Jump to Navigation | Jump to Content
American Bar Association


Tobacco Suit Challenges Graphic Warning Mandate

By Diego Ibarguen and John P. D'Ambrosio – October 20, 2011


For nearly five decades, cigarette packages sold in the United States have borne on their sides textual warnings about the health risks associated with smoking. For most of us, these warnings have become part of the accepted landscape; we don’t tend to consciously question whether they raise any free-speech issues. Indeed, in the more than 45 years since those warnings first went into effect, no tobacco company has ever challenged their legality. Earlier this year, however, under the authority of the 2009 Family Smoking Prevention and Tobacco Control Act, the Food and Drug Administration (FDA) promulgated new regulations that require warnings containing graphic images occupying 50 percent of the front and back of all cigarette packaging and the top 20 percent of all cigarette advertisements. These images include a purported cadaver with a grisly autopsy scar on its chest, a digitally enhanced photograph of a man holding a lit cigarette as smoke escapes from a hole in his throat; diseased lungs, teeth, and gums; an image of smoke wafting toward a baby; and a man wearing a T-shirt depicting the universally known “no smoking” sign.

Now, claiming that the new warnings cross the line from conveying purely factual and uncontroversial information about the health risks of smoking (which is legally permissible) to governmental anti-smoking advocacy (which is not), several cigarette manufacturers have filed a federal lawsuit in the U.S. District Court for the District of Columbia challenging under the First Amendment the constitutionality of the FDA’s recently published regulation requiring these graphic warnings. R.J. Reynolds Tobacco Co. v. FDA [PDF], Civ. No. 11-1482 (D.D.C. Aug. 16, 2011), ECF No. 1.

The Graphic Warnings
Unprecedented and shocking as the images are, it is clear that the FDA’s reasons for choosing these particular warnings have far less to do with informing people about the health risks of smoking than they do with commandeering cigarette packages to tell people not to smoke. The FDA’s own regulatory impact study, which analyzed the benefits and costs of the new warnings, concluded that the warnings would reduce smoking rates by just 0.212 percent, which it described as “not statistically distinguishable from zero.” 75 Fed. Reg. [PDF] at 69,543 and 69,546. FDA concedes that it selected the warnings based not on their efficacy in conveying factual information, but rather, their anticipated emotional impact, and admits that it used measures of “salience . . . as a primary basis for distinguishing among the 36 proposed required warnings.” 76 Fed. Reg. [PDF] at 36,639. The FDA used the term “salience” as a euphemism for the findings of an FDA study of approximately 18,000 participants that the graphic warnings made viewers “depressed, discouraged, and afraid,” or were described with terms such as “difficult to look at.” Id.at 36,638 (internal quotation marks omitted). The same study found evidence that “recall of associated warning message statements may be reduced in the short term by moderately or highly graphic pictorial warnings versus text-only controls or less graphic pictorial warnings.” Id.at 36,639(emphases added). Indeed, the FDA’s study found that none of the 36 proposed combinations of images and textual warnings was effective at increasing awareness of the health risks of smoking or second-hand smoke exposure, increasing current smokers’ intention to quit smoking, or decreasing youth nonsmokers’ likelihood of taking up smoking. See generally Nonnemaker, J., et al., “Experimental Study of Graphic CigaretteWarning Labels: Final Results Report,” Docket No. FDA-2010-N-0568-0006, Contract No. HHSF-223-2009-10135G (Dec. 2010).

That the FDA sees the warnings as part of its own effort to disseminate antismoking messages is plain from the FDA’s public statements about the new warnings. As FDA Commissioner Hamburg candidly stated, the new warnings convert “every single pack of cigarettes in our country [into] a mini-billboard” for the government’s anti-smoking message. As Health and Human Services Secretary Kathleen Sebelius phrased it, the warnings will “rebrand our cigarette packs” and convey the message that “smoking is gross,” to “dispel the notion that somehow [tobacco use] is cool.” Furthermore, the FDA’s own “interactive tool”—which allows Internet users to slide between before and after images of a mock retail counter to see the impact the new warnings will have on cigarette displays—demonstrates that the impact of the warnings is to convert cigarette packaging and point-of-sale displays into antismoking messaging billboards.

