Whether the warning label disclosure requirements of the U.S. Food & Drug Administration’s Deeming Rule are a rational, well-justified response to the public health issues associated with cigars.
On July 15, 2016, the Cigar Association of America and two other non-profit trade associations for retailers and manufacturers sued the FDA on the ground that the agency’s Deeming Rule is unfair and compels speech in violation of the U.S. Constitution, and that the rulemaking process violates the Administrative Procedure Act (APA). The APA is a federal law that governs how federal agencies develop rules. The FDA filed its answer on October 26, 2016 and the plaintiffs filed a motion for summary judgment on February 13, 2017. Following the FDA’s July 2017 announcement of a new regulatory plan, the plaintiffs agreed to narrow the scope of their lawsuit and the court established a new briefing schedule. The plaintiffs filed a motion for summary judgment on Oct. 3, 2017, and on October 24, 2017, the FDA filed its opposition to the plaintiffs’ motion and its own motion for summary judgement, defending the new warnings.
On October 31, the Campaign for Tobacco-Free Kids, joined by the Consortium and six other public health organizations, filed an amicus brief, also defending the warnings. Our brief focuses on the health hazards of cigars, the industry’s efforts to make cigars appealing to kids and the importance of large, prominent health warnings on cigars.
Status of Litigation
The litigation is ongoing.