also examined sales over the same time period in the rest of Rhode
Island (Ref. 109). Sale of explicit flavor-named cigars (e.g.,
``cherry'') in Providence declined 93 percent, while ``concept''
flavor-named cigars (e.g., ``jazz'') increased 74 percent after policy
implementation compared to before policy implementation. Despite the
increase in ``concept'' flavor-named cigar sales, flavored cigar sales
decreased overall, suggesting that ``concept'' flavor-named cigar
consumption did not entirely replace explicit flavored-named cigar
consumption after the policy. The analysis found that average weekly
sales of all flavored cigars decreased 51 percent following policy
implementation in Providence compared to before policy implementation
and increased 10 percent across the rest of the state during the same
time period (Ref. 109). Average weekly sales of all cigars decreased 31
percent following policy implementation in Providence and decreased 6
percent across the rest of the state during the same time period (Ref.
109). This study illustrated that flavored cigar use decreased
following policy implementation alongside an increase in sales in the
rest of the state. While concept-flavored cigar sales increased in
Providence and the rest of the State, the overall decline in flavored
sales suggests that flavored cigar use was only partially offset by an
increase in concept-flavored use.
    Another evaluation of the Providence restrictions examined youth
tobacco use including cigar use through a school-based survey of over
2,000 10th and 12th grade students at two time points after
Providence's sales restriction was in effect: 2016 (3 years post-
restriction) and 2018 (5 years post-restriction) (Ref. 60). This
analysis found that youth current use of any tobacco product declined,
from 22.2 percent in 2016 to 12.1 percent in 2018; and current use of
cigars/cigarillos declined from 7.1 percent in 2016 to 1.9 percent in
2018 (Ref. 60). This study illustrates a decline in youth cigar use
after increased enforcement of the policy in Providence, which is
consistent with the analysis of sales data in Providence (Ref. 109).
    Lowell, MA, enacted a restriction on flavored tobacco except for
menthol-, mint-, or wintergreen-flavored tobacco products in October
2016. One study assessed short-term (6-month) impact of the Lowell, MA,
sales restriction on youth use of flavored tobacco using pre-post
design with a comparison community (Malden, MA). The comparison
community of Malden, MA, did not have a sales restriction and was
similar to Lowell, MA, in demographics, retailer characteristics, and
other point-of-sale policies (Ref. 61). The analysis evaluated youth
use of flavored tobacco products in Lowell and Malden at baseline
(November 2016-January 2017 in Lowell; September 2016 in Malden) and
followup approximately 6 months later (May 2017 in Lowell; April 2017
in Malden). Youth current use of any flavored tobacco products
decreased 2.4 percent in Lowell from baseline to followup periods and
increased 3.1 percent in the comparison community without a sales
restriction (Malden, MA) for a statistically significant estimated
difference of -5.7 percent between the communities (Ref. 61). When
considering the change in specific product use, ever use of flavored
cigars and current use of flavored cigars decreased in Lowell and
increased in the comparison community, although the changes were not
statistically significant. In general, there were no statistically
significant changes in youth use by specific tobacco products in
Lowell, in the comparison city, or in the difference estimate between
the communities when the models were adjusted for age, gender, and race
and ethnicity (Ref. 61). Youth current use of any non-flavored tobacco
products also decreased 1.9 percent in Lowell while increasing in the
comparison city by a statistically significant 4.3 percent for a
statistically significant estimated difference of -6.2 percent between
the communities (Ref. 61). This study showed that youth use of flavored
tobacco products declined potentially in response to a sales
restriction in a Massachusetts community compared to a similar
community without a sales restriction.
    Another study evaluated the impact of flavored tobacco sales
restrictions (excluding menthol, mint, and wintergreen) in Attleboro
and Salem, MA, on tobacco use among high school students (Ref. 110).
While youth tobacco use increased from baseline to followup in
Attleboro and Salem and in the comparison municipality of Gloucester,
MA, the increases in flavored tobacco use and non-flavored, mint, or
menthol tobacco use were statistically

