progression or failed cessation attempts (Refs. 186 and 187). The
addition of menthol as a characterizing flavor used in cigarettes
enhances nicotine addiction, particularly for youth and young adults,
through a combination of its flavor, sensory effects, and interaction
with nicotine in the brain.
    If this proposed rule is finalized, menthol as a characterizing
flavor would not be available to mask the harshness of smoking
cigarettes and make initial smoking experiences more appealing for new
users. FDA anticipates that implementation of the proposed standard
would result in fewer youth and young adults experimenting repeatedly
with cigarettes, becoming nicotine dependent, and progressing to
regular cigarette smoking. Through these impacts alone, the proposed
standard is appropriate for the protection of the public health, as it
would lead to a significant reduction in the number of new regular
cigarette smokers and the well-documented health impacts associated
with regular cigarette smoking.
    If this proposed rule is finalized, FDA expects a significant
reduction in youth initiation and progression to regular cigarette
smoking, which would ultimately protect youth from a lifetime of
addiction and disease, and premature death, attributable to cigarette
smoking. To the extent that youth and young adults in the United States
who would have initiated with menthol cigarettes do not initiate with
non-menthol cigarettes or other tobacco products, the proposed standard
would prevent future cigarette-related disease and death.
    FDA's expectation of a significant reduction in youth initiation
and progression to regular cigarette smoking is supported by real-world
experience of youth tobacco use prevalence decreasing following
implementation of policies restricting the sales of flavored tobacco
products. Two nationally representative studies assessing the impact of
the Special Rule for Cigarettes (section 907(a)(1)(A) of the FD&C Act),
which banned non-menthol flavored cigarettes, both found that youth
cigarette smoking rates decreased following implementation. In a study
using 2002-2017 NSDUH quarterly data with older adults (aged 50 and
older) as a comparison group, there was a temporary increase
(``temporary'' was undefined in the study) in the odds of past 30-day
cigarette smoking and past 30-day menthol cigarette smoking in youth
and young adults immediately after the Special Rule went into effect
(Ref. 188). Following the temporary increase, odds of past 30-day
cigarette smoking and past 30-day menthol cigarette smoking in youth
and young adults decreased through 2017 (Ref. 188). No increase in odds
of past 30-day cigarette smoking and past 30-day menthol cigarette
smoking was observed immediately after the Special Rule went into
effect or following through 2017 among older adults (ages 50 and
older). The study estimated the total effect of the Special Rule for
Cigarettes and

found that the flavored cigarette ban overall was associated with a
significant reduction in cigarette smoking for youth (ages 12-17),
young adults (ages 18-25), and adults (ages 26-49), but not older
adults (ages 50 and older). This includes reductions in menthol
cigarette smoking among youth and youth adults likely due to the
overall effect the Special Rule had on decreasing rates of smoking
among these groups over time.
    Another nationally representative study examining tobacco use among
U.S. middle and high school students before and after the Special Rule
for Cigarettes banning non-menthol flavored cigarettes, found an
overall decrease in the prevalence of youth cigarette smoking, fewer
number of cigarettes smoked per month, and an overall reduction in the
probability of using any type of tobacco (Ref. 189). Adjusting for
demographic variables, national-level tax inclusive price indices for
cigarettes and non-cigarette tobacco products, youth unemployment rate,
and time trends, there was a 17.1 percent reduction in the probability
of middle and high school students being a cigarette smoker after the
Special Rule for Cigarettes (Ref. 189). Additionally, middle and high
school smokers reported smoking 59 percent fewer cigarettes per month
after the Special Rule for Cigarettes (Ref. 189). While there were
increases in the use of some types of tobacco products, including
cigars (34.4 percent) and pipe tobacco (54.6 percent) that remained
available in flavored varieties, the probability of using any type of
tobacco overall was reduced by 6 percent (Ref. 189).
    In recent years, several U.S. localities and some states have
placed restrictions on the sale of menthol cigarettes in addition to
restrictions on the sale of other flavored tobacco products. Results
from evaluations of these policies provide evidence of decreases in use
and sales of tobacco products after policy implementation (Refs. 190-
193). In 2018, Minneapolis and St. Paul, Minnesota, expanded their
sales restrictions on flavored tobacco products (including e-
cigarettes) to include menthol, mint, and wintergreen tobacco products.
An evaluation of this sales restriction found decreases in youth
cigarette (3.8 percent to 2.3 percent), cigar (2.7 percent to 1.6
percent), smokeless tobacco (1.6 percent to 1.2 percent), and hookah
(2.4 percent to 1.3 percent) product use after policy implementation in
the Twin Cities metro area, which includes Minneapolis and St. Paul
(Ref. 192). An increase in youth e-cigarette prevalence from 10.5
percent to 15.7 percent occurred after the policy in the Twin Cities,
but this increase was lower than the rest of the State of Minnesota
where e-cigarette prevalence increased from 10.0 percent to 18.8
percent (Ref. 192). Although prevalence of youth overall tobacco use
increased after the policy in the Twin Cities from 12.2 percent to 16.5
percent and increased in the rest of the State from 13.9 percent to
20.1 percent, these increases were driven by youth e-cigarette use and
align with national youth tobacco use trends (Ref. 192). Importantly,
the increases in youth overall tobacco use after the policy were lower
in the Twin Cities than in the rest of the State, suggesting that the
policy mitigated increases in overall tobacco use.
    In July 2018, San Francisco, California, implemented a sales
restriction on all flavored tobacco products, including menthol
cigarettes. The San Francisco Department of Public Health announced
that enforcement would begin January 2019 and enforcement with routine
retailer compliance inspections began April 2019 (Ref. 194). An
evaluation of the impact of the San Francisco policy on tobacco product
sales, a proxy for consumption, found that total tobacco sales
decreased by a statistically significant 25 percent from before policy
implementation (July 2015-July 2018) to a post-policy enforcement
period (January-December 2019) (Ref. 190). This study also found a
statistically significant decrease in the overall sales of flavored
tobacco products (from 39,350 average weekly unit sales to 1,546
average weekly unit sales), including menthol cigarettes (from 21,463
average weekly unit sales to 860 average weekly unit sales), to low
levels after policy enforcement (Ref. 190). Findings that total tobacco
sales and flavored tobacco sales decreased post policy suggest that
consumers did not completely substitute non-flavored tobacco products
for flavored tobacco products, and that such a policy can be
implemented effectively and reduce sales of products as intended.
    Changes in sales of tobacco products in San Francisco after policy
enforcement were also reflected in young adult tobacco use patterns. A
retrospective study of a convenience sample of young adult ever tobacco
users in San Francisco found a statistically significant lower
prevalence of overall tobacco use among 18-to 24-year-olds (from 100
percent to 82.3 percent) and 25-to 34-year-olds (from 100 percent to
92.4 percent) about 11 months after policy enforcement (November 2019)
(Ref. 191).
    One study on San Francisco's flavored tobacco policy using 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.
195). 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. 196). As previously noted,
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. 190).
    In June 2020, Massachusetts implemented a statewide sales
restriction on flavored tobacco products (including menthol cigarettes)
(Ref. 193). An evaluation of retail sales data assessed State-level
cigarette sales per 1000 people in Massachusetts and comparison states
without statewide flavor sales restrictions (Ref. 193). After the
flavor sales restriction, the adjusted sales of cigarettes in
Massachusetts versus the comparison states decreased by 372.27 packs
per 1000 people for menthol cigarettes and by 282.65 pack per 1000
people for all cigarettes (Ref. 193).
    In addition to state and local menthol sales restrictions, in
recent years many provinces in Canada have implemented menthol sales
restrictions. An evaluation of provincial menthol sales restrictions in
Canada on youth and adult cigarette use found that provincial menthol
sales restrictions were associated with decreases in menthol cigarette
smoking (Ref. 197). While this study found that provincial menthol
sales restrictions were not associated with an overall change in youth
and adult past 30-day cigarette use, this finding is inconsistent with
the authors' supplemental analysis that found decreases in menthol
cigarette sales and no effect on non-menthol cigarette sales post-
implementation (Ref. 197). The study also found an increase in adult
self-reported purchasing of cigarettes from First Nations reserves,
which were exempt from the sales restriction (Ref. 197). This
purchasing behavior was not assessed among youth. In the United States,
however, the proposed menthol product standard would apply nationwide,
including on Tribal lands, which likely would increase the
effectiveness of a nationwide menthol standard as compared to Canada.

    In addition to the studies discussed in this section, as of
November 2021, at least 145 localities in the United States have passed
restrictions on the sale of menthol cigarettes in addition to other
flavored tobacco products (Ref. 198). FDA requests comments and data on
the impact of these menthol cigarette sales restrictions on non-users
and users of tobacco products.
    Evaluations of local non-menthol flavored tobacco product sales
restrictions also provide evidence of decreases in the use and sales of
tobacco products after policy implementation (Refs. 199-203). In
November 2010, New York City (NYC) began enforcing a sales restriction
on all flavored tobacco products except for menthol-flavored, mint-
flavored, and wintergreen-flavored tobacco products; all e-cigarettes
were excluded from the sales restrictions. An evaluation of the impact
of the policy on youth tobacco product use found that NYC youth (aged
13-17 years) had 37 percent lower odds of ever trying a flavored
tobacco product in 2013 after the policy was enforced compared to youth
in 2010. Similarly, youth in 2013 had 28 percent lower odds of ever
using any tobacco products compared to youth before the policy was
enforced (Ref. 199). Changes in youth flavored tobacco use patterns
were also reflected in changes in overall sales of flavored tobacco
products. Analyses of tobacco product sales found a statistically
significant decline in sales of overall flavored tobacco products
following policy implementation and enforcement (Refs. 199 and 200).
Similar to findings in NYC, an evaluation of a policy restricting the
sale of flavored tobacco products, including e-cigarettes and excluding
menthol cigarettes, in Providence, Rhode Island, found a decrease in
any tobacco product use among high school students after active
enforcement of the policy began (Ref. 202). More specifically, this
analysis found that youth current use of any tobacco product declined
from 22.2 percent in 2016 to 12.1 percent in 2018 (Ref. 202).
    In October 2016, Lowell, Massachusetts, a small locality, began
enforcing a sales restriction on all flavored tobacco products, except
for menthol; e-cigarettes were included in the sales restriction. An
evaluation of the short-term (6-month) impact of the policy found that
youth use of any flavored tobacco products and any non-flavored or
menthol tobacco products decreased in Lowell from baseline to followup
and increased in the comparison community; statistically significant
decreases in both any flavored and any non-flavored or menthol tobacco
use were observed when comparing changes from baseline to followup
between the two communities (Ref. 201). More specifically, youth self-
reported current use of any non-flavored tobacco products 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.
201). These data suggest that overall, youth did not switch to non-
flavored or menthol tobacco products and that the policy helped reduce
use of tobacco products among youth (Ref. 201).
    Additionally, a study of local level restrictions across
Massachusetts from 2011-2017 found that counties with a 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 smoked in the past 30 days and a
decrease in the likelihood of e-cigarette use among high school
students (Ref. 203). Another study evaluated the impact of flavored
tobacco sales restrictions (excluding menthol) in Attleboro and Salem,
Massachusetts, on tobacco use among high school students (Ref. 204).
While youth use of flavored tobacco products and nonflavored or menthol
tobacco products increased from baseline to followup in Attleboro and
Salem and in the comparison municipality, the increases were
significantly smaller in Attleboro and Salem than the comparison
municipality, suggesting that the policy mitigated increases in
flavored and nonflavored or menthol tobacco use (Ref. 204).
Furthermore, while no changes in youth overall tobacco use were
observed after a sales restriction on flavored tobacco products
(excluding menthol, mint, and wintergreen products) in Minneapolis and
St. Paul, Minnesota (18.1 percent to 17.6 percent), significant
increases in the prevalence of youth overall tobacco use were observed
in the rest of the state (12.4 percent to 15.7 percent), suggesting
that the policy may have prevented increases in overall tobacco use
(Ref. 192). As discussed previously, after this sales restriction was
expanded to include menthol, mint, and wintergreen tobacco products,
increases in youth overall tobacco use were lower in the Twin Cities
than in the rest of the State, suggesting that the expanded policy
diminished increases in overall tobacco use (Ref. 192).
    FDA acknowledges there may be limitations to relying on aggregate
tobacco sales information as a proxy for consumption. In addition,
overall sales data are more likely to be driven by adult than
adolescent use, given the larger size of the adult population as well
as the tendency for youth to acquire tobacco via social sources (Ref.
205). However, studies have shown that sales and consumption tend to be
highly correlated (Refs. 206-208). Additionally, sales data provide
information on purchases of tobacco products in a defined area (which
could include neighboring jurisdictions) (Refs. 200 and 209) and can
serve as a proxy for consumption of tobacco products after policy
implementation.
    Evaluations of local policies may underestimate the potential
impact of a national policy. Depending on availability of tobacco
products in jurisdictions neighboring those where local policies were
passed, users and non-users may easily be able to access tobacco
products from these locations. Even with these limitations, FDA finds
sales and local policy evaluation data useful and supportive in
informing our expectations about the impact of the proposed product
standard on tobacco product use and potential product substitution.
Overall, the evidence supports that sales and use of tobacco products
decrease as a result of flavored tobacco product sales restrictions.
FDA anticipates that a nationwide standard that prohibits the
manufacture and sale of menthol cigarettes would likely have a greater
impact in decreasing youth cigarette 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 to easily travel to neighboring jurisdictions within
the United States that do not have a menthol sales restriction or use
online retailers to purchase menthol cigarettes.
    Although there are limitations in attributing public health
outcomes to the evaluations described in this section, such evaluations
are useful to understand the anticipated effect of the proposed menthol
product standard. Findings from these evaluations generally suggest
that youth use of cigarettes would decrease following implementation of
the proposed product standard. With reduced menthol cigarette smoking,
we would see reduced smoking-related morbidity and mortality along with
diminished exposure to secondhand smoke among non-smokers, decreased
potential years of life lost, decreased disability, and improved
quality of life for the current and future generations to come. For
these reasons, FDA expects that prohibiting menthol as a characterizing

