study found that ``[freshmen college] students who used waterpipes and
cigars perceived them as less harmful than regular cigarettes'' (Ref.
119). These findings are consistent with the finding that perceiving
less product harm is associated with product use (id.). Moreover,
research has shown that such false beliefs about product risks can be a
significant predictor of subsequent use behavior (Refs. 120 and 121).
For instance, adolescents with the lowest perceptions of short-term
risks related to smoking were 2.68 times more likely to initiate
smoking (Ref. 121).
    In addition, some dissolvable tobacco products have a candy-like
appearance, frequently are sold next to candy, and are packaged to make
them more attractive to children, which can mislead consumers to think
that they are, in fact, candy or somehow safer than other tobacco
products (Refs. 17 and 79). This rule, if finalized, would apply the
same requirements to all dissolvable tobacco products, including those
that do not consist of cut, ground, powdered, or leaf tobacco.
    Many consumers believe that e-cigarettes are ``safe'' tobacco
products or are ``safer'' than cigarettes. FDA has not made such a
determination and conclusive research is not available. Several studies
have evaluated consumers' awareness of e-cigarettes and their
perceptions of risk. For example, researchers involved in Wave 8 of the
ITC Four-Country Survey (involving data from the United States, Canada,
Australia, and the United Kingdom) asked all those respondents who were
aware of e-cigarettes to relay their perceptions of the product (Ref.
36). The vast majority of the respondents who were aware of these
products indicated that they believed e-cigarettes were less harmful
than traditional cigarettes, including 65.9 percent of U.S.
respondents--despite, as noted, the absence of a firm body of evidence
to support such beliefs (id.). Two other surveys revealed similar
results: (1) An online survey in which 70.6 percent of individuals
aware of e-cigarettes believed that e-cigarettes were less harmful than
regular cigarettes and (2) a telephone survey in which 84.7 percent of
individuals aware of these products believed they were less harmful
than regular cigarettes (Ref. 23). However, while the use of e-
cigarettes may have prompted some smokers in the ITC Four-Country
Survey to reduce their overall cigarette smoking and to adopt non-daily
cigarette use, users of e-cigarettes were not more likely to quit than
nonusers of e-cigarettes (Ref. 36). Once again, there is not adequate
evidence that e-cigarette use is a safe alternative to conventional
cigarette smoking. See section VII.C.1 regarding the current mixed
evidence about potential short-term reduced smoking benefits from e-
cigarettes. Notably, as discussed in that section, many consumers have
strong, but to date unsubstantiated, beliefs that e-cigarettes are a
safe and effective way for quitting cigarette use, and many consumers
start

consuming e-cigarettes because of those unsubstantiated beliefs.
Researchers also have expressed concerns that e-cigarettes that deliver
very low levels of nicotine may be effective starter products for non-
tobacco product users (Ref. 101). Such risks could be mitigated by the
establishment of an FDA regulatory approach for these products that
focuses on limiting youth initiation (id.).
2. Mistaken Perception by Adolescents
    Nonclinical information, which includes cellular, tissue, and whole
animal-based laboratory studies, both informs and supports clinical
information. Most tobacco-related adverse health effects are long-term
effects, such as COPD and cancer. What can take years or decades to
develop in a human can be studied in nonclinical assays in mere days or
months. In addition, nonclinical studies allow for histopathology,
which yields strong scientific evidence of a biologically based cause
for a clinically detectable symptomology. Through nonclinical studies,
science is able to better control for exposure level of the product
being tested, as well as control for exposure time and to include a
recovery period, during which no exposure to the product can be
controlled. All of these aspects of nonclinical testing enable science
to better make the connection between an outcome, such as a toxicity
endpoint, and the experimental treatment, such as a specific tobacco
product or tobacco constituent. (See, e.g., Ref. 121.)
    Non-clinical research has shown that: (1) Alterations to the brain
caused by nicotine may have a lasting effect on the developing brain
(Ref. 55 at 668-676); (2) the rewarding effects of low and moderate
doses of nicotine were enhanced in adolescent animals as compared to
adult animals, while the aversion to high doses of nicotine normally
seen in adult animals were reduced (Ref. 60 at 658-663); (3) these
affects are long lasting, as exposure to nicotine during adolescence
reduced aversion to high doses of nicotine when the animals were tested
as adults; (4) the adolescent brain is differentially sensitive to both
the acute and repeated effects of nicotine relative to the adult brain
(Ref. 76 at 2295); and (5) there are significant differences in
nicotine sensitivity between early and late phases of adolescence (Ref.
60 and 76).
    Brain processes that lead to rational decision making continue to
mature through adolescence (Ref. 122 at 69-70). Acquisition of a fully
coordinated and controlled set of executive functions occurs relatively
later in development. As a result, several researchers have found that
young people may not have the ability to rationally consider the risks
and benefits involved with smoking and its long-term effects (Ref. 123
at 259-266). Young people also wrongly perceive that they are
personally at less risk than others who smoke, and youth underestimate
antismoking attitudes of their peers (id.). ``The belief pattern that
emerges from this study and other research is one in which many young
smokers perceive themselves to be at little or no risk from each
cigarette smoked because they expect to stop smoking before any damage
to their health occurs. In reality, a high percentage of young smokers
continue to smoke over a long period of time and are certainly placed
at risk by their habit'' (id.). Because they lack fully capable
executive function, youth seriously underestimate the future costs
associated with an addiction to nicotine (Ref. 55 at 4). Researchers
believe that youth underestimate the risks of smoking because they are
unable to appreciate the nature, severity, and probabilities of
consequences associated with smoking. Youth also fail to understand the
cumulative nature of the risk (Ref. 123 at 259-266). The proportion of
students seeing a great risk associated with being a smoker leveled off
during the past several years, according to recent research results, as
has the proportion of teens saying that they disapprove of smoking or
attach negative connotations to it (Ref. 83). Similarly, the
``Monitoring the Future'' survey identified a ``rebound'' in the rate
of smokeless tobacco product use by high school students, which
previously had declined from the mid-1990s to the early 2000s (id.).
Researchers attributed the ``rebound'' to leveling off perceptions of
harm caused by smokeless tobacco products, increased advertising of
these products, and a proliferation of new types of smoke-free tobacco
products (id.). In addition to systematically misunderstanding their
risks of harm from various tobacco products, youth and young people
also systematically underestimate their vulnerability to becoming
addicted to nicotine and the use of tobacco products, and overestimate
their ability to stop using tobacco products when they choose. See
section VII.C.

D. Use as Starter Products or Dual Use With Other Tobacco Products

    A non-cigarette ``tobacco product'' can be a starter product for
new tobacco users before they migrate to cigarettes or other tobacco
products, or for existing users to become dual users. In a 2008 study,
researchers estimated that there were 7.3 million adolescent cigarette
smokers in the United States in 2002 and 2004, and almost half of them
were polytobacco users (users of more than one type of tobacco product)
(Ref. 124). Of the estimated 3.3 million polytobacco users, 1.9 million
used one other tobacco product and 1.4 million used two or more other
products (id.). The 2012 Surgeon General's Report found that ``among
adolescent and young adult tobacco users, concurrent use of cigarettes,
smokeless tobacco, and/or cigars is common'' (Ref. 54 at 209).
According to the 2009 Youth Risk Behavior Surveillance, among high
school males who use tobacco, 13.2 percent smoke cigars (i.e., cigars,
cigarillos, or little cigars) only, 21.2 percent smoke cigars and
cigarettes, and 19.2 percent smoke cigarettes and cigars and also use
smokeless tobacco (Ref. 54 at 155, Figure 3.13).
    Significantly, studies of a variety of tobacco products suggest
that some non-cigarette tobacco users may go on to become addicted
cigarette smokers. For example, in one study of male smokeless tobacco
users who were nonsmokers at baseline, 44.8 percent were still
exclusively using smokeless tobacco at the 4-year followup, 25.5
percent had switched to smoking, 14.3 percent continued using smokeless
tobacco but also became smokers, and 15.2 percent were no longer using
any form of tobacco (Ref. 125). Thus, almost 40 percent of the original
smokeless tobacco users had either switched to cigarettes or become
dual users. In contrast, 78.7 percent of males who smoked at baseline
but did not use smokeless tobacco were still smokers 4 years later,
with only 0.8 percent switching to smokeless tobacco, 3.6 percent
continuing to smoke but becoming smokeless tobacco users as well, and
16.9 percent quitting tobacco product use altogether (id.). Similarly,
in a study of smokeless tobacco product use in young adult males,
current smokeless tobacco users were 233 percent more likely to have
initiated smoking at the 1-year followup than nonusers (Ref. 126).
Subjects who reported past smokeless tobacco product use were 227
percent more likely to begin smoking than participants who had never
used smokeless tobacco (id.). It is not yet clear whether users of the
proposed deemed products go on to become addicted to cigarettes, but
experts have expressed concern that e-cigarettes may draw more
consumers to nicotine-containing products (Refs. 101).
    Research involving tobacco products that would be covered by this
rule

reveals similar conclusions. The prevalence of hookah use appears to be
high among youth who have already tried cigarette smoking and is
associated with other tobacco product use behaviors. For example, in
one study involving 951 adolescents, researchers found that those who
had used hookah tobacco in the last 30 days concurrently used multiple
tobacco products including cigarettes (74.7 percent) and cigars,
cigarillos, and/or little cigars (48.1 percent) (Ref. 127). Given that
waterpipe smoking has been found to increase one's risk of nicotine
dependence, this tendency towards dual use is particularly concerning
(Ref. 93). Regular waterpipe smokers evidence similar withdrawal and
craving symptoms as cigarette smokers (Ref. 128). Engagement in
waterpipe tobacco product use among individuals that would otherwise
remain tobacco na[iuml]ve is of great concern, as about half of
waterpipe users are non-current cigarette smokers (Ref. 129). Waterpipe
smoking frequency predicts regular cigarette use 8 months later among
adolescent males (Ref. 130). Among high school non-smokers and
experimental smokers, there was a strong association between age 20/21
smoking and waterpipe use: Previous non-smokers were more likely to
smoke cigarettes if they use waterpipes, suggesting that waterpipe use
may have preceded cigarette use (Ref. 131). College students with
waterpipe experience, but no cigarette use, were more likely to express
intent to try a cigarette soon (Ref. 26).
    A cross-sectional health risk survey of approximately 4,500 high
school students revealed that high school-aged cigar smokers are more
susceptible to future cigarette smoking than nonusers. Specifically, in
students who tried cigars (defined as cigars, little cigars, and
cigarillos) first, 14.6 percent used cigarettes only, 12.2 percent used
cigars only, and 43.6 percent used both cigarettes and cigars (Ref.
117).

VI. Proposed Minimum Age and Identification Restrictions

    Currently, there are Federal minimum age and identification
requirements for cigarettes and smokeless tobacco prohibiting sales of
these tobacco products to individuals under 18 years of age. This
proposed rule would extend those requirements to all covered tobacco
products in order to curb initiation of other tobacco products among
youth. We note that the definition of ``covered tobacco products''
would depend on the universe of tobacco products that would be covered
this rule. Under Option 1, all cigars would be covered and, therefore,
these additional provisions would apply to all cigars. However, under
Option 2, only a subset of cigars (i.e., ``covered cigars,'' which
would exclude ``premium'' cigars) would be covered by the rule and,
therefore, these additional provisions would apply to only a subset of
cigars. Under section 906(d) of the Tobacco Control Act, the minimum
age and identification restrictions FDA is proposing here are
appropriate for the public health.