Such a sweeping assertion of government authority cannot be reconciled with the First Amendment, which, according to the Supreme Court in Wooley v. Maynard, 430 U.S. 705, 715 (1977), prohibits the government from compelling individuals or corporations to “use their private property as a ‘mobile billboard’ for the State’s ideological message.” And much more recently, in Sorrell v. IMS Health, Inc. [PDF], 131 S. Ct. 2653, 2671 (June 23, 2011), the Supreme Court explained that “[t]he State can express [its] view through its own speech. But a State’s failure to persuade does not allow it to hamstring the opposition. The State may not burden the speech of others in order to tilt public debate in a preferred direction.”

The textual warnings included in the new warnings, which are not challenged in the cigarette manufacturers’ lawsuit, are at least arguably factual. The textual warnings, which all begin with the word “Warning,” include “Cigarettes are addictive,” “Cigarettes cause fatal lung disease,” “Cigarettes cause stroke and heart disease,” “Smoking during pregnancy can harm your baby,” “Quitting smoking now greatly reduces serious risks to your health,” “Tobacco smoke can harm your children,” “Tobacco smoke causes fatal lung disease in nonsmokers,” “Smoking can kill you,” and “Cigarettes cause cancer.”

However, the images that accompany those textual warnings, together with the exhortation to call a tobacco quit line, 1-800-QUIT-NOW, are not. As one media outlet observed, “The whole idea is that the labels will grab people by the lapels and be the visual equivalent of someone yelling: ‘Stop smoking!’”

The Constitutional Challenge
The crux of the constitutional challenge to the new warnings is that they cross the line from purely factual and uncontroversial messages into pure government advocacy. Of course, the government could rent billboard space and post these warnings themselves to fully inform the public of actual risks. But the government cannot force the tobacco manufacturers to, in essence, urge their customers to change their behavior and not buy a legal product.

The constitutional line crossed by these warnings was laid down by the Supreme Court in Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626, 651 (1985), which held that, in cases where speech is inherently misleading, the government can impose required disclosures of “purely factual and uncontroversial information” as long as they are not “unjustified and unduly burdensome.” Such permissible required disclosures include, for example, the printing of the word “Poison” coupled with a skull and crossbones on containers of poisonous substances, or the posting of calorie counts on restaurant menus. Such information is purely factual and uncontroversial. Indeed, such information can assist the consumer in making an informed and rational purchasing decision.

However, the plaintiff tobacco manufacturers contend that the FDA’s graphic warnings go well beyond simply conveying “purely factual and uncontroversial information.” Therefore, the warnings are subject to strict scrutiny. This would require FDA to demonstrate that the warnings are “narrowly tailored to promote a compelling Government interest” and that no “less restrictive alternative would serve the Government’s purpose.” United States v. Playboy Entertainment Group [PDF], 529 U.S. 803, 813 (2000). As noted, the FDA’s own studies indicate that the warnings do not promote a government interest in increasing awareness of the health risks of smoking or second-hand smoke exposure, increasing smokers’ intention to quit smoking, or decreasing youth nonsmokers’ likelihood of taking up smoking. Nor can the FDA point to any incremental benefit of the new warnings over the existing warning regime. See Brown v. Entertainment Merchant Association [PDF], 131 S. Ct. 2729, 2738–39 (June 27, 2011). Furthermore, less restrictive alternatives to the required warnings abound, such as increasing funding for antismoking advertisements on various media; increasing taxes on tobacco products; or reducing the surface area of packaging occupied by the warnings to some smaller, while still significant, percentage. For example, the Seventh Circuit in Entertainment Software Association v. Blagojevich, 469 F.3d 641, 651–52 (7th Cir. 2006) invalidated a law that required a four-square-inch sticker stating “18” on the packaging of video games deemed to be sexually explicit, because “at four square inches, the ‘18’ sticker literally fails to be narrowly tailored.” The fact that the product at issue is tobacco, a legal product, does not justify the warnings, as there is no “‘vice’ exception” to the First Amendment. 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 513–14 (1996) (plurality opinion). In sum, because the warnings do not further a compelling interest nor use the least speech-restrictive means, the warnings fail strict scrutiny and violate the First Amendment rights of the tobacco manufacturers.