flavor in cigarettes would reduce the likelihood that youth and young
adults would initiate with and progress to regular menthol cigarette
smoking, thereby protecting many youth from a lifetime of addiction and
disease, and premature death, attributable to cigarette smoking. From
the expected impact on non-users alone, especially youth and young
adults, this proposed product standard is appropriate for the
protection of public health.

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

    In addition to the long-term public health benefits that would
accrue from the prevention or reduction of menthol cigarette smoking
among youth and young adults, FDA anticipates that the proposed
standard would increase the likelihood that many existing menthol
cigarette smokers would stop smoking cigarettes altogether, yielding
health benefits from smoking cessation. FDA expects that the proposed
prohibition of menthol as a characterizing flavor in cigarettes would
result in substantial changes in tobacco use patterns among current
tobacco users. Current menthol smokers would either: (1) Quit smoking
or tobacco use altogether; (2) transition to non-menthol cigarettes or
other combusted tobacco products; or (3) switch to other tobacco
products, including potentially less harmful products. Given the large
proportion of menthol cigarette use among smokers, the role of menthol
in reducing cessation success among cigarette smokers, and the
empirical evidence published through 2021 from policies restricting the
sales of flavored tobacco products in the United States and Canada, FDA
expects that the proposed product standard would lead many menthol
cigarette smokers to stop using cigarettes.
    As discussed previously, menthol's flavor and sensory properties
influence initiation and continued experimentation (see section IV.C of
this document). Additionally, these sensory properties are a major
factor for a smoker's continued use of menthol cigarettes. Smokers note
that menthol in cigarettes impacts their sensory experience, including
the perception of a better tasting, smoother, and more refreshing
cigarette that is easier to inhale and produces a cooling effect in the
mouth and throat; smokers report that these sensory effects from
menthol contribute to their continued smoking (Refs. 3-5, 107-108). In
a qualitative study, young adult menthol smokers (aged 18-24) reported
that the taste of menthol made cigarettes ``minty'', ``cool'', and
``refreshing'', stating that these factors influenced their initial
preference for menthol cigarettes (Ref. 5). They perceived menthol
cigarettes as smoother, less harsh, and ``easier to inhale'' than non-
menthol cigarettes, which were generally regarded as strong, harsh, and
``gross'' (Ref. 5). They also reported that menthol cigarettes deliver
a ``fuller'' smoke and ``hit hard,'' and seemingly require fewer
cigarettes to feel ``satisfied'' (Ref. 5). Among adult smokers aged 18
and older, another recent study found menthol cigarette smoking to be
associated with self-reported subjective reward, satisfaction, and
throat hit (Ref. 108). Similar findings have been noted in youth. In a
PATH Study of Wave 1 data, youth cigarette smokers (aged 12-17),
regardless of menthol use status, reported that menthol cigarettes are
easier to smoke (Ref. 107). The menthol product standard, if finalized,
would prohibit menthol as a characterizing flavor in cigarettes,
eliminating menthol's sensory cue, thereby reducing the reinforcing
appeal of cigarettes for current menthol smokers, and encouraging
current menthol smokers to quit smoking.
    The sensory effects of menthol serve to reinforce the effects of
nicotine. While nicotine dependence is the driving factor for all
tobacco use, including cigarettes, menthol's enhancement of nicotine
dependence and the sensory properties of menthol contribute to
continued use of menthol cigarettes, making it even more difficult to
quit smoking (Refs. 1, 34-35, 42, 36-37). While there is some
inconsistency in the literature regarding menthol's role on smoking
cessation, when considering the evidence from systematic reviews,
national surveys, longitudinal studies that evaluated cessation
outcomes over time, and menthol's effects on nicotinic receptors in the
brain, the totality of evidence supports that menthol in cigarettes
contributes to reduced cessation success among smokers, particularly
among Black smokers (Refs. 34-35, 42, 36-41).
    Data from TUS-CPS found that in 2007, reporting a quit attempt in
the past year was 8.8 percent higher among menthol smokers (41.4
percent) compared to non-menthol smokers (38.1 percent), but menthol
smokers had 3.9 percent lower rates of quitting within the past year
(menthol: 4.2 percent versus non-menthol: 4.4 percent) and 11.3 percent
lower rates of quitting within the past 5 years (menthol: 18.8 percent
versus non-menthol: 21.1 percent) compared to non-menthol smokers (Ref.
37). After adjusting for covariates, including nicotine dependence and
race/ethnicity, the likelihood of quitting was 3.5 percent lower for
quitting in the past year and 6 percent lower for quitting in the past
5 years in menthol compared with nonmenthol smokers (Ref. 37). Similar
results have been noted in more recent data from Waves 1-4 of the PATH
Study (2013-2018), which found that daily adult menthol smokers (ages
18 and older) had 24 percent lower odds of quitting smoking compared to
daily non-menthol smokers (Ref. 40). Another PATH study evaluated
short-term (30-day) and long-term (12-month) smoking abstinence among
menthol and non-menthol smokers who had attempted to quit smoking in
the past 12 months (Ref. 43). Menthol smoking decreased the probability
of 30-day smoking abstinence by 28 percent and the probability of 12-
month smoking abstinence by 53 percent compared to smoking non-menthol
cigarettes (Ref. 43). The majority of cigarette smokers in the United
States report wanting to quit smoking (2015 NHIS: 68.0 percent) (Ref.
210), and thus, in response to the proposed product standard, many
menthol cigarette smokers may seek to quit tobacco altogether or switch
to other, potentially less harmful products.
    FDA expects that, if this proposed rule is finalized and menthol is
prohibited as a characterizing flavor in cigarettes, many menthol
cigarette smokers will either quit smoking or switch to a non-combusted
tobacco product, such as ENDS. In an expert elicitation study
estimating transitions in use under both menthol ban and status quo
scenarios, the panel of experts estimated that an additional 20.1
percent of menthol smokers ages 35 to 54 would cease combustible
tobacco use over 2 years under a menthol ban compared to the status
quo, with about half (10.3 percent) switching to ENDS and about half
(10 percent) quitting all tobacco use (Ref. 211). The expert panel also
estimated that an additional 30.1 percent of menthol smokers ages 18 to
24 would cease combustible tobacco use over 2 years, with 15.6 percent
switching to ENDS and 12.3 percent quitting all tobacco use (Ref. 211).
Some menthol cigarette smokers may switch to non-menthol cigarettes.
The expert elicitation study suggested that among menthol smokers age
35 to 54, 45.7 percent would become non-menthol cigarette smokers
(compared to 4.6 percent under the status quo) while 3.7 percent would
become non-menthol cigar smokers (compared to no change under the
status quo) (Ref. 211). The expert elicitation study and the resulting
population modeling study,

which utilized the expert elicitation, are discussed in further detail
in section V.C.5 of this document.
    Among Hispanic and Latino smokers, studies also suggest that
menthol smokers have more difficulty quitting than non-menthol smokers
(Refs. 34, 151, 42, 36). Data from cross-sectional surveys using
nationally representative online cohorts of U.S. adults indicated that
Hispanic, non-Hispanic African American, and non-Hispanic other (those
who identified with more than two races) adults were more supportive of
a menthol ban than non-Hispanic White adults (Ref. 212) and that, among
menthol smokers, both African American and Hispanic adults were more
supportive of a menthol ban than White adults (Ref. 213). African
American adults and Hispanic adults are two of the three racial and
ethnic groups that, in 2019, had the highest prevalence of menthol
cigarette smoking.
    Prohibiting menthol as a characterizing flavor in cigarettes would
likely result in increased cigarette cessation among members of
historically underserved communities, including Black smokers, due to
increased quit attempts and lower likelihood of switching to non-
menthol cigarettes. A recent review of the literature found that among
smokers, African American menthol smokers had lower odds of smoking
cessation compared to non-menthol smokers (Ref. 41). As discussed
above, the totality of evidence supports that menthol in cigarettes
contributes to reduced cessation success. Data from national surveys
suggests that menthol likely plays a role in making quitting
particularly difficult for African American cigarette smokers (Refs.
34-37, 40). A focus group study among Black smokers found that taste
was the main reason for continuing to smoke a particular brand and was
a reason for smoking menthol rather than non-menthol cigarettes (Ref.
4). Additionally, participants agreed that menthol cigarettes were
``refreshing'', ``soothing'', and ``smooth'' while non-menthol
cigarettes were ``strong'' or ``harsh'' (Ref. 4). Participants'
preference for menthol cigarettes in this study was so strong that non-
menthol cigarettes were viewed as a cessation aid (Ref. 4). These
findings support that prohibiting menthol as a characterizing flavor in
cigarettes will reduce the appeal of cigarettes, lead to reduced
initiation and experimentation, and reduce the likelihood of subsequent
progression to regular, established smoking and smoking dependence
among vulnerable populations.
    While a menthol restriction is anticipated to benefit the general
population, the benefits of a menthol restriction on smoking cessation
are likely to be more pronounced among Black menthol smokers, as they
are less likely to switch to non-menthol cigarettes. Older and more
recent studies are consistent in their findings that there would be
increased likelihood of quitting smoking altogether for many menthol
smokers under a menthol ban. A 1993 study of adult cigarette smokers
found that 56 percent of Black smokers, compared to 28 percent of White
smokers, responded that they would not smoke non-menthol cigarettes if
they could not smoke menthol cigarettes (Ref. 214). While all menthol
smokers in a nationally representative study had lower odds of smoking
cessation compared to non-menthol smokers, when stratified by race and
ethnicity, African American menthol smokers had the lowest odds of
smoking cessation of any group (Ref. 40). A 2011-2016 analysis of data
from the Truth Initiative Young Adult Cohort showed that among past 30-
day menthol smokers, African American smokers had greater odds of
reporting that they would quit smoking if menthol cigarettes were
unavailable compared to White smokers (Ref. 215). Another study
evaluating the effect of a menthol sales restriction in seven Canadian
provinces indicated that non-White cigarette smokers were more likely
than White cigarette smokers to make a quit attempt (Ref. 216).
Additionally, one experimental study recruited 29 current menthol adult
smokers who were not currently using cessation treatments and were not
trying to quit (Ref. 217). Participants were switched from smoking
their usual brand menthol cigarettes to a matched-brand non-menthol
cigarette and were monitored multiple times across 2 weeks to model a
potential ban of menthol cigarettes (Ref. 217). After switching to non-
menthol cigarettes, participants had significantly lower nicotine
dependence scores and greater increases in quitting motivation and
confidence (Ref. 217). Findings from this study indicated that Black
smokers had greater reductions in cigarettes per day when compared to
non-Black smokers (defined as Hispanic, White, or ``Other'' smokers)
(Ref. 217). Taken together, these research findings suggest that the
proposed menthol product standard could help to reduce tobacco-related
health disparities as experienced by vulnerable populations.
    Findings from surveys asking menthol cigarette smokers what they
would do if menthol cigarettes were to be banned are consistent with
the Agency's expectation that many menthol smokers would attempt to
quit smoking following the implementation of the proposed menthol
standard. A recent literature review examined such surveys and based on
responses from U.S. menthol smokers, concluded that banning menthol
cigarettes would increase quit attempts and switching to potentially
less harmful tobacco products (Ref. 218). Across several surveys,
menthol smokers have said that if menthol cigarettes were no longer
available, they would consider quitting smoking altogether (Refs. 213,
219-223, 215). For example, a 2010 nationally representative survey
found that approximately 39 percent of adult menthol cigarette smokers
said they would ``try to stop smoking'' if menthol cigarettes were
banned (Ref. 213). In a 2014 survey, adult menthol smokers in Minnesota
were asked whether they would quit smoking if menthol cigarettes were
no longer sold in U.S. stores (Ref. 221). Just under half (46.4
percent) of menthol smokers responded that they would quit smoking
(Ref. 221). A longitudinal survey from 2011-2016 of young adult menthol
smokers found that an average of 23.5 percent of menthol smokers
reported that they would most likely quit smoking and not use any other
tobacco product in response to a menthol ban (Ref. 215).
    In another study of adolescent and adult cigarette smokers, more
than 35 percent of menthol smokers indicated their intentions to try to
quit smoking if a ban of menthol in cigarettes was enacted (Ref. 219).
Two studies report higher proportions of non-Hispanic Black menthol
smokers indicating their intentions to quit smoking than non-Hispanic
White menthol smokers following a menthol cigarette flavor ban;
however, these differences were not statistically significant in either
study (Refs. 219 and 213). In a longitudinal study of young adults,
non-Hispanic Black participants had significantly higher odds of
reporting that they would most likely quit smoking if menthol
cigarettes were no longer available compared to non-Hispanic White
participants (Ref. 215). A study in Ontario, Canada, that compared
individuals' behavioral intentions before a menthol sales restriction
was implemented with actual responses 1 year after implementation found
38 percent of those with behavioral intentions to quit cigarettes in
response to a menthol ban reported quitting 1 year after the menthol
ban was implemented (Ref. 224). Fifteen percent of those who planned to
switch to non-

