[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Rules and Regulations]
[Pages 36628-36777]
[FR Doc No: 2011-15337]

Vol. 76

Wednesday,

No. 120

June 22, 2011

Part II

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Part 1141

Required Warnings for Cigarette Packages and Advertisements; Final Rule

Federal Register / Vol. 76 , No. 120 / Wednesday, June 22, 2011 /
Rules and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1141

[Docket No. FDA-2010-N-0568]
RIN 0910-AG41

Required Warnings for Cigarette Packages and Advertisements

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations to add a new requirement for the display of health warnings
on cigarette packages and in cigarette advertisements. This rule
implements a provision of the Family Smoking Prevention and Tobacco
Control Act (Tobacco Control Act) that requires FDA to issue
regulations requiring color graphics, depicting the negative health
consequences of smoking, to accompany the nine new textual warning
statements required under the Tobacco Control Act. The Tobacco Control
Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA)
to require each cigarette package and advertisement to bear one of nine
new textual warning statements. This final rule specifies the color
graphic images that must accompany each of the nine new textual warning
statements.

DATES: This rule is effective September 22, 2012. See section VIII of
this document, Implementation Date, for additional information. The
incorporation by reference of a certain publication listed in the rule
is approved by the Director of the Federal Register as of September 22,
2012.

FOR FURTHER INFORMATION CONTACT: Gerie Voss or Kristin Davis, Center
for Tobacco Products, Food and Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850-3229,<PHONE_NUMBER><EMAIL_ADDRESS>or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction
    A. Purpose and Overview
    B. Background
II. Need for the Rule and Responses to Comments
    A. Cigarette Use in the United States and the Resulting Health
Consequences
    1. Smoking Prevalence and Initiation in the United States
    2. Health Consequences of Smoking
    B. Inadequacy of Existing Warnings
    C. Consumers' Lack of Knowledge of the Health Risks
    D. Larger, Graphic Warnings Communicate More Effectively
    E. Need To Refresh Required Warnings
III. FDA's Selection of Color Graphic Images
    A. Methodology for Selecting Images
    B. FDA's Research Study
    1. Study Design
    2. Use of FDA's Study Results in Selection of Images
    3. Comments on FDA's Research Study
    C. Comments to the Docket
    1. Comments Submitting Research on FDA's Proposed Required
Warnings
    2. Other Comments
    D. Selected Images
    1. ``WARNING: Cigarettes are addictive''
    2. ``WARNING: Tobacco smoke can harm your children''
    3. ``WARNING: Cigarettes cause fatal lung disease''
    4. ``WARNING: Cigarettes cause cancer''
    5. ``WARNING: Cigarettes cause strokes and heart disease''
    6. ``WARNING: Smoking during pregnancy can harm your baby''
    7. ``WARNING: Smoking can kill you''
    8. ``WARNING: Tobacco smoke causes fatal lung disease in
nonsmokers''
    9. ``WARNING: Quitting smoking now greatly reduces serious risks
to your health''
    10. Image for Advertisements With a Small Surface Area
    E. Non-Selected Images
    1. ``WARNING: Cigarettes are addictive''
    2. ``WARNING: Tobacco smoke can harm your children''
    3. ``WARNING: Cigarettes cause fatal lung disease''
    4. ``WARNING: Cigarettes cause cancer''
    5. ``WARNING: Cigarettes cause strokes and heart disease''
    6. ``WARNING: Smoking during pregnancy can harm your baby''
    7. ``WARNING: Smoking can kill you''
    8. ``WARNING: Tobacco smoke causes fatal lung disease in
nonsmokers''
    9. ``WARNING: Quitting smoking now greatly reduces serious risks
to your health''
    10. Image for Advertisements With a Small Surface Area
IV. Comments Regarding Textual Warning Statements
    A. Changes to Textual Warning Statements
    B. Attribution to the Surgeon General
    C. Foreign Language Translations
V. Description of the Final Rule
    A. Overview of the Final Rule
    B. Description of Final Regulations and Responses to Comments
    1. Section 1141.1--Scope
    2. Section 1141.3--Definitions
    3. Section 1141.10--Required Warnings
    4. Section 1141.12--Incorporation by Reference of Required
Warnings
    5. Section 1141.14--Misbranding of Cigarettes
    6. Section 1141.16--Disclosures Regarding Cessation
VI. Comments Regarding Implementation Issues
    A. Technical Issues Regarding Compliance
    B. Textual Statement Color Formats
    C. Random Display and Rotation of Warnings
VII. Legal Authority and Responses to Comments
    A. FDA's Legal Authority
    B. First Amendment Commercial Speech Issues
    C. Takings Under the Fifth Amendment
VIII. Implementation Date
IX. Federalism
X. Environmental Impact
XI. Analysis of Impacts
    A. Introduction and Summary
    B. Comments on the Preliminary Regulatory Impact Analysis
    1. General
    2. Need for the Rule
    3. Benefits
    4. Costs
    5. Distributional Effects
    6. Impact on Small Entities
    C. Need for the Rule
    D. Benefits
    1. Reduced Cigarette Smoking Rates
    2. Quantifying Benefits That Accrue to Dissuaded Smokers
    3. Reduced Fire Costs
    4. Summary of Benefits
    E. Costs
    1. Number of Affected Entities
    2. Costs of Changing Cigarette Labels
    3. Ongoing Costs of Equal and Random Display
    4. Market Testing Costs Associated With Changing Cigarette
Package Labels
    5. Advertising Restrictions: Removal of Noncompliant Point-of-
Sale Advertising
    6. Government Administration and Enforcement Costs
    7. Summary of Costs
    F. Cost-Effectiveness Analysis
    G. Distributional Effects
    1. Tobacco Manufacturers, Distributors, and Growers
    2. National and Regional Employment Patterns
    3. Retail Sector
    4. Advertising Industry
    5. Excise Tax Revenues
    6. Government-Funded Medical Services, Insurance Premiums, and
Social Security
    H. International Effects
    I. Regulatory Alternatives
    1. 24-Month Compliance Period
    2. 6-Month Compliance Period
    3. Alternative Graphic Images
    4. Summary of Regulatory Alternatives
    J. Impact on Small Entities
    1. Description and Number of Affected Small Entities
    2. Description of the Potential Impacts of the Final Rule on
Small Entities
    3. Alternatives to Minimize the Burden on Small Entities
XII. Paperwork Reduction Act of 1995
XIII. References

I. Introduction

A. Purpose and Overview

    The Tobacco Control Act was enacted on June 22, 2009, amending the
Federal Food, Drug, and Cosmetic Act (FD&C Act) and FCLAA, and
providing FDA with the authority to regulate tobacco products (Pub. L.
111-31; 123 Stat.

1776). Section 201 of the Tobacco Control Act modifies section 4 of
FCLAA (15 U.S.C. 1333) to require that the following nine new health
warning statements appear on cigarette packages and in cigarette
advertisements:
     WARNING: Cigarettes are addictive
     WARNING: Tobacco smoke can harm your children
     WARNING: Cigarettes cause fatal lung disease
     WARNING: Cigarettes cause cancer
     WARNING: Cigarettes cause strokes and heart disease
     WARNING: Smoking during pregnancy can harm your baby
     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.
    Section 201 of the Tobacco Control Act also states that ``the
Secretary [of Health and Human Services] shall issue regulations that
require color graphics depicting the negative health consequences of
smoking'' to accompany the nine new health warning statements.
    As discussed in the preamble to the proposed rule (75 FR 69524 at
69525, November 12, 2010), cigarette smoking kills an estimated 443,000
Americans each year, most of whom began smoking when they were under
the age of 18 (Ref. 1). Tobacco use is the foremost preventable cause
of premature death in the United States, and has been shown to cause
cancer, heart disease, lung disease, and other serious adverse health
effects (Ref. 2). The U.S. Government has a substantial interest in
reducing the number of Americans, particularly children and
adolescents, who use cigarettes and other tobacco products in order to
prevent the life-threatening health consequences associated with
tobacco use (section 2(31) of the Tobacco Control Act).
    Although FCLAA has required the inclusion of textual health
warnings on cigarette packages and in cigarette advertisements for many
years, there is considerable evidence, which was presented in the
preamble to the proposed rule (75 FR 69524 at 69529 through 69531) and
is discussed in section II.B of this document, that the existing
cigarette health warnings are given little attention or consideration
by viewers. A 2007 report from the Institute of Medicine (IOM)
described the warnings as ``invisible'' (Ref. 3), and found that they
fail to communicate relevant information in an effective way. The
warnings currently in use in the United States also fail to include any
graphic component, despite the evidence in the scientific literature
that larger, graphic health warnings promote greater understanding of
the health risks of smoking and would help to reduce consumption (see
75 FR 69524 at 69531 through 69533). In proposing this regulation and
preparing this final rule, we found substantial evidence indicating
that larger cigarette health warnings including a graphic component,
like those being required in this rule, would offer significant health
benefits over the existing warnings. Consistent with Executive Order
13563, this regulation is ``based on the best available evidence'' and
has allowed ``for public participation and an open exchange of ideas.''

B. Background

    On November 12, 2010, as directed by section 201 of the Tobacco
Control Act and in the interest of public health, we issued a proposed
rule seeking to modify the warnings that appear on cigarette packages
and in cigarette advertisements to include color graphic images
depicting the negative health consequences of smoking; these images
were proposed to accompany the nine new textual warning statements set
forth in section 201 of the Tobacco Control Act (see 75 FR 69524). The
Agency received more than 1,700 comments to the docket for the November
12, 2010, notice of proposed rulemaking (NPRM) on required warnings for
cigarette packages and advertisements. Comments were received from
cigarette manufacturers, retailers and distributors, industry
associations, health professionals, public health or other advocacy
groups, academics, State and local public health agencies, medical
organizations, individual consumers, and other submitters. These
comments are summarized and responded to in the relevant section(s) of
this document. Similar comments are grouped together by the topics
discussed or the particular portions of the NPRM or codified language
to which they refer.
    To make it easier to identify comments and FDA's responses, the
word ``Comment,'' in parenthesis, appears before the comment's
description, and the word ``Response,'' in parenthesis, appears before
FDA's response. Each comment is numbered to help distinguish among
different comments. Similar comments are grouped together under the
same comment number. The number assigned to each comment is purely for
organizational purposes and does not signify the comment's value or
importance or the order in which it was received.

