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

Filing 29

AMICUS BRIEF by WASHINGTON LEGAL FOUNDATION. (znmw, )

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA

R.J. REYNOLDS TOBACCO COMPANY;
LORILLARD TOBACCO COMPANY;
COMMONWEALTH BRANDS, INC.;
LIGGETT GROUP LLC; and SANTA FE
NATURAL TOBACCO COMPANY, INC.,

CIVIL ACTION NO: 11-1482(RCL)

Plaintiffs,
v.
UNITED STATES FOOD AND DRUG
ADMINISTRATION; MARGARET
HAMBURG, Commissioner of the United
States Food and Drug Administration; and
KATHLEEN SEBELIUS, Secretary of the
United States Department of Health and
Human Services,
Defendants.
______________________________________/
BRIEF OF WASHINGTON LEGAL FOUNDATION
AS AMICUS CURIAE IN SUPPORT OF
PLAINTIFFS’ MOTION FOR PRELIMINARY INJUNCTION

Daniel J. Popeo
Cory L. Andrews
Richard A. Samp (D.C. Bar# 367194)
(Counsel of Record)
WASHINGTON LEGAL FOUNDATION
2009 Massachusetts Ave, N.W.
Washington, D.C. 20036
[phone]
Counsel for Amicus Curiae

TABLE OF CONTENTS
Page
TABLE OF AUTHORITIES ........................................................................................................... i
INTEREST OF AMICUS CURIAE ................................................................................................1
STATEMENT OF THE CASE ........................................................................................................2
SUMMARY OF ARGUMENT .......................................................................................................3
ARGUMENT ...................................................................................................................................4
I.

THE GOVERNMENT’S PURPORTED RELIANCE ON ZAUDERER
AND ITS PROGENY IS ENTIRELY MISPLACED .........................................................4
A.

B.

II.

Because the Rule is Not Aimed at Preventing Consumer Deception,
Zauderer Does Not Apply .......................................................................................5
Because the Rule Does Not Concern the Disclosure of Purely Factual,
Noncontroversial Information, Zauderer Does Not Apply......................................8

NO CREDIBLE EMPIRICAL EVIDENCE LINKS THE RULE’S NEW
GRAPHIC WARNINGS REGIME TO THE GOVERNMENT’S STATED
OBJECTIVES ......................................................................................................................9

CONCLUSION ..............................................................................................................................15

TABLE OF AUTHORITIES
Page(s)
CASES:
44 Liquormart, Inc. v. Rhode Island,
517 U.S. 484 (1996) (plurality opinion) ...................................................................................8, 9
Bd. of Trustees v. Fox,
492 U.S. 469 (1989) ......................................................................................................................9
Cent. Hudson Gas & Electric Corp. v. Pub. Serv. Comm’n,
447 U.S. 557 (1980) ......................................................................................................................4
Cent. Ill. Light Co. v. Citizens Utility Bd.,
827 F.2d 1169 (7th Cir. 1987) ......................................................................................................8
Edenfield v. Fane,
507 U.S. 761 (1993) ........................................................................................................ 3-4, 9, 10
Entm’t Software Ass’n v. Blagojevich,
469 F.3d 641 (7th Cir. 2006) ........................................................................................................8
Glickman v. Wileman Bros. & Elliott, Inc.,
521 U.S. 457 (1997) ..................................................................................................................1, 6
Int’l Dairy Foods Ass’n v. Amestoy,
92 F.3d 67 (2d Cir. 1996)..............................................................................................................8
Johanns v. Livestock Mktg. Ass’n,
544 U.S. 550 (2005) ......................................................................................................................1
Milavetz, Gallop & Milavetz, P.A. v. United States,
130 S. Ct. 1324 (2010) ..................................................................................................................6
Pac. Gas & Elec. Co. v. Pub. Utils. Comm’n of Cal.,
475 U.S. 1 (1986) ......................................................................................................................6, 8
Rubin v. Coors Brewing Co.,
514 U.S. 476 (1995) ................................................................................................................8, 10
Thompson v. W. States Med. Ctr.,
535 U.S. 357 (2002) ......................................................................................................................9
United States v. United Foods, Inc.,
533 U.S. 405 (2001) ..............................................................................................................1, 6, 9
i 

