Court Opinion

ID: 807354
Source: CourtListenerOpinion
Date Created: 2012-08-24 14:17:27+00
Date Added: 2024-06-11T13:18:11.038113
License: Public Domain

United States Court of Appeals
         FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued April 10, 2012              Decided August 24, 2012

                        No. 11-5332

        R.J. REYNOLDS TOBACCO COMPANY, ET AL.,
                      APPELLEES

                             v.

          FOOD & DRUG ADMINISTRATION, ET AL.,
                     APPELLANTS

              Consolidated with No. 12-5063

       Appeals from the United States District Court
               for the District of Columbia
                   (No. 1:11-cv-01482)

    Mark B. Stern, Attorney, U.S. Department of Justice,
argued the cause for appellants. With him on the briefs were
Tony West, Assistant Attorney General, Beth S. Brinkmann,
Deputy Assistant Attorney General, Alisa B. Klein, Sarang V.
Damle, Daniel Tenny, and Lindsey Powell, Attorneys,
William B. Schultz, Acting General Counsel, U.S. Department
of Health and Human Services, Eric M. Blumberg, Deputy
                              2
Chief Counsel, and Karen E. Schifter, Senior Counsel. R.
Craig Lawrence, Assistant U.S. Attorney, entered an
appearance.

    Gregory A. Beck and Allison M. Zieve were on the brief
for amici curiae American Academy of Pediatrics, et al. in
support of appellants.

     Lawrence G. Wasden, Attorney General, Office of the
Attorney General for the State of Idaho, Brett T. DeLange,
Deputy Attorney General, John J. Burns, Attorney General,
Office of the Attorney General for the State of Alaska, Tom
Horne, Attorney General, Office of the Attorney General for
the State of Arizona, Dustin McDaniel, Attorney General,
Office of the Attorney General for the State of Arkansas,
Kamala D. Harris, Attorney General, Office of the Attorney
General for the State of California, George Jepsen, Attorney
General, Office of the Attorney General for the State of
Connecticut, Todd S. Kim, Solicitor General, Office of the
Attorney General for the District of Columbia, David M.
Louie, Attorney General, Office of the Attorney General for
the State of Hawai’i, Lisa Madigan, Attorney General, Office
of the Attorney General for the State of Illinois, Thomas J.
Miller, Attorney General, Office of the Attorney General for
the State of Iowa, William J. Schneider, Attorney General,
Office of the Attorney General for the State of Maine,
Douglas F. Gansler, Attorney General, Office of the Attorney
for the State of Maryland, Jim Hood, Attorney General,
Office of the Attorney General for the State of Mississippi,
Steve Bullock, Attorney General, Office of the Attorney
General for the State of Montana, Michael A. Delaney,
Attorney General, Office of the Attorney General for the State
of New Hampshire, Gary K. King Attorney General, Office of
the Attorney General for the State of New Mexico, Michael
DeWine, Attorney General, Office of the Attorney General for
                              3
the State of Ohio, Peter F. Kilmartin, Attorney General,
Office of the Attorney General for the State of Rhode Island,
Marty J. Jackley, Attorney General, Office of the Attorney
General for the State of South Dakota, Mark L. Shurtleff,
Attorney General, Office of the Attorney General for the State
of Utah, William H. Sorrell, Attorney General, Office of the
Attorney General for the State of Vermont, Vincent F.
Frazier, Attorney General, Office of the Attorney General for
the Virgin Islands, Robert M. McKenna, Attorney General,
Office of the Attorney General for the State of Washington,
and Darrell V. McGraw, Jr., Attorney General, Office of the
Attorney General for the State of West Virginia, were on the
brief for amici curiae States.

    Noel J. Francisco argued the cause for appellees. With
him on the briefs were Warren D. Postman, Philip J. Perry,
Jonathan D. Hacker, Floyd Abrams, Joel Kurtzberg, and
Patricia A. Barald.

    Bert W. Rein, John E. Barry, Robin S. Conrad, Kathryn
Comerford Todd, and Sheldon Gilbert were on the brief for
amicus curiae Chamber of Commerce of the United States of
America in support of appellees.

    Daniel J. Popeo, Cory L. Andrews, and Richard A. Samp
were on the brief for amicus curiae Washington Legal
Foundation.

     Robert Corn-Revere and Ronald G. London were on the
brief for amici curiae Association of National Advertisers
Inc., et al. in support of appellees.

     Jeffrey Light was on the brief for amicus curiae
Defending Animal Rights Today & Tomorrow in support of
neither party.
                                4

   Before: ROGERS and BROWN, Circuit Judges, and
RANDOLPH, Senior Circuit Judge.

    Opinion for the Court filed by Circuit Judge BROWN.

    Dissenting opinion filed by Circuit Judge ROGERS.

     BROWN, Circuit Judge: The Family Smoking Prevention
and Tobacco Control Act (“the Act”), Pub. L. No. 111-31,
123 Stat. 1776 (2009), directed the Secretary of the U.S.
Department of Health and Human Services to issue
regulations requiring all cigarette packages manufactured or
sold in the United States to bear one of nine new textual
warnings, as well as “color graphics depicting the negative
health consequences of smoking.” See id. § 201(a). Pursuant
to this authority, the Food and Drug Administration (“FDA”)
initiated a rulemaking proceeding through which it selected
the nine images that would accompany the statutorily-
prescribed warnings.        Five tobacco companies (“the
Companies”) challenged the rule, alleging that FDA’s
proposed graphic warnings violated the First Amendment. See
Compl. at 35-36. 1 The district court granted the Companies’
motion for summary judgment on February 29, 2012. 2 FDA
appeals, and we affirm.

1
  The Companies also alleged the graphic warnings violated the
Administrative Procedure Act (“APA”), specifically 5 U.S.C. §§
553(b)(3) and 706(2)(A). See Compl. at 37. Because we hold the
graphic warnings violate the First Amendment, we do not reach the
Companies’ APA claims.
2
   FDA originally appealed the district court’s grant of the
Companies’ motion for a preliminary injunction, but that ruling was
superseded by the court’s subsequent ruling on the merits.
                                5
I.   Background

     The Act gives FDA the authority to regulate the
manufacture and sale of tobacco products, including
cigarettes. In addition to requiring cigarette packages and
advertisements to bear one of nine new warning statements,
the Act mandates that the new warning labels comprise the
top 50 percent of the front and rear panels of cigarette
packages and 20 percent of the area of each cigarette
advertisement. Act § 201(a), 123 Stat. at 1842–45. The Act
directs the Secretary to issue final regulations identifying the
graphic component of the warnings by June 22, 2011, and
provides that the revised health warnings will take effect by
September 22, 2012. See 15 U.S.C. § 1333 note.

     Pursuant to the statutory directive, FDA issued a
Proposed Rule seeking comment on thirty-six potential
images for the new graphic warning labels. Required
Warnings for Cigarette Packages and Advertisements, 75 Fed.
Reg. 69,524, 69,534 (Nov. 12, 2010) (hereinafter Proposed
Rule). At the outset of the Proposed Rule, FDA asserted the
government’s “substantial interest in reducing the number of
Americans, particularly children and adolescents, who use
cigarettes and other tobacco products in order to prevent the
life-threatening health consequences associated with tobacco
use.” Id. at 69,525. In accordance with the requirements of
the Act, FDA proposed a dramatic expansion of the existing
health warnings, which it justified based on scientific
literature and a “strong worldwide consensus” 3 regarding the
3
  Countries/jurisdictions that have implemented pictorial warning
requirements for tobacco packaging include Australia, Belgium,
Brazil, Brunei, Canada, Chile, Colombia, Cook Islands, Djibouti,
Egypt, Hong Kong, India, Iran, Jordan, Latvia, Malaysia, Mauritius,
Mexico, Mongolia, New Zealand, Pakistan, Panama, Paraguay,
Peru, Romania, Singapore, Switzerland, Taiwan, Thailand, Turkey,
                                6
relative effectiveness of graphic warnings compared to the
text-only warnings the United States currently requires. Id.
The agency explained that by “clearly and effectively
convey[ing] the negative health consequences of smoking,”
the new warnings would discourage nonsmokers, particularly
minors, from “initiating cigarette use,” and encourage current
smokers to quit. Id. at 69,526.

     FDA promulgated the final set of nine images—one for
each warning statement—by regulations issued on June 22,
2011. See Required Warnings for Cigarette Packages and
Advertisements, 76 Fed. Reg. 36,628 (June 22, 2011)
(hereinafter Final Rule). FDA also required each graphic
image to bear the phone number of the National Cancer
Institute’s “Network of Tobacco Cessation Quitlines,” which
uses the telephone portal “1-800-QUIT-NOW.” Id. at 36,681.

     FDA based its selection of the final images on an 18,000-
person internet-based consumer study it commissioned. The
study divided respondents into two groups: a control group
that was shown the new text in the format of the current
warnings (located on the side of cigarette packages), and a
separate treatment group that was shown the proposed graphic
warnings, which included the new text, the accompanying
graphic image, and the 1-800-QUIT-NOW number. Id. at
36,638. Each group then answered questions designed to
assess, among other things, whether the graphic warnings,
relative to the text-only control, (1) increased viewers’
intention to quit or refrain from smoking; (2) increased

United Kingdom, Uruguay, and Venezuela. Countries/jurisdictions
with pending requirements include France, Guernsey, Honduras,
Malta, Norway, the Philippines, and Spain. It is worth noting that
the constitutions of these countries do not necessarily protect
individual liberties as stringently as does the United States
Constitution. Proposed Rule at 69,525 n.4.
                               7
viewers’ knowledge of the health risks of smoking or second-
hand smoke; and (3) were “salient,” which FDA defined in
part as causing viewers to feel “depressed,” “discouraged,” or
“afraid.” Id.

     In selecting these nine images, FDA reviewed and
responded to over a thousand public comments, including
joint comments submitted by plaintiffs-appellees RJ
Reynolds, Lorillard, and Commonwealth Brands. See id. at
36,629.      Several comments—including comments from
cancer researchers, nonprofits, and academics—criticized the
single exposure study design, noting it prevented the
government from assessing the long-term or actual effects of
the proposed warnings.            Two of these comments
recommended FDA conduct longitudinal research or post-
market surveillance to assess actual long-term effects. Id. at
36,639. FDA conceded the study did not permit it to reach
“firm” conclusions about the “long-term, real-world effects”
of the proposed warnings, but claimed the existing scientific
literature “provides a substantial basis for our conclusion that
the required warnings will effectively communicate the health
risks of smoking, thereby encouraging smoking cessation and
discouraging smoking initiation.” Id. Still other comments
asserted that FDA’s research study failed to provide evidence
that the proposed warnings would actually affect smoking
rates, significantly affect consumers knowledge of the risks of
smoking, or bring about actual behavior change. See id. at
36,640. But FDA disagreed, again relying on the “substantial
research” showing the effectiveness of similar graphic health
warnings in other countries. Id. (citing Proposed Rule at
69,531-34). 4 Another comment asserted that the study’s

4
   Tobacco manufacturers also criticized the “study’s use of
intentions to measure behavioral change and stated that FDA
should have presented data showing actual effects on behavior.”
                                  8
selection bias constituted a serious methodological flaw.
Namely, participants were recruited from an internet panel
and offered the opportunity to participate in an FDA-
sponsored research study. Id. at 36,643. FDA avoided the
substance of this argument by conceding that its study
“provides insight on the relative effectiveness of the various
warnings under consideration,” not on the “absolute effects of
the warnings in general.” Id.

     Some comments also criticized the lack of statistical
evidence supporting FDA’s belief that requiring cigarette
packages to bear the graphic warnings would reduce smoking
rates. See id. For example, the Companies noted that the
Canadian data revealed no statistically significant decline in
smoking rates for adolescents and adults after the introduction
of similar graphic warnings, which implied that the warnings
were ineffective and that FDA’s warnings would be
ineffective as well. Id. FDA summarily disagreed, stating
that the images it selected would satisfy its “primary goal,
which is to effectively convey the negative health

Final Rule at 36,642. FDA disagreed that intentions were an
inappropriate variable, explaining that while intentions do not
perfectly predict future behavior, they are a “necessary precursor.”
Id.     FDA also cites the “scientific literature[’s]” shocking
conclusion “that one’s intentions to quit smoking must be increased
before one makes the actual quit attempt.” Id. In response to
comments raising concerns about the lack of strong statistically
significant results concerning intention, FDA explained that
although its study made no attempt to show that increased intention
to quit translated to actual (let alone successful) quit attempts, “the
overall body of scientific literature” provides sufficient evidence
that the warnings, “by increasing public understanding of and
thoughts about the health risks of smoking, will be effective in
encouraging smoking cessation and discouraging smoking
initiation.” Id.
                              9
consequences of smoking on cigarette packages and in
advertisements,” which can help “both to discourage
nonsmokers . . . from initiating cigarette use and to encourage
current smokers to consider cessation.” Final Rule at 36,633.
FDA also explained that the data from Canada did not
indicate that the warnings had been ineffective, because other
studies showed that the warnings had been “effective at
providing . . . smokers with health information, making
consumers think about the health effects of smoking, and
increasing smokers’ motivations to quit smoking.” Id. at
36,634.