II. Need for the Rule and Responses to Comments

A. Cigarette Use in the United States and the Resulting Health
Consequences

1. Smoking Prevalence and Initiation in the United States
    In explaining the need for the proposed rule, we provided
information in the NPRM on smoking prevalence and initiation rates
among adults and children in the United States. As stated in the NPRM
(75 FR 69524 at 69526), approximately 46.6 million U.S. adults (or 20.6
percent of the adult population) are cigarette smokers (Ref. 4).
Moreover, almost half (46.3 percent) of youth in grades 9 through 12 in
the United States have tried cigarette smoking, and 19.5 percent of
youth in grades 9 through 12 are current cigarette smokers (Ref. 5 at
p. 10). Smoking rates among U.S. adults have shown virtually no change
during the 5-year period from 2005 to 2009 (Ref. 4), and smoking rates
among U.S. youth have not decreased from 2006 to 2009 (Ref. 6).
    Furthermore, each year millions of U.S. adults and children become
new smokers. Data from the 2008 National Survey on Drug Use and Health
indicate that 2.4 million persons aged 12 or older in the United States
smoked cigarettes for the first time in the past 12 months (Ref. 7 at
p. 59). In addition, these data indicate that almost 1 million
Americans aged 12 or older started smoking cigarettes daily within the
past 12 months (Ref. 7 at p. 60).
    In other words, approximately 6,600 people aged 12 or older in the
United States become new cigarette smokers every day, and more than
2,500 individuals become new daily cigarette smokers every day (Ref. 7
at pp. 59-60). Moreover, nearly 4,000 of the people who become new
cigarette smokers every day and nearly 1,000 of the individuals who
become new daily cigarette smokers every day are children under the age
of 18 (Ref. 7 at pp. 59-60). These statistics for youth smokers are
particularly concerning, as studies suggest that the age people start
smoking can greatly influence how much they smoke per day and how long
they smoke, which in turn influences their risk of tobacco-related
disease and death (Refs. 8, 9, and 10).
    FDA received many comments that were strongly supportive of the
proposed rule, some of which provided data and information consistent
with that in the NPRM regarding cigarette use prevalence and initiation
in the United States (75 FR 69524 at 69526 through 69527). Many of
these comments also stated that smokers would be more

likely to quit smoking and that nonsmokers would be less likely to
start smoking if cigarette advertisements and packages display,
visually and graphically, the health effects of cigarettes. Most of
these comments expressed a belief that the required warnings would help
reduce the existing and future use of cigarettes. Some comments that
were supportive of the proposed rule discussed the smoking prevalence
and initiation rates in the United States in particular populations.
These comments, and FDA's responses, are summarized in the following
paragraphs.
    (Comment 1) Multiple comments indicated that people with less
education and lower incomes have higher smoking prevalence rates in
general. One comment from a health care association indicated that
women of low educational background have higher smoking prevalence
rates and that many of these women still are not aware of cigarettes'
impact on life expectancy, heart disease, and pregnancy.
    (Response) We agree that adults with low education levels have
higher than average smoking prevalence rates. For example, as discussed
in the NPRM (75 FR 69524 at 69526), 49.1 percent of adults with a
General Education Development certificate (GED) and 28.5 percent of
adults with less than a high school diploma were current smokers in
2009, compared with 5.6 percent of adults with a graduate degree (Ref.
4). We also agree that graphic health warnings may be particularly
important communication tools for these smokers, as there is evidence
suggesting that countries with graphic health warnings demonstrate
fewer disparities in health knowledge across educational levels (Ref.
11 at p. 18 and Ref. 3 at p. 295).
    (Comment 2) Multiple comments noted that smoking rates vary by race
and ethnicity, with American Indians/Alaska Natives having the highest
rates. One comment also noted that the health and economic costs of
smoking vary by race and ethnicity. For example, the comment stated
that African-American smokers suffer disproportionately from smoking-
related diseases, including lung cancer, heart disease, and strokes
(citing Ref. 12), and called for measures to address these disparities.
    One comment from a State public health agency indicated that racial
minority populations and economically disadvantaged populations have
smoking prevalence rates that are two to three times higher than the
general population.
    (Response) We agree that smoking rates vary by race and ethnicity
and socioeconomic status. For example, prevalence data from 2009 for
current U.S. adult cigarette smokers indicate that, among racial/ethnic
groups, adults reporting multiple races had the highest smoking
prevalence (29.5 percent), followed by American Indians/Alaska Natives
(23.2 percent) (Ref. 4). We also agree that economically disadvantaged
populations have higher smoking prevalence rates. For example, data
from 2009 indicate that the prevalence of current smoking was higher
among U.S. adults living below the Federal poverty level (31.1 percent)
than among those at or above this level (19.4 percent) (Id.). We have
selected required warnings that will help effectively convey the
negative health consequences of smoking to a wide range of population
groups, including different racial and ethnic groups and different
socioeconomic groups, and that can help both to discourage nonsmokers
from initiating cigarette use and to encourage current smokers to
consider quitting. For additional information regarding our selection
of required warnings to reach a broad range of population groups, see
section III of this document regarding our selection of the final
images.
    (Comment 3) Multiple comments stated that tobacco use disparities
exist among lesbian, gay, bisexual, and transgender individuals. One
comment from a community organization stated that lesbian, gay,
bisexual, and transgender individuals smoke at rates almost 50 percent
to 200 percent higher than the rest of the population and strongly
supported the proposed rule.
    (Response) We agree that evidence suggests that gay, lesbian,
bisexual, and transgender populations have higher smoking rates than
their heterosexual counterparts (Ref. 13). The required warnings will
help convey information about various health risks of smoking to
individuals from a wide range of demographic groups and will help
encourage smoking cessation and discourage smoking initiation.
    (Comment 4) One comment from a nonprofit research organization
indicated that members of the U.S. military have rates of smoking that
are unacceptably high, particularly among younger members. The comment
detailed the negative outcomes of smoking to military personnel,
including lower physical performance, an increased risk of injury
during physical tasks, a greater number of days sick and unable to
report for duty, poorer job performance, and a higher likelihood of
premature discharge from active duty, and stated that smoking and its
negative effects among active duty personnel costs the military an
estimated $1 billion annually in health care and lost productivity
(Ref. 14). The comment also referred to evidence suggesting the tobacco
industry has targeted military members and fought efforts to reduce
tobacco product consumption by military personnel, and indicated that
the proposed rule is an important step in protecting military members
from the health harms of cigarette use and will likely decrease
cigarette use among military personnel.
    (Response) We agree that members of the U.S. military have higher
smoking prevalence rates than the general population; approximately
20.6 percent of the U.S. adult population smoke cigarettes, while data
from 2008 indicate that 31 percent of active duty military personnel
smoke cigarettes (Ref. 15). We agree that the required warnings will
help convey information about various health risks of smoking to a wide
range of individuals, including members of the U.S. military and
veterans who began smoking while in military service, and that the
required warnings will encourage smoking cessation and discourage
smoking initiation in these individuals.
2. Health Consequences of Smoking
    Smoking is responsible for at least 443,000 premature deaths per
year in the United States, and each year cigarettes are responsible for
approximately 5.1 million years of potential life lost (Ref. 1). Annual
direct health care expenses due to smoking total approximately $96
billion, and annual productivity losses due to premature deaths alone
from cigarette smoking total approximately $96.8 billion (Id.).
    The Agency received many comments that were supportive of the
proposed rule, some of which reiterated the health risks of smoking
described in the NPRM (75 FR 69524 at 69527 through 69529) and stressed
the need for measures, such as graphic health warnings, to curb smoking
in the United States in order to improve health and to reduce the
massive health care costs attributable to tobacco-related illnesses.
Some of these comments cited data demonstrating that smoking is the
leading cause or most powerful risk factor for particular diseases,
such as chronic obstructive pulmonary disease (COPD), bladder cancer,
and atherosclerosis.
    However, FDA also received multiple comments disputing the health
risks of smoking. These comments and FDA's responses are summarized in
the following paragraphs.
    (Comment 5) One comment from an individual expressed a belief that
addiction to nicotine is 99 percent

psychological and only 1 percent pharmacological, and that nicotine is
no more addictive than caffeine.
    (Response) We disagree with the assertion that nicotine addiction
does not have a substantial physiologic component. While we acknowledge
that behavioral processes play a role in initiation and maintenance of
nicotine addiction, nicotine is a powerful pharmacologic agent that
acts in a variety of ways at different sites in the body. As stated in
the NPRM, nicotine causes physical dependence characterized by
withdrawal symptoms that usually accompany nicotine abstinence (75 FR
69524 at 69528). Regarding the relative addictiveness of nicotine and
caffeine, caffeine is distinct from nicotine in its abuse liability,
which includes a consideration of multiple factors, including the
dependence potential of a substance and the degree to which it produces
adverse effects (see Ref. 16 at p. 304). Caffeine produces only minimal
disruptive physiological effects and, unlike nicotine from tobacco
products, caffeine is generally not used in ways that are considered to
be of significant adverse health effect (see Id. at pp. 285 and 304).
    (Comment 6) One comment stated that nicotine withdrawal is the only
medical condition that is irrefutably caused by cigarettes.
    (Response) We disagree with this comment. While nicotine addiction
is one negative health effect of cigarette smoking, it is not the only
medical condition irrefutably caused by cigarettes. As detailed in the
2004 report of the Surgeon General, ``The Health Consequences of
Smoking,'' which summarizes thousands of peer-reviewed scientific
studies and was itself peer-reviewed, cigarettes have been shown to
cause an ever-expanding number of diseases and conditions, including
lung cancer, laryngeal cancer, oral cavity and pharyngeal cancers,
esophageal cancer, bladder cancer, pancreatic cancer, kidney cancer,
stomach cancer, cervical cancer, acute myeloid leukemia, all the major
clinical cardiovascular diseases, COPD, and a range of acute
respiratory illnesses (Ref. 2).
    Maternal smoking during pregnancy causes a reduction in lung
function in infants, and women who smoke during pregnancy are more
likely to experience premature rupture of the membranes, placenta
previa, and placental abruption (Id. at pp. 508 and 576). Smoking also
increases rates of preterm delivery and shortened gestation, and women
who smoke are twice as likely as nonsmokers to have low birth weight
infants; smoking also increases the risk of sudden infant death
syndrome (SIDS) (Id. at pp. 569, 576, 587 and 601).
    Children who smoke experience impaired lung growth and an early
onset of lung function decline (Id. at pp. 508-509, 2004 SG). Smoking
during adulthood also leads to a premature onset of accelerated age-
related decline in lung function (Id. at p. 509). Smoking also results
in poor asthma control and causes a range of respiratory symptoms in
children, adolescents, and adults, including coughing, phlegm,
wheezing, and shortness of breath (Id.).
    Furthermore, cigarette smokers have poorer overall health status
compared to nonsmokers, and an increased risk of adverse surgical
outcomes related to wound healing and respiratory complications
compared to nonsmokers. Smokers are also at an increased risk for hip
fractures, and smoking increases the risk for periodontitis, cataract,
and the occurrence of peptic ulcer disease in persons who are
Heliobacter pylori positive (Id. at pp. 717-719, 736, 777, 780, and
813).
    In addition, exposure to secondhand smoke has been shown to cause a
variety of negative health effects in nonsmokers, including lung
cancer, cardiovascular disease, and respiratory symptoms (see Ref. 17).
    (Comment 7) Some comments were submitted by individuals disputing
the negative health consequences of smoking that are described in the
graphic warnings. These comments generally indicated that the
individuals submitting the comments were smokers, and that they and/or
their family members (who were exposed to secondhand smoke) had not
experienced negative health effects from smoking.
    (Response) We disagree with these comments. Cigarette smoking has
been shown to cause a wide range of negative health consequences, as
detailed in the previous response. Furthermore, it can be years before
some of the negative health consequences of smoking clinically
manifest. Thus, the personal health status of the individuals
submitting these comments could change in the future. A scientific
determination that a product causes a particular negative health
consequence is based on data from large groups of individuals, and the
fact that an individual product user has not experienced (or has not
yet experienced) a particular negative health consequence does not mean
the product does not cause that harm.
    Moreover, to the extent these comments indicate that many smokers
do not fully understand the serious health risks of cigarettes or do
not believe that these risks apply to them, they illustrate the need
for health warnings that effectively communicate the negative health
consequences of smoking to consumers. For additional information
regarding consumers' lack of knowledge of smoking risks, see section
II.C of this document.
    (Comment 8) One comment stated that cigarettes are a minor public
health concern compared to obesity and alcohol, and that cigarette use
results in less health care costs than medical treatment for the obese.
    (Response) As discussed in the NPRM, cigarette smoking is the
leading cause of preventable death and disease in the United States
(Ref. 4). Furthermore, cigarettes are responsible for health care
expenditures and productivity losses resulting in a combined economic
burden of approximately $193 billion per year (Ref. 1). The total costs
of smoking to society are much higher, as the estimate for productivity
losses does not include costs associated with smoking-related
disability, employee absenteeism, or costs associated with secondhand-
smoke attributable disease morbidity and mortality (Id.).
    We disagree that cigarettes are a minor public health concern, even
as compared to other public health issues, and also disagree with the
implication that the public health issue of smoking should not be
addressed because other public health issues exist. The required
warnings will have a significant, positive impact on public health (75
FR 69524 at 69526), and as a result will help mitigate the single
largest cause of preventable death and disease in the United States.