menthol cigarettes, 34 percent of those who planned to switch to other
flavored tobacco products, 19 percent of those who planned to switch to
contraband, and 24 percent of those who were unsure of their response
before the menthol ban also reported quitting cigarettes 1 year after
the menthol ban (Ref. 224).
    An additional study asked U.S. adult menthol smokers to complete a
hypothetical shopping task in a virtual store under one of four
experimental conditions that simulated various policy scenarios (1--no
ban, 2--replacement of menthol cigarettes and ads with green
replacement versions (i.e., the term ``menthol cigarettes'' is replaced
with the term ``green cigarettes''), 3--menthol cigarette ban, 4--all
menthol tobacco product ban) and assessed tobacco purchases (Ref. 225).
This study found that participants in scenarios with a menthol
cigarette ban and all menthol tobacco product bans were less likely to
purchase cigarettes than participants who were exposed to no ban (Ref.
225). This finding supports FDA's expectation that many menthol
cigarette smokers would quit smoking altogether after implementation of
a menthol product standard.
    Real-world experience from Canada's laws prohibiting the sale of
menthol tobacco products provides information on the potential
behavioral impacts the menthol product standard could have on cigarette
use in the United States. Studies evaluating the impact of these laws
have found increased reports of quit attempts and quitting smoking
following policy implementation (Refs. 226, 224, 227, 216). These
findings are consistent with the Agency's expectation that, following
implementation, the proposed menthol product standard would increase
the number of menthol cigarette smokers who quit cigarette use. After
menthol sales restrictions in Quebec, Ontario, Prince Edward Island,
Newfoundland, and Labrador, and a nationwide restriction covering
British Columbia, Saskatchewan, and Manitoba, smokers from these
provinces reported high rates of quit attempts and quitting smoking
(Refs. 226, 224, 227, 216). In a study of Ontario 1 year after policy
implementation, 56 percent of study participants who were smokers
before the sales restriction reported making a quit attempt and 19
percent reported quitting smoking (Ref. 224). In a study of smokers
from the Canadian provinces previously mentioned, 21.5 percent of pre-
ban menthol smokers reported quitting smoking (defined as those who had
currently quit or cut down to smoking less than monthly) after policy
implementation (Ref. 216). Another study of adult smokers from Canadian
provinces that implemented menthol sales restrictions found a small
non-significant increase in the likelihood of ever trying to quit
following policy implementation (Ref. 197). While the percent of
smokers who reported quitting post-policy in these studies varies based
on the length of time after policy implementation, geographic location,
and definition of quitting, the percent of quitting post-policy in
these studies was higher than the percent of current smokers from
Ontario who reported quitting smoking 30 days or longer pre-policy in
2014 (7.9 percent) (Ref. 228). This suggests the various Canadian
menthol sales restrictions contributed to increases in the number of
smokers who quit smoking. The high rates of quit attempts and quitting
smoking in Canada after menthol sales restrictions support FDA's
expectation that a ban on menthol cigarettes would increase the
likelihood that existing menthol cigarette smokers will stop smoking
cigarettes altogether. For reference, in 2018 in the United States,
recent successful quitting (quit smoking for >=6 months during the past
year) was 7.5 percent among those who were either current smokers who
smoked for >=2 years or former smokers who quit during the past year
(Ref. 229). Even if only a portion of the increase in cessation seen in
Canada is experienced in the United States as a result of the proposed
menthol standard, there would still be a significant net public health
benefit.
    Further supporting FDA's expectation that a prohibition on menthol
cigarettes would increase quitting by menthol cigarette smokers is
evidence from Canada that menthol smokers there report higher rates of
quit attempts and quitting smoking than non-menthol smokers (Refs. 224,
227, and 216). Studies from Ontario 1 year and 2 years after policy
implementation found a higher likelihood of quit attempts and quitting
smoking among those who reported smoking menthol cigarettes daily
before the sales restriction (baseline) when compared with smokers who
reported smoking non-menthol cigarettes daily (Refs. 224 and 227).
Similarly, in a study looking across seven Canadian provinces with
menthol sales restrictions, menthol smokers were more likely than non-
menthol smokers to make a quit attempt and remain quit (quit greater
than 6 months at follow-up and were long-term quitters who stopped
smoking before the nationwide ban and remained quit) (Ref. 216). In
addition, there is evidence that previous menthol smoking is not
associated with relapse (Refs. 227 and 216). This suggests that menthol
sales restrictions help those who quit smoking menthol cigarettes to
stay quit. Taken together, the results from these studies support FDA's
expectation that menthol smokers will achieve quit rates similar to or
higher than non-menthol smokers because of a menthol product standard.
    Findings on cessation from Ontario are consistent with analyses of
tobacco manufacturer wholesale sales data and retail scanner data
(Refs. 230 and 231). These data are often used as a proxy for cigarette
consumption. An analysis of wholesale cigarette sales data in 10
Canadian provinces found an overall decrease of 4.6 percent in total
cigarette sales after menthol cigarette bans (Ref. 232). Another
analysis of tobacco manufacturer wholesale sales data showed that total
cigarette sales declined by 128 million units following the Ontario
menthol sales restriction compared to British Columbia, a Canadian
province demographically similar to Ontario that did not have a menthol
sales restriction in place at the time of the study, in which no
significant changes were observed (Ref. 230).
    There are considerations in relying on: (1) Canadian-based data to
inform U.S. policy and (2) tobacco manufacturer wholesale sales and
retail sales data as a proxy for consumption. With regard to the
Canadian-based data to inform U.S. policy, it is important to note that
menthol cigarettes comprise a larger proportion of cigarettes sales in
the United States (e.g., 26 percent in the United States versus 4
percent in Canada in 2001) and that a larger proportion of Black
cigarette smokers in the United States use menthol cigarette brands
(e.g., 78.4 percent of Black cigarette smokers in the United States
versus 9.8 percent of Black cigarette smokers in Canada in 2002) (Ref.
88). Therefore, findings from Canada likely underestimate the impact of
a menthol cigarette ban in the United States. Findings from Canada's
menthol sales restrictions corroborate evidence from evaluations of
flavored tobacco product sales restrictions in the United States (e.g.,
Massachusetts; Providence, RI; New York City, NY; San Francisco, CA)
that found that sales and use of tobacco products covered by the flavor
restriction decreased after implementation (Refs. 193, 200, 199, 209,
190).
    With regard to relying on tobacco manufacturer wholesale sales and
retail sales data as a proxy for consumption, such data do not
completely reflect individual-level tobacco use behaviors.

For example, smokers may have obtained cigarettes through channels not
included in the Ontario sales data (e.g., other provinces) or switched
to non-restricted products, which may result in an overestimation of
the impacts. The analysis of tobacco manufacturer wholesale data found
a significant decline in the overall cigarette sales in Ontario in the
month following Ontario's menthol sales restriction. This was followed
by a statistically significant increase in the sales of overall
cigarettes driven by an increase in non-menthol cigarettes in Ontario,
suggesting a slight rebound effect; however, overall cigarette sales
approximately 8 months following the menthol sales restriction were
lower than study baseline (October 2012) (Ref. 230). Similarly, an
analysis of retail sales data found a small increase (0.4 percent) in
sales of non-menthol cigarettes in the 6 months following policy
implementation (Ref. 231). In spite of this limitation, considering
sales data with the self-report data suggests increased smoking
cessation occurred as a result of the sales restriction.
    As mentioned previously, several U.S. localities have placed
restrictions on the sale of menthol cigarettes in addition to
restrictions on the sale of flavored tobacco products. FDA is aware of
two studies that report on the impact of the policy in San Francisco on
cessation. The first, a retrospective study with a relatively small
convenience sample of young adult ever tobacco users in San Francisco
found of 20 exclusive menthol cigarette smokers before the policy, 5
percent (n=1) quit any tobacco use after the policy and, among 61
menthol cigarette and other tobacco users before the policy, 3.3
percent (n=2) quit after the policy (Ref. 191). A second study
examining the impact of the same policy among clients enrolled in a San
Francisco residential substance use disorder treatment facility found
that participants surveyed about 5 months after the policy (n=102) were
statistically significantly less likely to report menthol as the usual
cigarette smoked compared to participants surveyed before the policy
(Ref. 233). This study found no evidence that the policy was associated
with decreased number of cigarettes per day or increased readiness to
quit among current smokers (Ref. 233). The marginal effects observed in
this study are not entirely unanticipated. Smoking prevalence rates are
substantially higher among individuals with substance use disorder
compared to those in the general population (Refs. 234-237), and these
individuals report increased nicotine dependence levels (Ref. 238) and
have less success at quitting smoking than individuals without
substance use disorders (Refs. 239 and 240). Additionally, studies show
that drugs of abuse may have unique pharmacological interactions with
nicotine, increasing the reinforcing effects of both smoking and drug
use among these populations (Refs. 241-244). This population with
substance use disorder may have been less sensitive to the regional
menthol ban compared to the general population due to their unique risk
factors and pervasive patterns of tobacco use.
    Taken together, these two San Francisco studies provide limited
evidence of the impact of a menthol cigarette sales restriction on
cessation in the United States (Refs. 191 and 233). Both studies rely
on convenience samples and do not include a control group (Refs. 191
and 233) limiting their generalizability to people other than study
participants. In addition, the retrospective study of a convenience
sample of young adult ever tobacco users in San Francisco (Ref. 191),
only collects data after the policy was implemented. Given this, FDA
relies more on the evidence from Canada which includes multiple
longitudinal cohort studies of the general population at different time
points following policy implementation and in various locations that
have implemented menthol sales restrictions to inform expectations on
the impact of the proposed product standard on cessation.
    As discussed previously, evaluations of local policies may
underestimate the potential impact of a national policy. Depending on
availability of tobacco products in jurisdictions neighboring those
where local policies were passed, users and non-users may easily be
able to access tobacco products from these locations. For example, in
the study examining clients enrolled in San Francisco residential
substance use disorder treatment facilities, 50 percent of menthol
smokers reported purchasing menthol cigarettes in San Francisco after
the menthol sales restriction (Ref. 233). Overall, the evidence
supports that following a menthol sales restriction or ban, adult
menthol cigarette smokers' quit attempts and quitting smoking
increases. FDA anticipates that a nationwide standard that prohibits
the manufacture and sale of menthol cigarettes would likely have a
greater impact in increasing cigarette smokers' quit attempts and
quitting smoking 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 to easily
travel to neighboring jurisdictions within the United States that do
not have a menthol sales restriction or use online retailers to
purchase menthol cigarettes. While the 2020 Surgeon General's Report,
``Smoking Cessation'', concluded that ``the evidence is suggestive but
not sufficient to infer that restricting the sale of certain types of
tobacco products . . . increases smoking cessation . . . ,'' this
assessment was based on empirical evidence published through 2019 (Ref.
245). Numerous studies have been published since the 2020 Surgeon
General's Report and were considered in FDA's assessment of the impact
of a proposed product standard on cessation. The recently published
evaluation studies have examined the impact of menthol sales
restrictions in multiple Canadian provinces (Refs. 216, 230, 227, 231-
232, 197) and state and local jurisdictions in the United States (Refs.
190-191, 233, 193). When these studies are considered with the
evaluation evidence published before 2020, FDA concludes that there is
substantial evidence of increases in quit attempts and quitting by
adult smokers after a menthol cigarette sales restriction (Refs. 77,
197, and 193). Further, recent longitudinal data from the PATH study
and a systematic review of the literature all indicate that menthol
cigarette smoking is associated with reduced cessation success compared
to non-menthol smokers (Refs. 40, 43, and 41). Thus, by banning menthol
cigarettes, FDA expects to increase smoking cessation across the
population. This is further evidenced by expert elicitation and
simulation studies, which assessed and modeled menthol restrictions in
the United States, resulting in substantial estimated public health
benefits (Refs. 46 and 211). These findings, all more recent than the
2020 Surgeon General's Report, suggest that a menthol ban is
appropriate for the protection of the public health.
    The sum of the available evidence, including the interaction of
menthol and nicotine in the brain, the continued use of menthol
cigarettes by millions of Americans, the difficulties of quitting
smoking for menthol smokers, and the empirical evidence from policies
restricting the sales of menthol cigarettes in Canada and flavored
tobacco products in the United States, suggest that the proposed
standard would lead many menthol cigarette smokers to stop using
cigarettes, yielding considerable health benefits. There are currently
more than 18.5 million menthol cigarette smokers ages

