concepts from further consideration, and inform a future quantitative
consumer research study (see section VI.E).
    FDA used a photorealistic illustration format for the images rather
than photographs, because this format best allowed depicting specific
features of the health conditions as described by the textual warning
statements. The photorealistic illustration format also facilitated
providing factually accurate images that depict common presentations of
the health conditions in a realistic and objective format devoid of
non-essential elements. Using photorealistic images allowed further
editing and refinements for clarity and ease of understanding
throughout the research and development process for new cigarette
health warnings. A certified medical illustrator developed high
quality, medically accurate, photorealistic images in close
collaboration with FDA staff. After the photorealistic images were
created, FDA paired each textual warning statement (the 9 TCA
statements and the 15 revised statements tested in the first
quantitative consumer research study) with a concordant image for
further testing.
    To do this further testing, FDA evaluated the photorealistic images
through a series of 20 qualitative focus groups with adolescent
smokers, adolescents at risk for starting smoking, and adult smokers
(OMB control number 0910-0796, ``Qualitative Study on Consumer
Perceptions of Cigarettes Health Warning Images''). The focus groups
examined what factual information the images conveyed to participants
about the negative health consequences of cigarette smoking in the
absence of a paired textual warning statement, as well as how
concordant participants considered the images to be when paired with
potential textual warning statements (both TCA

statements and the revised statements). Based on feedback received in
these focus groups, FDA further refined some images for additional
clarity and eliminated other images that were not well understood or
where potential confusion could not be resolved through additional
revisions. FDA then completed final pairings of textual warning
statements and concordant photorealistic images for testing in the
final quantitative consumer research study.
    As noted earlier (see section VI.C), FDA selected a total of 15
textual warning statements for further testing. However, two of the
textual warning statements (fatal lung disease in nonsmokers, COPD)
shared similar concordant images (diseased lungs). To preserve the
option of potentially requiring both warning statements but without
using two similar images, FDA paired an additional concordant image
that tested well in the qualitative focus groups (man with oxygen tank)
with the COPD warning statement for further testing. Therefore, FDA
prepared a total of 16 statement-and-image pairings to test in the
final quantitative consumer research study.

E. FDA's Consumer Research Study on New Cigarette Health Warnings

    Once FDA examined opportunities to promote greater public
understanding of the risks associated with cigarette smoking, developed
potential revised statements to address gaps in public understanding,
tested the revised statements in a consumer research study, and
developed concordant photorealistic images that depict the negative
health consequences of smoking, the Agency prepared a set of 16
cigarette health warnings (statements paired with their concordant
photorealistic images) to be tested in a final consumer research study.
The purpose of the final research study was to assess the extent to
which any of the cigarette health warnings, developed through FDA's
science-based, iterative research process, increase understanding of
the negative health consequences of cigarette smoking. For warnings to
be considered for this proposed rule, FDA decided that a warning tested
in this final consumer research study must demonstrate statistically
significant improvements, as compared to the control condition, on both
the two outcomes of ``new information'' and ``self-reported learning''
(more discussion about the study design, including the control and
outcomes follows).
1. Study Design
    FDA's final research study on new cigarette health warnings was a
three-session internet-based consumer research study using an online
research panel (OMB control number 0910-0866, ``Experimental Study of
Cigarette Warnings''). The study included 9,760 participants,
including: (1) Adolescents (aged 13-17 years) who were current smokers
and those at risk for starting smoking; (2) younger adults (aged 18-24
years) who were current smokers and nonsmokers; and (3) older-adults
(aged 25 years and older) who were current smokers and nonsmokers.
Study participants in all age groups were assigned to a condition that
determined which warnings they viewed during the study. Participants in
the control condition viewed one of the four current Surgeon General's
cigarette warnings. Participants in each of the treatment conditions
viewed one of 16 of the new cigarette health warnings (i.e., text-image
pairings) FDA developed through the process described in sections VI.B-
D. Table 2 provides a list of the 16 textual warning statements (paired
with images) that FDA evaluated in this study.

   Table 2--Text of Cigarette Health Warnings Tested in FDA's Consumer
                             Research Study
------------------------------------------------------------------------
                               Statements
-------------------------------------------------------------------------
WARNING: Cigarettes are addictive.
WARNING: Tobacco smoke can harm your children.
WARNING: Smoking can kill you.
WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.
WARNING: Quitting smoking now greatly reduces serious risks to your
 health.
WARNING: Smoking causes head and neck cancer.
WARNING: Smoking causes bladder cancer, which can lead to bloody urine.
WARNING: Smoking during pregnancy stunts fetal growth.
WARNING: Smoking can cause heart disease and strokes by clogging
 arteries.
WARNING: Smoking causes COPD, a lung disease that can be fatal. [paired
 with an image of diseased lungs]
WARNING: Smoking causes COPD, a lung disease that can be fatal. [paired
 with an image of man with oxygen tank]
WARNING: Smoking reduces blood flow, which can cause erectile
 dysfunction.
WARNING: Smoking reduces blood flow to the limbs, which can require
 amputation.
WARNING: Smoking causes type 2 diabetes, which raises blood sugar.
WARNING: Smoking causes age-related macular degeneration, which can lead
 to blindness.
WARNING: Smoking causes cataracts, which can lead to blindness.
------------------------------------------------------------------------

    All participants viewed their assigned warnings on both a mock
three-dimensional cigarette package that could be rotated on screen and
as part of a mock full-page magazine cigarette advertisement in either
their current (e.g., on the side of the package for the Surgeon
General's warnings) or proposed (e.g., on the top 50 percent of the
front and rear panel of the package for the new cigarette health
warnings) size and location.
    The study took place over three sessions over more than two weeks
for each respondent. During the first session, participants answered
baseline questions about their beliefs about the negative health
consequences of cigarette smoking. Next, they viewed their assigned
warning on both the mock cigarette package and in the mock cigarette
advertisement and answered questions assessing the following outcomes:
     Whether the warning was new information to participants
(``new information);
     Whether participants learned something from the warning
(``self-reported learning'');
     Whether the warning made participants think about the
health risks of smoking (``thinking about risks'');
     Whether the warning was perceived to be informative
(``perceived informativeness'');

     Whether the warning was perceived to be understandable
(``perceived understandability'');
     Whether the warning was perceived to be a fact or opinion
(``perceived factualness'');
     Whether participants reported beliefs linking smoking and
each of the health consequences presented in the warning (``health
beliefs'');
     Whether the warning was perceived to help participants
understand the negative health effects of smoking (``perceived
helpfulness understanding health effects'');
     Whether the warning grabbed their attention
(``attention''); and
     Whether the warning was recalled (``recall'').
    Approximately 1 day later, during the second session, participants
viewed their assigned warning again and answered questions assessing
their beliefs about the negative health consequences of cigarette
smoking. Approximately 14 days after the second session, during the
third session (i.e., a delayed post-test), participants answered
questions about their beliefs about the negative health consequences of
cigarette smoking as well as questions assessing recall of the warning
they viewed.
    More details about the study methodology, including the sample size
calculation and analysis plan, can be found in the study report, which
we have included in this docket (Ref. 153).\9\
---------------------------------------------------------------------------

    \9\ As with the first consumer research study, FDA will conduct
a peer review of this consumer research study. FDA's peer review
plans are available online at https://www.fda.gov/science-research/science-and-research-special-topics/peer-review-scientific-information-and-assessments.
---------------------------------------------------------------------------

2. Study Findings
    The results of the final consumer research study allowed FDA to
draw important conclusions that provide a basis for the cigarette
health warnings included in this proposed rule. Overall, relative to
the average of the Surgeon General's warnings, most of the new
cigarette health warnings were reported to be new information; resulted
in greater self-reported learning; led to thinking about risks; were
higher on perceived informativeness, perceived understandability, and
perceived helpfulness understanding health effects; increased agreement
with accurate health beliefs over time; attracted attention; and were
recalled.
    As discussed above (see section VI.C.3), FDA determined that the
outcomes ``new information'' and ``self-reported learning'' are
predictive for the task of identifying which of the cigarette health
warnings increase understanding of the negative health consequences of
cigarette smoking. Participants were significantly more likely,
relative to the control condition (i.e., the Surgeon General's
warnings), to report that, for 13 of the 16 cigarette health warnings
tested (except for the warnings related to addiction, smoking can kill,
and quitting smoking), the new cigarette health warnings provided new
information and resulted in greater self-reported learning (see Ref.
153, Table 4-1, ``Summary of Results'').
    More details about the full study results can be found in the study
report, which we have included in this docket (Ref. 153).
3. How Study Findings Were Used
    Because the purpose of this final quantitative consumer research
study was to identify which of the cigarette health warnings increase
understanding of the negative health consequences of cigarette smoking,
the study was not designed to put the cigarette health warnings in a
rank order or compare individual results of one cigarette health
warning to another. FDA evaluated the research results for each
individual cigarette health warning to determine which warnings to
include in this proposed rule.
    FDA is including in this proposed rule only the warnings that
demonstrate statistically significant improvements, as compared to the
control condition (i.e., the Surgeon General's warnings), on both the
outcomes of ``new information'' and ``self-reported learning'' (i.e.,
knowledge gain). Following review of the findings of the final
quantitative consumer research study, FDA is proposing 13 cigarette
health warnings that use the following 12 statements:
     WARNING: Tobacco smoke can harm your children.
     WARNING: Tobacco smoke causes fatal lung disease in
nonsmokers.
     WARNING: Smoking causes head and neck cancer.
     WARNING: Smoking causes bladder cancer, which can lead to
bloody urine.
     WARNING: Smoking during pregnancy stunts fetal growth.
     WARNING: Smoking can cause heart disease and strokes by
clogging arteries.
     WARNING: Smoking causes COPD, a lung disease that can be
fatal. [paired with two images] \10\
---------------------------------------------------------------------------

    \10\ As discussed in section VI.D, FDA paired two concordant
images (i.e., diseased lungs, man with oxygen tank) with the COPD
warning statement for final testing. Both text and image pairings
demonstrated statistically significant improvements, as compared to
the control condition (i.e., the Surgeon General's warnings), on
both the outcomes of ``new information'' and ``self-reported
learning'' (i.e., knowledge gain).
---------------------------------------------------------------------------

     WARNING: Smoking reduces blood flow, which can cause
erectile dysfunction.
     WARNING: Smoking reduces blood flow to the limbs, which
can require amputation.
     WARNING: Smoking causes type 2 diabetes, which raises
blood sugar.
     WARNING: Smoking causes age-related macular degeneration,
which can lead to blindness.
     WARNING: Smoking causes cataracts, which can lead to
blindness.
    The cigarette health warnings using the following three statements
did not demonstrate statistically significant improvements, as compared
to the control condition, on the outcomes of ``new information'' and
``self-reported learning'' and therefore are not included as part of
this proposed rule:
     WARNING: Cigarettes are addictive.
     WARNING: Smoking can kill you.
     WARNING: Quitting smoking now greatly reduces serious
risks to your health.

VII. FDA's Proposed Required Warnings

    The initial section 4(d) of the FCLAA, as amended by section 201 of
the Tobacco Control Act, directs FDA to issue ``regulations that
require color graphics depicting the negative health consequences of
smoking'' to accompany the textual warning statements specified in
section 4(a)(1) of the FCLAA. A second section 4(d) of the FCLAA, as
created by section 202(b) of the Tobacco Control Act, permits FDA,
through notice and comment rulemaking, to adjust the format, type size,
color graphics, and text of any of the label requirements if such a
change would promote greater public understanding of the risks
associated with the use of tobacco products. FDA interprets these
provisions of the FCLAA to permit a rulemaking that establishes new
cigarette health warnings and at the same time adjusts the text and
color graphic requirements, including the number of required warnings,
so long as the adjustments promote greater public understanding of the
risks of the use of tobacco products.
    As described in section VI.B, FDA undertook a science-based,
iterative research and development process to consider whether
revisions to the textual warning statements specified in section 4(1)
of the FCLAA would promote greater public understanding of the risks
associated with cigarette smoking. The empirical results

demonstrate sufficient scientific support to adjust the textual warning
statements. Also, as described in section VI.D, FDA carefully developed
and tested concordant color graphics, in the form of photorealistic
images, depicting the negative health consequences of smoking to
accompany each of the textual warning statements included in this
proposed rule. Based on the results of FDA's research, we intend to
finalize some or all of the 13 new cigarette health warnings proposed
in this rule. We invite comment on how many warnings should be selected
for the final rule and whether fewer than, more than, or exactly nine
warnings would advance the Government's interest in promoting greater
public understanding of the negative health consequences of smoking.
    The 13 proposed warnings, each of which consists of a textual
warning statement paired with a concordant photorealistic image
depicting the negative health consequences of smoking, are available in
an electronic PDF in this docket (Ref. 18). For the final rule, the
required warnings will be contained in a document entitled ``Required
Cigarette Health Warnings,'' as is further discussed in section II.C.
    These proposed required warnings, as shown through the robust
scientific evidence described in detail in sections V and VI and in the
remainder of this section, are factual and accurate, advance the
Government's interest, and are not unduly burdensome (see section VIII
for a more detailed discussion). In determining which proposed
cigarette health warnings will be required in the final rule, FDA will
consider public comments submitted to this docket, full research
results from our final quantitative consumer research study (including
peer reviewer comments), scientific literature, and other
considerations as discussed in this proposal.

