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

Filing 47

REPLY to opposition to motion re 35 MOTION for Summary Judgment filed by MARGARET A. HAMBURG, KATHLEEN G. SEBELIUS, UNITED STATES FOOD AND DRUG ADMINISTRATION. (Crane-Hirsch, Daniel)

IN THE 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)

REPLY IN SUPPORT OF DEFENDANTS’
MOTION FOR SUMMARY JUDGMENT

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

DRAKE CUTINI
DANIEL K. CRANE-HIRSCH
Attorneys, Consumer Protection Branch

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

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

TABLE OF CONTENTS
Page
INTRODUCTION ......................................................................................................................... 1
ARGUMENT ................................................................................................................................. 1
I.

Requirements that Sellers Disclose Serious Health Risks to
Potential Consumers Are Not “Compelled Speech” or
“Viewpoint Based Restrictions” Subject to Strict Scrutiny ................................... 1

II.

The Statutory Requirement for Updated Health Warnings, and
FDA’s Implementation of that Requirement, Readily Survive
First Amendment Scrutiny Under Any Standard of Review ................................. 7
A.

Plaintiffs’ Request that this Court Reweigh the Scientific
Evidence that Was Before Congress and the FDA Is
Contrary to Controlling Precedent ............................................................. 7

B.

Plaintiffs Offer No Valid Basis for Rejecting the Legislative
Judgments Underpinning the Revised Health Warning Requirement ....... 9

III.

Plaintiffs’ Purported APA Claim Suffers from the Same Defects as
Their First Amendment Argument and Reduces to the Contention
that FDA Should Have Declined To Implement the Statutory Mandate ............. 19

IV.

Plaintiffs Provide No Proper Legal Basis for Their Request To Delay
Implementation of the Warning Requirements .................................................... 23

TABLE OF AUTHORITIES
Cases:

Page

Advocates for Highway & Auto Safety v. Federal Motor Carrier Safety Admin.,
429 F.3d 1136 (D.C. Cir. 2005) .............................................................................................. 6
Bad Frog Brewery, Inc. v. N.Y. State Liquor Auth.,
134 F.3d 87 (2d Cir. 1998) ..................................................................................................... 1
Bd. of Trustees v. Fox,
492 U.S. 469 (1989) ................................................................................................................ 1
Central Hudson Gas & Electric Corp. v. Public Service Commission,
447 U.S. 557 (1980) ............................................................................................................ 2, 7
FDA v. Brown & Williamson Tobacco Corp.,
529 U.S. 120 (2000) ................................................................................................................ 8
Hurley v. Irish-American Gay, Lesbian & Bisexual Group of Boston,
515 U.S. 557 (1995) ................................................................................................................ 3
Miami Herald Publishing Co. v. Tornillo,
418 U.S. 241 (1974) ................................................................................................................ 2
Milavetz, Gallop & Milavetz, P.A. v. United States,
130 S. Ct. 1324 (2010) .................................................................................................... 1, 2, 7
Ohralik v. Ohio State Bar Ass’n,
436 U.S. 447 (1978) ................................................................................................................ 1
Pacific Gas & Electric Co. v. Public Utilities Commission of California,
475 U.S. 1 (1986) .................................................................................................................... 3
Trans Union LLC v. FTC,
295 F.3d 42 (D.C. Cir. 2002) .................................................................................................. 1
Turner Broadcasting System, Inc. v. FCC,
512 U.S. 622 (1994) ................................................................................................................ 3
Turner Broadcasting System, Inc. v. FCC,
520 U.S. 180 (1997) ............................................................................................................ 8, 9
United States v. Philip Morris,
566 F.3d 1095 (D.C. Cir. 2009) .............................................................................................. 3
ii

West Virginia State Board of Education v. Barnette,
319 U.S. 624 (1943) ................................................................................................................ 2
Wooley v. Maynard,
430 U.S. 705 (1977) ................................................................................................................ 2
Zauderer v. Office of Disciplinary Counsel,
471 U.S. 626 (1985) ............................................................................................................. 2, 7
Statutes:
5 U.S.C. § 706 ............................................................................................................................. 23
5 U.S.C. § 706(2) ........................................................................................................................ 18
15 U.S.C. § 1333 Note ................................................................................................................ 19
Pub. L. No. 111-31, 123 Stat. 1776 (2009) .............................................................................. 1, 19
Regulations:
58 Fed. Reg. 51,735 (1993) ......................................................................................................... 21
61 Fed. Reg. 19,818 (May 3, 1996) ............................................................................................. 17
75 Fed. Reg. 52,352 (Aug. 25, 2010) .................................................................................... 17, 18
75 Fed. Reg. 69,524 (Nov. 12, 2010) ................................................................................ 8, 16, 18
76 Fed. Reg. 3,821 (2011) ........................................................................................................... 21
76 Fed. Reg. 36,628 (Jun. 22, 2011) ................................................... 4, 5, 6, 8, 10, 12, 18, 20, 21
Orders:
Executive Order 12,866 (1993) .................................................................................................. 21
Executive Order 13,563 (2011) .................................................................................................. 21
Legislative Materials:
Testimony of Richard Bonnie, Chair of IOM’s Committee on Reducing
Tobacco Use, H.R. 1108, 110th Cong. 42 (2007) .................................................................. 16
iii