12 and older in the United States (Ref. 44). Thus, even small changes
in initiation and cessation would result in a significant reduction in
the burden of death and disease caused by smoking. Further, given the
high concentration of menthol cigarette smoking among underserved
communities, the effect of the standard on reducing cigarette smoking
would be expected to be greater in these populations. From the expected
public health impact on current adult menthol cigarette smokers alone,
this proposed product standard is appropriate for the protection of the
public health.
    As discussed in section III.B.4 of this document, FDA intends to
work with HHS to enlist and collaborate with other entities at the
Federal, Tribal, State, and local levels who provide support to menthol
smokers who quit or want to quit as a result of a prohibition of
menthol as a characterizing flavor in cigarettes going into effect.

C. Benefits and Risks to the Population as a Whole

    We expect that the proposed menthol product standard, if finalized,
would reduce tobacco-related harms. As discussed in section IV of this
document, the addition of menthol as a characterizing flavor to
cigarettes makes it easier to start smoking, easier to continue
smoking, and harder to quit smoking. By prohibiting the addition of
menthol as a characterizing flavor to cigarettes sold in the United
States, FDA anticipates that reductions in population harm would be
realized through long-term health benefits resulting from prevention of
cigarette uptake and progression to regular cigarette smoking among
youth and young adults, as described in section V.A of this document,
as well as shorter-term health benefits resulting from increased
cessation of cigarette smoking among current menthol smokers, as
described in section V.B of this document. Each of these impacts alone
would result in significant health benefits to the U.S. population. In
totality, they provide overwhelming evidence that the proposed standard
would result in substantial health benefits over both the short- and
long-term. In this section, we summarize the health benefits of never
progressing to regular cigarette smoking, the health benefits of
quitting smoking, the potential health benefits of switching from
cigarettes to potentially less harmful tobacco products, and the health
benefits of not being exposed to secondhand smoke. We also describe
findings from population modeling studies that estimate the public
health impact of the proposed standard. Finally, we describe potential
risks of the product standard, including risks of countervailing
effects of the tobacco standard such as increasing demand for
contraband.
1. Given the Harmful Effects of Cigarette Smoking, Never Progressing to
Regular Smoking Prevents Death and Disease
    Never progressing to regular cigarette smoking prevents death and
disease caused by smoking. Any effects of a menthol ban on preventing
youth, young adult, and even adult never smokers from initiating/
experimenting and progressing to regular cigarette smoking will have a
population health benefit. According to the 2014 Surgeon General's
Report, ``The Health Consequences of Smoking: 50 Years of Progress'',
which summarizes thousands of peer-reviewed scientific studies and is
itself peer-reviewed, smoking remains the leading preventable cause of
death in the United States, and cigarettes have been shown to cause an
ever-expanding number of diseases and health conditions (Ref. 1). As
stated in the report, ``cigarette smoking has been causally linked to
disease of nearly all organs of the body, to diminished health status,
and to harm to the fetus'' and ``[t]he the burden of death and disease
from tobacco use in the United States is overwhelmingly caused by
cigarettes and other combusted tobacco products'' (Ref. 1 at 37).
    The 2014 Surgeon General's Report estimates that 16 million people
live with diseases caused by smoking cigarettes (Ref. 1). Comparing
mortality to morbidity, for every person who dies from smoking, 30 more
are living with a smoking-attributable disease (Ref. 1). Smoking is
causally associated with a number of diseases affecting nearly all
organs in the body, such as numerous types of cancer, heart disease,
stroke, lung diseases such as chronic obstructive pulmonary disease,
and diabetes, in addition to putting individuals at increased risk for
tuberculosis, certain eye diseases, and immune system issues (Ref. 1).
Furthermore, maternal smoking is causally associated with multiple
adverse fetal outcomes, including fetal growth restriction and low
birth weight, premature rupture of the membranes, placenta previa,
placental abruption, preterm birth, preeclampsia, reduction of lung
function in infants, and sudden infant death syndrome (SIDS) (Ref. 1).
    A study using 2006-2012 data from the NHIS estimated that 6.9
million U.S. adults had a combined 10.9 million self-reported smoking-
attributable medical conditions, highlighting that smoking cigarettes
often causes co-morbid diseases (Ref. 246). The study noted that the
morbidity estimates are likely underestimates due to underreporting of
diseases in surveys and the lack of assessment of several major medical
conditions (Ref. 246). Thus, it is likely that the true morbidity
burden in the United States is substantially more than these estimates.
    An analysis of the National Longitudinal Mortality Study, a
longitudinal population-based, nationally representative health survey
with mortality data from the National Death Index, found that exclusive
regular cigarette smokers had substantially higher all-cause mortality
risks than never tobacco users (Ref. 247). Another analysis, which
examined NHIS data, found that life expectancy was shortened by more
than 10 years among current cigarette smokers, compared with those who
had never smoked (Ref. 248). Even non-daily smokers have higher
mortality risk than never smokers. A recent study pooled data from the
1991, 1992, and 1995 NHIS and were linked to data from the National
Death Index through 2011 (Ref. 249). The study indicated that lifelong
non-daily smokers, who had smoked cigarettes on a median of 15 days and
50 cigarettes per month, had a 72 percent higher overall mortality risk
resulting in about a 5-year shorter lifespan, than never smokers (Ref.
249). The study also found a gradient in number of cigarettes smoked
among non-daily users, with higher mortality risks observed among
lifelong non-daily smokers who reported 31-60 cigarettes per month and
more than 60 cigarettes per month than never smokers, but no difference
among those who smoked 11-30 cigarettes per month (Ref. 249). Daily
smokers in the study had an even higher mortality risk and shorter
survival (about 10 years less) than never smokers (Ref. 249).
    As previously discussed, menthol cigarette smoking facilitates
progression to regular cigarette smoking among youth and young adults.
African American smokers are more likely than smokers from other racial
and ethnic groups to try a menthol cigarette as their first cigarette,
regardless of age (Refs. 33, 25, and 31). FDA anticipates that a
menthol restriction will prevent a substantial number of youth, and
especially Black youth, from initiating menthol cigarette smoking,
thereby decreasing progression to regular cigarette smoking, resulting
in reduced tobacco-related morbidity and mortality associated with
menthol cigarette smoking.

2. Given the Harmful Effects of Cigarette Smoking, Quitting Smoking
Reduces Death and Disease
    Quitting cigarette smoking, including menthol cigarettes,
substantially reduces the likelihood of tobacco-related death and
disease. As stated in the 2004 Surgeon General's Report, ``[q]uitting
smoking has immediate as well as long-term benefits, reducing risks for
diseases caused by smoking and improving health in general'' (Ref.
250). The 2020 Surgeon General's Report also concluded, ``[s]moking
cessation is beneficial at any age. Smoking cessation improves health
status and enhances quality of life.'' (Ref. 245). As previously noted,
FDA expects that, if this proposed rule is finalized, there will be a
significant increase in smoking cessation in the U.S. population (see
section V.B).
    The benefits associated with smoking cessation happen quickly (Ref.
250). Within 2 to 12 weeks of quitting smoking, an individual's lung
function and blood circulation improve (Ref. 250). During the first 1
to 9 months after cessation, coughing and shortness of breath decrease
(Ref. 250). Within several months of quitting smoking, individuals can
expect improvement in lung function (Ref. 250).
    The benefits continue for those who remain smoke-free. Smoking
cessation reduces the risk of cancers and other diseases (Ref. 245).
For example, the risk of fatal lung cancer in adults over 55 is about
25 times higher among smokers relative to people who have never smoked
(Ref. 251). After 10-15 years of abstinence from smoking, the risk of
lung cancer is about 50 percent of the risk for individuals who
continue to smoke (Ref. 245). The risk of cancer of the mouth, throat,
esophagus, stomach, bladder, cervix, pancreas, liver, kidney, colon,
rectum, and the risk of acute myeloid leukemia also decreases (Refs.
252 and 245). The evidence is also sufficient to infer that the risk of
stroke decreases after smoking cessation, and approaches that of never
smokers over time (Ref. 245). Furthermore, the evidence is sufficient
to infer that the relative risk of coronary heart disease among former
smokers compared with never smokers falls rapidly after cessation and
then declines more slowly (Ref. 245).
    Even smokers who quit smoking after the onset of life-threatening
disease experience health benefits from cessation. Quitting smoking
after a diagnosis reduces the chance of recurrences and future health
problems. For example, people who quit smoking after having a heart
attack can reduce their chances of having a second heart attack by 50
percent (Ref. 252). For those persons who have already developed
cancer, quitting smoking reduces the risk of developing a second cancer
(Refs. 253-256). Additionally, quitting smoking after a diagnosis of
lung cancer reduces the risk of cancer progression and mortality (Ref.
257). Researchers also estimate that for current smokers diagnosed with
coronary heart disease, quitting smoking reduces the risk of death
overall, and reduces the risk of recurrent heart attacks and
cardiovascular death by 30 to 40 percent (Refs. 245 and 256). The 2020
Surgeon General's Report concluded that quitting smoking reduces the
risk of fatal stroke, and earlier reports have also said that it is
reasonable to assume that quitting smoking would reduce the risk of
recurrent strokes (Refs. 245 and 256). Quitting smoking also helps the
body tolerate the surgery and treatments, such as chemotherapy and
radiation, associated with certain smoking-related diseases (Refs. 250,
253, 256, 258) and reduces the risk of respiratory infections compared
to continued smoking (Refs. 256 and 259).
    Given the reduction in risk of smoking-related death and disease
associated with cessation, those who successfully quit smoking increase
their life expectancy. Using data from the Cancer Prevention Study II
(CPS II), an ongoing study of 1.2 million adults, scientists have found
that men who smoked at 35 years old and continued to smoke until death
had a life expectancy of 69.3 years, compared with a life expectancy of
76.2 years for those who stopped smoking at age 35 (Ref. 260). After
adjusting for the subsequent quit rate among current smokers at
baseline (to account for the possibility that some current smokers at
baseline quit smoking or some former smokers relapsed during followup
and, thus, were incorrectly classified as continuing smokers in the
unadjusted analysis), the life expectancy for male former smokers
increased to 77.8 years (a life extension of 8.5 years) (Ref. 260).
Women who smoked at 35 years old and continued to smoke until death had
a life expectancy of 73.8 years, compared with a life expectancy of
79.7 years for those who stopped smoking at age 35 (Ref. 260). After
adjustment for the subsequent quit rate among current smokers at
baseline, the life expectancy for female former smokers increased to 81
years (a life extension of 7.7 years) (Ref. 260). Further, a man aged
60 to 64 who smokes 20 cigarettes (one pack) or more per day and then
quits smoking reduces his risk of dying during the next 15 years by 10
percent (Ref. 256).
    While cessation is beneficial for all ages, the health benefits are
greatest for people who stop smoking at earlier ages (Refs. 256 and
250). Scientists in the United Kingdom found those who quit smoking at
age 30 reduce their risk of dying prematurely from smoking-related
diseases by more than 90 percent (Refs. 261 and 262). Those who quit at
age 50 reduce their risk of dying prematurely by 50 percent compared to
those who continue to smoke (Ref. 262). Using data from the NHIS,
researchers also estimated that life expectancy in the United States
would increase 4 years among smokers quitting cigarettes at 55 to 64
years of age, and 10 years among smokers quitting cigarettes at 25 to
34 years of age (Ref. 248). Scientists using the CPS II data (while
accounting for the possibility that some current smokers at baseline
quit smoking and some former smokers relapsed during followup) found
that even smokers who quit at age 65 had an expected life increase of 2
years for men and 3.7 years for women (Ref. 260).
    As discussed previously, there is a lower quit rate among smokers
of menthol cigarettes than there is for non-menthol cigarettes. FDA
anticipates that prohibiting menthol as a characterizing flavor in
cigarettes would improve smoking cessation outcomes in adult smokers
and result in longer life expectancies for more individuals.
Additionally, FDA anticipates that this proposed product standard will
benefit vulnerable populations by reducing tobacco-related morbidity
and mortality by improving quitting and cessation among these
populations. As previously discussed, the role of menthol in cigarettes
in reducing cessation success among smokers is more pronounced among
certain population groups, in particular, among Black smokers.
Additionally, research has shown that cigarette smokers from
underserved communities bear a disproportionate burden of tobacco-
related morbidity and mortality. African Americans, and in particular
African American men, experience the highest rates of incidence and
mortality from tobacco-related cancers compared to people from other
racial and ethnic groups (Refs. 263 and 264). Additionally, mortality
due to tobacco-related disease such as heart disease, stroke, and
hypertension is higher among African Americans compared to other racial
and ethnic groups (Refs. 265-270, 50). Furthermore, as previously
discussed, compared to White smokers, Black smokers report they may be
more likely to quit smoking altogether if menthol

