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RJR v. FDA: A First Amendment Challenge to Graphic Image Warning Labels on Cigarettes

The U.S. District Court for the District of Columbia struck down on Feb. 29 a U.S. Food and Drug Administration (FDA) regulation that required “graphic image” warning labels on cigarette packages. R.J. Reynolds v. FDA, No. 11–1482, 2012 WL 653828, at *8 (D. D.C. Feb. 29, 2012). These warnings, common in other countries, consist of graphic, full-color images that depict the dangers of smoking. Among those that would have been required by the FDA were images of “a man exhaling cigarette smoke through a tracheotomy hole in his throat,” “a pair of diseased lungs next to a pair of healthy lungs,” and “a diseased mouth afflicted with what appear to be cancerous lesions.” Id. at *2. These would have covered the top half of both the front and back panels of all cigarette packages, and the top 20 percent of all printed cigarette advertisements. Id. However, the District Court, in a 19-page opinion written by Judge Richard J. Leon, found that these regulations violated plaintiff cigarette companies’ free speech rights under the First Amendment.


The FDA rule that was struck down was intended to implement the Family Smoking Prevention and Tobacco Control Act (FSPTCA), a law signed by President Obama on June 22, 2009. Id. at *1. The FSPTCA gave the FDA the explicit authority to regulate the manufacture and sale of tobacco products. Id. It also directed the Secretary of the U.S. Department of Health and Human Services to “issue regulations that require color graphics depicting the negative health consequences of smoking.” Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, §201(d), 123 Stat. 1776 (2009). These images would be combined with one of nine textual warnings provided by Congress. For instance, “WARNING: Cigarettes cause cancer.” R.J. Reynolds, 2012 WL at *1-2. The combined graphic and textual warnings would have to cover the top 50 percent of the front and back panels of all cigarette packages, and the top 20 percent of all printed cigarette advertising. Id. at *2. Congress gave the FDA 24 months to issue the necessary regulations, and the industry a further 15 months to implement them. Id.

The FDA submitted a proposed rule for public notice and comment on Nov. 12, 2010. Id. The proposed rule contained 36 graphic images that could be paired with the textual warnings created by Congress. Id. It also required cigarette packages to include a “reference to a smoking cessation assistance resource” and laid out requirements for what such a resource must provide. Id. (citation omitted). After receiving more than 1,700 comments, the FDA issued its final rule on June 22, 2011. Id. Of the 36 proposed images, the FDA included only nine in the final rule, which would be rotated according to an agency-approved plan. Id. These images would be paired with one of the textual warnings and the phone number for a smoking cessation hotline, “1-800-QUIT-NOW.” Id. at *3.

In response to the final rule, five tobacco companies – R.J. Reynolds, Lorillard, Commonwealth Brands, Liggett, and Sante Fe – filed suit challenging the FDA regulation. Id. at *1. Motions for a preliminary injunction and for summary judgment and a permanent injunction were filed on Aug. 19, 2011. Id. at *3. On Nov. 7, 2011, the District Court granted the tobacco companies’ motion for a preliminary injunction, finding that they had shown a substantial likelihood of success on the merits. R.J. Reynolds v. FDA, 823 F.Supp. 2d 36, 53 (D. D.C. 2011).

A few months later, the District Court issued its Feb. 29 ruling granting the tobacco companies’ motion for summary judgment. In its decision, the court ordered implementation of the relevant provisions of the FSPTCA to be stayed until 15 months after the FDA issues new regulations. R.J. Reynolds v. FDA, No. 11-1482 (D. D.C. Feb. 29, 2012) (order granting permanent injunction).

The Court’s Decision

In its opinion, before reaching the merits of the dispute, the court first examined what level of judicial scrutiny it should apply to the FDA’s regulation. After reviewing relevant First Amendment jurisprudence, it determined that it had to review the regulations under a strict scrutiny standard. In applying this standard, it found the regulation unconstitutional.

Applicable Level of Scrutiny

The court began its analysis to determine the correct level of scrutiny by noting that the First Amendment protects “both the right to speak freely and the right to refrain from speaking at all.” Id. at *4 (citation omitted). A speaker “has the autonomy to choose the content of his own message” and “for corporations as for individuals, the choice to speak includes within it the choice of what not to say.” Id. (citations omitted). “As plaintiffs so aptly stated, although ‘the Government may engage in advocacy using its own voice[,] . . . it may not force others, such as Plaintiffs, to serve as its unwilling mouthpiece.” Id. (citation omitted). Therefore, any law that “mandates speech that a speaker would not otherwise make” is compelled speech that is presumptively unconstitutional. Id. (citations omitted).