A. Effectiveness of Proposed Restrictions and Section 906(d) Standard

    The age and identification restrictions that FDA is proposing on
the sale of covered tobacco products meet the requirements of the
section 906(d) standard and are appropriate for the protection of the
public health. The goal of the proposed age restrictions is to reduce
youth initiation of tobacco use, thereby reducing the number of people
who suffer from tobacco-related illnesses and death and the number of
people who are exposed to secondhand smoke.
    Currently, not all states have laws preventing the sale of tobacco
products that would be covered by this rule to those under the age of
18. This proposed action to prohibit sales of covered tobacco products
to individuals under 18 years of age at a minimum would be the most
effective way to keep youth from going to another nearby jurisdiction
that sells tobacco products to those under age 18. FDA intends to work
with retailers to emphasize the importance of continued training for
employees so that they will understand both the importance of the
minimum age restriction as well as how to enforce it. The Center for
Substance Abuse Prevention Draft Conference Edition Report on
Responsible Retailing outlines how a ``comprehensive program of
responsible retailing, properly designed and implemented, can
contribute to the elimination of sales of tobacco and other age-
restricted products to minors'' (Ref. 132 at 1) (see Refs. 133 and
134). FDA intends to use an aggressive nationwide enforcement program
for any new Federal program which will, we believe, increase compliance
and deter youth consumption of addictive tobacco products. FDA's
current nationwide tobacco retail inspection enforcement program, which
is implemented through contractual agreements between FDA and state or
local partners, where feasible, will be able to incorporate new
products or policies to provide additional uniformity to the
enforcement of tobacco laws and regulations.
    There is clear evidence that actively enforced minimum age
requirements and identification requests in the states are useful in
reducing illegal sales of tobacco to youth (Refs. 135, 136, 137, and
138). A literature review found that every intervention that prevented
the sale of tobacco to minors has been associated with an observed
reduction in tobacco product use by youth (Ref. 138). The author
reviewed more than 400 published articles and 400 government reports
concerning tobacco sales to minors (id.). There were 19 interventions
in which the sale of tobacco to minors was disrupted (id.). In each
case, the intervention was followed by a decline in youth tobacco use.
Contrary to claims that efforts to disrupt the sale of tobacco to
minors are futile because social sources would ``fill the void making
tobacco more available,'' adolescents who purchase tobacco products
``are the primary social sources for other youth'' (id.). The
disruption of commercial distribution to youth ``creates supply
shortages, driving up the cost of tobacco on the street and
discouraging sharing among peers as smokers protect their supply''
(id.). Declines in tobacco product use were seen in rural communities,
suburban communities, across large regions or states, and countrywide.
Moreover, among all the materials reviewed, none demonstrated a
significant reduction in commercial distribution of tobacco to minors
unaccompanied by reductions in the number of youth who use tobacco
(id.). The author concluded that all available evidence indicates that
interventions that successfully disrupt the sale of tobacco to minors
can be expected to reduce the rate of tobacco product use among
adolescents.
    Three small, cross-sectional studies have also found reductions in
tobacco product use following decreases in tobacco accessibility (Ref.
133 citing Refs. 134, 139, and 140). For example, the investigators in
one study surveyed more than 600 7th and 8th grade students in
Woodridge, IL, before and approximately 2 years after a local law on
retailer licensing and youth possession of tobacco was passed (Ref.
139). With active enforcement of the law, illegal sales of tobacco to
individuals under 18 years old were reduced from 70 percent of the
sample of retailers surveyed to 5 percent at the end of the 2-year
compliance review period (id.). Experimental smoking among middle
school students studied dropped from 46 percent to 23 percent 2 years
after the law's passage, and

regular smoking rates dropped from 16 percent to 5 percent (id.).
    Similarly, another study examined youth smoking rates and purchase
behaviors in a longitudinal analysis of 12 communities (Ref. 141). Test
purchases were conducted to determine whether merchant compliance with
access restrictions can lead to lower youth smoking rates. Then these
levels of merchant compliance were compared with youth smoking rates.
From 1992 to 1996, frequent smoking increased by 28 percent in the
communities with retailer compliance levels less than 80 percent, but
frequent smoking decreased by 16 percent in the communities with
retailer compliance levels greater than 80 percent (id.).
    Moreover, a number of studies have observed at least some
correlation between the enforcement of youth access restrictions and
reduced tobacco product use among youth when enforcement is coupled
with educational campaigns, and FDA has conducted and plans to continue
to conduct various types of public education regarding tobacco
products. For example, in a four-community study in Monterey County,
CA, where sales of tobacco products to individuals under 18 were
prohibited, researchers studied an intervention group (with educational
campaigns for the community and merchants) and a control group. In
communities with the tobacco intervention, the proportion of stores
selling tobacco to individuals under 18 dropped from 75 percent at
baseline to 0 percent after 34 months; while in the control
communities, the proportion of stores selling tobacco to minors only
dropped from 64 percent to 39 percent (Ref. 133). Additionally, 7th
graders in the intervention communities were significantly less likely
to use tobacco over the course of the study (13.1 percent at baseline
vs. 12.6 percent post-test), while 7th graders in the comparison
communities were significantly more likely to use tobacco (15.6 percent
at baseline vs. 18.6 percent post-test) (id.). In communities using
tobacco intervention policies, treatment effects were evident among the
youngest students (7th grade at baseline) but were not sustained at 34
months, and no significant effects were found for 9th and 11th graders
(id.). Based on these data, the authors concluded that there was some
evidence, albeit inconsistent, that reducing tobacco sales to
individuals under 18 lowered tobacco product use among this age group,
and that younger adolescents are more responsive to educational
campaigns for the community and merchants than older adolescents (id.).
    Similarly, in a randomized community trial involving 14 Minnesota
communities (7 intervention communities and 7 control communities),
communities that passed a comprehensive youth tobacco access ordinance
showed less pronounced increases in adolescent daily smoking relative
to control communities (Ref. 137). During the intervention period,
there was statewide media attention on youth access to tobacco.
Additionally, during the intervention period, state retailer
associations and the tobacco industry launched statewide campaigns to
educate retailers and their employees about Minnesota tobacco age-of-
sale law and ways to avoid violating it (id.). The authors posited
that, to the extent both intervention and control communities showed
reductions in illegal sales to individuals under 18, the community
mobilization and education portions of the intervention may have played
a role in increasing the perception among students that they would not
be able to purchase tobacco or discouraged them from trying to do so
(id.).
    FDA is aware of two studies that question the link between actively
enforced youth access laws and tobacco use. One 2-year controlled study
in six Massachusetts communities (from 1994 to 1996) that examined the
impact of enforcement of youth access restrictions on smoking behaviors
found that despite a significant and continued increase in compliance
by retailers, young people reported little decline in their ability to
purchase tobacco products. The study also found no relationship between
merchant compliance and smoking prevalence (Ref. 142).
    In addition, a meta-analysis of previous studies showed no
detectable relationship between the level of merchant compliance with
youth access laws and 30-day or regular smoking prevalence and no
visible evidence of a threshold effect after compliance reached a
certain level (e.g., 80 or 90 percent) (Ref. 143). Although the authors
noted that one limitation of the analysis was the relatively small
number of controlled studies evaluating the effects of youth access
restrictions on teen smoking prevalence, they observed that the
consistency of the results increased their confidence in the study's
conclusions (id.). Researchers speculated that there was no reported
reduction in youth access, despite increased compliance rates by
retailers, either because youth went to other communities that did not
rigorously enforce the minimum age requirement to purchase cigarettes
or tricked retailers into believing that they were older (id.). While
more data and a larger sample size are needed to support this
hypothesis, these researchers did state that FDA regulations setting a
national standard for tobacco sales could have an effect on tobacco
product use nationwide if there were careful monitoring of compliance
(id.).
    Several studies discussed potential reasons for the mixed findings
on the impact of youth access laws on youth tobacco use. Researchers
found that when youth access laws exist and are enforced, youth users
of tobacco, particularly beginning users, may resort to social sources
of tobacco (such as friends, parents, or strangers) or to stealing
(either from parents or from tobacco product retailers) (Ref. 141).
This phenomenon may explain why some data show that where decreases in
youth tobacco product use do result from youth access restrictions, the
decreases are concentrated among heavier teen smokers and/or frequent
smokers (Refs. 141 and 144).
    Although the literature is mixed on the role compliance and
enforcement plays in the ability of youth access restrictions to affect
youth tobacco use, because the minimum age and identification
requirements FDA is proposing here would be Federal requirements, they
would apply across the entire United States. More uniform enforcement
by FDA working in conjunction with states would minimize youth's
ability to circumvent the current patchwork of youth access
restrictions by attempting to buy tobacco products in jurisdictions
where enforcement may be more lax. At least one study shows that
perceived accessibility to tobacco products contributes to tobacco
initiation and escalation among youth (Ref. 145). Accordingly, FDA
concludes that the proposed minimum age and identification
restrictions, combined with comprehensive and consistent enforcement at
the Federal level and in partnership with states, will decrease the
likelihood of youth smoking initiation and, therefore, are appropriate
for the protection of the public health under section 906(d) of the
FD&C Act.
    The proposed minimum age and identification restrictions for
covered tobacco products are reasonable restrictions to curb youth
tobacco product use that would not hamper adult access to these
products. Adults seeking to purchase cigars or other covered tobacco
products would continue to take the same steps as they had in the past
to purchase these products. The only group that would find it more
difficult to purchase these products would be the youth population. In
addition, FDA believes

that these restrictions are necessary to prevent reinforcement of
existing misperceptions by youth that certain tobacco products--those
for which there are no minimum age or identification requirements--are
safe for their use. The absence of such requirements for covered
tobacco products could give youth a false sense of security about the
safety of those products sold without these restrictions.
    Moreover, the proposed rule would simplify retailer compliance with
tobacco access restrictions. This restriction would make all
cigarettes, smokeless tobacco, and covered tobacco products in a
retailer's establishment subject to the same age and identification
requirements. The proposed restrictions would make compliance less
cumbersome for retailers who sell tobacco products in stores throughout
the United States, because they would have a uniform age and
identification requirement to enforce across their stores (rather than
several state and local laws that could result in differing age
restrictions and application to types of tobacco products). Currently,
the state and local age restrictions vary with respect to the types of
tobacco products to which they apply. For example, while Kentucky
prohibits the sale of tobacco products to persons under 18, the
provision does not define ``tobacco product'' in this context and,
therefore, may not cover proposed deemed tobacco products such as pipe
tobacco and e-cigarettes (Ky Rev Stat. Sec.  438.310). Similarly,
Delaware's age restrictions apply to any product that ``contains
tobacco,'' which could be construed to apply less broadly than the
proposed federal restriction that also would apply to products that are
derived from tobacco (Del. Code Ann. tit. 11, Sec. Sec.  1115, 1116).
With a consistent Federal regulation, retailer owners would be able to
more quickly train employees regarding the restriction without needing
to differentiate between a variety of products that contain similar
packaging and many of the same ingredients. Better retailer compliance
and enforcement can make it more difficult for youth to access
dangerous tobacco products, which FDA believes would, in turn, limit
their use of such products.

B. Application to Proposed Vending Machine Restrictions

    Section 1140.14(b)(3) of the proposed regulation would ban the sale
of covered tobacco products in vending machines, unless the vending
machine is located in a facility where the retailer ensures that
individuals under 18 years of age are prohibited from entering at any
time. This restriction is appropriate for the protection of the public
health because it ensures that persons under the age of 18 cannot
purchase covered tobacco products without a retailer having to verify
their age and identification.
    Section 1140.16(c) currently prohibits the sale of cigarettes and
smokeless tobacco in vending machines except those located in
facilities where individuals under 18 years of age are not permitted to
enter at any time. The preamble to FDA's 1995 proposed rule regarding
restrictions on youth access to cigarettes and smokeless tobacco
identified numerous studies and surveys showing that significant
percentages of young people are able to purchase cigarettes from
vending machines (60 FR 41314 at 41324-41326, August 11, 1995). Based
on studies demonstrating how easily youth and young adults could
purchase cigarettes from vending machines and surveys of actual
purchasing behavior, the Agency concluded that the provision would
eliminate a primary source of cigarettes for at least 2 percent of 17-
year-old smokers and 22 percent of 13-to-17-year-old smokers (60 FR
41314 at 41324 and 41325; 61 FR at 44396 at 44449).
    As with cigarettes and smokeless tobacco, a ban on vending machine
sales in places accessible to individuals under 18 would eliminate an
easy means of access to covered tobacco products, especially for
younger children. In addition, this proposed restriction is an
important adjunct to the proposed minimum age and identification
requirements. Without the proposed restriction on vending machines, use
of vending machines to obtain covered tobacco products would likely
circumvent the proposed minimum age and identification restrictions.
For example, a 2002 review of youth access policies found that although
vending machines and shoplifting represented approximately 5 percent or
less of youth supply, the flow of cigarettes comes from a variety of
sources (Ref. 146). If it becomes more difficult for youth to buy
cigarettes over the counter, greater numbers of youth will purchase
them from vending machines or older peers, or borrow or steal from
parents (id.). Thus, unless vending machines restrictions are part of
this rule, these well-recognized substitution effects could limit the
effectiveness of the minimum age and identification restrictions FDA is
proposing (Refs. 133 and 140).
    Furthermore, more recent research confirms that purchases of
cigarettes from vending machines occur regardless of locks, warning
signs, and other physical restrictions. A 2009 German study on youth
access to tobacco vending machines concluded that electronic locking
devices on vending machines were not sufficient to limit youth access
to tobacco. The study also found that youth were able to circumvent the
electronic locking devices and still obtain cigarettes (Ref. 147).
Accordingly, the proposed restriction is designed to prevent youth
access to the vending machines themselves.
    According to the most recent data that is currently available,
tobacco product vending machine sales declined sharply in recent
decades, with 2007 sales totaling $46.9 million (Ref. 148). Since 2007
there has been expansive growth in e-cigarette sales (which were
negligible in 2007), and vending machine sales of e-cigarettes are not
prohibited or restricted to any significant extent at the Federal,
state, or local levels. The proposed rule produces public health
benefits to the extent that e-cigarettes, cigars, and other proposed
deemed products are currently being sold through vending machines or
would be in the future.
    We also note that FDA's proposed restriction regarding the use of
vending machines is not intended to apply to facilities in which the
retailer ensures that no person under 18 years of age is present. We
believe this limitation is appropriate because this rule would prohibit
access by youth without imposing additional requirements upon retailers
who serve the over 18-year-old population.

