarily in
food, concluded that preference for sweetness and saltiness is
generally higher for children than it is for adults; and the level of
sugar selected as most preferred in clinical experiments decreased
between adolescence and adulthood (Ref. 94). The researchers
hypothesized that the higher caloric needs of youth to sustain growth
likely account for the more pronounced preference for sweetness in
youth (Ref. 94).
Laboratory research has confirmed that the chemical-specific flavor
sensory cues associated with fruit flavors in tobacco products are
often the same as those found in popular candies (Refs. 95 and 96).
While inhaling flavored chemicals is in many ways very different than
ingesting flavored foods, researchers reviewed the levels of flavor
chemicals in several brands of candy and Kool-Aid drink mix and
concluded that the chemical amounts and combinations largely overlapped
with similarly labeled ``cherry,'' ``grape,'' ``apple,'' ``peach,'' and
``berry'' cigar and other tobacco products (Refs. 95 and 96).
Overall, FDA finds that evidence regarding the role of flavors in
increasing appeal of cigars to youth and young adults, promoting
progression to regular use, and increasing the addiction potential
indicates that removing flavors from cigars would reduce initiation and
use of such products, especially among youth and young adults. As a
majority of adult regular tobacco users become dependent on or addicted
to nicotine as youth and young adults, reducing initiation and use of
cigar products in youth would reduce the likelihood that youth progress
to nicotine dependence and regular use, as well as subsequent tobacco-
related illness and death. Therefore, FDA anticipates that removing
flavors from cigars would substantially reduce tobacco-related disease
and death as a result of averted youth initiation.
E. Characterizing Flavors Increase Youth and Young Adult
Experimentation With Tobacco Products, Including Cigars, and Make
Progression to Regular Tobacco Use More Likely
Cigars are more commonly used among youth and young adults relative
to other combusted tobacco products, including cigarettes. An analysis
of PATH Study data found that new cigar use (i.e., initiation since a
prior wave of data collection) at Waves 2, 3, or 4 (2014-2017) was more
common (14.5 percent youth, 19.7 percent young adults, 6.3 percent
adults aged 25 and older) relative to new cigarette use (i.e.,
initiation since a prior wave) (14.0 percent youth, 7.1 percent young
adults, 1.1 percent adults aged 25 and older) (Ref. 29). Data from the
2019 National Survey on Drug Use and Health (NSDUH) found that each day
1,210 youth 12-17 years and 3,163 young adults aged 18 to 25 years
tried a cigar for the first time (Ref. 59 at Table A.3A). In 2019,
prevalence of past 30-day cigar use surpassed that of past 30-day
cigarette use among U.S. high school students for the first time (Ref.
97). Flavors make tobacco products, including cigars, easier to use and
reinforce tobacco use among youth and young adults. FDA finds that
eliminating characterizing flavors (other than tobacco) in cigars would
decrease the number of first-time users of cigars who progress to
regular use.
The process of becoming a regular cigar smoker includes stages of
experimentation, development of nicotine dependence, and progression to
regular use (Refs. 98 and 99). FDA finds that eliminating flavored
cigar varieties would decrease the number of youth experimenting and
the likelihood that youth will progress to regular, sustained use of
tobacco products, and, thus, would reduce the risk of tobacco-related
death and disease.
Experimentation with cigars can lead to nicotine dependence and
regular use in less than one year. Longitudinal data from the
nationally representative Truth Longitudinal Cohort (2014-2019) were
used to examine the progression from cigar initiation to regular use
among youth and young adults aged 15 to 25 years (Ref. 100). Nearly
half (44.7 percent) of participants who initiated cigar use reported
current (i.e., past-30-day) cigar use 6 months after initiation (Ref.
100). Compared to participants who did not become past-30-day users 6
months after initiation, those who were past-30-day users engaged in a
higher frequency of cigar use during the initial 6-month period, were
younger, non-Hispanic African American, and were more likely to use
other tobacco products. For example, non-Hispanic African American
participants (relative to non-Hispanic White participants) had over
twice the odds of past-30-day cigar use and had a higher average
frequency of use (2.21 days/month vs. 1.34 days/month, respectively) 6
months after initiation of cigar use (Ref. 100).
Experimentation with flavored cigar use is associated with
subsequent use. Another study used longitudinal data from Waves 1
(2013-2014) and 2 (2014-2015) of the PATH Study to assess whether there
is a prospective association between first flavored use of a tobacco
product and subsequent use of that specific product (Ref. 28). This
analysis found that first use of any flavored cigar or first use of
flavored cigarillos and filtered cigars (including menthol) at Wave 1
(2013-2014) of the nationally representative PATH Study was
subsequently associated with daily or nondaily use of these products in
young adults (aged 18-24 years) and adults (aged 25 years and older) 1
year later (2014-2015) compared with first non-flavored use (Ref. 28).
Studies have shown that menthol's flavor and sensory effects reduce
the harshness of smoking among new users and facilitate experimentation
and progression to regular smoking of menthol products, particularly
among youth and young adults (Refs. 29 and 74-76). A subsequent
analysis using Waves 1-4 (2013-2017) of PATH Study data assessed the
relationship between new use of a menthol/mint-flavored or other
flavored (e.g., fruit, alcohol,
[[Page 26407]]
chocolate, candy, and other flavor) cigar at Wave 2 or 3 with cigar use
at a subsequent wave (Wave 3 or 4) compared to first use of a non-
flavored cigar (Ref. 29). The analysis found that among youth (aged 12-
17 years) and young adults (aged 18-24 years), first use of any
menthol/mint-flavored or other flavored cigar (e.g., fruit, alcohol,
chocolate, candy, and other flavor) was associated with greater odds of
past 30-day use of these products at the subsequent wave compared with
first use of a non-flavored (i.e., tobacco) cigar, even after
controlling for sociodemographic variables (Ref. 29). Youth who first
used a menthol/mint-flavored cigar or other flavored cigar were 72
percent (menthol/mint) and 47 percent (other flavor) more likely to be
past-30-day cigar users at a subsequent wave (1 or more years later)
compared to those first using a non-flavored cigar. Similarly, young
adults (aged 18-24 years) who first used a menthol/mint-flavored cigar
or other flavored cigar were 71 percent and 52 percent more likely to
be past-30-day cigar users at a subsequent wave compared to those first
using a non-flavored cigar (Ref. 29). For both youth and young adults,
the association between the first flavor used and subsequent cigar use
was not statistically significantly different for menthol/mint-flavored
compared to other flavored cigars. Among adults (25 years and older),
first use of an ``other'' flavored cigar (e.g., fruit, alcohol,
chocolate, candy, and other flavor) was also associated with higher
likelihood of subsequent past 30-day cigar use (Ref. 29). Overall, this
study extends findings from the Wave 1 (2013-2014) to Wave 2 (2014-
2015) PATH Study analysis (Ref. 28) finding that among youth and young
adults newly using cigars, first use of any menthol/mint-flavored cigar
or other flavored cigar is associated with greater continued use of
these products at the subsequent wave compared with first use of non-
flavored cigars (Ref. 29).
Several studies examining nicotine dependence found that smoking
cigars fosters addiction by reducing cravings and the urge to smoke to
a similar magnitude as cigarettes (Refs. 101-103). Cigars, like
cigarettes, have also been shown to decrease acute nicotine withdrawal
symptoms (e.g., craving, anxiousness) (Ref. 104). Available scientific
data on nicotine's addictiveness demonstrate that the adolescent brain
is more vulnerable to developing nicotine dependence than the adult
brain (Ref. 17). Exposure to substances such as nicotine can disrupt
brain development and may lead to long-term consequences for cognitive
function (Refs. 105 and 106). Exposure to nicotine from cigarette
smoking in adolescence is associated with changes in the brain that
could increase the likelihood for addiction and dependence as adults
(Ref. 34). Furthermore, nicotine exposure in adolescence may have
lasting effects; it has been associated with decreased attention,
increased impulsivity, and various lasting mental health conditions in
adult smokers (Ref. 34). While research is not yet able to fully
disentangle whether the association of nicotine with changes in
attention and impulsivity are primarily a result of nicotine exposure
or partially due to pre-existing vulnerability to changes in attention
and impulsivity (Ref. 34), considerable research shows that exposure to
nicotine in adolescence causes long-term changes in the brain, with
implications for nicotine dependence, attention, and impulsivity, as
well as other areas of cognitive function and substance use (Refs. 17
and 34). Researchers analyzing data from the 2017-2018 NYTS found that
43.1 percent of middle and high school students using cigars in the
past 30 days reported nicotine dependence, including feeling a strong
craving to use a tobacco product or using a tobacco product within 30
minutes of waking (Ref. 107). An analysis of Waves 1-4 (2013-2017) PATH
data did not find a longitudinal association between first use of a
menthol- or mint-flavored cigar and nicotine dependence scores (Ref.
29). Similarly, a cross-sectional analysis of 2017-2018 NYTS data found
that exclusive use of cigars was associated with lower odds of
reporting dependence compared to exclusive use of another product (Ref.
107). However, frequent cigar use (use on 20 or more days in the past
30 days) as well as current cigar use including both exclusive and
polyuse of cigars was associated with increased odds of youth reporting
nicotine dependence (Ref. 107). In this analysis, use of cigars in
combination with other tobacco products was common: 76.1 percent of
youth past 30-day cigar users used cigars in combination with one or
two additional tobacco products (Ref. 107). Given the role of frequent
use and polyuse in the relationship between cigar use among youth and
dependence, the authors noted ``the importance of examining behaviors
related to use, as they can affect and/or exacerbate the risk of
nicotine dependence'' (Ref. 107).
Given that nicotine is highly addictive and present in all cigars,
as youth experimenters continue to use these products, there is a risk
of nicotine dependence and progression to regular use, resulting in an
increased risk of developing the many negative health consequences
associated with regular cigar use. Based on the totality of the
evidence, prohibiting characterizing flavors (other than tobacco) in
cigars would reduce the appeal and ease of use of such products and is
an important step toward reducing the likelihood of nicotine
dependence, experimentation, and progression to regular use.
