Wave 5 (2018-2019) PATH Study data indicated that among young adults
(aged 18-24 years) who used cigars some or every day, 54.1 percent of
traditional cigar users, 66.5 percent of cigarillo users, and 65.1
percent of filtered cigar users reported flavoring as a reason for
cigar use (Ref. 12). Similarly, among adults over 25 years old who used
cigars

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

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

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

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

C. Benefits and Risks to the Population as a Whole

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

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

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

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

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

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

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

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

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

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

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

D. Conclusion

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

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

VII. Additional Considerations and Requests for Comments

A. Section 907 of the FD&C Act

    FDA is required by section 907 of the FD&C Act to consider the
following information submitted in connection with a proposed product
standard:
     For a proposed product standard to require the reduction
or elimination of an additive, constituent (including a smoke
constituent), or other component of a tobacco product because FDA has
found that the additive, constituent, or other component is or may be
harmful, scientific evidence submitted by any party objecting to the
proposed standard demonstrating that the proposed standard will not
reduce or eliminate the risk of illness or injury (section
907(a)(3)(B)(ii) of the FD&C Act).
     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 parties to submit a draft or proposed tobacco product
standard for the Agency's consideration (section 907(c)(2)(B)) and
information regarding structuring the standard so as not to advantage
foreign-grown tobacco over domestically grown tobacco (section
907(c)(2)(C)). In addition, FDA invites the Secretary of Agriculture to
provide any information or analysis which the Secretary of Agriculture
believes is relevant to the proposed tobacco product standard (section
907(c)(2)(D) of the FD&C Act).
    FDA is requesting all relevant documents and information described
in this section with this proposed rule. Such documents and information
may be submitted in accordance with the ``Instructions'' included in
the preliminary information section of this document.
    Section 907(d)(5) of the FD&C Act allows the Agency to refer a
proposed regulation for the establishment of a tobacco product standard
to the Tobacco Products Scientific Advisory Committee (TPSAC) at the
Agency's own initiative or in response to a request for good cause made
before the expiration of the comment period. If FDA opts to refer this
proposed regulation to TPSAC, the Agency will publish a notice in the
Federal Register announcing the TPSAC meeting to discuss this proposal.

B. Pathways to Market

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

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

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

C. Considerations and Request for Comments on Scope of Products

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

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

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

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

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

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

VIII. Description of the Proposed Rule

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

A. Scope (Proposed Sec.  1166.1)

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

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

B. Definitions (Proposed Sec.  1166.3)

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

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

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

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

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

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

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

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

IX. Proposed Effective Date

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

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

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

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

X. Preliminary Economic Analysis of Impacts

A. Introduction

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

B. Summary of Costs and Benefits

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

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

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

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

XI. Analysis of Environmental Impact

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

XII. Paperwork Reduction Act of 1995

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

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

XIII. Federalism

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

XIV. Consultation and Coordination With Indian Tribal Governments

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

XV. References

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

*1. Tynan, M.A., T. McAffee, G. Promoff, et al., ``Consumption of
Cigarettes and Combustible Tobacco--United States, 2000-2011.''
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