The Cigar Association of America (CAA), Cigar Rights of America (CRA), and International Premium Cigar and Pipe Retailers Association (IPCPR) filed a motion for Summary Judgement and opening brief in the lawsuit challenging the U.S. Food and Drug Administration (FDA)’s Final Deeming Rule on premium cigars and pipes. The motion was filed February 13th, 2017 in U.S. District Court for the District of Columbia.
A Summary Judgement is a procedural move that essentially requests the Court to promptly dispose of a case because there are no facts at issue. In this case, the trade associations are asking the court to “throw out” the FDA’s 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. This is based on nine points.
- 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.
- The FDA also improperly treats pipes as “components” of a tobacco product and therefore subject to regulation.
In a press release announcing the filing, Glynn Loope, Executive Director of Cigar Rights of America said, “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 will demonstrate to the court that the Deeming Rule is fundamentally flawed and legally deficient.”
The Court Date for the lawsuit is scheduled for July 28, 2017.