F. Real-World Experiences Demonstrate That Restricting Characterizing
Flavors in Tobacco Products, Including Cigars, Decreases Tobacco Use
As previously discussed in section IV.A of this document, Congress
passed the Tobacco Control Act in 2009 to address the premature death,
disease, and other serious health conditions caused by tobacco use. To
address the appeal and use of flavored combusted tobacco products among
the Nation's youth, in 2009, the Tobacco Control Act prohibited
cigarettes with characterizing flavors other than tobacco or menthol.
Researchers analyzed repeated cross-sectional data from the NYTS and
concluded that the ban was associated with a 17 percent reduction in
the probability of being a cigarette smoker and a 6 percent reduction
in the probability of any tobacco use (i.e., cigarette, cigars,
smokeless tobacco, or pipe tobacco) in the past 30 days among U.S.
middle and high school students (Ref. 50). While cigarette smoking
decreased among the Nation's youth following implementation of the
Tobacco Control Act, researchers noted that youth use of cigars and
pipe tobacco, which remained available in flavored varieties, rose
after implementation of the ban on characterizing flavors in cigarettes
(Ref. 50).
While the prior analysis (Ref. 50) was limited in its ability to
attribute changes in tobacco use, particularly flavored use, directly
to the Federal restriction (as the NYTS was not designed to evaluate
such a policy), recent evaluation studies implementing pre-post study
designs with geographic comparisons provide real-world examples of how
tobacco product use changes as a result of a sales restriction on
characterizing flavors in tobacco products, including cigars. Such
recent evaluations of restrictions on the sale of tobacco products with
characterizing flavors in U.S. localities include studies of New York,
NY (NYC); Providence, RI; Lowell, MA; Attleboro and Salem, MA; San
Francisco, CA; Minneapolis and St. Paul, MN (Twin Cities); as well as
Canada (See table 1, below,
[[Page 26408]]
summarizing the evaluation studies). Taken in totality, the real-world
experience of state and local jurisdictions implementing sales
restrictions on flavored tobacco products provide insight into the
likely responses of youth and young adults as well as current cigar
smokers to a proposed product standard restricting characterizing
flavors (other than tobacco) in cigar products, including decreases in
youth cigar use and cigar consumption among current cigar smokers.
Table 1--Summary of Evaluation Studies on Sales Restrictions Including Flavored Cigars
--------------------------------------------------------------------------------------------------------------------------------------------------------
Key outcome
Jurisdiction Policy \1\ Effective or Retailer exemptions Study design & Sample size measures \2\ and
enforcement year reference findings
--------------------------------------------------------------------------------------------------------------------------------------------------------
NYC, NY................... Restriction 2010.................. Tobacco bars with Pre/Post Design Youth Tobacco Use: Sales: Flavored
includes all >=10% gross income (Ref. 51). n=1708 (2010); cigars dollar
flavored products from tobacco sales. n=8814 (2013). sales declined.
except menthol-, Cigar dollar
mint-, and sales of non-
wintergreen- flavored cigars
flavored products. increased.
In 2020, Youth (aged 13-17
restriction was years) Tobacco
expanded to Use: Youth had
include flavored lower odds of
Electronic ever trying a
Nicotine Delivery flavored tobacco
Systems (ENDS) product and of
products, ever using
including menthol- tobacco products.
, mint-, and
wintergreen-
flavored ENDS
products.
Pre/Post Design N/A............... Sales: Overall
with Comparison cigar unit sales
(Ref. 108). declined.
Flavored cigar
unit sales
declined.
Flavored cigar
unit sales
increased in
comparison
counties.
Providence, RI............ Restriction 2013.................. All smoking bars... Pre/Post Design N/A............... Sales: Decrease in
includes all with Comparison flavored cigar
flavored products (Ref. 109). unit sales.
except menthol, Decreases in
mint, and overall cigar
wintergreen unit sales.
flavors. Flavored cigar
unit sales
increased in the
rest of the
State.
Post-only Design n=2,150 (2012); Youth (10th and
(Ref. 60). n=2,062 (2016); 12th grade
n=2,223 (2018). students) Tobacco
Use: Youth
current use of
any tobacco
product declined.
Youth (10th and
12th grade
students) Cigar
Use: Youth
current use of
cigars/cigarillos
declined.
Lowell, MA................ Restriction 2016.................. Adult-only (21+ Post-only Design Lowell: Baseline Youth (9th-12th
includes all years old) retail with Comparison n=593; follow-up grade students)
flavored products tobacco stores (Ref. 61). n=524. Flavored Tobacco
(except menthol, with >=90% of Malden (comparison Use: Youth
mint, or sales from tobacco community): current use of
wintergreen). products. baseline n=636; any flavored
follow up n=646. tobacco products
decreased in
Lowell and
increased in the
comparison
community, a
statistically
significant
difference.
Youth (9th-12th
grade students)
Non-Flavored
Tobacco Use:
Youth current use
of any non-
flavored tobacco
products also
decreased in
Lowell and
increased in the
comparison
community, a
statistically
significant
difference.
Attleboro & Salem, MA..... Restriction 2016 (Attleboro); 2017 Adult-only (21+ Pre/Post Design Attleboro: Youth (9th-12th
includes all (Salem). years old) retail with Comparison Baseline n=1413; grade students)
flavored products tobacco stores (Ref. 110). follow up n=1565. Flavored Tobacco
(except menthol, with >=90% of Salem: Baseline Use:
mint, or sales from tobacco n=480; follow up Statistically
wintergreen). products. n=620. significantly
All smoking bars... Gloucester smaller increases
(comparison in current use of
municipality): Flavored in
Baseline n=539; Attleboro and
follow up n=629. Salem than in the
comparison
municipality.
Youth (9th-12th
grade students)
Non-Flavored
Tobacco Use:
Significantly
smaller increases
in current use of
non-flavored or
menthol tobacco
in Attleboro and
Salem than in the
comparison
municipality.
[[Page 26409]]
Twin Cities, MN........... Restriction 2016.................. Minneapolis: Adult- Pre/Post Design Minnesota Youth Youth (6th-12th
includes all only (18 years and with Comparison Tobacco Survey: grade students)
flavored products older) licensed (Ref. 111). More than 4,000 Cigar Use: Before
(except menthol, tobacco product students and after the
mint, or shops with >=90% participated in 2016 restriction
wintergreen). revenue from sale the 2017 survey on flavored
of tobacco. statewide. tobacco products
St. Paul: Adult- (except menthol,
only (18 years and mint, and
older) retail wintergreen),
stores with >=90% cigar use did not
revenue from sale change in the
of tobacco. Twin Cities but
increased in the
rest of the
State.
Restriction 2018.................. Minneapolis: Sales Pre/Post Design Minnesota Student Youth (8th, 9th,
expanded to of mint-, menthol- with Comparison Survey (8th, 9th, 11th grade
include menthol, , and wintergreen- (Ref. 111). 11th grade students) Cigar
mint, and flavored tobacco students): More Use: Before and
wintergreen in products at adult than 170,000 after the 2018
2018. only (21 years and participating restriction on
older) liquor students in 2019. flavored tobacco
stores. products,
St. Paul: Sales of including
mint-, menthol-, menthol, mint,
and wintergreen- and wintergreen,
flavored tobacco cigar use
products at liquor declined more in
stores that also the Twin Cities
hold a license for compared to the
tobacco sales. rest of the
State.
San Francisco, CA......... Restriction 2019.................. None............... Post-only Design n=247............. Young Adult (aged
includes all (Ref. 62). 18-24 years)
flavored products Cigar Use:
(including Statistically
menthol). significant
decrease in
flavored cigar
use. Decrease in
overall cigar
use, but the
decline was not
statistically
significant.
Young Adult (aged
25-34 years)
Cigar Use:
Decreases in
overall cigar use
and flavored
cigar use, but
the declines were
not statistically
significant.
Pre/Post Design N/A............... Sales:
with Comparison Statistically
(Ref. 52). significant
decreases in
overall tobacco
and flavored
tobacco unit
sales.
Statistically
significant
decreases in
overall cigar and
flavored cigar
unit sales. The
comparison cities
had more modest
decreases or no
statistically
significant
change.
Canada.................... Restriction 2010.................. None............... Pre/Post Design N/A............... Sales: Decreases
includes flavored (Ref. 112). in overall cigar
little cigars/ and flavored
cigarillos (except cigar units sold.
menthol); Increase in
unflavored unflavored cigar
cigarillos minimum units sold.
packs of 20.
Pre/Post Design Over 46,000 Youth (aged 15-24
(Ref. 113). observations. years) Cigarillo
Use: Decreases in
past 30-day
cigarillo use.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Tobacco products covered under flavored tobacco restrictions differed across jurisdictions, particularly in regard to menthol status and inclusion
of ENDS.
\2\ Outcome measures differed across studies, with some focused specifically on sales data, whereas others measured tobacco use (cigar specific and/or
all tobacco use), across differing age groups.
In November 2010, NYC began enforcing a restriction on sales of all
flavored tobacco products except for menthol-flavored, mint-flavored,
and wintergreen-flavored tobacco products; all e-cigarettes were
excluded from the sales restrictions. An evaluation of the impact on
total cigar sales of NYC's flavor restriction found a considerable
[[Page 26410]]
reduction in overall sales, a proxy for overall consumption, after
controlling for temporal trends in sales and the potential for
purchases across the city border (Ref. 108). This evaluation used
retail scanner data to assess changes in total cigar units sold before
and after the NYC flavor restriction went into effect. For comparison,
the analysis also examined sales in nine counties in New York and New
Jersey proximal to NYC, as well as sales in the United States overall,
over the same timeframe. In NYC, sales of all flavored tobacco products
combined declined 27.1 percent, and sales of flavored cigars declined
22.3 percent at policy implementation. The NYC flavor restriction was
associated with a statistically significant 11.6 percent decrease in
total cigar sales in NYC immediately following policy implementation,
while cigar sales in the comparison area and nationally did not
statistically significantly change. The decrease in overall cigar sales
observed in NYC suggests that consumers did not completely substitute
non-flavored cigars for flavored cigars because of the restriction
(Ref. 108). This study showed that the concurrent decrease in unit
sales of flavored tobacco products and flavored cigars observed in NYC
was not offset by an increase in non-flavored cigars or tobacco
products not included in the restriction. Furthermore, these findings
were similar to results from an earlier analysis of the NYC policy that
used more limited data (Ref. 51). This more limited study analyzed data
from stores with overall sales of at least $2 million per year in NYC
and found that the restriction was associated with an 86 percent
decrease in flavored cigar dollar sales and only a 5 percent increase
in unflavored cigar dollar sales (Ref. 51).