Other Authorities:
David Hammond, Health Warnings Messages on Tobacco Products: A Review,
20 Tobacco Control 327 (2011) .......................................................................... 12, 13, 14, 18
Ellen Peters, et al., The Impact and Acceptability of Canadian-Style Cigarette
Warning Labels Among U.S. Smokers and Nonsmokers,
9 Nicotine & Tobacco Research 473 (2007) ......................................................................... 13
European Commission, Directorate General for Health and Consumers,
A Review of The Science Base to Support the Development of Health Warnings
for Tobacco Packages (2009) ................................................................................................ 13
FDA, Experimental Study of Graphic Cigarette Warning Labels,
Final Results Report (Dec. 2010) ..................................................................................... 6, 20
Geoffrey T. Fong, et al., The Impact of Pictures on the Effectiveness of Tobacco Warnings,
87 Bulletin of the World Health Organization 640 (2009) ................................................... 13
Institute of Medicine, Ending the Tobacco Problem: A Blueprint for
the Nation (2007) ............................................................................................................. 11, 14
Karine Gallopel-Morvan, et al., The Use of Visual Warnings in Social
Marketing: The Case of Tobacco, 64 J. Business Research 7 (2011) .................................... 13
Patrick Jamieson & Daniel Romer, What Do Young People Think They
Know About the Risks of Smoking? in Smoking: Risk, Perception & Policy
(Paul Slovic ed., 2001) ..................................................................................................... 10, 11
Paul Slovic, Cigarette Smokers: Rational Actors or Rational Fools?, in Smoking: Risk,
Perception, & Policy (Paul Slovic ed., 2001) ................................................................. 11, 12
Victoria White, et al., Do Graphic Health Warning Labels Have an Impact on Adolescents’
Smoking-Related Beliefs and Behaviors?, 103 Addiction 1562 (2008) ............................... 14

iv

INTRODUCTION
Plaintiffs misapprehend several fundamental principles of First Amendment and
administrative law in their challenge to the graphic warnings required by the Family Smoking
Prevention and Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776 (2009), as implemented
by the Food and Drug Administration (“FDA”). Those legal principles, when properly applied,
compel judgment in the government’s favor. We discussed these principles and their application
at length in our opposition to plaintiffs’ summary judgment motion and cross-motion for
summary judgment. Plaintiffs’ Opposition adds little of substance to their previous filing, and
our Reply will limit itself accordingly and will not repeat at length matters already fully treated.
ARGUMENT
I.

Requirements that Sellers Disclose Serious Health Risks to Potential Consumers
Are Not “Compelled Speech” or “Viewpoint Based Restrictions” Subject to Strict
Scrutiny.
A. Virtually absent from plaintiffs’ argument is any recognition that the statute they

challenge regulates quintessential commercial speech, i.e., advertisements proposing the sale of a
product, and product packaging. See, e.g., Milavetz, Gallop & Milavetz, P.A. v. United States,
130 S. Ct. 1324, 1339 (2010); Bad Frog Brewery, Inc. v. N.Y. State Liquor Auth., 134 F.3d 87,
97 (2d Cir. 1998) (explaining that product labels “are a form of advertising”). Regulations of
commercial speech do not trigger the requirements of strict scrutiny. See, e.g., Bd. of Trustees v.
Fox, 492 U.S. 469, 479–80 (1989) (rejecting application of a “least-restrictive-means
requirement” to restrictions on commercial speech); Trans Union LLC v. FTC, 295 F.3d 42,
52–53 (D.C. Cir. 2002) (declining to apply strict scrutiny to regulations restricting the disclosure
of consumer credit information); see also Ohralik v. Ohio State Bar Ass’n, 436 U.S. 447, 456
(1978) (“To require a parity of constitutional protection for commercial and noncommercial

speech alike could invite dilution, simply by a leveling process, of the force of the Amendment’s
guarantee with respect to the latter kind of speech.”).
Plaintiffs nonetheless argue that the requirements in the Tobacco Control Act for revised
health warnings are subject to more stringent scrutiny than the review accorded to restrictions on
commercial speech under Central Hudson Gas & Electric Corp. v. Public Service Commission,
447 U.S. 557 (1980). But the Supreme Court has made clear that disclosure requirements are not
subject to great scrutiny; indeed, requirements for disclosure to consumers are subject to “less
exacting scrutiny” than restrictions on commercial speech because they are not affirmative
limitations on speech. Milavetz, 130 S. Ct. at 1339 (emphasis added). Thus, a requirement that
commercial actors disseminate factual and accurate information as part of their commercial
communications must be sustained if the requirement is “reasonably related” to an identified
governmental interest, and is not so “[u]njustified or unduly burdensome” as to “chill[] protected
commercial speech.” Id. at 1339–40 (citing Zauderer v. Office of Disciplinary Counsel, 471
U.S. 626, 651(1985)).
Plaintiffs seek to circumvent this difficulty by invoking a line of decisions addressing
compelled ideological speech that have never been applied to the regulation of commercial
speech. We explained in our Opposition/Cross-Motion that cases such as Wooley v. Maynard,
430 U.S. 705 (1977), Miami Herald Publishing Co. v. Tornillo, 418 U.S. 241 (1974), and West
Virginia State Board of Education v. Barnette, 319 U.S. 624 (1943), involved attempts by the
government to “‘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, and are thus inapposite here. Gov’t S.J. Br. 24–29.

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In their Opposition, plaintiffs do not argue that the required health warnings are an effort
to “prescribe what shall be orthodox in politics, nationalism, religion or other matters of
opinion,” and any attempt to do so would be implausible. Instead, they attempt to rely on yet
other decisions that likewise did not concern regulation of commercial speech. See Pl. S.J. Opp.
4–5. For example, the passage plaintiffs quote from Turner Broadcasting System, Inc. v. FCC,
512 U.S. 622, 641 (1994), did not address commercial speech, but instead addressed core
protected speech. Similarly Pacific Gas & Electric Co. v. Public Utilities Commission of
California, 475 U.S. 1, 8–9 (1986), specifically held that the speech at issue was not commercial
speech. See also United States v. Philip Morris, 566 F.3d 1095, 1142 (D.C. Cir. 2009)
(distinguishing Pacific Gas & Electric as not involving “the government’s ability to dictate the
content of mandatory speech” in the “commercial context.”). The statement in Hurley v. IrishAmerican Gay, Lesbian & Bisexual Group of Boston, 515 U.S. 557, 573 (1995), that “a speaker
has the autonomy to choose the content of his own message” likewise has no bearing on the
commercial speech or product disclosure analysis here because it addressed non-commercial
expressive conduct of parade marchers.
Plaintiffs’ repeated references to the health warning as a “viewpoint-based restriction[],”
Pl. S.J. Opp. 7, underscores the deep-seated flaws in their analysis. Plaintiffs identify no
decision that has applied the rubric of viewpoint discrimination to regulation of commercial
speech, let alone to any form of consumer warning or disclosure about product risks. Moreover,
plaintiffs do not and cannot explain the nature of the “viewpoint discrimination.” The statute
mandates nine health disclosures:
WARNING: Cigarettes are addictive.
WARNING: Tobacco smoke can harm your children.
3