    After FDA finalized the Rule, the Companies filed suit in
the district court, claiming the cigarette warnings required
under the Act and FDA’s implementing regulations violated
the First Amendment.        The district court granted the
Companies’ motion for a preliminary injunction on November
7, 2011, and subsequently granted their motion for summary
judgment. FDA appeals, and we review de novo the district
court’s decision to grant summary judgment. Davis v.
Pension Benefit Guar. Corp., 571 F.3d 1288, 1291 (D.C. Cir.
2009).

    II. Level of Scrutiny

     The Companies do not dispute Congress’s authority to
require health warnings on cigarette packages, nor do they
challenge the substance of any of the nine textual statements
mandated by the Act. The only question before us is whether
FDA’s promulgation of the graphic warning labels—which
incorporate the textual warnings, a corresponding graphic
image, and the “1-800-QUIT-NOW” cessation hotline
number—violates the First Amendment. We begin our
analysis by determining the applicable level of scrutiny.
                               10
     Both the right to speak and the right to refrain from
speaking are “complementary components of the broader
concept of individual freedom of mind” protected by the First
Amendment. Wooley v. Maynard, 430 U.S. 705, 714 (1977).
Any attempt by the government either to compel individuals
to express certain views, see id. at 714-15, or to subsidize
speech to which they object, see United States v. United
Foods, Inc., 533 U.S. 405, 410-11 (2001), is subject to strict
scrutiny. The general rule “that the speaker has the right to
tailor the speech[] applies not only to expressions of value,
opinion, or endorsement, but equally to statements of fact the
speaker would rather avoid.” Hurley v. Irish-Am. Gay,
Lesbian & Bisexual Grp. of Bos., 515 U.S. 557, 573-74
(1995). This holds true whether individuals, see W. Va. State
Bd. of Educ. v. Barnette, 319 U.S. 624, 642 (1943), or
corporations, see Pac. Gas & Elec. Co. v. Pub. Utils.
Comm’n, 475 U.S. 1, 16 (1986) (plurality opinion), are being
compelled to speak.

     This case contains elements of compulsion and forced
subsidization. The Companies contend that, to the extent the
graphic warnings go beyond the textual warnings to shame
and repulse smokers and denigrate smoking as an antisocial
act, the message is ideological and not informational. “[B]y
effectively shouting well-understood information to
consumers,” they explain, “FDA is communicating an
ideological message, a point of view on how people should
live their lives: that the risks from smoking outweigh the
pleasure that smokers derive from it, and that smokers make
bad personal decisions, and should stop smoking.” In effect,
the graphic images are not warnings, but admonitions:
“[D]on’t buy or use this product.” 5 No one doubts the

5
  The question here is whether the graphic warnings actually do
constitute the type of disclosure requirements that are reviewable
                                11
government can promote smoking cessation programs; can
use shock, shame, and moral opprobrium to discourage people
from becoming smokers; and can use its taxing and regulatory
authority to make smoking economically prohibitive and
socially onerous. And the government can certainly require
that consumers be fully informed about the dangers of
hazardous products. But this case raises novel questions
about the scope of the government’s authority to force the
manufacturer of a product to go beyond making purely factual
and accurate commercial disclosures and undermine its own
economic interest—in this case, by making “every single pack
of cigarettes in the country [a] mini billboard” for the
government’s anti-smoking message. 6

    Even assuming the Companies’ marketing efforts
(packaging, branding, and other advertisements) can be
properly classified as commercial speech, and thus subject to

under Zauderer’s relaxed standard”—what the dissent characterizes
as “attempts ‘only to prescribe what shall be orthodox in
commercial advertising,” Dissent at 8 (quoting Zauderer v. Office
of Disciplinary Counsel, 471 U.S. 626, 651 (1985))—or whether
they are more akin to attempts to “prescribe what shall be orthodox
in . . . matters of opinion,” Zauderer, 471 U.S. at 651, as the
Companies contend. The dissent overlooks the element of
compulsion, which at least creates an argument in favor of applying
strict scrutiny.
6
  FDA, Tobacco Strategy Announcement (Nov. 10, 2010), available
at
http://www.fda.gov/TobaccoProducts/NewsEvents/ucm232556.htm
; see also Press Briefing by Press Secretary Jay Carney, Health and
Human Services Secretary Kathleen Sebelius, and FDA
Commissioner Margaret Hamburg (June 21, 2011), available at
http://www.whitehouse.gov/the-press-office/2011/06/21/press-
briefing-press-secretary-jay-carney-secretary-health-and-human-
ser.
                               12
less robust First Amendment protections, a thorny question
remains: how much leeway should this Court grant the
government when it seeks to compel a product’s manufacturer
to convey the state’s subjective—and perhaps even
ideological—view that consumers should reject this otherwise
legal, but disfavored, product? Neither the Act nor the
agency’s regulation squarely addresses this question.
However, for present purposes, we can assume, without
deciding, that if such compulsion is constitutionally
permissible, the state’s actions must still withstand the
applicable level of scrutiny.

     Courts have recognized a handful of “narrow and well-
understood exceptions” to the general rule that content-based
speech regulations—including compelled speech—are subject
to strict scrutiny. See Turner Broad. Sys., Inc. v. FCC, 512
U.S. 622, 641 (1994). There are two primary exceptions in
the commercial speech context. First, “purely factual and
uncontroversial” disclosures are permissible if they are
“reasonably related to the State’s interest in preventing
deception of consumers,” provided the requirements are not
“unjustified or unduly burdensome.” Zauderer, 471 U.S. at
651. Second, restrictions on commercial speech are subject to
less stringent review than restrictions on other types of
speech. For a statute burdening commercial speech to
survive, the government must affirmatively prove that (1) its
asserted interest is substantial, (2) the restriction directly and
materially advances that interest, and (3) the restriction is
narrowly tailored. See Cent. Hudson Gas & Elec. Corp., v.
Pub. Serv. Comm’n, 447 U.S. 557, 566 (1980). While this
test is not quite as demanding as strict scrutiny, it is
significantly more stringent than Zauderer’s standard, which
is akin to rational-basis review.
                              13
     The district court concluded the graphic warnings were
“not the type of purely factual and uncontroversial”
disclosures reviewable under the less stringent Zauderer
standard. R.J. Reynolds Tobacco Co. v. FDA, Civ. Case No.
11-1482, at 11 (D.D.C. Feb. 29, 2012) (hereinafter “Merits
Opinion”). Applying strict scrutiny, the court held that FDA
failed to satisfy its burden of demonstrating that the Rule is
narrowly tailored to achieve a compelling government
interest. See id. at 17-19. FDA argues that the district court
erred in finding the Zauderer standard inapplicable.
Alternatively, it contends that the district court erred by
failing to apply the intermediate-level scrutiny generally
afforded to commercial speech, and that the graphic warnings
pass constitutional muster under Central Hudson.          We
address each argument in turn.

    a.   Applicability of the Zauderer Standard

     In Zauderer, the Court applied a lower level of scrutiny
to regulations requiring attorneys to fully disclose information
about the actual cost and consequences of services. 471 U.S.
at 651-52. Noting that the First Amendment’s protection of
commercial speech is premised on its informational value to
consumers, the Court reasoned that an advertiser’s
constitutional interest in not providing additional factual
information was “minimal.” Id. at 561. Although the Court
acknowledged that “unjustified or unduly burdensome
disclosure requirements might offend the First Amendment by
chilling protected commercial speech,” it “h[e]ld 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.” Id.; see also
Milavetz, Gallop & Milavetz, P.A. v. United States, 130 S. Ct.
1324, 1340 (2010) (applying the Zauderer standard to
                                14
disclosure requirements “intended to combat the problem of
inherently misleading commercial advertisements”).

     The Supreme Court has never applied Zauderer to
disclosure requirements not designed to correct misleading
commercial speech. FDA argues that Zauderer’s lenient
standard of scrutiny applies to regulations that serve a
different governmental interest: disclosure of the health and
safety risks associated with commercial products. See
Appellant’s Br. at 26.

     But by its own terms, Zauderer’s holding is limited to
cases in which disclosure requirements are “reasonably
related to the State’s interest in preventing deception of
consumers.” 471 U.S. at 651. Zauderer “carries no authority
for a mandate unrelated to the interest in avoiding misleading
or incomplete commercial messages.” Glickman v. Wileman
Bros. & Elliot, Inc., 521 U.S. 457, 491 (1997) (Souter, J.,
dissenting, joined by Rehnquist, C.J., and Scalia and Thomas,
JJ.) (explaining why Zauderer was inapplicable in that case). 7
In United States v. United Foods, for example, the Court
declined to apply the Zauderer standard when evaluating a
federal law requiring mushroom producers to pay an
assessment to support generic advertising.         The Court
distinguished Zauderer because there was no suggestion “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. And as the Court explained
in Pacific Gas, “[n]othing in Zauderer suggests . . . that the
7
  Justice Souter noted that, although it was not cited by the
government in Glickman, Zauderer represented “the closest pass at
authority for his limited rationale of commercial speech protection”
because it was “our only examination of a commercial-speech
mandate before today.” 521 U.S. at 490.
                               15
State is equally free to require [entities] to carry the messages
of third parties, where the messages themselves are biased
against or are expressly contrary to the [entity’s] views.” 475
U.S. at 15 n.12 (plurality opinion).

     Ibanez v. Florida Department of Business and
Professional Regulation also suggests that Zauderer should
be construed to apply only when the government affirmatively
demonstrates that an advertisement threatens to deceive
consumers. In that case, the state Board of Accountancy
contended that an attorney’s use of her Certified Financial
Planner designation in an advertisement was “potentially
misleading,” and thus entitled the Board to require her to
include a disclaimer. 512 U.S. 136, 146 (1994). But the
Court declined to apply Zauderer, finding that “given the state
of this record,” the Board failed “to point to any harm that is
potentially real, not purely hypothetical.” Id. Put simply, the
government could not seek review under the lenient Zauderer
standard absent a showing that the advertisement at issue
would likely mislead consumers.

     In fact, the Court’s only recent application of the
Zauderer standard involved a disclosure requirement that
“share[d] the essential features of the rule at issue in
Zauderer.” Milavetz, 130 S. Ct. at 1340. In Milavetz, a law
firm challenged a provision of the Bankruptcy Abuse
Prevention and Consumer Protection Act of 2005
(“BAPCPA”) that required professionals qualifying as debt
relief agencies to “clearly and conspicuously disclose in any
advertisement of bankruptcy assistance services . . . that the
services or benefits are with respect to bankruptcy relief under
this title.” 11 U.S.C. § 528(a)(3). BAPCPA also required
qualifying professionals to state that “[w]e are a debt relief
agency. We help people file for bankruptcy relief under the
Bankruptcy Code.” Id. § 528(a)(4). The Court upheld the
                               16
statute’s disclosure requirement because, as in Zauderer, the
law firm’s advertisements were “inherently misleading”—in
this case, because they “promis[ed] . . . debt relief without any
reference to the possibility of filing for bankruptcy, which has
inherent costs.” Milavetz, 130 S. Ct. at 1340. One Justice
even cautioned against interpreting the Court’s holding as a
“presumptive[] endorse[ment of] laws requiring the use of
government-scripted disclaimers in commercial advertising,”
noting that Zauderer does not stand for the proposition that
government “can constitutionally compel the use of a scripted
disclaimer in any circumstance in which its interest in
preventing consumer deception might plausibly be at stake.”
Id. at 1343-44 (Thomas, J., concurring in part and concurring
in the judgment).

