• D.C. Circuit Affirms District Court Decision Striking Down FDA Regulation Requiring Graphic Warnings on Cigarette Packages
  • September 27, 2012 | Authors: Ricardo Carvajal; James P. Ellison
  • Law Firm: Hyman, Phelps & McNamara, P.C. - Washington Office
  • A divided three-judge panel of the D.C. Circuit affirmed U.S. District Judge Richard Leon’s grant of summary judgment to plaintiffs in R.J. Reynolds et al v. FDA et al.. In brief, Judge Leon had applied strict scrutiny to FDA’s regulation requiring the display on cigarette packages of graphic warnings intended to dissuade would-be smokers, and concluded that the regulation was not “narrowly tailored to achieve a compelling government interest.” The D.C. Circuit agreed with the district court’s result, but for reasons different than those expressed in the district court decision.

    Writing for the majority, Circuit Judge Brown began by noting that FDA’s regulation - and indeed the authorizing statute - might not be constitutional even if it could withstand “the applicable level of scrutiny”:

    [H]ow 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 ideological - view that consumers should reject this otherwise legal, but disfavored, product?

    Assuming - without deciding - that that “such compulsion is constitutionally permissible,” the majority held the Zauderer standard of scrutiny (typically applied in cases in which consumers could be misled) to be inapplicable because the graphic warnings are not necessary to prevent current cigarette packaging from misleading consumers, and because those warnings “certainly do not impart purely factual, accurate, or uncontroversial information.” The majority also rejected strict scrutiny - the standard applied by the district court - as inapplicable to cases involving a compelled commercial disclosure. Instead, the majority applied intermediate scrutiny under Central Hudson and found the regulation unconstitutional under this standard.

    The majority noted that “the only explicitly asserted interest in either the Proposed or Final Rule is an interest in reducing smoking rates.” The majority found that “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. Finally, the majority batted down FDA’s asserted interest in “effectively communicating health information” as “merely a description of the means by which it plans to accomplish its goal of reducing smoking rates, and not an independent interest capable of sustaining the Rule.” In a dissenting opinion, Circuit Judge Randolph advocated for the application of Zauderer scrutiny, and faulted the majority for “failing to examine both of the government’s stated interests” (i.e., “effectively conveying information about the negative health consequences of smoking to consumers” and “decreasing smoking rates”).

    An appeal appears likely. Shortly after the decision, HHS issued the following statement:

    This administration is determined to do everything we can to warn young people about the dangers of smoking, which remain the leading cause of preventable death in America. The new warning labels in FDA’s rule are an effective tool in our efforts to both educate current smokers, especially young people, about the dangers of smoking; and help stop teenagers from smoking in the first place.

    As noted previously, this case appears headed for the Supreme Court. Assuming the government seeks Supreme Court review, we should know by next year whether the Court intends to address the several unsettled issues raised by this case.