R.J. REYNOLDS TOBACCO COMPANY et al v. UNITED STATES FOOD AND DRUG ADMINISTRATION et al

Filing 26

AMICUS BRIEF by AMERICAN ACADEMY OF PEDIATRICS, AMERICAN CANCER SOCIETY, AMERICAN CANCER SOCIETY CANCER ACTION NETWORK, AMERICAN HEART ASSOCIATION, AMERICAN LEGACY FOUNDATION, AMERICAN LUNG ASSOCIATION, AMERICAN MEDICAL ASSOCIATION, AMERICAN PUBLIC HEALTH ASSOCIATION, CAMPAIGN FOR TOBACCO FREE KIDS, PUBLIC CITIZEN. (znmw, )

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
R.J. REYNOLDS TOBACCO CO., et al.,
Plaintiffs,
v.

No. 1:11-cv-1482 (RJL)

UNITED STATES FOOD AND DRUG
ADMINISTRATION, et al.,
Defendants.

MEMORANDUM OF AMICI CURIAE AMERICAN ACADEMY OF
PEDIATRICS, AMERICAN CANCER SOCIETY, AMERICAN CANCER
SOCIETY CANCER ACTION NETWORK, AMERICAN HEART
ASSOCIATION, AMERICAN LEGACY FOUNDATION, AMERICAN LUNG
ASSOCIATION, AMERICAN MEDICAL ASSOCIATION, AMERICAN PUBLIC
HEALTH ASSOCIATION, CAMPAIGN FOR TOBACCO-FREE KIDS, AND
PUBLIC CITIZEN IN OPPOSITION TO PLAINTIFFS’ MOTION FOR
PRELIMINARY INJUNCTION

TABLE OF CONTENTS
INTEREST OF AMICI ....................................................................................................................1
BACKGROUND .............................................................................................................................2
ARGUMENT 4
I.

The Government Has a Strong Interest in More Effectively Informing
Consumers About the Deadly Effects of Tobacco. ..............................................................4

II.

Current Warnings Have Failed To Inform Consumers Effectively About
the Risks of Tobacco Use. ...................................................................................................7

III.

Substantial Evidence Supports the Revised Warning Requirements. ................................14
A.

The Evidence Demonstrates That Large, Graphic Warnings on the
Front of Cigarette Packaging Are Most Effective at Reducing
Smoking and Informing Consumers About the Risks of Tobacco
Use. ........................................................................................................................14

B.

Plaintiffs’ Criticism of the FDA’s Rulemaking Fails to Rebut the
Overwhelming Weight of Evidence Demonstrating the Warnings’
Effectiveness. .........................................................................................................16
1.

The FDA’s Regulatory-Impact Analysis Does Not
Undermine the Evidence on Which Congress Relied. ...............................17

2.

The FDA’s Consumer Research Was Not Intended to Prove
By Itself the Effectiveness of Graphic Warnings. .....................................21

CONCLUSION ..............................................................................................................................24

i

Plaintiff tobacco companies in this case seek a preliminary injunction against
enforcement of the enhanced warnings required by the Family Smoking Prevention and Tobacco
Control Act (FSPTCA), which mandates that cigarette packaging and advertising include “color
graphics depicting the negative health consequences of smoking.” Pub. L. No. 111-31, § 201(a).
Amici curiae submit this brief to highlight three related points important to the balance of harms
and of the public interest required by the preliminary-injunction analysis. First, tobacco use is
this nation’s number one preventable cause of premature death and disease, and Congress thus
has a uniquely strong interest in ensuring effective warnings. Second, overwhelming evidence
demonstrates that existing warnings have failed to inform the public adequately of the risks of
tobacco use, and that the industry has intentionally undermined those warnings by
misrepresenting the health consequences of smoking and marketing their products to children.
Third, evidence also establishes that the large, graphic warnings required by the FSPTCA are
effective both at raising public awareness of the risks of smoking and at reducing tobacco use.
That evidence includes numerous consumer surveys, scientific studies, and a consensus of the
most respected national and international authorities in the field—including the Surgeon General,
the President’s Cancer Panel, the National Cancer Institute, the Institute of Medicine, and the
World Health Organization. Taken together, these considerations weigh heavily against
plaintiffs’ motion for a preliminary injunction.
INTEREST OF AMICI
Amici curiae are ten nonprofit public health organizations, consumer advocacy groups,
and physicians’ associations that for decades have worked to educate the public about and
protect the public from the devastating health and economic consequences of tobacco use. Amici
have broad knowledge about the history of tobacco regulation and the tobacco industry’s
promotional techniques and are particularly well qualified to assist the Court in understanding
1

the substantial public interest advanced by the provisions of the FSPTCA challenged here. A
description of each organization is included in the motion for leave to file this brief. All parties
have consented to the filing of this memorandum.
BACKGROUND
The Family Smoking Prevention and Tobacco Control Act (FSPTCA) responds to what
the Supreme Court has described as “perhaps the single most significant threat to public health in
the United States.” FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 161 (2000). The
statistics are grim: An estimated 443,000 people in this country die each year from tobaccorelated illnesses, such as cancer, respiratory illnesses, and heart disease. FDA, Required
Warnings for Cigarette Packages and Advertisements, 76 Fed. Reg. 36,628, 36,629 (June 22,
2011) (final rule); CDC, Smoking and Tobacco Use: Fast Facts (March 2011).1 These numbers
make cigarettes the “leading cause of preventable death and disease” in the United States,
“resulting in more deaths each year than AIDS, alcohol, illegal drug use, homicide, suicide, and
motor vehicle crashes combined.” FDA, Required Warnings for Cigarette Packages and
Advertisements, 75 Fed. Reg. 69,524, 69,526 (Nov. 12, 2010) (notice of proposed rulemaking).
Since the first Surgeon General’s report on the hazards of smoking was issued in 1964, more
than 12 million people in the United States have died from smoking cigarettes. President’s
Cancer Panel, Annual Report: Promoting Healthy Lifestyles 61 (2006-2007) (President’s Cancer
Panel Report).2
The FSPTCA adopts a comprehensive set of rules governing marketing of tobacco
products, but this case challenges the FDA’s implementation of only one aspect of the law—its
1

Available at http://www.cdc.gov/tobacco/data_statistics/fact_ sheets/fast_facts/index.