B. Inadequacy of Existing Warnings

    In the preamble to the proposed rule, FDA explained how cigarette
packages and advertisements can be effective channels for communication
of important health information, particularly given that pack-a-day
smokers are potentially exposed to warnings more than 7,000 times per
year (75 FR 69524 at 69529). However, the existing warnings have
suffered from three crucial problems: (1) They have not changed in more
than 25 years, (2) they often go unnoticed, and (3) they fail to convey
relevant information in an effective manner. FDA also explained that
larger, graphic warnings communicate the health risks of smoking more
effectively. The preamble to the proposed rule presented extensive
evidence from other countries' experiences with graphic warnings as
well as information from the 2007 IOM Report (75 FR 69524 at 69531). On
the

basis of the available scientific evidence, the IOM concluded that
larger, graphic warnings would promote greater public knowledge of the
health risks of using tobacco and would help reduce consumption (Ref.
3).
    We received numerous comments regarding the adequacy of the
existing warnings that appear on cigarette packages and advertisements.
The large majority of these comments supported our analysis of the
existing warnings, but a few comments disagreed with this analysis.
These comments, and our responses, are summarized in the following
paragraphs.
    (Comment 9) A substantial number of comments, including those from
health institutions, nonprofit organizations, academics, and consumers,
agreed with FDA's conclusion that the existing warnings that appear on
cigarette packages and advertisements are ineffective at conveying the
health risks of smoking (75 FR 69524 at 69529 through 69531).
    However, one comment stated that the current warnings were
``fine.'' Two comments expressed the belief that the existing warnings
have worked successfully in the current information environment.
    (Response) We disagree with the comments stating that the existing
warnings that appear on cigarette packages and advertisements are
effective. As several other comments noted, the Surgeon General has
long recognized that the cigarette warnings are deficient. For example,
in its 1994 report the Surgeon General noted that the warnings had
become ineffective due to their size, shape, and familiarity (Ref. 18).
That same year, the IOM concluded that the warnings were ``inadequate *
* * and woefully deficient when evaluated in terms of proper public
health criteria'' (Ref. 19 at p. 237). Yet those same warnings are
still in use more than 16 years after the Surgeon General's report and
26 years after their inception. Accordingly, we conclude that the
existing warnings for cigarettes do not adequately communicate the
health risks of smoking.

C. Consumers' Lack of Knowledge of the Health Risks

    In the preamble to the proposed rule, FDA described how the
existing warnings that currently appear on cigarette packages and
advertisements have largely gone unnoticed by both smokers and
nonsmokers (75 FR 69524 at 69530). FDA also provided clear evidence
that the warnings have failed to convey appropriately crucial
information such as the nature and extent of the health risks
associated with smoking cigarettes (75 FR 69524 at 69530 through
69531).
    FDA received many comments regarding the level of consumers'
knowledge regarding the health risks of smoking. Several comments
stated that consumers are adequately informed about the risks of
smoking or even overestimate the risks of smoking, while many other
comments explained that consumers lack knowledge about a wide variety
of smoking risks. A summary of these comments, and our responses, is
included in the following paragraphs.
    (Comment 10) Several comments, including comments from tobacco
product manufacturers and individual consumers, objected to the new
required warnings, in part because they claimed that consumers already
know the health risks associated with smoking. The submitters expressed
the belief that the new warnings are unnecessary, because the new
warnings provide information that the public has been aware of for many
years.
    (Response) We disagree. Many comments provided significant evidence
to support the notion that consumers, including those in communities
with low literacy rates and military personnel, actually lack knowledge
or underestimate the risks associated with smoking. As discussed in
this document, this lack of knowledge may involve either an incomplete
understanding of the statistical risks or a failure to understand the
personal (as opposed to the statistical) risks (see also section XI.B.2
of this document). There is also a possibility that the risks are not
considered at the time of purchase, even if they are understood--a
special problem for those who are deciding whether to start to smoke.
The requirements adopted here should help to counteract all of these
problems.
    While most smokers understand that smoking poses certain
statistical risks to their health, many fail to appreciate the severity
and magnitude of those risks (Refs. 20 and 21), and there is evidence
that even when smokers appreciate the statistical risk, they
underestimate the personal risk that they face (Ref. 22). A 2007 survey
found that two in three smokers underestimate the chance of a smoker
developing lung cancer compared to a nonsmoker (Ref. 23). The survey
also found that up to a third of smokers erroneously believe that
certain activities, such as exercise and taking vitamins, could
``undo'' most of the effects of smoking (Id.).
    Other research also highlights how smokers underestimate the health
effects of smoking. For example, in a 2008 survey, more than one-
quarter of current smokers did not agree that smoking increases a
person's chances of getting cancer ``a lot'' (Ref. 24). Furthermore,
one study, involving smokers' perception of their personal risk, found
that only 40 percent of current smokers believed they had a higher-
than-average risk of cancer and only 29 percent believed they had a
higher-than-average risk of heart disease (Ref. 25). Even among heavy
smokers (those who smoke at least 40 cigarettes per day), less than
half believed they were at increased risk for these diseases (Id.). In
another demonstration of underestimation of personal risk, a study
found that adolescent smokers underestimated their personal risk, even
if they had an accurate sense of the statistical risk (Ref. 22).
    A 2005 study of smokers in the United States and three other
countries found that there were significant gaps in smokers' knowledge
about the risks of smoking and that smokers living in countries where
health warnings referred to specific disease consequences of smoking
were much more likely to be aware of those consequences (Ref. 26). The
study concluded that smokers are not fully informed about the risks of
smoking, and that warnings that are graphic, larger, and more
comprehensive in content are more effective in communicating the health
risks of smoking (Id.).
    Thus, even if consumers are aware of certain negative health
consequences of smoking, such as lung cancer and emphysema, and even if
they are aware of certain statistical risks, many smokers underestimate
their personal risks, and many Americans are under-informed about other
health risks associated with smoking. For example, while nearly all
daily smokers in one study correctly identified that smoking caused
lung cancer (99 percent) and emphysema (97 percent), a lower percentage
of respondents correctly identified smoking as causing low birth weight
babies (88 percent), worsened asthma (85 percent), miscarriages (76
percent), other cancers (69 percent), head and neck cancers (68
percent), cervical cancer (48 percent), stomach ulcers (46 percent),
reproductive difficulties (44 percent), osteoporosis (41 percent), and
SIDS (40 percent) (Ref. 27). In fact, research indicates that most
people know only one or two of the many diseases causes by smoking. One
survey found that while a majority of people knew that smoking caused
life-threatening illnesses, more than half of the respondents were
unable to name a smoking-related illness other than lung cancer (Ref.
28). Similarly, researchers

found that when asked about health risks of smoking, 39 percent of
respondents either answered incorrectly or said they did not know (Ref.
29).
    Americans also lack adequate understanding of the addictive nature
of cigarettes. Although one comment provided local surveys showing that
adults already know that cigarettes are addictive, there is also
evidence that many adolescents do not appreciate the addictive nature
of cigarettes. The 2007 IOM Report explained that ``adolescents
misperceive the magnitude of smoking harms and the addictive properties
of tobacco and fail to appreciate the long-term dangers of smoking,
especially when they apply the dangers to their own behavior'' (Ref. 3
at p. 93). In addition, one survey found that fewer than 5 percent of
daily smokers in high school think that they still will be smoking at
all in 5 years, yet more than 60 percent of high school smokers are
regular daily smokers 7 to 9 years later (Ref. 30). Another survey
found that only 7.4 percent of adult smokers and 4.8 percent of young
smokers expected to smoke longer than 5 years when they started, but 87
percent of these adults and 76 percent of these youth reported that
they had been smoking for more than 5 years (Ref. 31).
    There is also evidence that certain demographic groups are even
less aware of the negative health consequences of smoking, which is
particularly concerning in light of the evidence that these groups also
have some of the highest smoking prevalence rates (see section II.A.1
of this document). For example, research shows that knowledge of
smoking risks is lower among people with lower incomes and fewer years
of education (Refs. 32 33 and 24). Smokers in the military also
underestimate the actual risk of serious disease and substantially
underestimate their own risks (a point that fits well with the evidence
of underestimation of personal risks) (Refs. 34 35 and 36).
    In addition to underestimating the risks smoking poses to their own
health, Americans underestimate the health effects of secondhand smoke
on others. In the 2010 Report, ``How Tobacco Smoke Causes Disease: The
Biology and Behavioral Basis for Smoking-Attributable Disease,'' the
Surgeon General concluded that ``many of the effects from active
smoking can be observed in persons involuntarily exposed to cigarette
smoke'' (Ref. 37). In addition, individual studies have shown that
secondhand smoke triggers childhood asthma and is associated with both
heart disease and cancer (Ref. 17). Yet, most parents believe that
smoke exposure has little or no negative impact on children's asthma
(Ref. 38), and a 2009 study found that nearly one-fifth of Americans do
not believe that secondhand smoke is dangerous to nonsmokers (Ref. 39).
    There is a final point. Even if many people do have an accurate
understanding of the statistical risk, and even if, in the abstract,
many smokers also have an accurate understanding of their personal
risk, that understanding may be too abstract to be thought of at the
time of purchase, especially (but not only) for those who are starting
to smoke. Efforts to make the relevant risks salient are justified and
indeed required under the Tobacco Control Act.
    (Comment 11) A few comments claimed that adults actually
overestimate the risks of smoking-related disease, and stated that this
further underscores the lack of a need for graphic health warnings. In
particular, one comment referred to a Montana survey in which adults
believed that smoking caused colon cancer.
    (Response) We disagree with these comments. While the Montana
survey referred to in one of the comments indicates that some consumers
are not aware of the precise relationship between smoking and certain
diseases (for example, the 2004 Surgeon General's report notes that the
evidence is suggestive but not sufficient to infer a causal
relationship between smoking and colorectal cancer (Ref. 2 at p. 26)),
we are aware of significant research indicating that many consumers are
not sufficiently aware of the risks associated with smoking, as
discussed in the previous response. We find that the weight of evidence
clearly demonstrates that many consumers lack adequate knowledge about
the health risks of smoking--especially the personal risks. In
addition, the comments claiming that adults overestimate smoking's
risks fail to take into account consumers' lack of knowledge of other
health risks due to smoking, like the dangers of secondhand smoke,
reproductive difficulties, and miscarriages, as described in the
previous response.

D. Larger, Graphic Warnings Communicate More Effectively

    Since Canada first introduced graphic health warnings for
cigarettes in 2001, an extensive evidence base has been developed to
examine the effects of graphic health warnings in Canada and in the
more than 30 other countries that have adopted similar requirements for
graphic health warnings on cigarettes. As FDA extensively discussed in
the NPRM (75 FR 69524 at 69531 through 69533), the research literature
indicates that large graphic health warnings, such as those being
required in this rule, are more likely than text-only warnings to (1)
get consumers' attention, (2) influence consumers' awareness of
cigarette-related health risks, and (3) affect smoking intentions and
behaviors. FDA received many comments on the efficacy of large, graphic
warnings, as well as comments regarding the potential for any rebound
effect from the use of graphic warnings. Those comments, and FDA's
responses, are summarized in the following paragraphs.
    (Comment 12) A wide variety of comments, including those from
health institutions, nonprofit organizations, and academics, agreed
with FDA's findings in the NPRM that larger, graphic warnings are
effective.
    However, several comments stated that the changes in the format and
placement of the warnings being proposed, including the use of graphic
images, will not result in reductions in cigarette use given the
experiences in other countries. For example, one comment noted that
Health Canada's own data found, among other things, that there was no
statistically significant decline in smoking incidence consumption for
adolescents or adults after the introduction of graphic warnings. This
comment expressed the belief that Canada's warnings have been
ineffective and that FDA's graphic health warnings will be similarly
ineffective.
    (Response) For the reasons stated in the NPRM, we conclude that
larger, graphic warnings are effective in conveying the health risks of
smoking, influencing consumer awareness of these risks, and affecting
smoking intentions. We disagree with comments stating that the change
in format and placement of the warnings will not be effective. The set
of required warnings we have selected will satisfy our primary goal,
which is to effectively convey the negative health consequences of
smoking on cigarette packages and in advertisements, and this effective
communication can help both to discourage nonsmokers, including minor
children, from initiating cigarette use and to encourage current
smokers to consider cessation to greatly reduce the serious risks that
smoking poses to their health.
    The research literature clearly indicates that larger, graphic
warnings are effective at communicating the health risks associated
with smoking, encouraging users to quit smoking, and discouraging
nonsmokers from beginning to smoke. We already included significant
research to