significantly smaller in Attleboro and Salem than the comparison
municipality, suggesting that the policy mitigated increases in tobacco
use (Ref. 110). This study found that youth tobacco use increased at a
lower rate within the two municipalities covered by sales restrictions
compared to the municipality without a restriction. Therefore, the
study findings suggest that the flavored tobacco restriction may have
prevented increases in tobacco use.
    In 2016, Minneapolis and St. Paul, Minnesota, commonly referred to
as the Twin Cities, also implemented sales restrictions that included
all flavored tobacco products, including ENDS but excluded menthol,
mint, and wintergreen flavors. These sales restrictions exempted adult-
only (18 years and older) licensed tobacco product shops with at least
90 percent or greater revenue from sales of tobacco in Minneapolis and
adult-only (18 years and older) retail stores with at least 90 percent
or greater revenue from sales of tobacco in St. Paul. In 2018, the Twin
Cities expanded the restrictions to include mint-, menthol-, and
wintergreen-flavored tobacco products. However, sales of mint-,
menthol-, and wintergreen-flavored tobacco products were permitted in
adult-only (aged 21 years and older) liquor stores in Minneapolis and
liquor stores that also hold a license for tobacco sales in St. Paul.
An analysis of the Minnesota restrictions examined youth tobacco use
prevalence in the seven-county Twin Cities metropolitan area, including
Minneapolis and St. Paul, and compared it to the rest of the State of
Minnesota using data from two cross-sectional surveys: The Minnesota
Youth Tobacco Survey (MYTS) and the Minnesota Student Survey (MSS)
(Ref. 111). The analysis used MYTS data from students in grades 6-12 to
estimate tobacco use before (2014) and after (2017) the Twin Cities
implemented flavor policies in 2016 that included all tobacco products
but excluded menthol, mint, and wintergreen flavors. The analysis used
MSS data from students in grades 8, 9, and 11 to assess changes in
tobacco use before (2016) and after (2019) when the flavor restrictions
were expanded to include mint, menthol, and wintergreen flavors. Using
the MYTS data to assess youth tobacco use while the 2016 flavor
restriction (excluding menthol, mint, and wintergreen) was in effect,
the prevalence of tobacco product use overall and cigar use did not
change in the Twin Cities among 6-12th graders; however, e-cigarette
use increased 34.1 percent. In contrast, tobacco use prevalence
overall, cigar use, and e-cigarette use increased at greater rates in
the rest of the state (+26.6 percent, +71.3 percent, and +114 percent,
respectively). Using the MSS data to assess youth tobacco use after the
2019 flavor restriction (including menthol, mint, and wintergreen) was
implemented, tobacco use and e-cigarette use among students in grades
8, 9, and 11 increased in the Twin Cities; however, the increase was
smaller than the rest of the state (34.6 percent vs. 44.6 percent
tobacco use increase; 49.5 percent vs. 88.9 percent e-cigarette
increase). Cigar use declined more in the Twin Cities compared to the
rest of the state (-42.4 percent and -23.7 percent, respectively).
Cigarette use decreased more in the Twin Cities relative to the rest of
the State (-40.5 percent and -22.6 percent, respectively). Use of any
menthol or mint tobacco product decreased in both areas (-5.9 percent
Twin Cities and -15.7 percent rest of state), and use of non-cigarette
tobacco products (e.g., cigars, smokeless tobacco, e-cigarettes,
hookah) with flavors other than mint or menthol increased in both areas
(+5 percent Twin Cities and +10.2 percent rest of state) (Ref. 111).
    Given the differences in survey items, timing of data collection,
and that the MYTS and MSS data included all seven counties of the Twin
Cities metropolitan area, including some counties not implementing
flavor restrictions, the observed prevalence changes may reflect
contextual factors beyond the restrictions in the cities of Minneapolis
and St. Paul. For example, the 2019 MSS data collection was shortly
after the policies including mint, menthol, and wintergreen went into
effect; therefore, the study may underestimate the effect of the policy
on youth behavior change. However, the study observed stable and
decreasing cigar use among youth across the surveys in the Twin Cities
relative to the rest of the state, which suggests the sales restriction
slowed youth cigar use.
    In 2018, San Francisco, CA, enacted restrictions on flavored
tobacco products. Changes following the 2018 San Francisco restriction
on all flavored (including menthol) tobacco product sales were
evaluated and compared with sales in two California comparison cities
without such sales restrictions: San Jose and San Diego (Ref. 52). The
analysis used Nielsen retail scanner sales data to estimate within-city
changes in average weekly unit sales of tobacco products for San
Francisco and comparison cities for three time periods: Pre-policy
(June 2015-July 2018; pre-policy); policy enactment (July 2018-January
2019) and policy enforcement (January 2019-December 2019).\14\ Sales of
flavored tobacco products overall and of flavored cigars specifically
decreased a statistically significant 96 percent from the pre-policy
period through the enforcement period in San Francisco (Ref. 52). In
the comparison cities, average weekly sales of flavored tobacco
products either decreased more modestly, yet still statistically
significantly (e.g., 10 percent for all flavored products and 13
percent for flavored cigars in San Diego), or did not have a
statistically significant change from pre-policy to policy enforcement,
with the exception of flavored ENDS (which statistically significantly
increased by 195 percent in San Jose and 118 percent in San Diego) and
flavored smokeless tobacco (which statistically significantly increased
by 3 percent in San Diego). Predicted average weekly total cigar sales
decreased by 51 percent in San Francisco from pre-policy to policy
enforcement, suggesting that there was not complete substitution of
flavored cigars for non-flavored cigars (Ref. 52). This study observed
a decline in overall tobacco product sales and flavored tobacco product
sales, suggesting that there was not complete substitution of tobacco
or non-flavored products for flavored products following the flavor
restriction in San Francisco.
---------------------------------------------------------------------------

    \14\ Although enforcement of this policy was slated to begin in
January 2019, compliance inspections with penalties did not commence
until April 2019.
---------------------------------------------------------------------------

    Another study evaluated the impact of the San Francisco restriction
on all flavored (including menthol) tobacco products on use of cigars
among a small convenience sample (n=247) of young adults aged 18-34
years who used tobacco products prior to the restriction (Ref. 62).
After implementation of the flavor restriction in San Francisco, among
young adults aged 18-24 years, there was a statistically significant
decrease in use of flavored cigars (from 19.4 percent to 6.5 percent)
and decrease in cigar use overall that was not statistically
significant (Ref. 62). There were decreases in the prevalence of cigar
use overall and use of flavored cigars among 25-34-year-old
respondents, but the declines were not statistically significant. Among
the 25-34 age group, there was a statistically significant decrease in
flavored e-cigarette use (from 56.2 percent to 48.1 percent) and dual
use of e-cigarettes with cigars (from 14.1 percent to 9.7 percent).
This study showed among young adults, flavored cigar use may have
declined following the San Francisco sales restriction, and the
decrease was not offset by an increase in non-flavored cigar use.

