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 statutorilyprescribed 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”3regarding 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 secondhand 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 postmarket 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 FDAsponsored 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/pressbriefing-press-secretary-jay-carney-secretary-health-and-humanser. 
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 wellunderstood 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 WarnerLambert, 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 tobaccorelated 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 contentbased 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.