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

Filing 31

SUPPLEMENTAL MEMORANDUM to 18 Opposition to Plaintiffs' Motion for Preliminary Injunction filed by MARGARET A. HAMBURG, KATHLEEN SEBELIUS, UNITED STATES FOOD AND DRUG ADMINISTRATION. (Cutini, Drake) Modified to add link on 10/3/2011 (znmw, ).

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
R.J. REYNOLDS TOBACCO
COMPANY, et al.,
Plaintiffs,
v.
UNITED STATES FOOD AND
DRUG ADMINISTRATION, et al.,
Defendants.

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

DEFENDANTS’ SUPPLEMENTAL BRIEF IN SUPPORT OF THEIR
OPPOSITION TO PLAINTIFFS’ MOTION FOR A PRELIMINARY INJUNCTION

Of Counsel:

TONY WEST
Assistant Attorney General

WILLIAM B. SCHULTZ
Acting General Counsel

BETH S. BRINKMANN
Deputy Assistant Attorney General

ELIZABETH H. DICKINSON
Acting Associate General Counsel
Food and Drug Division

MAAME EWUSI-MENSAH FRIMPONG
Acting Deputy Assistant Attorney General

ERIC M. BLUMBERG
Deputy Chief Counsel, Litigation
KAREN E. SCHIFTER
Senior Counsel
U.S. Department of Health & Human Services
Office of the General Counsel
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

DRAKE CUTINI
DANIEL K. CRANE-HIRSCH
Attorneys, Consumer Protection Branch
MARK B STERN
ALISA B. KLEIN
SARANG V. DAMLE
DANIEL TENNY
LINDSEY POWELL
Attorneys, Appellate Staff
Civil Division, Room 7217
U.S. Department of Justice
950 Pennsylvania Ave., NW
Washington, DC 20530

The Court’s questions at the preliminary injunction hearing focused on plaintiffs’ contentions
regarding the use of images in conjunction with text in the warnings required by Congress, and this
brief responds to the issues discussed in the colloquies with counsel.
Plaintiffs do not contest the accuracy of the text of the warnings required by the Tobacco
Control Act or question Congress’s authority to require their inclusion in cigarette packaging and
advertising. Nor do they dispute that Congress mandated that the text be complemented by images
of the type already required in Canada and other countries.
Plaintiffs argue that inclusion of images transforms the warnings into “compelled speech”
subject to strict scrutiny. Their contentions are without anchor in First Amendment doctrine, and
fundamentally misapprehend the way in which images reinforce the accompanying text. As shown
below, a host of studies and extensive scientific literature establish that viewers read, recall, and
process text information more often and more effectively when the text is combined with an
associated image. Plaintiffs complain that visual images evoke an emotional response. But they do
not contend that the images are inaccurate or convey a different message than the text. If the images
inspire concern or even anxiety about the consequences of smoking, they do so only because the
images, in combination with the text, convey accurate information about the consequences of
consuming plaintiffs’ highly addictive product, which “‘kills more people each year in the United
States than acquired immunodeficiency syndrome (AIDS), car accidents, alcohol, homicides, illegal
drugs, suicides, and fires, combined.’” FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120,
134–35 (2000) (quoting 61 Fed. Reg. 44,396, 44,398 (Aug. 28, 1996)).
A. 1. At several points in the preamble to the final rule, FDA addressed contentions that
images provoke emotions rather than convey information. The agency noted, for example, that
commenters had criticized various images as “‘disturbing’” or “eliciting emotions,” including the
image “depicting a man smoking through a tracheostomy opening,” the image “depicting healthy