A. FDA's Proposed Required Warnings

    As discussed above, we assessed whether the new cigarette health
warnings, developed through FDA's science-based, iterative research
process, will advance the Government's interest in promoting greater
public understanding of the negative health consequences of cigarette
smoking. Based on available data and information available to us at
this time, including results from FDA's final consumer research study
(see section VI for a full description of the final consumer research
study) (Ref. 153), we identified 13 cigarette health warnings for this
proposed rule.
    Each of the proposed warnings described in this section
demonstrated statistically significant higher levels of providing new
information and self-reported learning when compared to the control
condition (i.e., the Surgeon General's warnings) (Ref. 153). While the
final consumer research study was designed to measure a range of
outcomes related to consumer understanding, as an initial matter, FDA
is including in this proposed rule only the warnings that demonstrate
statistically significant improvements, as compared to the control
condition (i.e., the Surgeon General's warnings), on both the outcomes
of ``new information'' and ``self-reported learning'' (i.e., knowledge
gain). As described above, the scientific literature demonstrates that
these two outcomes are predictive for the task of assessing which of
the new cigarette health warnings increase understanding of the risks
associated with cigarette smoking. Other study outcomes provide
additional, useful information and are reflected in the study report
(Ref. 153).
    FDA solicits comment on the individual cigarette health warnings
included in this proposal, and we ask that comments provide data and
factual information that would help us to further consider which
proposed warnings to include in the final rule or whether such warnings
should be altered, consistent with the Government's interest, and how.
For additional consideration, the following subsections provide
relevant scientific support for each of the proposed required warnings.
    1. WARNING: Tobacco smoke can harm your children.
    This proposed warning consists of the TCA statement ``WARNING:
Tobacco smoke can harm your children'' paired with a concordant,
factually accurate, photorealistic image depicting a negative health
consequence of secondhand smoke exposure in children. The image shows
the head and shoulders of a young boy (aged 8-10 years) wearing a
hospital gown and receiving a nebulizer treatment for chronic asthma
resulting from secondhand smoke exposure.
    Since 2004, several Surgeon General's Reports have confirmed the
causal link between exposure to secondhand smoke and several negative
health consequences in children, including middle ear disease,
respiratory symptoms, impaired lung function, lower respiratory
illness, and SIDS (Refs. 8, 154, and 155). The 2006 Surgeon General's
Report stated that the evidence is sufficient to conclude--the highest
level of evidence of causal inferences from the criteria applied in the
Surgeon General's Reports--that secondhand smoke exposure from parental
smoking causes the following negative health effects: Lower respiratory
illness in infants and children; middle ear disease in children,
including acute and recurrent otitis media and chronic middle ear
effusion; cough, phlegm, wheeze, and breathlessness among children of
school age, and ever having asthma among children of school age; the
onset of wheeze illnesses in early childhood; persistent adverse
effects on lung function across childhood; and a lower level of lung
function during childhood (Ref. 155). More recently published studies
on the topic support the Surgeon General's Reports' conclusion that
parental secondhand smoke influences child health, particularly
respiratory health (Refs. 156-158).
    2. WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.
    This proposed warning consists of the TCA statement ``WARNING:
Tobacco smoke causes fatal lung disease in nonsmokers'' paired with a
concordant, factually accurate, photorealistic image depicting fatal
lung disease. The image shows gloved hands holding a pair of diseased
lungs containing cancerous lesions from chronic secondhand smoke
exposure.
    The 1986 and subsequent Surgeon General's Reports have confirmed
the causal link between secondhand smoke exposure and lung cancer, a
fatal lung disease, among nonsmokers (Refs.155 and 159). The conclusion
in the 2006 Surgeon General's Report extends to all secondhand smoke
exposure, regardless of location of exposure (e.g., at home, at work,
in other settings); the combined evidence from multiple studies
indicates a 20 to 30 percent increase in the risk of lung cancer from
secondhand smoke exposure associated with living with a smoker (Ref.
155). For example, a meta-analysis of 43 studies, including studies
conducted in both the United States and outside of the United States,
found that the relative risk of lung cancer among nonsmoking women who
live with partners who smoke (i.e., the risk of the lung cancer among
nonsmokers living with smokers compared to nonsmokers not living with
smokers) was 1.29 (Ref. 160). This means that nonsmoking women who live
with partners who smoke have 1.29 times higher risk of lung cancer
compared to nonsmoking women who live with partners who do not smoke.
Recent studies support and extend these conclusions (Refs. 161-164). In
addition to the many lung cancer deaths caused directly by smoking,
researchers

estimate that another 5 percent of all lung cancer deaths, or 7,300
deaths annually (as measured in 2006), can be attributed to secondhand
smoke exposure (Ref. 165).
    3. WARNING: Smoking causes head and neck cancer.
    This proposed warning consists of the revised textual warning
statement ``WARNING: Smoking causes head and neck cancer'' paired with
a concordant, factually accurate, photorealistic image depicting neck
cancer. The image shows the head and neck of a woman (aged 50-60 years)
who has neck cancer caused by cigarette smoking. The woman has a
visible tumor protruding from the right side her neck just below her
jawline.
    Common head and neck cancers include mouth, nose, pharynx, and
larynx. Since 1979, Surgeon General's Report have recognized that
smoking causes head and neck cancers, and the 2004 Surgeon General's
Report stated that the evidence is sufficient to infer a causal
relationship--the highest level of evidence of causal inferences from
the criteria applied in the Surgeon General's Reports--between smoking
and cancers of the oral cavity, pharynx, and larynx (Ref. 154),
building on the strong conclusions of causality from previous reports.
The magnitude of this relationship is substantial--male and female
smokers who currently smoke and have smoked only cigarettes experience
10- and 5-fold higher risk of head and neck cancers than lifetime
nonsmokers, respectively. The 2004 Surgeon General's Report summarized
clinical studies showing that premalignant lesions in the mouth and
throat are most commonly found in areas that have direct contact with
tobacco or smoke and that quitting smoking causes most premalignant
lesions to regress and reduces oral and pharyngeal cancer incidence and
mortality (Ref. 154). In 2015, there were 44,430 new cases of cancer of
the oral cavity and pharynx and 12,292 new cases of cancer of the
larynx (Ref. 166). There were approximately 14,000 deaths from head and
neck cancer in 2016 (approximately 10,000 from cancer of the lip, oral
cavity, and pharynx, and approximately 3,900 from cancer of the larynx)
(Ref. 166). Most head and neck cancers are attributable to smoking,
with almost 70 percent of lip, oral cavity, pharynx, and larynx cancer
deaths from 2000 to 2004 attributable to smoking, representing 7,900
deaths a year (Ref. 30).
    4. WARNING: Smoking causes bladder cancer, which can lead to bloody
urine.
    This proposed warning consists of the revised textual warning
statement ``WARNING: Smoking causes bladder cancer, which can lead to
bloody urine'' paired with a concordant, factually accurate,
photorealistic image depicting bloody urine. The image shows a gloved
hand holding a urine specimen cup containing bloody urine resulting
from bladder cancer caused by cigarette smoking.
    The association between smoking and bladder cancer has been noted
since the first Surgeon General's Report in 1964, and a causal
conclusion was reported in the 1990 report (Refs. 183 and 219). The
2014 Surgeon General's Report again confirmed that the evidence is
sufficient to infer a causal relationship--the highest level of
evidence of causal inferences from the criteria applied in the Surgeon
General's Reports--between cigarette smoking and bladder cancer (Ref.
8). Recent research illustrates that even smoking a few cigarettes per
day is associated with an increased risk of bladder cancer (Ref. 167)
and that low intensity/long duration smoking is particularly associated
with increased bladder cancer risk (Ref. 168). In most cases, blood in
the urine (called hematuria) is the first visible sign of bladder
cancer (Ref. 169), although there are other causes of hematuria. The
number of cases of bladder cancer related to smoking is considerable.
There were 73,000 bladder cancer cases in the United States in 2015 and
16,650 deaths from bladder cancer in 2017 (Ref. 166). According to the
American Cancer Society, 1 in 27 men and 1 in 89 women will develop
bladder cancer during their lifetime (Ref. 170). The Centers for
Disease Control and Prevention (CDC) has estimated that 40 percent of
bladder cancer deaths in 2000 through 2004 were attributable to
smoking, representing almost 5,000 deaths a year (Ref. 30).
    5. WARNING: Smoking during pregnancy stunts fetal growth.
    This proposed warning consists of the revised textual warning
statement ``WARNING: Smoking during pregnancy stunts fetal growth''
paired with a concordant, factually accurate, photorealistic image
depicting a negative health consequence of smoking during pregnancy: An
infant with low birth weight resulting from stunted fetal growth. The
image shows a newborn infant on a medical scale, and the digital
display on the scale reads four pounds.
    The 2004 Surgeon General's Report concluded for the first time that
the evidence was sufficient to infer a causal relationship--the highest
level of evidence of causal inferences based on the criteria applied in
the Surgeon General's Reports--between maternal smoking and fetal
growth restriction and preterm delivery (Ref. 154). The 2004 Surgeon
General's Report summarized many studies that found a consistent and
strong relationship between smoking and reduced birth weight as well as
a strong dose-response relationship between smoking intensity and birth
weight, and the 2010 Surgeon General's Report cited additional studies
further supporting that conclusion (Ref. 171). New studies published
since 2014 further support the causal relation between smoking and
restricted fetal growth (Refs. 172-175).
    In the United States, around eight percent of newborns have low
birth weight each year (Ref. 176). The CDC reported that low birth
weight was twice as common among smoking mothers compared to nonsmoking
mothers in Ohio in a 6-month period in 1989, with 20 percent of cases
of low birth weight among infants during the same period due to
maternal smoking (Ref. 177). Low birth weight was almost 60 percent
more common among mothers who smoked during pregnancy than mothers who
did not in a study in Massachusetts in 1998 (Ref. 32). The California
EPA estimated 24,500 cases of low birth weight due to maternal exposure
to environmental tobacco smoke (i.e., secondhand smoking) in the United
States per year (Ref. 34).
    6. WARNING: Smoking can cause heart disease and strokes by clogging
arteries.
    This proposed warning consists of the revised textual warning
statement ``WARNING: Smoking can cause heart disease and strokes by
clogging arteries'' paired with a concordant, factually accurate,
photorealistic image depicting a patient who recently underwent heart
surgery to treat heart disease caused by smoking. The image shows the
chest of a man (aged 60-70 years) wearing an open hospital gown. The
man has a large, recently-sutured incision running down the middle of
his chest and is undergoing post-operative monitoring.
    Surgeon General's Reports since the 1970s have concluded that
smoking is causally related to heart disease and stroke (Refs. 154 and
178). The 2014 Surgeon General's Report summarized the evidence and
focused on new insights into causal mechanisms gained since the earlier
report (Ref. 8). Coronary heart disease--often simply called heart
disease--is a disorder of the blood vessels of the heart that can lead
to a heart attack. A heart attack happens when an artery becomes
blocked, preventing oxygen and nutrients from getting to the heart.
Stroke occurs when blood supply to part of the brain is interrupted or
reduced, depriving brain