Page(s)
Wooley v. Maynard,
430 U.S. 705 (1977) ..................................................................................................................3, 4
Zauderer v. Office of Disciplinary Counsel,
471 U.S. 626 (1985) ..........................................................................................1, 3, 4, 5, 6, 7, 8, 9
CONSTITUTIONAL & STATUTORY PROVISIONS:
Administrative Procedure Act,
5 U.S.C. § 500, et seq....................................................................................................................3
Family Smoking Prevention and Tobacco Control Act,
Pub. L. No. 111-31, 123 Stat. 1776 ..............................................................................................2
U.S. Const. amend. I .............................................................................................................. passim
OTHER AUTHORITIES:
76 Fed. Reg. 36,628 (June 28, 2011) ............................................................................. 2, 10-11, 14
Fischer, Paul M., et al., “Recall and Eye Tracking Study of Adolescents Viewing Tobacco
Advertisements,” J. of the Am. Med. Assoc., 261: 84-89 (1989) ..........................................11, 14
Hammond, David, “Health Warning Messages On Tobacco Products: A Review,” Tobacco
Control, 20: 327-337 (August 17, 2011) ....................................................................................12
Leschner, Glenn, et al., “Motivated Processing of Fear Appeal and Disgust Images in Televised
Anti-Tobacco Ads,” 23(2) Journal of Media Psychology, 77-89 (2011) ............................. 12-13
Obermayer, Herman, The William Rehnquist You Didn’t Know, ABA JOURNAL (Mar. 2010) .......8
RAND Europe, Final Report on Assessing the Impacts of Revisiting the Tobacco Products
Directive (September 2010) ........................................................................................................13
Robinson, Thomas N., et al., “Do Cigarette Warning Labels Reduce Smoking: Paradoxical
Effects Among Adolescents,” Archives of Pediatrics & Adolescent Med., 151(3): 267-72
(1997) ..............................................................................................................................11, 12, 14
Wardle, Heather, et al., “Final Report: Evaluating the Impact of Picture Warnings on Cigarette
Packets,” Public Health Research Consortium (2010) ...............................................................13
Weinstein, Neil D., “Public Understanding of the Illness Caused by Cigarette Smoking,”
Nicotine & Tobacco Research, 6(2), 349-55 (April 2004) .........................................................12

INTEREST OF AMICUS CURIAE
The interests of the Washington Legal Foundation (WLF) are more fully set forth in its
accompanying motion for leave to file this brief. Founded in 1977, WLF is a public interest law
and policy center with supporters in all 50 states. WLF regularly participates as amicus curiae in
litigation to promote economic liberty, free enterprise, and a limited and accountable
government. In particular, WLF has devoted substantial resources over the years to defending
free speech rights, both of individuals and of the business community. To that end, WLF has
regularly appeared before this and other federal and state courts in cases raising important First
Amendment issues, especially those involving compelled speech. See, e.g., Johanns v. Livestock
Mktg. Ass’n, 544 U.S. 550 (2005); United States v. United Foods, Inc., 533 U.S. 405 (2001);
Glickman v. Wileman Bros. & Elliott, Inc., 521 U.S. 457 (1997).
WLF strongly objects to government efforts to compel individuals or corporations to
speak against their will.  WLF believes that Plaintiffs have a high probability of success on the
merits and supports each of the arguments made in Plaintiffs’ memorandum in support of the
motion for preliminary injunction (Dkt. 11). We write separately, however, to address the
Government’s contention that Zauderer v. Office of Disciplinary Counsel of Supreme Court of
Ohio, 471 U.S. 626 (1985), supplies the appropriate level of First Amendment scrutiny in this
case. Simply put, the new graphic warnings the FDA seeks to impose in this case are not
ordinary disclosure requirements of the kind upheld in Zauderer. Rather, they are the sort of
controversial, nonfactual disclosures of which Zauderer very clearly did not approve. Such
ideological messages have nothing to do with protecting consumers from being misled—a
bedrock requirement of Zauderer. If anything, Zauderer actually highlights the constitutional
defect in the FDA’s position.