cigarettes were unavailable following a menthol restriction (Refs. 214,
215, and 217). Based on these collective findings, FDA anticipates that
the proposed product standard will improve smoking cessation outcomes
among vulnerable populations, in particular, Black smokers, leading to
a reduction in adverse tobacco-related health effects in these
populations.
3. Given the Harmful Effects of Cigarette Smoking, Switching to a
Potentially Less Harmful Nicotine Delivery Product May Reduce Death and
Disease
    FDA recognizes that smokers who choose to switch completely to a
potentially less harmful nicotine delivery product to maintain their
nicotine dose also could, to the extent that those products result in
less harm, significantly reduce their risk of tobacco-related death and
disease (Ref. 271). The least harmful nicotine delivery products
available to smokers are the pharmaceutical nicotine replacement
therapies already approved by FDA as both safe and effective cessation
tools, many of which are available in a variety of flavors, including
mint, which could appeal to menthol smokers. However, smokers may also
transition to tobacco products which utilize other forms of nicotine
delivery in place of smoking combusted cigarettes. These include
smokeless tobacco, dissolvable products, and ENDS products, among
others.
    In surveys, some menthol cigarette smokers and some dual users of
menthol cigarettes and ENDS report intending to use ENDS if menthol
cigarettes were no longer available (Refs. 221, 272, and 222).
Experimental marketplace studies also suggest that, in addition to
taking other actions, some menthol smokers may switch partially or
fully to ENDS in the event of a menthol cigarette ban (Refs. 273 and
225). These empirical findings are consistent with the 2020 Surgeon
General's Report, titled ``Smoking Cessation,'' and several systematic
reviews, which suggest that some adult cigarette smokers report using
ENDS to try to reduce or quit smoking (Refs. 245, 274-276). The
literature also suggests that cigarette smokers who use ENDS more
frequently (versus less frequently) have improved success in switching,
however the long-term patterns of use remain unknown (Refs. 271, 277-
279).
    In an expert elicitation study estimating effects of a menthol ban
on transitions in use, the panel of experts estimated that among
menthol smokers aged 35 to 54 years, 55.1 percent would remain
combustible tobacco users (a reduction of 20.1 percent from the status
quo), with another 20 percent switching to a ``novel nicotine delivery
product,'' defined in the study as ENDS or heated tobacco products
(HTPs) (a 10.3 percent increase from the status quo), and about 22.5
percent quitting all tobacco use (a 10.0 percent increase from the
status quo) (Ref. 211). Additionally, the experts estimated that among
those aged 12 to 24 years who would have initiated as menthol cigarette
smokers, under the menthol ban, 41.1 percent would still initiate
combustible tobacco use (including non-menthol cigarettes, cigars, or
illegal menthol cigarettes), while 17.6 percent would instead initiate
with a ``novel nicotine delivery product,'' such as ENDS or HTPs; the
result is a 58.9 percent reduction in combustible tobacco initiation
from the status quo (Ref. 211). Additional details of the expert
elicitation study and resulting population model study can be found in
section V.C.5 of this document.
    Data from the 2017 Ontario menthol sales restriction did not show
increases in menthol smokers' self-reported use of e-cigarettes (Ref.
280) or increases in retail sales of e-cigarettes (Ref. 231) following
policy implementation. To the extent that this may occur following
implementation of this product standard, FDA recognizes that completely
switching from combusted tobacco products to ENDS has the potential to
reduce some tobacco-related disease risks among individual users (Ref.
271). However, cessation of all tobacco products leads to the greatest
reduction in tobacco-related disease and death (Ref. 245).
4. Having Fewer People Smoke Cigarettes Will Reduce Smoking-Related
Death and Disease Associated With Secondhand Smoke Exposure
    Secondhand smoke exposure is harmful to the health of non-smokers.
The 2006 Surgeon General's Report, ``The Health Consequences of
Involuntary Exposure to Secondhand Smoke,'' concluded that ``secondhand
smoke exposure causes premature death and disease in children and in
adults who do not smoke'' (Ref. 281). Exposure to secondhand smoke is a
cause of cancer and respiratory and cardiovascular disease (Ref. 1).
According to the 2014 Surgeon General's Report, more than 437,000
premature deaths per year are caused by active cigarette smoking, and
an additional 41,280 premature deaths among adults aged 35 years and
older are due to secondhand smoke (Ref. 1). Specifically, the 2014
Surgeon General's Report estimated secondhand smoke causes
approximately 7,330 deaths from lung cancer and 33,950 deaths from
coronary heart diseases in non-smokers annually (Ref. 1).
    Secondhand smoke is particularly harmful to children. The 2014
Surgeon General's Report estimated that secondhand smoke is associated
with 150,000 to 300,000 lower respiratory tract infections in infants
and children under 18 months of age, 790,000 doctor's office visits
related to ear infections per year, and 202,000 asthma cases each year
(Refs. 282 and 1). In 2014, the Surgeon General reported 400 SIDS
deaths related to perinatal smoking or exposure to secondhand smoke;
the ``Reproductive Outcomes'' section describes the impact of perinatal
smoking (Ref. 1). Children of parents who smoke, when compared with
children of nonsmoking parents, have an increased frequency of
respiratory infections like pneumonia and bronchitis (Ref. 256).
Children exposed to tobacco smoke in the home are also more likely to
develop acute otitis media (middle ear infections) and persistent
middle ear effusions (fluid behind the eardrum) (Ref. 256).
    More recent data from the 2013-2014 NHANES estimates that
approximately 58 million American non-smokers (1 in 4) were exposed to
secondhand smoke, including 14 million children (Ref. 283).
Approximately half of all U.S. children aged 3 to 18 years are exposed
to cigarette smoke regularly at home or other locations that still
permit smoking (Ref. 1). In 2019, approximately one-quarter of middle
and high school students reported breathing in secondhand smoke in
their homes or in a vehicle (Ref. 284).
    The burden of secondhand smoke exposure is experienced
disproportionately among members of some racial or ethnic groups and
lower income groups. Among nonsmokers age 3 and older, findings from
2011-2018 NHANES data indicate that non-Hispanic Black persons 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. 285). From 1999 to 2012, the percentage of the nonsmoking
population age 3 and older exposed to secondhand smoke (defined in the
study as levels 0.05-10 ng/mL) declined across all racial and ethnic
groups (Ref. 286). However, a significantly 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. 286).
    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. 49). 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. 27). 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. 284). While secondhand smoke exposure in homes and
vehicles significantly declined from 2011 to 2018, secondhand smoke
exposure in homes among non-Hispanic Black students did not change
(Ref. 284). Home smoking bans (or 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, higher levels
of annual household income, and both parents being Hispanic, non-
Hispanic, Other race, or other combinations of parents of different
race/ethnicities were associated with the higher reporting of a
complete home ban as compared to lower levels of parental educational,
lower levels of annual household income, and both parents being non-
Hispanic White, respectively (Ref. 287). Such findings are consistent
with a higher degree of autonomy over 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. 288). 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. 288).
The proposed product standard is anticipated to reduce smoking-related
morbidity and mortality for these vulnerable populations, especially
youth.
    FDA expects that the proposed menthol product standard would reduce
the number of smokers and decrease non-smokers' exposures to secondhand
smoke. As evidenced by evaluations of smoke-free policies, decreasing
exposure to secondhand smoke will reduce exposure to tobacco smoke
pollution and decrease smoking-related death and disease (Refs. 289 and
290).
5. Results From Simulation Models Are Consistent With the Findings That
Prohibiting Menthol Cigarettes Would Benefit the Population's Health
    The population health benefit of prohibiting menthol cigarettes has
been examined in several simulation studies conducted in the past
decade (Refs. 46, 211, 291, 45). A 2021 study by Levy et al. simulated
the future benefit of a menthol cigarette ban on the U.S. population as
a whole over the 2021-2060 period (Ref. 46). This model compared a
Status Quo Scenario, in which no menthol ban was implemented, to a
simulated Menthol Ban Scenario in which a complete ban on menthol
cigarettes and cigars was implemented in 2021.\12\ Additionally, as
part of the model, it took into account the use of ENDS products
(``nicotine vaping products'') by smokers and non-smokers over the
study period (Refs. 46, 211, and 291).
---------------------------------------------------------------------------

    \12\ The Menthol Ban Scenario models a ban of menthol in
cigarettes and cigars, but includes only the benefits attributed to
the menthol cigarette ban. Cigars are covered in the model because
it is assumed that menthol cigarette smokers could simply switch to
menthol cigars if a menthol cigarette ban was put in place and if
menthol cigars were still available. FDA's expectation is that, even
if menthol was not prohibited as a characterizing flavor in cigars,
this rule would still reduce initiation and experimentation of
cigarette smoking, decrease nicotine dependence and addiction, and
increase cessation among current menthol cigarette smokers. However,
since FDA is concurrently pursuing a proposed rule, published
elsewhere in this issue of the Federal Register, that would prohibit
characterizing flavors (other than tobacco) in cigars, the Menthol
Ban Scenario is directly applicable.
---------------------------------------------------------------------------