An evaluation of the impact of the NYC flavored tobacco restriction
on youth tobacco use found that NYC youth (aged 13-17 years) had 37
percent lower odds of ever trying a flavored tobacco product in 2013
after the policy went into effect compared to youth in 2010. Similarly,
in 2013, youth had 28 percent lower odds of ever using any tobacco
product compared to youth before the policy went into effect (Ref. 51),
suggesting that the decreases in overall sales and consumption of
flavored tobacco products, including cigars, was also reflected in
declines in youth tobacco experimentation. This study illustrated that
youth tobacco use declined following the NYC sales restriction.
Providence, RI, implemented a sales restriction on tobacco products
with characterizing flavors other than menthol, mint, or wintergreen in
January 2013 (Ref. 109). An evaluation in Providence, similar to the
analysis in NYC, used retail scanner data to assess changes in total
cigar units (both flavored and not flavored, including menthol, mint,
and wintergreen flavors) sold before and after the Providence flavor
restriction went into effect (Ref. 109). For comparison, the analysis
also examined sales over the same time period in the rest of Rhode
Island (Ref. 109). Sale of explicit flavor-named cigars (e.g.,
``cherry'') in Providence declined 93 percent, while ``concept''
flavor-named cigars (e.g., ``jazz'') increased 74 percent after policy
implementation compared to before policy implementation. Despite the
increase in ``concept'' flavor-named cigar sales, flavored cigar sales
decreased overall, suggesting that ``concept'' flavor-named cigar
consumption did not entirely replace explicit flavored-named cigar
consumption after the policy. The analysis found that average weekly
sales of all flavored cigars decreased 51 percent following policy
implementation in Providence compared to before policy implementation
and increased 10 percent across the rest of the state during the same
time period (Ref. 109). Average weekly sales of all cigars decreased 31
percent following policy implementation in Providence and decreased 6
percent across the rest of the state during the same time period (Ref.
109). This study illustrated that flavored cigar use decreased
following policy implementation alongside an increase in sales in the
rest of the state. While concept-flavored cigar sales increased in
Providence and the rest of the State, the overall decline in flavored
sales suggests that flavored cigar use was only partially offset by an
increase in concept-flavored use.
Another evaluation of the Providence restrictions examined youth
tobacco use including cigar use through a school-based survey of over
2,000 10th and 12th grade students at two time points after
Providence's sales restriction was in effect: 2016 (3 years post-
restriction) and 2018 (5 years post-restriction) (Ref. 60). This
analysis found that youth current use of any tobacco product declined,
from 22.2 percent in 2016 to 12.1 percent in 2018; and current use of
cigars/cigarillos declined from 7.1 percent in 2016 to 1.9 percent in
2018 (Ref. 60). This study illustrates a decline in youth cigar use
after increased enforcement of the policy in Providence, which is
consistent with the analysis of sales data in Providence (Ref. 109).
Lowell, MA, enacted a restriction on flavored tobacco except for
menthol-, mint-, or wintergreen-flavored tobacco products in October
2016. One study assessed short-term (6-month) impact of the Lowell, MA,
sales restriction on youth use of flavored tobacco using pre-post
design with a comparison community (Malden, MA). The comparison
community of Malden, MA, did not have a sales restriction and was
similar to Lowell, MA, in demographics, retailer characteristics, and
other point-of-sale policies (Ref. 61). The analysis evaluated youth
use of flavored tobacco products in Lowell and Malden at baseline
(November 2016-January 2017 in Lowell; September 2016 in Malden) and
followup approximately 6 months later (May 2017 in Lowell; April 2017
in Malden). Youth current use of any flavored tobacco products
decreased 2.4 percent in Lowell from baseline to followup periods and
increased 3.1 percent in the comparison community without a sales
restriction (Malden, MA) for a statistically significant estimated
difference of -5.7 percent between the communities (Ref. 61). When
considering the change in specific product use, ever use of flavored
cigars and current use of flavored cigars decreased in Lowell and
increased in the comparison community, although the changes were not
statistically significant. In general, there were no statistically
significant changes in youth use by specific tobacco products in
Lowell, in the comparison city, or in the difference estimate between
the communities when the models were adjusted for age, gender, and race
and ethnicity (Ref. 61). Youth current use of any non-flavored tobacco
products also decreased 1.9 percent in Lowell while increasing in the
comparison city by a statistically significant 4.3 percent for a
statistically significant estimated difference of -6.2 percent between
the communities (Ref. 61). This study showed that youth use of flavored
tobacco products declined potentially in response to a sales
restriction in a Massachusetts community compared to a similar
community without a sales restriction.
Another study evaluated the impact of flavored tobacco sales
restrictions (excluding menthol, mint, and wintergreen) in Attleboro
and Salem, MA, on tobacco use among high school students (Ref. 110).
While youth tobacco use increased from baseline to followup in
Attleboro and Salem and in the comparison municipality of Gloucester,
MA, the increases in flavored tobacco use and non-flavored, mint, or
menthol tobacco use were statistically
[[Page 26411]]
significantly smaller in Attleboro and Salem than the comparison
municipality, suggesting that the policy mitigated increases in tobacco
use (Ref. 110). This study found that youth tobacco use increased at a
lower rate within the two municipalities covered by sales restrictions
compared to the municipality without a restriction. Therefore, the
study findings suggest that the flavored tobacco restriction may have
prevented increases in tobacco use.
In 2016, Minneapolis and St. Paul, Minnesota, commonly referred to
as the Twin Cities, also implemented sales restrictions that included
all flavored tobacco products, including ENDS but excluded menthol,
mint, and wintergreen flavors. These sales restrictions exempted adult-
only (18 years and older) licensed tobacco product shops with at least
90 percent or greater revenue from sales of tobacco in Minneapolis and
adult-only (18 years and older) retail stores with at least 90 percent
or greater revenue from sales of tobacco in St. Paul. In 2018, the Twin
Cities expanded the restrictions to include mint-, menthol-, and
wintergreen-flavored tobacco products. However, sales of mint-,
menthol-, and wintergreen-flavored tobacco products were permitted in
adult-only (aged 21 years and older) liquor stores in Minneapolis and
liquor stores that also hold a license for tobacco sales in St. Paul.
An analysis of the Minnesota restrictions examined youth tobacco use
prevalence in the seven-county Twin Cities metropolitan area, including
Minneapolis and St. Paul, and compared it to the rest of the State of
Minnesota using data from two cross-sectional surveys: The Minnesota
Youth Tobacco Survey (MYTS) and the Minnesota Student Survey (MSS)
(Ref. 111). The analysis used MYTS data from students in grades 6-12 to
estimate tobacco use before (2014) and after (2017) the Twin Cities
implemented flavor policies in 2016 that included all tobacco products
but excluded menthol, mint, and wintergreen flavors. The analysis used
MSS data from students in grades 8, 9, and 11 to assess changes in
tobacco use before (2016) and after (2019) when the flavor restrictions
were expanded to include mint, menthol, and wintergreen flavors. Using
the MYTS data to assess youth tobacco use while the 2016 flavor
restriction (excluding menthol, mint, and wintergreen) was in effect,
the prevalence of tobacco product use overall and cigar use did not
change in the Twin Cities among 6-12th graders; however, e-cigarette
use increased 34.1 percent. In contrast, tobacco use prevalence
overall, cigar use, and e-cigarette use increased at greater rates in
the rest of the state (+26.6 percent, +71.3 percent, and +114 percent,
respectively). Using the MSS data to assess youth tobacco use after the
2019 flavor restriction (including menthol, mint, and wintergreen) was
implemented, tobacco use and e-cigarette use among students in grades
8, 9, and 11 increased in the Twin Cities; however, the increase was
smaller than the rest of the state (34.6 percent vs. 44.6 percent
tobacco use increase; 49.5 percent vs. 88.9 percent e-cigarette
increase). Cigar use declined more in the Twin Cities compared to the
rest of the state (-42.4 percent and -23.7 percent, respectively).
Cigarette use decreased more in the Twin Cities relative to the rest of
the State (-40.5 percent and -22.6 percent, respectively). Use of any
menthol or mint tobacco product decreased in both areas (-5.9 percent
Twin Cities and -15.7 percent rest of state), and use of non-cigarette
tobacco products (e.g., cigars, smokeless tobacco, e-cigarettes,
hookah) with flavors other than mint or menthol increased in both areas
(+5 percent Twin Cities and +10.2 percent rest of state) (Ref. 111).
Given the differences in survey items, timing of data collection,
and that the MYTS and MSS data included all seven counties of the Twin
Cities metropolitan area, including some counties not implementing
flavor restrictions, the observed prevalence changes may reflect
contextual factors beyond the restrictions in the cities of Minneapolis
and St. Paul. For example, the 2019 MSS data collection was shortly
after the policies including mint, menthol, and wintergreen went into
effect; therefore, the study may underestimate the effect of the policy
on youth behavior change. However, the study observed stable and
decreasing cigar use among youth across the surveys in the Twin Cities
relative to the rest of the state, which suggests the sales restriction
slowed youth cigar use.