1 

WLF also doubts the empirical effectiveness of the FDA’s new warnings regime. No
credible evidence exists that the proposed graphic warnings would accomplish the Government’s
stated goal of reducing smoking rates among adults and children. Indeed, FDA’s own regulatory
impact analysis concluded that the estimated impact the new warnings will have on smoking
rates is “not statistically distinguishable from zero.” In the absence of any evidence that the new
warnings will “have a significant, positive impact on public health,” there can be no justification
for drastically commandeering the packaging and advertising of a perfectly legal product.
STATEMENT OF THE CASE
Plaintiffs, five American tobacco manufacturers, challenge the FDA’s final rule (“the
Rule”) implementing Section 201 of the Family Smoking Prevention and Tobacco Control Act,
Pub. L. No. 111-31, 123 Stat. 1776 (2009). See FDA, Required Warnings for Cigarette Packages
and Advertisements, 76 Fed. Reg. 36,628 (June 22, 2011). Although federal law has long
required warnings regarding the health risks of smoking to appear on every pack of cigarettes
and in every cigarette advertisement, the Rule goes much further by commandeering the
manufacturer’s brand and packaging in order to convey the Government’s own anti-smoking
message, which Plaintiffs find objectionable.
Specifically, the Rule requires cigarette manufacturers to prominently display nine new
warnings on their packaging and advertising; these warnings must occupy the top 50% of the
front and back panels of every cigarette package and the top 20% of all printed advertising. The
warnings contain text accompanied by controversial graphic images, including various images of
diseased body parts and an image of a body on an autopsy table. They also contain the directive
“QUIT-NOW” and urge consumers to call a telephone hotline to learn how to stop smoking.
These new warning and labeling requirements will become effective for all cigarette packages
manufactured on or after September 22, 2012, and introduced into commerce on or after October
2 

22, 2012.
On August 16, 2011, Plaintiffs filed suit (Dkt. 1) seeking to invalidate the Rule under
both the First Amendment and the Administrative Procedure Act, 5 U.S.C. §§ 553(b)(3), 705,
706(2)(A). Plaintiffs subsequently moved for summary judgment and a permanent injunction
(Dkt. 10) and simultaneously moved for preliminary injunction (Dkt. 11). The Government
opposes (Dkt. 18) Plaintiffs’ motion for preliminary injunction. WLF hereby submits this
amicus brief in support of Plaintiffs’ motion (Dkt. 11) for preliminary injunction.
SUMMARY OF ARGUMENT
The First Amendment guarantees “both the right to speak freely and the right to
refrain from speaking at all.” Wooley v. Maynard, 430 U.S. 705, 714 (1977). As a result,
the Supreme Court has repeatedly struck down laws that compel a speaker to convey a
message dictated by the government. In an effort to side step the Supreme Court’s
longstanding compelled speech jurisprudence, the Government contends that Zauderer v.
Office of Disciplinary Counsel of Supreme Court of Ohio, 471 U.S. 626 (1985), supplies
the appropriate level of First Amendment scrutiny in this case. Not so.
The new graphic warnings the FDA seeks to impose on tobacco manufacturers in
this case are not ordinary disclosure requirements of the kind upheld in Zauderer.
Rather, they are the sort of controversial, nonfactual disclosures that Zauderer very
clearly did not allow. Such ideological messages have nothing to do with protecting
consumers from being misled—a requirement of Zauderer. If anything, Zauderer
actually highlights the constitutional defect in the City’s reasoning.
Even in the commercial speech context, the Supreme Court has also made clear that it is
the regulators who bear the burden of justifying their regulation. See, e.g., Edenfield v. Fane,