    One study of San Francisco's flavored tobacco policy using 2019
Youth Risk Behavior Survey (YRBS) data reported that San Francisco's
flavor restriction was associated with increased odds of cigarette
smoking among high school students relative to other school districts
(Ref. 114). However, another study reported a methodological mistake
with these findings: data collection for the 2019 YRBS in San Francisco
occurred in Fall 2018, prior to when the San Francisco flavor
restriction was enforced in April 2019 (Ref. 115). As noted above,
another study of the San Francisco policy observed an overall decline
in tobacco product sales and total cigarette sales, suggesting that
there was not complete substitution of tobacco or unflavored products
for flavored products following the flavor restriction in San Francisco
(Ref. 52).
    In addition to the local U.S. jurisdictions discussed previously, a
study of local level restrictions across Massachusetts from 2011-2017
found that counties with greater proportion of county residents covered
by local policies that limit the sale of flavored tobacco products
(excluding menthol) were associated with a decrease in the number of
days high school students smoked cigarettes in the past 30 days and a
decrease in the likelihood of their e-cigarette use (Ref. 116). This
study illustrates the potential for flavor restrictions to reduce youth
tobacco use.
    Evaluations of a national flavored tobacco policy in Canada
reinforce trends observed in jurisdictions that enacted flavored
tobacco policies in the United States, including a decrease in cigar
sales and a decrease in use of cigars among young people. In 2009, the
government of Canada prohibited the use of characterizing flavors
(excluding menthol) in cigarettes and cigars under 1.4 grams, or in any
cigar that had a filter or non-spiral wrap. Using wholesale sales
volumes, one evaluation examined trends in sales of flavored cigars
during the 2004-2016 period, with equal periods of 6 years before and 6
years after enactment of the 2009 restriction (Ref. 112). The analysis
found that overall cigar sales decreased 49.6 million units and sales
of flavored cigars decreased 59 million units in the quarter
immediately following policy enactment (i.e., first quarter of 2010).
Sales of cigars with no flavor descriptors increased 9.6 million units
in the quarter immediately after policy implementation (Ref. 112).
Another evaluation assessed the impact of Canada's 2010 ban on the sale
of flavored cigarillos (Ref. 113). This evaluation analyzed data from
the 2007 to 2011 Canadian Tobacco Use Monitoring Survey and found that
the policy was associated with a statistically significant 2.3
percentage point decrease in past 30-day cigarillo use and a
statistically significant 4.3 percentage point increase in past 30-day
abstinence, defined as no cigar use in the prior 30 days among previous
cigarillo users among young people aged 15 to 24 years. Cigarillo use
declined in the older age group, 25 to 65 years, but the decline was
not statistically significant. The study noted that there was some
evidence of a small increase in use of cigars other than cigarillos or
little cigars that were not included in the policy, and the analysis
did not distinguish flavored cigarillo from unflavored cigarillos (Ref.
113).
    Taken in totality, these studies of the impact of real-world
restrictions on flavored tobacco products provide insight into the
likely responses of youth and young adults as well as current cigar
smokers to the proposed standard, including decreases in youth and
adult cigar use. However, we acknowledge there are limitations to the
application of these findings. One limitation includes the timing of
data collection on cigar use. Some of the evaluation studies rely on
data collection only after the policy with retrospective recall of
cigar use prior to policy implementation. Furthermore, the duration of
followup time varied between studies, and those with shorter followup
times (e.g., Refs. 61 and 62) may have underestimated the impact on
cigar use. Limitations also include that some studies rely on aggregate
tobacco sales information as a proxy for consumption, rather than data
concerning individual-level tobacco use behaviors. Certain analyses
used cigar sales as a proxy for consumption, given that sales and
consumption tend to be highly correlated (Refs. 117-119). Furthermore,
a number of noted studies used state or nationally representative
surveys of youth and young adults to assess differences in tobacco use
before and after policy implementation. Some of these studies were able
to assess changes in cigar use specifically, while others assessed
changes in overall tobacco use or flavored tobacco use more broadly.
Lastly, smokers may have obtained flavored cigars through alternate
means (e.g., internet sales) that would not have been captured in sales
data in these studies, or smokers may have switched to tobacco products
not subject to restrictions, which may have resulted in an
overestimation of the impacts of the restrictions, unless changes in
overall tobacco use was accounted for. Despite these limitations, these
real-world evaluations provide important insight into how sales and
tobacco use change in response to restrictions on flavored tobacco
products, including cigars. These evaluation studies further
demonstrate that the proposed prohibition on characterizing flavors
(other than tobacco) in cigar products would reduce the rate of youth
and young adult experimentation and progression to regular tobacco use
and increase cessation among current cigar smokers. Section VI of this
document draws on such findings to estimate the impact of the proposed
rule on population health, including the likelihood that existing cigar
smokers would stop smoking as well as the likelihood that nonusers
would start smoking cigars.

G. Flavored Cigars Are Marketed Disproportionately in Underserved
Communities and to Vulnerable Populations

    Tobacco marketing activities--e.g., advertising and promotions--are
effective in promoting sales, increasing tobacco use, and engendering
positive attitudes about tobacco companies and their products among
youth, young adults, and other vulnerable populations (Refs. 37, 120,
and 121). With regard to cigars, decades of targeted marketing
activities have helped make cigars more appealing and affordable and
contributed to the pervasive and enduring nature of disparities in
cigar use in vulnerable populations.
    A robust body of scientific evidence shows that tobacco is
disproportionately marketed in underserved communities and to
vulnerable populations, such as youth and young adults, some racial and
ethnic populations, individuals who identify as LGBTQ+, pregnant
persons, those with lower household income and educational attainment,
and individuals with behavioral health conditions. Storefront and
outdoor tobacco marketing as well as point-of-sale marketing are all
disproportionately present in African American/Black, Hispanic/Latino,
and low-income communities (Refs. 122-129). Additionally, tobacco
companies have historically targeted African Americans, LGBTQ+
communities, and low-income populations by using strategies such as
offering coupons and other price promotions to entice these groups to
use tobacco products (Refs. 122 and 130). This evidence holds true for
combusted tobacco products, including cigar and flavored cigar
products.
    Industry documents reveal that tobacco companies have for many