In 2018, San Francisco, CA, enacted restrictions on flavored
tobacco products. Changes following the 2018 San Francisco restriction
on all flavored (including menthol) tobacco product sales were
evaluated and compared with sales in two California comparison cities
without such sales restrictions: San Jose and San Diego (Ref. 52). The
analysis used Nielsen retail scanner sales data to estimate within-city
changes in average weekly unit sales of tobacco products for San
Francisco and comparison cities for three time periods: Pre-policy
(June 2015-July 2018; pre-policy); policy enactment (July 2018-January
2019) and policy enforcement (January 2019-December 2019).\14\ Sales of
flavored tobacco products overall and of flavored cigars specifically
decreased a statistically significant 96 percent from the pre-policy
period through the enforcement period in San Francisco (Ref. 52). In
the comparison cities, average weekly sales of flavored tobacco
products either decreased more modestly, yet still statistically
significantly (e.g., 10 percent for all flavored products and 13
percent for flavored cigars in San Diego), or did not have a
statistically significant change from pre-policy to policy enforcement,
with the exception of flavored ENDS (which statistically significantly
increased by 195 percent in San Jose and 118 percent in San Diego) and
flavored smokeless tobacco (which statistically significantly increased
by 3 percent in San Diego). Predicted average weekly total cigar sales
decreased by 51 percent in San Francisco from pre-policy to policy
enforcement, suggesting that there was not complete substitution of
flavored cigars for non-flavored cigars (Ref. 52). This study observed
a decline in overall tobacco product sales and flavored tobacco product
sales, suggesting that there was not complete substitution of tobacco
or non-flavored products for flavored products following the flavor
restriction in San Francisco.
---------------------------------------------------------------------------
\14\ Although enforcement of this policy was slated to begin in
January 2019, compliance inspections with penalties did not commence
until April 2019.
---------------------------------------------------------------------------
Another study evaluated the impact of the San Francisco restriction
on all flavored (including menthol) tobacco products on use of cigars
among a small convenience sample (n=247) of young adults aged 18-34
years who used tobacco products prior to the restriction (Ref. 62).
After implementation of the flavor restriction in San Francisco, among
young adults aged 18-24 years, there was a statistically significant
decrease in use of flavored cigars (from 19.4 percent to 6.5 percent)
and decrease in cigar use overall that was not statistically
significant (Ref. 62). There were decreases in the prevalence of cigar
use overall and use of flavored cigars among 25-34-year-old
respondents, but the declines were not statistically significant. Among
the 25-34 age group, there was a statistically significant decrease in
flavored e-cigarette use (from 56.2 percent to 48.1 percent) and dual
use of e-cigarettes with cigars (from 14.1 percent to 9.7 percent).
This study showed among young adults, flavored cigar use may have
declined following the San Francisco sales restriction, and the
decrease was not offset by an increase in non-flavored cigar use.
[[Page 26412]]
One study of San Francisco's flavored tobacco policy using 2019
Youth Risk Behavior Survey (YRBS) data reported that San Francisco's
flavor restriction was associated with increased odds of cigarette
smoking among high school students relative to other school districts
(Ref. 114). However, another study reported a methodological mistake
with these findings: data collection for the 2019 YRBS in San Francisco
occurred in Fall 2018, prior to when the San Francisco flavor
restriction was enforced in April 2019 (Ref. 115). As noted above,
another study of the San Francisco policy observed an overall decline
in tobacco product sales and total cigarette sales, suggesting that
there was not complete substitution of tobacco or unflavored products
for flavored products following the flavor restriction in San Francisco
(Ref. 52).
In addition to the local U.S. jurisdictions discussed previously, a
study of local level restrictions across Massachusetts from 2011-2017
found that counties with greater proportion of county residents covered
by local policies that limit the sale of flavored tobacco products
(excluding menthol) were associated with a decrease in the number of
days high school students smoked cigarettes in the past 30 days and a
decrease in the likelihood of their e-cigarette use (Ref. 116). This
study illustrates the potential for flavor restrictions to reduce youth
tobacco use.
Evaluations of a national flavored tobacco policy in Canada
reinforce trends observed in jurisdictions that enacted flavored
tobacco policies in the United States, including a decrease in cigar
sales and a decrease in use of cigars among young people. In 2009, the
government of Canada prohibited the use of characterizing flavors
(excluding menthol) in cigarettes and cigars under 1.4 grams, or in any
cigar that had a filter or non-spiral wrap. Using wholesale sales
volumes, one evaluation examined trends in sales of flavored cigars
during the 2004-2016 period, with equal periods of 6 years before and 6
years after enactment of the 2009 restriction (Ref. 112). The analysis
found that overall cigar sales decreased 49.6 million units and sales
of flavored cigars decreased 59 million units in the quarter
immediately following policy enactment (i.e., first quarter of 2010).
Sales of cigars with no flavor descriptors increased 9.6 million units
in the quarter immediately after policy implementation (Ref. 112).
Another evaluation assessed the impact of Canada's 2010 ban on the sale
of flavored cigarillos (Ref. 113). This evaluation analyzed data from
the 2007 to 2011 Canadian Tobacco Use Monitoring Survey and found that
the policy was associated with a statistically significant 2.3
percentage point decrease in past 30-day cigarillo use and a
statistically significant 4.3 percentage point increase in past 30-day
abstinence, defined as no cigar use in the prior 30 days among previous
cigarillo users among young people aged 15 to 24 years. Cigarillo use
declined in the older age group, 25 to 65 years, but the decline was
not statistically significant. The study noted that there was some
evidence of a small increase in use of cigars other than cigarillos or
little cigars that were not included in the policy, and the analysis
did not distinguish flavored cigarillo from unflavored cigarillos (Ref.
113).
Taken in totality, these studies of the impact of real-world
restrictions on flavored tobacco products provide insight into the
likely responses of youth and young adults as well as current cigar
smokers to the proposed standard, including decreases in youth and
adult cigar use. However, we acknowledge there are limitations to the
application of these findings. One limitation includes the timing of
data collection on cigar use. Some of the evaluation studies rely on
data collection only after the policy with retrospective recall of
cigar use prior to policy implementation. Furthermore, the duration of
followup time varied between studies, and those with shorter followup
times (e.g., Refs. 61 and 62) may have underestimated the impact on
cigar use. Limitations also include that some studies rely on aggregate
tobacco sales information as a proxy for consumption, rather than data
concerning individual-level tobacco use behaviors. Certain analyses
used cigar sales as a proxy for consumption, given that sales and
consumption tend to be highly correlated (Refs. 117-119). Furthermore,
a number of noted studies used state or nationally representative
surveys of youth and young adults to assess differences in tobacco use
before and after policy implementation. Some of these studies were able
to assess changes in cigar use specifically, while others assessed
changes in overall tobacco use or flavored tobacco use more broadly.
Lastly, smokers may have obtained flavored cigars through alternate
means (e.g., internet sales) that would not have been captured in sales
data in these studies, or smokers may have switched to tobacco products
not subject to restrictions, which may have resulted in an
overestimation of the impacts of the restrictions, unless changes in
overall tobacco use was accounted for. Despite these limitations, these
real-world evaluations provide important insight into how sales and
tobacco use change in response to restrictions on flavored tobacco
products, including cigars. These evaluation studies further
demonstrate that the proposed prohibition on characterizing flavors
(other than tobacco) in cigar products would reduce the rate of youth
and young adult experimentation and progression to regular tobacco use
and increase cessation among current cigar smokers. Section VI of this
document draws on such findings to estimate the impact of the proposed
rule on population health, including the likelihood that existing cigar
smokers would stop smoking as well as the likelihood that nonusers
would start smoking cigars.
G. Flavored Cigars Are Marketed Disproportionately in Underserved
Communities and to Vulnerable Populations
Tobacco marketing activities--e.g., advertising and promotions--are
effective in promoting sales, increasing tobacco use, and engendering
positive attitudes about tobacco companies and their products among
youth, young adults, and other vulnerable populations (Refs. 37, 120,
and 121). With regard to cigars, decades of targeted marketing
activities have helped make cigars more appealing and affordable and
contributed to the pervasive and enduring nature of disparities in
cigar use in vulnerable populations.
A robust body of scientific evidence shows that tobacco is
disproportionately marketed in underserved communities and to
vulnerable populations, such as youth and young adults, some racial and
ethnic populations, individuals who identify as LGBTQ+, pregnant
persons, those with lower household income and educational attainment,
and individuals with behavioral health conditions. Storefront and
outdoor tobacco marketing as well as point-of-sale marketing are all
disproportionately present in African American/Black, Hispanic/Latino,
and low-income communities (Refs. 122-129). Additionally, tobacco
companies have historically targeted African Americans, LGBTQ+
communities, and low-income populations by using strategies such as
offering coupons and other price promotions to entice these groups to
use tobacco products (Refs. 122 and 130). This evidence holds true for
combusted tobacco products, including cigar and flavored cigar
products.
Industry documents reveal that tobacco companies have for many
[[Page 26413]]
decades strategically marketed flavored cigars to encourage trial and
initiation among vulnerable populations. For example, a 1969 industry
report noted the introduction of new flavored cigar products ``aimed
directly at youth,'' as well as marketing campaigns targeting youth by
including special offers, such as record albums (Refs. 16 and 79).
Similarly, a 1972 report on the findings of an industry consumer
research study concluded that adding menthol and mint flavor to little
cigars was appealing to young (not defined) study participants and
recommended marketing this flavored cigar product at a lower price
point than cigarettes in order to attract young users (Refs. 16 and
131). Industry documents also disclose that tobacco companies targeted
Black consumers, including by offering sampling and distribution
opportunities as well as publishing advertisements in Black-only
newspapers (Refs. 16, 132, and 133). Furthermore, hip-hop artists, DJs,
and music events are all avenues tobacco companies have used to attract
African Americans to use flavored little cigars and cigarillos (Ref.
16). Industry market research also studied how to increase cigar use
among young women, including the addition of flavors to improve
palatability and mildness and thereby promote product trial. Segments
of the industry used this information to inform marketing and product
development targeted at women such as adding appealing flavors,
reducing cigar size so they could fit into purses or pockets, and
including celebrities in advertisements (Refs. 16 and 131).
The tobacco industry's historic practice of marketing to vulnerable
populations has resulted in long-term consequences for these
communities. Scientific evidence indicates that tobacco marketing
influences social norms around tobacco use, making tobacco use more
socially acceptable and increasing the likelihood of tobacco use (Refs.
134-137). In underserved communities where the tobacco industry has
disproportionately marketed over decades, these social norms are
transferred through social networks of peers and generations of
families, thereby contributing to present-day tobacco-related health
disparities in these populations (Refs. 134, 135, 138, and 139).
Furthermore, recent scientific evidence indicates that tobacco
companies continue to target populations from underserved communities
with cigar marketing, including flavored cigar marketing (see, e.g.,
Refs. 140-146). Across diverse marketing platforms, ranging from
traditional print media to online platforms, populations from
underserved communities are disproportionately exposed to cigar
advertisements.