WARNING: Cigarettes cause fatal lung disease.
WARNING: Cigarettes cause cancer.
WARNING: Cigarettes cause strokes and heart disease.
WARNING: Smoking during pregnancy can harm your baby.
WARNING: Smoking can kill you.
WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.
WARNING: Quitting smoking now greatly reduces serious risks to your health
Each of these warnings is a statement of fact, not an expression of “viewpoint.” Plaintiffs do not
dispute the accuracy of any of these warnings, and do not challenge Congress’s authority to
mandate their inclusion on cigarette packaging. Pl. S.J. Br. 20.
B. Because plaintiffs do not and cannot take issue with the substance of the warnings,
their argument necessarily depends on the claim that the inclusion of images fundamentally
transforms the nature of the required disclosures in such a way as to require strict scrutiny. Pl.
S.J. Opp. 10–12. Plaintiffs offer no doctrinal basis for this distinction, nor do they identify
support for it in the record before Congress and the FDA. The images do not convey a message
different than that of the accompanying text, and plaintiffs’ Opposition makes no showing to the
contrary. The agency explained that “the addition of graphics to warnings for cigarettes is a
difference in form only and does not change the fundamental content of the messages, which
convey factual information about smoking.” 76 Fed. Reg. 36,628, 36,696 (Jun. 22, 2011).
Plaintiffs provide no response to the FDA’s clearly correct assessment. Similarly, although
plaintiffs complain that some of the images include “digital enhancements,” Pl. S.J. Opp. 10–11,
they do not dispute FDA’s explanation that the “effects shown in the photographs are, in fact,
accurate depictions of the effects of sickness and disease.” 76 Fed. Reg. at 36,696. Indeed, the
comments submitted to the agency during rulemaking “did not dispute that the images proposed

4

to accompany the warning statements accurately depict the negative health consequences of
smoking.” Ibid.
Plaintiffs fare no better with their claim that one of the images—that of an infant in an
incubator—is a “non-factual cartoon drawing[].” Pl. S.J. Opp. 10–11. Plaintiffs do not take
issue with FDA’s explanation that “[t]he style of the depiction—here, a graphic illustration—
does not make it less factual.” 76 Fed. Reg. at 36,696. Indeed, plaintiffs concede that even more
highly abstract graphics would be constitutionally permissible. Specifically, plaintiffs assert that
the only acceptable images would be “charts or graphs,” or abstract graphics like the following:

Pl. S.J. Opp. 10. There is no legal basis for treating the images chosen by FDA as raising
different First Amendment concerns than plaintiffs’ preferred style of graphic warning.
Plaintiffs’ graphic shows a hand about to be burned that, together with the text “HOT!”, conveys
the consequence of failing to heed the warning. The image of the baby in an incubator and the
image of diseased lungs function in a similar fashion, by complementing and reinforcing the
textual warnings that they accompany.
Moreover, if plaintiffs believed that FDA should have implemented the statutory mandate
by adopting this type of image, it was incumbent on them to say so during the rulemaking. As a

5

result of their failure to do so, FDA had no opportunity to examine or respond to such
alternatives. Plaintiffs thus should be deemed to have waived reliance on these alternatives. See
Advocates for Highway & Auto Safety v. Federal Motor Carrier Safety Admin., 429 F.3d 1136,
1150 (D.C. Cir. 2005).
C. We have previously discussed plaintiffs’ misunderstanding of the concept of salience,
Gov’t S.J. Br. 34–37, a misunderstanding that plaintiffs repeat in declaring that the warnings
impermissibly “evoke an emotional reaction against smoking,” Pl. S.J. Opp. 10–11, and that
FDA impermissibly considered the emotional reaction of viewers to the proposed warnings, id.
at 12, 14. Plaintiffs, however, do not respond to FDA’s explanation that consumers’ emotional
and cognitive responses to warnings are relevant not because they demonstrate that the warnings
have “shock value,” but because such responses reliably predict the likelihood that consumers
will understand and appreciate the warnings’ message. See FDA, Experimental Study of
Graphic Cigarette Warning Labels, Final Results Report 4-1 (Dec. 2010) (“FDA Study Report”);
see also 76 Fed. Reg. at 36,641 (“The 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[.]”). More fundamentally, plaintiffs cite no case law suggesting that the effect of the
warning on a viewer is relevant to the level of scrutiny owed to a commercial speech restriction.
Plaintiffs likewise reiterate their mistaken assertion that the inclusion of a telephone
number for a nationally recognized smoking cessation resource—1-800-QUIT-NOW—renders
the warnings subject to strict scrutiny. Pl. S.J. Opp. 12–13. Again, plaintiffs cite no case law or
other doctrinal support for this assertion. Plaintiffs do not deny that their own websites contain

6

links to similar smoking cessation resources, and that Lorillard’s website advises consumers to
call the same resource that plaintiffs in this forum allege to be “ideological.” See Gov’t S.J. Br.
44–45. In any event, in context, the number at most conveys the same message as the warning
statement “Quitting smoking now greatly reduces serious risks to your health.”
The full anomaly of plaintiffs’ invocation of strict scrutiny is demonstrated by their
challenge to the size and placement of the health warnings. No principle of law suggests that a
large health warning is subject to a different standard of constitutional scrutiny than a small
warning. Similarly, there is no doctrinal support for the contention that warnings with images
are subject to a different standard of scrutiny than warnings that do not include images.
II.

The Statutory Requirement for Updated Health Warnings, and FDA’s
Implementation of that Requirement, Readily Survive First Amendment Scrutiny
Under Any Standard of Review.
A.