decades strategically marketed flavored cigars to encourage trial and
initiation among vulnerable populations. For example, a 1969 industry
report noted the introduction of new flavored cigar products ``aimed
directly at youth,'' as well as marketing campaigns targeting youth by
including special offers, such as record albums (Refs. 16 and 79).
Similarly, a 1972 report on the findings of an industry consumer
research study concluded that adding menthol and mint flavor to little
cigars was appealing to young (not defined) study participants and
recommended marketing this flavored cigar product at a lower price
point than cigarettes in order to attract young users (Refs. 16 and
131). Industry documents also disclose that tobacco companies targeted
Black consumers, including by offering sampling and distribution
opportunities as well as publishing advertisements in Black-only
newspapers (Refs. 16, 132, and 133). Furthermore, hip-hop artists, DJs,
and music events are all avenues tobacco companies have used to attract
African Americans to use flavored little cigars and cigarillos (Ref.
16). Industry market research also studied how to increase cigar use
among young women, including the addition of flavors to improve
palatability and mildness and thereby promote product trial. Segments
of the industry used this information to inform marketing and product
development targeted at women such as adding appealing flavors,
reducing cigar size so they could fit into purses or pockets, and
including celebrities in advertisements (Refs. 16 and 131).
    The tobacco industry's historic practice of marketing to vulnerable
populations has resulted in long-term consequences for these
communities. Scientific evidence indicates that tobacco marketing
influences social norms around tobacco use, making tobacco use more
socially acceptable and increasing the likelihood of tobacco use (Refs.
134-137). In underserved communities where the tobacco industry has
disproportionately marketed over decades, these social norms are
transferred through social networks of peers and generations of
families, thereby contributing to present-day tobacco-related health
disparities in these populations (Refs. 134, 135, 138, and 139).
Furthermore, recent scientific evidence indicates that tobacco
companies continue to target populations from underserved communities
with cigar marketing, including flavored cigar marketing (see, e.g.,
Refs. 140-146). Across diverse marketing platforms, ranging from
traditional print media to online platforms, populations from
underserved communities are disproportionately exposed to cigar
advertisements.
    Brick-and-mortar tobacco retailers are present in disproportionate
numbers in neighborhoods of underserved communities, particularly in
Black communities. Studies have found that the more Black residents
there are in a census tract, the more tobacco retailers there are in
that census tract, with a statistically significant positive
association between tobacco retailer density and the proportion of
residents who are Black (Refs. 124-127). Two systematic reviews and
several studies found that tobacco retailers in predominately African
American/Black neighborhoods were statistically significantly more
likely to sell cigars and cigarillos, were statistically significantly
more likely to have exterior advertisements for cigars and cigarillos,
and were statistically significantly more likely to sell cigars and
cigarillos at a lower price, as compared to tobacco retailers in other
neighborhoods (Refs. 125, 127, and 146-149). Furthermore, two
nationally representative studies found that retailers in Black
neighborhoods were more likely to place interior advertisements at or
below 3 feet off the floor, at a point where cigar advertisements are
more visible to youth, compared to tobacco retailers in predominately
non-Hispanic White neighborhoods (Refs. 143 and 144).
    Higher exposure to tobacco advertisements and retailing are
associated with disparities in tobacco use susceptibility and tobacco
use among youth. For example, a nationally representative study of
youth found that exposure to cigar advertisements at the point-of-sale
was statistically significantly associated with high curiosity about
using cigars, with non-Hispanic Black (14.8 percent) and Hispanic youth
(11.9 percent) being statistically significantly more likely to be
highly curious about cigars as compared to non-Hispanic White youth
(7.6 percent). This finding raises concern because curiosity about
using tobacco products predicts tobacco use susceptibility, tobacco use
initiation, and progression to regular tobacco use among youth (Ref.
150). Similarly, a longitudinal study of middle and high school
students found that recall of tobacco advertisements and products at
the point-of-sale at baseline predicted current cigar use at a 6-month
followup (Ref. 151). Additionally, one cross-sectional study found that
youth who reported going to a corner, convenience, or other retail
store on the way to or from school frequently had statistically
significantly higher odds of current use of cigars, little cigars, and
cigarillos (Ref. 152).
    Taken together, scientific evidence indicates that cigars and
flavored cigars historically have been and continue to be
disproportionately marketed in underserved communities and that the
presence of flavors in cigars is intended to encourage trial and
initiation and deter tobacco cessation. The differences found in
exposure to flavored cigar marketing contribute to observed disparities
in tobacco use and associated tobacco-related health disparities and
health outcomes among vulnerable populations, as further discussed in
section V.F of this document. While targeted marketing is only one
factor in the development and perpetuation of flavored cigar use and
related harms, this background helps to explain and provide critical
context for the outcomes and disparities that undermine public health
and are of great concern to FDA. FDA remains committed to improving
health outcomes across the population as a whole, including within
groups that experience disproportionate levels of tobacco use, such as
the vulnerable populations discussed in this section.

V. Cigar Use Is Common, Addictive, and Harmful

A. Prevalence of Cigar Use Among Youth, Young Adults, and Older Adults
in the United States

    Patterns of cigar use differ markedly by age group, race and
ethnicity, household income and educational attainment, and among
others who have systematically experienced greater obstacles to health
based due to the inequitable distribution of social, political,
economic, and environmental resources, such as individuals who identify
as LGBTQ+ and persons with disabilities.
1. Cigar Use Prevalence in Youth and Young Adults
    Evidence from national surveys, including the Monitoring the Future
study of 8th, 10th, and 12th grade students and the NYTS of middle and
high school students, has suggested that, similar to cigarettes, cigar
use has been on the decline among U.S. youth in recent years (Refs. 153
and 154). However, in 2020, cigars were the most commonly reported
combusted tobacco product used by youth (Ref. 7). Nationwide, in 2020,
nearly 1 million youth had smoked a cigar on at least 1 day during the
past 30 days (Ref. 7). According to the 2020 NYTS, an

