The next phase in the cigar industry's challenge of the U.S. Food and Drug Administration's Final Deeming Rule has begun.
The three major lobbying groups that represent the cigar industry—the Cigar Rights of America, the International Premium Cigar and Pipe Retailers Association and the Cigar Association of America—jointly filed a Motion for Summary Judgment and opening brief on February 13 in the U.S. District Court for the District of Columbia. The motion serves as the next step in the cigar industry's litigation challenging the FDA's Final Deeming Rule, which began last July when the groups joined forces and filed a lawsuit in the same court.
A motion for summary judgment (MSJ) is usually filed when one party in a lawsuit believes that the other party has no case and therefore shouldn't even go before a jury because only one outcome would be legally possible. A judge then reviews the case and decides whether or not to grant the MSJ. In this instance, the motion shows that the cigar lobbying groups believe their case is so strong, that it should not go before a jury at all—or that if it does, a jury could only rule in favor of the cigar industry.
In order to win, the cigar lobbying groups must demonstrate that their case is legally indisputable, and the 65-page opening brief document aims to prove it. The brief lays out numerous arguments as it asks the court to annul the FDA's Final Deeming Rule's regulations, which most notably include costly quarterly user fees, pre-market approval for new products and more stringent packaging/warning label guidelines.
The MSJ argues that the Final Deeming Rule not only threatens the livelihood of cigar companies and imposes unreasonable demands, but also violates the First and Fifth Amendments.
"The premium cigar industry continues its adamant objection to the Deeming Rule and its defective implementation," said Glynn Loope, executive director of the Cigar Rights of America, in a press release. "This process has resulted in premium, handmade 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."
Some of the primary arguments included in the filing are the following:
• 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 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.
• FDA unreasonably imposed the new warning label requirements without making statutorily mandated findings.
• FDA erroneously interpreted the Tobacco Control Act to treat retailers who blend pipe tobacco as tobacco product manufacturers.
• FDA erroneously classified pipes as "components" of a tobacco product.
"As the cigar industry navigates through this new world of regulation, I'm happy that CAA, IPCPR and CRA can all work together," said Craig Williamson, president of the Cigar Association of America. "Everyone recognizes that we are stronger as one voice to push back against unfair treatment by the FDA. It is our hope that this lawsuit will bring relief to the entire cigar and pipe tobacco industry."
Should the court deny the summary judgment and conclude that the facts of the lawsuit can indeed be reasonably disputed, the hearing would be set for July 28.
This article first appeared in the February 21 edition of Cigar Insider.