2

Available at http://deainfo.nci.nih.gov/advisory/pcp/annualReports/pcp06rpt/pcp06rpt.

htm.
pdf.

2

requirement of graphic warnings on cigarette packages and advertisements. Specifically, the Act
requires tobacco companies to print one of nine textual warnings on the top half of the front and
back of cigarette packaging. FSPTCA § 201(a) (amending 15 U.S.C. § 1333). The statute
requires warnings to be in 17-point type and appear either in black text on a white background or
white text on a black background. Id.
Most importantly for this case, the FSPTCA required the FDA, by June 2011, to “issue
regulations [for cigarette packaging] that require color graphics depicting the negative health
consequences of smoking.” Id. (amending 15 U.S.C. § 1333(d)). In implementing this
requirement, the FDA examined graphic warnings used in other countries and consulted with
“experts in the fields of health communications, marketing research, graphic design, and
advertising” to develop a set of proposed warnings. 75 Fed. Reg. at 69,534. In November 2010,
the FDA published in the Federal Register and on the agency’s website 36 proposed graphic
warnings that “depict[] the negative health consequences of smoking” and “illustrate[] the
message conveyed by the accompanying textual warning statement.” 76 Fed. Reg. at 36,636. The
notice set forth much of the extensive evidence on which Congress relied in passing the law,
demonstrating both that existing warnings have failed to adequately inform consumers about the
health risks of tobacco and that larger, graphic warnings used in other countries have been much
more effective at accomplishing that goal. 75 Fed. Reg. at 69,529-35.
The agency received more than 1,700 comments “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.” 76 Fed. Reg. at 36,629. Based on the comments and on its

3

own research on the effectiveness of the proposed images, the FDA selected nine graphic
warnings to illustrate each of the nine textual warnings written by Congress. Id. at 36,636.
Before the FDA had published its final rule on the graphic warnings, however, several
tobacco companies—including many of the plaintiffs here—sued the FDA in the U.S. District
Court for the Western District of Kentucky to enjoin eleven provisions of the Act, including the
warning requirements. In Commonwealth Brands, Inc. v. United States, 678 F. Supp. 2d 512,
528-32 (2010), the court rejected the plaintiffs’ challenge to the warnings and granted summary
judgment to the government on that issue. The court found “Congress’s decision to revise the
content and format of the tobacco warnings justified” by evidence that the pre-FSPTCA
warnings were largely ignored by consumers and “fail[ed] to convey relevant information in an
effective way.” Id. at 530-31 (quoting Institute of Medicine, Ending the Tobacco Problem: A
Blueprint for the Nation 291 (2007) (IOM Report)).3 The court also rejected the plaintiffs’
argument that “the new warnings are too large and too prominent,” noting the “international
consensus” that had developed behind similar warnings. Id. at 531. The decision is on appeal to
the Sixth Circuit.
ARGUMENT
I.

The Government Has a Strong Interest in More Effectively Informing Consumers
About the Deadly Effects of Tobacco.
As Commonwealth Brands recognized in rejecting the tobacco companies’ challenge to

the statutory warning requirement, Congress has a strong interest in ensuring that consumers are
effectively informed about the health consequences and addictive impact of cigarettes. 678 F.
Supp. 2d at 531-32. Indeed, given that tobacco is the “leading cause of preventable death and

3

Available at http://books.nap.edu/openbook.php?record_id=11795.

4

disease” in the United States, 75 Fed. Reg. at 69,526, it is difficult to imagine any product for
which the government has a stronger interest in ensuring effective warnings to consumers.
Tobacco products are unique among consumer goods: They kill up to one-half of the
people who use them as they are intended to be used. World Health Organization, Report on the
Global Tobacco Epidemic 8 (2008) (WHO Report);4 President’s Cancer Panel Report 61.
Cigarette smoke can accurately be described as poison. It contains 7,000 chemicals, 250 of
which cause cancer or are otherwise toxic. U.S. Department of Health and Human Services, How
Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking Attributable
Disease: A Report of the Surgeon General iii (2010).5 A recent figure estimates that 158,000
people in the United States die each year from lung and bronchial cancer caused by smoking.
CDC, Smoking-Attributable Mortality, Years of Potential Life Lost, and Productivity Losses–
United States, 2000-2004 (2008).6 Smoking also causes cardiovascular disease (including heart
attacks), coronary heart disease, emphysema, aortic aneurysms, bladder cancer, esophageal
cancer, kidney cancer, laryngeal cancer, oral cancer, pancreatic cancer, acute myeloid leukemia,
stomach cancer, uterine cancer, cervical cancer, and liver cancer. United States v. Philip Morris
USA, Inc., 449 F. Supp. 2d 1, 147-48 (D.D.C. 2006), aff’d in relevant part, 566 F.3d 1095 (D.C.
Cir. 2009); see FSPTCA § 2(2). And exposure to secondhand smoke causes heart disease and
lung cancer, as well as other health problems. CDC, Health Effects of Secondhand Smoke (2011)
(reporting that, each year, secondhand smoke causes approximately 46,000 non-smokers to die
prematurely, mostly as a result of heart disease; causes 3,400 nonsmokers to die of lung cancer;

4
5

Available at http://www.who.int/tobacco/mpower/en/.
Available at http://www.surgeongeneral.gov/library/tobaccosmoke/report/full_report.

