R.J. Reynolds Tobacco Co., et al. v. FDA, et al., No. 11-5332 (D.C. Cir. 2012)Annotate this Case
The Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776, directed the Secretary to issue regulations requiring all cigarette packages manufactured or sold in the United States to bear one of nine new textual warnings, as well as "color graphics depicting the negative health consequences of smoking." Companies challenged the FDA's rule through which it selected nine images that would accompany the statutorily-prescribed warnings. The court held that the FDA failed to present any data showing that enacting their proposed graphic warnings would accomplish the agency's stated objective of reducing smoking rates. Therefore, the court vacated the graphic warning requirements and remanded to the FDA. The court also vacated the permanent injunction issued by the district court.