The Cigar Association of America, the International Premium Cigar & Pipe Retailer Association and Cigar Rights of America filed a motion for Summary Judgement and opening brief in the cigar industry’s litigation challenging the FDA’s final deeming rule. This is the next phase in the premium cigar industry’s joint litigation challenging the FDA’s new regulations and rules that have impacted the industry since they were announced back in May 2016.
The three industry associations are petitioning the court to vacate and set aside the deeming rule because it is unlawful and in violation of the Administrative Procedures Act, as well as the First and Fifth Amendments to the Constitution.
The following arguments were made in the filing:
- The FDA’s final rule improperly subjected cigars and pipe tobacco to all aspects of the regulations;
- FDA arbitrarily imposed premarket review provisions without clarifying the substantial equivalence pathway for cigars and pipe tobacco;
- FDA impermissibly denied to cigars and pipe tobacco of the same stay of enforcement pending review of premarket applications as was provided to cigarettes;
- FDA rejected “Option 2” exempting premium cigars from regulation without any basis;
- FDA’s decision to impose user fees on some, but not all, of the newly deemed products is contrary to law and exceeds statutory authority;
- FDA’s Final Rule is based on a flawed cost-benefit analysis and imposes an unreasonable burden on small businesses;
- FDA’s Final Rule warning label requirements violate the First Amendment; and
- FDA unreasonably imposed the new warning label requirements without making statutorily mandated findings.
In a press release, Glynn Loope, Executive Director of Cigar Rights of America, commented: “The premium cigar industry continues its adamant objection to the Deeming Rule and its defective implementation. This process has resulted in premium hand-made cigars being subjected to requirements that will cause irreparable economic harm to this artisan industry, and the Main Street America small businesses that rely upon it. We trust that the merits of our argument with demonstrate to the court that the deeming rule is fundamentally flawed and legally deficient.”