     Zauderer, Ibanez, and Milavetz thus establish that a
disclosure requirement is only appropriate if the government
shows that, absent a warning, there is a self-evident—or at
least “potentially real”—danger that an advertisement will
mislead consumers. Ibanez, 512 U.S. at 146. In this case, the
proposed disclosure requirements would apply to both
cigarette advertisements and cigarette packages. The Act
bans any labeling or advertising representing that any tobacco
product “presents a lower risk of tobacco-related disease or is
less harmful than one or more other commercially marketed
tobacco products,” “contains a reduced level of a substance or
presents a reduced exposure to a substance,” or “does not
contain or is free of a substance.” 21 U.S.C. § 387k. The Act
also bans advertising or labeling using the descriptors “light,”
“mild,” “low,” or similar descriptors. Id. In light of these
restrictions, and in the absence of any congressional findings
on the misleading nature of cigarette packaging itself, there is
no justification under Zauderer for the graphic warnings.
                                 17

     The dissent’s argument that cigarette packages and other
advertisements that fail to prominently display the negative
health consequences of smoking are misleading, see Dissent
at 12-13, seems to blame the industry for playing by the
government’s rules. The Companies have never argued that
no disclosure requirements are warranted; they merely object
to the form and content of the specific requirements proposed
by the FDA. Indeed, it seems likely the FDA did not make
any such claims because the industry has complied precisely
with all of the government’s previous disclosure
requirements, and continues to do so. Moreover, the
Companies generally acknowledge the need for effective
warnings and concede in their brief that they would be
amenable to a number of new disclosure requirements,
including putting the Act’s new text on the side of packages,
the bottom front of packages and advertisements, or using less
shocking graphics. Appellees’ Br. at 58. 8

    The amicus States suggest that the graphic warnings be
evaluated in the context of the years of deception that
preceded them. 9 States’ Br. at 7. Citing Warner-Lambert Co.

8
  The dissent also claims that the government has provided “more
than sufficient evidence that cigarette packages and other
advertisements remain likely to mislead consumers notwithstanding
the existing warnings.” Dissent at 11. In the Final Rule, the FDA
found that consumers are uninformed about “the nature and extent
of the health risks associated with smoking cigarettes,” Final Rule
at 36,632, such as “the severity and magnitude” of those risks, their
personal risks, the effects of secondhand smoke, and the highly
addictive nature of cigarettes. See id. at 36,632-33. But none of the
proposed warnings purport to address the information gaps
identified by the government.
9
  To the extent that there is a concern about the Companies’ past
deception, the Act precludes them from “portray[ing] the use of
tobacco as . . . healthful to minors,” see Act § 2(17), 123 Stat. at
                              18

v. FTC, 562 F.2d 749 (D.C. Cir. 1977) they claim this Court
has found that even advertisements that do not appear
deceptive in isolation can constitute “part of a continuing
deception of the public” absent highly visible warnings. Id. at
769. But the States’ argument overlooks the broader context
of that decision. Warner-Lambert involved a petition for
review of an FTC order requiring the Warner-Lambert
company to cease and desist from advertising that its product,
Listerine mouthwash, prevents, cures, or alleviates the
common cold. Id. at 752. As a remedial measure, the
Commission required Warner-Lambert to include the
following disclosure in every future advertisement for
Listerine for a defined period: “Contrary to prior advertising,
Listerine will not help prevent colds or sore throats or lessen
their severity.” Id. at 753. In other words, the disclosure
statement was required as part of a corrective order which the
Commission found necessary to “dissipate the effects of
respondent’s deceptive representations.” Id. at 769; see also
Novartis Corp. v. FTC, 223 F.3d 783, 788-89 (D.C. Cir.
2000) (upholding the Commission’s corrective order
imposing disclosure requirements on drug manufacturer).

     By contrast, FDA does not frame this rule as a remedial
measure designed to counteract specific deceptive claims
made by the Companies, nor did it offer a remedial
justification for the graphic warnings during the rulemaking
proceeding. While the Companies’ representations about
“light” or “low tar” cigarettes might have been misleading,
see United States v. Philip Morris USA Inc., 566 F.3d 1095,
1124-26 (D.C. Cir. 2009), the Act now prohibits such

1778, by precluding the Companies from using “light” and other
descriptors. See 21 U.S.C. § 387k. And Congress’s objection to
the Companies’ portrayal of smoking as “socially acceptable” is
likewise remedied by the constraints of the Act.
                              19

statements. See 21 U.S.C. § 387k. Unlike in Warner-
Lambert, FDA has not shown that the graphic warnings were
designed to correct any false or misleading claims made by
cigarette manufacturers in the past. 10 Nor did it show that
absent disclosure, consumers would likely be deceived by the
Companies’ packaging in the future. Rather, FDA framed the
warnings as general disclosures about the negative health
effects of smoking. The warnings thus represent an ongoing
effort to discourage consumers from buying the Companies’
products, rather than, as in Warner-Lambert, a measure
designed to combat specific deceptive claims.

     Moreover, the graphic warnings do not constitute the type
of “purely factual and uncontroversial” information,
Zauderer, 471 U.S. at 651, or “accurate statement[s],”
Milavetz, 130 S. Ct. at 1340, to which the Zauderer standard
may be applied. The disclosures approved in Zauderer and
Milavetz were clear statements that were both indisputably
accurate and not subject to misinterpretation by consumers.
See Zauderer, 471 U.S. at 633 (describing the disciplinary
rule that required “that any advertisement that mentions
contingent-fee rates must disclos[e] whether percentages are
computed before or after deduction of court costs and
expenses”); Milavetz, 130 S. Ct. at 1330 (describing BAPCPA
disclosure requirements, including, inter alia, a statement that
“[w]e are a debt relief agency. We help people file for relief
under the Bankruptcy Code.”).

     The FDA’s images are a much different animal. FDA
concedes that the images are not meant to be interpreted
literally, but rather to symbolize the textual warning

10
   Such matters are the subject of a pending—and entirely
separate—line of litigation against the Companies. See Philip
Morris USA Inc., 566 F.3d 1095.
                              20

statements, which provide “additional context for what is
shown.” Final Rule at 36,655. But many of the images
chosen by FDA could be misinterpreted by consumers. For
example, the image of a man smoking through a tracheotomy
hole might be misinterpreted as suggesting that such a
procedure is a common consequence of smoking—a more
logical interpretation than FDA’s contention that it
symbolizes “the addictive nature of cigarettes,” which
requires significant extrapolation on the part of the
consumers. Id. at 36,649. Moreover, the graphic warnings
are not “purely” factual because—as FDA tacitly admits—
they are primarily intended to evoke an emotional response,
or, at most, shock the viewer into retaining the information in
the text warning. See Appellant’s Br. at 33 (citing research
showing that “pictures are easier to remember than words”);
id. at 38 (citing FDA’s finding that a substantial body of
scientific literature shows that emotional responses, such as
worry and disgust, “reliably predict the likelihood that
consumers will understand and appreciate the substance of the
warnings”).

     In fact, many of the images do not convey any warning
information at all, much less make an “accurate statement”
about cigarettes. For example, the images of a woman crying,
a small child, and the man wearing a T-shirt emblazoned with
the words “I QUIT” do not offer any information about the
health effects of smoking. And the “1-800-QUIT-NOW”
number, when presented without any explanation about the
services provided on the hotline, hardly sounds like an
unbiased source of information. These inflammatory images
and the provocatively-named hotline cannot rationally be
viewed as pure attempts to convey information to consumers.
They are unabashed attempts to evoke emotion (and perhaps
embarrassment) and browbeat consumers into quitting. See
Final Rule at 36,697 (“[R]isk information is most readily
                              21

conveyed by warnings that elicit . . . strong emotional and
cognitive reactions . . . .”). While none of these images are
patently false, they certainly do not impart purely factual,
accurate, or uncontroversial information to consumers.
Consequently, the images fall outside the ambit of Zauderer.

    b. Applicability of Central Hudson

     Because this case does not fall within the narrow enclave
carved out by Zauderer, we must next determine which level
of scrutiny—strict or intermediate—is appropriate. The
district court held that compelled speech that falls outside the
Zauderer framework is subject to strict scrutiny. See Merits
Op. at 14-16. See also Disc. Tobacco City & Lottery, Inc. v.
United States, 674 F.3d 509, 554 (6th Cir. 2012) (deciding
between applying strict scrutiny or Zauderer to compelled
commercial speech); Entm’t Software Ass’n v. Blagojevich,
469 F.3d 641, 652 (7th Cir. 2006) (same). The government
argues that we should view the graphic warnings as
restrictions on commercial speech, which are analyzed under
the less rigorous standard established by Central Hudson.
Despite the contrary views of other circuits, our governing
precedent makes clear that Central Hudson is the appropriate
standard.

     This Court recently evaluated the constitutionality of
compelled commercial speech in United States v. Philip
Morris, where it reviewed a district court order requiring the
defendant tobacco manufacturers to publish corrective
statements on their websites, in newspapers, and on major
television networks. 566 F.3d at 1142-43. This Court began
by noting that “[b]ecause commercial speech receives a lower
level of protection under the First Amendment, burdens
imposed on it receive a lower level of scrutiny from the
courts.” Id. After acknowledging that “the standard for
                                 22

assessing burdens on commercial speech has varied,” the
Court concluded that “the Supreme Court’s bottom line is
clear: the government must affirmatively demonstrate its
means are narrowly tailored to achieve a substantial
government goal.” Id. at 1143. See also Novartis Corp., 223
F.3d at 789 (evaluating a corrective remedy involving
corrective statements under Central Hudson). Because this
case also involves a compelled commercial disclosure, we
follow the lead of Philip Morris and apply the intermediate
standard set forth in Central Hudson.

III. Evaluating   the         Graphic        Warnings        Under
Intermediate Scrutiny

     Under Central Hudson, the government must first show
that its asserted interest is “substantial.” 447 U.S. at 566. 11 If
so, the Court must determine “whether the regulation directly
advances the governmental interest asserted, and whether it is
not more extensive than is necessary to serve that interest.”
Id. The party seeking to uphold a restriction on commercial
speech bears the burden of justifying it. Edenfield v. Fane,
507 U.S. 761, 770-71 (1993). Because this case involves a
challenge to final agency action, the Administrative Procedure
Act governs our review of the record. See 5 U.S.C. §
706(2)(B) (providing that the APA applies to allegations that
agency action is “contrary to constitutional right, power,
privilege, or immunity”). The APA requires us to “hold
unlawful and set aside agency action, findings, and

11
   Central Hudson also provides that commercial speech only
receives First Amendment protection if it is a lawful activity and is
not misleading or fraudulent. 447 U.S. at 566. Neither party
seriously disputes that the cigarette packaging and advertisements
regulated by the Act satisfy this threshold requirement.
                                 23

conclusions found to be . . . unsupported by substantial
evidence.” 5 U.S.C. § 706(2).

     Unlike rational-basis review, the Central Hudson
standard does not permit this Court to “supplant the precise
interests put forward by [FDA] with other suppositions.”
Edenfield, 507 U.S. at 768. We thus begin by identifying
FDA’s asserted interests.

     A review of the statute and the administrative record
makes clear that the graphic warnings are intended to
encourage current smokers to quit and dissuade other
consumers from ever buying cigarettes. One of the Act’s
many stated purposes is “promot[ing] cessation to reduce
disease risk and the social costs associated with tobacco-
related diseases.” Act § 3.9. The only explicitly asserted
interest in either the Proposed or Final Rule is an interest in
reducing smoking rates. The Proposed Rule states in its
preamble that the government has a “substantial interest in
reducing the number of Americans, particularly children and
adolescents, who use cigarettes and other tobacco products.”
Proposed Rule at 69,525. And the preamble to the Final Rule
reiterates the same interest. Final Rule at 36,629. 12 Although

12
  Moreover, the Institute of Medicine Report, on which FDA relies
for some of its evidence supporting the Rule, states unequivocally
that “the primary objective of tobacco regulation is not to promote
informed choice but rather to discourage consumption of tobacco
products . . . as a means of reducing tobacco-related death and
disease.” Institute of Medicine, Ending the Tobacco Problem: A
Blueprint for the Nation 291 (2007), available at
http://www.nap.edu/catalog.php?record_id=11795.         The Report
goes on to state that “[e]ven though tobacco products are legally
available to adults, the paramount public health aim is to reduce the
number of people who use and become addicted to these products,
                                 24

counsel attempted to disclaim this interest at oral argument,
the administrative record shows otherwise: the primary
objective of the Rule was “both to discourage nonsmokers
from initiating cigarette use and to encourage current smokers
to consider quitting.” Id. at 36,630.