Plaintiffs’ Request that this Court Reweigh the Scientific Evidence that Was
Before Congress and the FDA Is Contrary to Controlling Precedent.

Under Central Hudson, regulations of commercial speech are upheld if they directly
advance a substantial governmental interest. 447 U.S. at 566. Under Zauderer and Milavetz, a
commercial disclosure requirement is subject to “less exacting scrutiny,” and must be sustained
so long as it is “‘reasonably related’” to an identified governmental interest, and the disclosure is
not so “[u]njustified or unduly burdensome” as to “chill[] protected commercial speech.”
Milavetz, 130 S. Ct. at 1339–40 (quoting Zauderer, 471 U.S. at 651). For the reasons already
discussed, the statutorily required disclosures meet both of these standards. Moreover, although
they are not subject to strict scrutiny, we explained in our motion for summary judgment that
they would properly be upheld even if that standard were applicable. Gov’t S.J. Br. 23.
Plaintiffs nevertheless assert that the government has “waived” any contention that the statute
7

would survive strict scrutiny. Pl. S.J. Opp. 20. This assertion is incorrect and also fails to
appreciate the gravity of the inquiry undertaken by a court when it considers the validity of an
Act of Congress, particularly a statute that addresses the consequences of using plaintiffs’
products which, “particularly among children and adolescents, pose[] 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).
As our summary judgment motion explains, the revised health warnings serve public
health interests of the highest order. See Gov’t S.J. Br. 14–20. The purpose of the warnings is
“to effectively convey the negative health consequences of smoking on cigarette packages and in
advertisements.” 76 Fed. Reg. at 36,697. Those interests are substantiated by a wealth of
evidence gathered over decades by all three branches of government, public health organizations,
and scientific researchers. That evidence, which is discussed at length in FDA’s rule and in the
government’s Opposition/Cross-Motion, shows that: (1) consumers generally, and youth in
particular, do not adequately appreciate the risks of smoking; (2) the current Surgeon General
warnings, which occupy only four percent of the surface area of packaging and advertising, are
“functionally invisible,” 75 Fed. Reg. 69,524, 69,531 (Nov. 12, 2010); and (3) warnings like
those mandated by the Act convey the warning message far more effectively than the current
Surgeon General’s warnings, particularly when paired with color graphics depicting the negative
health consequences of smoking.
Plaintiffs improperly urge this Court to reweigh the costs and benefits of the rule and the
scientific evidence that was before Congress and the FDA. Pl. S.J. Opp. 21–22. That approach
is fundamentally inconsistent with First Amendment jurisprudence. The Supreme Court has

8

stressed that “[t]he Constitution gives to Congress the role of weighing conflicting evidence in
the legislative process.” Turner Broadcasting System, Inc. v. FCC, 520 U.S. 180, 199 (1997).
Accordingly, in considering plaintiffs’ constitutional challenges, the role of the Court is not to
“reweigh the evidence de novo, or to replace Congress’ factual predictions with [its] own.” Id. at
211 (internal quotation marks and citation omitted). “Even in the realm of First Amendment
questions where Congress must base its conclusions upon substantial evidence, deference must
be accorded to its findings as to the harm to be avoided and to the remedial measures adopted for
that end, lest [a court] infringe on traditional legislative authority to make predictive judgments
when enacting nationwide regulatory policy.” Id. at 196.
Thus, the “relevant inquiry” for the Court “is not whether Congress, as an objective
matter, was correct” in its determinations as to the problems to be addressed or the tailoring of
the remedies. Id. at 211. “Rather, the question is whether the legislative conclusion was
reasonable and supported by substantial evidence in the record before Congress.” Ibid. As long
as that standard is satisfied, “summary judgment for [the government] is appropriate regardless
of whether the evidence is in conflict.” Ibid. (emphasis added).
B.

Plaintiffs Offer No Valid Basis for Rejecting the Legislative Judgments
Underpinning the Revised Health Warning Requirement.

Plaintiffs attack nearly all of the legislative judgments underpinning the revised health
warnings. These arguments, however, share a common theme: they ignore all scientific findings
that contradict plaintiffs’ view of the “dispositive facts.” Pl. S.J. Opp. 22. On each of these
points, Congress’s judgment regarding the necessity of revised warnings “was reasonable and
supported by substantial evidence.” Turner Broadcasting System, 520 U.S. at 211.

9

1. Plaintiffs dispute Congress’s determination that the current warnings have not
adequately informed consumers about the health risks of smoking. They urge that “the risks of
smoking are universally known and, in fact, overestimated by the American public.” Pl. S.J.
Opp. 27. Plaintiffs’ contention rests entirely on the declaration of their expert, Dr. W. Kip
Viscusi, who posits that consumers have a sufficient understanding of the risks of smoking as
long as they are aware that cigarettes commonly cause disease. See Viscusi Statement 14–16.
Scientific studies, however, have consistently and repeatedly shown that consumers do
not adequately appreciate even the basic statistical risks of smoking.1 See generally Gov’t S.J.
Br. 18–19, 29–31; 76 Fed. Reg. at 36,632. Thus, FDA noted that “[i]n a 2008 survey, more than
one-quarter of current smokers did not agree that smoking increases a person’s chances of
getting cancer ‘a lot.’” 76 Fed. Reg. at 36,632. Another study found that “only 40 percent of
current smokers believed they had a higher-than-average risk of cancer and only 29 percent
believed they had a higher-than-average risk of heart disease.” Ibid. “Even among heavy
smokers (those who smoke at least 40 cigarettes per day), less than half believed they were at
increased risk for these diseases.” Ibid.
Notably, the studies that plaintiffs rely upon actually support Congress’s decision. For
instance, plaintiffs cite one particular study because it included a finding that youth