estimated 960,000 middle and high school students (3.5 percent),
including 5.0 percent (770,000) of high school students (grades 9-12)
and 1.5 percent (180,000) of middle school students (grades 6-8), had
smoked a cigar (cigar, cigarillo, or little cigar) in the preceding 30
days (Ref. 7). The most recent NYTS data also found that, of those
youth who use cigars, the largest proportion use cigarillos (44.1
percent), followed by regular cigars (33.1 percent), and little cigars
(22.6 percent) (Ref. 8). Of note, 21.8 percent of youth who are current
users report not knowing which cigar type they use (Ref. 8).
    While there has been an overall downward trend in cigar use among
youth in general, cigar use--particularly flavored cigar use--remains
significant, and this decrease has not been equitably experienced as
the popularity of cigar use remains disproportionately high among non-
Hispanic Black youth (Ref. 7). Tobacco-related health disparities
result, in part, from inequitable practices and denial of opportunities
that prevent some communities from fully participating in aspects of
economic, social, and civic life. These inequities influence
vulnerabilities that some populations experience across the continuum
of tobacco use. For example, disparities in initiation and prevalence
of cigar use that are connected to inequitable treatment and
opportunities likely contribute to and reinforce the continued tobacco-
related vulnerabilities of Black youth as subsequent disparities are
observed along the continuum of tobacco use for these youth. The 2020
NYTS data show that the popularity of cigars is especially high among
non-Hispanic Black middle and high school students, as 6.5 percent
reported past 30-day cigar use compared to 2.8 percent of non-Hispanic
White students (Ref. 7). Additionally, the findings show that cigar use
was statistically significantly higher than cigarette use among non-
Hispanic Black high school students in 2020, with 9.2 percent reporting
having smoked cigars during the past 30 days, compared with 2.8 percent
reporting having smoked cigarettes (Ref. 7). Data also indicate that
non-Hispanic Black youth have a higher risk than White youth of
initiating cigar use at earlier ages. An analysis of 2013-2017 PATH
Study youth (aged 12-17 years) data indicated that, when compared to
non-Hispanic White youth, non-Hispanic Black youth were 47 percent more
likely to initiate past 30-day cigarillo or filtered cigar use and 111
percent more likely to be ``fairly regular'' users of these products
(Ref. 25). These observed disparities in cigar use initiation are
associated with higher levels of current cigar use and frequency of
cigar use among Black youth and young adults. An analysis of data from
a longitudinal cohort study found that once Non-Hispanic African
American youth and young adults had initiated cigar use, they had twice
the odds of current cigar use within 6 months relative to non-Hispanic
Whites (Ref. 100). Also, within 6 months of initiation, the average
frequency of use and days per month used was higher for non-Hispanic
African Americans compared to non-Hispanic Whites (Ref. 100). Findings
from the 2013 Cuyahoga County Youth Risk Behavior Survey indicate that
non-Hispanic Black youth had statistically significantly higher odds of
using cigars as compared to non-Hispanic White youth (Ref. 155).
Disparities in cigar use among Black youth may also pose additional
concerns due to the increased risk associated with polyuse with other
combusted tobacco products. Cigarette smoking being perceived as
harmful reduced the likelihood of cigar use among all racial and ethnic
categories of youth except for non-Hispanic Black youth, who were
statistically significantly more likely to be current cigar users if
they perceived smoking cigarettes as harmful (Ref. 155). Moreover, use
of cigars among Black youth disproportionately leads to cigarette
smoking. In a nationally representative longitudinal study of youth,
ever cigar use statistically significantly increased the odds of
subsequent past-30-day cigarette use among non-Hispanic Black youth
(Ref. 156). However, ever cigar use did not increase the odds of
subsequent past 30-day cigarette use among non-Hispanic White youth
(Ref. 156). This study found that 9.1 percent of cigarette initiation
among non-Hispanic Black youth was directly attributable to cigar use,
compared with only 3.9 percent among non-Hispanic White youth (Ref.
156).
    Youth and young adults who identify as LGBTQ+ also face tobacco-
related health disparities when compared with non-LGBTQ+ counterparts,
including higher prevalence of tobacco product use as well as cigar
use.\15\ In 2020, NYTS analysis found that past 30-day use of any
tobacco product was higher among youth identifying as lesbian, gay, or
bisexual than heterosexual youth (25.5 percent vs. 15.1 percent) (Ref.
7). Past 30-day cigar use was nearly twice as prevalent among youth
identifying as lesbian, gay, or bisexual than heterosexual youth (6.0
percent vs. 3.1 percent) (Ref. 7). Findings from an analysis of Wave 3
PATH Study data (2015-2016) indicated that, similar to patterns among
adults, lesbian and bisexual girls have even higher disparities and are
more than twice as likely than their heterosexual peers to report ever
using cigars (11.3 percent vs. 5.2 percent) and to have used cigars in
the past 30 days (3.2 percent vs. 1.0 percent) (Ref. 157). An analysis
of the 2015 YRBS data found that lesbian and bisexual girls have
statistically significantly higher current use prevalence of cigars
than their heterosexual peers (16.4 percent for lesbian girls, 10.2
percent for bisexual girls, 5.4 percent for heterosexual girls), as do
gay and bisexual boys (20.0 percent for gay boys, 16.9 percent for
bisexual boys, and 13.5 percent for heterosexual boys) (Ref. 158).
Findings from a nationally representative cohort study indicated that
young adults who identified as homosexual reported higher ever cigar
use compared to young adults who identified as heterosexual (Ref. 159).
Transgender youth also are statistically significantly more likely than
non-transgender youth to report ever using any tobacco product (53.6
percent vs. 31.5 percent) including cigars (16.1 percent vs. 7.5
percent) and past 30-day use of more than one tobacco product,
including cigars (10.2 percent vs. 3.5 percent) (Ref. 157). Study
findings from a young adult cohort study indicated that past 30-day
little cigars/cigarillos/bidis use was greater for young adults who
identified as LGBT in comparison to those who did not identify as LGBT
(Ref. 160).
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    \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.
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    Youth with disabilities also have higher rates of cigar use than
their nondisabled peers. In one study of more than 20,000 11th graders
in Oregon that controlled for sociodemographic risk factors of tobacco
use, the proportion of little cigar use among students with at least
one reported disability (7.0 percent) was statistically significantly
higher than among students without a disability (5.4 percent) (Ref.
161).
2. Cigar Use in Adults
    Cigars are also a popular tobacco product among adults. In the 2019
National Health Interview Survey (NHIS), 3.6 percent of adults 18 or
older reported currently using cigars some or every day, behind
cigarettes (14 percent)