Brick-and-mortar tobacco retailers are present in disproportionate
numbers in neighborhoods of underserved communities, particularly in
Black communities. Studies have found that the more Black residents
there are in a census tract, the more tobacco retailers there are in
that census tract, with a statistically significant positive
association between tobacco retailer density and the proportion of
residents who are Black (Refs. 124-127). Two systematic reviews and
several studies found that tobacco retailers in predominately African
American/Black neighborhoods were statistically significantly more
likely to sell cigars and cigarillos, were statistically significantly
more likely to have exterior advertisements for cigars and cigarillos,
and were statistically significantly more likely to sell cigars and
cigarillos at a lower price, as compared to tobacco retailers in other
neighborhoods (Refs. 125, 127, and 146-149). Furthermore, two
nationally representative studies found that retailers in Black
neighborhoods were more likely to place interior advertisements at or
below 3 feet off the floor, at a point where cigar advertisements are
more visible to youth, compared to tobacco retailers in predominately
non-Hispanic White neighborhoods (Refs. 143 and 144).
Higher exposure to tobacco advertisements and retailing are
associated with disparities in tobacco use susceptibility and tobacco
use among youth. For example, a nationally representative study of
youth found that exposure to cigar advertisements at the point-of-sale
was statistically significantly associated with high curiosity about
using cigars, with non-Hispanic Black (14.8 percent) and Hispanic youth
(11.9 percent) being statistically significantly more likely to be
highly curious about cigars as compared to non-Hispanic White youth
(7.6 percent). This finding raises concern because curiosity about
using tobacco products predicts tobacco use susceptibility, tobacco use
initiation, and progression to regular tobacco use among youth (Ref.
150). Similarly, a longitudinal study of middle and high school
students found that recall of tobacco advertisements and products at
the point-of-sale at baseline predicted current cigar use at a 6-month
followup (Ref. 151). Additionally, one cross-sectional study found that
youth who reported going to a corner, convenience, or other retail
store on the way to or from school frequently had statistically
significantly higher odds of current use of cigars, little cigars, and
cigarillos (Ref. 152).
Taken together, scientific evidence indicates that cigars and
flavored cigars historically have been and continue to be
disproportionately marketed in underserved communities and that the
presence of flavors in cigars is intended to encourage trial and
initiation and deter tobacco cessation. The differences found in
exposure to flavored cigar marketing contribute to observed disparities
in tobacco use and associated tobacco-related health disparities and
health outcomes among vulnerable populations, as further discussed in
section V.F of this document. While targeted marketing is only one
factor in the development and perpetuation of flavored cigar use and
related harms, this background helps to explain and provide critical
context for the outcomes and disparities that undermine public health
and are of great concern to FDA. FDA remains committed to improving
health outcomes across the population as a whole, including within
groups that experience disproportionate levels of tobacco use, such as
the vulnerable populations discussed in this section.
V. Cigar Use Is Common, Addictive, and Harmful
A. Prevalence of Cigar Use Among Youth, Young Adults, and Older Adults
in the United States
Patterns of cigar use differ markedly by age group, race and
ethnicity, household income and educational attainment, and among
others who have systematically experienced greater obstacles to health
based due to the inequitable distribution of social, political,
economic, and environmental resources, such as individuals who identify
as LGBTQ+ and persons with disabilities.
1. Cigar Use Prevalence in Youth and Young Adults
Evidence from national surveys, including the Monitoring the Future
study of 8th, 10th, and 12th grade students and the NYTS of middle and
high school students, has suggested that, similar to cigarettes, cigar
use has been on the decline among U.S. youth in recent years (Refs. 153
and 154). However, in 2020, cigars were the most commonly reported
combusted tobacco product used by youth (Ref. 7). Nationwide, in 2020,
nearly 1 million youth had smoked a cigar on at least 1 day during the
past 30 days (Ref. 7). According to the 2020 NYTS, an
[[Page 26414]]
estimated 960,000 middle and high school students (3.5 percent),
including 5.0 percent (770,000) of high school students (grades 9-12)
and 1.5 percent (180,000) of middle school students (grades 6-8), had
smoked a cigar (cigar, cigarillo, or little cigar) in the preceding 30
days (Ref. 7). The most recent NYTS data also found that, of those
youth who use cigars, the largest proportion use cigarillos (44.1
percent), followed by regular cigars (33.1 percent), and little cigars
(22.6 percent) (Ref. 8). Of note, 21.8 percent of youth who are current
users report not knowing which cigar type they use (Ref. 8).
While there has been an overall downward trend in cigar use among
youth in general, cigar use--particularly flavored cigar use--remains
significant, and this decrease has not been equitably experienced as
the popularity of cigar use remains disproportionately high among non-
Hispanic Black youth (Ref. 7). Tobacco-related health disparities
result, in part, from inequitable practices and denial of opportunities
that prevent some communities from fully participating in aspects of
economic, social, and civic life. These inequities influence
vulnerabilities that some populations experience across the continuum
of tobacco use. For example, disparities in initiation and prevalence
of cigar use that are connected to inequitable treatment and
opportunities likely contribute to and reinforce the continued tobacco-
related vulnerabilities of Black youth as subsequent disparities are
observed along the continuum of tobacco use for these youth. The 2020
NYTS data show that the popularity of cigars is especially high among
non-Hispanic Black middle and high school students, as 6.5 percent
reported past 30-day cigar use compared to 2.8 percent of non-Hispanic
White students (Ref. 7). Additionally, the findings show that cigar use
was statistically significantly higher than cigarette use among non-
Hispanic Black high school students in 2020, with 9.2 percent reporting
having smoked cigars during the past 30 days, compared with 2.8 percent
reporting having smoked cigarettes (Ref. 7). Data also indicate that
non-Hispanic Black youth have a higher risk than White youth of
initiating cigar use at earlier ages. An analysis of 2013-2017 PATH
Study youth (aged 12-17 years) data indicated that, when compared to
non-Hispanic White youth, non-Hispanic Black youth were 47 percent more
likely to initiate past 30-day cigarillo or filtered cigar use and 111
percent more likely to be ``fairly regular'' users of these products
(Ref. 25). These observed disparities in cigar use initiation are
associated with higher levels of current cigar use and frequency of
cigar use among Black youth and young adults. An analysis of data from
a longitudinal cohort study found that once Non-Hispanic African
American youth and young adults had initiated cigar use, they had twice
the odds of current cigar use within 6 months relative to non-Hispanic
Whites (Ref. 100). Also, within 6 months of initiation, the average
frequency of use and days per month used was higher for non-Hispanic
African Americans compared to non-Hispanic Whites (Ref. 100). Findings
from the 2013 Cuyahoga County Youth Risk Behavior Survey indicate that
non-Hispanic Black youth had statistically significantly higher odds of
using cigars as compared to non-Hispanic White youth (Ref. 155).
Disparities in cigar use among Black youth may also pose additional
concerns due to the increased risk associated with polyuse with other
combusted tobacco products. Cigarette smoking being perceived as
harmful reduced the likelihood of cigar use among all racial and ethnic
categories of youth except for non-Hispanic Black youth, who were
statistically significantly more likely to be current cigar users if
they perceived smoking cigarettes as harmful (Ref. 155). Moreover, use
of cigars among Black youth disproportionately leads to cigarette
smoking. In a nationally representative longitudinal study of youth,
ever cigar use statistically significantly increased the odds of
subsequent past-30-day cigarette use among non-Hispanic Black youth
(Ref. 156). However, ever cigar use did not increase the odds of
subsequent past 30-day cigarette use among non-Hispanic White youth
(Ref. 156). This study found that 9.1 percent of cigarette initiation
among non-Hispanic Black youth was directly attributable to cigar use,
compared with only 3.9 percent among non-Hispanic White youth (Ref.
156).
Youth and young adults who identify as LGBTQ+ also face tobacco-
related health disparities when compared with non-LGBTQ+ counterparts,
including higher prevalence of tobacco product use as well as cigar
use.\15\ In 2020, NYTS analysis found that past 30-day use of any
tobacco product was higher among youth identifying as lesbian, gay, or
bisexual than heterosexual youth (25.5 percent vs. 15.1 percent) (Ref.
7). Past 30-day cigar use was nearly twice as prevalent among youth
identifying as lesbian, gay, or bisexual than heterosexual youth (6.0
percent vs. 3.1 percent) (Ref. 7). Findings from an analysis of Wave 3
PATH Study data (2015-2016) indicated that, similar to patterns among
adults, lesbian and bisexual girls have even higher disparities and are
more than twice as likely than their heterosexual peers to report ever
using cigars (11.3 percent vs. 5.2 percent) and to have used cigars in
the past 30 days (3.2 percent vs. 1.0 percent) (Ref. 157). An analysis
of the 2015 YRBS data found that lesbian and bisexual girls have
statistically significantly higher current use prevalence of cigars
than their heterosexual peers (16.4 percent for lesbian girls, 10.2
percent for bisexual girls, 5.4 percent for heterosexual girls), as do
gay and bisexual boys (20.0 percent for gay boys, 16.9 percent for
bisexual boys, and 13.5 percent for heterosexual boys) (Ref. 158).
Findings from a nationally representative cohort study indicated that
young adults who identified as homosexual reported higher ever cigar
use compared to young adults who identified as heterosexual (Ref. 159).
Transgender youth also are statistically significantly more likely than
non-transgender youth to report ever using any tobacco product (53.6
percent vs. 31.5 percent) including cigars (16.1 percent vs. 7.5
percent) and past 30-day use of more than one tobacco product,
including cigars (10.2 percent vs. 3.5 percent) (Ref. 157). Study
findings from a young adult cohort study indicated that past 30-day
little cigars/cigarillos/bidis use was greater for young adults who
identified as LGBT in comparison to those who did not identify as LGBT
(Ref. 160).
---------------------------------------------------------------------------
\15\ FDA acknowledges that sexual orientation is distinct from
gender identity and that discussion and consideration of these
factors in the context of public health should recognize and account
for that distinction. However, the relevant scientific studies cited
herein do not provide data separated by sexual orientation and
gender identity. Due to these study limitations, we discuss sexual
orientation and gender identity in a combined manner, despite their
important distinctions.