3 

507 U.S. 761, 770 (1993) (“[T]he party seeking to uphold a restriction on commercial speech
carries the burden of justifying it.”). Although the Government bears the burden of establishing
the empirical effectiveness of the FDA’s new warnings regime, no credible evidence exists that
the proposed graphic warnings would accomplish the Government’s stated goal of reducing
smoking rates among adults and children. Indeed, FDA’s own regulatory impact analysis
concluded that the estimated impact the new warnings will have on smoking rates is “not
statistically distinguishable from zero.”
In the absence of any evidence that the new warnings will “have a significant, positive
impact on public health,” there can be no justification for drastically commandeering the
packaging and advertising of a perfectly legal product. WLF respectfully suggests that before
the FDA imposes the severe warnings and labeling regime of the sort proposed by the Rule, it
ought to have solid evidence that such drastic measures will achieve their intended objectives.
ARGUMENT
I.

THE GOVERNMENT’S PURPORTED RELIANCE ON ZAUDERER AND
ITS PROGENY IS ENTIRELY MISPLACED
Plaintiffs’ supporting memorandum of law convincingly demonstrates that the

FDA’s new Rule cannot withstand any version of First Amendment scrutiny. It cannot
survive either the strict scrutiny required in cases where the government seeks to compel
government-preferred speech, Wooley v. Maynard, 430 U.S. 705, 715 (1977), or the
intermediate Central Hudson test customarily applied to commercial speech restrictions,
Central Hudson Gas & Elec. v. Public Serv. Comm’n, 447 U.S. 557 (1980). WLF will
not repeat those arguments here.
We write separately to refute the Government’s suggestion that Zauderer v. Office
of Disciplinary Counsel of Supreme Court of Ohio, 471 U.S. 626 (1985), controls this
4 

case. The new mandatory warnings imposed by the Rule are not ordinary disclosure
requirements of the kind upheld in Zauderer. Rather, they are the sort of controversial,
nonfactual disclosures of which Zauderer very clearly did not approve. Indeed, the
admonition to “QUIT-NOW” does not “disclose” anything; rather, it is an ideological
message that has nothing to do with protecting consumers from being misled.
A.

Because the Rule is Not Aimed at Preventing Consumer Deception, Zauderer Does
Not Apply.
In its opposition to Plaintiffs’ motion, the government seeks to invoke the dramatically

reduced standard of review associated with Zauderer on the basis of nothing more than bald
assertions. See Dkt. 18 at 25 (citing Zauderer for the proposition that “[a] still more relaxed
standard applies when a regulation does not preclude the conveyance of a truthful message but,
as in this case, mandates the inclusion of additional information”). Contrary to the
Government’s claim, Zauderer offers no support for the FDA’s First Amendment position in this
case. In Zauderer, the Supreme Court overturned a state court’s reprimand of an attorney for an
advertisement that was neither false nor deceptive but sustained the reprimand to the extent that
the advertisement omitted a disclosure that a client would be liable for costs in the event a
contingent-fee lawsuit was unsuccessful. Upholding the disclosure requirement for the sole
purpose of correcting misleading commercial speech, Zauderer cautioned:
We recognize that unjustified or unduly burdensome disclosure requirements
might offend the First Amendment by chilling protected commercial speech. But
we hold that an advertiser’s rights are adequately protected as long as disclosure
requirements are reasonably related to the State’s interest in preventing
deception of consumers.
471 U.S. at 651 (emphasis added). Thus, Zauderer squarely held that disclosure requirements
are permissible only if necessary “to dissipate the possibility of consumer confusion or
deception.” Id. Indeed, the Court upheld the state’s imposition of a disclaimer only after finding
5 