substantiate this conclusion in the preamble to the proposed rule, and
the comments did not specifically dispute this analysis (see 75 FR
69524 at 69531 through 69532). In addition, as we noted in the NPRM,
the available evidence demonstrates that graphic health warnings are
(1) more likely to be noticed than text-only warnings, (2) more
effective for educating smokers about the health risks of smoking and
for increasing the time smokers spend thinking about the health risks,
and (3) associated with increased motivation to quit smoking (Id.). As
several comments noted, evidence from countries with graphic health
warnings also indicates that such warnings are an important information
source for younger smokers, and that pictures are effective in
conveying messages to children (Ref. 40 at pp. 3, 20, and 24-26). These
important effects of graphic warnings are sustained longer than any
impact from text-only warnings (Ref. 41).
    Further, the data from Health Canada does not indicate that the
warnings have been ineffective at conveying the health risks of smoking
and impacting smoking intentions. We cited several studies in the
preamble (including data from Health Canada) that illustrated the
effectiveness of the Canadian graphic health warnings, which have been
found effective at providing youth and adult smokers with health
information, making consumers think about the health effects of
smoking, and increasing smokers' motivations to quit smoking, among
other things (see 75 FR 69524 at 69532). For example, national surveys
conducted on behalf of Health Canada indicate that approximately 95
percent of youth smokers and 75 percent of adult smokers report that
the Canadian pictorial warnings have been effective in providing them
with important health information (Ref. 3 at p. 294).
    (Comment 13) One comment suggested that the new required warnings
will have a greater impact on nonsmokers who inadvertently view
cigarette packages than on smokers and, therefore, will not be
effective in achieving FDA's goals.
    (Response) We are not aware of any evidence to substantiate this
comment. Further, our required warnings are intended to have an impact
on both smokers and nonsmokers. As stated in the preamble to the
proposed rule, ``the new required warnings are designed to clearly and
effectively convey the negative health consequences of smoking on
cigarette packages and in cigarette advertisements, which would help
both to discourage nonsmokers, including minor children, from
initiating cigarette use and to encourage current smokers to consider
cessation to greatly reduce the serious risks that smoking poses to
their health'' (75 FR 69524 at 69526). Therefore, the warnings are
intended to have an impact on nonsmokers as well as smokers, and the
required warnings will effectively communicate the negative health
consequences of smoking to both of these important audiences.
    (Comment 14) Several comments, including comments from cigarette
manufacturers and individual consumers, expressed concerns that the new
required warnings on cigarette packages and advertisements would cause
people not to look at packages or cause them to hold their cigarettes
in decorative cases. The comments also indicated that some of the
proposed images would induce youth to purchase cigarettes rather than
deter them from smoking, because the new images would be striking to
youth. These comments stated that this ``rebound effect'' would
undermine the intent of the warnings and decrease their effectiveness.
    (Response) We disagree. Comments expressing concerns about a
potential rebound effect did not provide persuasive scientific evidence
to demonstrate such an effect is likely to occur (or that it would have
sufficient magnitude to be a significant concern). The comments
referenced older studies that did not specifically address graphic
warnings on cigarette packages and advertisements, and also referred to
a qualitative study conducted on the European Union's graphic warnings,
in which some focus group participants commented that some warnings
were humorous or that they were not persuasive in educating consumers
about dental diseases associated with smoking (Ref. 42). When weighing
this qualitative information against the quantitative research
available, including evidence from countries with graphic health
warning requirements, as well as the findings of the expert panel of
the IOM in its 2007 report (see Ref. 3), the information referenced in
the comments is not persuasive. (While focus groups can provide useful
information, it is well known that they are not as reliable as real-
world evidence for drawing conclusions about causal relationships and
generalizing results to the population as a whole (Ref. 43).)
    Furthermore, we note that in the European Union qualitative study
referenced in the comments, the researchers concluded that pictures
have the potential to add a powerful element to health warning messages
and that the old text-only messages were not working (Ref. 42 at p.
43). They also noted that some of the warning messages the comments
referred to, including the referenced dental disease image, provoked a
highly emotional response in all the countries surveyed despite the
comments from certain focus group participants (Id. at p. 35). The
research literature suggests that images that evoke emotional responses
can increase the likelihood smokers will reduce their smoking, make an
attempt to quit, or quit altogether (Ref. 44).
    While one comment said that the failure of fear-inducing messages
based on health effects is ``well-known in areas outside of smoking
prevention,'' the comment did not provide sufficient evidence of such
failure in the area of smoking prevention. In fact, as some comments
discussed, there is scientific evidence relating to cigarette graphic
health warnings illustrating the success of fear-inducing messages
(see, e.g., Ref. 44). For example, one comment referred to research
that found that smokers exposed to Canada's graphic health warnings
generally did not try to avoid the fear-inducing messages, and that any
avoidance engaged in by smokers does not appear to undermine quitting
intentions or attempts (citing Ref. 45). Similarly, researchers
analyzing data related to graphic warnings found that:

    [T]here is no evidence that pictorial warnings lead to boomerang
effects. An analysis of data from the ITC Four Country Survey found
that the Australian pictorial warnings, introduced in 2005, led to
greater avoidant behaviours (e.g. covering up the pack, keeping it
out of sight, or avoiding particular labels), compared to Canada,
the United Kingdom, and the USA. Importantly, those smokers who
engaged in avoidant behaviours were no less likely to intend to quit
or to attempt to quit replicating the findings of a study of the
Canadian warnings. Thus, although pictorial warnings can lead to
avoidance and defensive reactions, such reactions are actually
indicators of positive impact.

(Ref. 46, citing Refs. 20 and 44). To the extent that smokers engage in
any defensive avoidance with respect to the new required warnings, we
are adding a reference to a cessation resource to give smokers an
immediate way to act upon this impulse and access cessation assistance.
The research literature suggests that such a reference is effective in
diminishing potential avoidance effects in response to messages that
arouse fear (see Ref. 40 at pp. 39-41). See section V.B.6 of this
document for additional information regarding our rationale and
authority for including a reference to a cessation resource in the
required warnings.
    (Comment 15) Several comments expressed concern about the potential

effectiveness of the new required warnings, particularly those that are
fear-based, with certain portions of the population. These comments
expressed the following concerns: (1) Many youths and young adults are
rebellious and will be attracted to what they perceive as the
``forbidden fruit;'' (2) fear-based warnings fail with groups that have
low self-esteem; (3) fear-based warnings fail with adolescents, because
they tend not to be influenced by health-based deterrents; and (4) the
new required warnings are ``high fear messages'' that may actually
inhibit reductions in smoking, because they decrease a person's
perceived ability to quit smoking. These comments expressed the belief
that the new required warnings would be ineffective.
    (Response) While acknowledging the concerns, we disagree. It is
true that messages that induce fear, pointing to a risk, may not be
effective when people are unaware of how to reduce the risk, but in
this case, the best way to reduce the risk is clear. We have chosen a
balanced set of images, including those that may arouse fear and those
that may generate other emotional responses in certain individuals in
order to reach a diverse population of smokers and nonsmokers, as well
as youth, young adults, and adults. Furthermore, as is explained in
more detail in section III.B of this document, we conducted a research
study to quantitatively evaluate the relative efficacy of the proposed
required warnings in communicating the health harms of smoking to
adults (aged 25 or older), young adults (aged 18 to 24), and youth
(aged 13 to 17). The nine selected required warnings showed positive
effects on important study measures in all study populations, including
youth, relative to the text-only control. In particular, as is
discussed in more detail in section III of this document, the selected
required warnings showed strong impacts on the salience measures in our
research study, including emotional and cognitive measures.
    The research literature suggests that these measures are likely to
be related to behavior change. For example, the literature suggests
that risk information is most readily communicated by messages that
arouse emotional reactions (see Ref. 45), and that smokers who report
greater negative emotional reactions in response to cigarette warnings
are significantly more likely to have read and thought about the
warnings and more likely to reduce the amount they smoke and to quit or
make an attempt to quit (Ref. 44). The research literature also
suggests that warnings that generate an immediate emotional response
from viewers can confer negative feelings about smoking and undermine
the appeal and attractiveness of smoking (Ref. 45 and Ref. 40 at pp.
37-38). In addition, research has shown that younger adolescents are
more likely to notice and think about health warnings that include
graphic images (Ref. 47).
    The required warnings will effectively communicate the negative
health consequences of smoking, and we do not agree that they will have
unintended negative effects among younger population groups.
    (Comment 16) One comment expressed concern that the new graphic
images on cigarette packages and advertisements would actually make
cigarette smokers sicker, as the images would increase smokers' anxiety
and damage their self-esteem.
    (Response) We disagree. We are not aware of any scientific evidence
to support this claim. In fact, as discussed in the preamble to the
proposed rule, the available evidence suggests that graphic health
warnings can benefit the public health by increasing smokers'
intentions to quit and reducing the likelihood of initiation by
nonsmokers (75 FR 69524 at 69532).
    (Comment 17) A few comments stated that fear-based warnings fail to
work when the message being conveyed is already clearly understood and
does not provide new information. These comments expressed the view
that, because consumers already understand the risks associated with
smoking, the new required warnings would not be effective in achieving
FDA's goals.
    (Response) We disagree. As explained in section II.C of this
document, there is substantial evidence demonstrating that the premise
of these comments is not correct and that many consumers do not
adequately understand the personal risks associated with smoking.

E. Need To Refresh Required Warnings

    As amended by the Tobacco Control Act, FCLAA includes provisions
that can help prevent or delay the wear out of the new required
warnings. For example, section 4(c)(1) of FCLAA (15 U.S.C. 1333(c)(1))
indicates that the required warnings on cigarette packages must 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 warning
plan approved by FDA. Section 4(c)(2) of FCLAA requires the warnings to
be rotated quarterly in cigarette advertisements, also in accordance
with a warning plan approved by FDA.
    Nevertheless, as stated in the NPRM, we intend to monitor the
effects of the new required warnings once they are put into use. We
will conduct research and keep abreast of scientific developments
regarding the efficacy of various required warnings and the types and
elements of various warnings that improve efficacy. As stated in the
NPRM, we will use the results of our monitoring and such research to
help determine whether any of the textual warning statements or
accompanying graphic images should be revised in a future rulemaking
(75 FR 69524 at 69534). This commitment to continued empirical testing
is consistent with Executive Order 13563, section 1, which states that
our regulatory system ``must measure, and seek to improve, the actual
results of regulatory requirements.''
    FDA received numerous comments regarding the need periodically to
refresh the warnings to minimize wear out, which we have summarized and
responded to in the following paragraphs.
    (Comment 18) Many comments, including comments from health
institutions, nonprofit organizations, and academics, suggested that
FDA should refresh the graphic warnings on a regular basis because
consumers can become habituated to and ignore warnings. The comments
referred to scientific research on the effectiveness of graphic
warnings for cigarette packages and advertisements, which strongly
recommends that warnings be periodically refreshed to maintain their
effectiveness and impact on consumers (Refs. 18, 42, 44, and 26). The
comments suggested a wide range of timeframes as to when FDA should
refresh the graphic warnings. One comment suggested that FDA track the
effectiveness of the required warnings on a quarterly basis and that
the results of any testing be made publicly available. One comment
suggested that FDA establish a conclusion that new graphic warnings for
cigarette packages and advertisements will be required at no more than
a 2-year interval. A few comments also suggested that FDA establish a
target schedule for reconsideration and revision of the warnings, which
would include ongoing consumer research and re-examination of the
effectiveness of the required warnings.
    (Response) We agree that refreshing the required warnings on a
periodic basis can help maintain their effectiveness. Researchers have
found that graphic images and text messages are likely to have greater
impact at the time they are introduced and that

meaningful impact of the warnings may decline with repeated exposure
(Ref. 41). Rotating a variety of cigarette warnings and updating the
warnings periodically is likely to minimize the negative effects of
overexposure (Ref. 3).
    However, we are not aware of any research that warrants the
selection of a particular timeframe for future iterations of required
warnings. As stated by several comments, there is no definitive rate at
which the warnings will wear out, as it depends on many factors
including the variety of message executions, exposure level, and the
appeal of the message.
    We recognize the value of conducting ongoing evaluation of the
effects of the required warnings after they enter the marketplace. We
also intend to monitor and evaluate the effects of the required
warnings, and to monitor the warnings for potential wear out. In
addition, we will keep abreast of scientific developments regarding the
efficacy of various required warnings and the types and elements of
various warnings that improve efficacy. As noted, this monitoring is
consistent with Executive Order 13563, which recognizes the importance
of measuring ``actual results'' and of analyzing significant rules
after they are in effect to determine whether they should be
``modified, streamlined, expanded, or repealed so as to make the
agency's regulatory program more effective or less burdensome in
achieving the regulatory objectives.''
    When we determine that changes to the required warnings are
appropriate (including changes to the textual warning statements and/or
the color graphic images) because they would promote greater public
understanding of the risks associated with smoking, we can exercise our
authority to initiate a new rulemaking to modify the required warnings
under section 202(b) of the Tobacco Control Act (adding subsection (d)
to section 4 of FCLAA).\1\
---------------------------------------------------------------------------