and e-cigarettes (4.5 percent) (Ref. 68). Comparing 2011 to 2019, while
past month cigarette smoking and cigar use were both statistically
significantly lower in young adults (aged 18-25 years), the absolute
decline in cigar use was less than the decline in cigarette use (33.5
percent in 2011 to 17.5 percent in 2019 for cigarettes; 10.9 percent in
2011 to 7.7 percent in 2019 for cigars) (Ref. 59). For adults (aged 26
years or older), cigarette use in 2011 was statistically significantly
higher compared to in 2019; however, cigar use remained relatively
stable and did not significantly change (21.9 percent in 2011 to 18.2
percent in 2019 for cigarettes; 4.2 percent in 2011 to 4.0 percent in
2019 for cigars) (Ref. 59). The 2019 NSDUH found that among adults aged
26 or older in 2019, 1,420 individuals initiated cigar use each day,
considerably more than the 247 who initiated cigarette smoking each day
in that year (Ref. 59).
    Prevalence of cigar smoking, however, varied by the type of cigar
smoked. Analysis of Wave 5 (2018-2019) data from the PATH Study found
that, 4.8 percent of young adults (aged 18-24 years) used traditional
cigars; 7.9 percent used cigarillos, and 2.4 percent used filtered
cigars in the past 30 days (Ref. 63). According to the most recent data
from the PATH Study (2018-2019), 3.5 percent of adults (aged 25 years
and older) used traditional cigars, 3.3 percent used cigarillos, and
1.6 percent used filtered cigars in the past 30 days (Ref. 63).
    Similar to youth and young adults, adults (aged 25 years and older)
reported use of flavored cigars and are expected to benefit from the
proposed product standard if finalized. Wave 5 (2018-2019) data from
the PATH Study showed that 36.0 percent of adult cigar smokers (aged 25
years and older) reported past 30-day use of flavored cigar from 2018-
2019 (Ref. 63). Among adult cigar smokers, a statistically
significantly greater proportion of adult traditional cigar smokers
(19.7 percent) reported use of a flavored cigar in the past 30 days
compared with adult smokers of all other cigar types (46.5 percent for
cigarillos and 48.7 percent for filtered cigars) (Ref. 63). The
proportion of adults using flavored cigars within each of the cigar
types did not differ over time across recent PATH Waves 4-5 (2016-2019)
(Ref. 63).
    A disproportionate proportion of cigar smoking occurs among
vulnerable populations; this burden has grown over the past two
decades. In the 2019 NHIS, 4.4 percent of non-Hispanic Black, 3.8
percent of non-Hispanic White, and 3.0 percent of Hispanic adults
reported some or everyday cigar use (Ref. 68). In an analysis of 2002-
2016 NSDUH data for individuals aged 12 and older, non-Hispanic Black
individuals were statistically significantly more likely than all other
racial and ethnic groups to have used cigars in the past 30 days (Ref.
162). Decreases in prevalence of cigar use have not been observed in
non-Hispanic Black adults as they have for other racial and ethnic
groups (Ref. 162). There were no statistically significant changes in
past 30-day use prevalence between 2002-2016 in the NSDUH data among
non-Hispanic Black and non-Hispanic other/mixed race adults while there
were decreases among both non-Hispanic White and Hispanic adults.
Further, over this same time period, cigar use decreased among non-
Hispanic White men and stayed the same among non-Hispanic White women,
but it increased among non-Hispanic Black women and remained the same
among non-Hispanic Black men (Ref. 162). When considering more recent
NSDUH data, these racial and ethnic disparities have persisted, with
the prevalence of past 30-day cigar smoking remaining statistically
significantly higher among non-Hispanic Blacks compared to non-Hispanic
Whites through 2019 (Ref. 59).
    A recent analysis of PATH Study data from Wave 3 (2015-2016) showed
differences in daily cigar smoking by racial and ethnic group (Ref.
163). Non-Hispanic Black individuals are statistically significantly
more likely to report that they have ever been a ``fairly regular''
cigar smoker (5.4 percent) than non-Hispanic White cigar smokers (2.5
percent) and to report that they smoke cigars daily (1.9 percent),
compared to non-Hispanic White cigar smokers (0.5 percent), with these
differences being most pronounced for cigarillos (3.7 percent vs. 0.9
percent) (Ref. 163). Hispanic adults were more likely to smoke cigars
within 30 minutes of waking, when compared with non-Hispanic Whites
(Ref. 163). The analysis found a consistently higher prevalence of use
for non-Hispanic Blacks, compared with non-Hispanic Whites for three
cigar-smoking outcomes (past 30-day use, daily use, and established
use) across all the cigar types (Ref. 163).
    Differences in prevalence have been observed across cigar type and
in the use of flavors across racial and ethnic populations. In the PATH
Study, past 30-day cigarillo use was statistically significantly higher
among non-Hispanic Black young adults (aged 18-24 years) and adults
(aged 25 years and older) compared with non-Hispanic Whites and
Hispanics at all waves (2013-2019) (Ref. 63). Past 30-day use of
flavored traditional cigars was statistically significantly higher
among non-Hispanic Black older adults (aged 25 years and older)
compared to non-Hispanic White adults at Waves 2-5 (2014-2019) and
compared to Hispanic adults at Waves 2-3 (2014-2016) and Wave 5 (2018-
2019) (Ref. 63). An analysis of survey data on college students
indicated that Black young adults were three times more likely to smoke
flavored cigars than White young adults (Ref. 66). Hispanic and Asian
participants were also more likely to use flavored cigars over non-
flavored cigars compared to non-Hispanic White participants (Ref. 66).
Younger participants (aged 18-24 years) had greater odds of using
flavored cigars when compared to older participants (aged 25-29 years)
(Ref. 66).
    Differences in prevalence of cigar use have also been observed
across other population groups. Research indicates social gradient
effects (where higher levels of household income and educational
attainment are linked to better health outcomes and lower levels of
household income and educational attainment are linked to poorer health
outcomes) for cigar use. Data from the 2012-2013 NATS show that higher
educational levels and higher annual household income generally were
associated with lower prevalence of usual use of cigarillos, other mass
market cigars, and of little filtered cigars (Ref. 164). Data from the
PATH Study in 2018-2019 show that there was a statistically significant
difference in past 30-day cigar use by education level as 7.3 percent
of adults (aged 25 years and older) with less than a high school
diploma smoked cigars in the past 30 days, compared to 3.8 percent of
adults with a college degree or higher (Ref. 63). Among adults who used
any cigar in the past 30 days, individuals with a college degree were
statistically significantly less likely to use a flavored cigar (20.0
percent) than individuals categorized as having less than a high school
diploma (44.9 percent), a high school diploma (37.4 percent), or some
college (42.9 percent) (Ref. 63).
    Tobacco-related cancers are a leading cause of death among adults
experiencing homelessness (Ref. 165). In a study of 470 unhoused
individuals, the analysis found that past 30-day use of all tobacco
products was high and that 74.0 percent of respondents reported use of
cigars and over half (55 percent) reported use of flavored cigars in
the past 30 days (Ref. 166).
    Adults over 18 with at least one chronic health condition (e.g.,
heart disease, hypertension, stroke, diabetes, asthma, lung cancer,
hepatitis, human