---------------------------------------------------------------------------
Youth with disabilities also have higher rates of cigar use than
their nondisabled peers. In one study of more than 20,000 11th graders
in Oregon that controlled for sociodemographic risk factors of tobacco
use, the proportion of little cigar use among students with at least
one reported disability (7.0 percent) was statistically significantly
higher than among students without a disability (5.4 percent) (Ref.
161).
2. Cigar Use in Adults
Cigars are also a popular tobacco product among adults. In the 2019
National Health Interview Survey (NHIS), 3.6 percent of adults 18 or
older reported currently using cigars some or every day, behind
cigarettes (14 percent)
[[Page 26415]]
and e-cigarettes (4.5 percent) (Ref. 68). Comparing 2011 to 2019, while
past month cigarette smoking and cigar use were both statistically
significantly lower in young adults (aged 18-25 years), the absolute
decline in cigar use was less than the decline in cigarette use (33.5
percent in 2011 to 17.5 percent in 2019 for cigarettes; 10.9 percent in
2011 to 7.7 percent in 2019 for cigars) (Ref. 59). For adults (aged 26
years or older), cigarette use in 2011 was statistically significantly
higher compared to in 2019; however, cigar use remained relatively
stable and did not significantly change (21.9 percent in 2011 to 18.2
percent in 2019 for cigarettes; 4.2 percent in 2011 to 4.0 percent in
2019 for cigars) (Ref. 59). The 2019 NSDUH found that among adults aged
26 or older in 2019, 1,420 individuals initiated cigar use each day,
considerably more than the 247 who initiated cigarette smoking each day
in that year (Ref. 59).
Prevalence of cigar smoking, however, varied by the type of cigar
smoked. Analysis of Wave 5 (2018-2019) data from the PATH Study found
that, 4.8 percent of young adults (aged 18-24 years) used traditional
cigars; 7.9 percent used cigarillos, and 2.4 percent used filtered
cigars in the past 30 days (Ref. 63). According to the most recent data
from the PATH Study (2018-2019), 3.5 percent of adults (aged 25 years
and older) used traditional cigars, 3.3 percent used cigarillos, and
1.6 percent used filtered cigars in the past 30 days (Ref. 63).
Similar to youth and young adults, adults (aged 25 years and older)
reported use of flavored cigars and are expected to benefit from the
proposed product standard if finalized. Wave 5 (2018-2019) data from
the PATH Study showed that 36.0 percent of adult cigar smokers (aged 25
years and older) reported past 30-day use of flavored cigar from 2018-
2019 (Ref. 63). Among adult cigar smokers, a statistically
significantly greater proportion of adult traditional cigar smokers
(19.7 percent) reported use of a flavored cigar in the past 30 days
compared with adult smokers of all other cigar types (46.5 percent for
cigarillos and 48.7 percent for filtered cigars) (Ref. 63). The
proportion of adults using flavored cigars within each of the cigar
types did not differ over time across recent PATH Waves 4-5 (2016-2019)
(Ref. 63).
A disproportionate proportion of cigar smoking occurs among
vulnerable populations; this burden has grown over the past two
decades. In the 2019 NHIS, 4.4 percent of non-Hispanic Black, 3.8
percent of non-Hispanic White, and 3.0 percent of Hispanic adults
reported some or everyday cigar use (Ref. 68). In an analysis of 2002-
2016 NSDUH data for individuals aged 12 and older, non-Hispanic Black
individuals were statistically significantly more likely than all other
racial and ethnic groups to have used cigars in the past 30 days (Ref.
162). Decreases in prevalence of cigar use have not been observed in
non-Hispanic Black adults as they have for other racial and ethnic
groups (Ref. 162). There were no statistically significant changes in
past 30-day use prevalence between 2002-2016 in the NSDUH data among
non-Hispanic Black and non-Hispanic other/mixed race adults while there
were decreases among both non-Hispanic White and Hispanic adults.
Further, over this same time period, cigar use decreased among non-
Hispanic White men and stayed the same among non-Hispanic White women,
but it increased among non-Hispanic Black women and remained the same
among non-Hispanic Black men (Ref. 162). When considering more recent
NSDUH data, these racial and ethnic disparities have persisted, with
the prevalence of past 30-day cigar smoking remaining statistically
significantly higher among non-Hispanic Blacks compared to non-Hispanic
Whites through 2019 (Ref. 59).
A recent analysis of PATH Study data from Wave 3 (2015-2016) showed
differences in daily cigar smoking by racial and ethnic group (Ref.
163). Non-Hispanic Black individuals are statistically significantly
more likely to report that they have ever been a ``fairly regular''
cigar smoker (5.4 percent) than non-Hispanic White cigar smokers (2.5
percent) and to report that they smoke cigars daily (1.9 percent),
compared to non-Hispanic White cigar smokers (0.5 percent), with these
differences being most pronounced for cigarillos (3.7 percent vs. 0.9
percent) (Ref. 163). Hispanic adults were more likely to smoke cigars
within 30 minutes of waking, when compared with non-Hispanic Whites
(Ref. 163). The analysis found a consistently higher prevalence of use
for non-Hispanic Blacks, compared with non-Hispanic Whites for three
cigar-smoking outcomes (past 30-day use, daily use, and established
use) across all the cigar types (Ref. 163).
Differences in prevalence have been observed across cigar type and
in the use of flavors across racial and ethnic populations. In the PATH
Study, past 30-day cigarillo use was statistically significantly higher
among non-Hispanic Black young adults (aged 18-24 years) and adults
(aged 25 years and older) compared with non-Hispanic Whites and
Hispanics at all waves (2013-2019) (Ref. 63). Past 30-day use of
flavored traditional cigars was statistically significantly higher
among non-Hispanic Black older adults (aged 25 years and older)
compared to non-Hispanic White adults at Waves 2-5 (2014-2019) and
compared to Hispanic adults at Waves 2-3 (2014-2016) and Wave 5 (2018-
2019) (Ref. 63). An analysis of survey data on college students
indicated that Black young adults were three times more likely to smoke
flavored cigars than White young adults (Ref. 66). Hispanic and Asian
participants were also more likely to use flavored cigars over non-
flavored cigars compared to non-Hispanic White participants (Ref. 66).
Younger participants (aged 18-24 years) had greater odds of using
flavored cigars when compared to older participants (aged 25-29 years)
(Ref. 66).
Differences in prevalence of cigar use have also been observed
across other population groups. Research indicates social gradient
effects (where higher levels of household income and educational
attainment are linked to better health outcomes and lower levels of
household income and educational attainment are linked to poorer health
outcomes) for cigar use. Data from the 2012-2013 NATS show that higher
educational levels and higher annual household income generally were
associated with lower prevalence of usual use of cigarillos, other mass
market cigars, and of little filtered cigars (Ref. 164). Data from the
PATH Study in 2018-2019 show that there was a statistically significant
difference in past 30-day cigar use by education level as 7.3 percent
of adults (aged 25 years and older) with less than a high school
diploma smoked cigars in the past 30 days, compared to 3.8 percent of
adults with a college degree or higher (Ref. 63). Among adults who used
any cigar in the past 30 days, individuals with a college degree were
statistically significantly less likely to use a flavored cigar (20.0
percent) than individuals categorized as having less than a high school
diploma (44.9 percent), a high school diploma (37.4 percent), or some
college (42.9 percent) (Ref. 63).
Tobacco-related cancers are a leading cause of death among adults
experiencing homelessness (Ref. 165). In a study of 470 unhoused
individuals, the analysis found that past 30-day use of all tobacco
products was high and that 74.0 percent of respondents reported use of
cigars and over half (55 percent) reported use of flavored cigars in
the past 30 days (Ref. 166).
Adults over 18 with at least one chronic health condition (e.g.,
heart disease, hypertension, stroke, diabetes, asthma, lung cancer,
hepatitis, human
[[Page 26416]]
immunodeficiency virus infection, anxiety, depression, substance abuse)
have been shown in one study to be more than one and a half times more
likely than those without a chronic health condition to use cigars,
with no statistically significant changes over time (Ref. 167). In
particular, adults who have anxiety, depression, or substance use
disorders have cigar use rates statistically significantly greater than
those with no chronic health conditions (Ref. 167). This association
holds for mentholated tobacco products, including cigars, which are
used disproportionately by young adults (aged 18-34 years) who report
mental health disorders, with past 30-day menthol tobacco product use
being associated with greater odds of anxiety and depression when
controlling for other tobacco and mental health risk factors (Ref.
168). Likewise, using Waves 1-4 (2013-2017) of PATH Study data, adults
who reported past-year severe internalizing problems were more likely
to have initiated use of flavored cigarillos since the prior PATH wave,
and were also more likely to be past-30-day users of flavored
cigarillos (Ref. 169).
Adults who identify as LGBTQ+ are more likely to use tobacco
products, including cigars, and to meet the criteria for nicotine
dependence when compared to their heterosexual and cisgender peers,
with these associations being stronger for some racial and ethnic
populations (Refs. 68, 157, 159, 160, and 170-173). For example, while
adults who identified as gay/lesbian, bisexual, and ``conflicting''
(defined by study authors as those who identified as ``heterosexual,
had engaged in either no sexual behavior or exclusively heterosexual
behavior, but reported some levels of same-sex attraction'') are more
likely than their heterosexual peers to use tobacco and meet tobacco
use disorder criteria, Hispanic and non-Hispanic Black bisexual adults
have even stronger associations for current tobacco use than do their
White bisexual peers (Ref. 172). Overlapping forms of disadvantage can
interact to create and exacerbate tobacco-related health disparities.
For example, discrimination experienced on the basis of gender identity
or sexual orientation often overlaps with discrimination experienced on
the basis of race or disability.\16\ As discussed in section IV.G of
this document, the tobacco industry disproportionately targets its
marketing to those who identify as LGBTQ+ and some racial and ethnic
populations. For example, adults who identify as lesbian, gay,
bisexual, or transgender report higher rates of tobacco media exposure
compared to their peers who do not identify as lesbian, gay, bisexual,
or transgender (Ref. 141), which can lead to use of tobacco products,
including cigars (Refs. 141 and 172).