    The simulation used the Smoking and Vaping Model (SAVM), a model
capable of simulating the population health effects of cigarette
smoking and ENDS use for specific birth cohorts. For this study, the
model was extended to evaluate non-menthol and menthol cigarettes
separately, with the following use states captured in the model
compartments: (1) Never users, (2) menthol smokers, (3) non-menthol
smokers, (4) exclusive ENDS users, (5) former smokers using ENDS, (6)
former smokers, and (7) former ENDS users.
    The SAVM first utilized historical data from the NHIS (1965-2013)
for estimates of smoking prevalence (specific model inputs can be found
in the manuscript) (Refs. 46, 211, and 291). The model projected
prevalence estimates of never, current, and former smoking by age and
gender beginning in 2013. The model was then recalibrated using 2013-
2018 NHIS data to improve model estimates of smoking prevalence after
ENDS products became more widely available around 2013. Next, age- and
gender-specific rates of smoking initiation (i.e., any initiation of
regular cigarette smoking by age 40) and cessation (i.e., cessation of
regular cigarette smoking for 2 years, including those who temporarily
use ENDS but ultimately quit all tobacco use), cigarettes-to-ENDS
switching (i.e., cessation of regular cigarette smoking with initiation
of regular ENDS smoking), and initiation of ENDS use (i.e., initiation
of regular ENDS use without regular cigarette smoking) were modeled
using PATH Study data, with separate rates of initiation, cessation and
switching for menthol and non-menthol smokers. To simplify the model,
dual users of cigarettes and ENDS were not modeled separately from
current smokers. Smokers who switched to ENDS before age 35 were
treated the same as exclusive ENDS users, while smokers who switched to
ENDS age 35 or later were considered separately as former smokers using
ENDS. Additionally, the transitions modeled were unidirectional;
relapse (i.e., reinitiating regular cigarette smoking or ENDS use after
entering any group containing former smokers/users) was not considered
in the model. Although age- and gender-specific effects were modeled,
other sources of population heterogeneity, such as race, ethnicity,
socioeconomic status, and geographical location, were not simulated.
    Based on PATH Study data and other publications, the ratio of
menthol to non-menthol cessation was modeled as 0.8 and the ratio of
menthol to non-

menthol switching was modeled as 0.9, in effect modeling menthol
cigarette smokers as 20 percent less likely to quit smoking and 10
percent less likely to switch to ENDS than non-menthol smokers (Refs.
46 and 211). Based on PATH Study data, all cigarettes-to-ENDS switching
was assumed to decline 10 percent annually from 2018. The excess
relative risk of mortality for ENDS products compared to cigarettes was
set at 0.15, in effect modeling the mortality risk of ENDS use as 15
percent of the mortality risk of cigarette smoking over the same
period.
    To estimate the specific effects of a menthol ban on current and
future tobacco use, an expert elicitation (EE) was conducted (Ref.
211). The EE used a systematic approach to identify eleven leading
academic experts on topics related to the impacts of menthol flavor
bans in tobacco products. Experts estimated a number of behaviors under
a menthol ban, such as continued (illicit) menthol product use, menthol
to non-flavored product switching, switching to other nicotine products
(e.g., ENDS, smokeless tobacco products), and tobacco cessation. These
estimates were adapted to fit the simpler structure of the SAVM. For
example, transitions from cigarettes to HTPs were treated as
transitions to ENDS, while transitions from menthol cigarettes to non-
menthol cigars were treated as a transition to non-menthol cigarettes.
Transitions to smokeless tobacco products were also treated as
transitions to non-menthol cigarettes. Experts estimated the effects of
a menthol ban for youth and young adults ages 12-24 who would otherwise
have initiated menthol smoking by age 24 (i.e., counterfactual menthol
smokers), which were used to calculate the ongoing initiation rates
beginning with the simulated ban in 2021 in the Menthol Ban Scenario.
Among menthol smokers in both the Status Quo Scenario and Menthol Ban
Scenario, experts estimated transitions over a 2-year period for ages
18-24 and 35-54, which were modeled as mean net differences applied to
menthol smokers up to age 30 and over age 30, respectively. The ban was
assumed to have no effects on non-menthol smokers. In the expert
elicitation study, it is likely that when the experts were answering
survey questions around tobacco use behaviors under a future menthol
ban, they considered the products available in the market at the time.
The marketplace of products may change over time due to a variety of
reasons, and it is possible that changes in the marketplace, if known,
may impact experts' judgements about how menthol smokers and non-users
at risk for initiation may act in response to a menthol ban.
    The model estimated smoking-attributable deaths averted and life-
years lost averted over the 2021-2060 period (Ref. 46). Compared to the
Status Quo Scenario, in which no menthol ban was implemented, under the
Menthol Ban Scenario the estimated overall smoking prevalence declined
14.7 percent by 2026 and 15.1 percent by 2060. This overall decrease
was due to a sharp reduction in menthol smoking (down 92.5 percent by
2026, and 96.5 percent by 2060), coupled with a smaller increase in
non-menthol smoking (up 47.4 percent by 2026, and 58.0 percent by 2060)
over the same time period. The ban was also estimated to increase ENDS
use 22.6 percent by 2026, up to a 26.5 percent relative increase by
2060. Totaling the effects, the model estimated 654,000 premature
deaths and 11,300,000 life-years lost averted by 2060.
    The study authors also conducted several sensitivity analyses to
determine which model parameters had the greatest influence on outcome
estimates (Ref. 46). Increasing the ratio of menthol to non-menthol
cessation rate from 0.8 to 1.0, in effect making menthol cigarettes no
harder to quit than non-menthol cigarettes, had the greatest impact on
the model estimates, resulting in decreasing deaths averted by 29.5
percent (to 461,000) and life-years lost averted by 24.2 percent (to
8.58 million). Eliminating the 10 percent annual declines in cigarette-
to-ENDS switching from the model, in effect increasing the appeal of
complete switching for smokers in later years of the model, reduced
deaths averted by 20.5 percent (to 520,000) and life-years lost averted
by 21.9 percent (to 8.83 million). Other sensitivity analyses included
10 percent absolute increases and decreases in the excess relative risk
of ENDS products to cigarettes, and 10 percent relative changes in
smoking initiation, smoking cessation, time-independent cigarette-to-
ENDS switching, ENDS initiation, and ENDS cessation. All of these
sensitivity analyses resulted in modest (under 10 percent) changes to
model-predicted deaths and life-years lost averted.
    In addition to the SAVM study, a 2011 study by Levy et al. that
simulated the future benefit of a menthol cigarette ban was also
consistent with the findings of other studies. This study estimated
potential impacts of a U.S. menthol ban on future smoking prevalence
and smoking attributable mortality for the total population, and for
African Americans specifically (Ref. 45). The model used data from the
2003 TUS-CPS to characterize current smoking status, initiation and
cessation rates by cigarette type, various other sources to
characterize smoking relapse rates, and CPS II to characterize
mortality risks, which were treated as equivalent for menthol and non-
menthol smokers. The analysis simulated the 2010-2050 period, with a
menthol ban going into effect in 2011. The study compared three menthol
ban scenarios against a status quo scenario with no menthol ban:
    1. 10 percent of menthol smokers quit permanently and 10 percent
who would have initiated as menthol smokers do not take up smoking,
    2. 20 percent of menthol smokers quit permanently and 20 percent
who would have initiated as menthol smokers do not take up smoking, and
    3. 30 percent of menthol smokers quit permanently and 30 percent
who would have initiated as menthol smokers do not take up smoking.
    The study estimated that by 2050, under these menthol ban
scenarios, 324,000 (scenario 1) to 634,000 (scenario 3) smoking
attributable deaths would have been averted in the United States
overall, while relative declines in smoking prevalence were expected to
range from 4.8 percent to 9.7 percent, under scenarios 1 and 3,
respectively. Among African Americans, by 2050, an estimated 92,000 to
238,000 smoking attributable deaths would have been prevented, while
relative declines in smoking prevalence ranged from 9.1 percent to 24.8
percent (under scenarios 1 and 3, respectively) (Ref. 45).
    In conclusion, population health models simulating menthol ban
policies are consistent with a substantial public health benefit. The
2021 simulation by Levy et al., using the SAVM model, estimated
approximately 650,000 premature deaths averted and 11.3 million life-
years lost averted in the first 40 years of a menthol cigarette and
cigar ban beginning in 2021 (Refs. 46, 211, and 291). The prevalence of
smoking was also estimated to decline 15.1 percent in that period.
Sensitivity analyses demonstrated that lower cessation among menthol
smokers compared to non-menthol smokers was a notable driver of the
public health impact of the simulated menthol ban. The overall findings
were consistent with the 2011 simulation by Levy et al. that estimated
324,000-634,000 premature deaths averted under a similar ban and time
period (Ref. 45).\13\
---------------------------------------------------------------------------

    \13\ The Further Consolidated Appropriations Act, 2020, made it
unlawful for any retailer to sell a tobacco product to any person
younger than 21 years of age (Pub. L. 116-94, section 603 (2019)).
The quantitative estimates of the impact of a menthol ban on
premature mortality presented in these studies do not take into
account the impact of T21. However, given the long lag period
between smoking initiation and premature mortality from smoking, any
impact of T21 on the mortality benefits described in this rule would
not be observed for decades into the future. See section II.C.4.a of
the Preliminary Regulatory Impact Analysis (PRIA) for a discussion
of T21 impacts on premature smoking-attributable deaths averted
(Ref. 292).

---------------------------------------------------------------------------

6. Public Health Benefits Not Addressed in the Smoking and Vaping Model
    While the SAVM projections of the potential impact from a menthol
product standard suggest a significant public health benefit to the
United States resulting from substantial reductions in smoking
prevalence, these analyses do not address other additional benefits.
    First, the SAVM simulation does not account for increased quality
of life from decreased tobacco-related morbidity. The Surgeon General
has reported that about 30 individuals will suffer from at least one
smoking-related disease for every person that dies from smoking each
year (Ref. 245). Researchers in one study estimated that individuals
are living with 14 million major smoking-related conditions in the
United States, including more than 7.4 million cases of chronic
obstructive pulmonary disease, nearly 2.3 million heart attacks, 1.8
million cases of diabetes, nearly 1.2 million stroke events, more than
300,000 cases of lung cancer, and nearly 1 million cases of other
smoking-attributable cancers (bladder, cervix, colon/rectum, kidney,
larynx, mouth, tongue, lip, throat, pharynx, stomach) (Ref. 246).
Another study, which examined disparities in tobacco-related cancer
incidence and mortality, found that tobacco-related mortality decreased
between 2004 and 2013, however tobacco-related cancer incidence and
mortality rates remain highest among African Americans, accounting for
more than 39,000 deaths annually between 2009 and 2013 (Ref. 293).
Cigarette smoking, in addition to causing disease, can diminish overall
health status, leading to higher risks for surgical complications,
including wound healing and respiratory complications, increased
absenteeism from work, and greater use of health care services (Ref.
1). Increased smoking cessation, reduced cigarette consumption, and
lower progression to regular cigarette smoking would reduce not only
the mortality from smoking, but it also would reduce the enormous
burden of cigarette-attributable disease in the United States.
    Second, the SAVM simulation does not account for the public health
impacts of reduced secondhand smoke exposure. Exposure to secondhand
smoke is a cause of cancer, respiratory, and cardiovascular disease
(Ref. 1). Secondhand smoke exposure is currently estimated to be
responsible for over 41,000 deaths annually in the United States (Ref.
1). Reducing secondhand smoke exposure through increased smoking
cessation, reduced cigarette consumption, and lower progression to
regular cigarette smoking would reduce the more than 7,300 lung cancer
deaths and nearly 34,000 coronary heart disease deaths annually
attributed to secondhand smoke (Ref. 1). Exposure to secondhand smoke
can also cause adverse health effects in infants and children. Exposure
to cigarette smoke among children and adolescents can trigger asthma
attacks and lead to more frequent respiratory infections compared to
those not exposed to smoke (Ref. 1). Prenatal tobacco exposure and
postnatal secondhand smoke exposure increase the risks of fetal deaths,
fetal growth restriction/low birth weight, respiratory conditions, and
SIDS (Ref. 1).
    Third, the SAVM simulation does not isolate differential effects as
experienced by vulnerable populations. Menthol cigarette use, and the
disease and death linked to such use, is disproportionately high among
members of vulnerable populations such as African Americans and other
racial and ethnic groups, those with lower household income, and those
who identify as LGBTQ+ (Refs. 55-57, 21-24, 44). As a result, a menthol
restriction is expected to confer larger benefits among these
vulnerable populations by promoting improved public health outcomes.
For example, studies have shown that after switching to non-menthol
cigarettes, Black menthol smokers had greater reductions in cigarettes
per day when compared to non-Black menthol smokers (Ref. 217). In
comparison to White smokers, a higher prevalence of Black smokers
report they would not smoke a non-mentholated cigarette if they could
not smoke a mentholated cigarette (Ref. 214), a higher prevalence of
Black menthol smokers reported intentions to quit following a menthol
restriction (Refs. 219 and 215), and Black menthol smokers had lower
odds of reporting that they would switch to a non-menthol brand (Ref.
213). Prior modeling has shown that by 2050, following a 2011 menthol
ban, an estimated 92,000 to 238,000 smoking attributable deaths among
African Americans would have been prevented, comprising almost one-
third of the total deaths averted by the ban (Ref. 45). The relative
reduction in African Americans' smoking prevalence in 2050 was also
projected to range between 9.1 and 24.8 percent compared to the status
quo of no menthol ban (Ref. 45).
    Finally, the analysis does not account for reductions in harms
caused by smoking-related fires. Lower prevalence of cigarette smoking,
and reduced cigarette consumption are likely to decrease the occurrence
of fires caused by smoking materials, including cigarettes and other
lighted tobacco products. Even though all states have instituted laws
requiring fire-safety-compliant cigarette paper (adoption began in 2003
with all states adopting these laws by 2012), smoking remained the
second leading cause of residential fire deaths in the United States in
2018 (Ref. 294). In 2011, an estimated 90,000 fires in the United
States were caused by smoking materials, of which 17,600 occurred in
the home (Ref. 295). Between 2012 and 2016, there were an average of
18,100 home structure fires per year started by smoking material,
accounting for around 1 in 20 of all home fires (5 percent) (Ref. 296).
The fatality rate for smoking-related residential building fires is
seven times greater than for nonsmoking related fires (Ref. 297).
Moreover, smoking materials remain the leading cause of fatal home
fires in the United States and smokers themselves are not the only
victims (Refs. 295 and 296). One out of every four fatal victims of
smoking-material fires were not the smoker whose cigarette initiated
the fire (Ref. 298). Reductions in smoking as a result of the proposed
standard are likely to have an impact on the 590 deaths and over 1,100
injuries from smoking-attributable structure fires (Ref. 296).
    We note that, while the impact of a proposed rule prohibiting
menthol as a characterizing flavor in cigarettes is likely to be
sizable, there is uncertainty in precisely quantifying the effects.
Although the exact magnitude of the effects of the proposed ban are
uncertain, because of the sheer number of smokers currently using
menthol cigarettes--an estimated 18.5 million persons ages 12 and older
(Ref. 44)--even modest decreases in the percentage of the population
initiating smoking and increases in the percentage of the population
quitting smoking would save many lives.