tissue of oxygen and nutrients (Ref. 179). Atherosclerosis, or clogged
arteries, is a disease in which plaque builds up inside the arteries
that carry oxygen-rich blood to the heart and other parts of the body
and can lead to heart attack and stroke through thrombosis, or blockage
of the arteries (Refs. 8 and 179). Most coronary heart disease involves
atherosclerosis, or clogged arteries. The 2004 Surgeon General's Report
concluded that evidence from several different populations, multiple
age groups, and both genders is sufficient to conclude that there is a
causal relationship--the highest level of evidence of causal inferences
from the criteria applied in the Surgeon General's Reports--between
smoking and atherosclerosis and related health conditions such as heart
disease and stroke (Ref. 154). Across many studies over time, a clear
dose-response relationship has been established with smoking more
cigarettes and smoking for a longer time linked to greater risk of
heart disease and stroke. More recent evidence demonstrates that even a
very low frequency of smoking (i.e., even as few as one cigarette per
day) has a measurable increase in the risk for cardiovascular disease
(Ref. 180). The 2004 Surgeon General's Report further concluded that
the evidence is sufficient to infer a causal relationship--the highest
level of evidence of causal inferences from the criteria applied in the
Surgeon General's Reports--between smoking and subclinical (or very
early signs of) atherosclerosis (Ref. 154).
    The public health burden of heart disease and stroke is
considerable. It has been estimated that, in the United States, over 2
million people have had a heart attack during their lifetime and over 1
million have had a stroke during their lifetime due to smoking (Ref.
21). The mortality burden is also substantial. There are approximately
635,000 deaths from heart disease and 140,000 deaths from stroke in the
United States each year (Ref. 181). Recent data showed that the
mortality risk (i.e., the risk of dying) for current smokers compared
to never smokers from heart disease was 2.50 times greater for men and
2.86 times greater for women. The risk of having a stroke was 1.92
times greater for men and 2.10 times greater for women who were current
smokers compared to never smokers (Ref. 182). The proportion of all
deaths from heart attack and stroke due to active smoking is notable--
24.1 percent for heart disease deaths and 11.3 percent for stroke
deaths. This represents approximately 100,000 deaths from heart attack
due to smoking, and 15,000 stroke deaths due to smoking (Ref. 8).
    7. WARNING: Smoking causes COPD, a lung disease that can be fatal.
[image of diseased lungs]
    This proposed warning consists of the revised textual warning
statement ``WARNING: Smoking causes COPD, a lung disease that can be
fatal'' paired with a concordant, factually accurate, photorealistic
image depicting COPD. The image shows gloved hands holding a pair of
diseased, darkened lungs removed from a smoker with COPD. Because a
similar image of diseased lungs was paired with the TCA statement
regarding fatal lung disease in nonsmokers, FDA paired this revised
statement with two different images for final testing (see next
subsection).
    Chronic obstructive pulmonary disease (COPD) includes the diseases
emphysema and chronic bronchitis. The 1964 Surgeon General's Report
concluded that smoking is a primary cause of chronic bronchitis, and
subsequent reports summarized additional evidence to conclude, in the
2004 Surgeon General's Report, at the highest level of evidence of
causal inferences from the criteria applied in the Surgeon General's
Reports, that the evidence is sufficient to infer a causal relationship
between active smoking and COPD morbidity and mortality (Refs. 154,
183, and 184). The 2014 Surgeon General's Report reinforced and
extended this evidence to discuss the relationship between smoking and
COPD mortality (Ref. 8). The 2014 Surgeon General's Report concluded
that the evidence is sufficient to infer--once again, the highest level
of evidence of causal inferences from the criteria applied in the
Surgeon General's Reports--that smoking is in fact the dominant cause
of COPD in the United States (Ref. 8). The report also concluded that
smoking causes all elements of COPD, including emphysema and damage to
the airways of the lung (Ref. 8).
    The public health burden of COPD is substantial. The National
Heart, Lung, Blood Institute estimates that there are 12 million U.S.
adults currently living who have been diagnosed with COPD and another
12 million who have COPD but have not yet been diagnosed (Ref. 185). It
has also been estimated that approximately 7.5 million people currently
living with COPD (whether diagnosed or undiagnosed) have the disease
because of smoking (Ref. 21). The mortality risk from COPD for current
smokers compared to never smokers was 25.61 times higher for men and
22.35 times higher for women, according to 50-year trends published in
the New England Journal of Medicine (Ref. 182). There are about 128,000
COPD deaths in the United States each year, of which 101,000 (79
percent) are attributable to smoking (Ref. 8).
    8. WARNING: Smoking causes COPD, a lung disease that can be fatal.
[image of man with oxygen tank]
    This proposed warning consists of the revised textual warning
statement ``WARNING: Smoking causes COPD, a lung disease that can be
fatal'' paired with a concordant, factually accurate, photorealistic
image depicting a man receiving oxygen support because he has COPD
caused by cigarette smoking. The image shows the head and neck of a man
(aged 50-60 years) who has a nasal canula under his nose supplying
oxygen; the oxygen tank can be seen behind his left shoulder. Because,
based on the findings from previous qualitative testing (see section
VI.D), both this warning statement and the TCA statement regarding
fatal lung disease in nonsmokers were paired with similar images of
diseased lungs (see previous subsection), FDA decided to pair this
revised statement with an additional concordant image for testing in
the final quantitative consumer research study.
    As explained in the previous subsection (``7. WARNING: Smoking
causes COPD, a lung disease that can be fatal. [image of diseased
lungs]''), COPD includes the diseases emphysema and chronic bronchitis.
The 1964 Surgeon General's Report concluded that smoking is a primary
cause of chronic bronchitis, and subsequent reports summarized
additional evidence to conclude, in the 2004 Surgeon General's Report,
at the highest level of evidence of causal inferences from the criteria
applied in the Surgeon General's Reports, that the evidence is
sufficient to infer a causal relationship between active smoking and
COPD morbidity and mortality (Refs. 154, 183, and 184). The 2014
Surgeon General's Report reinforced and extended this evidence to
discuss the relationship between smoking and COPD mortality (Ref. 8).
The 2014 Surgeon General's Report concluded that the evidence is
sufficient to infer--once again, the highest level of evidence of
causal inferences from the criteria applied in the Surgeon General's
Reports--that smoking is in fact the dominant cause of COPD in the
United States (Ref. 8). The report also concluded that smoking causes
all elements of COPD, including emphysema and damage to the airways of
the lung (Ref. 8).
    The public health burden of COPD is substantial. The National
Heart, Lung, Blood Institute estimates that there are

12 million U.S. adults currently living who have been diagnosed with
COPD and another 12 million who have COPD but have not yet been
diagnosed (Ref. 185). It has also been estimated that approximately 7.5
million people currently living with COPD (whether diagnosed or
undiagnosed) have the disease because of smoking (Ref. 21). The
mortality risk from COPD for current smokers compared to never smokers
was 25.61 times higher for men and 22.35 times higher for women,
according to 50-year trends published in the New England Journal of
Medicine (Ref. 182). There are about 128,000 COPD deaths in the United
States each year, of which 101,000 (79 percent) are attributable to
smoking (Ref. 8).
    9. WARNING: Smoking reduces blood flow, which can cause erectile
dysfunction.
    This proposed warning consists of the revised textual warning
statement ``WARNING: Smoking reduces blood flow, which can cause
erectile dysfunction'' paired with a concordant, factually accurate,
photorealistic image depicting a man who is experiencing erectile
dysfunction caused by smoking. The image shows a man (aged 50-60 years)
sitting on the edge of a bed and leaning forward, with one elbow
resting on each knee. The man's head is tilted down, with his forehead
pressed into the knuckles of his right hand. Behind him on the bed, his
female partner looks off in another direction.
    The 2014 Surgeon General's Report concluded, for the first time,
that the evidence is sufficient to infer a causal relationship--the
highest level of evidence of causal inferences from the criteria
applied in the Surgeon General's Reports--between smoking and erectile
dysfunction (Ref. 8). This conclusion is supported by the consistency
of the strength of the association across numerous studies that
evaluated rates of erectile dysfunction among smokers. For example, a
recent meta-analysis of studies that included 50,360 participants found
that smoking more cigarettes and smoking for a longer time were
associated with increased erectile dysfunction risk (Ref. 186).
    Erectile dysfunction is likely under-reported in epidemiological
studies; therefore, the effect estimates observed in studies are likely
an underestimate. However, given that limitation of being under-
reported in studies, at least 20 percent of all men have some degree of
erectile dysfunction (Ref. 187). Among men between the ages of 40 and
70 years, approximately 50 percent have some degree of erectile
dysfunction (Ref. 187). Smokers have been found to have a 40 percent
increased risk of erectile dysfunction in studies such as the Health
Professionals Follow-up Study and the Olmsted County Study of Urinary
Symptoms and Health Status (Refs. 27 and 28).
    10. WARNING: Smoking reduces blood flow to the limbs, which can
require amputation.
    This proposed warning consists of the revised textual warning
statement ``WARNING: Smoking reduces blood flow to the limbs, which can
require amputation'' paired with a concordant, factually accurate,
photorealistic image depicting the feet of a person who had several
toes amputated due to tissue damage resulting from peripheral vascular
disease caused by cigarette smoking.
    Peripheral arterial disease (PAD), also known as peripheral
vascular disease (PVD), is a condition in which narrowed arteries
reduce blood flow to the limbs, especially the legs. Plaque is made up
of fat, cholesterol, calcium, fibrous tissue, and other substances in
the blood. Over time, plaque can harden and narrow the arteries. This
limits the flow of oxygen-rich blood to organs and other parts of the
body. PAD/PVD usually affects the arteries in the legs (Ref. 188).
Complications of PAD/PVD occur because of decreased or absent blood
flow and may include amputation or loss of limb due to tissue not
getting enough oxygen from blood and dying. The 1983 Surgeon General's
Report entitled ``The Health Consequences of Smoking: Cardiovascular
Disease'' summarized evidence regarding smoking and PAD/PVD and
concluded that cigarette smoking is the most powerful risk factor
predisposing to this condition and that smoking cessation plays an
important role in its medical and surgical management (Ref. 189). Since
that time, other Surgeon General's Reports have extended this evidence
base, through the 2014 report (Ref. 8).
    The population health burden of PAD/PVD is substantial. Overall
prevalence of PAD/PVD was found to be 13.5 percent in 2012 in the
Atherosclerosis Risk in Communities study, a multi-site, biracial,
prospective cohort study investigating the causes and clinical effects
of atherosclerosis in four U.S. communities (Ref. 190). A meta-analysis
of studies of PAD/PVD and smoking found that the risk of the condition
was 2.71 times greater for current smokers and 1.67 times greater for
former smokers compared to never smokers (Ref. 26). In its summary of a
recent prospective analysis using the Women's Health Study, which
evaluated the relationships of smoking and smoking cessation with PAD/
PVD, the 2014 Surgeon General's Report showed that risk estimates have
increased over time (Ref. 8). Results from that study found higher
risks than those in the meta-analysis; compared to never smokers, the
risk of PAD/PVD in the Women's Health Study was 3.16 times greater for
former smokers, 11.94 times greater for current smokers reporting less
than 15 cigarettes per day, and 21.08 times greater for current smokers
reporting 15 or more cigarettes per day (Ref. 191).
    One estimate from a review of the scientific literature suggests
that there are between 160,000 and 180,000 amputations due to PAD/PVD
annually in the United States, and, among people with critical limb
ischemia (i.e., a severe blockage of the arteries that greatly reduces
blood flow due to PAD/PVD), 25 percent have amputations each year (Ref.
192). Another article estimates that ``over 90% of all limb amputations
in the Western world occur as a direct or indirect consequence'' of
PAD/PVD (Ref. 193).
    11. WARNING: Smoking causes type 2 diabetes, which raises blood
sugar.
    This proposed warning consists of the revised textual warning
statement ``WARNING: Smoking causes type 2 diabetes, which raises blood
sugar'' paired with a concordant, factually accurate, photorealistic
image depicting a personal glucometer device being used to measure the
blood glucose level of a person with type 2 diabetes caused by
cigarette smoking. The digital display reading of 175 mg/dL and a
notation on the glucometer indicate a high blood sugar level.
    The 2014 Surgeon General's Report concluded, for the first time,
that: (1) The evidence is sufficient to infer--the highest level of
evidence of causal inferences from the criteria applied in the Surgeon
General's Reports--that cigarette smoking is a cause of type 2
diabetes; (2) the risk of developing diabetes is 30 to 40 percent
higher for active smokers than nonsmokers; and (3) there is a
relationship between increased number of cigarettes smoked and
increased risk of developing diabetes (Ref. 8). Across the 25 studies
included in the 2014 Surgeon General's Report updated summary, the
associations were strong and consistent and were found in many
subgroups, and these results have been replicated in many different
study populations and study locations.
    The public health burden of smoking and diabetes is substantial.
The prevalence of diabetes among U.S. adults was estimated to be 12.1
percent in 2005 through 2010 National Health and Nutrition Examination
Survey data (Ref. 194). A meta-analysis of studies