lungs juxtaposed with lungs damaged by smoking,” the image “depicting a lesion consistent with
that caused by oral cancer,” and the image “depicting a man with an autopsy scar.” 76 Fed. Reg.
36,628, 36,696 (June 22, 2011).
As FDA noted, “[t]he comment did not assert, however, that the effects shown in the images
are false, i.e., that they are not manifestations of negative health consequences of smoking, such as
throat, lung, and oral cancer, and death.” Ibid. The agency emphasized: “The fact that the images
are disturbing or evoke emotion does not mean that they are not factual representations of the effects
of smoking. . . . As such, it is not surprising that the warnings regarding the negative health
consequences of smoking would evoke emotions such as fear of being stricken with life-threatening
cancer or disgust at what it might be like to have that happen.” Ibid.
FDA repeatedly explained that consideration of the emotional response of viewers is germane
because it predicts the likelihood that viewers will notice and process the information contained in
the text. The agency noted that “[t]he overall body of scientific evidence indicates that health
warnings that evoke strong emotional responses enhance an individual’s ability to process the
warning information, leading to increased knowledge and thoughts about the harms of cigarettes and
the extent to which the individual could personally experience a smoking-related disease.” Id. at
36,641. The images selected “were designed to correlate with [the] warning statements,” and the
“available evidence base highlights the value of the text and images in graphic health warnings
relating to one another in a meaningful way.” Id. at 36,637 (citations omitted).
2. The evidence before Congress and the FDA amply demonstrated that the message of the
text is conveyed more effectively when combined with an accompanying image. One study showed
that while “‘83 percent of Canadian students mentioned health warnings in a recall test of cigarette
packages,’ only ‘7 percent of U.S. students’ did the same.” Commonwealth Brands, Inc. v. U.S., 678
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F. Supp. 2d 512, 531 (W.D. Ky. 2010) (citation omitted). In another study, when “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 . . . the Canadian graphic warnings significantly
increased aided recall of the warnings, increased depth of message processing, and increased the
perceived strength of the message.” 75 Fed. Reg. 69,524, 69,531 (Nov. 12, 2010) (citation omitted).
These findings are consistent with focus group research in which young adults in the United States
“reported that the Canadian warnings were more visible and more informative than the warnings
appearing on cigarette packages in the United States.” 75 Fed. Reg. at 69,531 (citation omitted).
Recent research confirms that warnings combining images and text are more effective in
conveying the risks identified in the text. For instance, from 1995 to 2005, Australia required
cigarette manufacturers to display large, text-only warnings covering the top 25% of the front of the
pack. David Hammond et al., Effectiveness of Cigarette Warning Labels in Informing Smokers
about the Risks of Smoking, 15 Tobacco Control iii19, iii20 (2005). After Australia introduced
pictorial warnings in 2006, a longitudinal study of youth “found that students were more likely to
read, attend to, think about, and talk about health warnings after the pictorial warnings were
implemented.” David Hammond, Health Warnings Messages On Tobacco Products: A Review, 20
Tobacco Control 327, 330 (2011) (discussing 2008 study); see also Karine Gallopel-Morvan et al.,
The Use of Visual Warnings in Social Marketing: The Case of Tobacco, 64 J. Business Research 7,
7 (2011) (study comparing the EU’s large text-only warnings to its new pictorial warnings concluded
that the results “clearly demonstrate[] that visual messages, as opposed to text warnings, are more

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effective”). Research also “suggests that larger pictorial warnings sustain their effects longer,” as
compared to their text-only counterparts. See Hammond, 20 Tobacco Control at 333.1
3. These results should not be surprising. It is axiomatic in cognitive psychology that
“pictures are easier to remember than words.” S. David Leonard et al., Comprehension and Memory,
in WARNINGS AND RISK COMMUNICATION 148 (Michael S. Wogalter et al., eds. 1999). The brain
has distinct coding systems for words and for images, and information in the “image” memory
system is more likely to be retained and is more easily retrieved. This is particularly the case for
words “representing abstract concepts.” Ibid. Information that is coded in both systems is
particularly easy to remember “because theoretically more ‘paths’ are created in memory, making
the information more accessible (more likely to be cued) at later times.” Ibid. Thus, even apart from
tobacco-specific research, studies have “found that pictorials in combination with conspicuous print
facilitated recollection of warning contents,” and that “the enhanced memory was directly related to
the fact that the warning was noticed in the first place.” Wendy A. Rogers et al., Warning Research:
An Integrative Perspective, 42 Human Factors 102, 114 (Spring 2000); see also, e.g., Steven Young
& Michael Wogalter, Comprehension and Memory of Instruction Manual Warnings: Conspicuous