The court found that the FDA’s final rule did not fit within the exception for compelled commercial speech established by the Supreme Court in Zauderer v. Office of Disciplinary Counsel of Sup. Ct. of Ohio, 471 U.S. 626 (1985). R.J. Reynolds, 2012 WL at *4. Zauderer states that courts must apply a lesser standard of scrutiny for a “narrow category” of laws that require companies to disclose “purely factual and uncontroversial information” for the purpose of protecting consumers from “confusion or deception.” Id. (citations omitted). However, even these laws may violate the First Amendment if they are “unjustified or unduly burdensome.” Id. (citation omitted).

The court found Zauderer inapplicable for a number of reasons. First, the images were not designed to protect consumers from confusion or deception, but rather “were crafted to evoke a strong emotional response calculated to provoke the viewer to quit or never start smoking.” Id. The court pointed to an Institute of Medicine report – “an authority chiefly relied upon by the Government” – that said as much: “it is time to state unequivocally that the primary objective of tobacco regulation is not to promote informed choice but rather to discourage consumption of tobacco products.” Id. (citation omitted). Second, the court found that the proposed graphic images were “neither factual nor accurate.” Id. at *5. “For example, the image of the body on the autopsy table suggests that smoking leads to autopsies; but the Government provides no support to show that autopsies are a common consequence of smoking.” Id. Instead, the court found that the government was symbolizing the “addictive nature of smoking,” which is something very different from the simple conveyance of factual information contemplated by Zauderer. Id. Rather than promoting informed choice, the government was advocating to consumers that they should “QUIT NOW.” Id.

The court compared the FDA’s rule to the statute struck down by the Seventh Circuit in Entertainment Software Association v. Blagojevich, 469 F.3d 641 (7th Cir. 2006). There, an Illinois statute – the Violent Video Games Law – required video game retailers to affix a four-square-inch sticker with the number “18” on any video game that the statute deemed “sexually explicit.” R.J. Reynolds, 2012 WL at *6 (citations omitted). However, the Seventh Circuit held that a compelled label based on what the state deemed to be “sexually explicit” was too “opinion-based” to fit within Zauderer’s requirement that compelled commercial speech be “of purely factual and uncontroversial information.” Id. (citations omitted). The District Court analogized this to the current case because “like the stickers in Blagojevich, the graphic images ‘ultimately communicate a subjective and highly controversial message.’” Id. (citations omitted). Zauderer does not apply because the compelled speech is not purely factual and uncontroversial. Id. Therefore, the court held that the FDA’s rule must be reviewed under the standard of strict scrutiny. This required the court to determine whether the regulation was narrowly tailored to achieve a compelling government interest. Id.

Application of Strict Scrutiny

The court began its application of strict scrutiny analysis by noting that “although the Government contends that it has a compelling interest… its stated purpose does not seem to comport with the thrust of its arguments or with the evidence it offers to support the Rule.” Id. (citations omitted). More specifically, while the FDA’s claimed purpose was to inform consumers – particularly the young and uneducated – of the dangers of smoking, the court found that “it is clear that the Government’s actual purpose is not to inform or educate, but rather to advocate a change in behavior – specifically to encourage smoking cessation and to discourage potential new smokers from starting.” Id. (emphasis in original). The combination of the graphic images with the toll free number demonstrated that “the government’s actual purpose is to convince consumers that they should ‘QUIT NOW.’” Id. The court found that this was not a compelling government purpose: “Although an interest in informing or educating the public about the dangers of smoking might be compelling, an interest in simply advocating that the public not purchase a legal product is not.” Id. (emphasis in original).

Despite finding that the regulation did not serve a compelling government interest, the court went on to address the narrow tailoring issue and again found that the FDA’s rule falls short. For one, the court objected to the size of the warning labels: “the sheer size and display requirements for the graphic images are anything but narrowly tailored.” Id. at *7 (citations omitted). “These dimensions alone clearly demonstrate ‘that the Rule was designed to achieve the very objective articulated by the Secretary of Health and Human Services: to ‘rebrand our cigarette packs,’ treating… ‘every single pack of cigarettes in our country’ as a ‘mini-billboard.’ A ‘mini-billboard,’ indeed, for its obvious anti-smoking agenda!’” Id. (citations omitted). The FDA’s argument that it could not second-guess Congress’s mandate – even if that mandate violated the First Amendment – was, for the court, “an oh-too-convenient dodge” that did not allow the FDA to implement rules inconsistent with the Constitution. Id.

