Case Note  |  Volume 163

The Future of Government-Mandated Health Warnings After R.J. Reynolds and American Meat Institute

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163 U. Pa. L. Rev. Online 177 (2014).

Posted on Dec 3, 2015

Case Note - The Future of Government-Mandated Health Warnings After <i> R.J. Reynolds</i> and <i>American Meat Institute</i>








Government‐mandated disclosures and warnings aimed at promoting public health are ubiquitous. Alcoholic beverage labels bear government warnings against alcohol consumption during pregnancy. Both prescription and over‐the‐counter drugs must comply with extensive Food and Drug Administration (FDA) labeling requirements. Automobiles carry mandatory safety rating labels. Cigarette packages have included warnings about the dangers of smoking since 1965. Even chain restaurants must now follow the federal nutrition labeling requirements that have applied to food packaging for two decades. Warnings and disclosure requirements are likely to become even more widespread given President Obama's 2011 executive order encouraging administrative agencies to use these “[f]lexible [a]pproaches” wherever “relevant, feasible, . . . consistent with regulatory objectives, and . . . permitted by law.”

Despite their widespread use as a regulatory tool, government‐mandated warnings and disclosures are not immune from legal challenge. In the 2012 case of R.J. Reynolds Tobacco Co. v. FDA, the U.S. Court of Appeals for the D.C. Circuit invalidated FDA's graphic cigarette warnings on First Amendment grounds. The tobacco manufacturers' challenge forced the D.C. Circuit to wade into unchartered waters. Although there is a long line of Supreme Court cases addressing First Amendment challenges to commercial speech restrictions (e.g., advertising bans), the Court has heard only two challenges to commercial speech disclosure requirements, neither involving government‐mandated warnings. Further, while the Court has been clear that it reviews commercial speech restrictions under the Central Hudson intermediate scrutiny test, it has applied a standard akin to rational basis review when examining purely factual disclosure requirements targeting consumer deception, without explaining in what other circumstances rational basis review would apply. Thus, faced with a novel question of law, the R.J. Reynolds court concluded that the graphic cigarette warning requirements did not merit rational basis review protection, because (1) they did not seek to cure consumer deception and (2) they were not purely factual and uncontroversial warnings, but rather “admonitions: ‘[D]on’t buy or use this product.'” After deciding that Central Hudson intermediate scrutiny was the correct standard of review, the court held the warnings unconstitutional because FDA failed to produce sufficient evidence—indeed, “failed to present any data”—that the warnings would directly and materially advance its goal of reducing smoking rates. Although most commentators expected the case to go to the Supreme Court, FDA instead withdrew the proposed images and said it would issue revised graphic warnings.

To the extent that R.J. Reynolds could be read as holding that only commercial speech mandates that are both purely factual and designed to correct consumer deception receive rational basis review, it was overruled by the 2014 en banc decision of the D.C. Circuit, American Meat Institute v. USDA. Aligning the court's position with that of other circuits, the D.C. Circuit held in American Meat Institute that Zauderer v. Office of Disciplinary Counsel, the first Supreme Court case to apply rational basis review to a government‐mandated disclosure requirement, extended “beyond problems of deception”—and thus applied to the U.S. Department of Agriculture (USDA) country‐of‐origin disclosures at issue in the case.

Given that the D.C. Circuit is responsible for reviewing many federal agency regulations, American Meat Institute marks a significant victory for regulators. A contrary holding—one limiting the protection of Zauderer rational basis review to compelled speech aimed at curing deception—would have threatened to unsettle the current regulatory regime, and would have particularly threatened mandates aimed at promoting public health. These disclosure requirements often do not target potentially deceptive commercial speech, and they rarely are supported by the level of evidence R.J. Reynolds deemed necessary to satisfy Central Hudson intermediate scrutiny. (These evidentiary difficulties arise in part because many public health problems are complex and cannot be eradicated by a disclosure requirement alone.) While R.J. Reynolds raised important questions about the effectiveness of disclosure requirements, the First Amendment should not be an insurmountable obstacle when the commercial speaker's constitutionally protected interest is, as the Court has said, “minimal” and the government interest is substantial.

Although American Meat Institute lessened the blow R.J. Reynolds dealt to regulators, both decisions left open important questions about the First Amendment treatment of government‐mandated warnings that are neither “purely factual and uncontroversial” disclosures nor overt government‐sanctioned opinions, and about whether graphic cigarette warnings belong in this middle ground. R.J. Reynolds only addressed the constitutionality of the nine warnings before it, and left unanswered whether another graphic warning depicting the negative health consequences of smoking could be constitutional. But, in characterizing FDA's graphic warnings as “a much different animal” than the mandated statements to which the Supreme Court has previously applied rational basis review, and in viewing them as “intended to evoke an emotional response, or, at most, shock the viewer into retaining the information in the text warning,” R.J. Reynolds strongly implied that no graphic cigarette warning could ever receive rational basis review protection. Not only did the court seem to demand Central Hudson intermediate scrutiny review for all government‐mandated graphic warnings, it created an overly burdensome intermediate scrutiny test by misapplying the Administrative Procedure Act's (APA) “substantial evidence” standard to its First Amendment analysis, and by failing to look beyond the Court's abstract statements about Central Hudson to its application of the test.

Part I of this Note outlines the Supreme Court's commercial speech jurisprudence. It explains the Court's differential treatment of commercial speech restrictions and compelled commercial speech, and it outlines the open question of whether Zauderer, and its accompanying rational basis review protection, is limited to mandates aimed at correcting deception. Part II discusses the various interpretations of Zauderer advanced by circuit courts. It defends the broader interpretation of Zauderer adopted by the First Circuit, Second Circuit, and, most recently, the D.C. Circuit in American Meat Institute, and it criticizes the narrow interpretation articulated in R.J. Reynolds. Part II likewise outlines the doctrinal support and policy justifications for a broader interpretation of Zauderer, with particular focus on the importance of recognizing the government's interest in promoting public health as worthy of rational basis review. Part III then looks at how FDA could issue revised graphic cigarette warnings that would pass constitutional muster. It examines the type of graphic cigarette warnings that could potentially merit review under the Zauderer standard, argues that R.J. Reynolds misapplied the Central Hudson intermediate scrutiny standard, suggests a better view of Central Hudson as applied to graphic cigarette warnings, and describes post‐Reynolds scientific research supporting the effectiveness of graphic warnings.


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