     Assuming FDA’s interest in reducing smoking rates is
substantial, 13 we next evaluate whether FDA has offered
substantial evidence showing that the graphic warning
requirements “directly advance[] the governmental interest
asserted,” Cent. Hudson, 447 U.S. at 566, to a “material
degree,” Fl. Bar v. Went For It, Inc., 515 U.S. 618, 626
(1995). The government bears the burden of justifying its
attempt to restrict commercial speech, Edenfield, 507 U.S. at
770, and its burden is not light. A restriction that “provides
only ineffective or remote support for the government’s
purposes,” id. at 770, is not sufficient, and the government
cannot satisfy its burden “by mere speculation or conjecture.”
Rubin v. Coors Brewing Co., 514 U.S. 476, 487 (1995). The
requirement that a restriction directly advance the asserted
interest is “critical,” because without it, the government
“could [interfere with] commercial speech in the service of
other objectives that could not themselves justify a burden on
commercial expression.” Id.

through a focus on children and youths,” and recommends that the
“warnings must be designed to promote this objective.” Id.
13
   Like the district court, we are skeptical that the government can
assert a substantial interest in discouraging consumers from
purchasing a lawful product, even one that has been conclusively
linked to adverse health consequences. Nonetheless, the Supreme
Court has at least implied that the government could have a
substantial interest in reducing smoking rates because smoking
poses “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).
                              25

     FDA has not provided a shred of evidence—much less
the “substantial evidence” required by the APA—showing
that the graphic warnings will “directly advance” its interest
in reducing the number of Americans who smoke. FDA
makes much of the “international consensus” surrounding the
effectiveness of large graphic warnings, but offers no
evidence showing that such warnings have directly caused a
material decrease in smoking rates in any of the countries that
now require them. While studies of Canadian and Australian
youth smokers showed that the warnings on cigarette packs
caused a substantial number of survey participants to think—
or think more—about quitting smoking, Proposed Rule at
69,532, and FDA might be correct that intentions are a
“necessary precursor” to behavior change, Final Rule at
36,642, it is mere speculation to suggest that respondents who
report increased thoughts about quitting smoking will actually
follow through on their intentions. And at no point did these
studies attempt to evaluate whether the increased thoughts
about smoking cessation led participants to actually quit.
Another Australian study reported increased quit attempts by
survey participants after that country enacted large graphic
warnings, but found “no association with short-term quit
success.” Proposed Rule at 69,532. Some Canadian and
Australian studies indicated that large graphic warnings might
induce individual smokers to reduce consumption, or to help
persons who have already quit smoking remain abstinent. See
id. But again, the study did not purport to show that the
implementation of large graphic warnings has actually led to
a reduction in smoking rates.

    FDA’s reliance on this questionable social science is
unsurprising when we consider the raw data regarding
smoking rates in countries that have enacted graphic
warnings. FDA claims that Canadian national survey data
                                 26

suggest that graphic warnings may reduce smoking rates. But
the strength of the evidence is underwhelming, making FDA’s
claim somewhat misleading. In the year prior to the
introduction of graphic warnings, the Canadian national
survey showed that 24 percent of Canadians aged 15 or older
smoked cigarettes. In 2001, the year the warnings were
introduced, the national smoking rate dropped to 22 percent,
and it further dropped to 21 percent in 2002. Id. at 69,532.
But the raw numbers don’t tell the whole tale. FDA concedes
it cannot directly attribute any decrease in the Canadian
smoking rate to the graphic warnings because the Canadian
government implemented other smoking control initiatives,
including an increase in the cigarette tax and new restrictions
on public smoking, during the same period. Id. Although
FDA maintains the data “are suggestive” that large graphic
warnings “may” reduce smoking consumption, id., it cannot
satisfy its First Amendment burden with “mere speculation
and conjecture.” Rubin, 514 U.S. at 487.

     FDA’s Regulatory Impact Analysis (“RIA”) 14 essentially
concedes the agency lacks any evidence showing that the
graphic warnings are likely to reduce smoking rates. One
way in which the RIA analyzed the expected benefits of the
Rule was by comparing the impact of similar warnings
introduced in Canada in 2000. See Final Rule at 36,719-20.
It (1) analyzed the change in smoking trends in Canada before
and after 2000; (2) assumed any difference in the post-2000
change between Canada and the United States was solely
attributable to the introduction of graphic warnings; and (3)

14
   Such an analysis is required under Executive Order 12866, 58
Fed. Reg. 51,735 (Sept. 30, 1993), which directs agencies to assess
all costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select the approach that maximizes net
benefits.
                               27

assumed similar warnings would have an identical impact on
U.S. smoking rates. See id. at 36,755. Describing its
approach as “rudimentary,” FDA acknowledged that apart
from differences in cigarette taxes, the RIA “d[id] not account
for potential confounding variables,” id. at 36,720-21, such as
the introduction of more stringent smoking bans and
advertising restrictions in Canada during the relevant time
period, or the fact that Canadian cigarette prices are generally
higher than U.S. prices. Plaintiffs’ Comment Letter on
Proposed Rule (Jan. 11, 2010) and Statement of Robert S.
Maness.

     Logic dictates that these procedural shortcuts would, if
anything, lead to an overly optimistic prediction of the
efficacy of the proposed graphic warnings. Not so. The RIA
estimated the new warnings would reduce U.S. smoking rates
by a mere 0.088%, Final Rule at 36,721, a number the FDA
concedes is “in general not statistically distinguishable from
zero.” Id. at 36,776. Indeed, because it had access to “very
small data sets,” FDA could not even reject the statistical
possibility that the Rule would have no impact on U.S.
smoking rates. Id.

     FDA has thus presented us with only two studies that
directly evaluate the impact of graphic warnings on actual
smoking rates, and neither set of data shows that the graphic
warnings will “directly” advance its interest in reducing
smoking rates “to a material degree.” Rubin, 514 U.S. at 487.
And one of the principal researchers on whom FDA relies
recently surveyed the relevant literature and conceded that
“[t]here is no way to attribute . . . declines [in smoking] to the
new health warnings.” David Hammond, Health Warnings
Messages on Tobacco Products: A Review, 20 Tobacco
Control       327,      331        (2011),        available     at
http://tobaccocontrol.bmj.com/content/20/5/327.full.pdf.        In
                                28

light of the number of foreign jurisdictions that have enacted
large graphic warning labels, the dearth of data reflecting
decreased smoking rates in these countries is somewhat
surprising, and strongly implies that such warnings are not
very effective at promoting cessation and discouraging
initiation. While APA review of final agency action is
deferential, it surely does not require us to accept a flawed
interpretation of Canadian survey data or the agency’s own
projected 0.088% decrease in the U.S. smoking rate as
“substantial evidence” that its warnings will advance its stated
interest.

     FDA attempts to downplay the significance of the RIA by
explaining that it “must be included in all federal rulemaking
to improve the internal management of the Federal
Government,” and that it “was not intended to second-guess
Congress’s judgment regarding the value of new health
warnings.” Pet. Reply Br. at 15-16. 15 FDA attempts to
rehabilitate its findings by noting the analysis made only the
“unremarkable point” that it is “difficult [to] determine with
statistical precision the relative causal impact of the relevant
contributing factors,” particularly given the very small data
sets to which FDA had access. Id. at 16. But FDA cannot get
around the First Amendment by pleading incompetence or
15
   FDA also urges us to defer to Congress’s judgment regarding the
efficacy of the graphic warnings. See Turner Broad. Sys., Inc. v.
FCC, 520 U.S. 180, 196 (1997). But deference is only warranted
where Congress “base[s] its conclusions upon substantial
evidence,” id., and Congress’s predictive judgments are not
“insulated from meaningful judicial review.” Turner, 512 U.S. at
666. Deference is not appropriate here, because we find little
evidence showing that the graphic warnings will advance the stated
purpose of the statute—“promot[ing] cessation to reduce disease
risk and the social costs associated with tobacco-related diseases.”
Act. § 3.9.
                              29

futility. Because FDA bears the burden of justifying its
proposed restraint on speech, it cannot claim—rather
perversely—that its own analysis was irrelevant because it
lacked precision and was based on insufficient data. Central
Hudson requires FDA to find and present data supporting its
claims prior to imposing a burden on commercial speech.

     Alternatively, FDA asserts an interest in “effectively
communicating health information” regarding the negative
effects of cigarettes. Appellant’s Br. at 28. But as FDA
concedes, this purported “interest” describes only the means
by which FDA is attempting to reduce smoking rates: “[t]he
goal of effectively communicating the risks of cigarette
smoking is, of course, related to the viewer’s decision to quit,
or never to start, smoking.” Id. at 47. The government’s
attempt to reformulate its interest as purely informational is
unconvincing, as an interest in “effective” communication is
too vague to stand on its own. Indeed, the government’s
chosen buzzwords, which it reiterates through the rulemaking,
prompt an obvious question: “effective” in what sense?
Allowing FDA to define “effectiveness” however it sees fit
would not only render Central Hudson’s “substantial interest”
requirement a complete nullity, but it would also eviscerate
the requirement that any restriction “directly advance” that
interest. See 447 U.S. at 566. In this case, both the statute
and the Rule offer a barometer for assessing the effectiveness
of the graphic warnings—the degree to which they encourage
current smokers to quit and dissuade would-be smokers from
taking up the habit. See Final Rule at 36,630, 36,707-08. As
such, FDA’s interest in “effectively communicating” the
health risks of smoking is merely a description of the means
by which it plans to accomplish its goal of reducing smoking
                              30

rates, and not an independent interest capable of sustaining
the Rule. 16

     IV. Conclusion

     In the Proposed Rule, FDA lamented that their previous
efforts to combat the tobacco companies’ advertising
campaigns have been like bringing a butter knife to a gun
fight. According to the FTC, tobacco companies spent
approximately $12.49 billion on advertising and promotion in
2006 alone, employing marketing and advertising experts to
incorporate current trends and target their messages toward
certain demographics. Proposed Rule at 69,531. The graphic
warnings represent FDA’s attempt to level the playing field,
not only by limiting the Companies’ ability to advertise, but
also by forcing the Companies to bear the cost of
disseminating an anti-smoking message. But as the Supreme
Court recently reminded us, “[t]hat the [government] finds
expression too persuasive does not permit it to quiet the
speech or to burden its messengers.” Sorrell v. IMS Health
Inc., 131 S. Ct. 2653, 2671 (2011). The First Amendment
requires the government not only to state a substantial interest
justifying a regulation on commercial speech, but also to
show that its regulation directly advances that goal. FDA
failed to present any data—much less the substantial evidence
required under the APA—showing that enacting their
proposed graphic warnings will accomplish the agency’s
stated objective of reducing smoking rates. The Rule thus
cannot pass muster under Central Hudson.

16
   The dissent accuses us of “choosing to ignore” this interest,
thereby ignoring our explanation that the government’s stated
interest in “effectively” communicating information is illusory
absent some barometer for assessing that effectiveness.
                               31

The APA directs that we “shall . . . set aside [the] agency
action . . . found to be contrary to constitutional right.” 5
U.S.C. § 706(2). We therefore vacate the graphic warning
requirements and remand to the agency. In so doing, we also
vacate the permanent injunction issued by the district court, in
furtherance of our obligation to “set aside” the unlawful
regulation. See, e.g., N. Air Cargo v. United States Postal
Serv., 674 F.3d 852, 861 (D.C. Cir. 2012) (“It was quite
anomalous [for the district court] to issue an injunction.
When a district court reverses agency action and determines
that the agency acted unlawfully, ordinarily the appropriate
course is to identify a legal error and then remand to the
agency, because the role of the district court in such situations
is to act as an appellate tribunal.”).
     ROGERS, Circuit Judge, dissenting: The threshold question
in this government appeal is whether the district court applied
the correct level of scrutiny in addressing the tobacco
companies’ First Amendment challenge to the requirement that
they disclose the negative health consequences of smoking on
cigarette packages and other advertisements.1 The speech at
issue — proposing the sale of cigarettes — is indisputably
commercial speech. Consequently, contrary to the district
court’s application of strict scrutiny, the question is whether,
under the traditional standards adopted by the Supreme Court,
the government’s warning label requirement is subject to the
“less exacting scrutiny” of Zauderer v. Office of Disciplinary
Council of the Supreme Court of Ohio, 471 U.S. 626, 650–51
(1985), or to intermediate scrutiny under Central Hudson Gas
& Electric Corp. v. Public Service Commission of New York,
447 U.S. 557, 566 (1980). In affirming the grant of summary
judgment to the tobacco companies, the court applies the wrong
level of scrutiny, disregarding the tobacco companies’ history of
deceptive advertising and the government’s stated “primary
goal, which is to effectively convey the negative health
consequences of smoking on cigarette packages and in
advertisements,” Required Warnings for Cigarette Packages and
Advertisements, 76 Fed. Reg. 36,628, 36,633 (June 22, 2011)
(“Final Rule”).

