Required Warnings for Cigarette Packages and Advertisements, 69524-69565 [2010-28538]

Agencies

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

[Federal Register Volume 75, Number 218 (Friday, November 12, 2010)]
[Proposed Rules]
[Pages 69524-69565]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28538]



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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; Proposed 
Rule

Federal Register / Vol. 75 , No. 218 / Friday, November 12, 2010 / 
Proposed Rules

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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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its regulations to add a new requirement for the display of health 
warnings on cigarette packages and in cigarette advertisements. The 
proposed rule would implement 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 that will be 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 proposed rule, once finalized, would specify the color graphics 
that must accompany each of the nine new textual warning statements.

DATES: Interested persons may submit either electronic or written 
comments on this proposed rule by January 11, 2011. See section IV.G of 
this document for the proposed effective date of a final rule based on 
this proposed rule.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2010-
N-0568 and/or RIN number 0910-AG41, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and Regulatory Information Number (RIN) for this 
rulemaking. All comments received may be posted without change to 
https://www.regulations.gov, including any personal information 
provided. For additional information on submitting comments, see the 
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number(s), found in brackets in the heading of this document, 
into the ``Search'' box and follow the prompts and/or go to the 
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852.

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. Legal Authority and Background
II. Cigarette Use in the United States and the Resulting Health 
Consequences
    A. Smoking Prevalence Among Adults and Children
    B. Initiation of Smoking Among Adults and Children
    C. Costs to Society and Health Effects of Cigarettes
    1. Costs of Smoking to Society
    2. Negative Health Effects of Cigarettes
III. Data Concerning Health Warnings
    A. Current Warnings on Cigarette Packages and Advertisements Are 
Inadequate
    1. Current Warnings Have Not Changed in More Than Twenty-Five 
Years
    2. Current Warnings Often Go Unnoticed
    3. Current Warnings Fail to Convey Relevant Information in an 
Effective Manner
    B. Larger, Graphic Warnings Communicate More Effectively: 
International Experience
    1. Getting Consumers' Attention
    2. Influencing Consumers' Awareness of Cigarette-Related Health 
Risks
    3. Impacting Smoking Intentions and Behaviors
    C. Benefits of FDA's Proposed Required Warnings
    1. The Addition of Graphic Images Will Have a Significant, 
Positive Impact on Public Health
    2. The Revised Textual Statements Will Communicate More 
Effectively
    D. FDA's Process for Development and Plan for Selection of the 
Required Warnings
IV. Description of Proposed Regulations
    A. Section 1141.1--Scope
    B. Section 1141.3--Definitions
    C. Section 1141.10--Required Warnings
    D. Section 1141.12--Incorporation by Reference of Required 
Warnings
    E. Section 1141.14--Misbranding of Cigarettes
    F. Section 1141.16--Disclosures Regarding Cessation
    G. Proposed Effective Date
V. Paperwork Reduction Act of 1995
VI. Executive Order 13132: Federalism
VII. Environmental Impact
VIII. Analysis of Impacts
    A. Introduction and Summary
    B. Need for Rule
    C. Benefits
    1. Reduced Smoking Rates
    2. Expected Life-Years Saved
    3. Benefits of Reduced Premature Mortality
    4. Reduced Emphysema
    5. Reduced Fire Costs
    6. Medical Services
    7. Summary of Benefits
    8. Uncertainty Analysis
    D. Costs
    1. Number of Affected Entities
    2. Costs of Changing Cigarette Labels
    3. Market Testing Costs Associated With Changing Cigarette 
Package Labels
    4. Advertising Restrictions: Removal of Noncompliant Point-of-
Sale Advertising
    5. Government Administration and Enforcement Costs
    6. Summary of Costs
    E. Cost-Effectiveness Analysis
    F. Distributional Effects
    1. Tobacco Manufacturers, Distributors, and Growers
    2. National and Regional Employment Patterns
    3. Retail Sector
    4. Advertising Industry
    5. Excise Tax Revenues
    G. International Effects
    H. Regulatory Alternatives
    1. 24-Month Compliance Period
    2. Six-Month Compliance Period
    3. Summary of Regulatory Alternatives
    I. 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
IX. Comments
X. References

I. Legal Authority and Background

    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 nine new 
health warning statements appear on cigarette packages and in cigarette 
advertisements:
     WARNING: Cigarettes are addictive
     WARNING: Tobacco smoke can harm your children