1

Plaintiffs dispute the results of a 1981 review by the Federal Trade Commission finding
that consumers were unaware of the health risks of smoking, by noting that the study was
conducted before the revision of cigarette warnings in 1984, and that one of the researchers who
provided data on which the FTC relied disputed the results of the review. Pl. S.J. Opp. 30–31;
see also id. at 44. Plaintiffs fail to note, however, that the FTC study was cited by the Surgeon
General’s 1994 report, and was discussed in the government’s brief only to counter plaintiffs’
claim that the Surgeon General, in that report, had admitted that consumers already comprehend
the risks of smoking, see Gov’t S.J. Br. 15 n.6. In any event, the results of the FTC’s 1981
review have only been reinforced by more recent studies.
10

“overestimated the extent to which smoking increases the risk of lung cancer,” but neglect to
mention the larger number of significant information gaps the same study also found. See
Patrick Jamieson & Daniel Romer, What Do Young People Think They Know About the Risks of
Smoking? in SMOKING: RISK, PERCEPTION & POLICY 51, 53 (Paul Slovic ed., 2001) (quoted in Pl.
S.J. Opp. 28). Jamieson & Romer found that 20 percent of smokers and 19 percent of
nonsmokers studied did not know whether secondhand smoke is hazardous to nonsmokers. Id. at
57. And, significantly, that study also concluded that “14- to 22-year-olds do not have a
consistent and realistic sense of the addictive nature of smoking.” Id. at 52.
In an effort to undermine the Jamieson & Romer study, plaintiffs mistakenly describe it
as finding only that “when adolescent smokers were asked to estimate the specific number of
years by which smoking shortens an average smoker’s life, 28 percent stated they did not know.”
Pl. S.J. Opp. 29 (emphasis added). What that study actually showed is that nearly 26 percent of
adolescent smokers and 18 percent of nonsmokers reported that they did not know whether
smoking two or more packs of cigarettes a week would shorten their life span by any amount.
See Jamieson & Romer, supra, at 55–56; see also Institute of Medicine, Ending the Tobacco
Problem: A Blueprint for the Nation 90 (2007) (“IOM Report”) (describing the Jamieson &
Romer study in this way). For all of these reasons, plaintiffs cannot plausibly suggest that the
government has “merely point[ed] to alleged information deficits on issues that the graphic
warnings do not even purport to redress.” Pl. S.J. Br. 28.
Moreover, to the extent that consumers have an accurate sense of certain statistical risks
of smoking, Viscusi’s belief in the adequacy of this statistical knowledge depends on a simplistic
view of risk perception that has been persuasively rejected by independent experts in the field.

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See, e.g., Paul Slovic, Cigarette Smokers: Rational Actors or Rational Fools?, in SMOKING:
RISK, PERCEPTION, & POLICY 97, 107–110 (Paul Slovic ed., 2001) (detailing the
“[s]hortcomings” in Viscusi’s approach). Those experts have concluded that mere awareness
that smoking carries negative health consequences, and even awareness of certain statistical
risks, are insufficient to ensure that consumers appreciate the risks that smoking poses to them
personally, in part because of the addictive power of nicotine. 76 Fed. Reg. at 36,632-33. Dr.
Paul Slovic, for example, has explained that “[a]lthough most smokers acknowledge a high
degree of risk associated with many years of smoking, many believe they can get away with
some lesser amount of smoking before the risk takes hold.” Slovic, supra, at 109. That
prediction, as Slovic concluded, is usually proven false, because smokers start to show the
effects of nicotine addiction “within days to weeks of the onset of occasional use of tobacco.”
Ibid. (emphasis added). Although the government cited Slovic’s research in its opening brief,
Gov’t S.J. Br. 18–19, plaintiffs do not address it.
2. Plaintiffs’ argument that “there is no evidence” that mandated health warnings
“increase knowledge of smoking risks,” Pl. S.J. Br. 33, likewise depends on studious avoidance
of contrary scientific findings. See generally 76 Fed. Reg. 36,633–36 (discussing studies). As
we explained at length in our Opposition/Cross-Motion, Gov’t S.J. Br. 16–20, numerous studies
examining pictorial warnings have concluded that such warnings do increase consumers’
understanding of the health risks of smoking. See, e.g., David Hammond, Health Warnings
Messages on Tobacco Products: A Review, 20 Tobacco Control 327, 329–30 (2011). Plaintiffs
have offered no convincing response to this body of scientific literature, which substantially
supports Congress’s decision to revise the health warnings.

12

Thus, although plaintiffs assert that the “studies relied upon in the Rule advocate the use
of graphics based not on their factual content, but rather, on their ability to arouse ‘fear, disgust,
or anger,’” Pl. S.J. Opp. 13–14, each of the studies from which plaintiffs quote isolated sentences
actually concludes that depictions of the health consequences of smoking ensure that consumers
notice and remember the factual content of the health warning. David Hammond, whom
plaintiffs repeatedly attempt to co-opt as supporting their position, see, e.g., P.I. Hr’g Tr. 73,
rejected their view decisively in the review article from which plaintiffs quote. Hammond’s
actual conclusion is that the existing studies “suggest that health warnings with pictures are
significantly more likely to draw attention, result in greater information processing and improve
memory for the health message.” David Hammond, Health Warnings Messages on Tobacco
Products: A Review, 20 Tobacco Control 327, 329–30 (2011). Likewise, Ellen Peters and her
colleagues, from whose article plaintiffs also quote an isolated statement out of context, Pl. S.J.
Opp. 14 & n.4, concluded that “considerable psychological research suggests that the mere
presentation of hazard information is not sufficient to motivate perceptions of risk,” and that
“[r]isk is most readily communicated by information that arouses emotional associations with the
activity.” Ellen Peters, et al., The Impact and Acceptability of Canadian-Style Cigarette
Warning Labels Among U.S. Smokers and Nonsmokers, 9 Nicotine & Tobacco Research 473,
479 (2007). And the review by Geoffrey T. Fong and colleagues likewise resoundingly supports
Congress’s and the FDA’s position, rather than plaintiffs’: “Taken as a whole, the research on
pictorial warnings shows that they are: (i) more likely to be noticed than text-only warning
labels; (ii) more effective for educating smokers about the health risks of smoking and for
increasing smokers’ thoughts about the health risks; and (iii) associated with increased