that the possibility of deception was “self-evident” and that “substantial numbers of potential
clients would be so misled” without the state’s disclosure rule. Id. at 652. By its own terms,
Zauderer applies only to mandated disclosures that serve the government’s interest in preventing
deception of consumers.
If anything, Zauderer actually highlights the constitutional defect in the FDA’s Rule.
And subsequent Supreme Court cases have only reaffirmed that the “reasonably related” test of
Zauderer has real teeth. In United States v. United Foods, Inc., 533 U.S. 405 (2001), the Court
invalidated under the First Amendment a federal requirement that mushroom producers pay an
assessment for generic advertising, to which they objected. In its short opinion, the Court
distinguished Zauderer:
Noting that substantial numbers of potential clients might be misled by omission
of the explanation, the [Zauderer] Court sustained the requirement as consistent
with the State’s interest in “preventing deception of consumers.” There is no
suggestion in the case now before us that the mandatory assessments imposed to
require one group of private persons to pay for speech by others are somehow
necessary to make voluntary advertisements non-misleading for consumers.
533 U.S. at 416 (emphasis added). Time after time, the Court has cautioned that Zauderer does
not apply unless the state demonstrates an actual likelihood that consumers will be misled absent
the disclosure. See e.g. Milavetz, Gallop & Milavetz, P.A. v. United States, 130 S. Ct. 1324,
1339-40 (2010) (upholding a disclosure requirement directed at “misleading commercial
speech” but emphasizing that Zauderer is limited “to combat[ing] the problem of inherently
misleading commercial advertisements”); Glickman v. Wileman Bros. & Elliott, 521 U.S. 457,
490 (1997) (Souter, J., dissenting) (“[H]owever long the pedigree of such mandates may be, and
however broad the government's authority to impose them, Zauderer carries no authority for a
mandate unrelated to the interest in avoiding misleading or incomplete commercial messages.”);
Pacific Gas & Elec., 475 U.S. at 15 n.12 (“Nothing in Zauderer suggests . . . that the State is
6 

equally free to require [entities] to carry the message of third parties, where the messages
themselves are biased against or are expressly contrary to the [entity’s] views.”).
Here, the mandatory graphic warnings imposed by the Rule are not necessary to make the
sale of cigarettes non-misleading. Consumers are well aware of the health risks posed by
tobacco; federal law has long required warnings regarding the health risks of smoking to appear
on every pack of cigarettes and in every cigarette advertisement. Nor can the government
credibly claim that it requires cigarette manufacturers to convey the message “QUIT-NOW” in
order to somehow prevent consumer deception—rather than merely to discourage consumers
from smoking. Indeed, the FDA does not even claim that preventing consumers from being
deceived or misled is a primary motivation behind the Rule. See Dkt. 18 at 33 (conceding that
the Rule’s primary purpose is “to effectively convey the negative health consequences of
smoking on cigarette packages and in advertisements”). Unlike unwittingly retaining an attorney
with the expectation of incurring no expenses only to be saddled with legal costs as in Zauderer,
there is nothing inherently deceptive or misleading to consumers about buying cigarettes.
The theory underlying the new Rule appears to be that no rational person would choose
to use tobacco products, and that those who do are obviously misinformed about the health risks.
But that theory is belied by human experience, which demonstrates that individuals routinely
choose to engage in a wide range of activities that others would consider overly risky—from
mountain climbing and bungee jumping to eating red meat and sunbathing. As a good friend of
Chief Justice William Rehnquist recently recounted:
I often speculated as to why a man who was smart, disciplined, intellectually
focused and strong-willed could not break the tobacco habit. Whenever I brought
up the subject, he explained that he knew he could quit. As a matter of fact, he
said that he had gone cold turkey for extended periods several times in his life.
But he greatly enjoyed cigarettes. And he knowingly accepted the trade-offs.
Several times he explained his [smoking habit] in an idiom he particularly liked:
7 

“Let’s just say that I am an informed bettor.”
Herman Obermayer, The William Rehnquist You Didn’t Know, ABA JOURNAL (Mar. 2010). But
satisfying “consumer curiosity alone is not a strong enough state interest to sustain compulsion
of even an accurate, factual statement . . . in a commercial context.” Int’l Dairy Foods Ass’n v.
Amestoy, 92 F.3d 67, 74 (2d Cir. 1996).
B.