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     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 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.
    Section 202(b) of the Tobacco Control Act amends section 4 of FCLAA 
(15 U.S.C. 1333) to add a new subsection \1\ that permits FDA to, after 
notice and an opportunity for the public to comment, adjust the format, 
type size, color graphics, and text of any health warning statement if 
such a change would promote greater public understanding of the risks 
associated with the use of tobacco products. Similarly, section 202(b) 
of the Tobacco Control Act permits FDA to adjust the format, type size, 
and text of any other disclosures required under the FD&C Act, using 
the same process and upon the same basis as for adjusting the health 
warning statements.\2\ Among the provisions of the FD&C Act that 
provide authority to require disclosures is section 906(d) (21 U.S.C. 
387f(d)). This provision authorizes FDA to issue regulations 
restricting the sale or distribution of cigarettes and other tobacco 
products, including restrictions on the advertising and promotion of 
such products, if FDA determines the restriction is appropriate for 
protecting the public health.
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    \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.''
    \2\ Provisions regarding adjustments to the health warnings and 
other disclosures are also in sections 4(b)(4) and 4(d) of FCLAA, as 
amended by section 201 of the Tobacco Control Act.
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    These requirements are supplemented by the FD&C Act's misbranding 
provisions, which require that product advertising and labeling include 
proper warnings. For example, a tobacco product is deemed misbranded 
under section 903(a)(1) or (a)(7)(A) of the FD&C Act (21 U.S.C. 
387c(a)(1) or (a)(7)(A)) if its labeling or advertising is false or 
misleading in any particular. Under section 201(n) of the FD&C Act (21 
U.S.C. 321(n)), in determining whether labeling or advertising is 
misleading, the agency considers, among other things, the failure to 
reveal material facts concerning the consequences that may result from 
the customary or usual use of the product. Similarly, under section 
903(a)(8)(B) of the FD&C Act (21 U.S.C. 387c(a)(8)(B)), a tobacco 
product is deemed misbranded unless the manufacturer, packer, or 
distributor includes in all advertisements and other descriptive 
printed matter a brief statement of, among other things, the relevant 
warnings. Moreover, a tobacco product is deemed misbranded under 
section 903(a)(7)(B) of the FD&C Act (21 U.S.C. 387c(a)(7)(B)) if it is 
sold or distributed in violation of regulations prescribed under 
section 906(d) of the FD&C Act. Under section 701(a) of the FD&C Act 
(21 U.S.C. 371(a)), FDA has authority to issue regulations for the 
efficient enforcement of the FD&C Act.
    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 
America, and has been shown to cause cancer, heart disease, and other 
serious adverse health effects (Ref. 2). In enacting the Tobacco 
Control Act, Congress found that providing FDA with authority to 
regulate tobacco products, including the advertising and promotion of 
such products, would result in significant benefits to the American 
public in human and economic terms (section 2(12) of the Tobacco 
Control Act). 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). Virtually all 
new users of tobacco products are minor children and a reduction in 
tobacco use by this population alone could significantly reduce 
tobacco-related death and disease in the United States (Ref. 3 at pp. 
5-6).
    In 1964, the Surgeon General of the Public Health Service issued 
the landmark report titled ``Smoking and Health,'' which 
comprehensively assessed the available scientific evidence relating to 
the health effects of cigarette smoking and concluded that cigarette 
smoking is a health hazard of sufficient importance in the United 
States to warrant appropriate remedial action. Subsequently, Congress 
passed the Federal Cigarette Labeling and Advertising Act (FCLAA) of 
1965 (Pub. L. 89-92); this legislation required that a printed warning 
appear on cigarette packages to warn consumers of the potential hazards 
of cigarette smoking. This warning requirement was modified by later 
amendments to FCLAA, including the Comprehensive Smoking Education Act 
(CSEA) of 1984 (Pub. L. 98-474), which extended the warning requirement 
to cigarette advertising. The current requirements for cigarette 
package and advertising warning statements are set forth in FCLAA.
    Although FCLAA has required the inclusion of textual health 
warnings on cigarette packages and in cigarette advertisements for many 
years, there is considerable evidence that the current warnings are 
given little attention or consideration by viewers (Id. at p. 168). 
These warnings, which have not changed in over twenty-five years, have 
been described as ``invisible'' and fail to convey relevant information 
in an effective way (Ref. 4; Ref. 5 at p. 291). The current warnings 
also fail to include any graphic component. In proposing this current 
regulation, FDA examined the scientific literature and found 
substantial evidence indicating that prominent warnings including a 
graphic component would offer significant public health benefits over 
the current warnings used in the United States (see Section III). FDA 
also found evidence of a strong worldwide consensus that effective 
tobacco health warnings should be large and should include a graphic 
image component. For example, the World Health Organization's (WHO) 
Framework Convention on Tobacco Control (FCTC),\3\ an evidence-based 
treaty that provides a regulatory strategy for addressing the serious 
negative impacts of tobacco products, calls for warnings that are 
rotating, ``large, clear, visible and legible.'' The treaty recommends 
that the warnings occupy 50 percent or more of the principal display 
areas, and states that they may be in the form of or include pictures 
or pictograms. WHO FCTC art. 11.1(b). Worldwide, over 30 countries/
jurisdictions have implemented pictorial warnings on tobacco packages 
and requirements for pictorial warnings are pending in several other 
countries/jurisdictions.\4\
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    \3\ There are 168 signatories to the WHO's Framework Convention 
on Tobacco Control as of August 2010. At this time, the United 
States is a signatory but has not ratified this treaty.
    \4\ Countries/jurisdictions that have implemented pictorial 
warning requirements for tobacco packaging include: Australia; 
Belgium; Brazil; Brunei; Canada; Chile; Colombia; Cook Islands; 
Djibouti; Egypt; Hong Kong; India; Iran; Jordan; Latvia; Malaysia; 
Mauritius; Mexico; Mongolia; New Zealand; Pakistan; Panama; 
Paraguay; Peru; Romania; Singapore; Switzerland; Taiwan; Thailand; 
Turkey; United Kingdom; Uruguay; and Venezuela. Countries/
jurisdictions with pending requirements include: France; Guernsey, 
Honduras; Malta; Norway; Philippines; and Spain.

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    Therefore, as directed by section 201 of the Tobacco Control Act, 
and in the interest of the public health, we are proposing to modify 
the required warnings that appear on cigarette packages and in 
cigarette advertisements to include color graphics depicting the 
negative health consequences of smoking. Specifically, we are proposing 
to add a new part 1141 to Title 21 of the Code of Federal Regulations, 
which would require new warnings on cigarette packages and in cigarette 
advertisements. These new required warnings would consist of the nine 
textual warning statements set forth in section 201 of the Tobacco 
Control Act accompanied by color graphics depicting the negative health 
consequences of smoking. As required by section 201 of the Tobacco 
Control Act, the new warnings would appear prominently on packages and 
in advertisements, occupying at least 50 percent of the area of the 
front and rear panels of cigarette packages and 20 percent of the area 
of advertisements. Under sections 201 and 202 of the Tobacco Control 
Act, FDA may adjust the type size, text, and format of the textual 
warning statements. For example, under section 4(d) of FCLAA (as 
amended by section 201 of the Tobacco Control Act), FDA may adjust the 
type size, text, and format as FDA determines appropriate so that both 
the textual warning statements and the accompanying graphics are clear, 
conspicuous, legible and appear within the specified area. Such 
adjustments, including adjustments to the text of some of the textual 
warning statements, are included for some of the new warnings FDA is 
proposing.
    These proposed modifications to the warnings currently required in 
the United States would promote greater public knowledge of the health 
risks of using cigarettes and would help reduce the initiation of 
smoking and the prevalence of cigarette use among Americans, and thus 
help prevent the life-threatening health risks posed by cigarettes. 
Specifically, 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.

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

    In the United States, cigarette smoking is the leading cause of 
preventable death and disease (Ref. 6), resulting in more deaths each 
year than AIDS, alcohol, illegal drug use, homicide, suicide, and motor 
vehicle crashes combined (Ref. 7). Each day, an estimated 6,600 
Americans (nearly 4,000 of them under the age of 18) become new smokers 
(Ref. 8 at p. 59), and due to the highly addictive nature of 
cigarettes, many will find it difficult to quit smoking, despite the 
severe health risks associated with cigarette use. Most smokers begin 
smoking before they are 18 years old (Ref. 3 at p. 6)--more than 80 
percent of established adult smokers began smoking before age 18 (Ref. 
9)--and about half of adolescents who continue to regularly smoke will 
eventually die from smoking-attributable disease (Ref. 10). Smoking 
causes at least 443,000 premature deaths annually in the United States, 
and each year cigarettes are responsible for approximately 5.1 million 
years of potential life lost, direct health care expenditures of 
approximately $96 billion, and at least $96.8 billion in annual 
productivity losses in the United States (Ref. 1). The public health 
benefits that would result from reducing the number of Americans who 
smoke, and thus preventing the life-threatening consequences associated 
with cigarette use, are substantial.

