Review and Special Articles
Analysis of Legal and Scientific Issues in Court Challenges to Graphic Tobacco Warnings

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Abstract

Smoking is the leading preventable cause of death in the U.S., yet cigarette health warnings in the U.S. are among the weakest in the world. In 2011, the FDA issued regulations mandating that graphic warnings be displayed on every cigarette pack sold in the U.S. Almost immediately, the tobacco industry challenged the warnings on First Amendment grounds. In March 2013, the FDA withdrew the graphic warning mandate, choosing instead to pursue additional research and then issue requirements for a new set of warnings. These warnings almost certainly will be challenged by the tobacco industry. The current paper describes the legal standards that will be used to assess the warnings, and the empirical questions that must be answered in order to determine whether each standard has been met. The paper also identifies errors the FDA could make in choosing images to be evaluated that would cause the images to be unable to meet the standards, regardless of the scientific evidence the FDA can establish.

To be on safest ground, the FDA should adopt images that depict factual health consequences of smoking and should avoid images that could be interpreted as opinions. The FDA will have a high likelihood of prevailing in legal challenges to the warnings if there is evidence demonstrating that graphic warnings are necessary to counter past industry deception or that graphic warnings affect smoking behavior better than textual warnings. Even without evidence of the impact of graphic warnings on behavior, strong evidence that they affect behavioral intent, and that intent predicts behavior, should be sufficient for the warnings to be upheld. Alternatively, evidence that graphic warnings lead to more accurate consumer assessment of smoking risks should also be sufficient.

Introduction

Smoking kills an estimated 443,000 Americans each year, more than any other modifiable risk factor.1 Substantial evidence indicates that the risks of smoking are still misunderstood, particularly by youth and the most marginalized in American society.2 Yet the U.S. has some of the weakest tobacco warning labels in the world. The warnings are comparatively small and unobtrusive, include only text, and have not been updated in almost 30 years.3 Today, large, prominent warning labels that include graphics have become the international standard and are provided for in Article 11 of the Framework Convention on Tobacco Control.4

In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act (FSPTCA). This act, among other provisions, requires the tobacco industry to place graphic warning labels (GWLs) on tobacco products and gives the Food and Drug Administration (FDA) the authority to specify exactly what images and text those warnings must include.5 In June 2011, the FDA issued regulations specifying nine graphic warnings (Figure 1).

Although most western democracies give little or no protection to commercial expression, such as marketing and advertising, American constitutional law views such protection as necessary for well-functioning economic markets. However, such forms of expression are usually less protected than other types of speech. Thus, it was perhaps inevitable that GWLs would be challenged in the courts. Even before the FDA determined what graphic warnings would be required, the tobacco industry sued, alleging a violation of the First Amendment’s prohibition on government-compelled speech.

Two federal courts of appeals considered the industry’s arguments and came to opposing conclusions. The 6th Circuit Court of Appeals upheld the warning labels as factual disclosures that were reasonable ways of ensuring that consumers understand the risks of smoking.6 The Court of Appeals for the Washington DC Circuit, on the other hand, invalidated the GWL requirements, writing that “the FDA has not provided a shred of evidence … showing that the graphic warnings will ‘directly advance’ its interest in reducing the number of Americans who smoke.”7

There was a good chance that the government would have prevailed had the appeal reached the Supreme Court, but this was not a certain outcome.8 But the FDA chose not to appeal to the Supreme Court, because, as discussed below, one image was particularly vulnerable. Thus, rather than risk defeat, which might have prevented the future use of any type of warning, the FDA chose instead to revoke its graphic warning regulation and “undertake research to support a new rulemaking consistent with the Tobacco Control Act.”9

The tobacco industry also appealed the 6th Circuit’s decision to uphold the warnings, and in April 2013, the Supreme Court chose not to hear the case.10 This decision was expected because, after the FDA withdrew the warnings, the only question left for the Court to review was whether every graphic warning would always violate the First Amendment; this type of review, termed a facial challenge, is disfavored by the court. Contrary to what some advocacy groups have asserted,11 the Court made no decision on the validity of GWLs when it chose not to hear the appeal.12

When the FDA has completed the additional research on graphic warnings and mandates a new set of images, the tobacco industry very likely will sue again to block use of either all the images or individual ones that are particularly vulnerable. In fact, an attorney for Lorillard has already stated that “there will obviously be a good deal more litigation” about GWLs.11 Therefore, it is important that the research conducted by the FDA target the evidence that is required in order for the use of graphic warnings to be upheld under judicial review. The current paper analyzes the legal standards the courts are likely to apply in evaluating the warnings, and the empirical questions contained within the standards. An outline is provided of the types of evidence that are needed in order for the warnings to survive under each standard, with a particular focus on areas in which the warnings are potentially vulnerable.

Section snippets

Legal Standard

The Supreme Court has never decided a case that contains exactly the same issues raised by challenges to GWLs. Its past decisions regarding commercial speech generally have dealt with prohibitions on commercial expression, not on legally mandated disclaimers. In those cases in which the Supreme Court has addressed disclaimers or warnings, these have been written, not pictorial, making them less susceptible to ambiguities of interpretation. The result of these decisions is an uncertain legal

Rational Basis Review

Rational basis review is lenient, and the government almost always wins. To prevail, government lawyers merely would have to show that the graphic warnings have some legitimate purpose and that a rational Congress and the FDA could believe that mandating the warnings would serve that purpose. The courts apply this standard when a factual disclaimer is necessary to prevent consumer deception. For example, in 2011, the Supreme Court upheld a requirement that debt-relief agencies state in their

Intermediate Scrutiny

Most courts have applied rational basis review only to deceptive advertising, so it is likely the FDA will have to meet a higher, intermediate standard of review, often called the Central Hudson test, for the case in which the Supreme Court first described it. The Court has applied it only to mandatory limitations on commercial speech, not mandated disclosures, but some lower courts have applied it to factual disclaimers about recombinant bovine growth hormone in milk,29 dental services,30 and

Strict Scrutiny

The final standard the courts might apply is called strict scrutiny, the least lenient constitutional review a law can be afforded. A few courts have asserted that compelled commercial disclaimers should undergo strict scrutiny, relying primarily on a 2001 case in which the Supreme Court applied strict scrutiny to a law requiring mushroom handlers to subsidize industry-wide advertisements.17 More recently, however, the Supreme Court implied, but did not directly decide, that commercial

Conclusion

When the FDA issues new GWLs, they are likely to be challenged by the tobacco industry on First Amendment grounds. Because the courts have never squarely addressed how the constitution applies to GWLs, the FDA cannot know with certainty whether its regulations will be upheld or even what legal standard the courts will apply to them. However, enough evidence exists to support the warnings under the legal standards the courts are most likely to apply, and the warnings have a reasonable chance of

Acknowledgments

No financial disclosures were reported by the authors of this paper.

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