In what might be considered a major development in the cigar industry’s lawsuit against the U.S. Food and Drug Administration (FDA), the cigar trade associations have motioned the court for a preliminary injunction and partial summary judgment to prevent the FDA from moving forward with portions of the Deeming Regulations. The areas being targeted surround implementing warning regulations and user fees. A summary judgment is a procedural move that essentially requests the Court to promptly dispose of a case because there are no facts at issue.
Ultimately, the cigar industry is looking to temporarily halt the implementation of warning labels and user feeds with the injunction. Longer term, they are hoping a partial summary judgment against these rules leads to them getting thrown out.
In terms of the warning labels, both the motion for preliminary injunction and partial summary judgment state, “Plaintiffs are incurring millions in costs to redesign packages and advertising, now, and those costs will multiply each month until the August 10, 2018 compliance date. The cost of molding speech to a requirement violates the First Amendment and is classic irreparable harm.”
The industry has argued the warning labels have have a greater burden on cigar and pipe tobacco:.This is pointed out int the motion for preliminary injunction.
The agency failed to make the findings required by the TCA to justify imposition of the warning requirements, imposed the new warning requirements without accounting for the efficacy of existing warning label regimes, and insisted on a warning scheme that imposes greater burdens on cigars and pipe tobacco than cigarettes, despite the fact that the agency recognizes that cigarettes carry a greater public health risk. The warning requirements are arbitrary, capricious, an abuse of discretion, and not in accordance with law; contrary to constitutional right, power, privilege, or immunity; and in excess of statutory jurisdiction, authority, or limitations, or short of statutory right
With the user fees, both motions call out the fact that while cigar and pipe tobacco are subject to them, e-cigarettes are not. “The FDA mangled Congress’s mandate that every industry regulated under the TCA pay for its own regulation. In the Deeming Rule, the FDA chose to regulate cigars, pipe tobacco, and e-cigarettes. Of those, it is charging only cigars and pipe tobacco, which in turn pay for the cost of regulating e-cigarettes. The Act calls these “user fees,” but when all “users” of a regulatory system do not pay, it is a “tax.” Nothing gives the FDA that power.”
Not covered under the motions are the regulations imposed by the Deeming Regulations are new products now requiring premarket approval by the FDA in order to enter the marketplace. Recently the FDA has stated it is reexamining this portion of the Deeming Rule.
The lawsuit against the FDA is a joint effort between the Cigar Association of America (CAA), Cigar Rights of America (CRA), and International Premium Cigar and Pipe Retailers (IPCPR). With the current timeline, opening arguments are expected to commence early next year.