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After reviewing a broad range of scientific evidence regarding the effect of health-warning
messages on tobacco products, including the benefits of adding graphics to already large text-only
warnings, Dr. Hammond concluded that, as compared to text-only warnings, “pictorial warnings are
more likely to be noticed and read by smokers, are associated with stronger beliefs about the health
risks of smoking, as well as increased motivation to quit smoking.” Hammond, 20 Tobacco Control
at 330. Plaintiffs nevertheless cite the same publication to insist that Dr. Hammond believes that
pictorial warnings are ineffective. See Pl. Reply Br. 11 n.12; Hearing Tr. at 73, 76–77. In the
passage quoted by plaintiffs, Dr. Hammond notes the difficulties inherent in determining the extent
to which pictorial warnings accounted for the documented decline in Canadian smoking rates
following their introduction, noting that the decline may also have been influenced by other public
health measures. See id. at 331. As we explain in our Opposition (at 23–24), the critical question
in assessing the warnings is their effectiveness in conveying health risk information, not the extent
to which the warnings are shown to decrease smoking rates.
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Print and Pictorial Icons, 32 Human Factors 637, 646 (1990) (comparing the relative effectiveness
of instruction-manual warnings with and without pictorials, and finding that “warnings that have
both conspicuous print and illustrative pictorial icons enhance comprehension and memory of the
warnings’ message content”).
4. Conveying information in cigarette warnings poses special difficulties that make the use
of images particularly appropriate. First, although the health consequences of smoking are severe,
they generally do not become manifest for many years. Because of that time lag, smokers—and
adolescents in particular—tend to disregard or discount discomforting factual information about the
consequences of using plaintiffs’ product. See Paul Slovic, Cigarette Smokers: Rational Actors or
Rational Fools?, in SMOKING: RISK, PERCEPTION, & POLICY 97, 109–10 (Paul Slovic ed., 2001); U.S.
v. Philip Morris USA, Inc., 449 F. Supp. 2d 1, 936 (D.D.C. 2006) (“[T]he general public, and youth
in particular, significantly underestimate the risks of beginning and continuing to smoke.”), aff’d in
relevant part, 566 F.3d 1095 (D.C. Cir. 2009), cert. denied, 130 S. Ct. 3501 (2010).
Second, plaintiffs’ current customers comprise a market of addicts who are particularly prone
to discount or ignore text-only content. Plaintiffs’ own expert in Commonwealth Brands emphasized
the tenacity of the addiction to nicotine, the “substance in tobacco that inveterate smokers crave.”
Rodu Decl. ¶ 40 (R. 72-1, No. 1:09-cv-117 (W.D. Ky)). The consequences of that addiction,
Dr. Rodu stressed, are deadly: he acknowledged that if people stopped smoking, “there would be
over 400,000 fewer tobacco-related deaths in America each year.” Id. ¶ 5.
Third, new consumers, who are not already addicted, are primarily children and adolescents.
Congress found that the “overwhelming majority of Americans who use tobacco products begin
using such products while they are minors and become addicted to the nicotine in those products
before reaching the age of 18.” Legislative Finding 31. Congress also found that “[a]dvertising,
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marketing, and promotion of tobacco products have been especially directed to attract young
persons,” Legislative Finding 15, who “are particularly vulnerable to cigarette marketing because
they are not capable of making a fully informed decision whether to start or continue smoking for
a variety of reasons, including the fact that they underestimate personal risks and lack the judgment
which can only be developed through experience.” Philip Morris, 449 F. Supp. 2d at 578. Studies
have long since established that children and adolescents acquire information far more readily when
text is accompanied by illustrations. Summarizing the results of over 50 studies, one study explained
that “[i]llustrations can help learners understand what they read, can help learners remember what
they read, and can perform a variety of other instructional functions.” See W. Howard Levie &
Richard Lentz, Effects of Text Illustrations: A Review of Research, 30 Educ. Comm. & Tech. J. 195,
226 (1982).
Smoking rates are also closely correlated with education levels. FDA noted 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,” and “that graphic health warnings may be particularly important
communication tools for these smokers, as there is evidence suggesting that countries with graphic
health warnings demonstrate fewer disparities in health knowledge across educational levels.” 76
Fed. Reg. at 36,630 (citations omitted); see also Commonwealth Brands, 678 F. Supp. 2d at 531