VII. Proposed Required Warning Statements

    FDA is proposing to require the following health warning on all
covered tobacco products, as well as cigarette tobacco and roll-your-
own tobacco: ``WARNING: This product contains nicotine derived from
tobacco. Nicotine is an addictive chemical.'' We note that the
definition of ``covered tobacco products'' would depend on the universe
of tobacco products that would be covered this rule. Under Option 1,
all cigars would be covered and, therefore, this additional requirement
would apply to all cigars. However, under Option 2, only a subset of
cigars (i.e., ``covered cigars,'' which would exclude ``premium''
cigars) would be covered by the rule and, therefore, this additional
requirement would apply to only a subset of cigars. FDA is proposing a
self-certification option for manufacturers who certify that their
tobacco product does not contain nicotine (and that they have data to
support that assertion). Such a product would be required to

bear the statement, ``This product is derived from tobacco.''
    FDA is proposing that this warning statement be required to appear
on the packages and in the advertisements for all proposed newly
covered tobacco products and other tobacco products for which health
warnings are not otherwise required by Federal law or regulation (i.e.,
cigarette tobacco and roll-your-own tobacco). As discussed in section
V.A, the addictive nature of nicotine in tobacco products is clear.
    In 2000, in settlements with the FTC, the seven largest U.S. cigar
manufacturers agreed to include warnings about significant adverse
health risks of cigar use in their advertising and packaging. (See,
e.g., In re Swisher International, Inc., Docket No. C-3964.)
    Under the 2000 FTC consent orders, virtually every cigar package
and advertisement is required to clearly and conspicuously display one
of several warnings on a rotating basis, including the following:
     Cigar Smoking Can Cause Cancers of the Mouth and Throat,
Even If You Do Not Inhale.
     Cigar Smoking Can Cause Lung Cancer and Heart Disease.
     Cigars Are Not a Safe Alternative to Cigarettes.
     Tobacco Smoke Increases the Risk of Lung Cancer and Heart
Disease, Even in Nonsmokers.
    Based on FDA's authority under section 906(d) of the FD&C Act, FDA
is proposing to adopt these four cigar warning statements from the FTC
consent orders--which the vast majority of cigars already use--in
addition to the warning statement regarding addictiveness. These
warning statements will be randomly displayed and distributed on cigar
product packages and rotated in advertisements. For cigars sold
individually that are not packaged, FDA is proposing that the cigar
warnings all be included on a sign located at the point-of-sale at each
cash register in any retail establishment where such cigars are sold.
If FDA's proposal to deem tobacco products to be subject to its
``tobacco product'' authorities is finalized, FDA and the FTC will
consult to harmonize national requirements for health warnings on cigar
product packages and in advertisements. In addition, under Option 1,
these warning requirements would now apply to all small and large
cigars, not just to those manufactured by the seven companies subject
to the FTC orders.
    FDA's proposal that these cigar warnings be randomly distributed on
packages and rotated in advertisements is consistent with the
requirements established by Congress in the Tobacco Control Act for
statutorily covered products. Section 4 of the Federal Cigarette
Labeling and Advertising Act and section 204 of the Tobacco Control Act
require the random distribution and rotation of warnings for cigarettes
and smokeless tobacco products, respectively. Therefore, FDA is not
proposing to treat cigars differently from currently regulated tobacco
products. Further, rotation of warning labels already occurs under the
FTC consent decrees. The WHO also has recognized the need to rotate
health warnings for tobacco products. In the WHO's Framework Convention
on Tobacco Control (FCTC),\4\ an evidence-based treaty that provides a
regulatory strategy for addressing the serious negative impacts of
tobacco products, calls for warnings that are rotating, ``large, clear,
visible and legible.'' (WHO FCTC article 11.1(b).) However, FDA
recognizes that the random distribution of warning statements on cigar
product packages and the rotation of statements on advertisements can
result in significant costs for cigar manufacturers. Therefore, FDA
requests comments on other possible methods (e.g., randomly assigning
warning statements per individual cigar or Universal Product Code) to
ensure that the warnings have a maximum public health impact by
reaching as many individuals as possible yet do not grow stale from
overuse. FDA requests comments and data showing that such alternative
methods would still achieve FDA's public health goals yet would reduce
costs for cigar manufacturers.
---------------------------------------------------------------------------

    \4\ There are 168 signatories to the WHO's Framework Convention
on Tobacco Control as of August 2010. At this time, the United
States is a signatory but has not ratified this treaty.
---------------------------------------------------------------------------

    In the following sections, we discuss the bases for the proposed
warning statements. We discuss how FDA's proposed health warning
statements and the exercise of authority in this area meet the
requirements for implementing a restriction regarding the sale and
distribution of a tobacco product under section 906(d) of the FD&C Act.
We also explain the importance of including the proposed health
warnings on small and large cigars given the scientific evidence
regarding the serious adverse health risks associated with cigar use,
the age of initiation of cigar use, and the increasing popularity of
cigars among youth (in particular, small cigars), as well as the fact
that many of these products already display most of these warnings. In
addition, we explain that these warning statements, as well as the
proposed additional warning for covered tobacco products (and cigarette
tobacco and roll-your-own tobacco), will effectively communicate to
consumers the addictive nature of the nicotine in these products. FDA
believes that consumers should clearly understand and appreciate the
dangers of tobacco use. Greater awareness and understanding of the
dangerous health effects of tobacco product use will help consumers
better understand the potential consequences of their purchase and use
of tobacco products.

A. Requiring Health Warnings Is Appropriate for the Protection of the
Public Health

    The purpose of health warnings is to help current and potential
tobacco users understand and appreciate the serious adverse health
consequences associated with tobacco product use and the addictive
nature of tobacco products. Adolescents do not accurately understand
the health risks associated with smoking, and smokers tend to
underestimate the risk of harm (Ref. 149). FDA believes it is
reasonable to apply this notion of imperfect smoking-related knowledge
to other forms of tobacco product use as well. Given the dangers
associated with continued use of tobacco products, FDA believes it is
critical to include a warning on all such products to help consumers
better understand and appreciate the addictive nature of these
products.
    For more than 45 years, Congress has required textual health
warnings for cigarettes on product packages. Warnings in cigarette
advertising have been required since the FTC issued its 1972 consent
orders and since 1984 by statute. (See in re Lorillard et al., 80 FTC
455 (1972); Comprehensive Smoking Education Act, Pub. L. 98-474
(1984).) For almost 25 years, Congress has required textual health
warnings for smokeless tobacco packages and advertisements. The FCTC
also requires health warnings on tobacco product packages (article 11)
and in tobacco product advertising (article 13). The 2000 consent
orders between seven cigar manufacturers and the FTC required health
warnings for cigar packages and advertisements. Thus, requiring health
warnings on all tobacco products subject to the FD&C Act is consistent
with existing laws, practices, and international standards.
    The health warnings that FDA is proposing, which concern risks
associated with the use of tobacco products, are clearly material with
respect to the consequences that may result from the use of those
products. For all covered tobacco products (as

well as cigarette tobacco and roll-your-own tobacco) that contain
nicotine, the proposed regulation would require a warning about the
addictive nature of nicotine in the product. For small and large
cigars, the warnings also convey information about health consequences,
including certain cancers, cardiovascular disease, and effects on
others exposed to secondhand smoke. It is important for consumers who
are making purchasing decisions to understand that, unlike most other
consumer products, once tobacco product use is initiated, it can be
very difficult to stop using the product.
    Consumers also may be unaware of the presence and addictive nature
of nicotine in all of these products, as they can be the first tobacco
product that a young person uses before progressing to cigarette
smoking or use of other tobacco products, as discussed in section V. In
addition, once a user becomes addicted, he or she likely would increase
use and, therefore, increase his or her risk of suffering from other
negative health effects given the dose-response relationship associated
with many of these products (Ref. 49). Therefore, the warnings FDA is
proposing would provide highly material information that all consumers
should know about the consequences of using tobacco products. Failure
to disclose material facts about tobacco products, such as the presence
and addictive nature of the nicotine in the products, is likely to
mislead consumers. See In re Lorillard, et al., 80 FTC 455 (1972)
(consent order resolving charges that failure to disclose statutory
health warning for cigarettes in cigarette advertising was deceptive
and unfair). See also In re Swisher International, Inc., Docket No. C-
3964; In re Havatampa, Inc., Docket No C-3965; In re Consolidated Cigar
Corp., Docket No. C-3966; In re General Cigar Holdings, Inc., Docket
No. C-3967; In re John Middleton, Inc., Docket No. C-3968; In re Lane
Limited, Docket No., C-3969; In re Swedish Match North America, Inc.,
Docket No. C-3970 (consent orders resolving allegations that failure to
disclose the adverse health consequences of cigar use was deceptive and
unfair).
    The proposed requirements to include health warnings on tobacco
product packages and in advertisements also would satisfy the standard
in section 906(d) of the FD&C Act, which allows the Agency to issue a
regulation to require restrictions on the sale or distribution of a
tobacco product, if the regulation ``would be appropriate for the
protection of the public health.'' According to the statute, the
determination as to whether a regulation would be appropriate for the
public health must be based on the risks and benefits to the population
as a whole (including tobacco users and nonusers) and taking into
account how the regulation could impact the likelihood of existing
users stopping use of the product and the likelihood of new users
starting to use the product (section 906(d)(1)(A) and (B) of the FD&C
Act).
    The public health benefits to both users and nonusers from this
regulation would be significant. As discussed in sections V.B and
VII.E, there is substantial evidence that certain tobacco products
within the scope of this regulation cause serious diseases and death
and that secondhand smoke causes deadly diseases in nonsmokers. The
addictive nature of tobacco products also has been well-documented (see
section V.A). These proposed warnings would help ensure that youth and
young adults, who may be more susceptible to the addictiveness of
nicotine, have a greater awareness of the dangers associated with these
products before they might become addicted. As discussed in section
VII.B, researchers have found that tobacco health warnings on product
packages and in advertisements can effectively provide this important
health information to consumers. FDA believes that the proposed
warnings would help both users and nonusers better understand and
appreciate these dangers.