A. Smoking Prevalence Among Adults and Children

    Adults. A significant percentage of U.S. adults are cigarette 
smokers. For example, results from the 2009 National Health Interview 
Survey (NHIS) indicate that approximately 46.6 million U.S. adults (or 
20.6 percent of the adult population) are cigarette smokers (Ref. 6). 
Among these adult smokers, the vast majority--78.1 percent, or 
approximately 36.4 million people--smoke every day (Id.). There are 
also subsets of the adult population with smoking prevalence rates that 
are significantly higher than the overall average. For example, the 
highest prevalence rates have been observed in adults with low 
education levels. Data indicate that 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 (Id.).
    Children. Among children, data from the 2009 Youth Risk Behavior 
Survey (YRBS), a nationally representative survey of students in grades 
9-12 in the United States, showed that almost half (46.3 percent) of 
U.S. high school students had tried cigarette smoking, and an estimated 
19.5 percent of students were current cigarette smokers (Ref. 11 at p. 
10). Of these current cigarette smokers, 7.8 percent reported that they 
had smoked more than 10 cigarettes per day on the days they smoked (Id. 
at p. 11). Overall, approximately 7.3 percent of high school students 
in 2009 were frequent cigarette users, and 11.2 percent of students 
under the age of 18 had been daily smokers at some point during their 
lifetime (Id. at pp. 10-11). Furthermore, follow-up studies of youth 
smokers have indicated that a significant number of students who are 
light smokers (i.e., students who are not daily smokers or who smoke 
less than 10 cigarettes per day) in high school will become heavy 
smokers after leaving high school (Ref. 12).
    Trends. During the period of 1998-2009, the proportion of U.S. 
adults who were current cigarette smokers declined from 24.1 percent to 
20.6 percent. However, the proportion did not decline from 2008 to 2009 
(20.6 percent in both years), and during the five-year period of 2005 
to 2009, rates showed virtually no change (20.9 percent in 2005 and 
20.6 percent in 2009) (Ref. 6).
    For children, data from the YRBS show that smoking prevalence rates 
increased rapidly in the early 1990s, peaking around 1997. Prevalence 
then declined during the late 1990s, but the rate of decline slowed 
during 2003-2009 (Ref. 13). According to 2009 data from the University 
of Michigan's Monitoring the Future survey, cigarette smoking rates 
among 8th, 10th, and 12th grade U.S. students declined only slightly 
from 2007 to 2009, at a much slower pace than observed previously. 
Specifically, over the two-year time period from 2007 to 2009, smoking 
prevalence fell by just 0.6, 0.9 and 1.5 percentage points among 8th, 
10th, and 12th graders, respectively (Ref. 12). Data from this survey 
also indicate that the proportion of students who perceive a great risk 
associated with being a smoker has leveled off in the past several 
years (Id.).

B. Initiation of Smoking Among Adults and Children

    As discussed in section II.A, roughly one-fifth of Americans are 
current cigarette smokers. Although the cigarette industry regularly 
loses customers through user cessation and

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through deaths caused by smoking, each year millions of U.S. adults and 
children become new smokers.
    For example, results from the 2008 National Survey on Drug Use and 
Health (NSDUH) indicate that the number of persons aged 12 or older who 
smoked cigarettes for the first time within the past 12 months was 2.4 
million (Ref. 8 at p. 59). This estimate was similar to the 2007 
estimate (2.2 million) but statistically significantly higher than the 
estimates for 2002 (1.9 million), 2003 (2.0 million) and 2004 (2.1 
million) (Id.). This 2008 estimate averages out to approximately 6,600 
new cigarette smokers every day (Id.). Most of these new cigarette 
smokers (nearly 4,000) were under the age of 18 (Id.). However, it is 
also notable that the number of people who began smoking at age 18 or 
older showed a significant increase over the last several years, 
jumping from approximately 600,000 in 2002 to 1 million in 2008 (Id. at 
p. 60).
    In addition, data from the 2008 NSDUH indicate that almost 1 
million Americans aged 12 or older had started smoking cigarettes daily 
within the past 12 months. Of these new daily smokers, 37.2 percent 
(350,000 persons) were younger than age 18 when they started smoking 
daily. In other words, each day in 2008 approximately 1,000 U.S. 
children became new daily smokers (Id.). This is particularly 
concerning from a public health perspective, as studies suggest that 
the age individuals begin smoking can greatly influence how much they 
smoke per day and how long they smoke, which will ultimately influence 
their risk of tobacco-related disease and death (Refs. 14 through 16). 
Data from animal studies also suggest that nicotine can cause permanent 
brain changes in the adolescent brain that lead to addiction and that 
these changes are greater in adolescents than in adults (Ref. 17). 
Furthermore, data from human studies indicate that the younger smokers 
start, the more likely they are to become addicted (Id.).