immunodeficiency virus infection, anxiety, depression, substance abuse)
have been shown in one study to be more than one and a half times more
likely than those without a chronic health condition to use cigars,
with no statistically significant changes over time (Ref. 167). In
particular, adults who have anxiety, depression, or substance use
disorders have cigar use rates statistically significantly greater than
those with no chronic health conditions (Ref. 167). This association
holds for mentholated tobacco products, including cigars, which are
used disproportionately by young adults (aged 18-34 years) who report
mental health disorders, with past 30-day menthol tobacco product use
being associated with greater odds of anxiety and depression when
controlling for other tobacco and mental health risk factors (Ref.
168). Likewise, using Waves 1-4 (2013-2017) of PATH Study data, adults
who reported past-year severe internalizing problems were more likely
to have initiated use of flavored cigarillos since the prior PATH wave,
and were also more likely to be past-30-day users of flavored
cigarillos (Ref. 169).
    Adults who identify as LGBTQ+ are more likely to use tobacco
products, including cigars, and to meet the criteria for nicotine
dependence when compared to their heterosexual and cisgender peers,
with these associations being stronger for some racial and ethnic
populations (Refs. 68, 157, 159, 160, and 170-173). For example, while
adults who identified as gay/lesbian, bisexual, and ``conflicting''
(defined by study authors as those who identified as ``heterosexual,
had engaged in either no sexual behavior or exclusively heterosexual
behavior, but reported some levels of same-sex attraction'') are more
likely than their heterosexual peers to use tobacco and meet tobacco
use disorder criteria, Hispanic and non-Hispanic Black bisexual adults
have even stronger associations for current tobacco use than do their
White bisexual peers (Ref. 172). Overlapping forms of disadvantage can
interact to create and exacerbate tobacco-related health disparities.
For example, discrimination experienced on the basis of gender identity
or sexual orientation often overlaps with discrimination experienced on
the basis of race or disability.\16\ As discussed in section IV.G of
this document, the tobacco industry disproportionately targets its
marketing to those who identify as LGBTQ+ and some racial and ethnic
populations. For example, adults who identify as lesbian, gay,
bisexual, or transgender report higher rates of tobacco media exposure
compared to their peers who do not identify as lesbian, gay, bisexual,
or transgender (Ref. 141), which can lead to use of tobacco products,
including cigars (Refs. 141 and 172).
---------------------------------------------------------------------------

    \16\ See, e.g., E.O. 13988, ``Preventing and Combating
Discrimination on the Basis of Gender Identity or Sexual
Orientation'' (86 FR 7023, January 25, 2021).
---------------------------------------------------------------------------