6

Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5745a3.htm.

pdf.

5

and increases the risk of sudden infant death).7 The FDA cited evidence that, in total, 443,000
people in this country die each year from tobacco-related illnesses. 76 Fed. Reg. at 36,629.
The need for more effective warnings is especially critical in light of tobacco’s impact on
youth. Although the tobacco industry for decades denied that it targeted youth in its advertising,
the industry’s own documents show that, early on, it understood the value of creating
sophisticated advertising messages directed toward young people and devoted “decades of
research and development of strategic plans designed to capture the youth market.” National
Cancer Institute, The Role of the Media in Promoting and Reducing Tobacco Use, Smoking and
Tobacco Control Monograph No. 19 (June 2008), at 157;8 Philip Morris, 449 F. Supp. 2d at 676
(finding the industry’s claim that it did not target youth to be false). It is thus no surprise that
Congress found that “virtually all” new tobacco users are minors. FSPTCA § 2(4). Every day,
almost 3,900 children under the age of 18 try smoking for the first time; and every day, almost
1,000 begin a daily smoking habit. Substance Abuse and Mental Health Servs. Admin., Results
from the 2008 National Survey on Drug Abuse and Health (2009);9 see also 61 Fed. Reg. at
44568 (more than one million minors try their first cigarette each year); President’s Cancer Panel
Report 64 (2005 figures). Nearly one-half of the children who become regular smokers will die
prematurely from a tobacco-related disease. President’s Cancer Panel Report, at 64.
By hooking new smokers when they are young and vulnerable to sophisticated
advertising messages, the industry creates lifelong customers. Nicotine’s strongly addictive
nature causes acute withdrawal symptoms and makes quitting very difficult. IOM Report, at 80.
7

Available at http://www.cdc.gov/tobacco/data_statistics/fact_sheets/secondhand_smoke
/health_effects/.
8
Available at http://www.cancercontrol.cancer.gov/tcrb/monographs/19/m19_complete_
accessible.pdf.
9
Available at http://oas.samhsa.gov/nsduh/2k8nsduh/2k8Results.cfm.

6

Although about 40 percent of smokers try to quit every year, the success rate is only two to five
percent. Id. at 82. Yet, as Judge Kessler found in 2006, “[w]hile nicotine shares certain key
attributes of heroin, cocaine, and other drugs,” tobacco companies lied to the public for years,
“assert[ing] that smoking is no more addictive than coffee, chocolate, and exercise.” Philip
Morris, 449 F. Supp. 2d at 209.
Because of the negative health impacts of tobacco use and the difficulty of quitting, a full
ninety percent of smokers regret having ever started to smoke. IOM Report, at 88. Congress has
a strong interest in ensuring that future consumers—and especially youth—are fully informed
about the risks they will face before they begin experimenting with a dangerous and highly
addictive drug, that current users understand the consequences and relative risk of continuing to
smoke, and that those who have quit are reminded of the risks of again taking up the habit.
II.

Current Warnings Have Failed To Inform Consumers Effectively About the Risks
of Tobacco Use.
Much of plaintiffs’ argument hinges on their assertions that the FSPTCA’s graphic

warnings are unnecessary because the existing warnings are sufficient and that Americans are
“well aware of the health risks of smoking.” Mem. in Supp. of Pls.’ Mot. for Summ. J. at 14. The
overwhelming evidence, however, refutes these assertions.
For more than 50 years, Congress and the federal government have attempted to better
inform the American public about the health consequences of cigarette smoking—adopting three
prior sets of warning labels, issuing repeated reports on the health consequences of smoking, and
seeking to curtail the industry’s deceptive health claims. Despite these efforts, numerous
consumer surveys, scientific studies, and a consensus of the most respected national and
international authorities in the field—including the Surgeon General, the President’s Cancer
Panel, the National Cancer Institute, the Institute of Medicine, and the World Health

7

Organization—have found that the public remains misinformed about the risks of smoking.
Moreover, the findings contained in the 1600-page decision of the U.S. District Court in United
States v. Philip Morris establish that the tobacco industry itself has undermined the existing
warnings by denying the dangers of smoking and repeatedly misleading the public about the
health hazards of their products. 449 F. Supp. 2d 1. Examining this complete record, Congress
and the FDA found that prior efforts have been inadequate to inform the American public fully.
As the FDA concluded, “[r]esearch has repeatedly illustrated that the current warnings …
frequently go unnoticed or fail to convey relevant information regarding health risks.” 75 Fed.
Reg. at 69,539.
A. The existing warnings—which were last updated in 1984 and have remained
unchanged for more than 25 years—are small and easy to ignore. These warnings occupy only
50% of the narrow side of cigarette packaging (not visible when the packages are on display) and
5% of cigarette advertisements:

