Required Warnings for Cigarette Packages and Advertisements, 36628-36777 [2011-15337]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Rules and Regulations]
[Pages 36628-36777]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15337]



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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, 877-287-1373, gerie.voss@fda.hhs.gov 
or kristin.davis@fda.hhs.gov.

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.

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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

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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

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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

[[Page 36632]]

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

[[Page 36633]]

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

[[Page 36634]]

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

[[Page 36635]]

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

[[Page 36636]]

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 propo