found the risk of type 2 diabetes to be 44 percent greater among
current smokers and 23 percent greater among former smokers compared to
never smokers (Ref. 25). Smoking has been estimated to cause 9,000 of
the 70,810 deaths (12.7 percent) due to diabetes in the United States
each year (Ref. 8).
    12. WARNING: Smoking causes age-related macular degeneration, which
can lead to blindness.
    This proposed warning consists of the revised textual warning
statement ``WARNING: Smoking causes age-related macular degeneration,
which can lead to blindness'' paired with a concordant, factually
accurate, photorealistic image depicting a closeup of an older man
(aged 65 years or older) who has age-related macular degeneration
caused by cigarette smoking. The man is receiving an injection in his
right eye to prevent additional vessel growth.
    Macular degeneration is an incurable eye disease that causes
blindness. The 2014 Surgeon General's Report on cigarette smoking
concluded, for the first time, that the evidence is sufficient to infer
a causal relationship--the highest level of evidence of causal
inferences from the criteria applied in the Surgeon General's Reports--
between cigarette smoking and the two major types of advanced age-
related macular degeneration (Ref. 8). The association is found across
a range of populations and through various study designs. The
prevalence of any macular degeneration among U.S. adults aged 40 years
and older was estimated to be 6.5 percent (Ref. 216). A meta-analysis
found that current smokers were approximately twice as likely (relative
risks for cohort studies of 2.06 and for case-control studies of 2.38),
as never smokers to have macular degeneration (Ref. 23).
    13. WARNING: Smoking causes cataracts, which can lead to blindness.
    This proposed warning consists of the revised textual warning
statement ``WARNING: Smoking causes cataracts, which can lead to
blindness'' paired with a concordant, factually accurate,
photorealistic image depicting a closeup of the face of a man (aged 65
years or older) who has a cataract caused by cigarette smoking. The
man's right pupil is covered by a large cataract.
    A cataract is a clouding of the lens in the eye that affects
vision. Without treatment, the area of clouding of the lens can
increase and eventually leads to blindness. The 2004 Surgeon General's
Report on cigarette smoking concluded that the evidence is sufficient
to infer a causal relationship--the highest level of evidence of causal
inferences from the criteria applied in the Surgeon General's Reports--
between smoking and nuclear cataracts (Ref. 154). A nuclear cataract is
one of the three types of cataracts and refers to the location of the
clouding in the lens of the eye. The epidemiologic studies examined in
the 2004 Surgeon General's Report found generally consistent
associations between smoking and nuclear cataracts, with most studies
reporting that smoking doubled or tripled the relative risk of nuclear
cataracts; in addition, a dose-response relationship was observed as
risk increased with the number of cigarettes smoked (Ref. 154). Data
for other types of cataracts were less strong, and these subtypes are
also less common in the population (Ref. 154). Authors have continued
to identify smoking as a major causal risk factor in the development
and progression of cataracts (Refs. 195-197). Studies of smoking
cessation and risk of cataracts has affirmed that risk decreases, but
is not equivalent to never smokers, upon elimination of the exposures
of tobacco smoke (Ref. 198).
    Prevalence of cataracts among U.S. adults aged 40 years and older
in 2010 was estimated to be 17.1 percent by the National Eye Institute
(Ref. 199). By age 75, more than half of non-Hispanic whites have
cataracts (Ref. 199). A meta-analysis found that the risk of cataracts
was about 50 percent higher for current smokers and 20 percent to 60
percent higher for former smokers compared to never smokers (Ref. 24).

VIII. First Amendment Considerations

    The Government may, consistent with the First Amendment, require
the disclosure of factual information in commercial marketing where the
disclosure is justified by a Government interest and does not unduly
burden protected speech. Zauderer v. Office of Disciplinary Counsel;
Nat'l Inst. of Family and Life Advocates v. Becerra, 138 S. Ct. 2361,
2372 (2018). The proposed new cigarette health warnings, including
their images, fully satisfy those requirements.
    The proposed warnings are factual and accurate. As described in
greater detail in section VI.A above, ``Review of the Negative Health
Consequences of Cigarette Smoking,'' in developing the new warnings,
FDA relied on the 2014 Surgeon General's Report, entitled ``The Health
Consequences of Smoking: 50 Years of Progress'' (Ref. 8), in addition
to previous reports of the Surgeon General and other scientific
literature, which together present a robust body of evidence
documenting the health consequences from both active smoking and
exposure to secondhand smoke across a range of diseases and organ
systems. In particular, Surgeon General's Reports provide definitive
syntheses of the available evidence on smoking and health (Ref. 8, p.
3). Surgeon General's Reports classify the strength of causal
inferences in a four-level hierarchy based upon work of the IOM (now
the National Academy of Medicine) and the IARC (Refs. 200 and 212).
Because of the rigor and consistent application of these causal
standards, the Surgeon General's Reports are the preeminent authority
for determinations of conditions caused by cigarette smoking and by
exposure to secondhand smoke. Every smoking-related condition in every
warning statement that FDA tested is supported at the very highest
level of evidence of causal inferences from the criteria applied in the
Surgeon General's Reports.
    Based upon this research and upon the substantial scientific
literature on the significant gaps and misperceptions in public
understanding of the negative health consequences of smoking (see
section V.A.3 above, ``There Remain Significant Gaps in Public
Understanding About the Negative Health Consequences of Cigarette
Smoking''), FDA developed initial versions of revised statements for
further review, testing, and refinement. These initial revised
statements were further reviewed by FDA internal epidemiological
experts to confirm that the health conditions under consideration were
causally linked to cigarette smoking or exposure to secondhand smoke.
    In parallel with FDA's work to develop and test revised warning
statements, the Agency also undertook an iterative, research-based
approach to develop and test color graphics depicting the negative
health consequences of cigarette smoking to accompany the statements.
As discussed in section VI.D above (``Developing and Testing Images
Depicting the Negative Health Consequences of Smoking to Accompany the
Textual Warning Statements''), FDA used a photorealistic illustration
format for the images because this format best allowed FDA to ensure
that the final images would be fully concordant with the ultimate
textual statements addressing the same health conditions. The
photorealistic illustration format also facilitated providing factually
accurate images that depict common presentations of the health
conditions in a realistic and objective format devoid of non-essential
elements.
    FDA also carefully considered the D.C. Circuit Court findings
regarding the

Agency's 2010-2011 cigarette warning rule, including the court's
statements criticizing the images as having been designed ``to evoke an
emotional response'' with ``inflammatory images and the provocatively-
named hotline.'' R.J. Reynolds Tobacco Co. v. FDA, 696 F.3d at 1216
(D.C. Cir. 2012). The court further found that some of the images
``could be misinterpreted by consumers'' and some did ``not convey any
warning information at all.'' Id. (emphasis omitted) (``For example,
the images of a woman crying, a small child, and the man wearing a T-
shirt emblazoned with the words 'I QUIT' do not offer any information
about the health effects of smoking.''). As discussed below, FDA's
science-based, iterative research process to develop and select the
current proposed cigarette health warnings thoroughly addresses any
such criticisms.
    To ensure that all proposed warnings are unambiguous, are unlikely
to be misinterpreted or misunderstood by consumers, and do convey
warning information, FDA repeatedly tested potential text statements,
potential images, and potential pairings of statements with images. To
assess the 9 statements set out in the TCA and the 17 potential revised
statements that were under consideration at the start of its consumer
research, FDA conducted 16 qualitative focus groups with adolescent
smokers, adolescents at risk for starting smoking, and adult smokers.
As discussed in section VI.B above (``Developing Revised Textual
Warning Statements''), these focus groups provided qualitative feedback
on consumers' comprehension of each potential statement; the
believability of each statement's content (e.g., that smoking causes
the health condition noted); whether the relationship between smoking
and the relevant health conditions was new information for them; and
other feedback to make the statement more understandable or convey the
intended message more clearly.
    This qualitative consumer focus group feedback informed FDA's
selection and refinement of the warning statements for the next phase
of research, a large (2,505 participant) quantitative consumer research
study that tested potential statements on their own, without images.
See details in section VI.C above (``FDA's Consumer Research Study on
Revised Textual Warning Statements'') and in the study results included
in this docket (Ref. 129). Obviating any potential concern that the
proposed new warnings would ``not convey any warning information at
all,'' Reynolds, 696 F.3d at 1216, FDA used the results of this
quantitative research, especially ``self-reported learning'' and ``new
information'' outcomes, to identify the warning statements, to be
paired with accompanying concordant photorealistic images, for testing
in the final quantitative consumer research study.
    FDA's rigorous process for developing the proposed images likewise
obviates any potential concerns of the kind raised in Reynolds that
they might ``not offer any information about the health effects of
smoking'' or be discordant from the text statements with which they are
paired. Id. FDA used different development and research processes to
select and study the images in this rule than it did for the 2010-2011
rulemaking. As discussed above, two of FDA's criteria for images
require them to be factually accurate and to be concordant with the
textual warning statements on the same health condition. FDA sought
repeated consumer feedback to ensure that its proposed images meet
these criteria, including 53 indepth individual interviews with
adolescents and adults, and later on, 20 qualitative focus groups with
adolescent smokers, adolescents at risk for starting smoking, and adult
smokers. Based on feedback received in these focus groups, FDA further
refined some images for additional clarity and identified and
eliminated images that were not well understood or where potential
confusion could not be resolved through additional revisions. See
details in section VI.D above (``Developing and Testing Images
Depicting the Negative Health Consequences of Smoking to Accompany the
Textual Warning Statements''). The Agency took careful and deliberate
steps to develop and test images that are unambiguous and unlikely to
be misinterpreted or misunderstood by consumers. Presenting the health
condition in an objective format devoid of non-essential elements
ensures that the focus of the image remains on the smoking-related
health condition. The process FDA engaged in to develop and study the
warnings was far more extensive than could be completed in the short
timeframe for the prior rule.
    The proposed warnings are clearly justified by the Government's
interest in promoting greater public understanding of the negative
health consequences of cigarette smoking. As the Supreme Court has
recognized, ``tobacco products are dangerous to health when used in the
manner prescribed.'' FDA v. Brown & Williamson Tobacco Corp., 529 U.S.
120, 135 (2000). Indeed, as discussed above, cigarette smoking remains
the leading cause of preventable disease and death in the United
States. Given the magnitude of this public health problem from
cigarette smoking, in the Tobacco Control Act Congress required nine
new health warning statements appear on cigarette packages and in
cigarette advertisements; directed FDA to develop color graphics
``depicting the negative health consequences of smoking'' to accompany
the warning statements; and provided that FDA may adjust the warnings
to ``promote greater public understanding of the risks associated with
the use of tobacco products'' (sections 201 and 202 of the Tobacco
Control Act). In reviewing and upholding the Tobacco Control Act's new
warning requirements, the Sixth Circuit concluded that ``[t]here can be
no doubt that the government has a significant interest in . . .
warning the general public about the harms associated with the use of
tobacco products.'' Disc. Tobacco City & Lottery, Inc. v. U.S., 674
F.3d 509, 519 (6th Cir. 2012).
    FDA's research and review of the scientific literature has
confirmed that many smokers and nonsmokers hold misperceptions about
the health risks associated with cigarette smoking, even among the
health conditions most commonly focused on in health warnings and
public health education campaigns. And studies have shown that
consumers are largely unaware of many of the negative health
consequences of cigarette smoking not mentioned in the current 1984
warnings (see section V.A.3 above, ``There Remain Significant Gaps in
Public Understanding About the Negative Health Consequences of
Cigarette Smoking''). Accordingly, the proposed rule is justified by
the Government's substantial interest in informing consumers regarding
the negative health consequences of smoking.
    Furthermore, the proposed warnings do not unduly burden protected
speech. As the Sixth Circuit held, the Tobacco Control Act's warning
requirement for cigarettes is not unduly burdensome because a
manufacturer has the ability to convey other information of its
choosing in the remaining space available. Disc. Tobacco City &
Lottery, Inc. v. U.S., at 530-31. By statute, the required warnings for
cigarette packages must comprise the top 50 percent of the front and
rear panels, and for advertisements at least 20 percent of the area at
the top of the advertisement. The Sixth Circuit found that ``ample
evidence support[s] the size requirements for the new warnings'' and
``that the remaining portions of their packaging'' are sufficient for
the