B. Effectiveness of Warnings

    The use of tobacco packages to help consumers better understand and
appreciate tobacco-related health risks has a number of advantages. The
frequency of exposure is high. In addition, package warnings are
delivered both at the time of tobacco product use and at the point of
purchase. Thus, the messages are delivered to tobacco users at the most
important times--when they are considering using or purchasing the
tobacco product. The messages on packages also help the public at
large, including potential tobacco users, better understand and
appreciate the health and addictiveness risks of using the products
(Ref. 56). Requiring health warnings in advertisements similarly is an
important means of helping consumers better understand and appreciate
the health consequences of tobacco use. (See In re Lorillard et al., 80
FTC 455 (1972); Federal Cigarette Labeling and Advertising Act (FCLAA),
15 U.S.C. 1331 et seq.; Comprehensive Smokeless Tobacco Health
Education Act of 1986 (CSTHEA), 15 U.S.C. 4402 et seq.)
    For the communication to be effectively understood and appreciated,
consumers must notice and pay attention to the warning. As discussed at
length in this section, the size, placement, and other design features
of the warning play a role in the effective communication of the
underlying message. As discussed in sections VIII.C.2 and VIII.C.3, the
proposed regulation would require that the health warning statements
comprise 30 percent of the area of the two principal display panels of
the package to help ensure that consumers notice and process the
critical information conveyed in the required warning statements. The
IOM, Congress, and Article 11 of the FCTC recognize the importance of
having the warnings cover at least 30 percent of the area of the
principal display panels, and users are more likely to recall warnings
that are in a larger size and that appear on the front/major surfaces
of the tobacco package (Ref. 58; 15 U.S.C. 4402(b); FCTC article 11).
Because the warnings would be required to appear on 30 percent of the
two principal display panels (which includes the front of the package),
FDA believes that the proposed warnings will be effective in helping
consumers better understand and appreciate critical information. We are
proposing a 30-percent size requirement for product packages to be
consistent with Congress' size requirements for similar text-only
warnings for smokeless tobacco under CSTHEA (15 U.S.C. 4402(a)(2)(A)),
rather than the 50-percent size requirement that Congress chose for
graphic warnings on cigarette packages. We invite comment on the
appropriateness of this size requirement.
    In addition, because a large font size increases the impact and
legibility of the warning, FDA is proposing that the warning statement
on packages and advertisements appear in the maximum font size that
would fit into the warning area. Given the variety of packaging sizes
for the tobacco products at issue in this regulation, it is not
feasible to specify a single font size for all products within the
scope of this regulation. Therefore, FDA is proposing that the font be
as large as possible to ensure that the required warning statement will
be noticed by consumers regardless of the package size. Research has
shown that using the largest possible lettering can increase warning
effectiveness and increasing font size aids communication (Ref. 150).
Similarly, the proposed requirement that the warnings appear in black
text on a white background or

white text on a black background will improve the legibility and
noticeability of the warnings (Refs. 58 and 150).
    The format requirements that FDA is proposing are similar to those
included in a 2001 European Union Directive, which have been shown to
increase the effectiveness of health warnings. European Union (EU)
Directive (2001/37/EC) requires that tobacco warnings in all member
countries meet certain minimum standards that are similar to those that
FDA is proposing (i.e., EU required health warnings comprise 30 percent
of the area on the front of package and 40 percent on the back of the
package; black Helvetica bold type on a white background; warnings to
occupy the greatest possible proportion of the warning area set aside
for the text required; messages centered in the warning area and
surrounded by a black border of 3 to 4 millimeters (mm) in width).
Prior to the 2001 Directive, warnings in most European Union countries
were very small and general. In one study conducted for the European
Commission, a majority of respondents considered the Directive's new
warning format more effective and more credible than the previous
format (Ref. 151). A study of Spanish university students also
concluded that text warnings based on the Directive significantly
increased perceptions of the risk of tobacco products (Ref. 152).
Additionally, in a study of similar warnings in the United Kingdom,
smokers indicated that their awareness of the warnings increased along
with thoughts about the health risks of smoking (Ref. 153).
    FDA believes that the fundamental similarities between cigarettes
and smokeless tobacco and other tobacco products allow for the
application of data regarding the effectiveness of cigarette and
smokeless tobacco warnings to warnings for other tobacco products.
Research dating back to the late 1980s has found that small warning
labels for cigarettes and small warning labels for smokeless tobacco
products alike were rarely noticed and suffered from low rates of
recall among youth (Refs. 154, 155, and 156). For example, in one eye-
tracking study, adolescents were asked to view five cigarette ads that
included a health warning (Ref. 155). The average viewing time of the
health warning was only 8 percent of the total time spent viewing the
ads, and participants subsequently demonstrated a low recall of the
warnings (id.). Similarly, a study of health warnings on oral snuff and
chewing tobacco pouches revealed that fewer than half of the subjects
recalled seeing the warnings and approximately one-third of those who
saw the warnings recalled the content (Ref. 156). These studies were
all based on the small warning sizes then required by United States
law. As discussed above, the Tobacco Control Act requires substantially
larger warnings for cigarettes and smokeless tobacco products, and this
proposed rule, if finalized, would require similarly sized warnings for
other tobacco products. Warning size clearly matters, as recall
increases significantly with font size (Ref. 156 at ii61). In a study
of recall of health warnings in smokeless tobacco ads, conducted with
895 young males, 63 percent of participants recalled a high contrast
warning in 10-point font; doubling the warning size to a 20-point font
increased recall from 63 percent to 76 percent representing a 20-
percent improvement in recall (Ref. 156 at ii61-ii62). Research on
cigarette-package warnings confirms that larger warnings are better
noticed and more likely to be recalled (Ref. 54 at 810; ref. 58 at App.
C-3; ref. 150). These studies support FDA's belief that requiring that
the proposed warnings appear in the maximum font size will improve
their noticeability.
    The content of the proposed messages also indicates that they
should help consumers understand and appreciate the relevant health
risks. In a qualitative study conducted for Health Canada, researchers
tested text-only smokeless product health messages, some of which are
similar to FDA's proposed health warnings for cigars. One of the tested
Canadian messages (This product causes mouth diseases) generally was
considered to be a low-impact message, which participants felt was not
a deterrent but merely a reminder (Ref. 159 at 11). However, FDA's
proposed message (adopting the existing FTC warning language) regarding
mouth diseases is more specific and alerts consumers that not only do
small and large cigars cause ``mouth diseases,'' they also cause cancer
of both the mouth and the throat. As the IOM explained with respect to
cigarette warnings, specific unambiguous warnings are more likely to be
noticed and less likely to be discounted than vague warnings (Ref. 58
at App C-3).
    Another Canadian tested message (Use of this product can cause
cancer) is similar to three of FDA's proposed warning messages. Most
respondents in the Canadian study considered this message to be
credible, although some found that the message was ``too vague to be
effective'' (Ref. 159 at 12). However, FDA's proposed health warnings,
adopting the existing FTC language, are more specific than the Canadian
message (referring to specific types of cancers, noting the risk of
mouth and throat cancers even for those that do not inhale, and
alerting users that the smoke released from their product can even
cause cancer in nonsmokers) (Ref. 58). FDA believes, therefore, that
the proposed warnings will be effective in helping current and
potential smokers understand and appreciate the adverse health
consequences related to cigar smoking.
    Researchers have studied the relationship between substance use and
memory for health warnings on cigarettes, smokeless tobacco, and
alcohol. For smokeless tobacco, researchers confirmed a statistically
significant correlation between use and recognition memory for the
product's health warnings (Ref. 157 at 147).
    Although there has not yet been extensive research regarding the
effectiveness of health warnings on tobacco products other than
cigarettes (Refs. 155, 156, 157, 158), existing studies support the use
of these messages. Canada's text-only health warning messages for
chewing tobacco and oral snuff packages (similar to the ones FDA is
proposing to apply to cigars) were issued in 2000 (Ref. 159), which the
qualitative study described above found to be effective at educating
consumers about the dangers associated with their use. In the instances
where consumers believed the messages were ineffective, FDA is
proposing messages that differ significantly from the Canadian messages
in that they provide additional, specific health information for
consumers.
    FDA intends to conduct research and keep abreast of scientific
developments regarding the efficacy of the final health warnings and
the ways in which their efficacy could be improved. We will use the
results of our monitoring and such research to help determine whether
any of the warning statements (if finalized) should be revised in a
future rulemaking. Under Option 2, these warning label requirements
would only apply to covered cigars and not to premium cigars.

C. Proposed Addictiveness Warning

    To FDA's knowledge, all tobacco products currently on the market
contain nicotine (Ref. 49 at 12). The Surgeon General has long
recognized the addictive nature of tobacco products due to the presence
of highly addictive nicotine that can be absorbed into the bloodstream
(See, e.g., Ref. 49 at 6-9). Nicotine is psychoactive and can serve as
a ``reinforcer'' to motivate tobacco-seeking and tobacco-using behavior
(Ref. 49 at 7). The patterns of nicotine

use are regular and compulsive, and a withdrawal syndrome usually
accompanies tobacco abstinence (Ref. 49 at 13). Tolerance develops to
nicotine such that repeated use results in diminished effects and can
be accompanied by increased intake (Ref. 49 at 13). The pharmacologic
and behavioral processes that determine tobacco addiction are similar
to those that determine addiction to other drugs (Ref. 49 at ii).
Leading national and international organizations, including WHO, the
American Psychiatric Association (APA), the American Cancer Society,
and the American Academy of Addiction Psychiatry, have recognized
chronic tobacco product use as a drug addiction (Ref. 49 at iii). WHO
and APA do not use identical definitions of ``addiction''; however,
they have in common several criteria for establishing a drug as
addicting--such as the fact that the user's behavior is largely
controlled by a psychoactive substance; the drug is reinforcing and the
user can develop a tolerance to it; and withdrawal can occur following
abstinence--and nicotine meets all these criteria (Ref. 49 at iv). See
section V.A for additional information regarding the addictiveness of
tobacco products.
    Accordingly, FDA proposes to help consumers better understand and
appreciate the addictiveness of tobacco product use by adding warnings
on packages and in advertisements for all covered tobacco products and
those products not already requiring a health warning under Federal law
or regulation (i.e., cigarette tobacco and roll-your-own tobacco). FDA
proposes that such warning would state: ``This product contains
nicotine derived from tobacco. Nicotine is an addictive chemical.''
1. Consumer Perceptions Regarding Addictiveness of Tobacco Products
    This warning is particularly important given consumers' erroneous
and unsubstantiated beliefs that tobacco products other than cigarettes
are either less addictive than cigarettes or are not addictive at all.
For example, in a survey of high school students, 46.3 percent of
participants--83.3 percent of whom were waterpipe users--believed their
product was less addictive and safer than cigarettes (Ref. 90 at 3, 4)
(also citing several additional studies where young adult waterpipe
users reported that their tobacco product was less addictive). Also, in
a qualitative study prepared for Health Canada consisting of smokeless
tobacco, cigars, and pipe users between the ages of 16 and 60 plus,
most large cigar smokers thought that their product was less addictive
than cigarettes or not addictive at all because they smoked for
pleasure or did not smoke daily (Ref. 158 at 1, 40). Small cigar
smokers in this study were split as to whether they believed their
product of choice was addictive (Ref. 158 at 41). While most chewing
tobacco and snuff users tended to believe these products were as
addictive as cigarettes, some believed their chew was not addictive
because the taste was such a turnoff (id.). Not only do these studies
further indicate the need for a warning statement to ensure that
consumers recognize that nicotine is addictive, but they also indicate
that broader education regarding the addictiveness of tobacco products
also may be necessary given that consumers in the Canadian study
incorrectly believed an individual could not be addicted to a product
that he or she ``disliked'' or did not use every day (id.).
    FDA also believes that this warning is necessary to reduce youths'
widely held but erroneous belief that certain tobacco products--those
for which there currently are no warnings regarding addictiveness--are
safe for their use (Ref. 51). Youth believe that they will be able to
stop using tobacco whenever they want to do so (id.). However, because
of the addictiveness of nicotine, they often have great difficulty
doing so. Thus, addiction warnings are particularly important for
youth. Health warnings are currently required for cigarettes and
smokeless tobacco under the Tobacco Control Act. The absence of a
health warning requirement for other tobacco products could reinforce
the existing false sense of security that youth have about the safety
of those products.
    Further, many consumers believe that the use of e-cigarettes will
help them quit smoking, even though this has not been proven by long-
term studies of significant numbers of e-cigarette users, and some
consumers forego proven cessation methods due to those unsubstantiated
beliefs. For example, in the ITC Four-Country Survey, 75.4 percent of
respondents indicated that they used e-cigarettes to help them reduce
their smoking and 85.1 percent reported using e-cigarettes to help them
quit smoking (Ref. 36). In a survey of current and former smokers, 80
percent of respondents reported that they used e-cigarettes to help
them reduce the number of cigarettes they use and 65 percent stated
they used e-cigarettes to try to quit using cigarettes (id.). Section
IV.D discusses the possible reduced usage of cigarettes that may be
associated with e-cigarettes and the limitation of existing studies. We
do not currently have sufficient data about these products to determine
what effects e-cigarettes have on the public health.
2. Alternative Statement for Products Without Nicotine
    The products for which FDA is proposing health warnings under this
rule all contain nicotine. FDA is not aware of any currently marketed
tobacco product that does not contain nicotine. However, in the event
that such products are developed, FDA proposes that manufacturers of
such products submit a certification of that fact (and the fact that
they have the data to support this assertion) to FDA. Products for
which such a certification has been submitted would not contain any
warning that would clearly indicate that it is a tobacco product.
Accordingly, FDA is proposing that such products include the following
alternative statement on their product packages and in their
advertisements: ``This product is derived from tobacco.'' FDA believes
it is important to alert consumers and retailers as to which items are
tobacco products. Even if a tobacco product does not contain nicotine,
it can still contain other addictive chemicals (like anabasine or
nornicotine, discussed in the preamble) or dangerous toxicants.
Therefore, FDA believes consumers should be aware that the product is,
in fact, a tobacco product. In addition, the statement would alert
consumers as to which products would require identification for
purchase and increase retailer awareness of the products for which they
must verify the age of consumers. FDA requests comments on this
alternative statement.
3. Request for Comments Regarding Addictiveness Warning for Certain
Categories of Tobacco Products
    FDA realizes that while all tobacco products are potentially
harmful and potentially addictive, different categories of tobacco
products may have the potential for varying effects on public health.
For example, some have advanced views that certain new tobacco products
that are non-combustible (such as e-cigarettes) may be less hazardous
than combustible products, given the carcinogens in smoke and the
dangers of secondhand smoke. Thus, FDA is seeking comments, including
supporting research, facts, and other evidence, as to whether all
tobacco products should be required to carry the proposed addictiveness
warning and if different warnings should be placed on different
categories of products.
    In addition, we note that this requirement would apply to products
that are derived from tobacco, and not