The FDA disputes the applicable level of review the court should apply. The plaintiffs argue, however, that under any standard of review, the warnings fail to pass constitutional muster. For example, if the district court were to apply the First Amendment standard for restrictions on commercial speech, the FDA would bear the burden of showing that the government’s asserted interest is substantial, the warnings directly advance that interest, and the warnings are not more extensive than is necessary to serve that interest. Central Hudson Gas & Electric Corp. v. Public Service Commission of New York, 447 U.S. 557, 564 (1980). Even if the FDA could show a legitimate interest in preventing consumer deception regarding smoking risks and show that the warnings would directly and materially advance that interest—which it concedes they do not—the warnings are clearly “more extensive than is necessary” to serve that interest. As noted, there are numerous less restrictive alternatives available to the FDA; indeed, if the warnings were found to satisfy Central Hudson, it is difficult to conceive of any rule that would fail this standard, and, thus, the government’s power to restrain commercial speech would be limitless.

The plaintiffs further argue that, if the district court were to erroneously analyze the warnings under the Zauderer exception for purely factual and uncontroversial information, the warnings would still fail constitutional scrutiny because the warnings are “unjustified [and] unduly burdensome.” Zauderer, 471 U.S. at 651. Again, the FDA’s own studies reflect that the warnings are not justified because they will not have a material effect on consumer beliefs or behavior. Furthermore, the warnings would commandeer 50 percent of the front and back of cigarette packages and require the display of disturbing images designed to encourage consumers to stay away, effectively drowning out the plaintiffs’ marketing of their lawful products in one of the few avenues for marketing available to them. See Ibanez v. Florida Department of Business & Professional Regulation, 512 U.S. 136, 146–47 (1994) (invalidating a requirement that any designation as an accounting “specialist” must be accompanied by a comprehensive disclaimer, where the harm was “purely hypothetical” and not “potentially real” and where the required speech “effectively rule[d] out” an accountant’s own speech).

The plaintiffs have moved for a preliminary injunction and for summary judgment, which are pending before the district court. If the district court concludes that the FDA’s new cigarette warnings are permissible, the risks to commercial speech would be grave. Indeed, it would be hard to imagine a limiting principle on the government’s ability to infringe on First Amendment rights—and, thus, to actively promote its own agenda—with regard to other lawful products that are disfavored by the government. For example, if the new cigarette package warnings are permissible, so too would be images of grossly obese individuals or bodies on autopsy tables to be displayed on fast food packages because the government disfavors obesity, or images of diseased livers or crying infants in incubators to be displayed on wine bottles to discourage adult consumption of alcohol. Such expansive government power to mandate the speech of others is anathema to the First Amendment.

Keywords: litigation, First Amendment, tobacco, advertising, FDA, smoking, cigarettes

Diego Ibarguen and John P. D’Ambrosio are associates at Cahill Gordon & Reindel LLP, which is counsel to Lorillard Tobacco Co., a plaintiff in R.J. Reynolds Tobacco Co. v. FDA [PDF], Civ. No. 11-1482.

Copyright © 2017, American Bar Association. All rights reserved. This information or any portion thereof may not be copied or disseminated in any form or by any means or downloaded or stored in an electronic database or retrieval system without the express written consent of the American Bar Association. The views expressed in this article are those of the author(s) and do not necessarily reflect the positions or policies of the American Bar Association, the Section of Litigation, this committee, or the employer(s) of the author(s).