As a result, the warnings go largely unnoticed by consumers. IOM Report, at 291.
Studies show that “small text warnings are associated with low levels of awareness and
poor recall.” David Hammond, Health Warning Messages on Tobacco Products: A Review,
Tobacco Control 3 (2011). In one study on how well students could recall the contents of
cigarette packaging, only seven percent of students in the United States mentioned health

8

warnings. David Hammond, Tobacco Packaging and Labeling: A Review of Evidence 5 (2007).10
At the same time, in Canada, where a warning appeared on the front of the package, 83 percent
of students mentioned the warnings. Id. Other studies show similar results for advertising. A
study of adolescents viewing tobacco advertisements found that more than 40% did not even
look at the warning statement included in the advertisement, while only about 35% looked at the
warning long enough to read any words in it. 75 Fed. Reg. 69,530. After viewing the ads,
adolescents were unable to recall the content of the warnings or even to recognize the warnings
in a list. Id.
Reviewing the available evidence, the Surgeon General concluded in 1994 that empirical
studies of “the visibility of cigarette warnings in advertising ... consistently indicate that the
Surgeon General’s warnings are given little attention or consideration by viewers.” Surgeon
General’s Report, at 168. Similarly, the Institute of Medicine concluded that text warnings in the
United States receive little notice by smokers. IOM Report, at C-3. The Institute described the
warnings as “woefully deficient,” and the Chair of the Institute’s Committee on Reducing
Tobacco Use described them as “invisible” to consumers. Family Smoking Prevention And
Tobacco Control Act: Hearing Before the House Subcommittee on Health of the Comm. on
Energy and Commerce, 110th Cong. 42 (2007) (testimony of Richard Bonnie).
In addition to failing to inform consumers about the risks of tobacco use, the current
warnings fail to change consumers’ decisionmaking or behavior. Although more than 400,000
people in the United States die every year from tobacco use, more than 45 million Americans
continue to smoke. And despite laws in all 50 states banning the sale of tobacco products to

10

Available at http://www.tobaccolabels.ca/factshee/article_.

9

anyone under age 18, one in five high school students smokes cigarettes. CDC, Cigarette Use
Among High School Students–United States, 1991-2009 (July 2010).11
B. Despite plaintiffs’ contention that the public “overestimates” the risks of smoking,
Mem. in Supp. of Pls.’ Mot. for Summ. J. at 14, extensive research and the FDA’s findings
demonstrate that tobacco users in the United States actually fail to appreciate the extent of the
health risks associated with tobacco use and, in fact, greatly underestimate their personal risk.
Although smokers generally understand that smoking can cause lung cancer, they are less
likely to understand the degree of risk involved. For example, one study found that more than a
quarter of smokers did not believe that smoking increased the risk of getting cancer “a lot.” 76
Fed. Reg. at 36,632. Smokers are also much less aware of the risk of different forms of cancer
and of other health risks caused by tobacco use. For example, fewer than half of smokers knew
that tobacco use causes stomach ulcers, infertility, osteoporosis, and sudden infant death
syndrome. Id. Indeed, one survey found that, “more than half of the respondents were unable to
name a smoking-related illness other than lung cancer.” Id. Up to a third of smokers also believe
that activities like exercise or taking vitamins can “undo” most of the negative effects of
smoking. Id. And knowledge about the health risks of smoking is even lower in some
demographics, including low-income Americans and those with fewer years of education. Id.
Based on this evidence, the FDA concluded that, “[w]hile most smokers understand that smoking
poses certain statistical risks to their health, many fail to appreciate the severity and magnitude of
those risks.” Id. at 36,632.
Even smokers who correctly recognize the risks of tobacco use in the abstract are much
less likely to appreciate their own risk of disease. One study found that only 40% of smokers
11

Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5926a1.htm.

10

believed they had a higher-than-average risk of cancer, and only 29% believed they had a higherthan average risk of heart disease. Id. Even among smokers who smoke 40 or more cigarettes per
day, less than half believed they were at increased risk of those diseases. Id. Smokers are also
more than twice as likely as nonsmokers to doubt that tobacco use, even for as long as 30 to 40
years, would cause death. IOM Report, at 90. And the FDA found that, even among smokers
who accurately understand their personal risk, “that understanding may be too abstract to be
thought of at the time of purchase” when warnings fail “to make the risks salient.” 76 Fed. Reg.
at 36,633.
These problems are particularly serious among youth. Evidence shows that “adolescent
smokers underestimated their personal risk, even if they had an accurate sense of the statistical
risk.” Id. at 36,632. The Institute of Medicine 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.”
IOM Report, at 93. Although adolescents overestimate the risks of lung cancer, they
underestimate the likelihood that they will suffer tobacco-related disease and the degree to which
smoking can shorten their lives. Id. at 89-90. Adolescents also “typically underestimate the
tenacity of nicotine addiction and overestimate their ability to stop smoking when they choose.”
President’s Cancer Panel Report, at 64; see also IOM Report, at 89, 91. Although fewer than 5
percent of daily smokers in high school think that they still will be smoking at all in 5 years,
more than 60 percent are still regular daily smokers 7 to 9 years later. 76 Fed. Reg. at 36,633.
Plaintiffs rely on three studies that they say show that smokers are already fully aware of
the dangers of smoking, but these studies reached the opposite conclusion. Mem. in Supp. of
Pls.’ Mot. for Summ. J. at 26 & n.19. For example, plaintiffs rely on Neil D. Weinstein, Public