just products that themselves contain tobacco, based on the definition
of ``tobacco product'' in section 201(rr) of the FD&C Act. As a result,
FDA recognizes that the use of the words ``tobacco product'' in the
warning might be thought to have the potential to confuse consumers.
Accordingly, FDA request comments, including supporting facts,
research, and other evidence regarding the following questions:
     Do the words ``tobacco product'' in this proposed warning
have the potential to cause confusion for consumers? If so, what are
the product types where such a warning could potentially confuse
consumers?
     If there are concerns about the use of the word ``tobacco
product,'' what other language should FDA consider utilizing in this
proposed warning?
     Would such other proposed language still have the ability
to notify consumers that certain products (especially those that look
like candy) are, in fact, tobacco products and potentially harmful and/
or addictive?

D. Age of Initiation for Cigar Smokers

    FDA's proposed warning statements are intended to educate both
youth and adults regarding the dangerous effects of cigar smoking in
order to provide consumers with the information to better understand
the potential consequences of their decisions, and in the case of
youth, to prevent youths from initiating use. There is a common
misconception that young people do not smoke cigars, and it is
therefore unnecessary to warn them of the dangers of cigar smoking
(Ref. 28 at 13). However, as discussed in this document, data show that
a substantial number of young people smoke cigars (defined as cigars,
little cigars, and cigarillos). Each day in the United States, more
than 3,000 youth under age 18 smoke their first cigar (Ref. 81). In
addition, young people who use both cigars and cigarettes are more
likely to be frequent users of both products (Ref. 117 at 647).
Therefore, the proposed warnings are necessary to alert young people to
the dangers of initiating cigar use, as well as to help current cigar
smokers better understand and appreciate the health risks of using
cigars.
    Young adults appear to be particularly interested in cigarillos, as
opposed to large cigars. The close resemblance of small cigars and many
cigarillos to cigarettes have led consumers, particularly children and
young adults, to substitute them for cigarettes (Ref. 160). Researchers
assessing studies designed to measure cigar use have found significant
increases in reported cigar prevalence when they reproduced the studies
but added examples of little cigar and cigarillo brands, indicating
consumer confusion between little cigars and cigarillos on one hand,
and cigarettes on the other, as well as indicating consumer
substitution of little cigars and cigarillos for cigarettes. For
example, researchers re-administered the Youth Risk Behavior Survey to
six Midwestern high schools and included a popular little cigar brand
name to the item measuring cigar use (Ref. 65). When the survey was
initially administered, the local rates of cigar and cigarette use were
consistent with national rates (id.). However, when the cigar item was
modified to include a little cigar brand-specific example, the
percentage of high school students reporting cigar use nearly doubled--
jumping from 12.9 percent to 20.7 percent (Ref. 65). Likewise,
researchers assessing data from the 2009 Virginia Youth Tobacco Survey
found that 57.3 percent of respondents who used a popular brand of
little cigars and cigarillos erroneously reported no general cigar use
(Ref. 66). These findings are consistent with focus group data for
2001, where researchers found that respondents generally (but wrongly)
did not think inexpensive cigarillos or little cigars were ``cigars,''
and where the rate of self-reported cigar use increased by 37.5 percent
once the definition of cigar was clarified (Ref. 161). Moreover, in a
secondary analysis of cigar use by persons aged 18 to 25 from the
National Survey on Drug Use and Health (2002-2008), researchers
determined that the top five cigar brands most frequently smoked by
current cigar users include little cigars or cigarillos (Ref. 162).
    Research also shows that youth may be initiating cigar use as much
as cigarette use. The National Survey on Drug Use and Health found that
of the more than 2.9 million people aged 12 and above who first used
cigars of any type in 2010, nearly 1.1 million (or approximately 37
percent) were under the age of 18 at initiation (Ref. 82). (This
amounts to nearly 3,000 youths initiating cigar use every day.) By
comparison, of the nearly 2.4 million people aged 12 and above who
first used cigarettes in 2010, 1.4 million (or approximately 58.3
percent) were under the age of 18 at initiation (Ref. 82). (This
amounts to 3,800 youths initiating cigarette use each day.) A 2009
study found similar results, reporting that approximately 14 percent of
high school students had smoked cigars at least 1 day during the
previous 30-day period, compared with 19.5 percent who had smoked
cigarettes at least 1 day during the same period (Ref. 167 at 10, 12).
    The Office of Inspector General of the Department of Health and
Human Services (HHS) also published figures in 1999 regarding the
patterns of cigar use. According to their survey, 76 percent of high
school and junior high teens knew other teens about their age who
smoked cigars (Ref. 35 at 4). While most teens' first exposure to
tobacco was with cigarettes, 22 percent of students in this survey
tried cigars first (Ref. 35 at 6). This is of particular concern given
that young people who start as cigar-only users are more susceptible to
becoming future cigarette users than other youth (id.). This report
also notes that manufactured cigars (i.e., most types of small cigars
and cigarillos) are most commonly used by teens due to their ease of
purchase, low cost, sweetened flavors, and pleasant aromas (Ref. 35 at
ii). More recent surveys have confirmed the popularity of small cigars
and cigarillos is due at least in part to the availability of a wide
variety of flavors (Ref. 162 citing Ref. 163; Ref. 164; Ref. 165).
Young consumers appear to view little cigars and cigarillos as being
less expensive and more convenient than large and premium cigars,
contributing to their popularity (Ref. 160).
    In addition, according to the 2001 National Household Survey on
Drug Abuse, the number of younger children initiating cigar use is
beginning to exceed the number of young adults initiating cigar use,
further highlighting the importance of health warnings. From 1965 until
1996, there were more cigar initiates among 18- to 25-year olds than
among 12- to 17-year olds (Ref. 166). Yet, from 1997 to 2000, the
number of new cigars users in the 12- to 17-year old group exceeded the
18- to 25-year-old initiates (id.).
    In some states, cigar smoking among youth may be even more popular
than cigarette smoking. For example, the 2009 Youth Risk Behavior
Surveillance study found that 18 percent of high school boys in
Massachusetts were cigarette smokers and 22 percent were cigar smokers
(Ref. 167 at 66, 72). Similarly, an Ohio survey of 4,335 students
showed cigars to be the most popular tobacco product among high school
students (Ref. 11 at 647). (See also Ref. 164.) These data indicate
that small and large cigars are no longer an ``alternative'' to
cigarette use, but rather they are the most popular tobacco product for
many young people.

E. Proposed Required Warning Statements for Small and Large Cigars

    FDA is proposing five health warning statements for use on all
cigar packages

and in all cigar advertisements. Under Option 1, all cigars would be
required to display these health warning statements. Under Option 2,
only a subset of cigars (i.e., those defined as ``covered cigars,''
which would exclude ``premium'' cigars) would be required to display
these warning statements. The first four warnings (discussed in this
document) are identical to four of the warnings included in the seven
consent orders that the FTC entered into with the largest mass
marketers of cigars. (See, e.g., In re Swisher International, Inc.,
Docket No. C-3964.) FDA is not proposing the fifth FTC warning (Tobacco
Use Increases The Risk Of Infertility, Stillbirth And Low Birth
Weight), because although cigarette smoking has been shown to cause
these health effects and cigar smoke is similar, the Agency is not
aware of studies specifically linking cigars to these reproductive
effects. FDA requests comment on its proposal to require the use of
only four of the five current FTC warnings for cigars.
1. WARNING: Cigar Smoking Can Cause Cancers of the Mouth and Throat,
Even if You Do Not Inhale
    The NCI's Monograph No. 9 provides a comprehensive, peer-reviewed
analysis of the trends in cigar smoking and potential public health
consequences. NCI identified a dose-response relationship for cigar
smoking and oral, laryngeal, pharyngeal, and esophageal cancers,
finding an increased risk of these diseases with greater numbers of
cigars smoked per day and deeper inhalation (Ref. 28 at 120-130). Cigar
smoking can cause cancers of the mouth and throat even for smokers who
do not inhale (id.). As a result, cigar smokers who do not inhale have
disease risks higher than those who have never smoked (Ref. 28 at ii).
FDA believes that a warning regarding these potential health
consequences is necessary because of consumers' widely held, but
erroneous, belief that cigars are safe products if users do not inhale
the smoke (id.).
    ``The data clearly establish cigar smoking as a cause of oral
cancer'' (Ref. 28 at 127). Regular cigar smokers who have never smoked
cigarettes, including those who do not inhale, experience significantly
elevated risks for oral, laryngeal, pharyngeal, and esophageal cancers
(Ref. 28 at ii and Ref. 62 at 738). While former cigarette smokers who
currently smoke cigars are more likely to inhale deeply than cigar
smokers who never smoked cigarettes, ``the mouth and oral cavity are
exposed to the carcinogens in smoke whether the smoke is inhaled or
not'' (Ref. 28 at 120). In addition, cigar smokers, including those who
do not inhale, have a similar risk of mouth and throat cancer as do
cigarette smokers, with an overall risk 7 to 10 times higher than for
those who have never smoked (Ref. 28 at 125). This similarity in risk
is likely due to the similar doses of tobacco delivered directly to the
oral cavity and esophagus by cigars and cigarettes (Ref. 30 at 738).
Likewise, NCI researchers found that the data taken as a whole support
cigar smoking as a cause of laryngeal cancer, noting that the relative
risk for those who smoke five or more cigars per day or who inhale
moderately or deeply approaches the risk for cigarette smokers (Ref. 28
at 130).
    The data also establish cigar smoking as a cause of esophageal
cancer (id.). Cigar smokers, regardless of whether they inhale, receive
a high smoke exposure to the mouth and tongue, and the esophagus is
exposed to the carcinogens of tobacco smoke, which collect on the
mouth's surface and are swallowed with saliva (id.). The risk of
esophageal cancer is several times higher among cigar smokers than
among those who have never smoked, and the relative risk of occurrence
is similar to that for cigarette smokers (id.).
    Several multinational research studies also have noted that cigar
smoking can cause oral cancers and other cancers, even for those who do
not inhale. For example, the European Prospective Investigation into
Cancer and Nutrition (EPIC) examined the effects on cancer incidence
for exclusive cigar smokers, and for cigar smoking in combination with
cigarettes, on 102,395 men from Denmark, Germany, Spain, Sweden, and
the United Kingdom (Ref. 168 at 2402). According to the EPIC study
findings, exclusive cigar smokers who did not inhale had approximately
a two-fold higher risk of lung, upper aerodigestive tract (which
includes oral cavity, pharynx, larynx, and esophagus), and bladder
cancers combined, compared to those who never smoked, and this risk was
six- or seven-fold higher in cigar smokers who inhaled (Ref. 168 at
2405). This increased risk was smallest for smokers who had quit both
cigarettes and cigars in the past and intermediate for those who
switched to only cigars, demonstrating the additional risk associated
with cigar smoking per se (Ref. 168 at 2409). Researchers confirmed a
carcinogenic effect from cigar smoking for upper aerodigestive tract
cancers and found that the risk of these hazards increased with
increased duration of smoking over the smoker's lifespan, increased
intensity per episode, and increased degree of smoke inhalation per
episode (id.).
    Similarly, the WHO International Agency for Research on Cancer
(IARC) published a monograph evaluating the carcinogenic risk to humans
from tobacco smoke and involuntary smoke exposure. The IARC explained:
``Cigar and/or pipe smoking is strongly related to cancers of the oral
cavity, oropharynx, hypopharynx, larynx, and oesophagus, the magnitude
of risk being similar to that from cigarette smoking. These risks
increase with the amount of cigar . . . smoking and with the
combination of alcohol and tobacco consumption'' (Ref. 169 at 1184).
2. WARNING: Cigar Smoking Can Cause Lung Cancer and Heart Disease
    As discussed in this section, research has shown that cigar smoking
can cause lung cancer and heart disease. Yet, national survey data
found that while 46.6 percent of cigar smokers believe smoking is a
high-risk behavior for developing cancer, they exhibit an ``optimistic
bias'' in estimates of their own risk of developing cancer over 20
years--only 8.7 percent consider themselves to be at high risk (Ref. 30
at 737). FDA believes this proposed warning is necessary to help both
consumers who may be considering smoking cigars and current smokers
better understand and internalize these potential (and critical) health
consequences.
a. Lung Cancer
    The evidence clearly establishes that cigar smoking can cause lung
cancer, but the rate of risk varies (Ref. 28 at 119-120 and Ref. 169 at
1180). Like the dose-response relationship apparent from cigar smoking
and mouth and throat cancers, the risk of dying from lung cancer
increases as the number of cigars smoked per day and the depth of
inhalation increase (Ref. 28 at 119-120). Overall lung cancer risk for
cigar smokers also may be similar to the risk for cigarette smokers
once the rates are adjusted for differences in inhalation levels and
quantity of cigars smoked daily (Ref. 28 at 120). For example, cigar
smokers smoking five or more cigars daily with moderate inhalation have
lung cancer risks similar to pack-a-day cigarette smokers (Ref. 28 at
119).
    Former cigarette smokers who currently smoke cigars are more likely
to inhale deeply than cigar smokers who have never smoked cigarettes,
increasing their lung cancer risk (Ref. 28 at 155). Cigarette smokers
who switch to smoking only cigars have lung cancer risks that are lower
than continuing cigarette smokers, but these risks appear to be
substantially greater than for