13

motivation to quit smoking.” Geoffrey T. Fong, et al., The Impact of Pictures on the
Effectiveness of Tobacco Warnings, 87 Bulletin of the World Health Organization 640, 640
(2009).2
Similarly, an Australian study showed that, after Australia introduced larger pictorial
warnings in 2006, “students were more likely to read, attend to, think about, and talk about
health warnings.” Hammond, supra, 20 Tobacco Control at 330 (citing Victoria White, et al.,
Do Graphic Health Warning Labels Have an Impact on Adolescents’ Smoking-Related Beliefs
and Behaviors?, 103 Addiction 1562 (2008)). Plaintiffs challenge the conclusions of this
study—which was published in a peer-reviewed scientific journal—for failing to control for
“new anti-smoking commercials [that] were aired on television” just prior to the survey. Pl. S.J.
Opp. 38–39. But as the researchers undoubtedly recognized, there was no need to control for the
commercials’ effects, as they were created only to “promote the new warning labels,” and
“depict[ed] two of the new health warnings . . . used on cigarette packs.” White, supra at 1563.
Rather than fairly address this full body of scientific evidence supporting the health
warning requirement, plaintiffs make misguided attacks on a handful of selected studies. Thus,
they criticize a 1995 study comparing Canadian warnings to U.S. warnings on the ground that
the study “does not address graphic warnings at all.” Pl. S.J. Opp. 38; see also id. at 44 (same).

2

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) (cited in Pl. S.J. Opp. 14
n.5) (“Regarding cognitive reactions, graphic warnings are more visible . . . , easier to
understand and increase awareness and knowledge of the health hazards of smoking.”); European
Commission, Directorate General for Health and Consumers, A Review of The Science Base to
Support the Development of Health Warnings for Tobacco Packages (2009) (cited in Pl. S.J. Opp.
14 n.5) (“Combined pictorial + text warnings are significantly more effective than text only
warnings, especially educating the public of the health risks and changing consumer behaviour.
They are also more effective than text only in minimising ‘wear out’ over time.”).
14

That study examined the difference between Canadian text-only warnings and U.S. warnings at a
time when the Canadian warnings were prominently displayed on the fronts of cigarette packs.
See IOM Report at C-4. The study’s finding that “83 percent of Canadian students mentioned
health warnings in a recall test of cigarette packages, compared to only 7 percent of U.S.
students,” ibid., is thus relevant to plaintiffs’ challenge to the size and placement of the warning.
Plaintiffs also continue their mistaken reliance on FDA’s consumer research study as
proof that the updated health warnings will not “affect consumers’ knowledge of smoking risk or
smoking intentions.” Pl. S.J. Opp. 33, 36. But plaintiffs fail entirely to address FDA’s point that
this study was not designed to provide an assessment of this sort, but instead only to provide one
basis for assessing the relative impact of different pictorial warnings based on participants’
exposure to one warning on one occasion. 76 Fed. Reg. at 36,639.
Plaintiffs make a few additional points regarding the efficacy of the graphic warning
requirement, none of which have merit. Plaintiffs urge that the required warnings will have no
effect on smokers, because of “the common phenomenon of ‘optimism bias,’ i.e., many people
believe (irrationally) that their chances of avoiding known risks are better than average.” Pl. S.J.
Opp. 29. In a similar vein, plaintiffs contend that providing children and youth with “additional
‘purely factual and uncontroversial’” information is pointless given the Government’s view that
children and adolescents are “not capable of making a fully informed decision whether or not to
start or continue smoking.” Id. at 31. These arguments, however, cut in the government’s favor:
the fact that consumers, by reason of their age, their naivete, or their addiction to nicotine, tend

15

to discount health warnings provides ample basis for Congress’s decision to implement
prominent warnings that cannot be easily ignored.3
3. Plaintiffs likewise err in claiming that the size and placement of the warnings
mandated by Congress—the top half of the front and back of cigarette packages and the top
twenty percent of advertisements—“exceeds anything plausibly necessary to dispassionately
inform consumers of even the most serious health risks.” Pl. S.J. Opp. 8–10. FDA and outside
experts have reasonably concluded that the current size and location of cigarette warnings
renders them “functionally invisible,” 75 Fed. Reg. at 69,531; see also Testimony of Richard
Bonnie, Chair of IOM’s Committee on Reducing Tobacco Use, H.R. 1108, Family Smoking
Prevention & Tobacco Control Act: Hearing Before the House Subcommittee on Health,
Committee on Energy and Commerce, 110th Cong. 42 (2007). Congress’s decision to increase
the size of the warning and move it to a more prominent location is eminently sensible in light of
the serious and undisputed harms created by use of plaintiffs’ products.
Plaintiffs erroneously assert that because many over-the-counter drugs display warnings
on the back or side of packaging, there is no reason for the warnings here to be displayed on the
front and back of packaging. See Pl. S.J. Opp. 8–9 (reproducing packaging for heartburn
medication). But over-the-counter drugs are wholly unlike plaintiffs’ products, which are lethal

3

Plaintiffs also dispute Congress and FDA’s reasonable conclusion that, even beyond
pictorial warnings’ demonstrated ability to convey health risks to consumers in general, such
warnings can be additionally justified on the ground that they are particularly important for
communicating to consumers with low education levels. Pl. S.J. Br. 41–42. Although plaintiffs
dispute the relevance of one of the scientific studies cited, ibid., they do not challenge FDA’s
finding that “research shows that knowledge of smoking risks is lower among people with lower
incomes and fewer years of education.” 76 Fed. Reg. at 36,633. Congress was not required to
adopt plaintiffs’ solution of providing text-only warnings, particularly given evidence that
graphic warnings are more effective.
16