companies ``to place their brand names, logos or other information.''
Id. at 531, 567. See also Spirit Airlines, Inc. v. United States Dep't
of Transp., 687 F.3d 403, 414 (D.C. Cir. 2012) (requirement for
airlines to make total price the most prominent cost figure does not
significantly burden airlines' ability to advertise). The scientific
literature strongly supports that larger warnings, such as those of the
size proposed in this rule, are necessary to ensure that consumers
notice, attend to, and read the messages conveyed by the warnings,
which leads to improved understanding of the specific health
consequences that are the subject of those warnings (Refs. 3 and 4).
See discussions above in, e.g., section V.A (``The Current 1984 Surgeon
General's Warnings Are Inadequate''); section V.B.2.a (``Pictorial
cigarette warnings increase knowledge and accurate health beliefs by
addressing gaps in public understanding about the negative health
consequences of smoking''). Accordingly, the proposed warnings are
constitutional under Zauderer.
    Although Zauderer provides the appropriate framework for review,
the rule also satisfies the elements of the test for commercial speech
articulated in Central Hudson Gas & Elec. Corp. v. Pub. Serv. Comm'n.
Under that test, agencies can regulate speech where the regulation
advances a substantial Government interest and the regulation is no
more extensive than necessary. This standard does not require the
Government to employ ``the least restrictive means'' of regulation or
to achieve a perfect fit between means and ends. Board of Trustees v.
Fox, 492 U.S. 469, 480 (1989). Instead, it is sufficient that the
Government achieve a ``reasonable'' fit by adopting regulations ``in
proportion to the interest served.'' Id.
    As discussed above, the Government's interest in informing the
public and correcting misperceptions about the risks of cigarette
smoking is undeniably substantial. See Disc. Tobacco City & Lottery,
Inc., 674 F.3d at 519. The proposed warnings directly and materially
advance the Government's interest by helping consumers understand the
negative health consequences associated with cigarette smoking. As
discussed above, the current 1984 warnings on cigarettes are virtually
invisible and ineffective (see section V.A above, ``The Current 1984
Surgeon General's Warnings Are Inadequate''). FDA has developed new
warnings with new information, in the form of text paired with
concordant images, to promote greater public understanding of the
negative health consequences of smoking. FDA's extensive qualitative
and quantitative consumer research--on potential statements, potential
images, and potential pairings of statements and images--amply
demonstrate that the proposed cigarette health warnings do in fact
promote better understanding by the public of the negative health
effects of smoking. All 13 of the proposed cigarette health warnings
statistically significantly outperformed the control condition (i.e.,
the current 1984 Surgeon General's warnings) on the dimensions of ``new
information'' and ``self-reported learning.'' See discussion above in
sections VI.B (``Developing Revised Textual Warning Statements'')
through VI.E (``FDA's Consumer Research Study on New Cigarette Health
Warnings''), and the consumer research study reports, which we have
included in the docket (Refs. 129 and 153). The warnings selected for
this proposal will advance the Government's interest.
    Finally, the regulation is appropriately tailored to achieve that
result. The warnings relate to the dangers of smoking cigarettes and
will be required on all cigarette packages and advertisements, so there
is nothing over- or underinclusive in the rule's scope. As the Sixth
Circuit held, the size of the warnings is justified by the ample data
demonstrating that larger warnings ``materially affect consumers'
awareness of the health consequences of smoking,'' Disc. Tobacco City &
Lottery, Inc., 674 F.3d at 530, and there is sufficient remaining room
for the manufacturers' speech.
    Accordingly, the proposed rule is constitutionally permissible
under the First Amendment.

IX. Description of the Proposed Rule

    Section 4 of the FCLAA, as amended by sections 201 and 202 of the
Tobacco Control Act, directs FDA to issue regulations requiring color
graphics depicting the negative health consequences of smoking to
accompany textual warning label statements, and permits FDA to adjust
the format, type size, color graphics, and text of any of the label
requirements, or establish the format, type size, and text of any other
disclosures required under the FD&C Act, if such a change would promote
greater public understanding of the risks associated with the use of
tobacco products. This proposed rule would replace part 1141 in Title
21 of the Code of Federal Regulations to implement these FCLAA
requirements. As described in detail in sections VI-VII, the proposed
required warnings are intended to promote greater public understanding
of the negative health consequences of cigarette smoking. We are
seeking comments on these proposed provisions; if you have comments on
specific provisions, we request that you identify the specific
provisions in your comments.

A. General Provisions (Proposed Subpart A)

1. Scope (Proposed Sec.  1141.1)
    As directed by section 4 of the FCLAA, proposed Sec.  1141.1(a)
would explain that proposed part 1141 sets forth the requirements for
the display of required warnings on packages and in advertisements
cigarettes (proposed Sec.  1141.3 includes a definition of cigarette).
These requirements would be applicable to manufacturers, distributors,
and retailers except as described in this proposed section. Retailers
who are also manufacturers would be subject to both the requirements
for retailers and manufacturers, as applicable.
    Proposed Sec.  1141.1(b) provides that the requirements of this
proposed part would not apply to manufacturers or distributors of
cigarettes that do not manufacture, package, or import cigarettes for
sale or distribution within the United States. This proposed subsection
is consistent with section 4(a)(3) of the FCLAA. Manufacturers and
distributors are defined in proposed Sec.  1141.3.
    In addition, retailers would not be in violation of the
requirements of section 4 of the FCLAA and this proposed part for
cigarette packaging that: (1) Contains a warning; (2) is supplied to
the retailer by a license- or permit-holding tobacco product
manufacturer or distributor; and (3) is not altered by the retailer in
a way that is material to 15 U.S.C. 1333 or proposed part 1141 (see
proposed Sec.  1141.1(c)). We believe most, if not all, retailers would
fall under this scenario.\11\ This proposed subsection is consistent
with section 4(a)(4) of the FCLAA. However, this proposed subsection
would require that a retailer ensure that all cigarette packages they
display or sell contain a warning that is unobscured by stickers,
sleeves, or other materials on the packages, for example.
---------------------------------------------------------------------------

    \11\ We note that manufacturers who are also retailers would be
subject to the proposed requirements as manufacturers.
---------------------------------------------------------------------------

    Under proposed Sec.  1141.1(d), the advertisement requirements in
proposed Sec.  1141.10 would apply to a retailer only if the retailer
is responsible for or directs the warnings for advertising.
Importantly, this provision would not relieve a retailer of liability
if the retailer displays in a location open to the public an
advertisement that does

not contain a warning or that contains a warning that has been altered
by the retailer in a way that is material to section 4 of the FCLAA or
the requirements of this proposed part.
    Retailers would be in violation of the FCLAA and this proposed part
if they alter cigarette packaging or advertising in a way that is
material to the requirements of section 4 of the FCLAA or proposed part
1141, for example, by obscuring or covering up the warning (e.g.,
blocking with a sticker or marker), shrinking the warning, or using a
sleeve to cover the warning. Retailers also would be liable if they
display, in a location open to the public, an advertisement that does
not contain a warning (proposed Sec.  1141.1(d)).
2. Definitions (Proposed Sec.  1141.3)
    Proposed Sec.  1141.3 provides the definitions for the terms used
in the proposed rule. Proposed Sec.  1141.3 sets forth the meaning of
terms as they apply to proposed subparts A and B of part 1141. Proposed
Sec.  1141.3 includes the following definitions from the FCLAA (15
U.S.C. 1332):
     Cigarette. As defined in section 3(1) of the FCLAA, the
term ``cigarette'' means: (1) Any roll of tobacco wrapped in paper or
in any substance not containing tobacco and (2) any roll of tobacco
wrapped in any substance containing tobacco which, because of its
appearance, the type of tobacco used in the filler, or its packaging
and labeling, is likely to be offered to, or purchased by, consumers as
a cigarette described in paragraph (1) of this definition.
     Commerce. As defined in section 3(2) of the FCLAA,
``commerce'' means--
    [cir] Commerce between any State, the District of Columbia, the
Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa,
Wake Island, Midway Islands, Kingman Reef, or Johnston Island and any
place outside thereof;
    [cir] Commerce between points in any State, the District of
Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands,
American Samoa, Wake Island, Midway Islands, Kingman Reef, or Johnston
Island, but through any place outside thereof; or
    [cir] Commerce wholly within the District of Columbia, Guam, the
Virgin Islands, American Samoa, Wake Island, Midway Island, Kingman
Reef, or Johnston Island.
     Package or packaging. As defined in section 3(4) of the
FCLAA, ``package'' means a pack, box, carton, or container of any kind
in which cigarettes are offered for sale, sold, or otherwise
distributed to consumers. The proposed rule would use ``packaging''
interchangeably with package.
     Person. As defined in section 3(5) of the FCLAA,
``person'' means an individual, partnership, corporation, or any other
business or legal entity.
     United States. As defined in section 3(3) of the FCLAA,
``United States,'' when used in a geographical sense, includes the
several States, the District of Columbia, the Commonwealth of Puerto
Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway
Islands, Kingman Reef, and Johnston Island. The term ``State'' includes
any political division of any State.
    In addition, FDA proposes the following definitions:
     Distributor. FDA proposes to define ``distributor'' as any
person who furthers the distribution of cigarettes, whether domestic or
imported, at any point from the original place of manufacture to the
person who sells or distributes the product to individuals for personal
consumption. Common carriers are not considered distributors for the
purposes of this proposed part.
    This proposed definition of distributor would be consistent with
the definition of distributor in section 900(7) (21 U.S.C. 387(7)) of
the FD&C Act. FDA believes using this definition would help ensure
consistent understanding of the scope of distributor across tobacco
product regulations issued by FDA. For example, Sec.  1140.3 (21 CFR
1140.3) uses a definition of distributor that is the same as this
proposed definition except that Sec.  1140.3 uses ``tobacco product''
instead of ``cigarette.''
     Front panel and rear panel. FDA proposes to define ``front
panel'' and ``rear panel'' to mean the two largest sides or surfaces of
the package.
    FDA is proposing to include a definition of front and rear panels
because section 4 of the FCLAA, in setting out the placement
requirements for the label statements, provides that each label
statement shall comprise the top 50 percent of the front and rear
panels of the package. This proposed definition would help ensure that
all persons responsible for complying with the FCLAA and this proposed
part identify the sides or surfaces of the cigarette package on which
the required warnings must appear. On almost all cigarette packages,
these two panels are oriented directly opposite from one another and
are the same size.
     Manufacturer. FDA proposes to define ``manufacturer'' as
any person, including any repacker or relabeler, who manufactures,
fabricates, assembles, processes, or labels a finished cigarette
product; or imports any cigarette that is intended for sale or
distribution to consumers in the United States.
     Retailer. FDA proposes to define ``retailer'' as any
person who sells cigarettes to individuals for personal consumption, or
who operates a facility where vending machines or self-service displays
of cigarettes are permitted. This definition would include any person
who sells cigarettes online (e.g., through a website or mobile phone
application).
    The proposed definitions of manufacturer and retailer are similar
to those used in part 1140 (which establishes sale and distribution
restrictions for cigarettes, as well as other tobacco products), but
with some edits to reflect that the scope of this proposed part is
cigarette packaging and advertisements.
3. Incorporation by Reference (Proposed Sec.  1141.5)
    Proposed Sec.  1141.5 would identify the material that FDA proposes
to incorporate by reference in this proposed part, entitled ``Required
Cigarette Health Warnings.'' This section states that FDA is proposing
to incorporate by reference each required warning, consisting of a
textual warning label statement and its accompanying color graphic. Any
final rule would provide information on how to obtain the electronic,
layered design files for each required warning, as well as technical
specifications to help manufacturers appropriately select, crop, and
scale the warnings to ensure the required warnings are accurately
reproduced during implementation across various sizes of cigarette
packaging and cigarette advertisements. This material would be
available for download either through FDA's website or a file transfer
protocol website. For ease of review for this proposed rule, we have
included an electronic PDF file, containing the proposed required
warnings, as a reference in the docket for this proposed rule (Ref.
18).
    As described in section II.C, FDA intends to provide the required
warnings selected for the final rule as electronic, layered design
files and incorporate those by reference. The material incorporated by
reference must meet the OFR's requirements for incorporating material
by reference, and thus the way this material is displayed may be
changed for the final rule to meet such requirements.
    Proposed Sec.  1141.5(a) would identify the material that FDA
proposes to incorporate by reference, ``Required Cigarette Health
Warnings,'' and how to obtain the material from FDA. This material
would include the electronic, layered design files for each required