    \1\ Section 202(b) of the Tobacco Control Act amends section 4
of FCLAA (15 U.S.C. 1333) to add a new subsection (d), ``Change in
Required Statements.'' However, section 201 of the Tobacco Control
Act also amends section 4 of FCLAA to add a new subsection (d),
``Graphic Label Statements.''
---------------------------------------------------------------------------

III. FDA's Selection of Color Graphic Images

A. Methodology for Selecting Images

    When we issued the NPRM, we proposed color graphic images to
accompany the nine textual warning statements required by Congress in
section 201 of the Tobacco Control Act. In all, we proposed 36
potential required warnings, consisting of the color graphic images FDA
developed and the nine textual warning statements from the Tobacco
Control Act. These 36 proposed required warnings were made available as
electronic files in portable document format (.pdf) and displayed in
the document entitled ``Proposed Required Warning Images,'' which was
included in the docket for the proposed rule. The proposed required
warnings were also made available on FDA's Web site. Consistent with
section 4 of FCLAA, 2 versions of each of the 36 proposed required
warnings were developed; one with the textual warning statement in
black font on a white background, and one with the textual warning
statement in white font on a black background.
    As explained in the preamble to the proposed rule (75 FR 69524 at
69534 through 69535), in considering and developing appropriate color
graphic images to accompany the nine textual warning statements set
forth in section 201 of the Tobacco Control Act, FDA assessed the
graphic warnings that other countries have required, and worked with
various experts in the fields of health communications, marketing
research, graphic design, and advertising to develop 36 proposed
required warnings. Each of the proposed color graphic images depicted
the negative health consequences of smoking, and the themes and
subjects depicted in each image illustrated the message conveyed by the
accompanying textual warning statement.
    The NPRM explained that we planned to select 9 final required
warnings from among the 36 proposed required warnings. We sought
comments on what color graphic images to require in this final rule,
including comments on the 36 proposed color graphic images included
with the NPRM.
    In addition, as is described in more detail in section III.B of
this document, we conducted research on the 36 proposed required
warnings to evaluate the relative effectiveness of the proposed color
graphic images and their accompanying textual warning statements at
conveying information about various health risks of smoking, and
additionally, at encouraging smoking cessation and discouraging smoking
initiation.
    In order to determine which color graphic images to require in the
final rule, we considered a number of factors. First, we considered the
relative effectiveness of the proposed required warnings based on the
strength of effect the different color graphic images had on the
various endpoints and across the populations included in our study (see
section III.B of this document for a more detailed description of the
research study).
    In addition, we considered the substantive public comments received
in the docket related to the 36 proposed required warnings (see section
III.C of this document for more information on the comments received;
the comments relating to each image are summarized and responded to in
sections III.D and III.E of this document). We also considered the
comments received in the docket that suggested that we use other images
in the required warnings, including images that have been used in other
countries' graphic health warnings. However, as discussed in more
detail in the following comment summaries and in section III.B of this
document, we selected images for the nine required warnings from among
the images we developed and proposed. Our research study, among other
information, indicated these required warnings will effectively
communicate the negative health consequences of smoking to a wide range
of population groups. As explained in the comment responses throughout
this section III, the comments submitted to the docket did not persuade
us that other images, including images used in other countries' graphic
health warnings, were more appropriate for use in the required warnings
than the images we selected.
    Furthermore, we considered the relevant scientific literature in
the docket, and in particular the extent to which the literature
supported or refuted aspects of the images and the extent to which the
literature helped determine the appropriate weight to give to other
information (including the appropriate weight to give to the various
endpoints considered in our research study).
    We also considered the variety and diversity reflected in the
images in making selection decisions in order to ensure that the final
set of required warnings effectively communicates risk information to a
diverse range of audiences, including audiences that have been targeted
by tobacco industry marketing efforts. We took into account the
importance of selecting a set of required warnings that includes a
diversity of styles (e.g., photographic versus illustrative), themes,
and human images (e.g., race, gender, age). This is consistent with the
evidence base for graphic health warnings from countries that have
already implemented such warnings, which indicates that variety is
important in enhancing the noticeability and salience of warnings and
broadening their relevance for target groups (Ref. 40 at p. 46 and Ref.
48 at

p. 9), and which suggests that warnings that include pictures of people
should broadly represent the ethnic/racial profile of the relevant
country (Ref. 11).
    We also considered whether to have one image accompany each of the
textual warning statements set forth in section 201 of the Tobacco
Control Act.
    We received multiple comments regarding our proposal to select 9
final required warnings and our proposal to select them from among the
36 proposed color graphic images that were made available with the
NPRM. We have summarized and responded to these comments in the
following paragraphs (we also received a number of comments on the
proposed color graphic images themselves; these comments are summarized
in sections III.D and III.E of this document. In addition, we received
a number of comments regarding our research study, which assessed the
relative effectiveness of the 36 proposed color graphic images; these
comments are summarized in section III.C of this document).
    (Comment 19) Several comments suggested that FDA select more than
one graphic image for each new textual warning statement. The comments
reasoned that by limiting the warnings to one graphic image per textual
statement, the health warnings would effectively communicate to fewer
segments of the smoking and nonsmoking populations. Some comments also
suggested that selecting more than one image per warning statement
would counteract wear out of the required warnings. One comment
suggested that FDA develop multiple series of images and require that
each series be used one at a time to delay wear out.
    (Response) We decline to select more than one image for each
warning statement as suggested in these comments. We believe that the
set of nine required warnings we selected will be sufficient at this
time to achieve our goal of effectively communicating the negative
health consequences of smoking and to prevent wear out of the required
warnings for several years. Furthermore, the nine selected required
warnings will appeal to a diverse range of audiences, and, as discussed
in section III.D of this document, the images selected showed
significant effects on important measures in our research study across
the three study populations (adults, young adults, and youth).
    We intend to monitor the effects of these required warnings once
they are put into use. We will conduct research and keep abreast of
scientific developments regarding the efficacy of various required
warnings and the types and elements of various warnings that improve
efficacy. Given the significant changes being made to the text, format,
and placement of the existing warnings by this rule, it will be
valuable to obtain relevant data on the effects of the complete set of
required warnings as soon as possible. If we were to expand the number
of required warnings, it could delay an assessment of efficacy of the
warnings under conditions of real-world use. We intend to use the
results of our monitoring and of research conducted on the required
warnings once they are in public use to determine whether changes
should be made to the required warnings in a future rulemaking,
including changes to add new images or to modify the existing required
warnings. Accordingly, at this time we decline to select more than nine
images.
    (Comment 20) Multiple comments suggested that FDA use graphic
warning images that have been tested or used in other countries instead
of or in addition to one or more of the images that FDA proposed. Some
of these comments indicated that images that are in use in other
countries would be more effective and educational than some or all of
FDA's proposed images.
    (Response) We decline to follow this suggestion. FDA's research
study evaluated the 36 proposed required warnings. The results from
this research study suggest that the nine selected required warnings
will effectively communicate negative health consequences of smoking to
a diverse range of audiences. Moreover, if we were to select images
that were not evaluated in our study, it would be difficult to
objectively assess the relative efficacy of such images compared to the
36 proposed images. Compared to the information provided by our
research study, the supporting information in the comments did not
convince us that the images suggested by those comments would more
effectively communicate the negative health consequences of smoking
than the images we have selected in this final rule.
    (Comment 21) A number of comments suggested that FDA use other
images than those published with the proposed rule. For example, some
comments recommended that FDA use images that depict real people with
real diseases and not models. A few recommended that FDA include images
that show negative cosmetic effects of smoking, such as stained fingers
and bad breath, in order to impact adolescents concerned about body
image. One comment suggested that FDA portray a picture of an obituary,
while another recommended the use of an image depicting the amount of
money smokers spend to purchase cigarettes every year.
    (Response) We decline to select the images suggested in these
comments. Each of the required warnings selected by FDA was
quantitatively tested to assess its relative effectiveness in
communicating the negative health consequences of smoking. In selecting
the set of nine required warnings, we considered the results of our
research study and a number of other factors and have concluded that
the nine selected required warnings effectively communicate the
negative health consequences of smoking. In addition, we are adopting
the nine textual warning statements mandated by Congress in section
4(a)(1) of FCLAA. The images selected were designed to correlate with
those warning statements; the available evidence base highlights the
value of the text and images in graphic health warnings relating to one
another in a meaningful way (see Ref. 40 at p. 41). Including images
inconsistent with the textual warning statements could confuse
consumers and detract from the effectiveness of the warnings.
Furthermore, some of our selected images do show the negative cosmetic
effects that can occur as a result of the health consequences of
smoking. Moreover, some of the images proposed for use in the comments,
such as an image showing the amount of money smokers spend to purchase
cigarettes, would not be consistent with the statutory requirement that
the required warnings depict the negative health consequences of
smoking.

B. FDA's Research Study

    As explained in the NPRM (75 FR 69524 at 69535), we conducted
research on the 36 proposed required warnings. Specifically, we
conducted an Internet-based consumer research study with over 18,000
participants that quantitatively examined the relative efficacy of the
36 proposed color graphic images in communicating the harms of smoking
to 3 target groups: Adult smokers (age 25 or older), young adult
smokers (aged 18 to 24), and youth (aged 13 to 17) who currently smoke
or who are susceptible to smoking.
    The purpose of the study was to: (1) Measure consumer attitudes,
beliefs, and intended behaviors related to cigarette smoking in
response to the proposed color graphic images and their accompanying
textual statements; (2) determine whether consumer responses to the
proposed color graphic images and their accompanying textual statements
differed across various groups based on age, smoking status, or

other demographic variables; and (3) evaluate the relative
effectiveness of the proposed color graphic images and their
accompanying textual warnings statements at conveying information about
various health risks of smoking, and additionally, at encouraging
smoking cessation and discouraging smoking initiation.
    We placed a report (Ref. 49; see also Ref. 50 \2\) that described
the research study and presented the results of the analyses from the
research study in the docket for the proposed rule and announced the
report's availability by a notice in the Federal Register on December
7, 2010 (see 75 FR 75936 at 75936 through 75937) so that the public had
an opportunity to comment on the results.
---------------------------------------------------------------------------

    \2\ While the numerical results reported in the study report
(Ref. 49) were correct, and while all of the results discussed in
this rule are accurately described, some of the descriptors
contained in the study report were in error. An errata sheet for the
study report (Ref. 50), which lists all the errors and the
corrections, has been prepared and is being placed in the docket.
These errors did not adversely impact commenters' ability to convey
their assessment of the images and the study results in their
comments. To the extent some comments included inaccurate statements
about the study results in their significant comments as a result of
the errors, we recognized the inaccuracy and were able to discern
the material points in the comment and evaluate them appropriately,
as is reflected in the comment summaries and responses.
---------------------------------------------------------------------------