and addictive when used as intended. That difference alone justifies placing warnings on
cigarette packs in a more prominent location. Furthermore, unlike medical product warnings,
cigarette warnings are not intended to enable consumers to safely use the product, as there is no
safe method of using cigarettes. Rather, cigarette warnings promote awareness of
cigarette-related health risks.
Plaintiffs are similarly incorrect in their assumption that product warning labels are
commonly relegated to the backs or sides of product packaging, in a format that “occup[ies] no
more space than necessary to render the relevant text readable.” Pl. S.J. Opp. 9. The Consumer
Product Safety Commission (CPSC) regularly requires potentially dangerous products to carry
large warnings on the front of product packaging. For example, in 1996, based on evidence that
then-existing warnings on packages of charcoal had been insufficient to prevent roughly 28
carbon-monoxide deaths per year caused by consumers burning charcoal in enclosed spaces,
CPSC engaged in rulemaking to “make the label more noticeable and more easily read and
understood.” 61 Fed. Reg. 19,818, 19,818 (May 3, 1996). The revised label occupies a
substantial portion of the front of charcoal bags, thus belying plaintiffs’ claim that the size and
placement of the warnings here represent a departure from other product warning labels.4
4. Plaintiffs also reiterate their argument that the warnings must be invalidated because
the government provided “no evidence” that the graphic warnings will have “any statistically
significant impact on smoking prevalence.” Pl. S.J. Opp. 22, 25. Plaintiffs fail, however, to
respond to the point that the First Amendment does not require the government to make a
showing of this sort. See Gov’t S.J. Br. 31–32.

4

See http://www.acetogo.com/photo/product/8281271.jpg (last accessed 12/7/2011).
17

In any event, plaintiffs are simply incorrect that the government provided “no evidence”
that the revised health warnings will likely reduce smoking rates. See id. at 32–33. Plaintiffs
seek to diminish the studies cited by the government by claiming that they only examine whether
the warnings make study participants “more motivated to quit,” and that this measure may be
tainted by “social desirability bias, wherein test subjects are biased in favor of providing a
socially desirably response.” Pl. S.J. Opp. 25. But plaintiffs fail to address FDA’s finding that
“[t]he more recent scientific literature shows that statements by smokers concerning their
intentions to quit smoking are predictive of their making subsequent quit attempts.” 75 Fed.
Reg. 52,352, 52,354 (Aug. 25, 2010) (emphasis added). Moreover, many of the cited studies in
fact asked more than just whether smokers were motivated to quit, and assessed consumers’
actual reduction in smoking. See, e.g., 75 Fed. Reg. at 69,532 (noting that in one Canadian
study, twenty-six percent of smokers who quit after the introduction of graphic warnings
reported that the “graphic warnings on cigarette packages helped them remain abstinent”);
Hammond, 20 Tobacco Control at 331 (summarizing the results of fifteen studies, and
concluding that “significant proportions of adult and youth smokers report that large text and
pictorial health warnings have reduced their consumption levels, increased their likelihood of
quitting, increased their motivation to quit and increased the likelihood of remaining abstinent
following a quit attempt”). Plaintiffs offer no response to these scientific findings.

18

III.

Plaintiffs’ Purported APA Claim Suffers from the Same Defects as Their First
Amendment Argument and Reduces to the Contention that FDA Should Have
Declined To Implement the Statutory Mandate.
Plaintiffs’ APA arguments continue to conflate the First Amendment and APA analyses

and the distinct institutional roles of Congress and the FDA. At bottom, plaintiffs’ APA
challenge is premised on a fundamental misunderstanding of FDA’s role in implementing the
warnings that Congress mandated in the statute and a mischaracterization of the agency’s
decision-making process.
A court will hold unlawful and set aside agency action under the APA only if the action
is arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law. 5 U.S.C.
§ 706(2). The agency action at issue in this case is FDA’s selection of the specific color images
that are to accompany the textual warnings Congress selected. Congress itself mandated that
such graphics accompany the textual warnings, and it further determined the size of the warnings
and their placement on cigarette packaging and advertisements. See 15 U.S.C. § 1333 Note.
Thus, as relevant, only the composition of the specific images was left to FDA’s discretion.
Plaintiffs’ assertion that FDA was free to disregard the statutory mandate is based on a
misreading of the relevant statutory provisions. See Pl. S.J. Opp. 48–49. While § 201(a) of Act
affords the Secretary leeway to “adjust the type, size, text and format of the label statements,”
that is, the textual portion of the warnings, that section does not authorize FDA to reduce the
overall size of the warning or exclude graphics. 15 U.S.C. § 1333 Note (emphasis added)
(stating that any such adjustments must ensure, among other things, that the graphic and text
“appear within the specified area”). Although a separate provision of the Act gives FDA
authority to engage in rulemaking to “adjust the format, type size, color graphics, and text of any

19

of the label requirements,” that provision requires a “find[ing] that such a change would promote
greater public understanding of the risks associated with the use of tobacco products.” Act
§ 202(b) (emphasis added). No such finding supports plaintiffs’ proposal to have “the Tobacco
Control Act’s new textual warnings be displayed in the same manner in which the Surgeon
General’s warnings have been displayed for years,” Comment Letter 3–4, and accordingly
§ 202(b) is of no aid to plaintiffs here.
Plaintiffs’ APA challenge to FDA’s rule is thus inextricably intertwined with their
challenge to the statutory mandate that the agency faithfully implemented. Neither in their
Opposition nor at any prior point have plaintiffs identified any image chosen by the FDA that is
inconsistent with the statutory mandate. Indeed, as explained at length in our summary judgment
motion, the agency, in exercising its delegated authority, engaged in a detailed examination of
potential images. Based on the ample evidence it collected, the agency selected nine images
that, together with the warning statements, would most effectively convey the health risks of
smoking to consumers. See Gov’t S.J. Br. 34–45. Specifically, FDA initially selected thirty-six
images as candidates to accompany the textual warnings. The agency then subjected those
images to rigorous review in order to ascertain which mix of images would most effectively
assist in conveying to a broad range of consumers the information in the text warnings. A study
involving 18,000 participants compared the images’ effect on several different variables,
including the salience metrics discussed above.5 See 76 Fed. Reg. at 36,639. As explained in the