     Because the warning labels present factually accurate
information and address misleading commercial speech, as

        1
            In the district court, the tobacco companies sought
injunctive relief and challenged the label warning requirement under
the First Amendment and the Administrative Procedure Act (“APA”).
The district court granted injunctive relief and summary judgment
upon applying strict scrutiny and ruling that the warning label
requirement violated the First Amendment. The district court did not
reach the APA claims. See R.J. Reynolds Tobacco Co. v. FDA, 2012
WL 653828 (D.D.C. 2012).
                                2

defined in Supreme Court precedent, Zauderer scrutiny applies,
and the government need show only that the warning label
requirement is reasonably related to its stated and substantial
interest in effectively conveying this information to consumers.
See Milavetz, Gallop & Milavetz, P.A. v. United States, 130 S.
Ct. 1324, 1339–40 (2010); Zauderer, 471 U.S. at 650–51; Spirit
Airlines, Inc. v. U.S. Dep’t of Transp., No. 11-1219, slip op. at
11 (D.C. Cir. July 24, 2012). Even treating Zauderer’s “less
exacting scrutiny” as limited to disclosure requirements serving
a governmental interest in preventing consumer deception, the
voluminous findings of our own courts, cited and supplemented
by Congress in the Family Smoking Prevention and Tobacco
Control Act (“Tobacco Control Act” or “Act”), Pub. L. No.
111-31, 123 Stat. 1776 (2009), and the Federal Drug
Administration (“FDA”) in the Final Rule, are more than
adequate to substantiate that interest.

     Regardless of which level of scrutiny applies, the court errs
in failing to examine both of the government’s stated interests.
In the rulemaking, the FDA articulated complementary, but
distinct, interests in effectively conveying information about the
negative health consequences of smoking to consumers and in
decreasing smoking rates. See, e.g., Final Rule, 76 Fed. Reg. at
36,633. The court dismisses the former interest as “too vague,”
Maj. Op. at 29, thereby sidestepping much of the substantial
evidence supporting the warning label requirement. Yet this
court has “recognize[d] that the government’s interest in
preventing consumer fraud/confusion may well take on added
importance in the context of a product . . . that can affect the
public’s health.” Pearson v. Shalala, 164 F.3d 650, 656 (D.C.
Cir. 1999). Tobacco products necessarily affect the public
health, and to a significant degree. Unlike other consumer
products, “tobacco products are ‘dangerous to health’ when used
in the manner prescribed.” FDA v. Brown & Williamson
Tobacco Corp., 529 U.S. 120, 135 (2000). They are also highly
                               3

addictive. Consequently, “tobacco use, particularly among
children and adolescents, poses perhaps the single most
significant threat to public health in the United States.” Id. at
161. Thus, the government’s informational interest “take[s] on
added importance,” Pearson, 164 F.3d at 656, and merits
independent consideration. Upon consideration of this interest,
the government appears to have met its burden under Central
Hudson as well as Zauderer, except with regard to the additional
inclusion of the “1-800-QUIT-NOW” number in each label.

     Accordingly, because the district court erred in applying
strict scrutiny to the commercial disclosures at issue, and
because those disclosures, except as discussed below, appear to
survive either level of scrutiny under traditional commercial
speech precedent, I would reverse the grant of summary
judgment, and I respectfully dissent.

                               I.

     The context of the challenged warning label requirement
can be summarized briefly. First, it is beyond dispute that the
textual statements in the warning labels required under the
Tobacco Control Act convey factually accurate information.
Tobacco use is the leading preventable cause of death in the
United States. It causes or contributes to at least sixteen kinds
of cancer, as well as heart and cerebrovascular disease, chronic
bronchitis, and emphysema, thereby “kill[ing] more than
400,000 Americans every year — more deaths than from AIDS,
alcohol, car accidents, murders, suicides, drugs, and fires,
combined.” President’s Cancer Panel, Promoting Healthy
Lifestyles 61 (2007) (hereinafter “PCP Report”); see id. at
61–62. The nicotine contained in tobacco is “one of the most
addictive substances used by humans.” Institute of Medicine,
Ending the Tobacco Problem: A Blueprint for the Nation 5
(2007) (hereinafter “IOM Report”). Despite increasing public
                                 4

awareness that smoking is dangerous to one’s health, most
people still lack “a complete understanding of the many serious
diseases caused by smoking, the true nature of addiction, or
what it would be like to experience either those diseases or
addiction itself.” United States v. Philip Morris USA, Inc., 449
F. Supp. 2d 1, 578 (D.D.C. 2006). Adolescents in particular
tend “to underestimate or be uninformed about the difficulty of
stopping smoking,” IOM Report at E-8; as a result, “they are
less likely to believe that the risk of addiction and related health
consequences apply to them,” id. at E-13. Over eighty percent
of adult smokers became addicted to tobacco at or below the age
of eighteen; of these smokers, half will die prematurely from a
tobacco-related disease. PCP Report at 64. In view of these
facts, the Supreme Court has recognized that “tobacco use,
particularly among children and adolescents, poses perhaps the
single most significant threat to public health in the United
States.” Brown & Williamson, 529 U.S. at 161.

     Second, it is also beyond dispute that the tobacco
companies have engaged in a decades-long campaign to deceive
consumers about these facts. Despite knowledge of “the
negative health consequences of smoking, the addictiveness and
manipulation of nicotine, [and] the harmfulness of secondhand
smoke,” tobacco company executives “made, caused to be
made, and approved public statements contrary to this
knowledge.” United States v. Philip Morris USA Inc., 566 F.3d
1095, 1121 (D.C. Cir. 2009). Specifically, they “publicly denied
and distorted the truth about the addictive nature of their
products, suppressed research revealing the addictiveness of
nicotine, and denied their efforts to control nicotine levels and
delivery,” all while “engineer[ing] their products around
creating and sustaining [nicotine] addiction.” Id. at 1107. The
tobacco company executives “knew of the[] falsity” of their
statements “at the time” and “made the statements with the
intent to deceive.” Id. at 1124.
                                 5

    Beginning in 1965, the government undertook to warn
consumers of the health risks associated with smoking by
requiring the inclusion of a health warning on the side of
cigarette packages. See Federal Cigarette Labeling and
Advertising Act of 1965, Pub. L. No. 89-92, 79 Stat. 282 (1965).
Congress last revised the content and format of these warning
labels in 1984. See Comprehensive Smoking Education Act of
1984, Pub. L. No. 98-474, 98 Stat. 2200 (1984). Since then,
“evidence regarding the ineffectiveness of the prescribed
warnings has continued to accumulate,” supporting the
conclusion that these warnings “are unnoticed and stale, and
they fail to convey relevant information in an effective way.”
IOM Report at 291.

     In view of this background, in 2009 Congress enacted the
Tobacco Control Act. Congress found that “[a] consensus exists
within the scientific and medical communities that tobacco
products are inherently dangerous and cause cancer, heart
disease, and other serious adverse health effects,” and that
“[n]icotine is an addictive drug.” Tobacco Control Act § 2(2),
(3), 123 Stat. at 1777 (codified at 21 U.S.C. § 387 Note (2011)).
Additionally, Congress found that in 2005 the tobacco
companies “spent more than $13 [billion] to attract new users,
retain current users, increase current consumption, and generate
favorable long-term attitudes toward smoking and tobacco use,”
id. § 2(16), “often misleadingly portray[ing] the use of tobacco
as socially acceptable and healthful to minors,” id. § 2(17).
Based on these and other findings, Congress required, as
relevant, the rotating display of one of nine textual warnings,2

        2
           “WARNING” precedes each of the textual statements,
which consist of the following: “Cigarettes are addictive”; “Tobacco
smoke can harm your children”; “Cigarettes cause fatal lung disease”;
“Cigarettes cause cancer”; “Cigarettes cause strokes and heart
disease”; “Smoking during pregnancy can harm your baby”;
                                 6

accompanied by “color graphics depicting the negative health
consequences of smoking” to be selected by the Secretary of
Health and Human Services, on cigarette packages and other
advertisements. Tobacco Control Act § 201(a), 123 Stat. at
1842–45 (codified at 15 U.S.C. § 1333 Note (2011)) (hereinafter
“Section 201”). These requirements become effective fifteen
months from the issuance of the implementing regulations. See
id. § 201(b).

     In the Final Rule, the FDA, acting on behalf of the
Secretary,3 stated that its “primary goal” in selecting the graphic
images pursuant to Section 201 was “to effectively convey the
negative health consequences of smoking on cigarette packages
and in advertisements.” Final Rule, 76 Fed. Reg. at 36,633; see
also id. at 36,641. The FDA also explained that “this effective
communication can help both to discourage nonsmokers,
including minor children, from initiating cigarette use and to
encourage current smokers to consider cessation to greatly
reduce the serious risks that smoking poses to their health.” See
id.; see also id. at 36,640. In selecting nine of the thirty-six
graphic images presented in the proposed rule, see Required
Warnings for Cigarette Packages and Advertisements, 75 Fed.
Reg. 69,524 (proposed Nov. 12, 2010) (“Proposed Rule”), the
FDA relied on the results of a consumer study conducted, in
part, “to quantitatively evaluate the [relative] efficacy of the

“Smoking can kill you”; and “Tobacco smoke causes fatal lung
disease in nonsmokers.” Tobacco Control Act § 201, 15 U.S.C.
§ 1333 Note.
        3
            Congress contemplated that the selection of the graphic
images would be made by the FDA in view of its “scientific expertise
. . . to evaluate the impact of labels, labeling, and advertising on
consumer behavior in order to reduce the risk of harm and promote
understanding of the impact of the product on health.” Tobacco
Control Act § 2(44), 21 U.S.C. § 387 Note.
                                 7

proposed required warnings in communicating the health harms
of smoking to adults . . . , young adults . . . , and youth” (“FDA
study”). Final Rule, 76 Fed. Reg. at 36,635; see id. at
36,637–39. In particular, the FDA focused on the salience
measures reported for each of the thirty-six graphic images
considered in the study; these measures included “[e]motional
reactions, cognitive reactions, and [reactions as to] whether the
warning was difficult to look at.” Id. at 36,696. Echoing the
Institute of Medicine in justifying its reliance on these measures,
the use of which “is well-established in the scientific literature,”
id. at 36,696–97, the FDA explained that “the literature suggests
that risk information is most readily communicated by messages
that arouse emotional reactions, and that smokers who report
greater negative emotional reactions in response to cigarette
warnings are significantly more likely to have read and thought
about the warnings . . . .” Id. at 36,639; see IOM Report at C-3.
After considering the results of the FDA study “and a number of
other factors,” the FDA “concluded that the nine selected
required warnings effectively communicate the negative health
consequences of smoking.” Id. at 36,637.

                                II.

     “Because the degree of protection afforded by the First
Amendment depends on whether the activity sought to be
regulated constitutes commercial or noncommercial speech, we
must first determine the proper classification of the [speech] at
issue here.” Bolger v. Youngs Drug Prods. Corp., 463 U.S. 60,
65 (1983) (emphasis added). Recognizing “the ‘commonsense’
distinction between speech proposing a commercial transaction,
which occurs in an area traditionally subject to government
regulation, and other varieties of speech,” the Supreme Court
has repeatedly instructed that the “Constitution . . . accords a
lesser protection to commercial speech than to other
constitutionally guaranteed expression,” Central Hudson, 447
                                  8

U.S. at 562–63 (citations and internal quotation marks omitted).4
The Court has reasserted this “commonsense” distinction in the
context of compelled speech, differentiating between attempts
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” and attempts “only to
prescribe what shall be orthodox in commercial advertising.”
Zauderer, 471 U.S. at 651 (citations and internal quotation
marks omitted).5

        4
           Notwithstanding any intimations it may have made in cases
such as Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011), the
Supreme Court has continued to apply the more deferential framework
of Central Hudson to commercial speech restrictions. See id. at
2667–68, 72. As the court acknowledges, see Maj. Op. at 21–22, it
therefore remains incumbent on this court to distinguish between
commercial and noncommercial speech for purposes of determining
the degree of protection afforded tobacco companies’ speech under the
First Amendment and, consequently, the level of scrutiny to apply.
See Philip Morris, 566 F.3d at 1142–43. In any event, the Supreme
Court’s rationale in Sorrell — that “the ‘fear that people would make
bad decisions if given truthful information’ cannot justify content-
based burdens on speech,” Sorrell, 131 S. Ct. at 2670–71 (quoting
Thompson v. W. States Med. Ctr., 535 U.S. 357, 374 (2002)) — does
not apply here, where it is the tobacco companies that seek to suppress
truthful information.
        5
            The tobacco companies advance no argument that their
cigarette packaging and advertisements propose anything other than
a commercial transaction. Nor could they, in part because of this
court’s determination that tobacco companies’ attempts to persuade
the public to purchase cigarettes, even in formats that did not
explicitly propose a commercial transaction, constituted commercial
speech. See Philip Morris, 566 F.3d at 1143–44. Instead, the tobacco
companies maintain that the character of the warning labels
themselves triggers the application of strict scrutiny. See Appellees’
Br. at 35–36. Turning the premise of the Supreme Court’s holding in
                                   9