    This section briefly describes the design of FDA's research study
and key endpoints examined in the research study; a full description of
the study and the several hundred pages of data and data analyses are
contained in the study report and accompanying appendices (Ref. 49)
that was placed in the docket for the proposed rule. This section also
describes how the results from this research study informed the
selection of the final required warnings.
    FDA received numerous comments in the docket related to the
research study; this section also includes a summary of the substantive
comments received about the research study and FDA's responses to these
comments.
1. Study Design
    FDA's research study evaluated the required warnings proposed for
each of the nine warning statements against a text-only control (which
contained the warning statement without any accompanying color graphic
image). Study participants were randomly assigned to be exposed to
either one of the 36 proposed required warnings (treatment groups) or
one of the 9 textual warning statements (control groups). Treatment
groups for each target population (adults, young adults, and youth)
viewed a hypothetical pack of cigarettes that included one of the
proposed required warnings, which appeared on the upper 50 percent of
the pack, while the control group viewed a hypothetical pack of
cigarettes with a warning statement (but no warning image), which
appeared on the side of the pack. Furthermore, among adults, an
additional treatment group viewed a hypothetical advertisement that
included one of the proposed required warnings, which encompassed
approximately 20 percent of the upper right area of the advertisement,
while a control group viewed a hypothetical advertisement with a
warning statement in the same location (but without a warning image)
that was presented using the size and format currently required by
FCLAA. The study tested the relative efficacy of each proposed required
warning relative to the text-only control for that warning statement
for the various outcomes measured.
    Each respondent viewed either a single cigarette package or
advertisement that displayed one of the proposed required warnings or a
text-only warning. Respondents answered questions about their immediate
reactions to the cigarette package or advertisement, related attitudes
and beliefs about smoking, as well as intentions to quit or start
smoking. At the end of the survey, subjects were asked to recall which
warning statement and image they saw earlier in the survey to assess
the accuracy of recall. In addition, 1 week after completing the
survey, subjects were re-contacted and asked to recall the warning
statement and image to which they were exposed. Overall, the following
key outcomes were measured after exposure to one of the required
warnings or the text-only control, and/or at 1 week follow-up:
     Salience--The study examined emotional and cognitive
responses to the cigarette packages and advertisements that bore health
warnings. Participants provided ratings of their responses to the
packages and advertisements. The ratings were aggregated to create two
scales: (A) An emotional reaction scale, which included ratings on how
the warning made the respondent feel, such as ``depressed,''
``discouraged,'' and ``afraid''; and (B) a cognitive reaction scale,
which included ratings on what the respondent thought about the
warning, such as ``believable,'' ``meaningful,'' and ``convincing''.\3\
Regression analyses were used to assess the relative impact of
treatment conditions on ratings as compared to the text-only control.
---------------------------------------------------------------------------

    \3\ Some additional cognitive measures, including the reaction
item ``the pack was difficult to look at'' (or, for the adult sample
viewing the print ad, ``the ad was difficult to look at'') were also
evaluated but were not reported as part of the composite cognitive
reaction scale. These items were not sufficiently correlated with
the other cognitive measures to include in the composite measure.
---------------------------------------------------------------------------

     Recall--The study measured participants' recall of the
nine warning statements after exposure to either one of the proposed
required warnings or the text-only control (baseline). Participants
were also re-contacted after 1 week and asked about their recall of the
warning statement they had viewed (1 week follow-up). The results were
analyzed to determine whether exposure to the proposed required
warnings elicited higher recall of the warning statements than exposure
to the text-only controls. In addition, in the treatment groups (i.e.,
participants who viewed one of the proposed required warnings), recall
of the image was assessed at baseline and at 1-week follow-up. Because
the control group did not view an image, the impact of the proposed
required warnings on image recall was measured against one of the
proposed required warnings for each warning statement that had been
selected to be the referent image and statistically assessing whether
recall of the images associated with the other proposed required
warnings was higher or lower than recall of the referent image.
     Influence on Beliefs--The study assessed whether the
proposed required warnings had a significant impact on beliefs about
the health risks of smoking to regular smokers relative to the text-
only control, as well as whether they had a significant impact on
beliefs about the health risks of secondhand smoke exposure to
nonsmokers relative to the text-only control.
     Behavioral Intentions--The study assessed whether the
proposed required warnings may have a significant impact on cessation,
by assessing smokers' intentions to quit smoking (i.e., asking
participants how likely it is that they would try to quit smoking
within the next 30 days). In youth, the study assessed whether the
proposed required warnings may have a significant impact on potential
initiation, using a measure of how likely youth felt they were to be
smoking 1 year from now.
    As the study report (Ref. 49) explains, the outcomes examined were
selected based on established theories of message processing and
health-related behavior change, which suggest that immediate emotional
and cognitive reactions to messages, and recall of messages, are part
of a process that eventually leads to

changes in beliefs and intentions and ultimately to behavior change.
2. Use of FDA's Research Study Results in Selection of Images
    As described in section III.A of this document, in order to
determine which color graphic images to require in the final rule, we
considered a number of factors, including the results from our research
study. We carefully examined the research results for the 36 proposed
required warnings on all the different outcomes in determining which
images to require in this final rule. However, the responses on the
salience measures served as a primary basis for distinguishing among
the 36 proposed required warnings for a number of reasons.
    First, many of the proposed required warnings elicited significant
impacts on the salience measures (emotional and cognitive measures),
which the research literature suggests are likely to be related to
behavior change (Ref. 51). For example, the literature suggests that
risk information is most readily communicated by messages that arouse
emotional reactions (see Ref. 45), and that smokers who report greater
negative emotional reactions in response to cigarette warnings are
significantly more likely to have read and thought about the warnings
and more likely to reduce the amount they smoke and to quit or make an
attempt to quit (Ref. 44). The research literature also suggests that
warnings that generate an immediate emotional response from viewers can
result in viewers attaching a negative affect to smoking (i.e., feel
bad about smoking), thus undermining the appeal and attractiveness of
smoking (Ref. 45 and Ref. 40 at pp. 37-38).
    In comparison to the salience measures, fewer of the proposed
required warnings elicited significant impacts on the beliefs measures
in our research study, and on the whole the proposed required warnings
did not elicit strong responses on the intentions measures. Given the
design of our research study, where participants had only a single
exposure to one proposed required warning, it is not surprising that
the proposed required warnings did not consistently show effects on
these beliefs and intentions measures, which are more eventual outcomes
in the behavior change process than the salience responses, which occur
more immediately. However, this does limit the utility of these longer-
term measures in discriminating across the proposed required warnings.
Thus, given the design of the study, the results on the salience
measures, which the research literature indicates are predictors of
more eventual behavioral outcomes, were considered to be more
meaningful than the results on the beliefs and intentions measures in
discriminating between the images.
    In addition, we gave greater weight to outcomes on the salience
measures than to outcomes on the statement recall measures for several
reasons. First, there is evidence to suggest that, while recall of
associated warning message statements may be reduced in the short term
by moderately or highly graphic pictorial warnings versus text-only
controls or less graphic pictorial warnings, these warnings still
increase intentions to quit through evoked emotional responses (Ref.
52). Second, as described previously, participants in the research
study were exposed to a single viewing of the proposed required
warnings, which does not allow for assessment of the effect that
repetitive viewing of the required warnings may have on recall. Recall
can be expected to increase in real world settings where consumers will
be exposed to the warnings multiple times. Third, recall was generally
high for all the proposed required warnings, even where there was not a
significant difference compared to the text-only control or where
recall was significantly lower for the proposed required warning than
for the text-only control. For example, for the nine required warnings
that we selected for use in this final rule, the research study shows
that recall of both the textual warning statements and the color
graphic images was high at both baseline and at 1-week follow-up,
exceeding 50 percent on all measures, and, in many cases, exceeding 80
percent.
3. Comments on FDA's Research Study
    FDA received a number of comments related to its research study in
the docket for the proposed rule, which are summarized and responded to
in the following paragraphs.
    a. Study design. Several comments addressed the cross-sectional
design of the study.
    (Comment 22) Several comments, including comments from cancer
researchers, nonprofit organizations, and academics noted that
participants in the study were exposed to a proposed required warning
only once in a controlled environment. These comments stated that the
single exposure study design makes it impossible to assess long term or
actual effects of the proposed required warnings. Two of these comments
recommended that FDA conduct longitudinal research or post-market
surveillance to assess actual long-term effects.
    (Response) We agree that the study design does not permit us to
reach firm conclusions about the long-term, real-world effects of the
proposed required warnings on the measured outcomes. As noted
previously, the purpose of the study was not to assess actual effects
but to assess the relative effects of the proposed required warnings on
various outcomes. Data on the relative effects of the various proposed
required warnings provided a more objective and scientific basis to
help select which required warnings should be included in the final
regulation. A cross-sectional design with a single exposure under
experimental conditions is appropriate for assessing relative effects.
For absolute effects, the scientific literature presented in the
preamble to the proposed rule provides a substantial basis for our
conclusion that the required warnings will effectively communicate the
health risks of smoking, thereby encouraging smoking cessation and
discouraging smoking initiation.
    However, we recognize the value of conducting an ongoing evaluation
of the effects of the required warnings after they enter the
marketplace, and we intend to monitor and evaluate their ability to
effectively communicate the negative health consequences of smoking.
This evaluation will provide information regarding whether the required
warnings effectively reach the appropriate target audiences, wear out
of the required warnings, and whether and what changes to the required
warnings may be appropriate in any future rulemaking on this subject.
    (Comment 23) A comment from tobacco product manufacturers stated
that a longitudinal study demonstrating that the required warnings
would have actual effects on smoking prevalence was necessary to
support the final regulation.
    (Response) We appreciate the value of longitudinal studies but
disagree that such a study is necessary to support the final
regulation. As discussed previously, our research study assessed the
relative efficacy of the 36 proposed required warnings published with
the NPRM, and the cross-sectional study design was appropriate for that
purpose. The scientific literature presented in the preamble to the
proposed rule provides a substantial basis for our conclusion that the
required warnings will effectively communicate the health risks of
smoking, thereby encouraging smoking cessation and discouraging smoking
initiation.