C. Costs to Society and Health Effects of Cigarettes

    Cigarettes are responsible for premature deaths from a variety of 
diseases, a substantial burden on the U.S. healthcare system, and 
significant economic losses to society (Ref. 1). Smoking is the primary 
causal factor for at least 30 percent of deaths from cancer, including 
90 percent of deaths from lung cancer, almost 80 percent of deaths from 
chronic obstructive pulmonary disease (COPD), and nearly one-fifth of 
all deaths from cardiovascular disease (Ref. 1 and Ref. 2 at pp. 39 and 
43).
1. Costs of Smoking to Society
    Data from the Centers for Disease Control and Prevention's (CDC) 
Smoking-Attributable Mortality, Morbidity, and Economic Costs (SAMMEC) 
system for 2000-2004, the most recent years for which analyses are 
available, indicate that cigarette smoking and exposure to cigarette 
smoke are responsible for at least 443,000 premature deaths each year 
(Ref. 1). For every person who dies from smoking, approximately 20 more 
people (8.6 million persons) suffer from at least one serious smoking-
related illness, primarily heart disease and COPD (Ref. 18). The three 
leading causes of smoking-attributable death for current and former 
smokers were lung cancer, ischemic heart disease, and COPD (Ref. 1). 
Cigarettes also have significant deleterious effects on nonsmokers. For 
example, maternal smoking during pregnancy resulted in an estimated 776 
infant deaths annually during 2000-2004, and each year an estimated 
49,400 lung cancer and heart disease deaths were attributable to 
exposure to secondhand smoke (Id.).
    Overall, each year cigarettes are responsible for approximately 5.1 
million years of potential life lost, direct health care expenditures 
of approximately $96 billion, and at least $96.8 billion in 
productivity losses due to premature deaths in the United States (Id.). 
The total costs of smoking to society are much higher, as this estimate 
of 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.). 
These health care expenditures and productivity losses result in a 
combined economic burden from cigarette smoking of approximately $193 
billion per year (Id.). There are also costs to the smoker and his or 
her family. One study estimated that the total cost of smoking over a 
lifetime, including private costs to the smoker and costs imposed on 
society (e.g., second hand-smoke and costs of Medicare, Medicaid, and 
Social Security) come to nearly $40 per pack of cigarettes smoked (Ref. 
19 at p. 11).
2. Negative Health Effects of Cigarettes
    The healthcare burdens, productivity losses, and deaths attributed 
to smoking are related to an array of diseases and health conditions 
caused by cigarettes. Beginning with the landmark 1964 report ``Smoking 
and Health,'' the U.S. Surgeon General has issued a series of reports 
addressing the health consequences of smoking and nicotine addiction. 
According to the most recent Surgeon General's Report, ``The Health 
Consequences of Smoking,'' which summarizes thousands of peer-reviewed 
scientific studies and is itself peer-reviewed, smoking remains the 
leading preventable cause of death in the United States, and cigarettes 
have been shown to cause an ever-expanding number of diseases and 
health conditions (Ref. 2 at pp. 9 and 25). As stated in the 2004 
Report, ``[s]moking harms nearly every organ of the body, causing many 
diseases and reducing the health of smokers in general * * * [and] 
[q]uitting smoking has immediate as well as long-term benefits, 
reducing risks for diseases caused by smoking and improving health in 
general'' (Id. at p. 25). The following discussion presents a summary 
of some of the diseases and conditions caused by cigarettes, and of the 
impact smoking cessation has on some of these conditions.
    Cancer. Cigarette smoking has long been tied to a variety of 
cancers. For example, there is overwhelming evidence that smoking 
causes lung cancer, and that the worldwide epidemic of lung cancer is 
attributable largely to smoking (Id. at p. 43). Studies indicate that 
the risk for developing lung cancer can be 20 or more times higher for 
smokers compared to lifelong nonsmokers, and the risk of lung cancer 
increases in smokers with the duration of smoking and the number of 
cigarettes smoked (Id.). There are extensive data showing that quitting 
smoking decreases the risk of lung cancer, and that this risk continues 
to decline as the duration of not smoking increases in comparison to 
the risk among continuing smokers (Id. at p. 49). However, the risk 
does not decline to the level of risk for those who have never smoked, 
even after 15 to 20 years of not smoking (Id. at p. 43).
    It also has been established for some time that cigarette smoking 
also causes a variety of other cancers, including laryngeal cancer, 
oral cavity and pharyngeal cancers, esophageal cancer, and bladder 
cancer (Id. at pp. 62, 67, 116, and 167). Furthermore, smoking has also 
been shown to cause pancreatic cancer, kidney cancer, stomach cancer, 
cervical cancer, and acute myeloid leukemia (Id. at p. 25).
    For all of these cancers, increasing smoking prevention and 
cessation would cause a significant decrease in the risk (Id. at ch. 
2). For example, smoking cessation halves the risk for cancers of the 
oral cavity and esophagus as soon as five years after cessation (Id. at 
p. 117).
    Cardiovascular disease. Smoking is causally related to all of the 
major

[[Page 69528]]