7. Potential Risks to the Population as a Whole of the Proposed Menthol
Product Standard Would Not Outweigh the Potential Benefits of the
Proposed Product Standard
    There are possible countervailing effects that could occur from the
proposed product standard, if finalized. Potential risks to the
population, however, would generally only occur among individuals
currently using tobacco or smoking cigarettes as FDA concludes there
are little to no risks to nonusers of tobacco. These potential risks do
not offset the anticipated benefits of the rule. The countervailing
effects on current tobacco users could include continued combusted
tobacco product smoking, smokers seeking to add menthol to their
combusted tobacco product, and the possibility of illicit trade. As
part of this rulemaking, FDA is required by the Tobacco Control Act to
consider information submitted on such possible countervailing effects,
including among vulnerable populations and other population subgroups.
    With the removal of menthol cigarettes from the tobacco
marketplace, some cigarette smokers may seek other sources of tobacco
and/or nicotine. These could include nicotine replacement therapy
products, non-menthol cigarettes, other combusted tobacco products, or
other potentially less harmful tobacco products. Findings from
evaluations of menthol sales restrictions in Canada suggest some users
switch to non-menthol cigarettes and flavored combusted tobacco
products following a menthol sales restriction (Refs. 226, 231, 230,
216, 193, 197).
    FDA acknowledges that the availability of flavored cigars may
impact the public health benefits of the proposed rule. FDA's
expectation is that, even if menthol is not prohibited as a
characterizing flavor in cigars, this rule would reduce initiation of
and experimentation with cigarette smoking, decrease nicotine
dependence and addiction to cigarettes, and increase the likelihood of
cessation among current menthol cigarette smokers. It is also unlikely
that all current or potential users of menthol cigarettes would switch
to or initiate with menthol cigars. In studies assessing the potential
impacts of banning menthol cigarettes, a minority of menthol smokers
indicated that they might switch to flavored cigars (Refs. 219, 273,
and 225). However, FDA is concurrently proposing a product standard to
prohibit characterizing flavors (other than tobacco) in cigars, which
would decrease the likelihood that menthol smokers would switch to
cigars as a result of the proposed menthol cigarette standard. Working
with others in HHS, FDA is currently exploring options to ensure that
smokers who would like to quit cigarettes or would like to quit tobacco
product use completely in response to the proposed standard will be
aware of and have access to resources that provide cessation support.
    FDA recognizes that, while some smokers may switch to non-menthol
flavored cigarettes, the risks of this won't outweigh the benefits from
smokers who quit smoking completely. FDA has no reason to believe that
individuals switching from menthol cigarettes to other combusted
tobacco products would be exposed to additional harm beyond their
current exposure level. FDA requests comments regarding additional
evidence on the extent and magnitude that menthol smokers will switch
to other combusted tobacco products.
    With the removal of menthol cigarettes from the tobacco
marketplace, some users could seek out products that will add menthol
to non-menthol cigarettes (e.g., drops, capsules, filter tips for RYO
tobacco, or cards that can be inserted into a cigarette pack or pouch
of rolling tobacco) (Refs. 226, 299, and 300),\14\ which would reduce
the benefits of the proposed rule. A study of smokers from Ontario
found that, before the menthol sales restriction, 4.4 percent of daily
menthol smokers had previously tried flavored additives (including
flavor cards, drops, oils, or other additives to add menthol to
tobacco) (Ref. 299). One month after the menthol sales restriction in
Ontario, 5.1 percent of daily menthol smokers had tried flavored
additives, 1 year after 12.5 percent had, and 2 years after 9.5 percent
had (Ref. 299). However, products used to alter or affect the
cigarette's performance, composition, constituents, or characteristics
are components and parts of the cigarette would also be subject to this
rule. Thus, to the extent that flavor cards, drops, oils, or other
additives that are components and parts of a cigarette contain menthol
as a characterizing flavor, such products would be prohibited under
proposed Sec.  1162.3. Therefore, FDA does not anticipate a substantial
number of individuals would utilize such products.
---------------------------------------------------------------------------

    \14\ While we recognize that some smokers could try to add
menthol e-cigarette liquids (or e-liquids) to non-menthol
cigarettes, we believe that the amount of e-liquid needed to impart
a menthol characterizing flavor would make the cigarette
unsmokeable.
---------------------------------------------------------------------------

    Even if some people were to modify their non-menthol cigarettes in
response to a menthol cigarette prohibition, FDA does not expect this
behavior to result in significant additional harm beyond what menthol
cigarette smokers are already being exposed to. Furthermore, with many
other tobacco products available on the marketplace and the prohibition
of products used to alter or affect the cigarette's performance,
composition, constituents, FDA does not expect that many individuals
would attempt to modify non-menthol cigarettes and thus, FDA does not
expect that this potential countervailing effect would significantly
reduce the impact of the rule (Ref. 299).
    Finally, the removal of menthol cigarettes from the marketplace
could result in some people seeking menthol cigarettes through the
illicit trade market. FDA is considering whether illicit trade could
occur as a result of a menthol product standard and potential
implications.
    Since the enactment of the Tobacco Control Act, FDA has been
committed to studying and understanding the potential effects of a
product standard on the illicit tobacco market. As part of FDA's
consideration of possible regulations, the Agency asked the National
Research Council (NRC) and Institute of Medicine (IOM) of the National
Academy of Sciences to assess the international illicit tobacco market,
including variations by country; the effects of various policy
mechanisms on the market; and the applicability of international
experiences to the United States (Ref. 301). In 2015, the NRC/IOM
issued its final report titled ``Understanding the U.S. Illicit Tobacco
Market: Characteristics, Policy Context, and Lessons from International
Experiences'' and concluded ``[o]verall, the limited evidence now
available suggests that if conventional cigarettes are modified by
regulations, the demand for illicit versions of them is likely to be
modest.'' (Ref. 301 at 9). In addition, in March 2018, FDA issued a
draft concept paper as an initial step in assessing the possible health
effects of a tobacco product standard in the form of demand for
contraband or nonconforming tobacco products (83 FR 11754). Among other
things, the draft concept paper examined the factors that might support
or hinder the establishment of a persistent illicit trade market
related to a product standard but did not reach any conclusions
regarding the potential demand that may develop due to a product
standard (Ref. 79).
    The recent implementation of local menthol restrictions in the
United States and restrictions outside of the United

States provides real-world experience regarding the potential for
illicit trade of menthol cigarettes. Evidence from Canada, England, and
the United States suggest that the impact of the proposed rule on the
illicit market would not be significant (Refs. 302, 226, 224, 216, 200,
209, 191, 303, 197). For example, a study evaluating a restriction on
sales of menthol cigarettes in Nova Scotia, Canada found that the
policy did not result in an increase in illicit cigarette seized (Ref.
302). The researchers noted that according to local Canadian
authorities there were only a few small seizures of menthol cigarettes
in the year following the policy (with the nature of the data analyzed
indicating that seizures were from businesses only, not individual
users, though the study is not clear on this point), and that there
were no further seizures of menthol cigarettes after the first year
(Ref. 302). Studies asking smokers about their responses to menthol
sales restrictions in Canada find a small percentage that continue to
use and purchase menthol cigarettes (Refs. 226, 224, and 216). When
menthol smokers were asked where they purchased menthol cigarettes
after menthol sales restrictions, a majority reported purchasing from
First Nations Reserves (54.7 percent), which were generally exempted
from the sales restrictions, followed by retail stores (31.0 percent);
few reported purchasing menthol cigarettes online (7.5 percent) (Ref.
216). The study, however, was not able to determine the proportion of
menthol cigarettes purchased by cigarette smokers post-policy that were
contraband (Ref. 216). The authors also noted it is unclear how smokers
were able to purchase menthol cigarettes at retail stores and
hypothesized that smokers could be reporting the purchase of non-
menthol cigarettes that were rebranded as menthol replacements with
color on the pack or in the brand name to suggest menthol-like
qualities (Ref. 216). Another study of a local Canadian menthol sales
restriction found that one month following implementation of Ontario's
menthol sales restriction, 14.1 percent of smokers reported using
menthol cigarettes purchased from a First Nations reserve, other
province, other country, or online (Ref. 226). A study of young adult
ever tobacco users in San Francisco found that a small percentage
reported purchasing flavored tobacco products illegally in San
Francisco (5 percent) and purchasing flavored tobacco products online
(15 percent) after the policy; however, this was a retrospective study
with a relatively small convenience sample (Ref. 191).
    These results are consistent with the expert elicitation study
discussed previously (Ref. 211). In the expert elicitation study, 50.5
percent of menthol smokers were expected to remain combusted tobacco
product users, with 40.3 percent becoming non-menthol cigarette
smokers, and 3.7 percent becoming non-menthol cigar smokers; however,
the experts also estimated that 6.5 percent would continue to use
illicit menthol cigarettes (Ref. 211).
    Taken together, these studies provide evidence that a major change
to the availability of products covered by this proposed rule (see
section VII.A) is not likely to lead to a surge in illicit menthol
cigarette use. In reaching this conclusion, FDA has considered several
factors that are likely to affect the potential for illicit trade. For
example, FDA anticipates that a nationwide standard that prohibits the
manufacture and sale of menthol cigarettes, coupled with FDA's
authority to take enforcement actions and other steps regarding the
sale and distribution of illicit tobacco products, would eliminate the
manufacture and distribution of these products. FDA also expects that a
nationwide product standard would eliminate the opportunity to easily
travel to neighboring jurisdictions within the United States that do
not have such menthol sales restrictions or use online retailers to
purchase menthol cigarettes. FDA thus anticipates that the rule would
result in much less illicit trade than observed in the case of a state
or local requirement and that any such trade would be significantly
outweighed by the benefits of the rule.
    If an illicit market develops after this proposed menthol standard
is finalized, FDA has the authority to take enforcement actions and
other steps regarding the sale and distribution of illicit tobacco
products, including those imported or purchased online (see section
VII.C of this document for additional information about FDA's
enforcement authorities). FDA conducts routine surveillance of sales,
distribution, marketing, and advertising related to tobacco products
and takes corrective actions when violations occur. After this proposed
menthol standard is finalized and goes into effect, it would be illegal
to import menthol cigarettes and such products would be subject to
import examination and refusal of admission under the FD&C Act.
Similarly, it would be illegal to sell or distribute menthol
cigarettes, including those sold online, and doing so may result in FDA
initiating enforcement or regulatory actions. We note that the Prevent
All Cigarette Trafficking Act of 2009 (PACT Act) establishes
restrictions that make cigarettes generally nonmailable through the
U.S. Postal Service, subject to certain exceptions (18 U.S.C. 1716E).
Outside of these exceptions, the U.S. Postal Service cannot accept or
transmit any package that it knows, or has reasonable cause to believe,
contains nonmailable cigarettes, smokeless tobacco, or ENDS.
    As previously noted, FDA's enforcement will only address
manufacturers, distributors, wholesalers, importers, and retailers.
This regulation does not include a prohibition on individual consumer
possession or use, and FDA cannot and will not enforce against
individual consumers for possession or use of menthol cigarettes. In
addition, State and local law enforcement agencies do not independently
enforce the FD&C Act. These entities do not and cannot take enforcement
actions against any violation of chapter IX of the Act or this
regulation on FDA's behalf. As noted previously, FDA recognizes concern
about how State and local law enforcement agencies enforce their own
laws in a manner that may impact equity and community safety and seeks
comments on how FDA can best make clear the respective roles of FDA and
State and local law enforcement.
    Based on the available evidence, FDA finds that, while there may be
potential countervailing effects that could diminish the expected
population health benefits of the proposed standard, such effects would
be significantly outweighed by the potential benefits of the proposed
menthol product standard.
    In this section, FDA has cited studies describing the potential
countervailing effects of the proposed product standard. FDA requests
additional information concerning the potential countervailing effects
discussed in this section, as well as any other potential
countervailing effects that could result from this rule, and how the
potential countervailing effects could be minimized. FDA is
particularly interested in receiving comments, including supporting
data and research, regarding whether and to what extent this proposed
rule would result in an increase in illicit trade in menthol cigarettes
and how any such increase could impact the marketplace or public
health.