Second, the court pointed to alternatives suggested by the plaintiffs as evidence that the FDA could have implemented a less burdensome rule that would have allowed the government to spread its message while passing constitutional muster. Id. For instance, the government could have disseminated its anti-smoking message itself, through advertising or statements to the press. Id. The FDA could have changed the display requirements, suggesting the space “appropriated” be reduced or confined to only either the front or back of the package. Id. The government could have changed the content of the images by choosing graphics not “designed to disgust the consumer.” Id. Finally, the government could have increased cigarette taxes, or improved efforts to prevent the sale of cigarettes to minors. Id. Because Congress had a number of less burdensome options it could have pursued, the court found that the one that it did choose was not sufficiently tailored to withstand judicial scrutiny.

On Appeal – States’ Amicus Brief and the Discount Tobacco Decision

The District Court’s decision was appealed by the FDA on March 5, and its rulings on the motions for a Preliminary Injunction and Summary Judgment were consolidated for appeal on March 9. Oral arguments for the case were heard by D.C. Circuit Court of Appeals on April 10.

In support of the FDA’s position, 24 states filed an amicus brief with the D.C. Circuit. Brief for Amicus Curiae States Idaho et al. as Amici Curiae Supporting Appellant FDA, R.J. Reynolds v. FDA (No. 11-5332). Asserting the states’ “comprehensive understanding of the public health consequences of tobacco use” and the particular danger of underage smoking, the states’ brief answers the District Court by emphasizing the wider context of public health and tobacco industry deception and argues that the Court erred by both ignoring that context and by misapplying First Amendment jurisprudence. Id. at 2.

The states argue that the District Court failed to recognize both the severe public health risk posed by cigarettes and the tobacco industry’s history of deceiving customers with regard to that risk. See id. at 4. In regard to the latter, the states note that in 2009, the D.C. Circuit “affirmed a judgment of the district court finding that the major cigarette companies… had engaged in a conspiracy of unprecedented magnitude and duration to deceive the American public about the lethal consequences of smoking and to addict them to a product the companies knew was lethal.” Id. at 3 (citing United States v. Philip Morris USA, Inc., 449 F.Supp. 2d 1 (D.D.C. 2006).) In the current case, the District Court showed no such appreciation for that history or its own precedent. Id. at 4. Nor did the court appreciate the public health risk posed by cigarettes, “the deadliest product sold in America, and one of the most addictive.” Id. at 3. The states note that “cigarettes are the only product sold legally that, when used as intended, cause death and disease” and “half of those who become regular smokers will die of tobacco-related disease.” Id. at 6 (citation omitted). Furthermore, “nearly all those who become regular smokers begin smoking when they are underage.” Id.

In the face of this background of health risk and industry deception, the states argue that, in order to be effective, the FDA’s warning labels “must be powerful, graphic, and trenchant.” Id. at 14. Current warning labels – “small, obscurely placed text-only warning labels” – “simply do not work.” Id. at 3. The states recognize the potency of the proposed warnings: “for almost any other product, their salience and emotional impact might well be disproportionate.” Id. at 24. However, they are necessary in order to counteract, “decades of deception by cigarette manufacturers,” and to connect emotionally to underage smokers, who are unlikely to be influenced by text-only warnings. Id. at 9 and 21.

That the warnings are powerful does not make them inconsistent with the First Amendment. Id. at 14. “The First Amendment does not prevent the government from requiring that lethal and addictive products carry warning labels that effectively inform consumers of the risks those products entail.” Id. at 3. Zauderer allows the government to compel commercial speech that discloses “purely factual and uncontroversial information” as long as the disclosure is reasonably related to the state’s interest and is not unjustified or unduly burdensome. R.J. Reynolds, 2012 WL at *4. By finding that Zauderer did not apply because the graphic images were not “purely factual and uncontroversial,” the states argue that the District Court “create[d] a false dichotomy between statements that are ‘factual’ or ‘noncontroversial’ and statements that elicit emotional reactions.” States’ Brief at 17. “The opposite of ‘factual’ is not ‘emotional’; the opposite of factual is ‘in error’ or ‘not in conformity with the facts or evidence.’” Id. at 17-18 (quoting Roget’s Int’l Thesaurus (4th ed. 1977)). The graphic images accompany and illuminate the textual warnings chosen by Congress, which all parties agree convey “factual and uncontroversial information.” Id. at 22. The cigarette companies’ objection, therefore, does not go to the substance of the warnings, but to the manner of their communication. Id. Because the substance is factually accurate, Zauderer should apply. See id. at 23. The warning labels readily survive Zauderer because they are reasonably related to the government’s interest in preventing the deception of consumers. Id. Nor are they unduly burdensome when seen in the context of the history of industry deception and addictiveness that they are designed to counteract. Id. at 25.