clinical cardiovascular diseases, with higher levels of smoking and 
longer duration of smoking increasing the risk of disease (Id. at p. 
397). Heart disease and stroke are the main types of cardiovascular 
disease caused by smoking and represent the first and third leading 
causes of death in the United States (Id. at p. 363). Studies have 
shown that smokers have a 70 percent greater death rate from coronary 
heart disease than nonsmokers, a twofold to fourfold greater incidence 
of coronary heart disease, and a twofold to fourfold greater risk of 
sudden death than nonsmokers (Ref. 20 at pp. 58-59). The beneficial 
impact of smoking cessation on these risks has also been well 
established. For example, one year after quitting smoking, a former 
smoker's additional risk of heart disease compared to a person who has 
never smoked is reduced by about half and, after 15 years of 
abstinence, this risk is similar to that of a person who never smoked 
(Ref. 2 at p. 363).
    Current smoking is also associated with a twofold to fourfold 
increase in the risk of stroke; smoking cessation steadily decreases 
this risk and, after 5 to 15 years of not smoking, the risk of stroke 
is indistinguishable from that for lifetime nonsmokers (Id. at p. 394).
    Smoking has also been shown to cause abdominal aortic aneurysm. 
Studies have shown that the risk of death from abdominal aortic 
aneurysm was increased more than fourfold in current smokers and 
twofold in former smokers; smoking is one of the few avoidable causes 
of this frequently fatal condition (Id. at pp. 396-97).
    Respiratory diseases. Smoking has negative effects on the entire 
lung--it impairs lung defenses against infection and causes the 
sustained lung injury that leads to COPD (Id. at p. 423). Cigarettes 
have been shown to cause a range of acute respiratory illnesses, 
including increased risk of pneumonia, and chronic respiratory 
diseases, which are leading causes of illness and death in the United 
States and worldwide (Id. at pp. 423, 508-509).
    For example, cigarette smoking is the leading cause of COPD in the 
United States, and this major public health problem could be almost 
completely prevented by smoking abstinence (Id. at p. 501). Although 
smoking cessation reduces the risk of COPD, the risk of COPD mortality 
among former smokers, even after 20 years or more of abstinence, 
remains elevated compared with the risk among people who have never 
smoked (Id.).
    Maternal smoking during pregnancy causes a reduction in lung 
function in infants, and children who smoke experience impaired lung 
growth and an early onset of lung function decline (Id. at pp. 508-
509). Smoking during adulthood also leads to a premature onset of 
accelerated age-related decline in lung function, while smoking 
cessation can return the rate of lung function decline to that of 
persons who have never smoked (Id. at pp. 480 and 509). Results from 
several investigations suggest that the benefits of smoking cessation 
for FEV1 decline (a measure of the air capacity of the lungs) are 
greatest for persons who stop smoking at younger ages (Id. at p. 480).
    Smoking also results in poor asthma control and it causes a range 
of respiratory symptoms in children, adolescents, and adults, including 
coughing, phlegm, wheezing, and shortness of breath (Id. at p. 509). 
Smoking cessation reduces the rates of these respiratory symptoms and 
of respiratory infections (Id. at p. 467).
    Reproductive effects. Smoking has well-documented negative effects 
on fertility, on pregnancies, and on infants and children born to women 
who smoke. For example, studies show that women who smoke have reduced 
fertility (Id. at p. 541). Women who smoke during pregnancy are more 
likely to experience premature rupture of the membranes, placenta 
previa, and placental abruption (Id. at p. 576). Smoking also increases 
rates of preterm delivery and shortened gestation, and studies have 
indicated that women who smoke are twice as likely to have low birth 
weight infants as women who do not smoke (Id. at pp. 576 and 569). 
Smoking also causes an increased risk of sudden infant death syndrome 
(SIDS) for infants whose mothers smoke during and after pregnancy (Id. 
at pp. 587 and 601).
    Other effects. Smoking has been shown to have a variety of other 
negative health effects. For example, cigarette smokers have poorer 
overall health status compared to nonsmokers; this may manifest as 
increased absenteeism from work and increased use of medical care 
services (Id. at p. 818). Smokers have an increased risk of adverse 
surgical outcomes related to wound healing and respiratory 
complications compared to nonsmokers (Id.). In postmenopausal women who 
smoke, smoking is associated with low bone density (Id. at p. 716). 
Smokers are also at an increased risk for hip fractures, which account 
for a significant proportion of the morbidity and mortality associated 
with osteoporosis (Id. at pp. 717-719). Smoking also increases the risk 
for periodontitis, cataract, and for the occurrence of peptic ulcer 
disease in persons who are Helicobacter pylori positive (Id. at pp. 
736, 777, 780 and 813). Furthermore, smokers are at a greater risk of 
dying from peptic ulcer disease than nonsmokers (Id. at p. 807).
    Addiction. Nicotine addiction is another negative effect of 
cigarette smoking. Nicotine is the primary chemical compound in tobacco 
that causes addiction, and the magnitude of public health harm caused 
by cigarettes is inextricably linked to the addictive nature of these 
products (Ref. 21 at p. 14; Ref. 5 at p. xi). Nicotine is psychoactive 
(mood altering) and can provide pleasurable effects; it also causes 
physical dependence characterized by withdrawal symptoms that usually 
accompany nicotine abstinence (Ref. 21 at p. 14). The pharmacologic and 
behavioral processes that determine tobacco addiction are similar to 
those that determine addiction to drugs such as heroin and cocaine (Id. 
at p. 9). Smokers develop tolerance to the effects of nicotine over 
time as well as a physical dependence on these effects, and as a result 
need greater amounts of nicotine over time to produce the same effects; 
thus smokers tend to smoke more over time to avoid withdrawal symptoms 
(Id. at pp. 50, 197-98). Withdrawal symptoms are common among persons 
attempting to quit smoking--in one study, 78 percent of subjects 
reported significant withdrawal symptoms (Id. at pp. 201-202).
    In addition to physical dependence, nicotine addiction also results 
in conditioned behavior in smokers in response to situations and 
environmental stimuli associated with cigarette use. Smokers typically 
use cigarettes in certain patterns--e.g., upon waking in the morning, 
after a meal, with a cup of coffee or an alcoholic beverage--and this 
patterned behavior is strongly reinforced by the pleasurable effects of 
nicotine (Id. at pp. 306-308; Ref. 17). Other stimuli associated with 
smoking itself, such as the smell of cigarette smoke or the sight of 
cigarette-associated paraphernalia, also become part of the 
conditioning process by repeated association with the desired 
physiological effects of nicotine (Ref. 21 at p. 307; Ref. 17). As 
these processes repeat over time as a result of regular smoking, these 
situations and stimuli become a powerful cue to smoke due to their 
association with the rewarding effects of nicotine, and the desire to 
smoke triggered by these situations can persist long after withdrawal 
symptoms subside (Ref. 17).
    As a result of nicotine addiction, only a minority of smokers can 
achieve permanent abstinence in an initial quit

[[Page 69529]]

attempt. There are data suggesting that more than 70 percent of smokers 
in the United States report that they want to quit, and approximately 
44 percent report that they try to quit each year (Ref. 19 at p. 15). 
This estimate is likely a significant underestimate of the actual 
number of quit attempts because unsuccessful quit attempts, 
particularly if short-lived or in the past, are often not reported in 
surveys. One study reported that at three months, 90.1 percent of quit 
attempts lasting less than one day, 63.7 percent of those lasting 
between a day and one week, and 38.9 percent of those lasting between 
one week and one month failed to be reported to researchers conducting 
surveys (Ref. 22). Many of the quit attempts that are reported are 
unsuccessful. For example, among the 19 million adults who reported 
attempting to quit in 2005, epidemiologic data suggest that only 4 to 7 
percent were successful (Ref. 19 at p. 15). Similarly, the Institute of 
Medicine (IOM), considering data for 2004, found that although 
approximately 40.5 percent of adult smokers reported attempting to quit 
in that year, only between 3 and 5 percent were successful (Ref. 5 at 
p. 82). Furthermore, adults with education levels at or below the 
equivalent of a high school diploma have the highest smoking prevalence 
levels but the lowest quit ratios (i.e., the ratio of persons who have 
smoked at least 100 cigarettes during their lifetime but do not 
currently smoke to persons who report smoking at least 100 cigarettes 
during their lifetime) (Ref. 23).
    Adolescents also experience low success rates when attempting to 
quit. Most Americans who use tobacco products begin using when they are 
under the age of 18 and become addicted before reaching the age of 18 
(Refs. 3 and 7). Although many adolescents believe ``they can quit 
[smoking] at any time and therefore avoid addiction,'' nicotine 
dependence can be rapidly established (Ref. 5 at p. 89; see also Ref. 
19 at p. 158). Research has shown that some adolescents report symptoms 
of withdrawal and craving within days or weeks of beginning to smoke 
(Ref. 24). As a result, many adolescents are nicotine dependent despite 
their relatively short smoking histories (Ref. 25). An analysis of data 
from the 2007 YRBS found that 60.9 percent of high school students who 
ever smoked cigarettes daily tried to quit smoking, but only 12.2 
percent were successful (Id.). Research among adolescents also 
highlights their poor understanding of the difficulty of quitting 
smoking--for example, one study found that only 3 percent of 12th grade 
daily smokers estimated that they would still be smoking in 5 years, 
while in reality 63 percent of this population is still smoking daily 7 
to 9 years later (Ref. 5 at p. 91).
    Benefits of reduced prevalence. Dramatic declines in the deaths 
caused by the conditions discussed above can be achieved by further 
reducing smoking prevalence rates. Smoking cessation has major and 
immediate health benefits for men and women of all ages, regardless of 
health status (Ref. 26 at p. i). Smoking cessation decreases the risk 
of the health consequences of smoking, and former smokers live longer 
than continuing smokers. For example, persons who quit smoking before 
age 50 have one-half the risk of dying in the next 15 years compared 
with continuing smokers (Id. at p. v).
    More importantly, preventing nonsmokers, particularly children, 
from starting smoking in the first instance would allow them to avoid 
nicotine addiction and the severe adverse health consequences of 
smoking. Preventing initiation would result in enormous public health 
benefits. As Congress found when enacting the Tobacco Control Act, 
``reducing the use of tobacco by minors by 50 percent would prevent 
well over 10,000,000 of today's children from becoming regular, daily 
smokers, saving over 3,000,000 of them from premature death due to 
tobacco-induced disease. Such a reduction in youth smoking would also 
result in approximately $75,000,000,000 in savings attributable to 
reduced health care costs'' (section 2(14) of the Tobacco Control Act).