(“[G]raphical warnings ‘may be particularly important for communicating’ with consumers with low
levels of education, given evidence that such smokers ‘are less likely to recall health information in
text-based messages than people with more education.’”) (citation omitted).
B. 1. The health warnings mandated by Congress pass muster under any level of scrutiny.
The relevant legal standard, as discussed in our opposition, is the “less exacting scrutiny” accorded
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to warnings and disclosures of accurate information in the commercial context. Milavetz, Gallop
& Milavetz, P.A. v. U.S., 130 S. Ct. 1324, 1339–40 (2010); Zauderer v. Office of Disciplinary
Counsel of Supreme Court of Ohio, 471 U.S. 626, 651 (1985). The health warnings also satisfy the
intermediate scrutiny standards applicable to commercial speech, see Central Hudson Gas & Elec.
Corp. v. Pub. Serv. Comm’n, 447 U.S. 557, 566 (1980), and, if it were thought to apply, strict
scrutiny. The government has a compelling interest in effectively conveying the health risks of
smoking, and the evidence before Congress showed that plaintiffs’ proposed alternatives are
ineffective. Plaintiffs assert that Congress should have omitted images altogether and confined the
text to the format “in which the Surgeon General’s warnings have been displayed for years.”
Comment Letter at 3-4. But nations throughout the world have recognized that text-only warnings
do not effectively communicate health risks, even when they are far more prominent than plaintiffs
assert is permissible. And text warnings in the current format are not merely ineffective but, the
evidence before Congress showed, virtually invisible. See Opp. to P.I. Mot. 16–18.
2. Plaintiffs’ invocation of the compelled speech doctrine is, in any event, altogether
implausible. They maintain that “the proposed warnings convey to smokers the Government’s view
that they should change in a significant way how they lead their lives,” and argue that “[t]he
viewpoint the Government proposes to be conveyed on the manufacturers’ packaging and advertising
is thus every bit as ideological as the message at issue in Wooley v. Maynard, 430 U.S. 705 (1977):
‘Live Free or Die.’” Comment Letter at 2. They declare that, “[i]n effect, the message and
viewpoint of FDA’s proposed graphic warnings is: ‘Live Smoke-Free or Die.’” Ibid.
Accurate information about the very real, very significant health risks of plaintiffs’ products
does not constitute an “ideological message.” As Dr. Rodu emphasized in his Commonwealth
Brands declaration, it is uncontested that persons seeking to avoid the deadly consequences of
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smoking should not consume cigarettes. Rodu Decl., supra, ¶ 40; see also Nat’l Citizens Comm.
for Broad. v. FCC, 567 F.2d 1095, 1100 n.13 (D.C. Cir. 1977) (citing with approval Larus & Brother
Co. v. FCC, 447 F.2d 876, 880 (4th Cir. 1971), which upheld the FCC’s determination that the
broadcast of “anti-smoking messages” did not trigger an obligation under the fairness doctrine to
broadcast views advocating smoking “because the issue is no longer a matter of public controversy”).
Plaintiffs not only publicly recognize the risks associated with their product but further
declare that, in light of those undisputed risks, consumers should not begin to smoke or should cease
smoking. Santa Fe Natural Tobacco Company offers this message to nonsmokers: “[W]e cannot
stress this enough: If you don’t smoke, don’t start.” http://www.sfntc.com. Elsewhere on the site
the company asserts: “We never encourage non-smokers to start, or existing smokers to smoke
more.” http://www.sfntc.com/Quit-Smoking/Overview.aspx. The website provides links to twenty
cessation resources and wishes smokers “the best of luck” in trying to quit. Ibid. Lorillard’s website
states that “[t]he only way to avoid the health effects of cigarette smoking is to not smoke. The best
way to reduce the health effects of cigarette smoking is to quit, and quitting smoking greatly reduces
serious risks to health.” http://www.lorillard.com/?s=quit+smoking. And in a recent submission
to FDA, Reynolds acknowledged that “it is indisputable that quitting is the only safe alternative to
using any tobacco product.” R.J. Reynolds, Citizen Petition 4, Docket No. FDA-2011-P-0573 (Jul.
8, 2011); see also R.J. Reynolds, Guiding Principles and Beliefs, available at www.rjrt.com/
prinbeliefs.aspx (“The best course of action for tobacco users concerned about their health is to
quit.”).
No parallel exists between this case and Wooley v. Maynard, in which the Supreme Court
held that motorists could not be required to display the motto “Live Free or Die” on their license
plates. 430 U.S. at 715–17. As the Court explained in Zauderer, the Wooley decision reflects the
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fundamental principle that the government may not “prescribe what shall be orthodox in politics,