Because the Rule Does Not Concern the Disclosure of Purely Factual,
Uncontroversial Information, Zauderer Does Not Apply.
Zauderer endorsed compelled disclaimer requirements solely for the purpose of

counteracting potentially misleading messages included in an advertisement. But the Supreme
Court has never suggested that “companies can be made into involuntary solicitors for their
ideological opponents.” Cent. Ill. Light Co. v. Citizens Utility Bd., 827 F.2d 1169 (7th Cir.
1987). Rather, Zauderer allowed the state to require that advertisers “include in [their]
advertising purely factual and uncontroversial information about the terms under which [their]
services will be available.” 471 U.S. at 651.
The Rule mandates warnings that do not even purport to convey purely factual or
noncontroversial information. Rather, they ultimately communicate “a subjective and highly
controversial message.” Entm’t Software Ass’n v. Blagojevich, 469 F.3d 641, 652 (7th Cir.
2006). “Such forced association with potentially hostile views burdens” free expression and
“risks forcing [retailers] to speak where [they] would prefer to remain silent.” Pacific Gas &
Elec., 475 U.S. at 18.
Nor can any potential health hazards posed by tobacco justify the government’s
invocation of Zauderer. The Supreme Court has repeatedly rejected assertions that there is a
“vice” exception to the First Amendment. Rubin v. Coors Brewing, 514 U.S. 476, 482 n.2
(1995); 44 Liquormart v. Rhode Island, 517 U.S. 484, 513-14 (1996). As Justice Stevens
8 

explained:
[T]he scope of any “vice exception” to the protection afforded by the First
Amendment would be difficult, if not impossible, to define. Almost any product
that poses some threat to public health or public morals might reasonably be
characterized by a state legislature as relating to “vice activity.” Such
characterization, however, is anomalous when applied to products such as
alcoholic beverages, lottery tickets, or playing cards, that may be lawfully
purchased on the open market.
44 Liquormart , 517 U.S. at 514. So long as the purchase and sale of cigarettes continue to be
lawful, there can be no basis for asserting that the health hazards posed by tobacco use justify a
relaxation of normal First Amendment constraints on government action. See United Foods,
Inc., 533 U.S. at 410-11 (“[T]hose whose business and livelihood depend in some way upon the
product involved no doubt deem First Amendment protection to be just as important for them as
it is for other discrete, little noticed groups.”).
For this and other reasons, the Government’s suggestion that the graphic warnings
imposed by the Rule are a valid regulation of commercial speech under Zauderer and its progeny
is meritless. Rather than being “factual and uncontroversial,” the question of whether or not to
smoke cigarettes is far more opinion-based and controversial than a simple disclosure
requirement.
II.

NO CREDIBLE EMPIRICAL EVIDENCE LINKS THE RULE’S NEW GRAPHIC
WARNINGS REGIME TO THE GOVERNMENT’S STATED OBJECTIVES
Even when the speech on which regulations are imposed is deemed “commercial

speech”—that is, speech that does no more than “propose a commercial transaction,” Bd. of
Trustees v. Fox, 492 U.S. 469, 473 (1989)—courts have made clear that it is the regulators who
bear the burden of justifying their regulations. See, e.g., Edenfield v. Fane, 507 U.S. 761, 770
(1993) (“[T]he party seeking to uphold a restriction on commercial speech carries the burden of
justifying it.”); Thompson v. W. States Med. Ctr., 535 U.S. 357, 373 (2002). The evidentiary
9 