    (Comment 24) Several comments discussed behavioral models similar
to that described in FDA's research study (see Ref. 49) and explained
how those models provide a rationale for how health warnings can
effectively communicate risk information about the harmful effects of
tobacco use. For example, one comment from a researcher working on an
international project to evaluate the impact of graphic health warnings
for tobacco products stated that the primary objectives of health
warnings are to educate and inform smokers and nonsmokers about the
many negative health consequences of smoking and to provide information
that can enhance their efficacy for quitting. The comment noted that
effective health warnings increase knowledge and thoughts about the
harms of cigarettes, the extent to which the smoker could personally
experience a smoking-related disease, and as a result, increase
motivation to quit smoking. Another academic who also is conducting
research on graphic health warnings commented that a wide variety of
research suggests that health warnings with pictures are significantly
more likely to draw attention, result in greater information
processing, and improve memory for warnings than text-only warnings. A
comment from a researcher with expertise in risk perceptions and
decisionmaking stated that changes in smoking behavior based on warning
labels appear to require four steps: (1) Immediate, negative affective
reactions to the potential consequences of smoking; (2) associations of
these emotional reactions to smoking cues; (3) increases in perceptions
of the risks of smoking, and finally (4) increases in quit
contemplation and reductions in smoking behaviors.
    (Response) We agree that the design of our research study is
consistent with established social science models (in psychology,
economics, and related fields) of risk communication and health
behavior change. The purpose of graphic health warnings is to
effectively communicate the negative health consequences of cigarette
use to smokers and nonsmokers, which is critical given the seriousness
of these consequences. Greater understanding of those health effects
will motivate some smokers to stop smoking and prevent some nonsmokers
from starting to smoke. The preamble to the proposed rule presented a
detailed discussion of the scientific literature to substantiate our
conclusion that graphic health warnings can be an effective means of
communicating important health information about the risks of smoking
(see 75 FR 69524 at 69531 through 69533). These comments provide
additional support for that conclusion.
    b. Study results. Several comments discussed the results from FDA's
research study.
    (Comment 25) Several comments, including comments from academics,
nonprofit organizations, and health professional organizations, stated
that FDA's research study provides data consistent with the overall
literature demonstrating the effectiveness of graphic health warnings.
For example, one comment stated that in general the study results are
consistent with prior findings that the addition of graphic images to
health warnings is beneficial in comparison to text-only warnings.
Another comment stated that, based upon the FDA study and the existing
scientific literature, it is possible to conclude that the proposed
graphic warnings are likely to be effective.
    Other comments, including comments from tobacco product
manufacturers, advertising industry associations, and a public policy
organization, asserted that FDA's research study fails to provide
evidence of efficacy. These comments stated that the study did not show
evidence that the proposed required warnings would actually affect
prevalence of smoking, and failed to demonstrate sufficient evidence
that the proposed required warnings would significantly affect consumer
knowledge of the risks of smoking or actual behavior change.
    (Response) We agree that the study is generally consistent with the
existing scientific evidence demonstrating that graphic health warnings
can effectively communicate the negative consequences of cigarette
smoking, and by doing so, can encourage smoking cessation and
discourage smoking initiation. We disagree that the study results do
not support the efficacy of the warnings. We presented substantial
research in the preamble to the proposed rule supporting the efficacy
of graphic health warnings (75 FR 69524 at 69531 through 69534), and
the results of our research study are consistent with that research.
    c. Study outcome measures. Numerous comments discussed the key
outcomes measured in FDA's research study.
    (Comment 26) FDA received a wide variety of comments concerning the
use of emotional reactions to assess the relative effectiveness of the
proposed graphic warnings. A number of comments, including those from
academics, medical institutions, and public health groups, supported
the inclusion of emotional reaction measures. These comments stated
that graphic health warnings that elicit strong emotional reactions,
especially negative feelings, are more effective in communicating the
negative health consequences of smoking and in motivating healthier
behaviors than warnings that do not elicit emotional reactions, and
indicate that these effects are well established in the scientific
literature.
    For example, one comment stated that the scientific literature
shows that graphic depictions of the negative health effects of smoking
arouse reasonable fears and are associated with greater consideration
of health risks, increases in motivations to quit, and ultimately with
attempts at cessation. Another comment stated that theoretical models
and studies in communications and social psychology suggest that
graphic health warnings can be effective because they elicit greater
emotional engagement with the information provided and it is that
engagement that drives behavior change. Another comment from an
academic researcher stated that considerable psychological research
suggests that risk is more readily communicated by information that
arouses emotional associations with the activity. Emotional reactions
can be readily accessed from memory by mere presentation of the
stimulus, and appear to be powerful predictors of smoking behavior. Yet
another comment stated that growing evidence from controlled
experiments and survey research indicates that, compared to text-only
warnings, graphic health warnings evoke stronger emotional responses
and increase motivations to quit or not start smoking. The comment
indicated that these studies are consistent with cognition and
neuroscience research demonstrating that relative to linguistic or text
information, imagery-based information can be processed more rapidly,
evoke stronger emotional responses, induce greater cognitive processing
and attitude change and can be recalled more easily.
    However, other comments stated that reliance on emotional measures
for assessing graphic health warnings is inappropriate. A joint comment
from tobacco product manufacturers stated that the study measured only
the effect of eliciting strong emotional and cognitive reactions, which
confirms that the warnings were intended not to inform consumers with
purely factual and uncontroversial information, but rather to shock
consumers into adopting the Government's preferred course of conduct.
Another tobacco product manufacturer commented that, to the extent FDA
selected images based on emotional or cognitive reactions and not

on ability to inform consumers about the health risks of smoking, the
regulations would not pass constitutional muster. A comment from a
public policy organization commented that emotional and cognitive
responses are irrelevant measures of effectiveness if there is no
behavior response.
    (Response) On the basis of our review of the relevant scientific
literature and the feedback received in the docket, we conclude that
our inclusion of emotional reaction measures to evaluate the relative
effects of the 36 proposed required warnings was appropriate and is
consistent with well-established principles in the scientific
literature. As discussed in the study report that was placed in the
docket (Ref. 49) and in other comments summarized in previously in this
document, eliciting strong emotional and cognitive reactions to graphic
warnings enhances recall and information processing, which helps to
ensure that the warning is better processed, understood, and
remembered. Thus, these responses can enhance the effective
communication of the health warning message. These responses in turn
influence short-term outcomes, such as later recall of the message and
changes in knowledge, attitudes, and beliefs related to the dangers of
tobacco use and exposure to secondhand smoke. As attitudes and beliefs
change, they eventually lead to changes in intentions to quit or to
start smoking and then later can lead to lower likelihood of smoking
initiation and greater likelihood of successful cessation.
    We disagree that use of emotional reaction measurements
demonstrates the Agency's intent to advocate a preferred position or
course of conduct. Each of the nine graphic warnings required by the
final regulations communicates negative health consequences of smoking
that are well-established in the scientific literature. Consistent with
the Tobacco Control Act, the purpose of these required warnings is to
communicate effectively and graphically the very real, scientifically
established adverse health consequences of smoking. The overall body of
scientific evidence indicates that health warnings that evoke strong
emotional responses enhance an individual's ability to process the
warning information, leading to increased knowledge and thoughts about
the harms of cigarettes and the extent to which the individual could
personally experience a smoking-related disease. Increased knowledge
and thoughts about the negative consequences of smoking, in turn, are
reasonably likely to result in more informed and healthier behaviors,
such as trying to quit smoking or deciding not to start.
    (Comment 27) We also received two comments concerning the cognitive
measure used in the study. A comment filed by tobacco product
manufacturers observed that ``looks cool'' was one of the measured
cognitive reactions. The comment stated that the study analysis omits
responses on whether the warnings ``looked cool,'' and contended that
if a substantial number of participants viewed a warning as ``looks
cool,'' the warning would be unlikely to have the intended effect. The
comment concluded that the ratings for the ``looks cool'' measure do
not appear to have been neutral; the comment stated that regression
results for the ``looks cool'' measure indicates that this measure
elicited one of the strongest estimated effects of the study and the
results go in the opposite direction of effectively communicating
health risk information.
    (Response) We disagree that data concerning the ``looks cool''
outcome was omitted or that the results for this outcome go in the
opposite direction of the intended effect of communicating the negative
health consequences of smoking. Although the ``looks cool'' outcome was
not included in the reported composite cognitive measure, the study
report (Ref. 49) includes the results for this measure in its
appendices. The measure was reverse coded, so that a higher value
corresponded with the intended directionality for other measures. Thus,
a high value for ``looks cool'' corresponds to a response of ``strongly
disagree'' from the respondent. The data presented in the appendices
demonstrate that for each of the nine selected required warnings,
significantly more participants disagreed that the warning ``looked
cool'' than participants who viewed the text-only control warning.
Eight of the nine required warnings elicited significantly higher
ratings than the text-only control warning across all target audiences.
Ratings for the ninth required warning, which includes the textual
statement ``WARNING: Quitting smoking now greatly reduces serious risks
to your health,'' show that significantly more adults disagreed that
the selected required warning ``looked cool.'' Responses for young
adults and youth were in the appropriate direction, but the responses
were not significantly different from the text-only control warning.
    (Comment 28) We also received a comment concerning the
believability measure. This comment raised a concern that some of the
36 proposed required warnings may be perceived as unrealistic because
they did not vividly portray immediate health risks, which could lead
some smokers to discount the warning. The comment recognized that a
believability measure was included in the study as part of the
cognitive reaction scale, but stated that specific results for
believability were not reported, and recommended that FDA examine the
mean scores of the specific believability items in conjunction with
other important measures included in the study.
    (Response) We agree with the comment that believability is a
helpful measure for assessing the relative effectiveness of warning
images. All of the selected images scored significantly higher than the
controls on the cognition measures, which included ratings on how
meaningful the warning was, whether it was informative, and whether it
was believable. While the results do not include mean scores for
believability and other individual measures, the appendices include the
parameter estimates from regression analyses on these individual
measures. The results show that, in most cases, the images selected for
the nine required warnings scored significantly better than the control
with respect to believability.
    (Comment 29) One comment stated that the statement recall measure
is less important and less relevant to decisions about smoking than
negative affective reactions because the warning statements are now
believed by smokers and nonsmokers.
    (Response) Statement recall was appropriately included as part of
the assessment of the relative effectiveness of the 36 proposed
required warnings. As discussed in section II.C of this document, while
both smokers and nonsmokers have some understanding about some of the
risks of smoking, there are significant gaps in their knowledge,
including about the magnitude and severity of the risks of smoking. We
also note that, as explained in section III.B.2 of this document,
although we carefully examined the research results on all the study
measures for the 36 proposed required warnings, including recall, the
responses on the salience measures served as a more important basis
than recall for distinguishing among the 36 proposed required warnings.
    (Comment 30) A joint comment submitted by tobacco product
manufacturers asserted that the study fails to demonstrate that the
published graphic warnings will have any discernible effects on smoking
risk beliefs.

    (Response) We disagree with this comment. Four of the nine selected
required warnings did show a significant impact on beliefs about the
health risks of smoking relative to the text-only control among at
least one study population. In addition, there is substantial evidence
in the scientific literature showing that graphic health warnings
effectively increase consumer understanding of the health risks of
smoking. In the preamble to the proposed rule (75 FR 69524 at 69531
through 69533), we presented substantial research showing that graphic
health warnings significantly increase consumer thoughts about and
understanding of the health risks of smoking after they were introduced
in other countries. In addition, as discussed previously in this
document, considerable scientific evidence shows that health warnings
that elicit strong emotional and cognitive reactions are better
processed and more effectively communicate information about the
negative health consequences of smoking. Each of the nine required
warnings elicited strong effects on the emotional and cognitive
reaction scales, which indicates that these warning will effectively
communication information about the negative health consequences of
smoking.
    Based on the results of our research study and the existing
scientific literature, we conclude that graphic health warnings,
including the nine selected required warnings, are likely to increase
consumer knowledge and understanding of the health risks of smoking.
    (Comment 31) A comment submitted by tobacco product manufacturers
criticized the study's use of intentions to measure behavioral change
and stated that FDA should have presented data showing actual effects
on behavior.
    (Response) We disagree that intentions are an inappropriate
variable for assessing potential behavioral changes. While measures of
intended behavioral outcomes do not perfectly predict a future behavior
outcome, it is a necessary precursor. The scientific literature
indicates that one's intentions to quit smoking must be increased
before one makes the actual quit attempt. Thus, we conclude that it was
appropriate in our research study to assess quit intentions as a proxy
for behavior change. In accordance with Executive Order 13563, after
the rule is in effect we will be undertaking analysis to better
understand the behavioral effects of the warnings.
    (Comment 32) Several comments raised concerns that the lack of
strong statistically significant results concerning intentions in FDA's
research study is an indication that the required warnings will not be
effective. For example, a comment submitted by tobacco product
manufacturers stated that the results of FDA's research study show that
graphic health warnings will not result in a statistically significant
reduction in youth initiation or overall prevalence of smoking, and
thus, confirms that the warnings will not be effective.
    (Response) We disagree that our study results indicate that the
required warnings will not be effective. It is important to recognize
that FDA's research study was not designed or intended to produce
evidence demonstrating actual effects on behavior. Rather, the study
was designed to provide data concerning the relative effects of the
graphic health warnings in order to provide a more objective and
scientific basis for our selection of the set of nine required warnings
in the final regulation. There is considerable evidence in the
scientific literature demonstrating that graphic health warnings
effectively increase awareness of the health risks of smoking, which is
the principal purpose of the warnings, and that this awareness in turn
can influence smoking intentions and behaviors. We included significant
research to substantiate this conclusion in the preamble to the
proposed rule (see 75 FR 69524 at 69531 through 69533). For example, as
discussed in the proposed rule, a 2007 report from an expert IOM panel
that evaluated the existing scientific evidence on health warnings
concludes that the available scientific evidence indicates that larger,
graphic health warnings would promote greater public understanding of
the health risks of using tobacco and would help to reduce consumption
(Ref. 3).
    FDA's research study cannot be viewed in isolation from the overall
body of scientific evidence evaluating the efficacy of graphic health
warnings. While the research study itself did not provide evidence of
strong effects on intentions (which, as noted in section III.B.2 of
this document, is not surprising given the single-exposure design of
the study), the overall body of scientific literature does provide
sufficient evidence that the required warnings, by increasing public
understanding of and thoughts about the health risks of smoking, will
be effective in encouraging smoking cessation and discouraging smoking
initiation.
    A number of comments provide additional support for our conclusion.
For example, a comment from a researcher conducting an international
longitudinal study on graphic health warnings states that studies show
that graphic depictions of smoking's adverse effects on the body are
associated with greater consideration of health risks, increases in
motivations to quit smoking, and ultimately, attempts at cessation. A
comment by a researcher with expertise in risk perceptions and
decisionmaking concludes that emotional associations to smoking appear
to be powerful predictors of smoking behavior and may well be causally
implicated in efforts to either stop or start smoking.
    (Comment 33) A comment from tobacco product manufacturers stated
that the responses to the ``smoking urges'' questions included in the
study would provide a better measure for assessing whether the proposed
required warnings affected smoking behavior and, referring to the
responses regarding these questions, the comment asserts that, on
balance, seeing the proposed required warnings increased the desire to
have a cigarette rather than decreased it.
    (Response) We disagree that our research study shows that, on
balance, seeing the proposed required warnings increased the desire to
have a cigarette. The ``smoking urges'' measures were reverse coded, so
that a higher value corresponded with the intended directionality for
other measures in the study. Thus, a high value corresponds to a
response of ``strongly disagree'' from the respondent. The data
presented in the study report appendices (Ref. 49, study report) show
that, for three of the nine selected required warnings, significantly
more participants in at least one target group disagreed with the
statement that they wanted a cigarette than participants exposed to the
text-only control warning. For one of the selected required warnings,
significantly more adult participants who viewed the warning on a
cigarette pack disagreed that they wanted a cigarette, but
significantly more adults who viewed the warning in a cigarette
advertisement agreed. For one of the selected required warnings,
significantly more participants in one target audience agreed that they
wanted a cigarette than participants exposed to the text-only control
warning. Results for the remaining selected required warnings and
sample groups were not significantly different from the text-only
control warning.
    Thus, on balance, the study does not show that exposure to the
final set of nine images increased the desire to smoke a cigarette
among study participants. As discussed in the previous response, the
overall body of