individuals who have quit smoking altogether (Ref. 28 at 120, 155).
    Likewise, in an analysis of the data from the Cancer Prevention
Study II (a large, long-term study of 1.2 million men and women),
researchers found that the risk of lung cancer mortality was
approximately 5 times higher for men who were current smokers of only
cigars at the start of the 12-year followup study period, compared with
men who never smoked (Ref. 170 at 334). This risk was higher for men
who smoked 3 or more cigars per day, who reported inhaling cigar smoke,
or who had smoked cigars for 25 years or more (id.). Notably, even
cigar smokers who reported that they did not inhale were approximately
three times more likely to die from lung cancer than those who never
smoked (id.).
b. Heart Disease
    Researchers have identified a pattern of elevated rates of coronary
heart disease and aortic aneurysm among cigar smokers who smoke heavily
or inhale deeply. Evidence from the Cancer Prevention Study, Surgeon
General's reports, and international studies further substantiate the
need to provide clear warnings to consumers of the risk of heart
disease associated with smoking cigars.
    The Cancer Prevention Study I (CPS I), which studied nearly 1
million men and women in 25 states, found evidence that the rate of
coronary heart disease increases with an increase in the numbers of
cigars smoked and greater depth of inhalation (Ref. 28 at 144-145).
Researchers also identified a significantly elevated risk of developing
coronary heart disease in those who smoked five or more cigars per day
and exhibited moderate and deep inhalation (id.). Data from CPS I also
suggested that cigar smokers are at an increased risk for aortic
aneurysm, experiencing a risk rate approaching the rate observed for
cigarette smokers (Ref. 28 at 151-152).
    Researchers analyzing data from the Cancer Prevention Study II (CPS
II) also examined death rates due to coronary heart disease related to
cigar smoking. The 1999 analysis looked at approximately 7,000 current
cigar smokers, 7,000 former cigar smokers, and 113,000 men who had
never regularly smoked tobacco to determine the risk of heart disease
for cigar smokers (Ref. 30 at 739). Among men younger than 75 years
old, current cigar smokers experienced a coronary heart disease death
rate about one-third higher than those who had never smoked (id.).
    In the 2010 Surgeon General's report on smoking hazards, titled
``How Tobacco Smoke Causes Disease,'' the Surgeon General found that
for older adult cigar smokers, particularly those who smoke more than
one cigar per day or inhale the smoke, the risk of heart disease is
moderately higher than that for nonsmokers (Ref. 50 at 362). Among the
studies relied upon by the Surgeon General was a study published in the
New England Journal of Medicine involving 17,774 men (1,546 who smoked
cigars and 16,228 who did not) ages 30 to 85 at baseline (from 1964
through 1973), who reported that they had never smoked cigarettes and
did not currently smoke a pipe (Ref. 33 at 1773). The researchers
determined that cigar smoking was associated with a moderate, but
significant, increase in the risk of coronary heart disease (Ref. 33 at
1778-1779).
    International researchers have reached similar conclusions
regarding the impact of cigar smoking on the risk of developing heart
disease. For example, in a study of more than 12,000 Danish people aged
30 and over, which looked at the risk of first acute myocardial
infarction, researchers found highly significant effects related to the
number of cigars used per day and the depth of inhalation of smoke
(Ref. 28 at 143). Another Danish study found the highest rates of
myocardial infarction for smokers of cheroots (a type of cigar) at the
rate of six or more per day, with a relative risk of more than four
times the risk for those who had never smoked (Ref. 28 at 142).
3. WARNING: Cigars Are Not a Safe Alternative to Cigarettes
    Many consumers wrongly believe that cigars are a safe alternative
to cigarettes. As discussed in section V.C, research suggests that
youth perceive cigars in a more positive light than cigarettes and
believe they are less harmful (Refs. 35 and 116). In addition, some
cigar smokers believe that cigars are a safe alternative to cigarettes
(Ref. 117). However, the dangers from cigar smoking are similar in
nature and magnitude to the adverse health effects associated with
cigarette smoking. FDA is proposing this health warning to dispel
consumers' widespread, but false, belief that cigars are a safe
alternative to cigarettes.
    The tobacco smoke from both cigars and cigarettes is carcinogenic
to humans, and the toxicants in cigar smoke may be even more dangerous
than those in cigarette smoke (Ref. 28). The smoke from both tobacco
products is formed largely from the incomplete combustion of tobacco,
resulting in cigar smoke being composed of the same toxic and
carcinogenic constituents as are in cigarette smoke (Ref. 28 at 3). In
addition, the lower porosity of cigar wrappers results in more carbon
monoxide per gram of tobacco burned than with cigarettes, and the
higher nitrate content of cigar tobacco causes higher concentrations of
nitrogen oxides, carcinogenic N-nitrosamines and ammonia (id.). When
bioassayed in animals (i.e., tested in animals to determine its
potency), the tar of cigar smoke has been found to be more carcinogenic
than the tar in cigarette smoke (id.). Data on cigarette smoking and
disease risk are more extensive than the data available for cigars;
however, given the similarities between the composition of cigar and
cigarette smoke, it is reasonable to assume that most of the diseases
caused by inhalation of tobacco smoke from cigarettes can be caused by
inhalation of tobacco smoke from cigars (Ref. 28 at 113). Therefore,
NCI found that ``cigar smoke is as, or more, toxic and carcinogenic
than cigarette smoke; and differences in disease risks produced by
using cigarettes and cigars relate more to differences in patterns of
use, and differences in inhalation, deposition and retention of cigar
smoke than to differences in smoke composition'' (Ref. 28 at 3).
    The mortality rates for cigar smokers also illustrate that cigars
are not a safe alternative to cigarettes. The overall mortality rates
for cigar smokers are higher than rates for those who have never
smoked, although they may be generally lower than the rates observed
for cigarette smokers (Ref. 28 at 112). In addition, the overall
mortality rates for those who inhale approach those rates for cigarette
smokers (Ref. 28 at 110-112). Further, although data on the risk for
those who switch from smoking cigarettes to only cigars are limited,
the existing data suggest that the risk of developing lung cancer for
persons who switch from cigarettes to cigars is substantially higher
than the risk for cigarette smokers who stop smoking all tobacco
products (Ref. 28 at 120). While those who smoke only cigars seem to
have a lower risk of cardiovascular disease than cigarette smokers,
cigarette smokers who switch to cigars often inhale the smoke and thus
are less likely to experience the lower risk of cardiovascular disease
(Refs. 170 and 28 at 145).
4. WARNING: Tobacco Smoke Increases the Risk of Lung Cancer and Heart
Disease, Even in Nonsmokers
    In section VII.E.2, we explain the risk of lung cancer and heart
disease associated with cigar smoke and the need to warn consumers
about these