11

Understanding of the Illnesses Caused by Cigarette Smoking, but that study found that “lung
cancer was the only illness that could be identified by a clear majority of respondents,” and
that—even as to lung cancer—people underestimated the fatality rate and overestimated length
of life. 6:2 Nicotine & Tobacco Res. 349, 349 (2004). The study concluded that, “even though
people recognize that smoking can lead to adverse health consequences, they do not have even a
basic understanding of the nature and severity of these consequences.” Id. The other studies on
which plaintiffs rely reached similar conclusions. See David Hammond, Effectiveness of
Cigarette Warning Labels in Informing Smokers About the Risks of Smoking: Findings From the
International Tobacco Control (ITC) Four Country Survey, 15 Tobacco Control iii19, iii19
(2006) (concluding that smokers “exhibited significant gaps in their knowledge of the risks of
smoking,” but that smokers in countries with larger, graphic warnings had more knowledge of
the risks); K. Michael Cummings, Are Smokers Adequately Informed about the Health Risks of
Smoking and Medicinal Nicotine?, 6:2 Nicotine & Tobacco Res. 1 (2004) (finding that “smokers
are misinformed about many aspects of the cigarettes they smoke … and that they want more
information about ways to reduce the health risks”).
C. Plaintiffs’ argument that the risks of smoking are well-known is particularly troubling
given that much of the public’s failure to understand those risks is directly attributable to the
industry’s deliberate misrepresentations. Although for many years the tobacco industry feigned
ignorance of the addictive nature of its products, the FDA’s tobacco rulemaking in 1995 and
1996, and the extensive findings of Judge Kessler in United States v. Philip Morris, 449 F. Supp.
2d 1, found overwhelming evidence that the industry’s public statements were lies. Judge
Kessler concluded:
[O]ver the course of more than 50 years, [the tobacco industry]
lied, misrepresented, and deceived the American public, including

12

smokers and the young people they avidly sought as “replacement
smokers,” about the devastating health effects of smoking and
environmental tobacco smoke, they suppressed research, they
destroyed documents, they manipulated the use of nicotine so as to
increase and perpetuate addiction, they distorted the truth about
low tar and light cigarettes so as to discourage smokers from
quitting, and they abused the legal system in order to achieve their
goal—to make money with little, if any, regard for individual
illness and suffering, soaring health costs, or the integrity of the
legal system.
Id. at 852.
The tobacco industry not only lied about the risks of smoking generally, but for decades
implemented a scheme to convince smokers that so-called “light,” “low-tar,” or “low-nicotine”
cigarettes were less harmful than regular cigarettes—claims that the industry knew to be false.
Id. at 445, 468, 531. To discourage smokers from quitting, the companies promoted their low-tar
brands to those who were concerned about cigarettes’ health hazards or considering quitting. Id.
at 508; see Philip Morris, 566 F.3d at 1107. The scheme was highly successful: Sales of
purportedly “low-tar” and “low-nicotine” brands increased from two percent of total cigarette
sales in 1967 to almost 92.7 percent in 2006. Philip Morris, 449 F. Supp. 2d at 508; FTC,
Cigarette Report for 2006, at 7 (2009);12 see also Philip Morris, 449 F. Supp. 2d at 507-08
(companies “continue to make[] false and misleading statements regarding low-tar cigarettes in
order to reassure smokers and dissuade them from quitting”).
*

*

*

More than fifty years of experience with less prominent warnings, and the industry’s
history of undermining those warnings by misrepresenting the risks of its products, demonstrate
that—unlike commercial speech restrictions held unconstitutional in other cases—Congress did
not adopt the FSPTCA warnings as a “first resort,” without exploring the feasibility of other
12

Available at http://www.ftc.gov/os/2009/08/090812cigarettereport.pdf.

13

options. See Thompson v. W. States Med. Ctr., 535 U.S. 357, 373 (2002). In concluding that the
current warnings are inadequate, Congress reasonably relied on the overwhelming evidence
showing the ineffectiveness of those warnings at either educating the public or changing
consumer behavior.
III.

Substantial Evidence Supports the Revised Warning Requirements.
A.

The Evidence Demonstrates That Large, Graphic Warnings on the Front of
Cigarette Packaging Are Most Effective at Reducing Smoking and Informing
Consumers About the Risks of Tobacco Use.

In adopting larger, graphic warnings, the United States joined a growing consensus
among nations that graphic warnings covering a substantial portion of the front panels of
cigarette packages are the most effective means of informing consumers about the risks of
smoking. Commonwealth Brands, 678 F. Supp. 2d at 531. At least 25 countries now require
graphics on cigarette packaging, including Canada, Brazil, Great Britain, Australia, India,
Thailand, Chile, and Switzerland. See Canadian Cancer Society, Cigarette Package Health
Warnings 3 (2008).13 Twenty-four countries require at least 50 percent of the front and back
panels (combined) of a cigarette container to be used for warnings. Id. at 6-7. Citing the success
of warnings in these countries, the World Health Organization recommends that warnings,
including both pictures and words, “should cover at least half of the packs’ main display areas
and feature mandated descriptions of harmful health effects.” WHO Report, at 34; see also
Commonwealth Brands, 678 F. Supp. 2d at 531.
The effectiveness of such warnings is documented in extensive independent research. A
recent review of ninety-four separate studies on tobacco warnings concluded that “the impact of
health warnings depends on their size and design.” Hammond, Health Warning Messages on

13

http://tobaccofreecenter.org/files/pdfs/en/WL_status_report_en.pdf.