      Indeed, in view of “material differences between disclosure
requirements and outright prohibitions on speech,” id. at 650,
the Supreme Court has taken this distinction a step further.
Whereas in the context of noncommercial speech, “compulsion
to speak may be as violative of the First Amendment as
prohibitions on speech” and thus trigger the same level of
scrutiny, id., in the context of commercial speech, compulsion
to speak may be less violative of the First Amendment than
prohibitions on speech and thus trigger a lower level of scrutiny,
see id. at 650–51. “Because the extension of First Amendment
protection to commercial speech is justified principally by the
value to consumers of the information such speech provides,”
the Court explained, “disclosure requirements trench much more
narrowly on an advertiser’s interests than do flat prohibitions on
speech . . . .” Id. at 651 (citations omitted); see id. at 651 n.14;
Va. Bd. of Pharmacy v. Va. Citizens Consumer Council, Inc.,
425 U.S. 748, 770 (1976). Consequently, while “unjustified or
unduly burdensome disclosure requirements might offend the
First Amendment by chilling protected commercial speech[,]
. . . an advertiser’s rights are adequately protected as long as

Zauderer on its head, they assert that “attempts to regulate ‘what shall
be orthodox in . . . matters of opinion’ — i.e., whether individuals
should buy and use a lawful product — must be subject to strict
scrutiny.” Appellees’ Br. at 31 (quoting Zauderer, 471 U.S. at 651).
To the contrary, because matters of opinion over whether individuals
should buy and use a lawful product fall squarely within the domain
of commercial advertising recognized by the Supreme Court, the
regulation thereof is not, as the district court ruled, subject to strict
scrutiny. See Zauderer, 471 U.S. at 651; Central Hudson, 447 U.S. at
562; Philip Morris, 566 F.3d at 1142–44. For this reason, the court’s
invocation of noncommercial compelled speech cases like Wooley v.
Maynard, 430 U.S. 705 (1977), West Virginia State Board of
Education v. Barnette, 319 U.S. 624 (1943), and Pacific Gas &
Electric Co. v. Public Utilities Commission of California, 475 U.S. 1
(1986), see Maj. Op. at 9–10, is unavailing.
                                   10

disclosure requirements are reasonably related to the State’s
interest in preventing deception of consumers.” Zauderer, 471
U.S. at 651; see Milavetz, 130 S. Ct. at 1339–40.6

     As the Supreme Court explained in Milavetz, where the
challenged requirements are “directed at misleading commercial
speech,” and where they “impose a disclosure requirement
rather than an affirmative limitation on speech, . . . the less
exacting scrutiny described in Zauderer governs [a court’s]
review.” 130 S. Ct. at 1339; see Spirit Airlines, No. 11-1219,
slip op. at 11. The warning label requirement meets both of
these criteria.

     First, the government need show only that the targeted
commercial speech presents the “possibility of deception” or a
“tendency to mislead.” Milavetz, 130 S. Ct. at 1340 (citation
and internal quotation marks omitted). If the speech is actually
misleading, it enjoys no First Amendment protection. See
Thompson v. W. States Med. Ctr., 535 U.S. 357, 367 (2002);
Central Hudson, 447 U.S. at 566. Where “the likelihood of
deception” is “hardly a speculative one,” the government need
not produce “evidence that [the] advertisements are misleading,”

        6
           As other circuits have recognized, in Zauderer the Supreme
Court appears simply to have held that a government interest in
protecting consumers from possible deception is sufficient to support
a disclosure requirement — not that this particular interest is necessary
to support such a requirement. See Zauderer, 471 U.S. at 650–51;
Discount Tobacco City & Lottery v. United States, 674 F.3d 509, 556
(6th Cir. 2012); N.Y. State Rest. Ass’n v. N.Y. City Bd. of Health, 556
F.3d 114, 133 & n.21 (2d Cir. 2009); Pharm. Care Mgmt. Ass’n v.
Rowe, 429 F.3d 294, 310 n.8 (1st Cir. 2005); Nat’l Elec. Mfrs. Ass’n
v. Sorrell, 272 F.3d 104, 115 (2d Cir. 2001). In view of the likelihood
of consumer confusion or deception shown here, there is no need to
determine whether the scope of Zauderer encompasses other
government interests.
                                 11

as the court may rely instead on experience and common sense.
Spirit Airlines, slip. op. at 13 (alteration in original) (quoting
Milavetz, 130 S. Ct. at 1340) (internal quotation marks omitted).
In Milavetz, the Supreme Court concluded that a law firm’s
advertisements were “inherently misleading” because they
“promise[d] . . . debt relief without any reference to the
possibility of filing for bankruptcy, which has inherent costs.”
Milavetz, 130 S. Ct. at 1340. Thus, absent any additional
evidence, the Court considered the omission of a reference to a
possible outcome with “inherent costs” to be sufficiently
misleading as to warrant review under Zauderer. Even
advertisements that display all the costs of a service may remain
misleading. In Spirit Airlines, this court addressed a Department
of Transportation (“DOT”) rule requiring that the most
prominent number displayed in airfare advertisements be the
total price, inclusive of taxes. Spirit Airlines, slip. op. at 4.
Notwithstanding the airlines’ compliance with preexisting
regulations requiring advertisements to display the entire ticket
cost as well as the amount of any tax, the court accepted DOT’s
determination, based on common sense and experience, “that it
was deceitful and misleading when the most prominent price
listed by an airline is anything other than the total, final price of
air travel.” Id. at 13. Accordingly, the court proceeded to
review the rule under Zauderer. See id. at 14.

      Even absent any affirmatively misleading statements, see
Maj. Op. at 16, cigarette packages and other advertisements that
fail to display the final costs of smoking in a prominent manner
are at least as misleading as the airline advertisements in Spirit
Airlines. Existing warnings, last revised in 1984, appear on one
side panel and occupy only four percent of cigarette packages.
See Final Rule, 76 Fed. Reg. at 36,678. Common sense,
experience, and substantial scientific evidence support the
conclusion that these warnings are ineffective. “For example,”
in 2007 the Institute of Medicine “concluded that U.S. package
                                12

warnings are both ‘unnoticed and stale.’” Proposed Rule, 75
Reg. at 69,530 (quoting IOM Report at 291); see generally id.
The government has thus provided more than sufficient evidence
that cigarette packages and other advertisements remain likely
to mislead consumers notwithstanding the existing warnings.
See Discount Tobacco City & Lottery v. United States, 674 F.3d
509, 562–63 (6th Cir. 2012). Yet it goes even further,
demonstrating that these warnings actually “have failed to
convey appropriately crucial information such as the nature and
extent of the health risks associated with smoking cigarettes.”
Final Rule, 76 Fed. Reg. at 36,632; see Proposed Rule, 75 Fed.
Reg. at 69,530–31 (citing studies); see also Discount Tobacco,
674 F.3d at 563–64. Even though “most smokers understand
that smoking poses certain statistical risks to their health,”
studies noted by the FDA show that “many fail to appreciate the
severity and magnitude of those risks.” Final Rule, 76 Fed. Reg.
at 36,632. Moreover, “many smokers underestimate their
personal risks.” Id. (noting, for example, studies in which only
a minority of smokers believed they were at increased risk for
cancer and heart disease). Many people are also unaware of the
effects of secondhand smoke on others. See id. at 36,633. And
adolescents in particular fail to appreciate the highly addictive
nature of cigarettes. See id.; see also Philip Morris, 449 F.
Supp. 2d at 578.

    Furthermore, even if (contrary to Supreme Court and this
court’s precedent) these findings were inadequate to establish a
“tendency to mislead,” this court has recognized that certain
advertisements, “although not misleading if taken alone,” can
“become[] misleading” when “considered in light of past
advertisements.” Warner-Lambert Co. v. FTC, 562 F.2d 749,
760 (D.C. Cir. 1977); see id. at n.57.7 In other words, a

        7
          The court attempts to distinguish Warner-Lambert on the
ground that the FDA “does not frame this rule as a remedial measure
                                  13

“tendency to mislead” may arise through efforts to “capitalize
on . . . prior deceptions by continuing to advertise in a manner
that builds on consumers’ existing misperceptions.” Philip
Morris, 566 F.3d at 1144–45 (citing Warner-Lambert, 562 F.2d
at 769). This court has already acknowledged the tendency of
cigarette marketing to mislead consumers based on the
companies’ decades of deception regarding each of the risks
identified in the warning labels. See Philip Morris, 566 F.3d at
1144; supra Part I.8 Consistent with that decision, Congress
found that “[t]obacco product advertising often misleadingly
portrays the use of tobacco as socially acceptable and healthful
to minors.” Tobacco Control Act § 2(17), 21 U.S.C. § 387
Note. These findings are more than “adequate to establish that

designed to counteract specific deceptive claims made by the
Companies.” Maj. Op. at 18. Even if Warner-Lambert’s reasoning
were limited to remedial measures, surely Congress could provide the
requisite “framing.” Especially in view of the high level of specificity
with which Congress crafted the warning label requirement, it was not
incumbent upon the FDA to supplement the congressional findings
already supporting the requirement. Nonetheless, the FDA did frame
its rule as a measure designed to counteract specific gaps in
consumers’ knowledge of the health risks of smoking, see Final Rule,
76 Fed. Reg. at 36,632–33 — gaps that align with specific deceptive
claims made by the tobacco companies, see Philip Morris, 566 F.3d
at 1106–07, 1118–19.
        8
           Indeed, in addressing a RICO injunction, this court recently
acknowledged the “reasonable likelihood” — notwithstanding the
restrictions imposed in the Tobacco Control Act — that the tobacco
companies would commit future RICO violations, United States v.
Philip Morris USA Inc., No. 11-5145, slip op. at 9 (D.C. Cir. July 27,
2012), where their past RICO violations consisted of proven
“misstatements and acts of concealment and deception . . . made
intentionally and deliberately . . . as part of a multi-faceted,
sophisticated scheme to defraud,” id. at 3; see United States v. Philip
Morris USA, Inc., 787 F. Supp. 2d 68, 74–75 (D.D.C. 2011).
                               14

the likelihood of deception in this case ‘is hardly a speculative
one.’” Milavetz, 130 S. Ct. at 1340; see Discount Tobacco, 674
F.3d at 562.

     Second, the warning label requirement does not impose “an
affirmative limitation on speech,” Milavetz, 130 S. Ct. at 1339;
rather, the warning labels disclose information about the
negative health consequences of smoking. (The one exception
is discussed infra.) Unlike other provisions of the Tobacco
Control Act, Section 201 does not restrict the information
conveyed to consumers, but requires additional information to
be conveyed with the aid of graphic images. Although the
tobacco companies object that the warnings “monopolize all the
prominent space on cigarette packages, and thereby make it
impossible for manufacturers to communicate their own
messages and their own viewpoints prominently in packaging,”
Joint Comments of R.J. Reynolds Tobacco Co., Lorillard
Tobacco Co. & Commonwealth Brands, Inc. 9 (Jan. 11, 2010)
(J.A. 216) (emphasis added), their objection rings hollow in the
absence of any evidence of difficulty in conveying their desired
messages, notwithstanding a decade of experience under a
similar warning label requirement in Canada. See Final Rule, 76
Fed. Reg. at 36,633, 36,698; Appellants’ Br. at Add. 6–12; cf.
Ibanez v. Fla. Dep’t Bus. & Prof’l Regulation, 512 U.S. 136,
146–47 (1994). Consequently, they fail to show that the
warning label requirement is “an affirmative limitation on
speech.” Milavetz, 130 S. Ct. at 1339; see Spirit Airlines, No.
11-1219, slip op. at 14. To the extent the warning labels
disclose factually accurate information about the cigarettes
being advertised, then, Zauderer offers the appropriate level of
scrutiny.

    The tobacco companies do not challenge the factual
accuracy of the textual statements included in the warning
labels. See Appellees’ Br. at 54–55. Nor could they reasonably
                                15

do so, given the scientific consensus “that tobacco products are
inherently dangerous and cause cancer, heart disease, and other
serious adverse health effects.” Tobacco Control Act § 2(2), 21
U.S.C. § 387 Note; see Final Rule, 76 Fed. Reg. at 36,641;
Proposed Rule, 75 Fed. Reg. at 69,527–29. The question for
purposes of the First Amendment analysis, then, is whether the
graphic images selected by the FDA to accompany the factually
accurate textual statements render the warnings nonfactual or
controversial. To answer this question, the court must —
although the court does not, see Maj. Op. at 19–20 — view the
images in connection with the textual warnings they accompany.
See, e.g., S. Air Transp., Inc. v. Am. Broad. Cos., Inc., 877 F.2d
1010, 1015 (D.C. Cir. 1989).