    Generally, findings indicate that adults who identify as lesbian,
gay, bisexual, or transgender have a higher prevalence of experimental
and current cigar use compared to their heterosexual peers (Refs. 159
and 173-175). Findings from an analysis of the 2012-2013 NATS data
indicated that among women who identified as lesbian or gay, bisexual,
or ``something else'' (an option provided in the study), cigar use was
more than triple the rate of heterosexual women (Ref. 176). Data from
the 2015-2017 NSDUH, indicate that lesbian and bisexual women had more
than twice the odds of using cigars in the past year relative to
heterosexual women (Ref. 170). These findings are consistent with those
from a 2013 cross-sectional survey study showing that lesbian and
bisexual women had more than twice the odds of current cigar use
relative to heterosexual women (Ref. 173).
    Adults who identify as transgender are more likely to use tobacco
products, including cigars, than their cisgender peers. In a national
cross-sectional online survey, transgender adults reported higher
current (past 30-day) use of any cigarette/e-cigarette/cigar product
(39.7 percent vs. 25.1 percent) (Ref. 177). This study also found that
transgender adults had higher current use of cigars (26.8 percent vs.
9.3 percent), specifically, when compared with cisgender adults as well
as statistically significantly higher odds of past 30-day tobacco
product use for any cigarette/e-cigarette/cigar product and for cigars,
compared to cisgender adults (Ref. 177).
    These disparities also exist for flavored cigar use, as data from
the 2009-2010 NATS indicated that adults who identify as lesbian, gay,
bisexual, or transgender have a higher prevalence of flavored cigar use
(8.2 percent) compared to the national prevalence (2.8 percent) and
when compared to cigar users nationally (42.9 percent) (Ref. 70). Data
from the 2011-2015 Truth Initiative Young Adult Cohort Study showed
that respondents who identified lesbian, gay, or bisexual had higher
odds of reporting past 30-day flavored large cigar and LCC use compared
to respondents who identified as straight/heterosexual (Ref. 67).
3. Polyuse of Tobacco and Cigar Prevalence
    FDA finds that recent trends toward polyuse of tobacco (i.e., the
use of two or more tobacco products) also support the Agency's
conclusion that this proposed rule would have positive impacts on
public health. Polyuse increases exposure to nicotine (Ref. 178) and
other harmful constituents of tobacco products and tobacco smoke. Using
data from the 2017-2018 NYTS survey, one study found that 40.8 percent
of middle and high school aged youth past 30-day tobacco users were
using two or more tobacco products in the past month (Ref. 107). Among
youth using cigars in the past 30 days, a majority, 76.1 percent, used
cigars in combination with one or two additional tobacco products (Ref.
107). Among youth in the 2017-2018 NYTS data, cigarettes and e-
cigarettes were the most common products used alongside cigars (Ref.
107).
    The cumulative exposure from polyuse can sustain and may increase
levels of tobacco dependence. A 2017-2018 analysis of NYTS data found
that 43.1 percent of youth current cigar smokers, including polyusers,
reported nicotine dependence, including feeling strong craving to use a
tobacco product or using a tobacco product within 30 minutes of waking
(Ref. 107). When looking at the association between cigar use and
dependence, frequent cigar use (i.e., use on 20 to 30 days in the past
30 days) was associated with increased odds of nicotine dependence as
compared to less frequent users (Ref. 107). Exclusive use of cigars was
associated with lower odds of dependence relative to exclusive use of
another tobacco product. However, most youth cigar users in the study
used cigars and one or more other tobacco products. When cigar use
included polyuse and exclusive use, youth cigar use was associated with
twice the odds of nicotine dependence (Ref. 107). Given the role of
frequent and polyuse in the relationship between cigar use among youth
and dependence, the authors note ``. . . the importance of examining
behaviors related to use, as they can affect and/or exacerbate the risk
of nicotine dependence'' (Ref. 107).
    An analysis of tobacco dependence among daily cigarette, cigar, and
e-cigarette users in the United States, using data from the 2012-2013
NATS, found that compared to cigarette-only smokers, dual cigarette and
cigar smokers exhibited greater dependence, with a higher average
number of cigarettes smoked per day (17.3 vs. 15.8), shorter times to
first tobacco use

after waking (21.4 minutes vs. 25.9 minutes), and more frequent
reporting of withdrawal and craving symptoms compared to exclusive
cigarette smokers (Ref. 179). In addition, data from Wave 1 (2013-2014)
of the PATH Study demonstrates that high nicotine dependence is two to
three times more likely among poly users compared to dual and single
product users (Ref. 180). Data from the 2012 and 2019-2020 NYTS also
noted that reports of dependence were consistently associated with
polyuse (Refs. 181 and 182).\17\ FDA anticipates this proposed product
standard would help to reduce the number of cigar users and, therefore,
the number of tobacco users who are poly users and likely even more
tobacco dependent.
---------------------------------------------------------------------------

    \17\ FDA is not aware of additional analyses that examine
dependence in youth in NYTS data using 2013-2018 data.
---------------------------------------------------------------------------

B. Flavored Cigar Use Exposes Users to Additional Toxicants

    All cigar users, including flavored cigar users, are exposed to
toxicants, including more than 50 carcinogens in mainstream and
sidestream cigar smoke (Ref. 183). In flavored combustible tobacco
products, including cigars, additional toxicity can result from the
chemicals formed when flavors are heated or burned (Refs. 184-187). For
example, acetaldehyde, formaldehyde, and benzene were found during
pyrolysis (i.e., thermal decomposition or the process of breaking down
a product under the presence of heat) of 18 different cigarette flavor
additives, and various polycyclic aromatic hydrocarbons (PAHs) were
also detected during pyrolysis of cocoa (Ref. 188). Similar results
would be expected for cigar flavor additives (Ref. 189). A study
conducted by the Centers for Disease Control and Prevention (CDC)
identified benzyl alcohol, piperonal, methyl cinnamate, and vanillin in
strawberry cigar filler (Ref. 190). The table below summarizes examples
of known respiratory and other relevant toxicities associated with
these ingredients (and subcomponents) and their potential pyrolysis
products.

    Table 2--Flavor Ingredient Pyrolysis and Potential Health Hazards
------------------------------------------------------------------------
                                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,

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

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

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

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

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

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

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

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

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

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

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

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

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

A. The Likelihood That Nonusers Would Start Using Cigars

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

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

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

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

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