14

Tobacco Products: A Review, supra, at 1. “[W]hereas obscure text-only warnings appear to have
little impact, prominent health warnings on the face of packages serve as a prominent source of
health information for smokers and non-smokers, can increase health knowledge and perceptions
of risk and can promote smoking cessation.” Id. As Commonwealth Brands held in rejecting the
industry’s arguments, “the government’s goal is not to stigmatize tobacco products on the
industry’s dime; the goal is to ensure that the health risk message is actually seen by consumers
in the first place.” 678 F. Supp. 2d at 530 (emphasis in original).
Experts also agree that package warnings are more effective—particularly among
youth—when they involve imagery. “[P]ictures with graphic depictions of disease and other
negative images [have] greater impact than words alone … .” WHO Report, at 34. Use of images
more effectively draws attention to the message and makes it more memorable, while prompting
consumers to think about the consequences of smoking. See Hammond, Tobacco Packaging and
Labeling: A Review of Evidence, supra, at 10. One study showed that 90 percent of young people
surveyed thought that picture warnings were informative and made smoking seem less attractive.
Id. at 8. Another study found that children are more likely to read, think about, and talk about
picture warnings on cigarette packaging than non-picture warnings. Id. at 9. Graphic warnings
are also important for communicating with consumers with low levels of education, given
evidence that those consumers “are less likely to recall health information in text-based
messages.” IOM Report, at 295, C-3 (noting one study showing that current warnings “require a
college reading level” and thus “may be inappropriate for youth and Americans with poor
reading abilities.”).
Finally, there is also strong scientific evidence demonstrating the value of including the
national quitline number, 1-800-QUIT-NOW, in the graphic warnings to inform consumers

15

about the availability of assistance if they want to quit. As the Institute of Medicine found,
quitlines have proven “effective … in helping individuals to stop smoking”—increasing smoking
abstinence by as much as 30 to 50 percent. Id. at 237. Based on a careful review of the evidence,
the U.S. Public Health Service similarly concluded that smokers who use telephone quitlines are
significantly more successful at quitting than those who get little or no counseling. U.S. Pub.
Health Serv., Clinical Practice Guidelines, Treating Tobacco Use and Dependence: 2008
Update 91-92 (2008).14 The Public Health Service’s guidelines accordingly recommend that
“clinicians and health care delivery systems should both ensure patient access to quitlines and
promote quitline use.” Id. at vii. These conclusions are consistent with well-established evidence
confirming that by providing a direct and immediate cue for action, quitlines significantly
increase the likelihood of changes in behavior. See, e.g., David B. Abrams, et al., Boosting
Population Quits Through Evidence-Based Cessation Treatment and Policy, 38 Am J. Prev.
Med. Supp. S351-363 (2010).
B.

Plaintiffs’ Criticism of the FDA’s Rulemaking Fails to Rebut the
Overwhelming Weight of Evidence Demonstrating the Warnings’
Effectiveness.

Plaintiffs ignore the entirety of the record on which Congress relied in adopting the new
warning requirements. Instead, they single out for criticism a regulatory-impact analysis and
consumer study conducted by the FDA to help it choose specific images to include in the
warnings. The rulemaking record as a whole, however, along with Congress’s findings and years
of experience documenting the effectiveness of large, graphic warnings, amply support the
chosen graphic warnings.

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Available at http://www.surgeongeneral.gov/tobacco/treating_tobacco_use08.pdf.

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1.

The FDA’s Regulatory-Impact Analysis Does Not Undermine the
Evidence on Which Congress Relied.

Plaintiffs argue that the agency’s regulatory-impact analysis fails to establish that tobacco
use in Canada declined after that country adopted graphic warnings similar to those required by
the FSPTCA. Mem. in Supp. of Pls.’ Mot. for Summ. J. at 19-22. The analysis, however, was
never intended to carry that burden. As the FDA explained, its regulatory-impact analysis was
subject to a “large uncertainty” because it was based on “very small data sets” and depended on
unmeasurable differences between the “social and policy climate of the U.S. and Canada.” 76
Fed. Red. at 36,721. Although, based on this limited data, the agency could “not reject, in a
statistical sense, the possibility that the rule will not change the U.S. smoking rate,” it also could
not reject the possibility that the rule would lead to significant reductions in tobacco use and thus
savings to the American public. Id. Regardless, the FDA’s difficulty in quantifying the impact of
the rule on smoking prevalence does nothing to undermine the extensive evidence—set forth in
detail in the FDA’s notice of proposed rulemaking and final rule, but ignored by plaintiffs—that
Canada’s warnings were effective both in substantially reducing tobacco use and in effectively
communicating information to consumers.
Studies show that Canadian smokers who have read, thought about, and discussed
graphic labels were more likely to have quit, tried to quit, or reduced their smoking. IOM Report,
at 295. One-fifth of Canadian smokers said that they smoked less, and one-third said they were
more likely to quit, because of the warnings. Id. Former smokers also identified the pictorial
warnings as important factors in quitting and in subsequently remaining nonsmokers. Id.
Moreover, there is evidence that pictorial warnings in Canada have been effective in deterring
children from taking up smoking. Approximately 6 years after the introduction of pictorial
warnings, more than 90% of surveyed Canadian youth agreed that pictorial warnings on