     Contrary to the tobacco companies’ suggestion, see
Appellees’ Br. at 24, the use of graphic images, even if digitally
enhanced, illustrated, or symbolic, does not necessarily make the
warnings nonfactual. The Supreme Court recognized in
Zauderer that “[t]he use of illustrations or pictures in
advertisements serves important communicative functions: it
attracts the attention of the audience to the advertiser’s message,
and it may also serve to impart information directly.” Zauderer,
471 U.S. at 647; see N.Y. Times Co. v. NASA, 920 F.2d 1002,
1005 (D.C. Cir. 1990); see, e.g., 16 C.F.R. § 1500.14 (2011)
(requiring skull-and-crossbones warnings on poisonous
products). In the Final Rule, the FDA concluded that “the
effects shown” in the images “are, in fact, accurate depictions of
the effects of sickness and disease caused by smoking,” Final
Rule, 76 Fed. Reg. at 36,696, and the tobacco companies do not
suggest otherwise. That such images are not invariably
comforting to look at does not necessarily make them
inaccurate. As the FDA went on to explain the obvious fact,
“the severe, life-threatening and sometimes disfiguring health
effects of smoking conveyed in the required warnings are
                                  16

disturbing and the images [it] . . . selected appropriately reflect
this fact.” Final Rule, 76 Fed. Reg. at 36,696.

     The tobacco companies further object that the graphic
images were chosen not to convey information, but to evoke
negative emotions and thereby discourage smoking. See
Appellees’ Br. at 26–27. The FDA explained, however, that
“considerable scientific evidence shows that health warnings
that elicit strong emotional and cognitive reactions,” as reflected
in their salience measures, “are better processed and more
effectively communicate information about the negative health
consequences of smoking.” Final Rule, 76 Fed. Reg. at 36,642;
see id. at 36,639, 41, 46; IOM Report at C-3. Thus, the FDA’s
reliance on salience measures was in the service of — not
inconsistent with — the warnings’ informational purpose.
Moreover, factually accurate, emotive, and persuasive are not
mutually exclusive descriptions; the emotive quality of the
selected images does not necessarily undermine the warnings’
factual accuracy.9 Comprehending the facts about the actual

        9
            The district court relied on Entertainment Software
Association v. Blagojevich, 469 F.3d 641 (7th Cir. 2006), for the
proposition that label requirements “ultimately communicat[ing] a
subjective and highly controversial message” fall outside the scope of
“purely factual and uncontroversial” disclosures permitted under
Zauderer. R.J. Reynolds, 2012 WL 653828 at *6 (quoting
Blagojevich, 469 F.3d at 652) (internal quotation marks omitted). But
Blagojevich involved labels that were necessarily subjective and
exclusively nonfactual. As the Supreme Court later explained,
because video games “communicate ideas — and even social
messages,” they enjoy full First Amendment protection, which guards
against government efforts “to restrict expression because of its
message, its ideas, its subject matter, or its content.” Brown v. Entm’t
Merchs. Ass’n, 131 S. Ct. 2729, 2733 (2011) (citation and internal
quotation marks omitted). The labels at issue in Blagojevich
represented exactly such an effort: the challenged provision required
                                  17

harms resulting from smoking is likely to provoke emotional
reactions and also to discourage the use of cigarettes. See Final
Rule, 76 Fed. Reg. at 36,647. The tobacco companies’ argument
leads to the counterintuitive conclusion that the more concerning
the negative health effects of a particular product, the more
constrained the government is in mandating disclosures of those
facts. Unsurprisingly, the tobacco companies point neither to
any case law in support of this argument nor to any legally
significant distinction between fact and emotion. See Appellees’
Br. at 24–25. Rather, the greater the harms to public health, the
greater the government’s interest in informing consumers of
those harms. See Pearson, 164 F.3d at 656. This interest is
especially great in view of the tobacco companies’ extensive
advertising that Congress found was “often misleading[]” and
designed to attract adolescents and new users, retain and expand
consumption, and “generate favorable long-term attitudes
toward smoking and tobacco use.” Tobacco Control Act
§ 2(16)–(18), 21 U.S.C. § 387 Note.

     Aside from their general objections to the inclusion of
graphic images for the above reasons, the tobacco companies
specifically object to five of the nine selected images. They
maintain that the images of a man smoking through a
tracheotomy hole in his throat and a man with chest staples on
an autopsy table convey misleading messages about the
consequences of smoking, and that the images of a man wearing
a t-shirt reading “I QUIT,” a baby enveloped in smoke, and a
woman crying convey no information about the consequences
of smoking whatsoever. See Appellees’ Br. at 25–26. All of

the label to be placed on games deemed “sexually explicit,” the state’s
definition of which was “far more opinion-based than the question of
whether a particular chemical is within any given product.”
Blagojevich, 469 F.3d at 652. These labels were nonfactual because
there were no facts to convey.
                                   18

these objections pertain to the images divorced from their
accompanying text and thus fail to address the relevant question
— whether the images render the overall message conveyed by
the warning labels nonfactual. Viewed with the text they
accompany, none of these images has that effect.

     The image accompanying the textual warning “Cigarettes
are addictive” depicts a man smoking through a tracheotomy
opening in his throat. Viewed with the accompanying text, this
image conveys the tenacity of nicotine addiction: even after
under undergoing surgery for cancer, one might be unable to
abstain from smoking. Indeed, government counsel represented
that this situation is not so extreme or unusual as the court and
the tobacco companies suggest. Compare Oral Arg. Tr. at 57
(stating that fifty percent of neck and head cancer patients
continue to smoke) with Maj. Op. at 20; Appellees’ Br. at 25.
This representation finds support from the President’s Cancer
Panel. “Smoking among cancer survivors (including individuals
diagnosed with, being treated for, and surviving cancer),” the
Panel reported, “is an underappreciated and understudied
problem.” PCP Report at 70. “[S]moking prevalence in this
population is approximately equivalent to people with no history
of cancer,” despite “mounting evidence confirm[ing] the adverse
effects of continued smoking on cancer treatment outcomes
regardless of treatment modality.” Id.10 This image thus serves
to underline the factual, and now uncontroversial, statement that
cigarettes are highly addictive.

        10
           See also 155 CONG. REC. S6021 (daily ed. June 3, 2009)
(statement of Sen. Lautenberg) (sharing testimony of woman who,
“despite the fact that she had essentially lost her voice box, . . . still
smoked through the hole in her throat,” and explaining that “[t]he hold
on people is almost unbreakable”).
                                19

     Similarly, the image of a man with staples in his chest lying
on an autopsy table works with, not against, the textual warning
“Smoking can kill you.” Assuming “autopsies are not a
common consequence of smoking,” Appellees’ Br. at 25, neither
are coffins or gravestones; yet the status evoked by images of an
autopsy-scarred man, a coffin, or a gravestone — death — is a
common consequence of smoking. See Proposed Rule, 75 Fed.
Reg. at 69,526; PCP Report at 61, 64. The FDA might have
opted for an image of a decaying cadaver or of a pile of ashes to
portray the likely physical consequences of smoking, but it was
not limited to such images in its representation of those
consequences. An autopsy scar is merely one way of
communicating that the man in the image is dead; viewed in
connection with the textual warning, the image conveys the
message that smoking can result in death.

     The images of a baby enveloped in smoke and a woman
crying both depict the significant harms of secondhand smoke.
These images accompany the textual warnings “Tobacco smoke
can harm your children” and “Tobacco smoke causes fatal lung
disease in nonsmokers,” respectively. Regarding the former
image, commenters noted that it would “clearly inform parents
that when they smoke in the presence of their children, their
children will also be inhaling toxins.” Final Rule, 76 Fed. Reg.
at 36,650. The latter image, as the FDA explained, highlights
the “emotional suffering” dimension of fatal lung disease and
other “negative health consequences caused by secondhand
smoke exposure.” Id. at 36,656. Those negative health
consequences are significant. Secondhand smoke “has been
established as a cause of approximately 3,000 lung cancer deaths
each year among nonsmokers in the United States”; it also “is a
significant contributor to cardiac, respiratory, and other diseases
in individuals exposed to it.” PCP Report at 95; see id. at
95–96. As a result, secondhand smoke exposure “claims the
lives of approximately 38,000 nonsmokers annually.” Id. at 95.
                               20

Addressing potential purchasers of cigarettes, these two warning
labels convey the message that smoking poses risks not only to
them, but also to their family members and others.

     Initially more problematic is the image of a man wearing a
t-shirt that reads “I QUIT,” which the tobacco companies
maintain “provides no information about smoking risks (or even
the benefits of quitting).” Appellees’ Br. at 26. But the tobacco
companies overstate the objection, for the image does address
the benefits of quitting. As the FDA viewed this image, in
connection with the textual warning “Quitting smoking now
greatly reduces serious risks to your health,” it conveys the
message “I quit, and I am alive and healthy.” This message
comports with the evidence showing that “[s]moking cessation
decreases the risk of the health consequences of smoking.”
Proposed Rule, 75 Fed. Reg. at 69,529. “For example, persons
who quit smoking before age 50 have one-half the risk of dying
in the next 15 years compared with continuing smokers.” Id.
Nothing in this image, or any other image selected by the FDA,
renders nonfactual or controversial the textual warning it
accompanies. The warning labels thus qualify as factually
accurate, uncontroversial disclosures.

     Because the warning labels are “directed at misleading
commercial speech,” and because they “impose a disclosure
requirement rather than an affirmative limitation on speech, . . .
the less exacting scrutiny described in Zauderer” should have
governed the district court’s review. Milavetz, 130 S. Ct. at
1339. While mindful that “unjustified or unduly burdensome
disclosure requirements might offend the First Amendment by
chilling protected commercial speech,” the district court should
have determined whether the warning label requirement was
“reasonably related” to the government’s interest in effectively
conveying the negative health consequences of smoking to
                               21

consumers. Zauderer, 471 U.S. at 651; see Milavetz, 130 S. Ct.
at 1339–40.

      Under this “less exacting scrutiny,” the warning label
requirement appears to pass muster. The government need only
justify the requirement on the basis of substantial evidence on
the record. See Nat’l Cable & Telecomms. Ass’n v. FCC, 555
F.3d 996, 1002 (D.C. Cir. 2009). In view of the scientific
literature supporting the FDA’s reliance on the salience
measures reported in its study, see Final Rule, 76 Fed. Reg. at
36,638, 36,642, 36,649–57, the warning label requirement is
reasonably related to the government’s interest in effectively
communicating information about the negative health
consequences of smoking. And in view of extensive scientific
literature, see Proposed Rule, 75 Fed. Reg. at 69,531 (citing
IOM Report at C-3–4), international experience, see id. at
69,531–32, domestic experience, see Final Rule, 76 Fed. Reg. at
36,632, and common sense, the size and placement of the
warning labels is also reasonably related to that interest.
Although some graphic images may evoke emotional reactions,
it is undisputed that smoking can cause the health consequences
they depict. Given the magnitude of the government interest in
informing consumers of these consequences (especially against
the tobacco companies’ history of consumer deception), the
expert judgment exercised by the FDA in selecting the graphic
images, and the absence of any evidence that similar restrictions
elsewhere have hindered the tobacco companies’ ability to get
their own message to consumers, the burden on the tobacco
companies’ First Amendment rights appears neither undue nor
unjustified. The warning label requirement thus appears
constitutional. See Zauderer, 471 U.S. at 651; cf. Discount
Tobacco, 674 F.3d at 569.

    Attempting to distinguish Zauderer, the court adopts the
view that the warning label requirement involves “elements of
                               22

compulsion and forced subsidization.” Maj. Op. at 10.
Commercial disclosure requirements can involve involuntary
statements and compliance costs. See, e.g., Milavetz, 130 S. Ct.
at 1340–41; Meese v. Keene, 481 U.S. 465, 467, 481–82 (1987).
Nonetheless, the Supreme Court has reviewed such requirements
under a different level of scrutiny than noncommercial
compelled speech, cf. Pac. Gas & Elec. Co. v. Pub. Utils.
Comm’n of Cal., 475 U.S. 1, 8–9 (1986), and under a different
set of considerations than compelled subsidies of private speech,
cf. United States v. United Foods, Inc., 533 U.S. 405 (2001).
Contrary to the court’s conclusion that “this case raises novel
questions about the scope of the government’s authority,” Maj.
Op. at 11, given the congressional findings and regulatory
record supporting the government’s interest in effectively
informing consumers of the negative, indeed potentially lethal,
consequences of smoking, the warning label requirement falls
within the scope of the Supreme Court’s traditional First
Amendment treatment of commercial disclosures.