III. Data Concerning Health Warnings

A. Current Warnings on Cigarette Packages and Advertisements Are 
Inadequate

    Section 201 of the Tobacco Control Act requires FDA to issue 
regulations mandating the use of color graphics depicting the negative 
health consequences of smoking to accompany the nine warning statements 
that are specified in section 4(a)(1) of FCLAA (15 U.S.C. 1333(a)(1)). 
The warning statements must be randomly displayed (i.e., in each 12-
month period, all of the different warnings must appear in as equal a 
number of times as is possible on each brand of the product and be 
randomly distributed in all areas of the United States in which the 
product is marketed) on cigarette packages and rotated quarterly in 
alternating sequence in cigarette advertisements, as provided by 
sections 4(c)(1) and 4(c)(2) of FCLAA (15 U.S.C. 1333(c)(1), (2)), as 
amended by the Tobacco Control Act. Congress directed that stronger and 
larger warning statements, accompanied by graphics, would replace the 
current text-only requirements. Data from studies indicate the current 
warnings on cigarette packages and advertisements are ineffective at 
communicating health risk information to consumers.
    Cigarette packages and advertisements can be effective channels for 
communication of important health information. The warning on a 
cigarette package can provide a clear, visible vehicle to communicate 
risk at the most crucial time for smokers and potential smokers. Pack-
a-day smokers are potentially exposed to warnings more than 7,000 times 
per year (Refs. 27-29). When utilized effectively, cigarette packages 
and advertisements can serve as an important channel for communicating 
health information to broad national audiences that include both 
smokers and nonsmokers.
    The inclusion of strong health warnings on packages and in 
advertisements can thus provide a critical opportunity to educate 
consumers about the health risks of cigarettes, support intentions 
among current smokers who want to quit or decrease cigarette 
consumption, and discourage nonsmokers, particularly youth, from 
initiating cigarette use. Prominent displays of warnings increase their 
effectiveness; larger warnings, with pictures, are more likely to be 
noticed by consumers, communicate information about health risks to 
consumers, and reinforce intentions among tobacco users who want to 
quit (Ref. 30).
    However, cigarette warnings in the United States have not been 
changed or improved in more than 25 years. The unchanging nature of 
these warnings, as well as their relatively small size and lack of a 
graphic image component, severely impairs their ability to effectively 
communicate to consumers. Research has repeatedly illustrated that the 
current warnings used in the United States frequently go unnoticed or 
fail to convey relevant information regarding health risks.
1. Current Warnings Have Not Changed in More Than Twenty-Five Years
    In response to the Surgeon General's first major report on smoking 
and health in 1964, Congress passed FCLAA to require warning labels on 
all cigarette packages. The warning, which was required to be 
conspicuous and legible, was written in small print and located on one 
of the side panels of each cigarette package. It stated ``CAUTION: 
Cigarette Smoking May Be Hazardous to

[[Page 69530]]

Your Health.'' This language appeared on all cigarette packs sold from 
January 1, 1966, through October 31, 1970. In 1969, Congress passed the 
Public Health Cigarette Smoking Act (Public Law 91-222), which slightly 
modified the warning statement on cigarette packages, but did not yet 
require any warnings on cigarette advertisements. The new warning 
language, ``Warning: The Surgeon General Has Determined That Cigarette 
Smoking Is Dangerous to Health,'' appeared on cigarette packages sold 
in the United States from November 1, 1970, through October 11, 1985. 
In 1972, the Federal Trade Commission (FTC) issued consent orders 
requiring six major cigarette manufacturers and distributors to include 
in all their cigarette advertisements a clear and conspicuous 
disclosure of the warning required to be on packages (Ref. 31 at 460-
65).
    In 1981, the FTC issued a report to Congress that concluded that 
the then-current health warning labels had little effect on public 
awareness and attitudes toward smoking. The FTC stated that the 
existing warning likely was ineffective because it ``(1) is overexposed 
and worn out, (2) lacks novelty, (3) is too abstract, and (4) lacks 
personal relevance'' (Ref. 32 at pp. 7-16).
    Subsequently, Congress again modified cigarette warnings by passing 
the CSEA, which required the following four rotational health warnings 
on packages and advertisements \5\:
---------------------------------------------------------------------------

    \5\ Slightly different health warnings were required on outdoor 
billboard advertisements.
---------------------------------------------------------------------------