burden is not light; for example, the Government’s burden of showing that a commercial speech
regulation advances a substantial government interest “in a direct and material way . . . ‘is not
satisfied by mere speculation or conjecture; rather, a government body seeking to sustain a
restriction on commercial speech must demonstrate that the harms it recites are real and that its
restrictions will alleviate them to a material degree.’” Rubin v. Coors Brewing Co., 514 U.S.
476, 487 (1995) (quoting Edenfield, 507 U.S. at 770-71).
In none of the cases in which the U.S. Supreme Court has addressed First Amendment
challenges to regulations on commercial speech has the Court so much as suggested that it was
willing to defer to a legislature’s determinations regarding the need for such restrictions or their
likely effectiveness. Such willingness would be inconsistent with the language quoted above; the
burden of demonstrating that speech restrictions alleviate real harms to “a material degree”
would amount to nothing if the government could meet that burden by simply pointing to
legislative fact-finding devoid of any empirical evidence.
WLF respectfully suggests that before the FDA imposes the severe warnings and labeling
regime of the sort proposed by the Rule, it ought to have solid evidence that such drastic
measures will achieve their intended objectives. WLF submits that no such evidence exists. In
the absence of any evidence that the new warnings will “have a significant, positive impact on
public health,” there can be no justification for drastically commandeering the packaging and
advertising of a perfectly legal product.
WLF is aware of no credible evidence that the proposed graphic warnings would
accomplish the Government’s stated goal of reducing smoking rates among adults and children.
Indeed, FDA’s own regulatory impact analysis concluded that the estimated impact the new
warnings will have on smoking rates is “not statistically distinguishable from zero.” 76 Fed.

10 

Reg. at 36,776. Notwithstanding these underwhelming findings, the FDA’s regulatory impact
analysis purporting to show that graphic warning labels will reduce smoking rates by even .0888
percent is highly problematic. In fact, if the years 1998 (the year the Master Settlement
Agreement took effect) or 2010 (the year the FDA Act’s other marketing restrictions took effect)
are excluded, FDA’s regulatory impact analysis would actually show an increase in smoking
rates.
The Government purports to rely on sociological studies to support the notion that
graphic warnings labels will somehow reduce the number of smokers in the United States. See
76 Fed. Reg. 36,628 (June 28, 2011). In particular, the Government touts studies suggesting that
the labels appearing on cigarette packages and advertisements under the pre-existing warnings
regime have gone largely unnoticed by smokers and non-smokers. See, e.g., Fischer, et al.,
“Recall and Eye Tracking Study of Adolescents Viewing Tobacco Advertisements,” J. of the
Am. Med. Assoc., 261: 84-89 (1989); Robinson, et al., “Do Cigarette Warning Labels Reduce
Smoking: Paradoxical Effects Among Adolescents,” Archives of Pediatrics & Adolescent Med.,
151(3): 267-72 (1997). But the studies relied on by the Government examine only whether
people notice the warnings, not whether the warnings cause people to alter their behavior. In
other words, none of these studies considers the likelihood that, even if consumers do take better
notice of the new graphic warnings, they may not choose to alter their smoking behavior.
Nor do these studies provide any indication that the new graphic warnings are somehow
likely to cause people to alter their smoking behavior. Rather, they convincingly demonstrate
that “[g]reater knowledge of warning labels on advertisements was not significantly associated
with either an increase or decrease in smoking.” Robinson, et al., supra, at 271. In fact, “the
observed association between warning label knowledge and subsequent increases in smoking

11 

may suggest that even if attention and recall can be improved, cigarette warning labels may do
more harm than good.” Id. at 272. These studies are completely silent on whether warning
labels are truly the most effective means of deterring smoking.
Many of the studies relied on by the Government do not even attempt to link the
knowledge and perceived risk of health problems with an increase in a smokers’ desire and
resolve to quit smoking. For example, one survey concedes that “[w]hether theories of decision
making and health behavior are correct that effective education about the seriousness of lung
cancer and other smoking-related disease will deter people from smoking or increase smokers’
efforts to quit remains an open question.” Neil D. Weinstein, “Public Understanding of the
Illness Caused by Cigarette Smoking,” Nicotine & Tobacco Research, 6(2), 349-55, at 355
(April 2004). Simply put, none of the studies relied on by the Government can empirically
attribute any greater effectiveness to graphic warning labels as opposed to increased public
education and media campaigns or other less drastic approaches.
Unsurprisingly, the FDA fails altogether to reference numerous studies demonstrating the
ineffectiveness of adopting graphic warnings of the type contemplated by the Rule. A recent
study by David Hammond—an anti-smoking researcher on whom the Government frequently
relies—reluctantly concludes: “[T]here is no way to attribute . . . declines [in smoking] to the
new health warnings given that [they] are typically introduced against a backdrop of other
tobacco control measures, including changes in price/taxation, mass media campaigns and
smoke-free legislation.” David Hammond, “Health Warning Messages On Tobacco Products: A
Review,” Tobacco Control, 20: 327-337, at 331 (August 17, 2011). See also Glenn Leshner, et
al., “Motivated Processing of Fear Appeal and Disgust Images in Televised Anti-Tobacco Ads,”
23(2) Journal of Media Psychology, 77-89 (2011) (concluding that the graphic ads accompanied

