FSPTCA Litigation on FDA Graphic Warnings

May 2, 2013

In June 2011, the FDA published a final rule including nine textual and graphic warnings it would require under the FSPTCA on 50% of the front and back of every cigarette pack. These images included a diseased lung, a cadaver bearing chest staples on an autopsy table and other similar pictures, along with textual warnings such as “WARNING: Cigarettes cause cancer.” Tobacco companies sued, alleging FDA had violated their First Amendment rights by compelling speech on the packs. The companies first asked for a preliminary injunction on the rule — meaning it would be suspended pending the outcome of the lawsuit — which was granted by Judge Leon last November. In March, Judge Leon ruled on the merits to invalidate the warnings, finding that the government had exceeded its authority under the Constitution, and compelled disclosures that were not purely factual or uncontroversial.  Unfortunately, the Court of Appeals for the DC Circuit struck down the new graphic warnings, saying that the government did not provide sufficient evidence to require the inflammatory pictures proposed by the FDA. Under the majority’s analysis, compelling the warnings violated the companies’ right to free speech. The government elected not to appeal the ruling to the US Supreme Court, but the FDA is likely to issue revised graphic warnings in the future.

We filed as amicus at both the trial and appellate levels of the case, giving the courts information on the health effects of tobacco use, as well as studies citing the efficacy of such graphic warnings used in other countries.