     ``SURGEON GENERAL'S WARNING: Smoking Causes Lung Cancer, 
Heart Disease, Emphysema, and May Complicate Pregnancy.''
     ``SURGEON GENERAL'S WARNING: Quitting Smoking Now Greatly 
Reduces Serious Risks to Your Health.''
     ``SURGEON GENERAL'S WARNING: Smoking by Pregnant Women May 
Result in Fetal Injury, Premature Birth and Low Birth Weight.''
     ``SURGEON GENERAL'S WARNING: Cigarette Smoke Contains 
Carbon Monoxide.''
    In addition, the law established the location and format for these 
warning statements and mandated that the warnings be rotated quarterly, 
which helped keep them from becoming stale. Despite a FTC 
recommendation to change the size and shape of warnings, Congress 
retained the size and rectangular format of previous warnings.
    More than twenty-five years have passed since these last changes, 
and there is a substantial body of evidence that these warnings do not 
effectively communicate information about the adverse health effects of 
smoking to the American public, as discussed in more detail below. 
Given the extreme hazards cigarettes pose to the public health, the 
revised warnings required under section 4 of FCLAA (15 U.S.C. 1333) and 
provided in this proposed rule are critical to the effective 
communication of the health risks of smoking, and should encourage 
current smokers to consider cessation and discourage nonsmokers from 
initiating use of cigarettes.
2. Current Warnings Often Go Unnoticed
    The CSEA requires the current warnings to be ``conspicuous and 
legible'' with the same package location and font size required on the 
date of enactment (i.e., October 12, 1984). However, researchers have 
found that these health warnings go largely unnoticed and unconsidered 
by both smokers and nonsmokers. For example, a major study into tobacco 
policy in the United States by the IOM in 2007 concluded that U.S. 
package warnings are both ``unnoticed and stale'' (Ref. 5 at p. 291). 
The Chair of the IOM's Committee on Reducing Tobacco Use has described 
the warnings on cigarette packs as ``invisible'' (Ref. 4).
    Research regarding warning statements in cigarette advertisements 
has shown similar results. For example, one study of the recall and 
eye-tracking of adolescents viewing tobacco advertisements found: 43.6 
percent of adolescents did not even look at the warning statement 
included in the advertisement; just 36.7 percent looked at the warning 
long enough to read any of its words; and the average viewing of the 
warning only accounted for 8 percent of the total viewing time (Ref. 
33). Researchers in this study also determined that adolescents are 
unable to recall the content of the current cigarette warnings or to 
correctly recognize the warnings from a list, indicating that the 
current warnings are likely to be ineffective among younger consumers 
(Id.).
    Another study of adolescents also found that they are not seeing, 
reading, and remembering health warnings on cigarette packages and 
advertisements (Ref. 34). In this study of ninth-grade students, only 
32 percent of regular smokers recalled seeing one of the current 
warnings which states: ``Quitting Smoking Now Greatly Reduces Serious 
Risks To Your Health'' (Id.). In addition, almost 20 percent 
incorrectly reported having seen a simulated health warning that is not 
among one of the four current required warnings (Id.).
    Data from a 1989 study indicate that consumers also fail to notice 
or read health warnings on outdoor billboards and taxicab cigarette 
advertisements (though these advertising media are no longer in common 
use). According to this study, which was published in the Journal of 
the American Medical Association, drivers only read the entire warning 
message on 5 percent of highway billboard advertisements and were only 
able to fully read the health warning on 18 of the 39 street 
advertisements used in this study (Ref. 35). Participants were unable 
to read, even partially, the Surgeon General's warnings in any of the 
47 taxicab advertisements used in this study (Id.). Yet, those same 
consumers were able to identify the brand name and imagery on 100 
percent of the highway billboards (Id.). Likewise, these participants 
were able to identify the brand name in 100 percent and the imagery in 
95 percent of the taxicab advertisements (Id.). These results indicate 
that the current warnings are not appropriately conspicuous in 
advertisements compared to the rest of the advertising message, as 
discussed in more detail below.
3. Current Warnings Fail To Convey Relevant Information in an Effective 
Manner
    Even when consumers notice and contemplate the current health 
warnings on cigarette packages and in advertisements, there is clear 
evidence that these warnings fail to appropriately convey crucial 
information such as the nature and extent of the health risks 
associated with smoking cigarettes. The current small, wordy text-based 
messages are ambiguous, providing less health information than is 
provided regarding many other consumer goods that have significantly 
less harmful impact on people's health (Ref. 36).
    In its 2007 Report, the IOM concluded that the current U.S. 
warnings fail to convey relevant health information in an effective way 
(Ref. 5 at p. 291). The IOM cited an International Tobacco Control 
Policy Evaluation Study, which found that 85 percent of Canadian 
respondents cited packages (which, in Canada, contain prominent text 
and graphic health warnings) as a source of health information, while 
only 47 percent of U.S. smokers cited packages as a health information 
source (Id. at 294, citing Ref. 37).
    Studies also have shown that the current warnings do not motivate 
consumers to look at them long enough to consider the concept being 
communicated. For example, researchers have found that the warning

[[Page 69531]]

statements fail to attract attention or to make the consumer 
appropriately aware of the health risks of smoking (Ref. 38). In a 
study of U.S. and Canadian smokers and nonsmokers, researchers found 
that participants voluntarily examined warnings on Canadian packages, 
which include prominent text and graphics, for longer durations than 
U.S. package warnings, because the current text-only messages used in 
the United States are not memorable for consumers (Id.). The mere 
textual presentation of vague hazard information in the current U.S. 
warnings is not sufficient to motivate perceptions of risk (Id.).
    The content and format of the current warnings have failed to 
successfully draw and hold consumers' attention, especially when placed 
in competition with the other text, images, and graphics that cigarette 
companies have used on packaging and in advertising, which have been 
thoroughly tested, regularly updated, and artfully crafted by tobacco 
companies. According to the most recent data from the FTC, tobacco 
companies spent approximately $12.49 billion on advertising and 
promotion in 2006 (Ref. 39 at p. 1). Tobacco companies frequently have 
employed marketing and advertising experts to craft campaigns with 
messages targeted to certain demographics (Ref. 40 at p. 7). The 
messages developed by companies in cigarette advertisements cover 96 
percent of the space, are continuously updated to incorporate current 
trends, and are targeted based on market research. In contrast, the 
current health warnings cover only 4 percent of advertising space, are 
solely textual, are not targeted to any population group, and consist 
of only four rotating messages that have not been updated for more than 
two and a half decades. On cigarette packages, these warnings appear 
only on one side panel. As a result, the important health messages 
frequently are functionally invisible in comparison to the rest of the 
advertisement and package (Ref. 33 at p. 88).
    Moreover, even if consumers notice the current warnings, those with 
less education may not be able to adequately comprehend the text-only 
messages. In its 2007 Report, the IOM expressed concern about the 
ability of consumers with less education to recall the information 
included in text-based messages (Ref. 5 at p. 295). The IOM cited a 
study of Canadian smokers' knowledge about the country's prior warning 
requirements, which, like the current U.S. health warnings, only 
contained four textual warning statements. In that study, researchers 
noted that comparatively few women with lower educational attainment 
were aware of messages warning of the impacts of smoking on life 
expectancy, heart disease, or pregnancy (Ref. 41). Because the current 
U.S. smoking population has various levels of education (including a 
high percentage of people with low educational attainment) and includes 
teenagers (who have yet to complete their education), the current text-
only warnings are inadequate.