     Unlike the graphic images envisioned in Section 201,
however, the additional inclusion of the telephone number “1-
800-QUIT-NOW” on each warning label does not directly
disclose factual information about the health consequences of
smoking. The FDA imposed this requirement, pursuant to
separate statutory authority, 21 U.S.C. § 387f(d), see Final Rule,
76 Fed. Reg. at 36,681, in order “to provide a place where
smokers and other members of the public can obtain smoking
cessation information from staff trained specifically to help
smokers quit by delivering unbiased and evidence-based
information, advice, and support,” Proposed Rule, 75 Fed. Reg.
at 69,540. In the FDA’s view, inclusion of the number would
also enhance the effectiveness of the warning labels. See Final
Rule, 76 Fed. Reg. at 36,681. To the extent the purpose is
directed toward reducing smoking rates, the constitutionality of
the number’s mandatory inclusion in the warning labels requires
                                23

examination under a different standard than Zauderer, to which
I now turn.

                                III.

      Where Zauderer scrutiny is inapplicable to a commercial
speech regulation, “the Supreme Court’s bottom line is clear: the
government must affirmatively demonstrate its means are
‘narrowly tailored’ to achieve a substantial government goal.”
Philip Morris, 566 F.3d at 1143 (quoting Bd. of Trs. v. Fox, 492
U.S. 469, 480 (1989)); see Milavetz, 130 S. Ct. at 1339. In
applying this level of intermediate scrutiny, the court must
determine (1) whether the speech “concern[s] lawful activity and
[is] not . . . misleading,” such that it enjoys First Amendment
protection; (2) whether the government asserts a substantial
interest; (3) “whether the regulation directly advances” that
interest; and (4) whether the regulation “is not more extensive
than is necessary to serve that interest.” Central Hudson, 447
U.S. at 566. With regard to the third prong of this test, the
Supreme Court has clarified that, although the government
“must demonstrate that the harms it recites are real and that its
restriction will in fact alleviate them to a material degree,” it
may do so “by reference to studies and anecdotes pertaining to
different locales altogether, or even . . . based solely on history,
consensus, and simple common sense.” Lorillard Tobacco Co.
v. Reilly, 533 U.S. 525, 555 (2001) (citations and internal
quotation marks omitted). And with regard to the fourth prong,
“[t]he government does not have to show that it has adopted the
least restrictive means for bringing about its regulatory
objective; it does not have to demonstrate a perfect
means—ends fit; and it does not have to satisfy a court that it
has chosen the best conceivable option.” Nat’l Cable, 555 F.3d
at 1002. “The only condition is that the regulation be
proportionate to the interests sought to be advanced,” id. — that
                               24

there be “a reasonable fit between the means and ends of the
regulatory scheme,” Lorillard, 533 U.S. at 561; see id. at 556.

      Even assuming that the graphic images, by depicting the
actual negative consequences of cigarette smoking and thereby
evoking emotional reactions, “go beyond . . . purely factual and
accurate commercial disclosures,” Maj. Op. at 11, there would
still appear, with one exception, no basis to conclude that the
warning label requirement violates the tobacco companies’ First
Amendment rights. The court reaches the opposite conclusion
by dismissing one of the two government interests stated in the
rulemaking. Its analysis is directed to a red herring of its own
creation. Although there are statements in the rulemaking
record regarding the government’s interest in reducing smoking
rates, see, e.g., Final Rule, 76 Fed. Reg. at 36,629; Proposed
Rule, 75 Fed. Reg. at 69,525, nothing in that record, much less
the White House press briefing cited by the court, see Maj. Op.
at 11 n.6, suggests these statements were intended to override
the clearly stated interest in effectively communicating
information about the negative health consequences of smoking
to consumers.        (Nor does the Institute of Medicine’s
characterization of the objectives of tobacco regulation, see Maj.
Op. at 23 n.12, detract from the FDA’s own statement of the
government’s “primary” interest.) To the contrary, in the
rulemaking the FDA stated repeatedly that, “[c]onsistent with
the Tobacco Control Act, the purpose of these required warnings
is to communicate effectively and graphically the very real,
scientifically established adverse health consequences of
smoking.” Final Rule, 76 Fed. Reg. at 36,641; see id. at 36,630,
36,633–42, 36,646–47, 36,696–97, 36,699; Proposed Rule, 75
Fed. Reg. at 69,526, 69,531–35. Even under Central Hudson
intermediate scrutiny, the court should have fully examined both
of the government’s stated interests.
                                25

     The government’s informational interest in effectively
conveying the negative health consequences of smoking clearly
qualifies as “substantial” under the second prong of Central
Hudson. “The Supreme Court has said ‘there is no question that
[the government’s] interest in ensuring the accuracy of
commercial information in the marketplace is substantial,’”
Pearson, 164 F.3d at 656 (quoting Edenfield v. Fane, 507 U.S.
761, 769 (1993)) (alteration in original), “and that the
government has a substantial interest in ‘promoting the health,
safety, and welfare of its citizens,’” id. (quoting Rubin v. Coors
Brewing Co., 514 U.S. 476, 485 (1995)). This court has
previously “recognize[d] that the government’s interest in
preventing consumer fraud/confusion may well take on added
importance in the context of a product . . . that can affect the
public’s health.” Id. And “tobacco use, particularly among
children and adolescents, poses perhaps the single most
significant threat to public health in the United States.” Brown
& Williamson, 529 U.S. at 161. Congress agreed. See Tobacco
Control Act § 2(29), 21 U.S.C. § 387 Note. The government
interest in effectively conveying the negative health
consequences of smoking takes on even greater importance in
view of the highly addictive nature of tobacco and the fact that
“the most serious harmful consequences of smoking are
cumulative, and occur in the distant future.” Philip Morris, 449
F. Supp. 2d at 577.

     The warning label requirement appears to meet the third and
fourth prongs of Central Hudson as well. The rulemaking
record includes substantial evidence from international
experience, see Proposed Rule, 75 Fed. Reg. at 69,531–32, and
the FDA Study, see Final Rule, 76 Fed. Reg. at 36,637–42,
supporting the government’s reasoned determination that the
warnings would “directly advance” its informational interest, not
least by “ensur[ing] that the health risk message[s] [are] actually
seen by consumers in the first instance.” Commonwealth
                               26

Brands, Inc. v. United States, 678 F. Supp. 2d 512, 530 (W.D.
Ky. 2010), aff’d in relevant part, Discount Tobacco, 674 F.3d at
569. “The harms [the government] recites are real” — caused
in part by the “often misleading” advertising that smoking is part
of a healthy lifestyle without consequences — and there is
substantial evidence to support the government’s conclusion that
the warning label requirement “will in fact alleviate [those
harms] to a material degree.” Lorillard, 533 U.S. at 555.
“[H]istory, consensus, and ‘simple common sense,’” id. (quoting
Florida Bar v. Went For It, Inc., 515 U.S. 618, 628 (1995)),
demonstrate as well that warning label requirement meets the
fourth prong of the Central Hudson test. The failures of
previous government efforts to convey the relevant information
through small, textual warnings on the side of cigarette
packages, see Final Rule, 76 Fed. Reg. at 36,631–32; Proposed
Rule, 75 Fed. Reg. at 69,530–31, similar to the alternatives the
tobacco companies now suggest, see Appellees’ Br. at 58–59,
are sufficient to show that the warning labels, with graphic
images, are “not more extensive than necessary to serve” the
government’s substantial interest in effectively conveying that
information to consumers.

     The one exception is the “1-800-QUIT-NOW” telephone
number. As mentioned, it is not designed directly to inform
consumers of the health consequences of smoking, but to assist
smokers in their cessation efforts. See Final Rule, 76 Fed. Reg.
at 36,681. Under Central Hudson intermediate scrutiny, the
government’s interest in reducing smoking rates is doubtless
substantial. See, e.g., Lorillard, 533 U.S. at 564; Brown &
Williamson, 529 U.S. at 161. There also is substantial evidence
to support the FDA’s determination that the display of the “1-
800-QUIT-NOW” number will directly advance this interest.
The biological and psychological effects of nicotine “can make
smoking cessation extremely difficult,” PCP Report at 62;
“about 40 percent of smokers try to quit” each year, but “95
                                27

percent of those who try to quit on their own relapse,” Final
Rule, 76 Fed. Reg. at 36,681. In comparison to minimal or no
counseling interventions, quitlines have been found to
“significantly increase abstinence rates.” Id. at 36,687 (citing
U.S. Dep’t Health & Human Servs., Public Health Serv.,
Treating Tobacco Use and Dependence: 2008 Update 91 (May
2008)); see also IOM Report at C-7. International experience
referenced in the rulemaking, see Final Rule, 76 Fed. Reg. at
36,682, further supports the common sense proposition that
informing smokers of cessation resources is likely to increase
rates of successful quit attempts.

     But the additional inclusion of the “1-800-QUIT-NOW”
number on the warning labels does not meet the fourth prong of
Central Hudson. The number is prominently presented in
imperative terms, directing consumers to “QUIT NOW.” That
command directly contradicts the tobacco companies’ desired
message at the point of sale, thereby imposing a significant
burden on their protected commercial speech. “In previous
cases addressing [the] final prong of the Central Hudson test,”
the Supreme Court has “made clear that if the Government could
achieve its interests in a manner that does not restrict speech, or
that restricts less speech, the Government must do so.”
Thompson, 535 U.S. at 371. Unlike the warning label
requirement imposed pursuant to Section 201 in response to the
demonstrated failures of previously attempted, less burdensome
warning requirements, the inclusion of the “1-800-QUIT-NOW”
number follows upon no apparent consideration of the
effectiveness of alternative means of connecting smokers to
cessation resources, such as a package insert.11 Absent an

        11
           See, e.g., Appellants’ Reply Br. at 30 (citing cessation
resource information displayed on the websites of one tobacco
company, http://www.lorillard.com/?s=quit+smoking and the
subsidiary of another, http://www.sfntc.com/Quit-Smoking/
                                28

explanation why such alternatives would be inadequate, the
government has failed to show the requisite “reasonable fit,”
Lorillard, 533 U.S. at 561. See Thompson, 535 U.S. at 373.12

                               IV.

     Finally, it bears noting that the court’s understanding of the
precedent governing the appropriate level of scrutiny, as well as
its dismissal of a well established and substantial government
interest, is inconsistent with the Supreme Court’s “principal”
justification for “exten[ding] . . . First Amendment protection to
commercial speech” — “the value to consumers of the
information such speech provides.” Zauderer, 471 U.S. at 651.
The Supreme Court has reiterated this justification in the
tobacco context. Addressing “substantial” restrictions on
tobacco advertising imposed by Massachusetts, the Court
identified as the “countervailing First Amendment interests” the
tobacco companies’ “interest in conveying truthful information
about their products to adults” and adults’ “corresponding
interest in receiving truthful information about tobacco
products.” Lorillard, 533 U.S. at 564. In view of this
justification, the Court has treated disclosure requirements “as
constitutionally preferable to outright suppression.” Pearson,
164 F.3d at 657 (citing recent cases). Here, the government has
required the tobacco companies not only to state, but also to
show, the significant negative health consequences of using their

Overview.aspx).
        12
            Neither the tobacco companies nor the rulemaking record
suggests that the FDA would not have promulgated the Final Rule had
the “1-800-QUIT-NOW” number been struck from the warning labels,
and it can be severed. See North Carolina v. EPA, 531 F.3d 896, 929
(D.C. Cir. 2008).
                                29

product as intended. The court identifies no principled
distinction, for purposes of determining the applicable level of
scrutiny, between the stating and the showing of such
information. In view of the record evidence — as well as
experience and common sense — supporting the communicative
power of graphic images accompanying textual warnings, no
such distinction appears to exist.

     Given the evidence demonstrating the tenacity of nicotine
addiction, the young age at which the vast majority of smokers
begin smoking cigarettes, these smokers’ “incomplete
understanding of the addictive nature of tobacco use that is
related, in part, to their inaccurate assessment of smoking risks
and their belief that they can quit at any time and therefore avoid
addiction,” IOM Report at 89, and the significant negative
health consequences of smoking, the government has an interest
of paramount importance in effectively conveying information
about the health risks of smoking to adolescent would-be
smokers and other consumers. The tobacco companies’ decades
of deception regarding these risks, especially the risk of
addiction, buttress this interest. Contrary to their arguments,
nothing in the Supreme Court’s commercial speech precedent
would restrict the government to conveying these risks in ways
that have already proved ineffective or would prohibit the
government from employing the communication tools tobacco
companies have wielded to great effect over the years.

    For these reasons, the district court erred in applying strict
scrutiny in sustaining the tobacco companies’ as-applied First
Amendment challenge to the Tobacco Control Act and the Final
Rule, and in issuing a permanent injunction. Because the
warning label requirement (absent the “1-800-QUIT-NOW”
number) appears to survive the First Amendment challenge
under either Zauderer or Central Hudson, I would reverse. It
would remain for the district court on remand to address the
                         30

tobacco companies’ challenges under the Administrative
Procedure Act, see supra note 1.