potential health consequences. Extensive data also exists regarding the
dangers of involuntary exposure to tobacco smoke, including cigar
smoke. Accordingly, FDA proposes to require a warning on cigar packages
and in advertisements to help cigar smokers and potential smokers
understand and appreciate that all tobacco smoke increases the risk of
lung cancer and heart disease for nonsmokers.
    It is well established that secondhand smoke causes premature death
and disease in youth and in adults who do not smoke (see, e.g., Ref.
171 at 11 and Ref. 172 at 83, 104). Adult exposure to secondhand smoke
has immediate adverse effects on the cardiovascular system and can lead
to lung cancer and coronary heart disease (Ref. 171 at 445, 532).
Tobacco smoke contains over 4,000 compounds, and there are more than 50
carcinogens in sidestream and mainstream smoke generated from cigars
(Ref. 28 at 96 and Ref. 171). Mainstream cigar smoke is the smoke that
one draws into his or her mouth from the butt end or mouthpiece of a
cigar; whereas sidestream cigar smoke is the smoke emitted from the
burning cone of a cigar during the interval between puffs (Ref. 28 at
65). The Surgeon General recently reiterated that cigar smoke contains
the same toxic substances as cigarette smoke, with varying
concentrations of these constituents found in different types and sizes
of cigars (Ref. 171 at 362 and Ref. 28 at 17-18). Even though tobacco
users (on average) smoke more cigarettes than cigars, the overall level
of toxicants in secondhand smoke from cigars actually is quantitatively
higher than it is in the secondhand smoke produced from cigarettes
(Ref. 28 at 79). Cigars also produce much higher levels of many indoor
pollutants than do cigarettes (Ref. 28 at iii). The smoke from one
cigar can take 5 hours to dissipate, exposing household members to a
considerable involuntary health risk (Ref. 28 at 163).
a. Lung Cancer and Secondhand Smoke
    More than 50 carcinogens have been identified in sidestream and
secondhand smoke (Ref. 171). Cigar smoke ``tar'' appears to be at least
as carcinogenic as cigarette smoke ``tar'' (id.). Exposure of
nonsmokers to secondhand smoke has been shown to cause a significant
increase in urinary levels of metabolites of tobacco-specific
nitrosamines, a carcinogen that specifically links exposure to
secondhand smoke with an increased risk for lung cancer (Ref. 171 at
65). All cigars produce higher levels of carcinogenic tobacco-specific
nitrosamines per gram in mainstream cigar smoke than cigarettes produce
in mainstream cigarette smoke (Ref. 28 at 75-76). Cigar smoke also
produces measurable amounts of lead and cadmium (Ref. 28 at 75-76).
Little cigars with filter tips and regular cigars contain higher levels
of certain nitrosamines in sidestream smoke than do filtered tip
cigarettes (Ref. 28 at 81).
    The Surgeon General recently reiterated that there was considerable
evidence that certain nitrosamines are major factors in the development
of lung cancer (Ref. 171 at 30). According to the Surgeon General, the
evidence was sufficient to infer a causal relationship between
secondhand smoke exposure and lung cancer among lifetime nonsmokers
(Ref. 171 at 434). Individuals living with smokers had a 20 to 30
percent increase in risk of developing lung cancer from secondhand
exposure (Ref. 171 at 445). Although the data to demonstrate a similar
causal relationship is not available, FDA believes it is reasonable to
expect that cigar smoke would produce similar effects, given that data
from the NCI cigar monograph showed that some carcinogens determined to
cause lung cancer are present at higher levels in cigar smoke than in
cigarette smoke and at comparable levels of other carcinogens linked to
lung cancer (Ref. 28 at 76-93).
b. Heart Disease and Secondhand Smoke
    The proposed health warning statement indicating that tobacco smoke
can cause heart disease is thoroughly supported by the evidence
reiterated in reports from the Surgeon General (as discussed in section
VII.E.2). FDA believes it is reasonable to expect that this finding
would produce similar effects with respect to secondhand cigar smoke
exposure based on the similar smoke profiles for cigars and cigarettes,
the risk of coronary heart disease associated with active cigar
smoking, and the low levels of toxicant exposure that can cause
coronary heart disease (Ref. 171).
    In a 2006 report regarding the health effects of exposure to
secondhand smoke, the Surgeon General concluded that exposure of adults
to secondhand smoke had immediate adverse effects on the cardiovascular
system and caused coronary heart disease (Ref. 171 at 11). Secondhand
smoke increased the risk of coronary heart disease nearly as much as
active heavy smoking. In fact, the estimated increase in risk of
coronary heart disease from exposure to secondhand smoke was 25 to 30
percent above that of unexposed persons (Ref. 171 at 519 and Ref. 83 at
532). Based on these data, the Surgeon General concluded that ``the
evidence is sufficient to infer a causal relationship between exposure
to secondhand smoke and increased risks of coronary heart disease
morbidity and mortality among both men and women'' (Ref. 171 at 15).
The IOM agreed, concluding that there is a causal relationship between
secondhand smoke exposure and cardiovascular disease, as well as a
causal relationship between secondhand smoke exposure and acute
myocardial infarction (Ref. 172 at 219).
    Even a relatively brief exposure to secondhand tobacco smoke can
lead to heart disease, as some studies have demonstrated. The IOM found
there is compelling circumstantial evidence that a relatively brief
exposure to secondhand smoke can bring about an acute coronary event
(Ref. 172 at 220).
    Given that the effects of secondhand smoke on coronary heart
disease are linked to the combustion of tobacco itself, FDA concludes
that exposure to secondhand cigar smoke can cause the same or similarly
dangerous effects as exposure to secondhand cigarette smoke.

VIII. Description of the Proposed Rule

A. Proposed Part 1100--Tobacco Products Subject to FDA Authority

    The proposed rule would add new part 1100 that would describe the
scope of FDA's authority over tobacco products, the requirements that
would apply to tobacco products, applicable definitions, and the
effective date of the rule.
1. Proposed Sec.  1100.1--Scope
    Section 201(rr) of the FD&C Act defines the term ``tobacco
product,'' in part, as any product ``made or derived from tobacco''
that is not a ``drug,'' ``device,'' or combination product under the
FD&C Act. The Tobacco Control Act permitted FDA to use the ``tobacco
product'' authorities in the FD&C Act to regulate cigarettes, cigarette
tobacco, roll-your-own tobacco, and smokeless tobacco automatically
(``This chapter shall apply to all cigarettes, cigarette tobacco, roll-
your-own tobacco, and smokeless tobacco'' (section 901 of the FD&C
Act)). Therefore, the provisions of the FD&C Act applicable to
``tobacco products'' currently apply only to those products.
    Section 901 of the FD&C Act provides that the Secretary of HHS, and
by delegation FDA, has the authority to ``deem'' any other tobacco
products to be subject to the FD&C Act. FDA is exercising this
authority and is

proposing, in Option 1 for proposed Sec.  1100.1 of this rule, to deem
all products meeting the definition of ``tobacco product,'' as defined
in section 201(rr) of the FD&C Act except accessories of a proposed
deemed tobacco product, to be subject to the FD&C Act. Because the
statutory definition of ``tobacco product'' includes ``any component,
part, or accessory'' and FDA has chosen to exclude ``accessory'' from
the scope of the deeming regulation at this time, the provisions of the
FD&C Act related to ``tobacco product'' also would apply to only the
components and parts of the proposed deemed tobacco products.
    To date, FDA has issued and finalized one such implementing
regulation: ``Exemptions From Substantial Equivalence Requirements''
(76 FR 38961, July 5, 2011). Therefore, if this rule is finalized, the
requirements in those regulations would apply to proposed deemed
tobacco products. Proposed deemed tobacco products also would be
covered by the ``Amendments to General Regulations of the Food and Drug
Administration'' rule that became effective on April 14, 2011 (76 FR
12563, March 8, 2011), and the ``Further Amendments to General
Regulations of the Food and Drug Administration to Incorporate Tobacco
Products'' rule that became effective on April 2, 2012 (77 FR 5171,
February 2, 2012) (conforming amendment regulations). Any entity that
manufactures, distributes, imports, or sells the proposed deemed
products is invited to comment on the substantial equivalence and
conforming amendment regulations. In addition, FDA will review existing
guidance documents to determine whether they need to be revised in
light of this rulemaking.
2. Proposed Sec.  1100.2--Requirements
    Option 1 for proposed Sec.  1100.2 would state that cigarettes,
cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and all
other tobacco products, as defined in section 201(rr) of the FD&C Act
except the accessories of such other tobacco products, are subject to
the FD&C Act and its implementing regulations. As previously explained,
FDA currently has authority to regulate cigarettes, cigarette tobacco,
roll-your-own tobacco, and smokeless tobacco with the regulatory tools
provided in the FD&C Act. If this proposed rule is finalized, all other
tobacco products that meet the statutory definition, in addition to
cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless
tobacco, and including the components and parts but not accessories of
such other tobacco products, would be subject to the FD&C Act and its
implementing regulations. Option 2 would limit the type of cigars that
would be subject to the FD&C Act and its implementing regulations. For
Option 2, only those cigars the meet the definition of ``covered
cigar'' would be subject to the FD&C Act and its implementing
regulations. FDA is requesting comments as to whether it is appropriate
to deem premium cigars and how non-combustible novel products like e-
cigarettes should be regulated. (See sections IV.C and IV.D.)
3. Proposed Sec.  1100.3--Definitions
    Option 1 for proposed Sec.  1100.3 would include one definition
that would apply to this part.
    The definition in proposed Sec.  1100.3 is a restatement of the
statutory definition of ``tobacco product'' found in section 201(rr) of
the FD&C Act. FDA proposes to restate the definition of ``tobacco
product'' in two parts: (1) Tobacco product means any product made or
derived from tobacco that is intended for human consumption, including
any component, part, or accessory of a tobacco product (excluding raw
materials other than tobacco used in manufacturing a component, part,
or accessory of a tobacco product) and (2) tobacco product does not
mean an article that is a drug, device, or combination product as those
terms are defined in the FD&C Act. We are repeating the statutory
definition of ``tobacco product'' in this proposed rule for easy
reference for readers of this regulation.
    Option 2 for this section would, in addition to defining ``tobacco
product,'' add definitions for ``cigar'' and ``covered cigar.'' A
``cigar'' would be defined as a tobacco product that also meets two
requirements: (1) It is not a cigarette and (2) it 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 FTC entered
into with the largest mass marketers of cigars. (See, e.g., In re
Swisher International, Inc., Docket No. C-3964.) ``Covered cigar''
would mean any cigar (as defined in Sec.  1100.3), but excluding any
cigar that meets the following requirements: (1) It is wrapped in whole
tobacco leaf; (2) it contains a 100 percent leaf tobacco binder; (3) it
contains primarily long filler tobacco; (4) it is made by combining
manually the wrapper, filler, and binder; (5) it does not have a
filter, tip or non-tobacco mouthpiece and the cap (or crown) of the
cigar is added by hand; (6) it has a retail price (after any discounts
or coupons) of no less than $10 per cigar (adjusted, as necessary,
every 2 years, effective July 1st, to account for any increases in the
price of tobacco products since the last price adjustment); (7) it does
not have a characterizing flavor other than tobacco; and (8) it weighs
more than 6 pounds per 1000. FDA is proposing this definition to limit
the scope of cigars covered under Option 2 by excluding ``premium''
cigars. As discussed earlier, FDA is soliciting comment on how this
proposed rule should apply to cigars.
4. Proposed Effective Date
    The requirements in the FD&C Act that currently apply to
cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless
tobacco became effective: (1) On the date of enactment of the Tobacco
Control Act (i.e., June 22, 2009) (referred to in this document as the
automatic provisions), (2) on deadlines based on or calculated from the
date of enactment of the Tobacco Control Act, or (3) upon issuance of a
guidance and/or rulemaking specified by the Tobacco Control Act.
    Likewise, FDA is proposing that the effective date of parts 1100
and 1140 be the date of publication of a final rule (if this proposed
rule is finalized) plus 30 days. All of the statutory provisions found
in the FD&C Act that currently are in effect for cigarettes, cigarette
tobacco, roll-your-own tobacco, and smokeless tobacco, or will be in
effect as of 30 days after the date of publication of the final rule,
would apply to proposed deemed tobacco products as a matter of law on
this effective date. Provisions that have not yet become effective as
of the date of publication of the final rule, but rather will become
effective when FDA issues a regulation or guidance, would not yet be in
effect for proposed deemed tobacco products (e.g., regulations
implementing section 915(a) of the FD&C Act for testing, reporting, and
disclosure of tobacco product constituents, ingredients, and additives,
including smoke constituents, by brand and subbrand). These provisions
would apply to all tobacco products subject to the FD&C Act (but not to
accessories of a tobacco product) only when the regulation or guidance
required by the statute is issued.
    The final rule publication date plus 30 days was chosen as the
proposed effective date to comply with 5 U.S.C. 553(d) (i.e., the
Administrative Procedure Act requires that a substantive rule provide a
30-day period before its effective date) and to be consistent with the
Tobacco Control Act. Many of the requirements in the FD&C Act became
effective on the date that the Tobacco Control Act was

enacted, such as sections 902 (adulterated tobacco products), 903
(misbranded tobacco products), and 904(b) (ability of FDA to request
the submission of certain documents from tobacco product manufacturers
or importers). See section VIII.A.1 where we discuss the effect of this
rule on implementing regulations and guidance documents that FDA has
already issued that pertain to ``tobacco products.''
5. Proposed Compliance Dates for Certain Provisions
    As described in VIII.A.4, not all of the requirements in the FD&C
Act became effective on the date of enactment of the Tobacco Control
Act. The effective date of some requirements are based on or calculated
from the date of enactment of the Tobacco Control Act, and some
requirements become effective only upon issuance of a guidance and/or
regulation specified by the Tobacco Control Act. For example, section
904(a)(1) of the FD&C Act requires each tobacco manufacturer to submit
an ingredient listing to FDA ``not later than 6 months after the date
of enactment'' of the Tobacco Control Act.
    To avoid confusion, and to provide time for firms to comply with
provisions that require labeling changes or information submissions to
the Agency, FDA is proposing compliance timeframes for certain
provisions. For consistency and fairness, FDA is generally using the
existing dates found in the Tobacco Control Act as a guide for
determining the timeframe for compliance with these provisions. Table
1B of this document lists certain provisions that would be applicable
to proposed deemed tobacco products and the dates on which FDA proposes
to start enforcing compliance with those provisions. FDA is seeking
comment on the proposed compliance dates for the provisions listed in
table 1B.

