Health Groups Respond in FDA Cigar Lawsuit

Six health groups, collectively known as Public Health Intervenors, have responded to a motion from cigar trade groups about whether the health groups should be allowed to participate as co-defendants alongside the U.S. Food & Drug Administration (FDA) in a lawsuit over the agency’s deeming regulations.

The health groups are:

• American Academy of Pediatrics
• American Cancer Society Cancer Action Network
• American Heart Association
• American Lung Association
• Campaign for Tobacco-Free Kids
• Truth Initiative

On Monday, they filed a response to a motion from the plaintiffs—the Cigar Association of America (CAA), Cigar Rights of America (CRA) and the International Premium Cigar & Pipe Retailers Association (IPCPR)—who opposed the organizations becoming co-defendants in CAA et al. vs FDA et al.

The health groups asked the court to be added to the lawsuit, because they fear FDA will not fully enforce the deeming regulations, something that was reinforced in Monday’s motion.

In the opening part of the motion, the groups point to an announcement last month that delayed the filing deadlines for substantial equivalence, a product approval process, and indicated FDA was looking into reevaluating parts of the rule, specifically related to cigars:

Moreover, the FDA has now made clear that it seeks flexibility to reconsider important aspects of the Deeming Rule, including its regulation of many cigars. The decisions and future rulemakings the FDA described on July 28 confirm that the FDA’s views of the Deeming Rule— including the costs and benefits of regulation in this area—differ substantially or at least diverge from those of Public Health Intervenors, putting an exclamation point on why Intervenors’ interests may not be adequately represented in this litigation. At an absolute minimum, the FDA Defendants will seek flexibility to revisit settled portions of the Rule, giving them a goal in this suit that is inconsistent with Intervenors’ interests.

The court will need to rule on whether the health groups should be allowed to be co-defendants. FDA stated it had no opinion on the matter other than perhaps the court should wait, as it believes the lawsuit might be heading in a different manner. The cigar trade groups objected on a variety of fronts, which is what the health groups were responding to.

Cigar smokers will likely find some joy in reading the motion as it clearly shows the health groups are concerned that FDA is likely to weaken the deeming regulations, however, it also shows the health groups might add complications to the process.

There’s a scenario, whether as co-defendants in this lawsuit or as plaintiffs in another lawsuit, the health groups will be opposed to FDA’s decisions regarding the deeming rules. The Monday filing argued that this could be made easier by adding them Public Health Intervenors to the lawsuit:

For similar reasons, granting intervention now rather than deferring resolution of the motion—as Defendants suggest—would promote judicial economy. For example, if Public Health Intervenors are granted party status, they can participate in discussions about concessions Defendants might make in exchange for Plaintiffs dropping their suit. If Public Health Intervenors are part of those negotiations, they can let Defendants know which concessions they would likely challenge in the future and help develop a resolution that prevents additional litigation.

Due to a variety of delays, the opening of oral arguments in the trial will not start until 2018.

Charlie Minato

I am an editor and co-founder of halfwheel.com/Rueda Media, LLC. I previously co-founded and published TheCigarFeed, one of the two predecessors of halfwheel. I have written about the cigar industry for more than a decade, covering everything from product launches to regulation to M&A. In addition, I handle a lot of the behind-the-scenes stuff here at halfwheel. I enjoy playing tennis, watching boxing, falling asleep to the Le Mans 24, wearing sweatshirts year-round and eating gyros. echte liebe.