nationalism, religion, or other matters of opinion or force citizens to confess by word or act their
faith therein.” Zauderer, 471 U.S. at 651 (citation and internal quotation marks omitted). In
contrast, “[b]ecause the extension of First Amendment protection to commercial speech is justified
principally by the value to consumers of the information such speech provides, [the seller’s]
constitutionally protected interest in not providing any particular factual information in his
advertising is minimal.” Ibid.
Decisions of the courts of appeals likewise cast no doubt on the validity of the warnings at
issue here. Cases cited by plaintiffs distinguish between uncontroversial factual disclosures (which
are reviewed under the relaxed standard of Zauderer) and “subjective” or “opinion-based”
disclosures. In Entertainment Software Ass’n v. Blagojevich, 469 F.3d 641 (7th Cir. 2006), for
example, the Seventh Circuit invalidated a law that required video game manufacturers to place a
warning label on games deemed to be “sexually explicit.” Id. at 651–52. The label was to be applied
only to games “that the average person, applying contemporary community standards would find,
with respect to minors, is designed to appeal or pander to the prurient interest.’” Id. at 643. That
definition incorporated “widely divergent local standards” of offensiveness, id. at 650, making it
“subjective and highly controversial” and therefore subject to strict scrutiny, id. at 652.
The Seventh Circuit, id. at 651–52, distinguished these subjective warnings from the
Vermont statute sustained by the Second Circuit in National Electrical Manufacturers A’ssn v.
Sorrell, 272 F.3d 104, 107 (2d Cir. 2001), which required manufacturers to label products containing
mercury and to inform consumers that these products should be recycled or disposed of as hazardous
waste. The Second Circuit noted that “the compelled disclosure at issue . . . was not intended to
prevent ‘consumer confusion or deception’ per se, but rather to better inform consumers about the
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products they purchase.” Id. at 115. The Second Circuit stressed that requiring “commercial actors
[to] disclose commercial information ordinarily does not offend the important utilitarian and
individual liberty interests that lie at the heart of the First Amendment,” and that it is sufficient to
establish “a rational connection between the purpose of a commercial disclosure requirement and
the means employed to realize that purpose.” Id. at 114–15 (citing Zauderer, 471 U.S. at 651).
Pacific Gas & Electric Co. v. Public Utilities Commission, 475 U.S. 1 (1986), which
plaintiffs invoked at the hearing, see Tr. 33–34, underscores plaintiffs’ misunderstanding of the
compelled speech precedent. PG&E included in its monthly billing envelope a newsletter featuring
items including political editorials. 475 U.S. at 5. In order to “offer the public a greater variety of
views” on these subjects, California required PG&E to include the speech of a third party that
frequently opposed PG&E in ratemaking proceedings. Id. at 12. The Supreme Court held that the
speech at issue was not commercial speech, noting that the PG&E newsletter “extends well beyond
speech that proposes a business transaction.” Id. at 8–9. The Court concluded that the case was on
all fours with Miami Herald Publishing Co. v. Tornillo, 418 U.S. 241, 244–45 (1974), which
invalidated a Florida law requiring newspapers to give political candidates an opportunity to reply
to any article impugning the candidate’s character or record. See 475 U.S. at 9–12.
The warnings at issue here bear no resemblance to the regulations in the cases plaintiffs cite.
Rather than an ideological message, the warnings convey accurate factual information about a
product that is deadly and addictive when used as intended by the manufacturers.

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Respectfully submitted,
Of Counsel:

TONY WEST
Assistant Attorney General

WILLIAM B. SCHULTZ
Acting General Counsel

BETH S. BRINKMANN
Deputy Assistant Attorney General

ELIZABETH H. DICKINSON
Acting Associate General Counsel
Food and Drug Division

MAAME EWUSI-MENSAH FRIMPONG
Acting Deputy Assistant Attorney General

ERIC M. BLUMBERG
Deputy Chief Counsel, Litigation
KAREN E. SCHIFTER
Senior Counsel
U.S. Department of Health & Human Services
Office of the General Counsel
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002

________/s/________________
DRAKE CUTINI
DANIEL K. CRANE-HIRSCH
Attorneys, Consumer Protection Branch
PO Box 386
Washington, DC 20044
202-307-0044 (Cutini)
[e-mail]
________/s/_________________
MARK B STERN
ALISA B. KLEIN
SARANG V. DAMLE
DANIEL TENNY
LINDSEY POWELL
Attorneys, Appellate Staff
Civil Division, Room 7217
U.S. Department of Justice
950 Pennsylvania Ave., NW
Washington, DC 20530
202-514–5735 (Damle)
Fax: [phone]
Email: [e-mail]

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