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Canadian cigarette packages had provided them with important information about the health
consequences of smoking and made it less likely that they would smoke. Given this and other
evidence, the Canadian Supreme Court unanimously rejected a challenge to the warnings by
tobacco companies there, concluding that “[t]he benefits flowing from the larger warnings are
clear.” Canada v. JTI-Macdonald Corp., [2007] S.C.C. 30 ¶ 139.
Studies of warnings outside Canada back up this conclusion. For example, a study of
graphic warnings introduced in Australia in 2006 found that the “self-reported impact” of
tobacco use “increased significantly” after the country adopted the enhanced warnings. Ron
Borland, et al., Impact of Graphic and Text Warnings on Cigarette Packs: Findings From Four
Countries Over Five Years, 18 Tobacco Control 358, 359-60 (2009). The study concluded that
Australia’s experience “strengthened the existing evidence that reactions to warnings predict
subsequent quitting.” Id. at 359; see also Victoria White, et al., Do Graphic Health Warning
Labels Have an Impact on Adolescents’ Smoking-Related Beliefs and Behaviors?, 103 Addiction
Res. Report 1562, 1562 (2008) (finding that the “introduction of graphic warning labels may help
to reduce smoking among adolescents”). Other studies have found similar effects of graphic
warnings in Malaysia, see Ahmed I. Fathelrahman, Smokers’ Responses Toward Cigarette Pack
Warning Labels in Predicting Quit Intention, Stage of Change, and Self-Efficacy, 11:3 Nicotine
& Tobacco Res. 248 (2009), and the European Union, see Constantine I. Vardavas, Adolescents
Perceived Effectiveness of the Proposed European Graphic Tobacco Warning Labels, 19 Eur. J.
Pub. Health 212 (2009).
Even if the evidence that the revised warnings will lead to a reduction in smoking were
not as compelling as it is, the First Amendment would not prohibit the government from
requiring tobacco companies to inform consumers more effectively about the risk of serious

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injury and death caused by their products. The primary purpose of warning labels is to
communicate information to consumers. Because “the extension of First Amendment protection
to commercial speech is justified principally by the value to consumers of the information such
speech provides, … the First Amendment interests implicated by disclosure requirements are
substantially weaker than those at stake when speech is actually suppressed.” Zauderer v. Office
of Disciplinary Counsel of Supreme Court of Ohio, 471 U.S. 626, 651 & n.4 (1985). Unlike
prohibitions on speech, disclosure requirements have no potential to “offend the core First
Amendment values of promoting efficient exchange of information.” Nat’l Elec. Mfrs. Ass’n v.
Sorrell, 272 F.3d 104, 113-14 (2d Cir. 2001). Indeed, such “disclosure furthers, rather than
hinders the First Amendment goal of the discovery of truth.” Id. at 114.
In Zauderer, for example, the Supreme Court upheld the constitutionality of a state bar
disciplinary regulation requiring attorneys that advertised contingent-fee representation to
disclose in their advertisements that clients may still have to bear certain costs. See 471 U.S. at
633. Notably, the court did not require the state to show that the disclosures would make
consumers less likely to hire the advertising attorney or would otherwise affect their decision
about whom to hire. Rather, the Court held the disclosure to be justified because the average
consumer might not understand the difference between fees and costs. Id. Similarly, the Court in
Milavetz, Gallop & Milavetz, P.A. v. United States upheld a federal law requiring “debt relief
agencies” to disclose, among other things, that their assistance “may involve bankruptcy relief.”
130 S. Ct. 1324, 1339 (2010). Again, the Court did not require evidence that the disclosure
would change consumer behavior. Noting that “the less exacting scrutiny described in Zauderer
governs” when “the challenged provisions impose a disclosure requirement rather than an
affirmative limitation on speech,” the Court found the government’s burden to be satisfied by

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“[e]vidence in the congressional record demonstrating a pattern of advertisements that hold out
the promise of debt relief without alerting consumers to its potential cost.” Id.
Numerous other federal, state, and local laws require advertisers to include health and
safety warnings that are necessary for consumers to understand the risks they will undertake if
they heed the advertiser’s commercial message. For example, the FDA mandates warnings on
drug labels, including prominent “black box” warnings, that emphasize particular hazards. 21
C.F.R. § 201.57. Likewise, the Federal Trade Commission mandates disclosures by automobile
dealers of warranty information in “Buyers’ Guides” on used cars, 16 C.F.R. § 455.2 (specifying
format and content of form required to be displayed on window of used car offered for sale to
consumers), disclosures in connection with promotion of franchising opportunities, id. § 316.1,
and disclosures of relationships between an endorser and a seller of a product, id. § 255.5. “There
are literally thousands of similar regulations on the books, such as product labeling laws,
environmental spill reporting, accident reports by common carriers, [and] SEC reporting as to
corporate losses.” Pharm. Care Mgmt. Ass’n v. Rowe, 429 F.3d 294, 316 (1st Cir. 2005). Such
laws have been widely upheld by the courts. See id. at 113-16 (upholding Maine law requiring
intermediaries between drug companies and pharmacies to disclose their conflicts of interest and
financial arrangements); see also, e.g., N.Y. State Rest. Ass’n v. N.Y. City Bd. of Health, 556 F.3d
114 (2d Cir. 2009) (upholding a New York City law requiring disclosure of calories on menus
and menu boards); Envt’l Def. Ctr. v. EPA, 344 F.3d 832, 848-851 (9th Cir. 2003) (upholding
requirement that storm-sewer providers distribute information concerning the environmental
hazards of stormwater discharges and steps the public can take to reduce pollutants); Sorrell, 272
F.3d 104 (upholding a Vermont law requiring manufacturers to inform consumers that products
contain mercury and should be recycled or disposed of as hazardous waste). Cf. UAW-Labor

