In early July, we reported that the four leading tobacco companies were threatening legal action against the Food and Drug Administration (FDA) over the nine new graphic cigarette health warnings that must appear on each cigarette package beginning in September 2012. This threat became a reality last month, when five tobacco companies – R.J. Reynolds, Lorillard, Commonwealth Brands, Liggett Group, and Santa Fe Natural – filed suit in the United States District Court for the District of Columbia against FDA, claiming that the final regulation specifying the new warnings (the “Rule”) violates the First Amendment as applied to Plaintiffs and was promulgated in violation of the Administrative Procedure Act (“APA”). Plaintiffs seek a declaration that the Rule is invalid and an injunction prohibiting FDA from enforcing against Plaintiffs the warnings requirements. Plaintiffs also seek a ruling that would postpone the effective date of the Rule for a period of 15 months after final judgment.
More specifically, in their Complaint, Plaintiffs claim that the warnings imposed by the Rule are not designed to convey uncontroversial factual information, but instead a governmental anti-smoking advocacy message that urges adult consumers to shun Plaintiffs’ products and exaggerates the effects of smoking. This compelled speech is unconstitutional, claim the Plaintiffs, because it does not further any compelling – or even substantial – government purpose. In this regard, according to Plaintiffs, FDA’s own regulatory impact analysis and experimental study concluded that the new warnings are unlikely to materially impact consumer smoking beliefs and behavior because the factual health information in each of the new warnings has already been disseminated to a large percentage of the population through the Surgeon General’s warnings and other means. In addition to not advancing any compelling or substantial governmental purpose, Plaintiffs argue that the warnings are not the least restrictive means available to accomplish any government purpose. Plaintiffs also claim that FDA violated the APA because it (1) acted arbitrarily and capriciously by attempting to justify the Rule on illogical, contradictory and unsupported grounds; and (2) failed to provide Plaintiffs with meaningful notice by not disclosing key technical data, methodologies, and assumptions underlying the Rule. In response to Plaintiffs’ allegations, FDA claims that it has flexibility in regulating commercial speech, and that Plaintiffs will not suffer significant economic harm in preparing the new warning labels. Plaintiffs have asserted that they will spend over several million dollars complying with the warnings requirements.
As previously reported here, three of the Plaintiffs in the D.C. lawsuit – R.J. Reynolds, Lorillard, and Commonwealth Brands – already filed a similar case against FDA two years ago in federal court in Kentucky that is now on appeal to the Sixth Circuit. FDA relies heavily on the Kentucky case in its response to Plaintiffs’ motion for preliminary injunction in the D.C. lawsuit, pointing out that the Kentucky district court rejected constitutional claims similar to those asserted by Plaintiffs in the D.C. lawsuit. On the other hand, the Plaintiffs in the D.C. lawsuit seek to distinguish the Kentucky lawsuit on the grounds that the two lawsuits raise different issues: the Kentucky lawsuit claims that the warnings requirement is facially unconstitutional, while the D.C. lawsuit challenges the constitutionality of the specific warnings promulgated by the Rule which were not even released at the time the Kentucky lawsuit was filed. Thus, Plaintiffs argue that the D.C. lawsuit “turns primarily on facts not available, litigated, or considered in the [Kentucky] case.”
A hearing on Plaintiffs’ preliminary injunction in the D.C. case is scheduled for September 21. The Sixth Circuit heard oral argument in the Kentucky case on July 27, but has not yet issued an opinion.