Furthermore, even if Zauderer did not apply, the states argue that the District Court should not have analyzed the warning labels under strict scrutiny. Id. at 26 “There is no legal basis for the district court’s determination that strict scrutiny must be employed to examine the warning label requirement.” Instead, the court should have applied the Central Hudson test, “the standard applied to compelled commercial speech that does not fall within the ambit of Zauderer.” Id. Under Central Hudson, compelled speech is constitutional if it directly and materially advances a substantial government interest and there is a reasonable fit between the government’s ends and the means chosen to achieve those ends. Id. at 28 (citation omitted). The states argue that the warning labels would survive scrutiny under this standard as well because the government has a compelling interest in communicating the health risks of smoking, scientific literature demonstrates that graphic warning labels promote greater understanding of those risks, and the government’s means are fitted to its ends. Id. at 28-29.

Discount Tobacco Decision

In addition to the states’ amicus brief, the Circuit Court will also have to contend with a recent decision by the Sixth Circuit in a very similar case, Discount Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509 (6th Cir. 2012). In that case, a group of cigarette companies – including three of the plaintiffs in the present action – filed a facial challenge to the constitutionality of the FSPTCA. See Commonwealth Brands, Inc. v. United States, 678 F.Supp. 2d 512, 519 (W.D. Ky. 2010). There, however, the District Court upheld the statute’s graphic image warnings against the very same First Amendment arguments presented before the court in the current case. Id. at 541. This part of the decision was affirmed by the Sixth Circuit on appeal. Discount Tobacco, 674 F.3d at 569. In its opinion, the Sixth Circuit did not review the statute under strict scrutiny, instead finding that “the case law requires a reasonable fit between the legislature’s ends and the means chosen to accomplish those ends, a means narrowly tailored to achieve the desired objective.” Id. at 523 (citation omitted). Under that standard, the court found “that the Act’s warnings are reasonably related to the government’s interest in preventing consumer deception” and upheld the graphic warnings requirement. Id. at 541.

While the subject matter of Discount Tobacco action is slightly different from that of the present action – the former is a facial challenge to the FSPTCA itself while the latter challenges the FDA’s implementing regulations – both the FDA and the amici states have urged the D.C. Circuit to adopt the Sixth Circuit’s reasoning. For its part, the FDA has argued that, in substance, the two challenges are the same: “in both cases, plaintiffs’ overarching claim is that the ‘purpose and effect of the warnings is to drown out Plaintiffs’ own constitutionally protected speech about their lawful products and replace it with the Government’s emotionally-charged anti-smoking message.’” Defendant’s Opposition to Plaintiff’s Motion for a Preliminary Injunction at 14, R.J. Reynolds v. FDA, 823 F.Supp. 2d 36 (2011) (No. 11-1482). The states make a similar point, arguing that the only differences between the cases are “(1) the choice of particular pictorial images and (2) the existence of a massive administrative record… supporting the need for pictorial warning labels.” States’ Brief at 17. Whether the D.C. Circuit will be persuaded by this or other arguments is unclear. Regardless, its decision is expected within the next few months.

Appeals Court Decision

At press time, (Aug. 24), the D.C. Circuit affirmed the District Court’s grant of summary judgment to the plaintiff tobacco companies. R.J. Reynolds Tobacco Co. v. FDA, No. 11-5332 (D.C. Cir. Aug. 24, 2012). The Circuit Court agreed with the District Court that the graphic warnings fall outside the ambit of the Zauderer case. It disagreed, however, with the District Court’s decision that strict scrutiny was appropriate and instead applied the intermediate Central Hudson standard “[b]ecause this case . . . involves a compelled commercial disclosure.” Slip op. at 22. The Circuit Court then concluded that the graphic warnings did not pass the Central Hudson test:

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 [Administrative Procedure Act]—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.

Id. at 30. The Circuit Court vacated the graphic warning requirements and remanded the matter to the FDA.

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