warning in a range of sizes and aspect ratios, including the textual
statements in English and Spanish, font files, color spaces, the
accompanying color graphics, and the white and black warning
backgrounds and borders. These layered design files would be
accompanied by technical specifications describing how to use the
layered design files to help manufacturers appropriately select, crop,
and scale the warnings to ensure the required warnings are accurately
reproduced during implementation of the required warnings on cigarette
packages and in cigarette advertisements. Manufacturers, distributors,
and, when applicable, retailers would obtain the required warnings by
downloading the files directly from FDA's website or via a file
transfer protocol website and accurately reproduce them on cigarette
packages and in advertisements as required by section 4 of the FCLAA
and proposed part 1141.
    This proposed section would also explain that the material is
incorporated by reference with the approval of the Director of the
Federal Register and where interested parties may obtain a copy of the
material (1 CFR part 51). Specifically, if the proposed incorporation
by reference is approved by the OFR and incorporated in the final rule,
interested parties would be able to examine the incorporated material
at that National Archives and Records Administration and at FDA's
Dockets Management Staff.
    Proposed Sec.  1141.5(b) would list the source where interested
parties may obtain a copy of the incorporated material, i.e., by
contacting FDA's Center for Tobacco Products at the address listed.

B. Required Warnings for Cigarette Packages and Advertisements
(Proposed Sec.  1141.10)

    To promote greater public understanding of the negative health
consequences of cigarette smoking, proposed Sec.  1141.10 would
establish required warnings for cigarette packages and advertising. The
proposed requirements comply with section 4 of the FCLAA and include a
textual warning label statement (proposed Sec.  1141.10(a)(1)) with an
accompanying color graphic (proposed Sec.  1141.10(a)(2)).
    Proposed Sec.  1141.10(a) would establish that a required warning
must contain both one of the textual warning label statements and a
color graphic to accompany the textual warning label statement. The
textual warning label statements that would be required will be set out
in any final rule. As FDA has described in section VI.D, we have
identified concordant color graphics proposed to accompany each textual
warning label statement. FDA invites comment on the proposed textual
warning statements and accompanying color graphics. Given the degree of
public and stakeholder interest in this area, and the legal
complexities involved, FDA also seeks proposals for alternative text
and images you believe would advance the Government's interest in
promoting greater public understanding of the negative health
consequences of smoking. If proposing alternative text and images to
those in this proposed rule, please provide scientific information that
supports that the alternative text and images would, in fact, promote
greater public understanding of the negative health consequences of
smoking. Proposals for alternative images should accompany either one
of FDA's proposed textual warning statements or an alternative textual
warning statement you are proposing. These comments and information
will help inform the required warnings to be included in a final rule.
    Section 4(d) of the FCLAA directs that the required warnings be
clear, conspicuous, and legible. Accordingly, proposed Sec.  1141.10(b)
and (c) are intended to address those FCLAA requirements. Proposed
Sec.  1141.10(b) would require that manufacturers and distributors (and
retailers in the specific circumstances described in proposed Sec.
1141.1(c)) obtain and accurately reproduce the required warning (which
would comprise the combination of the textual warning label statement
and its accompanying color graphic), from the electronic files
contained in the material to be incorporated by reference at proposed
Sec.  1141.5. These entities would be responsible for ensuring that the
required warnings are not distorted, obscured, or otherwise
inaccurately reproduced from the incorporated material when reproduced
for use in differing types of media (e.g., print, digital). For
example, the required warnings would need to be accurately reproduced,
including maintaining text specifications such as font face and size;
using capital letters for the word ``WARNING'' in each statement; and
maintaining the relationship of text to image for each warning. As per
the requirements laid out in section 4 of the FCLAA, the text of the
cigarette health warnings on packages must be black on a white
background, or white on a black background, in a manner that contrasts,
by typography, layout, or color, with all other printed material on the
package.
    Proposed Sec.  1141.10(c) would establish generally that it is
unlawful for any person to manufacture, package, sell, offer to sell,
distribute, or import for sale or distribution within the United States
any cigarette unless the package of which bears a required warning (as
described in proposed Sec.  1141.10(a)) in accordance with section 4 of
the FCLAA and this proposed part. This provision would apply to any
package, including a pack, box, carton, or container, all of which are
included in the definition of package in section 3(4) of the FCLAA.
Thus, in the instance of a carton that contains packs of cigarettes,
the carton and each pack would be required to bear a required warning.
This proposed requirement helps to promote public understanding of the
negative health consequences of cigarette smoking by ensuring that all
cigarette packages bear the required warning.
    In addition, proposed Sec.  1141.10(c)(1) would require that the
warning appear directly on the package and be clearly visible
underneath any cellophane or other clear wrapping. This proposed
requirement is intended to ensure that the warning is not obscured in
any way, e.g., any outer wrapping and tear tape would be required to be
clear and otherwise not interfere with the required warning's
visibility. For packages that are soft-sided (i.e., ``soft pack'' style
packaging), the overwrap closure must not obscure the warning, and, for
hinged lid packages, this would mean that no word of the textual
warning statement may be severed when the package is opened.
    Proposed Sec.  1141.10(c)(2) would implement the requirements in
section 4 of the FCLAA that the required warning comprise at least the
top 50 percent of the front and rear panels of the package. For cartons
(which are included in the definition of package), proposed Sec.
1141.10(c)(2) would specify that the required warning be located on the
left side of the front and rear panels of the carton and comprise at
least the left 50 percent of these panels. This proposed requirement is
intended to ensure that when cigarettes are sold in cartons and not as
individual packs, the required warnings are clearly visible,
conspicuous, and legible to consumers as required by the FCLAA. As
described earlier in this section, the required warning would need to
be on the carton and on each pack to ensure compliance with the FCLAA
and this proposed part.
    Proposed Sec.  1141.10(c)(3) would specify that the required
warning be positioned such that the text of the required warning and
other information on that panel of the package have the same
orientation. For example, if the front panel of a cigarette package
contains information, such as the brand

name of the cigarette, in a left to right orientation, the required
warning could not be placed such that it appears at a right angle to
this text. Rather, the required warning, including the textual warning
label statement, must also appear in a left to right orientation. This
would help ensure that the required warnings on cigarette packages
would be conspicuous and legible to consumers, as required by section 4
of the FCLAA and this proposed part.
    Cigarette advertisements are addressed in proposed Sec.
1141.10(d). This section would establish requirements related to
cigarette advertising, including that it is unlawful for any
manufacturer, distributor, or retailer of cigarettes to advertise or
cause to be advertised within the United States any cigarette unless
each advertisement bears a required warning in accordance with section
4 of the FCLAA and this proposed part. As per the requirements laid out
in section 4 of the FCLAA, the text of the cigarette health warnings in
advertisements must be black if the background is white and white if
the background is black.
    More specifically, for print advertisements and other
advertisements with a visual component, the required warning must
appear directly on the advertisement (proposed Sec.  1141.10(d)(1)).
Advertisements that would be subject to this proposed rule may appear
in or on, for example, promotional materials (point-of-sale or non-
point-of-sale), billboards, posters, placards, published journals,
newspapers, magazines, other periodicals, catalogues, leaflets,
brochures, direct mail, shelf-talkers, display racks, internet web
pages, electronic mail correspondence, and also may include those
communicated via mobile telephone, smartphone, microblog, social media
website, or other communication tool; \12\ websites, applications, or
other programs that allow for the sharing of audio, video, or
photography files; video and audio promotions; and items not subject to
the sale or distribution ban in Sec.  1140.34. Proposed Sec.
1141.10(d)(1) includes some of these examples for reference but neither
the examples in Sec.  1141.10 (d) nor this discussion are intended to
be exhaustive.
---------------------------------------------------------------------------

    \12\ FCLAA prohibits any advertising of cigarettes on radio,
television, or other media regulated by the Federal Communications
Commission.
---------------------------------------------------------------------------

    Proposed Sec.  1141.10(d)(2) would require that the warning
comprise at least 20 percent of the area of the advertisement in a
conspicuous and prominent format and location at the top of each
advertisement, and that no part of the required warning would fall in
the ``trim area'' (i.e., the area of an advertisement that is cut off
as part of the print publishing process). To meet the proposed
requirement, the required warning would need to be in the
advertisement's ``safe area'' (i.e., not in the trim area) and not be
placed in any area of an advertisement that may be cropped or folded
during final publishing. For advertisements in digital media, proposed
Sec.  1141.10(d)(2) would mean that a required warning must be
appropriately scaled in its coding for both standard desktop and mobile
sizes to ensure that the full required warning is visible on the screen
in its entirety (i.e., a user does not need to scroll in any direction
to see any areas of the warning), is located at the top of the screen,
and is displayed at each point of access to such advertisements. These
proposed requirements are consistent with the language of section 4(b)
of the FCLAA, which mandates that the required warning comprise at
least 20 percent of the area of the advertisement and specifies that
the advertisement appear in a conspicuous and prominent format and
location at the top of the advertisement. We recognize that there is a
wide variation in advertisement size and media, and we are requesting
comments and information on how advertisements in different types of
media might comply with these proposed requirements, including comments
on issues related to small-size advertisements, advertisements in
digital media, and non-visual advertisements.
    Proposed Sec.  1141.10(d)(3) would require that the text of the
required warning be in English, with the two exceptions established in
section 3(b) of the FCLAA. First, the text of the required warning
should not be in English when the advertisement appears in a non-
English medium. In that case, the text of the required warning would be
required to appear in the predominant language of the medium regardless
of whether the advertisement is in English (the predominant language is
the primary language used in the non-sponsored content in the
publication). For example, if the predominant language of the medium is
French, but the advertisement is in English, the text of the required
warning would be required to be in French. Second, the text of the
required warning would not need to appear in English when the
advertisement appears in an English language medium but the
advertisement is not in English; in this case, the text of the required
warning would need to appear in the same language as that principally
used in the advertisement. The purpose of the proposed requirement and
the two proposed exceptions in Sec.  1141.10(d)(3) is to help promote
public understanding of the negative health consequences of cigarette
smoking by ensuring that the textual warning label statement component
of the required warning is in the language that is most likely to be
understood by the majority of the public who would view the
advertisement.
    Proposed Sec.  1141.10(d)(4) would state that for English-language
or Spanish-language warnings, each required warning must be obtained
from the electronic files contained in ``Required Cigarette Health
Warnings,'' which would be incorporated by reference (see proposed
Sec.  1141.5). The required warnings would need to be accurately
reproduced as specified in ``Required Cigarette Health Warnings,'' to
help ensure that the required warnings are not distorted or obscured,
and are prominent and legible, consistent with the requirements of the
FCLAA and this proposed part.
    Proposed Sec.  1141.10(d)(5) would require that non-English-
language warnings, other than Spanish-language warnings, be adapted
using the English-language required warnings obtained from the
electronic files contained in ``Required Cigarette Health Warnings,''
which would be incorporated by reference at proposed Sec.  1141.5. As
with the proposed requirement in Sec.  1141.10(d)(4), the required
warnings would be required to be accurately reproduced as specified in
``Required Cigarette Health Warnings,'' but for these warnings this
would also include the substitution and insertion of a true and
accurate translation of the textual warning label statement in place of
the English-language version. The proposed rule would require that the
inserted textual warning label statement comply with all requirements
of section 4 of the FCLAA and this proposed part. The manufacturer,
distributor, or retailer would be required to accurately and
appropriately translate the textual warning label statement into the
appropriate non-English language or the advertisement would be in
violation of the FCLAA and this proposed part. The translated required
warning would also need to meet the area, format, and other
requirements of the FCLAA and this proposed part.
    Proposed Sec.  1141.10(e) would require that the required warnings
be indelibly printed on or permanently affixed to the package or
advertisement. These required warnings, for example, must not be
printed or placed on a label