                                Table 1B--Compliance Dates for Various Provisions
----------------------------------------------------------------------------------------------------------------
            FD&C Act citation                              Provision                        Compliance date
----------------------------------------------------------------------------------------------------------------
903(a)(2)...............................  A tobacco product shall be deemed           24 months after the
                                           misbranded if in package form unless it     issuance of the final
                                           bears a label containing--.                 regulation.
                                          (A) the name and place of business of the
                                           tobacco product manufacturer, packer, or
                                           distributor;
                                          (B) an accurate statement of the quantity
                                           of the contents in terms of weight,
                                           measure, or numerical count;
                                          (C) an accurate statement of the
                                           percentage of the tobacco used in the
                                           product that is domestically grown
                                           tobacco and the percentage that is
                                           foreign grown tobacco; and
                                          (D) the statement required under section
                                           920(a), except that under subparagraph
                                           (B) reasonable variations shall be
                                           permitted, and exemptions as to small
                                           packages shall be established, by
                                           regulations prescribed by the Secretary.
903(a)(3)...............................  A tobacco product is misbranded--if any     Effective date of part
                                           word, statement, or other information       1100 PLUS 1 year.
                                           required by or under authority of this
                                           chapter to appear on the label or
                                           labeling is not prominently placed
                                           thereon with such conspicuousness (as
                                           compared with other words, statements, or
                                           designs in the labeling) and in such
                                           terms as to render it likely to be read
                                           and understood by the ordinary individual
                                           under customary conditions of purchase
                                           and use.
903(a)(4)...............................  A tobacco product is misbranded--(4) if it  Effective date of part
                                           has an established name, unless its label   1100 PLUS 1 year.
                                           bears, to the exclusion of any other
                                           nonproprietary name, its established name
                                           prominently printed in type as required
                                           by the Secretary by regulation.
903(a)(8)...............................  A tobacco product is misbranded--(8)        Effective date of part
                                           unless, in the case of any tobacco          1100 PLUS 1 year.
                                           product distributed or offered for sale
                                           in any State, the manufacturer, packer,
                                           or distributor thereof includes in all
                                           advertisements and other descriptive
                                           printed matter issued or caused to be
                                           issued by the manufacturer, packer, or
                                           distributor with respect to that tobacco
                                           product--(A) a true statement of the
                                           tobacco product's established name as
                                           described in paragraph (4), printed
                                           prominently; and (B) a brief statement
                                           of--(i) the uses of the tobacco product
                                           and relevant warnings, precautions, side
                                           effects, and contraindications; and (ii)
                                           in the case of specific tobacco products
                                           made subject to a finding by the
                                           Secretary after notice and opportunity
                                           for comment that such action is
                                           appropriate to protect the public health,
                                           a full description of the components of
                                           such tobacco product or the formula
                                           showing quantitatively each ingredient of
                                           such tobacco product to the extent
                                           required in regulations which shall be
                                           issued by the Secretary after an
                                           opportunity for a hearing.
904(a)(1) and 904(c)(1).................  (a)(1) REQUIREMENT.--Each tobacco product   Effective date of part
                                           manufacturer or importer, or agents         1100 PLUS 6 months
                                           thereof, shall submit to the Secretary      (products on the market
                                           the following information: (1) Not later    as of the effective date)
                                           than 6 months after the date of enactment   or 90 days before
                                           of the Family Smoking Prevention and        delivery for introduction
                                           Tobacco Control Act, a listing of all       into interstate commerce
                                           ingredients, including tobacco,             (products entering the
                                           substances, compounds, and additives that   market after the
                                           are, as of such date, added by the          effective date).
                                           manufacturer to the tobacco, paper,
                                           filter, or other part of each tobacco
                                           product by brand and by quantity in each
                                           brand and subbrand.
                                          (c) TIME FOR SUBMISSION.--................
                                          (1) IN GENERAL.--At least 90 days prior to
                                           the delivery for introduction into
                                           interstate commerce of a tobacco product
                                           not on the market on the date of
                                           enactment of the Family Smoking
                                           Prevention and Tobacco Control Act, the
                                           manufacturer of such product shall
                                           provide the information required under
                                           subsection (a)..

904(a)(3)...............................  REQUIREMENT.--Each tobacco product          Effective date of part
                                           manufacturer or importer, or agents         1100 PLUS 3 years.
                                           thereof, shall submit to the Secretary
                                           the following information: (3) Beginning
                                           3 years after the date of enactment of
                                           the Family Smoking Prevention and Tobacco
                                           Control Act, a listing of all
                                           constituents, including smoke
                                           constituents as applicable, identified by
                                           the Secretary as harmful or potentially
                                           harmful to health in each tobacco
                                           product, and as applicable in the smoke
                                           of each tobacco product, by brand and by
                                           quantity in each brand and subbrand.
904(a)(4)...............................  REQUIREMENT.--Each tobacco product          Effective date of part
                                           manufacturer or importer, or agents         1100 PLUS 6 months
                                           thereof, shall submit to the Secretary      (current manufacturers)
                                           the following information: (4) Beginning    or 90 days prior to
                                           6 months after the date of enactment of     delivery for introduction
                                           the Family Smoking Prevention and Tobacco   into interstate commerce
                                           Control Act, all documents developed        (new manufacturers).
                                           after such date of enactment that relate
                                           to health, toxicological, behavioral, or
                                           physiologic effects of current or future
                                           tobacco products, their constituents
                                           (including smoke constituents),
                                           ingredients, components, and additives.
905(b), (c), (d), and (h)...............  905(b)--REGISTRATION BY OWNERS AND          If the final rule
                                           OPERATORS.--On or before December 31 of     publishes in the second
                                           each year, every person who owns or         half of the calendar
                                           operates any establishment in any State     year, FDA will designate
                                           engaged in the manufacture, preparation,    a date for owners and
                                           compounding, or processing of a tobacco     operators to register
                                           product or tobacco products shall           that is no later than 6
                                           register with the Secretary the name,       months into the
                                           places of business, and all such            subsequent calendar year.
                                           establishments of that person. If           (The registration date
                                           enactment of the Family Smoking             will be specified in a
                                           Prevention and Tobacco Control Act occurs   draft guidance for
                                           in the second half of the calendar year,    registration.).
                                           the Secretary shall designate a date no    The timeframes for
                                           later than 6 months into the subsequent     paragraphs (c) and (d)
                                           calendar year by which registration under   take effect after the
                                           this subsection shall occur.                date specified for (b)
                                          905(c)--REGISTRATION BY NEW OWNERS AND       occurs.
                                           OPERATORS.--Every person upon first
                                           engaging in the manufacture, preparation,
                                           compounding, or processing of a tobacco
                                           product or tobacco products in any
                                           establishment owned or operated in any
                                           State by that person shall immediately
                                           register with the Secretary that person's
                                           name, place of business, and such
                                           establishment.
                                          905(d)--REGISTRATION OF ADDED
                                           ESTABLISHMENTS.--Every person required to
                                           register under subsection (b) or (c)
                                           shall immediately register with the
                                           Secretary any additional establishment
                                           which that person owns or operates in any
                                           State and in which that person begins the
                                           manufacture, preparation, compounding, or
                                           processing of a tobacco product or
                                           tobacco products.
905(i)(1)...............................  PRODUCT LIST.--Every person who registers   Must submit at the time of
                                           with the Secretary under subsection (b),    initial registration; see
                                           (c), (d), or (h) shall, at the time of      date specified for
                                           registration under any such subsection,     905(b).
                                           file with the Secretary a list of all
                                           tobacco products which are being
                                           manufactured, prepared, compounded, or
                                           processed by that person for commercial
                                           distribution and which have not been
                                           included in any list of tobacco products
                                           filed by that person with the Secretary
                                           under this paragraph or paragraph (2)
                                           before such time of registration. Such
                                           list shall be prepared in such form and
                                           manner as the Secretary may prescribe and
                                           shall be accompanied by--(A) in the case
                                           of a tobacco product contained in the
                                           applicable list with respect to which a
                                           tobacco product standard has been
                                           established under section 907 or which is
                                           subject to section 910, a reference to
                                           the authority for the marketing of such
                                           tobacco product and a copy of all
                                           labeling for such tobacco product;.
                                          (B) in the case of any other tobacco
                                           product contained in an applicable list,
                                           a copy of all consumer information and
                                           other labeling for such tobacco product,
                                           a representative sampling of
                                           advertisements for such tobacco product,
                                           and, upon request made by the Secretary
                                           for good cause, a copy of all
                                           advertisements for a particular tobacco
                                           product; and
                                          (C) if the registrant filing a list has
                                           determined that a tobacco product
                                           contained in such list is not subject to
                                           a tobacco product standard established
                                           under section 907, a brief statement of
                                           the basis upon which the registrant made
                                           such determination if the Secretary
                                           requests such a statement with respect to
                                           that particular tobacco product.
907(a)(1)(B)............................  (B) ADDITIONAL SPECIAL RULE.--Beginning 2   Effective date of part
                                           years after the date of enactment of the    1100 PLUS 2 years.
                                           Family Smoking Prevention and Tobacco
                                           Control Act, a tobacco product
                                           manufacturer shall not use tobacco,
                                           including foreign grown tobacco, that
                                           contains a pesticide chemical residue
                                           that is at a level greater than is
                                           specified by any tolerance applicable
                                           under Federal law to domestically grown
                                           tobacco.
911(b)(2)(A)(i) and (ii)................  911(a)--IN GENERAL.--No person may          Use of ``light,'' ``low,''
                                           introduce or deliver for introduction       and ``mild'' descriptors:
                                           into interstate commerce any modified       Effective date of part
                                           risk tobacco product unless an order        1100 PLUS 1 year (stop
                                           issued under subsection (g) is effective    manufacture); Effective
                                           with respect to such product..              date of part 1100 PLUS 13
                                          911(b)(1)--MODIFIED RISK TOBACCO PRODUCT.--  months (stop
                                           The term 'modified risk tobacco product'    distribution).
                                           means any tobacco product that is sold or
                                           distributed for use to reduce harm or the
                                           risk of tobacco-related disease
                                           associated with commercially marketed
                                           tobacco products..
                                          (2) SOLD OR DISTRIBUTED.--

                                          (A) IN GENERAL.--With respect to a tobacco
                                           product, the term 'sold or distributed
                                           for use to reduce harm or the risk of
                                           tobacco-related disease associated with
                                           commercially marketed tobacco products'
                                           means a tobacco product--
                                          * * *
                                          (ii) the label, labeling, or advertising
                                           of which uses the descriptors light,
                                           mild, or low or similar descriptors; or
                                          * * *
                                          (3) EFFECTIVE DATE.--The provisions of
                                           paragraph (2)(A)(ii) shall take effect 12
                                           months after the date of enactment of the
                                           Family Smoking Prevention and Tobacco
                                           Control Act for those products whose
                                           label, labeling, or advertising contains
                                           the terms described in such paragraph on
                                           such date of enactment. The effective
                                           date shall be with respect to the date of
                                           manufacture, provided that, in any case,
                                           beginning 30 days after such effective
                                           date, a manufacturer shall not introduce
                                           into the domestic commerce of the United
                                           States any product, irrespective of the
                                           date of manufacture, that is not in
                                           conformance with paragraph (2)(A)(ii).
920(a)(1)...............................  (1) REQUIREMENT.--Beginning 1 year after    24 months after the
                                           the date of enactment of the Family         issuance of the final
                                           Smoking Prevention and Tobacco Control      regulation.
                                           Act, the label, packaging, and shipping
                                           containers of tobacco products other than
                                           cigarettes for introduction or delivery
                                           for introduction into interstate commerce
                                           in the United States shall bear the
                                           statement 'Sale only allowed in the
                                           United States'.
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    In most circumstances, the compliance dates FDA is proposing for
the proposed deemed tobacco products are similar to the timeframe in
which cigarettes, cigarette tobacco, roll-your-own tobacco, and
smokeless tobacco manufacturers or importers were required to comply
with the corresponding requirement. For example, the labeling
requirement in section 920(a)(1) of the FD&C Act required the label,
packaging, and shipping containers of tobacco products other than
cigarettes for introduction or delivery for introduction into
interstate commerce in the United States to bear the statement ``sale
only allowed in the United States'' beginning 1 year after the date of
enactment of the Tobacco Control Act. In table 1, the proposed
compliance date for this provision as applied to proposed deemed
tobacco product manufacturers would be 2 years after the effective date
of this rule. FDA is soliciting comments on the proposed compliance
dates in table 1.
6. Proposed Regulatory Approach for Newly Deemed Tobacco Products