B. Larger, Graphic Warnings Communicate More Effectively: International 
Experience

    In 2001, Canada introduced graphic health warnings depicting the 
adverse health consequences of smoking on the upper 50 percent of the 
two primary panels of cigarette packages. Those warnings, like the 
warnings proposed here, include a photograph or other image, a marker 
word ``WARNING,'' and a warning statement. By mid-2009, 28 countries 
also required graphic warnings and more countries are planning to do 
so.
    In its 2007 Report, the IOM concludes that the available scientific 
evidence indicates that larger, graphic health warnings would promote 
greater public knowledge of the health risks of using tobacco and would 
help reduce consumption (Ref. 5 at p. 295). Similarly, an article 
published by WHO concludes that, taken as a whole, the research on 
graphic health warnings show that they 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 (Ref. 42).
1. Getting Consumers' Attention
    Several design features are associated with greater salience (i.e., 
noticeability and readability) of health warnings, including the size 
and position of warnings on the cigarette package. Smokers are more 
likely to recall larger warnings, as well as warnings that appear on 
the front of packages (Ref. 5 at p. C-3). Warnings that include 
pictures or graphics likewise are more noticeable and more likely to be 
recalled than text-only warnings (Id. at p. C-4).
    In Canada, awareness of warnings on cigarette packages was almost 
universal among smokers and very high even among nonsmokers after that 
country required cigarette packages to display large, graphic warnings 
on the front and rear panels. In a 2001 cross-sectional survey 
sponsored by the Canadian Cancer Society, 90 percent of Canadian 
smokers and 49 percent of nonsmokers noticed changes to the Canadian 
health warnings after the introduction of pictorial warnings (Ref. 43). 
Similarly, a survey of youth sponsored by Health Canada showed that 73 
percent of those who have never smoked, 86 percent of ``puffers'' 
(i.e., those who had tried smoking but never smoked a whole cigarette), 
and 90 percent of those who have smoked beyond puffing reported seeing 
health warnings on cigarette packages in 2002, a year after the 
introduction of graphic warnings in Canada (Ref. 44). In a study of 
young adults, 98.5 percent of smokers, 88.9 percent of occasional 
smokers, and 67.5 percent of those who have never smoked reported that 
they were aware of the Canadian graphic health warnings (Ref. 45).
    Survey evidence also shows that awareness of health warnings on 
cigarette packages increased significantly after Australia required 
large, graphic warnings in 2006. In one study, smokers were more likely 
to report that over the past month they noticed the enhanced warnings 
and read or looked closely at them compared to the old warnings (Ref. 
46). Among students in year levels 8 to 12 in Melbourne, cognitive 
processing of cigarette warnings (i.e., reading, attending to, thinking 
and talking about the warnings) increased in the year that Australia 
adopted graphic warnings (Ref. 47). Developmental focus group research 
conducted for Australia as it considered whether to require graphic 
warnings similarly reported that graphic warnings on cigarette packs 
were potentially more likely to help people remember the health effects 
and warnings (Ref. 48).
    Experimental studies also indicate that requiring large, graphic 
warnings would significantly increase the salience of health warnings 
on cigarette packages. In one experimental study, U.S. college students 
were shown images of the Canadian cigarette warnings and the current 
warnings appearing on cigarette packs sold in the United States. 
Compared to the U.S. warnings, the Canadian graphic warnings 
significantly increased aided recall of the warnings, increased depth 
of message processing, and increased the perceived strength of the 
message (Ref. 49). Similarly, in focus group research conducted among 
young adults in the United States, participants reported that the 
Canadian warnings were more visible and more informative than the 
warnings appearing on cigarette packages in the United States (Ref. 
50).

[[Page 69532]]

2. Influencing Consumers' Awareness of Cigarette-Related Health Risks
    Large, pictorial warnings graphically convey the harm and danger 
that tobacco use causes, eliciting an immediate impact. Effective 
communication of the health risks associated with cigarette use is 
critical from a public health perspective, as smokers who perceive a 
greater health risk from smoking are more likely to want to quit and to 
be successful in their quit attempts (Ref. 37). 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. 5 at p. 294). The 2001 survey 
conducted by the Canadian Cancer Society found that the country's 
pictorial warnings, which had recently been introduced, resulted in 58 
percent of smokers reporting that they thought about the health effects 
of smoking more frequently than previously (Ref. 43). Among Canadian 
adult smokers in Ontario, 51 percent of study participants reported 
that the pictorial warnings made them think about the health effects of 
smoking (Ref. 51). Canadian smokers were more likely to report 
cigarette packages as a source of information about the health risks of 
smoking than smokers in the United States and other countries with 
text-only warnings (Ref. 37).
    Similarly, a study conducted for officials in Australia found that 
graphic warnings increased participants' knowledge and awareness of the 
health risks of smoking, especially among current smokers and recent 
quitters (Ref. 52). A street intercept study in Australia suggests that 
graphic warnings may also increase smokers' perceptions of their 
personal risks of smoking. In that study, 51 percent of participants 
stated that the graphic warnings on cigarette packs increased their 
perceived risk of dying from smoking (Ref. 53).
    Graphic warnings appear to influence risk perceptions among youth 
as well as adults. In a cross-sectional survey of middle and high 
school students in Greece, participants were shown several graphic 
warnings prepared by the European Union as well as text-only warnings. 
Study participants consistently selected the graphic warnings as more 
effective in making them think about the effects of smoking on health 
(Ref. 54). Similarly, in a youth survey conducted by Health Canada, 
approximately two-thirds of youth nonsmokers reported looking at the 
pictorial warnings at least once a week and, as indicated above, 95 
percent agreed that the warnings had been effective in providing them 
with important information about the health effects of smoking (Ref. 5 
at p. C-5).
    In an Internet-based study of current and former young adult 
smokers in the United States, the Canadian graphic warnings were rated 
as significantly more effective than the current U.S. warnings on 
cigarette packs for conveying concerns about the health risks of 
smoking (Ref. 55).
3. Impacting Smoking Intentions and Behaviors
    In addition to increasing consumer awareness of the health risks of 
smoking, the proposed graphic warnings also seek to impact changes in 
smoking behavior. There are some studies indicating that large, graphic 
warnings increase smokers' intentions to quit smoking or motivate them 
to quit smoking.
    The 2001 survey sponsored by the Canadian Cancer Society shows that 
44 percent of adult smokers stated that the Canadian graphic health 
warnings increased their motivation to quit smoking (Ref. 43). In 
another study of Canadian young adults (ages 20 to 24), 37