As expected, the cigar industry is asking the court for an injunction against the U.S. Food & Drug Administration’s (FDA) deeming regulations of cigars.
In a motion filed with the U.S. District Court as part of the ongoing lawsuit against FDA, three cigar trade groups—the Cigar Association of America (CAA), Cigar Rights of America (CRA) and the International Premium Cigar & Pipe Retailers Association (IPCPR)—requested summary judgment and an injunction on the warning label plan and FDA’s ability to collect user fees.
The filing largely centers on four pillars.
First, the groups argue that the warning labels, particularly the warning plan that would require manufacturers and retailers to submit plans for ads and their associated warning labels 12-months in advance, are unconstitutional.
“The agency failed to make the findings required by the (Tobacco Control Act) to justify imposition of warning requirements, imposed the new warning requirements without accounting for the efficacy of existing label regimes, and insisted on a warning scheme that imposes greater burdens on cigar and pipe tobacco than cigarettes, despite the fact that the agency recognizes that cigarettes carry a greater public health risk,” argues the motion.
The second area is in regards to user fees, which are fees paid by cigar makers to help fund FDA’s regulation of tobacco products. The fees, which will total $672 million for FY2018, are paid for by six product categories: cigarettes, roll-your-own, snuff, chewing tobacco, cigars and pipe tobacco.
Cigar makers will be responsible for about $66.4 million of that for FY2018, which is expected to be less than 5 cents per cigar.
In the motion, the groups argue that FDA’s decision not to regulate e-cigarettes violates the equal protection component of the fifth amendment.
hen FDA announced the deeming regulations last year, the agency said it did not believe it could impose user fees on e-cigarettes because the category was not listed in the Tobacco Control Act’s outline of user fees. That will likely change in 2020 when the law needs to be renewed and a new user fee schedule is set.
It should be noted that up until this past year, cigars and pipes did not pay user fees—because they were not being regulated—meaning that the other four categories were responsible for paying the user fees for the two categories.
Pipes are actually two of the four parts of the motion. The groups argue the Tobacco Control Act wrongly classifies retailers who blend pipe tobacco as “tobacco product manufacturers.” This means that any tobacconist that mixes their own pipe tobacco are subject to manufacturer regulations largely designed for businesses who primarily make tobacco products. Furthermore, the groups argue that pipes should not be considered a “component” under the deeming regulations.
The groups ask the court to grant partial summary judgment and:
- Vacate and set aside the:
- Warning labels
- Classification of retailers who blend pipe tobacco as manufacturers
- FDA’s definition of “component or part” to include pipes
- Vacate and set aside the user fee
- Declare the deeming rule violates the first amendment
- Enter a permeant injunction on the warning label requirement
- Enter a permeant injunction from implementing or enforcing the other challenged aspects of the deeming rule
- Enter a permeant injunction against the user fees
- Award plaintiffs their attorneys’ fees
There is also the possibility the court decides to grant a temporary restraining order, which would temporarily bar FDA from enforcing some parts of the deeming rule until a further ruling. Before that happens, FDA will need to respond in court.
On Sept. 19, Amit P. Mehta issued the following schedule:
- Oct. 3 — Plaintiffs” motion for summary judgment
- Oct. 10 — Briefs of any amici granted leaf to file in support of plaintiffs
- Oct. 24 — Defendants’ opposition and cross-motion for summary judgment
- Oct. 31 — Briefs of any amici granted leave to file support of defendants
- Nov. 7 — Plaintiff’s reply and opposition
- Nov. 21 — Defendants’ reply
- Dec. 1 — Plaintiffs appendix of excerpts of the administrative record
- Dec. 14 — Oral arguments on the motion(s)