---------------------------------------------------------------------------
\16\ See, e.g., E.O. 13988, ``Preventing and Combating
Discrimination on the Basis of Gender Identity or Sexual
Orientation'' (86 FR 7023, January 25, 2021).
---------------------------------------------------------------------------
Generally, findings indicate that adults who identify as lesbian,
gay, bisexual, or transgender have a higher prevalence of experimental
and current cigar use compared to their heterosexual peers (Refs. 159
and 173-175). Findings from an analysis of the 2012-2013 NATS data
indicated that among women who identified as lesbian or gay, bisexual,
or ``something else'' (an option provided in the study), cigar use was
more than triple the rate of heterosexual women (Ref. 176). Data from
the 2015-2017 NSDUH, indicate that lesbian and bisexual women had more
than twice the odds of using cigars in the past year relative to
heterosexual women (Ref. 170). These findings are consistent with those
from a 2013 cross-sectional survey study showing that lesbian and
bisexual women had more than twice the odds of current cigar use
relative to heterosexual women (Ref. 173).
Adults who identify as transgender are more likely to use tobacco
products, including cigars, than their cisgender peers. In a national
cross-sectional online survey, transgender adults reported higher
current (past 30-day) use of any cigarette/e-cigarette/cigar product
(39.7 percent vs. 25.1 percent) (Ref. 177). This study also found that
transgender adults had higher current use of cigars (26.8 percent vs.
9.3 percent), specifically, when compared with cisgender adults as well
as statistically significantly higher odds of past 30-day tobacco
product use for any cigarette/e-cigarette/cigar product and for cigars,
compared to cisgender adults (Ref. 177).
These disparities also exist for flavored cigar use, as data from
the 2009-2010 NATS indicated that adults who identify as lesbian, gay,
bisexual, or transgender have a higher prevalence of flavored cigar use
(8.2 percent) compared to the national prevalence (2.8 percent) and
when compared to cigar users nationally (42.9 percent) (Ref. 70). Data
from the 2011-2015 Truth Initiative Young Adult Cohort Study showed
that respondents who identified lesbian, gay, or bisexual had higher
odds of reporting past 30-day flavored large cigar and LCC use compared
to respondents who identified as straight/heterosexual (Ref. 67).
3. Polyuse of Tobacco and Cigar Prevalence
FDA finds that recent trends toward polyuse of tobacco (i.e., the
use of two or more tobacco products) also support the Agency's
conclusion that this proposed rule would have positive impacts on
public health. Polyuse increases exposure to nicotine (Ref. 178) and
other harmful constituents of tobacco products and tobacco smoke. Using
data from the 2017-2018 NYTS survey, one study found that 40.8 percent
of middle and high school aged youth past 30-day tobacco users were
using two or more tobacco products in the past month (Ref. 107). Among
youth using cigars in the past 30 days, a majority, 76.1 percent, used
cigars in combination with one or two additional tobacco products (Ref.
107). Among youth in the 2017-2018 NYTS data, cigarettes and e-
cigarettes were the most common products used alongside cigars (Ref.
107).
The cumulative exposure from polyuse can sustain and may increase
levels of tobacco dependence. A 2017-2018 analysis of NYTS data found
that 43.1 percent of youth current cigar smokers, including polyusers,
reported nicotine dependence, including feeling strong craving to use a
tobacco product or using a tobacco product within 30 minutes of waking
(Ref. 107). When looking at the association between cigar use and
dependence, frequent cigar use (i.e., use on 20 to 30 days in the past
30 days) was associated with increased odds of nicotine dependence as
compared to less frequent users (Ref. 107). Exclusive use of cigars was
associated with lower odds of dependence relative to exclusive use of
another tobacco product. However, most youth cigar users in the study
used cigars and one or more other tobacco products. When cigar use
included polyuse and exclusive use, youth cigar use was associated with
twice the odds of nicotine dependence (Ref. 107). Given the role of
frequent and polyuse in the relationship between cigar use among youth
and dependence, the authors note ``. . . the importance of examining
behaviors related to use, as they can affect and/or exacerbate the risk
of nicotine dependence'' (Ref. 107).
An analysis of tobacco dependence among daily cigarette, cigar, and
e-cigarette users in the United States, using data from the 2012-2013
NATS, found that compared to cigarette-only smokers, dual cigarette and
cigar smokers exhibited greater dependence, with a higher average
number of cigarettes smoked per day (17.3 vs. 15.8), shorter times to
first tobacco use
[[Page 26417]]
after waking (21.4 minutes vs. 25.9 minutes), and more frequent
reporting of withdrawal and craving symptoms compared to exclusive
cigarette smokers (Ref. 179). In addition, data from Wave 1 (2013-2014)
of the PATH Study demonstrates that high nicotine dependence is two to
three times more likely among poly users compared to dual and single
product users (Ref. 180). Data from the 2012 and 2019-2020 NYTS also
noted that reports of dependence were consistently associated with
polyuse (Refs. 181 and 182).\17\ FDA anticipates this proposed product
standard would help to reduce the number of cigar users and, therefore,
the number of tobacco users who are poly users and likely even more
tobacco dependent.
---------------------------------------------------------------------------
\17\ FDA is not aware of additional analyses that examine
dependence in youth in NYTS data using 2013-2018 data.
---------------------------------------------------------------------------
B. Flavored Cigar Use Exposes Users to Additional Toxicants
All cigar users, including flavored cigar users, are exposed to
toxicants, including more than 50 carcinogens in mainstream and
sidestream cigar smoke (Ref. 183). In flavored combustible tobacco
products, including cigars, additional toxicity can result from the
chemicals formed when flavors are heated or burned (Refs. 184-187). For
example, acetaldehyde, formaldehyde, and benzene were found during
pyrolysis (i.e., thermal decomposition or the process of breaking down
a product under the presence of heat) of 18 different cigarette flavor
additives, and various polycyclic aromatic hydrocarbons (PAHs) were
also detected during pyrolysis of cocoa (Ref. 188). Similar results
would be expected for cigar flavor additives (Ref. 189). A study
conducted by the Centers for Disease Control and Prevention (CDC)
identified benzyl alcohol, piperonal, methyl cinnamate, and vanillin in
strawberry cigar filler (Ref. 190). The table below summarizes examples
of known respiratory and other relevant toxicities associated with
these ingredients (and subcomponents) and their potential pyrolysis
products.
Table 2--Flavor Ingredient Pyrolysis and Potential Health Hazards
------------------------------------------------------------------------
Chemical reaction Health hazard of
Flavor ingredient product flavor ingredient
------------------------------------------------------------------------
Benzaldehyde............... Benzene, Carbon Respiratory
monoxide (CO) (Refs. irritant and
191 and 192). toxicant (Ref.
193).
Benzyl alcohol............. Benzene, toluene (Refs. Acute inhalation
194 and 195). toxicant; Nose,
throat, and
respiratory tract
irritant (Ref.
196).
Ethyl maltol............... Acetaldehyde, acrolein, Mutagen (Ref.
CO, formaldehyde, 1,3- 199).
butadiene, acetone,
propionaldehyde,
crotonaldehyde, methyl
ethyl ketone (Refs.
197 and 198).
Ethyl vanillin............. Benzene, naphthalene Respiratory
(Ref. 200). irritant (Ref.
201).
Hexyl acetate.............. CO (Ref. 202).......... Respiratory
irritant (Ref.
203).
Methyl cinnamate........... Styrene (Ref. 185)..... Sensitization
(Ref. 204).
Piperonal.................. 1,3-butadieneButadiene, Mutagenic;
benzene (Ref. 188). hepatoxic in rats
(Ref. 205).
Vanillin................... Benzene, catechol, Respiratory
naphthalene, phenol, irritant (Ref.
[ogr]-cresols, toluene 207).
(Refs. 200 and 206).
------------------------------------------------------------------------
FDA expects that the proposed product standard, if finalized, would
result in reduction or removal of such flavoring ingredients in cigars.
Reducing flavoring ingredients in cigars and, thereby, reducing these
toxicant levels in such products would reduce consumer exposure to
these toxicants and help to protect consumers from the health effects
of these toxicants.
C. Cigar Use Is Addictive
Through cigar smoke, nicotine can be absorbed by inhalation (like
cigarettes) or through the oral mucosa (like smokeless tobacco).
Multiple studies found that cigar smokers inhale (as evidenced by CO
levels), and plasma nicotine levels are similar to those of cigarette
smokers (Refs. 101-104 and 208).
All cigars contain nicotine, a highly addictive chemical. The
Surgeon General has long recognized that the addictive nature of
tobacco products is due to the presence of highly addictive nicotine
that can be absorbed into the bloodstream and pass into the brain
(e.g., Ref. 121). Nicotine is ``one of the most addictive substances
used by humans'' (Ref. 209). Given that nicotine is highly addictive
and present in all cigars, as experimenters continue to use these
products, there is a risk of nicotine dependence and progression to
regular use, resulting in an increased risk of developing the many
negative health consequences associated with regular cigar use.
Prohibiting characterizing flavors (other than tobacco) in cigars is an
important step toward reducing experimentation and progression to
regular use since it can reduce the appeal and ease of use of such
products and, consequently, the likelihood of nicotine addiction.
The amount of nicotine delivered, and the means through which it is
delivered, can either reduce or enhance nicotine's potential for abuse
and physiological effects (Ref. 6). Generally, the quicker the nicotine
delivery, rate of absorption, and attainment of peak concentrations,
the greater the potential that an individual will become addicted to
nicotine (Ref. 6). Research has found that little cigars deliver
nicotine levels that are similar to cigarettes and also reduce users'
urge to smoke cigarettes (Ref. 6). Large cigars can deliver as much as
ten times the nicotine of a filtered cigarette (Ref. 183). Factors
determinative of cigars' ability to deliver nicotine at a level capable
of producing dependence include the age of initiation, the rate of
nicotine absorption, the duration of exposure, the degree of cigar
smoke inhalation, and the development of tolerance to nicotine (Ref.
210).