D. Conclusion

    FDA has considered scientific evidence related to the likely impact
of the proposed rule prohibiting use of menthol as a characterizing
flavor in cigarettes on current nonusers, current users, and the U.S.
population as a whole. Based on these considerations, we find that the
proposed tobacco product standard is appropriate for the protection of
the public health because it would reduce the appeal and ease of
smoking cigarettes, particularly for young people and new users,
thereby decreasing the likelihood that nonusers of cigarettes who
experiment with these tobacco products would progress to regular
cigarette smoking. Additionally, the proposed tobacco product standard
is anticipated to improve the health of current smokers of menthol
cigarettes by decreasing cigarette consumption, increasing the
likelihood of cessation among this population, and decreasing
secondhand smoke exposure among current smokers and non-smokers. These
positive public health impacts will also address the significant health
disparities linked to menthol cigarettes.
    Tobacco use is the leading preventable cause of disease and death
in the United States (Ref. 1). As over 18.5 million Americans ages 12
and older smoke menthol cigarettes (Ref. 44), even modest reductions in
the percentage of people initiating and modest increases in the
percentage of people quitting smoking would lead to substantial
reductions in the over 480,000 annual deaths and approximately 16
million cases of disease attributed to combustible tobacco products in
the United States, as well as the economic and societal costs
associated with such illness and death.
    Each day in the United States, more than 1,500 youth under the age
of 18 smoke their first cigarette (Ref. 96). Additionally, nearly 90
percent of adult current daily cigarette smokers in the United States
report having smoked their first cigarette by the age of 18 (Ref. 1).
Nicotine is a highly addictive substance, and multiple studies have
shown that symptoms of nicotine dependence can arise early after youth
start smoking cigarettes, even among infrequent users (Refs. 184, 137,
and 135). Menthol in cigarettes enhances nicotine addiction through a
combination of its flavor, sensory effects, and interaction with
nicotine in the brain, facilitating repeated experimentation with
cigarettes and progression to regular cigarette smoking, which
repeatedly exposes the brain to nicotine (Refs. 6 and 9).
    Evidence shows that adding menthol to cigarettes soothes irritation
from nicotine and smoke inhalation, particularly among new smokers
(Ref. 7). Data from the 2013-2014 PATH Study indicate that 43 percent
of youth (aged 12-17 years), 45 percent of young adults (aged 18-24
years) and 30 percent of adults (aged 25 years and older) that have
ever smoked a cigarette reported that their first tobacco product was
mentholated (Ref. 31). Results from national studies also consistently
show a preference for smoking menthol cigarettes among youth and young
adult smokers, compared to older smokers, and existing research
suggests that the likelihood of progressing to regular, established
smoking is higher among youth who initiate with menthol smoking
compared to those starting with non-menthol cigarettes (Refs. 25, 29-
31, 8). The result is that nearly half of youth (48.6 percent) and
young adults (51 percent) and two in five (39 percent) adult smokers
report smoking menthol cigarettes (Ref. 44).
    Prohibiting the use of menthol as a characterizing flavor in
cigarettes would help to decrease future addiction, disease, and death
among youth at risk of tobacco use. FDA anticipates that the proposed
standard would produce substantial health benefits. Even small changes
in initiation and cessation would result in a significant reduction in
the burden of death and disease in the United States caused by smoking,
including reductions in smoking-related morbidity and mortality,
diminished exposure to secondhand smoke among non-smokers, decreased
potential years of life lost, decreased disability, and improved
quality of life for the current and future generations to come.
    While preventing initiation to regular cigarette smoking by even
modest amounts carries the greatest potential from this proposed
standard to improve population health in the long term, FDA anticipates
that the proposed standard would produce substantial short-term health
benefits resulting from decreased cigarette consumption and increased
cessation among current menthol cigarette smokers. In the United
States, there are currently over 18.5 million smokers of menthol
cigarettes ages 12 and older (Ref. 44). As previously described, the
health benefits of smoking cessation are substantial. A published
population modeling study estimated that as many as 654,000 smoking
attributable deaths would be avoided by the year 2060 if menthol
cigarettes were no longer available (Ref. 46). Beyond averted deaths,
societal benefits would include reduced smoking-related morbidity and
health disparities, diminished exposure to secondhand smoke among non-
smokers, decreased potential years of life lost, decreased disability,
and improved quality of life among former smokers.
    FDA's expectation that the proposed product standard would be
appropriate for the protection of the public health is reasonable and
well-supported by scientific evidence. Cigarettes are the most toxic
consumer product, when used as intended, and adding menthol as a
characterizing flavor makes cigarettes more appealing and easier to
smoke. Given the existing scientific evidence described in sections IV
and V of this document, FDA expects that implementing the proposed
menthol product standard would result in reduced smoking initiation and
progression among youth and young adults, and increased smoking
cessation among current cigarette smokers. Across the population, these
changes in cigarette smoking behaviors would lead to lower disease and
death in the United States in both the short term, and in the future,
due to diminished exposure to tobacco smoke among both smokers and non-
smokers.
    FDA anticipates the proposed product standard also will improve
health outcomes among vulnerable populations. As previously described,
menthol cigarette use, and the disease and death linked to such use, is
disproportionately high among members of vulnerable populations such as
African Americans and other racial and ethnic groups, those with lower
household income, and those who identify as LGBTQ+ (Refs. 55-57, 21-24,
44). For example, out of all non-Hispanic Black smokers, nearly 85
percent smoke menthol cigarettes, compared to 30 percent of non-
Hispanic White smokers who smoke menthol cigarettes (Ref. 44). As a
result, these population groups with the greatest menthol cigarette use
would be expected to experience the greatest benefit from the proposed
product standard through its impact on reducing youth initiation of and
experimentation with cigarette smoking, decreasing the likelihood of
nicotine dependence and addiction, and increasing the likelihood of
cessation. Accordingly, the proposed product standard is anticipated to
promote better public health outcomes across population groups.

VI. Additional Considerations and Requests for Comments

A. Section 907 of the FD&C Act

    FDA is required by section 907 of the FD&C Act to consider the
following

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

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

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

VII. Description of the Proposed Regulation

    We are proposing to establish a new 21 CFR part 1162 (part 1162)
that would prohibit menthol as a characterizing flavor in cigarettes.
Part 1162 would describe the scope of the proposed regulation,
applicable definitions, and the prohibition on use of menthol as a
characterizing flavor in cigarettes.

A. Scope (Proposed Sec.  1162.1)

    Proposed Sec.  1162.1(a) would provide that this part sets out a
tobacco product standard under the FD&C Act regarding the use of
menthol as a characterizing flavor in cigarettes. We are proposing that
this product standard would cover all products meeting the definition
of ``cigarette'' in section 900(3) of the FD&C Act (21 U.S.C. 387(3))
(proposed Sec.  1162.3 includes a definition of cigarette). This
includes all types, sizes, nicotine strengths and formulations of
cigarettes, cigarette tobacco and RYO tobacco, as well as HTPs that
meet the definition of a cigarette in the FD&C Act (cigarettes that are
HTPs).
    In general, as discussed in this document, menthol as a
characterizing flavor in tobacco products enhances product appeal,
usability, and addictiveness and has played a role in creating and
perpetuating tobacco-related health disparities. While these effects
raise concerns in the context of any tobacco product--none of which is
without risk--FDA recognizes that certain products that meet the
definition of cigarette in the FD&C Act may present different
considerations with respect to this proposed product standard. For
example, certain cigarettes may produce significantly fewer or lower
levels of toxicants or have significantly reduced potential for
creating or sustaining addiction. Recognizing that tobacco products
exist on a continuum of risk, with combusted cigarettes being the
deadliest, FDA recognizes that certain, specific products meeting the
definition of a cigarette (e.g., some that are not combusted or are
minimally addictive) may pose less risk to individual users or to
population health than other products meeting the definition of a
cigarette. FDA also notes that there is wide variability even within
certain types of cigarettes, such as variability in toxicants or youth
appeal among HTPs or minimally addictive cigarettes.\15\

Accordingly, FDA is considering options that would allow certain
products that present different considerations to seek exemptions from
the product standard on a case-by-case basis.
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    \15\ For additional information about the variability of tobacco
products, see the Premarket Tobacco Product Applications and
Recordkeeping Requirements (PMTA) final rule (86 FR 55300, October
5, 2021) available at https://www.federalregister.gov/documents/2021/10/05/2021-21011/premarket-tobacco-product-applications-and-recordkeeping-requirements.
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    Section 910 of the FD&C Act provides that those seeking to market
new tobacco products via a premarket tobacco application may justify a
deviation from a product standard to which it does not conform.
However, no similar provision exists for pre-existing products or
products that already are authorized under, or that seek authorization
under, other pathways, i.e., the substantial equivalence pathway or
exemption from substantial equivalence. FDA is considering whether a
final product standard rule should include a provision for requesting
an exemption from the standard for certain products within particular
categories, on a case-by-case basis, consistent with the potential for
differential public health impacts among products meetings the
definition of ``cigarette'', as discussed above.
    Accordingly, we are requesting comments on exemptions, including:
(1) Whether the final rule should include a provision that allows for
firms to request an exemption from the standard for specific products
of certain types (e.g., noncombusted, reduced nicotine), on a case-by-
case basis; (2) for what types of products should firms be eligible to
request an exemption; (3) for an exemption provision, how should the
Agency evaluate exemption requests, and what data and information
should firms be required to submit for this; and (4) if an exemption
provision should apply to products currently on the market at the time
of the final rule's effective date, how the exemption process should
work (e.g., require that any exemption request be received within 180
days of publication so the Agency has time to make a determination
before the effective date). As part of this, comments could address or