5

Plaintiffs’ claim that the findings of the FDA study are “consistent with random
sampling error,” Pl. S.J. Opp. 33–34, depends on ignoring the numerous and statistically
significant salience findings, which, as explained, showed that the selected warnings were likely
to effectively convey the warning messages. Thus, while plaintiffs claim that the Viscusi
statement “tabulat[es] results of [the] FDA Study Report,” id. at 33, Viscusi actually excludes all
20

government’s summary judgment brief, Gov’t S.J. Br. 34–37, 49–50, these salience metrics
provided an appropriate basis for distinguishing among potential images because they predict the
likelihood that viewers will notice and process the information contained in the text. See FDA
Study Report at 1-2, 4-1 (citing studies); 76 Fed. Reg at 36,639 (same). Relying in large part on
the results of that study, FDA in its final rulemaking selected nine images from the initial thirtysix. FDA also looked to the experience of other countries, including Canada, and to studies
documenting the efficacy of the images used in such countries to convey information about the
health risks of smoking. See, e.g., 76 Fed. Reg. at 36,636. Plaintiffs offer no challenge to this
method of selecting pictorial warnings.
Indeed, each of plaintiffs’ supposed APA challenges to the rule underscores the extent to
which their quarrel is not with the agency, but with Congress. Plaintiffs first urge that the rule is
arbitrary and capricious because “the Rule is not expected to advance the goal of reducing
smoking in a statistically significant way.” Pl. S.J. Opp. 48. They also contend that FDA erred
in failing to consider less burdensome alternatives to the pictorial warnings, and that FDA’s costbenefit analysis ignores obvious costs and does not support the decision to require pictorial
warnings. Id. at 46–48. Among other problems, each of these claims is properly leveled at the
initial decision to require that images accompany the textual warnings—a decision made by
Congress rather than FDA. As noted, FDA had no authority to second-guess that decision, nor
was it under any obligation to amass a record supporting it. Instead, the administrative record is
appropriately tailored to the task with which FDA was actually charged—i.e., selecting the
specific images that are to accompany the textual warnings chosen by Congress. The
of the study findings regarding salience. Compare Viscusi Statement 70–73 with FDA Study
Report appx. C, table C.1.
21

consideration of alternative measures and the costs and benefits of requiring pictorial warnings
were likewise matters for Congress to address when it enacted the warnings requirement in the
Tobacco Control Act. Accordingly, they are not properly the subject of an APA challenge.
Although these flaws suffice to dispose of plaintiffs’ claims, it is worth noting some of
the arguments’ additional defects. Plaintiffs have largely abandoned their reliance on the rule’s
regulatory impact analysis (RIA), which, as explained, see Gov’t S.J. Br. 46–47, was undertaken
in compliance with Executive Orders designed to “improve the internal management of the
Federal Government,” Executive Order 12,866, § 10, 58 Fed. Reg. 51,735, 51,744 (1993); see
Executive Order 13,563, § 7(d), 76 Fed. Reg. 3,821, 3,823 (2011), and not as a basis for
justifying either the rule or Congress’s decision to mandate graphic warnings. Nevertheless,
plaintiffs continue to mischaracterize the RIA, which does not in fact predict that the new
warnings will have little if any impact on smoking rates. See Pl. S.J. Opp. 48. As explained,
plaintiffs’ contrary argument depends on wrenching caveats in the RIA from their context. In
full, the relevant sentence states: “Although both of the estimation methods . . . lead to the
conclusion that graphic warning labels will reduce smoking rates, FDA has had access to very
small data sets, so our effectiveness estimates are in general not statistically distinguishable from
zero; we therefore cannot reject, in a statistical sense, the possibility that the rule will not change
the U.S. smoking rate.” 76 Fed. Reg. at 36,776. That statement emphasizes that FDA’s best
estimates suggest a reduction in smoking rates while acknowledging the methodological
challenges inherent in the analysis.
To the extent plaintiffs raise claims potentially cognizable under the APA, their
arguments are entirely without merit. It is difficult to understand why FDA’s rejection of certain

22

comments for lacking a “scientific” basis “reflects a lack of the even-handedness required by the
APA.” Pl. S.J. Opp. 49 & n.28. As exhaustively detailed in the government’s briefs to this
Court and in the rule’s preamble, FDA exercised its discretion in selecting images to accompany
the warning statements on the basis of an ample body of scientific evidence, and FDA’s rejection
of comments that were not so supported was not arbitrary or capricious. Similarly insubstantial
is plaintiffs’ assertion that FDA failed “to include in the record information necessary to ‘provide
the public with a meaningful opportunity to comment’ on the Proposed Rule.” Id. at 52.
Plaintiffs fail to explain exactly how any supposedly missing information was necessary to
permit them to respond fully to FDA’s proposed rulemaking.
IV.

Plaintiffs Provide No Proper Legal Basis for Their Request To Delay
Implementation of the Warning Requirements.
Plaintiffs ask this Court to invalidate FDA’s regulation and, in doing so, take the further

step of ordering that any new regulation not be effective until 15 months after its issuance. As
explained, because plaintiffs’ challenge to the rule is meritless, their request for this relief is
moot. See Gov’t S.J. Br. 54. But in any event, there would be no legal basis for this relief even
if plaintiffs prevail on some portion of their claim. Plaintiffs do not deny that the APA
authorizes judicial review of final agency action on the basis of an administrative record
compiled by the agency, and permits a court only to “set aside” those actions. See 5 U.S.C.
§ 706. Nor do plaintiffs deny that the APA does not permit a court to mandate the contours or
effective date of action yet to be taken; these are matters left to the agency’s discretion in the
first instance. There is thus no basis at this juncture for addressing plaintiffs’ contention that a
hypothetical future regulation with an effective date earlier than 15 months would be contrary to
the terms of the Tobacco Control Act.
23

Respectfully submitted,
Dated: December 9, 2011

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

________/s/________________
DRAKE CUTINI
DANIEL K. CRANE-HIRSCH
Attorneys, Consumer Protection Branch
PO Box 386
Washington, DC 20044
202-307-0044 (Cutini)
[e-mail]

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/_________________
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]
[e-mail]

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