12 

by threatening messages produce a defensive reaction among subjects and renders them less able
to process and attend to the message, thereby reducing the likely effectiveness of the antismoking advocacy).
Because merely emotional responses do not translate into behavioral change, a recent
study of the effectiveness of similar graphic warnings in the United Kingdom concludes that,
although the shocking images may have “made smoking seem less attractive,” such warnings had
no discernable impact on smoking behavior. See Heather Wardle, et al., “Final Report:
Evaluating the Impact of Picture Warnings on Cigarette Packets,” Public Health Research
Consortium (2010) (finding “no changes in the breadth or depth of people’s awareness of the
health risks of smoking” after implementation in the United Kingdom of graphic health
warnings).
RAND Europe’s September 2010 Final Report on “Assessing the Impacts of Revising the
Tobacco Products Directive” (the “RAND Report”) is perhaps the most comprehensive
government study to date of the impact on tobacco consumption of adopting policy measures of
the type contemplated by the Rule. See RAND Europe, Final Report on Assessing the Impacts of
Revisiting the Tobacco Products Directive (September 2010). Incredibly, even though it was
commissioned and funded by the European Union, the RAND Report concluded that adoption of
such policy measures would have virtually no impact on tobacco consumption. It concluded that
the effect on tobacco consumption would be highly uncertain and would at most lead to a 0.5%
reduction in smoking prevalence. Moreover, even those minimal impacts are subject to serious
question in light of the extensive criticism that has been directed at the RAND Report by leading
experts in the field. For example, the RAND Report included no quantitative econometric
analysis, failed to consider whether the likely increases in counterfeiting and black market sales

13 

would eliminate any reductions in smoking prevalence, and failed to consider whether the
increased price competition likely to be engendered by plain packaging would have similar
effects.
Ironically, following the notice and comment period, the FDA’s Final Rule dismissively
criticized some comments because they “referenced older studies that did not specifically address
graphic warnings on cigarette packages and advertisements.” See 76 Fed. Reg. 36,634. Yet
neither the 1989 Fischer study nor the 1997 Robinson study repeatedly relied on by the FDA
considered graphic warnings; both dealt solely with textual warnings. As a result, there is
nothing in either study to suggest that a graphic warning will somehow receive more attention or
be more effective at deterring smokers than the preexisting textual warning scheme.
In sum, there simply is no credible evidence that the regulations imposed by the Rule
would accomplish the legislation’s primary goal of reducing the incidence of smoking among
adults and children. In the absence of such evidence, there can be little justification for
proceeding with reforms that undoubtedly would have such a major adverse financial impact on
legally operating businesses.

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CONCLUSION
Amicus curiae Washington Legal Foundation respectfully requests that the Court grant
Plaintiffs’ motion for preliminary injunction.
Respectfully submitted,
/s/ Richard A. Samp
Daniel J. Popeo
Cory L. Andrews
Richard A. Samp (D.C. Bar No. 367194)
(Counsel of Record)
Washington Legal Foundation
2009 Massachusetts Ave., NW
Washington, D.C. 20036
Telephone: [phone]
Facsimile: [phone]
E-Mail: [e-mail]
Attorneys for Amicus Curiae

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