scientific literature provides ample evidence that the required
warnings, by increasing public understanding of and thoughts about the
health risks of smoking, are likely to encourage smoking cessation and
discourage smoking initiation. Data from our research study regarding
``smoking urges'' provide no basis for calling into question that
evidence.
    d. Study limitations and issues regarding methodology. A number of
comments discussed a wide variety of issues concerning limitations of
FDA's research study and raised various issues concerning the study
methodology.
    (Comment 34) Several comments, including comments from health
institutions, nonprofit organizations, and academics, raised concerns
that the demographics of FDA's research study did not include adequate
sample sizes for minority populations and persons of lower income or
lower education status. These comments noted that the findings of the
study therefore may not be relevant to populations with high smoking
prevalence and to those consumers who might be most impacted by graphic
health warnings. Some of the comments recommended further testing in
these populations.
    (Response) We recognize the importance of reaching populations with
high smoking prevalence, including various racial/ethnic groups and
persons of lower income or lower education status. The study report
provides analyses of the relative effects of the images within various
sub-groups, separating samples by gender, race, and education. The
analyses, for the most part, confirm that the relative effects of the
images are consistent across groups. As such, we have determined that
the required warnings will help to effectively convey the negative
health consequences of smoking to a wide range of audiences, including
different racial and ethnic populations and different socioeconomic
groups.
    (Comment 35) A comment from tobacco product manufacturers
criticized the study methodology because it did not include a
nationally representative sample of participants and claimed that this
failure biased the study results. The comment stated that the study
report (Ref. 49, study report) fails to disclose basic sampling
information and provides no indication that those conducting the study
adjusted for the effect of choosing participants by soliciting
volunteers. The comment concluded that this failure was significant
because the participants in the study may not reflect the population of
interest and may bias the statistical estimates.
    (Response) We disagree that the study results are invalid due to
the demographic composition of the sample. The research study was not
intended to be a survey of the national population, but rather a study
using random assignment to study conditions. The study included
individuals from certain target groups, particularly current smokers
and youth who may be susceptible to initiation of smoking. Statistical
methods were used to assess the relative impact of each of the proposed
required warnings on various outcomes, rather than to assess the
absolute impact one would expect to observe in the U.S. population as a
whole.
    (Comment 36) One comment raised a concern that lack of adequate
pretesting of the proposed required warnings evaluated in FDA's
research study could compromise the overall effectiveness of the pool
of images tested. The comment stated that it would have been more
helpful to conduct pilot testing with a very large group of images (at
least 20 per textual warning statement) to ensure testing and selection
of the most effective graphic warnings.
    (Response) We agree that more extensive pretesting may have been
useful. However, we disagree with the suggestion that the overall
effectiveness of the required warnings could be compromised by the
inability to conduct additional pretesting prior to the research study.
The results of the research study as well as research submitted by
others during this rulemaking proceeding indicate that the overall
efficacy of the pool of proposed required warnings is quite strong.
Based on those data, as well as the overall scientific literature, we
conclude that the required warnings will effectively communicate the
negative health consequences of smoking to smokers and nonsmokers.
    (Comment 37) A comment submitted by tobacco product manufacturers
asserted that selection bias is a serious methodological flaw of the
study. The comment stated that participants were recruited from an
Internet panel and offered the opportunity to participate in the
research study, creating a selection bias that was compounded by the
fact that the invitation to participate stated that the study was
funded by FDA. The comment noted that there is no indication that the
study corrected for the selection bias and opines that one would not
expect the selection bias to be neutral given the identification of FDA
as the sponsor of the study.
    (Response) We disagree that selection bias is a serious
methodological flaw of the study. Although we acknowledge the potential
for selection bias, we disagree that this potential bias was likely to
significantly affect the results of the study. Even if participants who
approve (or disapprove) of FDA were more likely to participate in the
study, one would expect that bias would affect all of the experimental
conditions, including the text-only control warnings. A bias of this
sort would affect the absolute effects of the warnings in general, but
not the pattern of relative effectiveness of individual warnings. As a
result, selection bias does not invalidate the results of the study,
which provides insight on the relative effectiveness of the various
warnings under consideration.
    (Comment 38) A comment from tobacco product manufacturers stated
that FDA's research study is seriously flawed because 32 percent of the
participants dropped out of the study before completing the
questionnaire. The comment stated that quitting the survey was not
likely to be a random event and may have been a result of smokers who
are not receptive to graphic health warnings dropping out. If so, the
comment suggested that this would have significantly overstated the
results of the study.
    (Response) We disagree that the drop-out rate observed in the study
undermines the validity of the results of the study. Table 3-1 from the
methodology report displays the total number of individuals entering
the study. However, these values represent the total number of
individuals who entered the study's ``landing page,'' which is the site
to which invitees link from the e-mail invitation. The invitation from
e-Rewards, as well as the landing page, refers to the study as a
``Study about Consumer Products.'' There were no references to FDA,
smoking, or tobacco in either the invitation or the landing page.
Though it is true that a number of invitees chose not to continue after
seeing the invitation or the landing page, their decision not to
participate cannot be attributed to a bias for or against FDA or the
implementation of graphic health warnings on cigarettes.
    In addition, the number of individuals identified as ``Quits'' in
table 3-1 of the methodology report includes individuals who quit after
viewing the landing page and those who quit after having been informed
of FDA's involvement and that the survey concerned smoking or tobacco.
Of those individuals identified as ``Quits'', only a very small number
were in the latter group (i.e., quit after being informed of FDA's
involvement and that the survey concerned smoking or tobacco). For

example, of the 13,673 respondents who entered the adult pack survey
(the point in time when they viewed the study's landing page), 2,179
chose at some point to discontinue. Of these, only 148 individuals, or
about 1.1 percent of those entering the study, chose to discontinue the
survey after being informed of FDA's involvement and that the survey
concerned smoking or tobacco. A similar pattern exists for all of the
study samples: In the adult pack follow-up sample 23 individuals, or
0.6 percent, chose to discontinue after being informed; in the adult ad
study sample 193 individuals, or 2.1 percent, chose to discontinue
after being informed; in the adult ad follow-up sample 26 individuals,
or 0.7 percent, chose to discontinue after being informed; in the young
adult study sample 152 individuals, or 1.3 percent, chose to
discontinue after being informed; in the young adult follow-up sample
11 individuals, or 0.3 percent, chose to discontinue after being
informed; in the youth study sample 104 individuals, or 0.3 percent,
chose to discontinue after being informed; and in the youth follow-up
sample 13 individuals, or 0.5 percent, chose to discontinue after being
informed. The drop-out rate, as calculated here, varies across the
study samples but never exceeds 2.1 percent. Therefore, we do not agree
that the drop-out rate invalidates the results of the study.
    (Comment 39) A comment from tobacco product manufacturers stated
that the youth component of FDA's research study is subject to a
response bias. The comment stated that the study failed to address the
risk that the youth participants might alter their responses due to a
concern that their parents might see the results.
    (Response) We disagree that the youth sample is likely subject to a
response bias. Youth participants were told at the outset of the study
that their responses would be kept confidential. Once the study was
complete, other household members could not retrieve those responses.
Moreover, if youth participants were concerned about parental awareness
of their participation, it would likely have resulted in a decision not
to participate rather than a decision to alter their responses.
    (Comment 40) A comment from tobacco product manufacturers raised a
concern that the youth sample is subject to a selection bias because
participants were derived from families whose parents also participated
in the study.
    (Response) We disagree. As discussed in section 2.2.3 of the
methodology report (included in the docket as part of the study report
(Ref. 49, study report)), most of the youth were sampled from a
separate youth panel, which was independent of the adult panel. Some of
the youth were sampled from the households of the adult panel. However,
those in the latter group were sampled independently and randomly from
the adults that participated in the study. Although possible, it is
unlikely that both a parent and child from a single household received
an invitation for the study and completed the study.
    (Comment 41) A comment from tobacco product manufacturers objects
to the manner in which the study assessed emotional and cognitive
reactions. The comment states that the study weighted the responses to
multiple questions, but fails to disclose the weights used and the
justification for those weights, and states that without information on
the weighting system, one cannot assess these measures for bias.
    (Response) We disagree with this comment. Section 4.2 of the
methodology report for our research study (included in the docket as
part of the study report (Ref. 49, study report)) indicates that a
factor analysis was used to determine the appropriate items to include
within each scale. A weighting scheme was not used. Rather, items were
combined using a simple summative scale. Use of a simple summative
scale is a widely-used method of analyzing these data.
    (Comment 42) A comment from tobacco product manufacturers states
that the study used an inappropriate methodology by measuring risk
awareness and smoking intentions on a scale. The comment states that
evaluating these measures on a scale is inappropriate for testing
awareness of a fact and also resulted in the authors making subjective
and undisclosed decisions about how to weight those values.
    (Response) We disagree. It is appropriate to measure the impact of
a warning on the strength of an individual's awareness, beliefs, and
intentions. To do this, one must use a scaled response, rather than a
dichotomous response, to each question. In the research study, items
were not weighted within each scale. Rather, they were combined using a
simple summation of ratings. This is a widely-used methodology for this
type of study.
    (Comment 43) A report attached to the comment from tobacco product
manufacturers criticizes FDA's research study for failing to assess
baseline knowledge among participants to determine whether the proposed
required warnings increased awareness of the health effects of smoking.
    (Response) The lack of an assessment of baseline knowledge does not
make the study results less reliable or invalid. In a study such as
FDA's research study, responses to the control conditions serve as
proxies for baseline knowledge, awareness, beliefs, and intentions.
Comparing the treatment responses to those of the control allow for an
assessment of the potential impact the treatment has on baseline
measures.

C. Comments to the Docket

    FDA received hundreds of comments on the 36 proposed required
warnings; the comments relating to each proposed required warning are
discussed in sections III.D and III.E of this document. Some comments
discussed the 36 proposed required warnings generally or discussed
different styles or themes used in the set of proposed required
warnings. These comments are summarized and responded to in this