affixed to a clear outer wrapper that is likely to be removed to access
the product within the package. This provision is intended to ensure
that the required warnings cannot be easily ripped off, obscured, or
otherwise tampered with, which would undermine the proposed
requirement. For an advertisement in digital media to meet this
proposed requirement, the required warning must remain on the
advertisement at all times and be clear, conspicuous, and legible as
required in section 4 of the FCLAA and this proposed part. Thus, for
example, it would not be enough to display the required warning only
for a period of time in an advertisement in digital media. We invite
comments and information on how advertisements in digital media might
appropriately satisfy this proposed requirement.
    Proposed Sec.  1141.10(f) would provide that no person may
manufacture, package, sell, offer for sale, distribute, or import for
sale or distribution within the United States cigarettes whose packages
or advertisements are not in compliance with section 4 of the FCLAA and
this proposed part, except as provided by proposed Sec. Sec.  1141.1(c)
and 1141.1(d).
    Proposed Sec.  1141.10(g) would establish marketing requirements
applicable to cigarettes. The marketing requirements would include the
random and equal display and distribution of the required warnings for
cigarette packages and quarterly rotation of the required warnings in
advertisements. The marketing requirements would also require
submission of a plan that provides for the random and equal display and
distribution of the required warnings on cigarette packaging and the
quarterly rotation of the required warnings in cigarette advertising,
as described under section 4 of FCLAA and part 1141 (referred to as
``plan''). These proposed requirements would ensure that all of the
required warnings would be displayed by the tobacco product
manufacturer, distributor, or retailer at the same time.
    As described in more detail in the following paragraphs, under
proposed Sec.  1141.10(g)(1), each required warning would be required
to be randomly displayed in each 12-month period, in as equal a number
of times as is possible on each brand of the product and the packages
randomly and equally distributed in all areas of the United States in
which the cigarette is marketed. A manufacturer, distributor, or
retailer would be required to submit a plan for random and equal
display and distribution of the required warnings for packaging to FDA
for approval. In addition, proposed Sec.  1141.10(g)(2) would establish
quarterly rotation requirements for the required warnings in
advertisements. Under this proposed requirement, the required warnings
for advertisements must be rotated quarterly in alternating sequence in
advertisements for each brand of cigarettes in accordance with a plan
approved by FDA. The manufacturer, distributor, or retailer would be
required to submit the plan for quarterly rotation of the required
warnings in advertisements to FDA for approval.
    For efficiency of review, each plan submitted under proposed Sec.
1141.10(g)(1) and (2) should cover both packaging and advertising,
rather than submitting each plan separately, to the extent applicable.
The tobacco product manufacturer, distributor, or retailer should
describe how their plan would achieve the random and equal display and
distribution of the required warnings on packages and the quarterly
rotation of the required warnings in advertisements.
    Under proposed Sec.  1141.10(g)(1), for each brand of cigarettes,
the plan for packaging would explain how each of the required warnings
would be randomly displayed during each 12-month period on each brand;
how each of the warnings would be displayed in as equal a number of
times as possible on each brand of the product; and how product
packages would be randomly and equally distributed in all areas of the
United States in which the product is marketed. FDA expects that a plan
for the random and equal display and distribution of required warnings
on packages would ordinarily be based on the date of manufacture or
shipment of the product.
    For each cigarette brand, the plan for advertising would be
required to explain how the required warnings would be rotated
quarterly in advertisements and how the quarterly rotations would occur
in alternating sequence (proposed Sec.  1141.10(g)(2)). Among other
things, the plan should specify the initial rotation timeframe on which
quarterly rotation is based and, if the rotation timeframe varies for
different types/forms of advertising, specify the different quarterly
timeframes associated with the different types/forms of advertising,
and describe the quarterly schedule for rotating each of the required
warnings for each cigarette brand. FDA would not consider a plan that
merely restated the regulatory requirements to be sufficiently detailed
to enable FDA to approve the plan.
    After FDA approval of an initial plan, a supplement to the approved
plan should be submitted to FDA and approved before making changes to
the random and equal display or distribution of required warning
statements on packages or the quarterly rotation of required warning
statements in advertisements. For a new brand, a new plan or a
supplement to an approved plan would be required to be submitted and
approved before displaying or distributing packages and advertisements
for that new brand.
    However, in lieu of a supplement to an approved plan for a new
brand, manufacturers may reference in their initial plan all brands in
their product listing(s) under section 905(i) of the FD&C Act and
incorporate any new brands into their approved plan, so long as no
other changes are made to the plan. For retailer-generated advertising,
retailers may list ``all brands'' in their plan, which would cover
future brands, so long as the plan provides for the same schedule for
quarterly rotation of the required warning statements for all brands.
    Proposed Sec.  1141.10(g)(3) would explain that FDA would review
each plan submitted. FDA's review of a plan would only be for the
purpose of determining compliance with the regulatory criteria for
approval of a plan, as set forth in proposed Sec.  1141.10(g)(1) and
(2). FDA requests that each plan include representative samples of
packages and advertisements with each of the required warnings. Such
samples would place the plan in context and, therefore, facilitate
FDA's review of the plan, not a review of the content of the package
labels and advertisements. During the course of a review of a plan, FDA
may request an amendment to a plan under review if FDA needs
clarification of information in the plan or other additional
information to determine whether FDA could approve the plan.
    As described in proposed Sec.  1141.10(g)(3), FDA intends to
approve the plan if it would: (1) Provide for the random and equal
distribution and display of the required warnings on packaging and the
quarterly rotation of the required warnings in advertising, as set out
in proposed Sec.  1141.10(g)(1) and (2) and (2) assure that all
required warnings would be displayed by the manufacturer, distributor,
or retailer at the same time. Approval of a plan would not represent a
determination by FDA that any specific package or advertisement
complies with any of the other requirements of the FCLAA and proposed
part 1141, including those regarding the placement, font type, size,
and color of the warnings, or any other requirements under the FD&C Act
and

its implementing regulations. FDA intends to communicate the approval
of a plan by issuing a letter to the submitter. After FDA approval of a
plan, if a manufacturer, distributor, or retailer intends to make
changes to the approved plan, they should first submit a supplement to
FDA for review and approval. To provide FDA sufficient time to review a
supplement to an approved plan, FDA strongly recommends allowing up to
6 months for FDA to review and approve a supplement. The amount of time
it would take FDA to review a supplement, however, would depend upon
the volume and quality of the submissions.
    Plans, and any amendments or supplements, should be submitted to
FDA's Center for Tobacco Products, Office of Compliance and
Enforcement. FDA intends to allow electronic submissions, via FDA's
Electronic Submissions Gateway (https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm), and written submissions,
directed to: Food and Drug Administration, Center for Tobacco Products,
Office of Compliance and Enforcement, Document Control Center, Bldg.
71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002.
FDA strongly encourages electronic submission to facilitate efficiency
and timeliness of submission and processing.
    Proposed Sec.  1141.10(g)(4) would establish that each manufacturer
required to randomly and equally display and distribute warnings on
packaging or quarterly rotate the required warnings in advertisements
in accordance with an FDA-approved plan under section 4 of the FCLAA
and this proposed part must maintain a copy of the FDA-approved plan
and make it available for inspection and copying by officers or
employees of FDA. The FDA-approved plan must be retained while in
effect and for a period of not less than 4 years from the date it was
last in effect. FDA has selected 4 years as a means to help ensure that
the FDA-approved plan would be available for at least one biennial FDA
inspection under sections 704 and 905(g) of the FD&C Act. Retaining the
FDA-approved plan for 4 years from the date it was last in effect would
allow FDA to evaluate, for example, whether the warnings are randomly
and equally displayed on product packaging during the time period in
which such products are offered for sale to consumers. In addition,
based on FDA's experience with smokeless plans, FDA has observed at
times in conducting inspections that firms, including contract
manufacturers, have not been aware of the FDA-approved plan that they
should be following. Requiring that the FDA-approved plan is retained
for 4 years from the date it was last in effect would help ensure that
FDA has the opportunity to confirm during the course of an inspection
that firms are aware of and following an approved plan.
    As discussed in section X, FDA intends to establish an effective
date for the submission of plans to FDA, by each person subject to
proposed Sec.  1141.10(g). This would require submission of plans no
later than 5 months from the date of publication of any final rule.
Although FDA believes this timeframe would provide sufficient time for
the plan to be submitted to FDA and reviewed by FDA in advance of the
effective date for the required warnings on packages and advertisements
(which, consistent with section 4 of the FCLAA, would be 15 months from
the publication date of any final rule), we encourage the submission of
these plans as soon as possible once the final rule is published.
    We invite comment on these proposed requirements, including whether
and how the number of final required warnings selected would affect the
random and equal display and distribution of the required warnings on
packages and the quarterly rotation of the required warnings in
advertisements.

C. Misbranding of Cigarettes (Proposed Sec.  1141.12)

    Proposed Sec.  1141.12(a) sets out that a cigarette package would
be deemed misbranded under section 903(a)(1) of the FD&C Act if its
package and labeling do not bear one of the required warnings in
accordance with section 4 of the FCLAA and this proposed part. In
addition, proposed Sec.  1141.12(a) would provide that a cigarette
would be deemed misbranded under section 903(a)(7)(A) of the FD&C Act
if its advertising does not bear one of the required warnings in
accordance with section 4 of the FCLAA and this proposed part.
    Proposed Sec.  1141.12(b) would explain that a cigarette
advertisement and other descriptive printed matter issued or caused to
be issued by the manufacturer, packer, or distributer, would be deemed
to include a brief statement of relevant warnings for the purposes of
section 903(a)(8) of the FD&C Act, if it bears one of the required
warnings in accordance with section 4 of the FCLAA and this proposed
part. However, FDA is proposing that a cigarette distributed or offered
for sale in any State would be deemed misbranded under section
903(a)(8) of the FD&C Act unless the manufacturer, packer, or
distributor includes in all advertisements and other descriptive
printed matter issued or caused to be issued by the manufacturer,
packer, or distributor with respect to the cigarette one of the
required warnings in accordance with section 4 of the FCLAA and this
proposed part. Section 201(a)(1) of the FD&C Act (21 U.S.C. 321(a)(1))
defines ``State'' as ``any State or Territory of the United States, the
District of Columbia, and the Commonwealth of Puerto Rico.'' The
warnings required by section 4 of the FCLAA for cigarette advertising
and packages are ``relevant warnings'' with respect to cigarettes as
that phrase is used in section 903 of the FD&C Act. For the purpose of
this proposed provision, ``other descriptive printed matter'' would
include the packages of cigarettes and would be required to bear one of
the required warnings.

X. Proposed Effective Dates

    FDA is proposing that the required warnings for packages and
advertisements (proposed Sec.  1141.10) would become effective 15
months after the date the final rule publishes in the Federal Register.
This proposed effective date is consistent with the language of section
201(b) of the Tobacco Control Act, which contemplates that the
amendments to the FCLAA established by the Tobacco Control Act would
take effect 15 months after the issuance of the regulations set out in
201(a) of the Tobacco Control Act. FDA is also proposing an effective
date for submission of plans under the FCLAA and this proposed part
(Sec.  1141.10(g)) of no later than 5 months after the final rule
publishes in the Federal Register. This would help ensure that FDA has
time to review the plan in advance of the effective date requiring that
packaging and advertising of cigarettes bear the required warnings.
    Thus, cigarette packages that do not comply with the requirements
of any final rule must not be manufactured for sale or distribution in
the United States as of the effective date (i.e., 15 months after the
date the final rule publishes in the Federal Register). Section 201(b)
of the Tobacco Control Act provides that, beginning 30 days after the
effective date, a manufacturer must not introduce into the domestic
commerce of the United States any product, irrespective of the date of
manufacture, that is not in conformance with section 4 of the FCLAA, as
amended by the Tobacco Control Act. As provided by section 201(b),
after the 30-day period, manufacturers would not be permitted

to introduce into domestic commerce any cigarette packages that do not
contain the required warnings, irrespective of the date of manufacture.
While this statutory limitation applies to only manufacturers, FDA
believes that keeping products without the required warnings under any
final rule on the market for an extended period would not be in the
interest of public health. We request comments regarding ways to
differentiate cigarette packages sold from existing inventory from
those that were manufactured after the effective date.
    In addition, as of 15 months from the publication of any final rule
mandating that cigarette packages and advertisements bear the required
warnings, no tobacco product manufacturer, distributor, or retailer of
cigarettes may advertise or cause to be advertised within the United
States any cigarette product unless the advertising complies with the
final rule.