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Employment & Training Corp. v. Chao, 325 F.3d 360, 365 (D.C. Cir. 2003) (upholding
requirement that federal contractors post notices at all of their facilities informing employees of
rights under federal labor law).
In this case, overwhelming evidence demonstrates that Canada’s enhanced warnings have
been highly effective at increasing public awareness about the risks of tobacco. In studies of
Canadian smokers, “approximately 95 percent of youth smokers and 75 percent of adult smokers
report that the pictorial warnings have been effective in providing them with important health
information,” and more than half “reported that the pictorial warnings have made them more
likely to think about the health risks of smoking.” IOM Report, at 294. Moreover, in a recent
study of more than 8,000 smokers from Canada, Australia, the United States, and the United
Kingdom over a five-year period, 85% of Canadian respondents cited packages as a source of
health information, compared to only 47% of U.S. smokers. Borland, Impact of Graphic and
Text Warnings, supra, at 358. In many countries, more smokers report getting information about
the health risks of smoking from warning labels than any other source except television. David
Hammond, Tobacco Labeling & Packaging Toolkit: A Guide to FCTC Article 11 (2009). Like
the required disclosure in Zauderer, the warnings thus ensure that consumers are better informed
about the products they are purchasing, thereby serving the same constitutional purpose as does
the commercial speech doctrine itself.
2.

The FDA’s Consumer Research Was Not Intended to Prove By Itself
the Effectiveness of Graphic Warnings.

Plaintiffs also criticize consumer research conducted by the FDA, arguing that the
evidence fails to demonstrate that the chosen warnings increase awareness about the risks of
smoking. Plaintiffs’ criticism misstates the purpose of the study and its role in the FDA’s
decision making. Like the agency’s regulatory-impact analysis, its consumer research was not

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designed to provide independent proof of the effectiveness of graphic warnings, which had
already been demonstrated by a large number of independent studies. Rather, the purpose of the
study was to test only the “relative efficacy” of each of the 36 graphic warnings proposed in the
agency’s notice of proposed rulemaking. FDA, Experimental Study of Graphic Cigarette
Warning Labels 1-1 (2010) (FDA Study) (emphasis added).
The study tested the effectiveness of each proposed graphic by exposing participants to a
single viewing of one of the warnings and measuring both the participants’ immediate reaction
and their ability to recall the warning’s content later. Id. at 1-3. Such measurements are relevant
in evaluating the relative effectiveness of warnings because evidence demonstrates that a
warning’s effect on long-term changes in knowledge and behavior depends on the viewer’s
“immediate emotional and cognitive reactions” to the warning. Id. at 4-1. As the study’s authors
explained, a strong immediate reaction “enhances recall and processing of the health warning,
which helps ensure that the warning is better processed, understood, and remembered.” Id. At 12. These “immediate responses” lead to “later recall of the message and changes in knowledge,
attitudes, and beliefs related to the dangers of tobacco use and exposure to secondhand smoke,”
and “eventually … to changes in intentions to quit/start smoking.” Id.
The study concluded that “[m]ost of the [proposed] warning images elicited strong
emotional and cognitive responses compared with controls,” and that participants’ recall of the
images was strong—exceeding 70% even one week after viewing. Id. at 4-1, 4-2. Moreover, the
images adopted by the FDA in its final rule were generally more likely than other proposed
images to be memorable and to make an impact on the viewer. Of the graphics proposed to
illustrate the warning “Cigarettes are addictive,” for example, the FDA selected a warning

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depicting a man blowing smoke through a hole in his throat, which the study found was the
image most likely to elicit a strong reaction from the viewer. Id. at 3-2, 3-4, 4-2.
Although these findings suggest that the FDA’s chosen warnings are likely to lead to
long-term effects on consumers’ attitudes and behavior, id. at 4-1, the study was not intended to
detect or measure such long-term effects directly. The effectiveness of graphic warnings on
tobacco packaging comes not from a single exposure, but from repeated exposure at the moment
when the viewer is deciding whether to purchase or use tobacco. As the FDA explained, “pack-aday smokers are potentially exposed to warnings more than 7,000 times per year.” 76 Fed. Reg.
at 36,631. But changes in behavior “are unlikely to be immediate or short-term,” FDA Study at
1-2, and the study’s design did “not allow for assessment of the effect [of] repetitive viewing of
the graphic warning labels.” Id. at 4-5.
Even given these limitations, the study found that, after only a single viewing, several of
the images had a significant impact on beliefs about the health risks of smoking. Id. at 4-3. And
although the study—as expected—did not find “strong evidence” that the warnings increased
subjects’ intention to quit smoking after a single viewing, several of the images showed a
statistically significant impact on the intention to quit in at least one sample group. Id.
Taken as a whole, the strength of the evidence reflected in Congress’s findings and the
rulemaking record is unique among commercial-speech cases. That a single study—not designed
for the purpose—does not on its own demonstrate the effectiveness of graphic warnings does
nothing to undermine the overwhelming weight of evidence that prominent, graphic warnings are
effective both at reducing tobacco use and at better informing consumers about the risks of
smoking. On the contrary, the ability of warnings to create any measurable effect in smokers’

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beliefs and intention to quit after only one viewing powerfully demonstrates the warnings’
effectiveness.
CONCLUSION
For the foregoing reasons and the reasons stated in the government’s memorandum, the
motion for a preliminary injunction should be denied.

September 16, 2011
Respectfully submitted,
/s/Gregory A. Beck
Gregory A. Beck
Allison M. Zieve
Public Citizen Litigation Group
1600 20th Street NW
Washington, DC 20009
202-588-1000
Attorneys for Amici Curiae
American Cancer Society, et al.

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