Cigar Association of America v. Food and Drug Administration, No. 18-5195 (D.C. Cir. 2020)Annotate this Case
Plaintiffs, three cigar and pipe tobacco industry associations, filed suit challenging various provisions of the FDA's Deeming Rule, which subjects newly regulated tobacco products, including cigars and pipe tobacco, to requirements akin to those previously imposed by statute on cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Plaintiffs contend that the warning requirements for cigars and pipe tobacco violate the Tobacco Control Act and the Administrative Procedure Act because the FDA did not adequately consider how the warnings would affect smoking. Plaintiffs also argued that the warning requirements violate the First Amendment.
The DC Circuit held that Congress required the FDA to consider whether any regulation under section 906(d)(1) of the Federal Food, Drug, and Cosmetic Act would likely affect the number of tobacco users. In promulgating the warning requirements for cigars and pipe tobacco, the court held that the FDA failed to satisfy that obligation. Therefore, the court reversed the district court's grant of summary judgment to the FDA and the denial of summary judgment to plaintiffs. The court dismissed as moot plaintiffs' appeal from the denial of their motion for a preliminary injunction. Finally, the court remanded for further proceedings.