XI. Severability and Other Considerations

    In accordance with section 5 of the Tobacco Control Act, the
various requirements established by this proposed rule, when finalized,
would be considered severable and the individual provisions of this
rule would be considered workable on their own. Section 5 of the
Tobacco Control Act states that, if any provision of a regulation
issued under the Act is held to be invalid, the remainder of the
regulation ``shall not be affected and shall continue to be enforced to
the fullest extent possible.'' (Section 5 of the Tobacco Control Act is
codified at 21 U.S.C. 387 note.) Consistent with that directive, it is
FDA's intent that the invalidity of any provision of the final rule
shall not affect the validity of any other part of the rule. In the
event any court or other lawful authority were to temporarily or
permanently invalidate, restrain, enjoin, or suspend any provision of
the final rule, FDA intends for the remaining parts to continue to be
valid.
    Each provision of the proposed rule is independently supported by
data and analysis as described or referenced in this preamble and, if
issued separately, would remain a proper exercise of FDA authority
under sections 201 and 202 of the Tobacco Control Act and sections 701,
704, 903, 905(g), and 909 of the FD&C Act, as amended by the Tobacco
Control Act. If a court were to invalidate some but not all of the
images within the cigarette health warnings, the corresponding textual
warning statements would go into effect without the invalidated images,
along with the remaining cigarette health warnings that pair a textual
warning statement with an image. The remaining pairings and the textual
warning statements without images would still be required to be
randomly and equally displayed and distributed on packages and
quarterly rotated in advertisements. This approach would advance the
Government's interest in promoting greater public understanding of the
negative health consequences of smoking.
    In the event that a court were to invalidate all of the images
within the cigarette health warnings, FDA intends for all the warnings
to go into effect with only their textual warning statements, without
the invalidated images. These too would be randomly and equally
displayed and distributed on packages and quarterly rotated in
advertisements as required. FDA believes this approach could serve as
an interim measure to address Congress's intent to replace the stale
Surgeon General's warnings and to promote greater public understanding
of the negative health consequences of smoking while FDA worked to
develop new pictorial warnings.
    If a court were to invalidate some of FDA's revised textual
warnings with their paired images but some remained valid, FDA intends
that the remaining revised textual warning statements and their paired
images would go into effect. Alternatively, FDA might also choose to
require that the textual warning statements specified in section 4(1)
of the FCLAA go into effect without an accompanying image. In
determining the appropriate approach, relevant circumstances could
include whether there were a sufficient number of warnings to be
randomly and equally displayed and distributed on packages and
quarterly rotated in advertisements as required by statute. As
described above, FDA proposes implementing text-only cigarette health
warnings as an interim measure as a means to address Congress's intent
to replace the stale Surgeon General's warnings and to promote greater
understanding of the negative health consequences of smoking while FDA
worked to develop new pictorial warnings.
    FDA invites public comment on the application of the severability
provision in section 5 of the Tobacco Control Act to this rulemaking
and how any severed portions of a final rule would operate, advance the
Government's interest, and address Congress's intent to replace the
stale 1984 Surgeon General's warnings. FDA also seeks comment on
whether additional codified language should be added for any of the
scenarios described in this section.
    FDA further requests public comment, in the event a court were to
invalidate all of the images within the cigarette health warnings or
were to vacate this rule once finalized, as to whether and how FDA
should implement textual warning statements without images as an
interim measure. Additionally, FDA requests comment on whether, in the
event that a court were also to invalidate the size or location of
revised cigarette warnings as directed by Congress (i.e., for packages,
at least the top 50 percent of the front and rear panels of the
packages), it should require that such interim textual warning
statements comprise, for example, at least the top 30 percent of the
front and rear panels of the packages, consistent with warnings for
other categories of tobacco products that are comprised of textual
statements only, while FDA sought to develop new pictorial warnings.

XII. Preliminary Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive
Order (E.O.) 12866, E.O. 13563, E.O. 13771, the Regulatory Flexibility
Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess
all costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). E.O. 13771 requires that the costs associated with significant
new regulations ``shall, to the extent permitted by law, be offset by
the elimination of existing costs associated with at least two prior
regulations.'' We believe that this proposed rule is an economically
significant regulatory action as defined by E.O. 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. We estimate that for a small manufacturer or importer who
would be affected by this proposed rule, one-time costs could represent
between 2.5 and 35.6 percent of their annual receipts and recurring
costs could represent from 0.4 to 4.4 percent of their annual receipts.
Hence, we find that the proposed rule will have a significant economic
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which

includes an assessment of anticipated costs and benefits, before
proposing ``any rule that includes any Federal mandate that may result
in the expenditure by State, local, and tribal governments, in the
aggregate, or by the private sector, of $100,000,000 or more (adjusted
annually for inflation) in any one year.'' The current threshold after
adjustment for inflation is $154 million, using the most current (2018)
Implicit Price Deflator for the Gross Domestic Product. This proposed
rule would result in an expenditure in any year that meets or exceeds
this amount.
    This proposed rule would require that one of up to 13 new cigarette
health warnings, each comprising a textual warning statement paired
with an accompanying color graphic image, appear on cigarette packages
and in cigarette advertisements. The proposed rule would further
require that, for cigarette packages, the required cigarette health
warnings be randomly displayed in each 12-month period, in as equal a
number of times as is possible on each brand of the product and be
randomly distributed throughout the United States in accordance with a
plan approved by FDA. The proposed rule would also require that, for
cigarette advertisements, the required cigarette health warnings must
be rotated quarterly in alternating sequence in advertisements for each
brand of cigarettes in accordance with a plan approved by FDA.
    Pictorial cigarette health warnings promote greater public
understanding about the negative health consequences of smoking as they
increase the noticeability of the warning's message, increase knowledge
and learning of the negative health consequences of smoking, and
benefit diverse populations that have disparities in knowledge about
the negative health consequences of smoking.
    The direct economic benefits of providing information on cigarette
health warnings are difficult to quantify, and we do not predict the
size of these benefits at this time. We discuss the informational
effects qualitatively.
    The cost of this proposed rule consists of initial and recurring
labeling costs associated with changing cigarette labels to accommodate
the new cigarette health warnings, design and operation costs
associated with the random and equal display and distribution of
required cigarette health warnings for cigarette packages and quarterly
rotations of the required warnings for cigarette advertisements,
advertising-related costs, and costs associated with government
administration and enforcement of the rule. Using a 20-year time
horizon, we estimate that the present value of the costs of this
proposed rule ranges from $1.3 billion to $1.9 billion, with a mean
estimate of $1.6 billion, using a three percent discount rate, and
ranges from $1.0 billion to $1.5 billion, with a mean estimate of $1.2
billion, using a seven percent discount rate (2018$). Annualized costs,
which are presented below in table 3, range from $88.6 million per year
to $129.7 million per year, with a mean estimate of $107.5 million per
year, using a three percent discount rate, and range from $94.6 million
per year to $139.8 million per year, with a mean estimate of $115.3
million per year, using a seven percent discount rate (2018$).
    Because it is not possible to compare benefits and costs directly
when the benefits are not quantified, we employ a break-even approach.
If the information provided by the cigarette health warning on each
cigarette package was valued at about $0.01 (for every pack sold
annually nationwide), then the benefits that would be generated by the
proposed rule would equal or exceed the estimated annual costs.

                                      Table 3--Summary of the Informational Effects and Costs of the Proposed Rule
                                                                 [in millions of 2018$]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                                     Primary        Low          High    ---------------------------------------------
                                     Category        estimate     estimate     estimate       Year       Discount                            Notes
                                                                                dollars        rate      Period  covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Informational Effects.........  .................    Pictorial cigarette health warnings promote greater public understanding about the negative health
                                                       consequences of smoking as they increase the noticeability of the warning's message, increase
                                                    knowledge and learning of the negative health consequences of smoking and help reduce disparities in
                                                       knowledge about the negative health consequences of smoking across diverse populations. If the
                                                     information provided by the cigarette health warning on each cigarette package was valued at about
                                                     $0.01 (for every pack sold annually nationwide), then the benefits that would be generated by the
                                                                      proposed rule would equal or exceed the estimated annual costs.
                                                  ------------------------------------------------------------------------------------------------------
Costs.........................  Annualized              $115.3        $94.6       $139.8         2018           7%  20 Years.........  Effective date of
                                 Monetized                                                                                15 months from
                                 $millions/year.                                                                                date of
                                                                                publication of
                                                                                final rule.
                                                         107.5         88.6        129.7         2018           3%  20 Years.........
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In line with E.O. 13771, in table 4 we estimate present and
annualized values of costs and cost savings over an infinite time
horizon. Based on these costs, when finalized this proposed rule would
be considered a regulatory action under E.O. 13771.

                    Table 4--E.O. 13771 Summary Table
          [in millions of 2016$, over an infinite time horizon]
------------------------------------------------------------------------
                                                                Primary
                             Item                               estimate
                                                                  (7%)
------------------------------------------------------------------------
Present Value of Costs.......................................     $985.8
Present Value of Cost Savings................................          0
Present Value of Net Costs...................................      985.8
Annualized Costs.............................................       69.0
Annualized Cost Savings......................................          0
Annualized Net Costs.........................................       69.0
------------------------------------------------------------------------
Notes: All amounts have been discounted relative to year 2016 from year
  2021, the latter of which is the estimated year in which the proposed
  rule would become effective once finalized. Because of this additional
  discounting step, the present value estimates presented here are in
  all instances lower than the comparable present value estimates
  associated with a 20-year time horizon. Effective date is 15 months
  from date of publication of the final rule.

    We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
preliminary analysis of economic impacts is available in the docket for
this proposed rule (Ref. 220) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

XIII. Analysis of Environmental Impact

    The labeling regulation is a class of actions that are ordinarily
categorically excluded under 21 CFR 25.30(k). Additionally, the
proposed action is not anticipated to pose serious harm to the
environment and to adversely affect a species or the critical habitat
of a species as stipulated under 21 CFR 25.21(b). The proposed action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. No extraordinary
circumstances exist that would require a preparation of an
environmental assessment or an environmental impact statement.

XIV. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that
are subject to review by OMB under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). A description of these provisions is given in
the Description section immediately below, with an estimate of the
annual reporting and recordkeeping burden. Included in the estimate is
the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
    FDA invites comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Title: Required Warnings for Cigarette Packages and Advertisements
    Description: The requirement for submission of plans for cigarette
packages and advertisements, and the specific marketing requirements
relating to the random and equal display and distribution of required
warning statements on cigarette packaging and quarterly rotation of
required warning statements in alternating sequence in cigarette
product advertising, appear in proposed Sec.  1141.10(d)(5). A record
of the FDA-approved plan must also be established and maintained.
    Description of Respondents: The respondents to this collection of
information are manufacturers, distributors, and certain retailers of
cigarettes who will be required to submit plans for cigarette packages
and advertisements to FDA.
    FDA intends to ask that each plan cover both packaging and
advertising to the extent applicable. The tobacco product manufacturer,
distributor, or retailer should demonstrate how they plan to achieve
the random and equal display and distribution of the required warning
statements on packages and the quarterly rotation in advertisements.
Required warnings for cigarettes must be randomly and equally displayed
and distributed on packages, and rotated quarterly in advertisements,
in accordance with an FDA-approved plan.
    Plans should be submitted to FDA no later than 5 months after the
date of publication of the final rule and before advertising or
commercially marketing a product that is subject to the rule. Packages
and advertisements of cigarettes would be required to bear the required
warnings beginning 15 months after the date of publication of the final
rule. FDA intends to request an amendment to a plan under review if FDA
needs clarification of information in the plan or other additional
information to determine whether it could approve the plan. Any such
amendments would likely increase the overall review time.