Cigar smoke contains many of the same harmful constituents as
cigarette smoke--including nicotine (Ref. 183). A single cigar can
contain as much tobacco as an entire pack of cigarettes, and nicotine
yields from smoke from a cigar can be up to roughly eight times higher
than yields from smoke from a non-filtered cigarette in machine smoking
regimens--with delivery of 1.7 milligrams (mg) in non-filtered
cigarettes compared to 3.8 mg in little cigars, 9.8 mg in cigarillos/
other mass market cigars, and 13.3 mg in ``premium'' cigars (Ref. 183).
Although the amount of nicotine taken in by a cigar user depends on
various factors,
[[Page 26418]]
such as how long the individual smokes the cigar, the number of puffs
taken, and the degree of inhalation, a leading review of the science of
cigar smoking concluded that ``[c]igars are capable of providing high
levels of nicotine at a sufficiently rapid rate to produce clear
physiological and psychological effects that lead to dependence, even
if the smoke is not inhaled'' (Ref. 210).
Research indicates that most cigar smokers unknowingly inhale some
amount of smoke, including cigar smokers who report that they do not
inhale (Ref. 211; see Ref. 212). Youth more commonly use cigarillos and
little filtered cigars that are designed to be inhaled, which may
increase their risk of poor health outcomes as well as addiction (Refs.
32 and 183). Little cigars are often indistinguishable from cigarettes
given their shape, size, filters, and packaging, and are perceived as
being healthier than cigarettes (Refs. 48 and 49). Even if cigar
smokers do not breathe or inhale smoke into their lungs, they are still
subject to nicotine's addictive effects through buccal absorption of
nicotine or nicotine absorption through the lips due to cigar tobacco's
alkalinity (Refs. 211, 213-215). Cigar smoke dissolves in saliva and
makes it possible for smokers to absorb sufficient amounts of nicotine
to create dependence (Ref. 213).
Nicotine can exist in protonated and freebase, or unprotonated,
forms; in the freebase form, it is most addictive because it is readily
absorbed by the buccal mucosa, respiratory tissues, skin, and the
gastrointestinal tract (Refs. 6 and 121). Freebase, unprotonated
nicotine amounts are generally higher in cigars than cigarettes due to
the higher pH of cigar smoke (Ref. 183). Nicotine absorbed across the
buccal mucosa, the mouth's membrane lining, can provide sustained
amounts of freebase nicotine to the tobacco product user, which, along
with the harshness of cigar smoke, may explain why cigar smokers are
less likely to intend to inhale than cigarette smokers (Ref. 183).
Cigars can deliver nicotine much like chewing tobacco or oral snuff,
with nicotine extraction from the unburned tobacco absorbed directly
through the buccal mucosa and lips (Ref. 183).
In addition, characterizing flavors may impact the effects of
nicotine. In particular, characterizing flavors, including menthol, can
activate the brain's reward circuit, producing rewarding effects that,
when added to tobacco products, can reinforce the effects of nicotine
(Refs. 13 and 14). The use of sweet/candy and other characterizing
flavors that appeal to youth produces a robust reinforcing effect in
young populations (Refs. 13 and 14). One animal study found that
flavors can enhance the reinforcing effects of low nicotine doses in
rodents (Ref. 216). The authors of this study suggest this effect may
influence nicotine exposure and subsequent dependence. While flavors
can activate the brain's reward circuit and produce rewarding effects
on their own (Ref. 14), these findings suggest that flavors and
nicotine can interact to enhance the reinforcing effects of nicotine
(Refs. 13, 216, and 217). Further studies demonstrate that menthol,
like nicotine, binds to nicotinic receptors in the brain (Refs. 218 and
219) and menthol alone can increase the number of nicotinic receptors
in the brain (Refs. 220 and 221). Increases in nicotinic receptors can
lead to greater withdrawal and cravings (Ref. 222). Evidence
demonstrates that menthol's effects on nicotine in the brain are
associated with behaviors indicative of greater addiction to nicotine
(Refs. 220 and 223). In an analysis of 2019-2020 NYTS data, use of one
or more flavored tobacco products, including menthol, during the past
30 days was associated with higher odds of reporting strong cravings
and desire to use tobacco within 30 minutes of waking compared to use
of an unflavored tobacco product (Ref. 182).
A cigar smoker's age is another factor that affects susceptibility
to nicotine addiction. The Surgeon General has noted that nicotine
dependence in cigar smokers could result from even a limited exposure
to nicotine during adolescence (Ref. 6). Analyses of data from the 2012
and 2019-2020 NYTS found that, although the percentage of middle and
high school students reporting various measures of dependence was lower
for cigars than for cigarettes, youth reported measures of nicotine
dependence when exclusively using cigars (Refs. 181 and 182). The
analysis of 2019-2020 NYTS data found that 14.8 percent of middle and
high school students who only smoked cigars reported strong cravings
for a tobacco product during the past 30 days (Ref. 182).
Prohibiting characterizing flavors (other than tobacco) in cigars
would reduce the appeal of cigars, particularly among youth and young
adults, and decrease the likelihood that nonusers would experiment with
cigars. It also would decrease the likelihood that current
experimenters would continue to use these products. Reducing the appeal
of cigars and experimentation is particularly important because, as
experimenters continue to use these products, they can develop
dependence, leading to regular use and increasing their risk of
developing the many negative health consequences associated with
regular cigar use.
D. Research Clearly Demonstrates a Causal Relationship Between Cigar
Smoking and Death and Disease
Flavored cigar smokers, like all cigar smokers, are at increased
risk for developing cancers of the mouth and throat, lung cancer, heart
disease, and many other adverse health consequences, with some groups
with higher rates of use at greater risk than others. As discussed in
section V.C of this document, those who experiment with flavored cigars
(due to their appeal and ease of use) can develop nicotine dependence,
placing infrequent cigar smokers at risk of progression to regular use
and to tobacco-related disease and death. Studies demonstrate that not
only is cigar smoking causally associated with many of the same
diseases as cigarette smoking, but cigar smoking risks can also exceed
those causally associated with cigarette use depending on the number of
cigars smoked and the depth of smoke inhalation (Ref. 32).
Cigar smoke contains many of the same harmful constituents as
cigarette smoke, and cigar smoke may have even higher levels of several
harmful compounds (Refs. 3, 23, and 224). For example, cigar smoke
contains higher amounts of carcinogenic, tobacco-specific N-
nitrosamines than cigarette smoke due to the relatively high
concentration of nitrate in cigar tobacco, which leads to formation of
cancer-causing nitrosamines during the fermentation process (Refs. 23;
183 at Chapter 3; and 224). Researchers have found urinary
concentrations of NNAL (a hazardous tobacco-specific nitrosamine)
measured in daily cigar smokers to be as high as those measured in
daily cigarette smokers (Refs. 225 and 226). Like exposure to cigarette
smoke, exposure to higher levels of cigar smoke for longer time periods
increases the adverse health risks caused by cigar smoking (Ref. 6).
Using NATS data for 2009-2010, researchers have estimated that
regular cigar smoking caused approximately 9,000 premature deaths or
almost 140,000 years of potential life lost among adults 35 years or
older (Ref. 3). A study of healthcare expenditures from 2000-2015 found
that cigar-attributable health care expenditures for adults totaled
$1.75 billion per year, with $284 million attributed to exclusive cigar
smoking and $1.5 billion attributed to non-exclusive cigar smoking
(i.e., cigar plus cigarette or smokeless tobacco use) (Ref. 4). The
overall mortality rates for cigar smokers who inhale generally
[[Page 26419]]
approach the same mortality rates observed for cigarette smokers (Ref.
183 at 110-112). In addition, overall mortality rates for all cigar
smokers (i.e., those who report inhaling as well as those who report
not inhaling cigar smoke) are higher than rates for those who have
never smoked, although they are generally lower than the rates observed
for cigarette smokers (Ref. 183 at 112). A recently published analysis
using more contemporary data from the National Longitudinal Mortality
Study, following participants for mortality from 1980 through the end
of 2011, also found that exclusive cigar smokers had an elevated risk
of all-cause mortality compared to never tobacco users, but lower than
exclusive cigarette smokers (Ref. 227). Another similar analysis using
the restricted-use National Health Interview Survey-Linked Mortality
Files (NHIS-LMF), following participants for mortality from 2000
through 2015, observed that current, daily cigar smokers had elevated
risk of all-cause mortality compared to never tobacco users (Ref. 228).
In addition, researchers studying cigar smokers in 2009 and 2010 found
that the average cigar or pipe smoker loses approximately 15 life-years
(Ref. 3).
Given this causal relationship between cigar smoking and all-cause
mortality, it is critical that FDA propose action to decrease the
appeal and ease of cigar use, making it less likely that youth and
young adults will experiment with cigars or progress to regular use.
FDA also expects that the proposed product standard, if finalized, will
cause a large number of existing cigar smokers to cease combusted
tobacco product use (as discussed in section VI of this document) and,
therefore, be less likely to suffer the negative health consequences of
cigar smoking.
1. Cancers of the Mouth and Throat
The National Cancer Institute's (NCI's) Tobacco Control Monograph
No. 9, which provides a comprehensive, peer-reviewed analysis of the
trends in cigar smoking and potential public health consequences,
identified a dose-response relationship for cigar smoking and certain
types of cancer (Ref. 183 at 120-130). Specifically, NCI's Tobacco
Control Monograph No. 9 identified a dose-response relationship for
cigar smoking and oral, laryngeal, pharyngeal, and esophageal cancers,
finding an increased risk of these diseases with greater numbers of
cigars smoked per day and deeper inhalation (Refs. 183 and 229-232).
Likewise, a systematic review of the mortality risks associated with
cigar smoking that identified 22 studies observed similar dose trends
(Ref. 32).
Cigar smoking can cause cancers of the mouth and throat even in
smokers who report they do not inhale (Ref. 183). According to the
NCI's Tobacco Control Monograph No. 9, the data clearly establish that
cigar smoking is a cause of oral cancer (Ref. 183). Regular cigar
smokers who have never smoked cigarettes, including those who report
that they do not inhale, experience elevated risks for oral, laryngeal,
pharyngeal, and esophageal cancers (Ref. 183). Although former
cigarette smokers who currently smoke cigars are more likely to inhale
more deeply than c
[…truncated; see source link]Indexed from Federal Register on May 4, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.