October 18, 2017 Charlie Minato FDA/Deeming Regulations,  News

Court Rejects Health Groups Attempt to Enter FDA Cigar Lawsuit

In July, six health groups asked to be named as co-defendants in a lawsuit regarding the U.S. Food & Drug Administration’s (FDA) regulation of premium cigars. Their motion has been denied.

U.S. District Court Judge Amit P. Mehta rejected the motion to intervene by the six groups, collectively known as Public Health Intervenors, ruling that the groups could not prove that the reversal of new FDA cigar regulations would cause “concrete and demonstrable injury” and that the groups could not prove FDA would not defend the rule.

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

They requested to be named as co-defendants to ensure that FDA defended the deeming regulations in full. The groups argued that recent actions, such as a three-month delay in implementation dates earlier this year and public comments from the head of FDA, suggested the agency was reconsidering parts of the rule, specifically the health warning label requirements.

In their petition, they argued that the reversal of the health warning requirement would cause financial harm because the groups would be forced to spend more time and money educating people about the health risks around tobacco. Ultimately, Judge Mehta ruled that the groups were unable to prove that this constituted injury as required by law.

FDA itself took no position about whether the groups should join the lawsuit, the three cigar trade groups suing the agency—the Cigar Association of America (CAA), Cigar Rights of America (CRA) and the International Premium Cigar & Pipe Retailers Association (IPCPR)—objected to their inclusion.

In his opinion, Mehta pointed out that FDA has given no indication they plan on reversing warning label requirements:

Proposed Intervenors have not given the court sufficient reason to believe that Defendants will not defend those requirements to the fullest. If anything, Defendants’ decision not to reconsider or delay implementation of the warning requirements, when they did so for other portions of the Rule initially contested by Plaintiffs, strongly suggests that Defendants will aggressively defend those requirements.

He also repeatedly pointed out the groups were unable to prove the harms constituted as injury:

Not one of the Proposed Intervenors has come forward with evidence showing that invalidating the Rule would inhibit the organization’s daily operations. Nor has any Proposed Intervenor demonstrated that it would incur “operational costs beyond those normally expended” to educate the public about the risks of tobacco if the Rule were to be stricken. Proposed Intervenors’ offer of proof fares no better when the court focuses only on the warning requirements. Proposed Intervenors offer no new evidence with their supplemental brief that focuses on the harm that would arise from invaliding the warning requirements.

In a separate ruling, Mehta granted the cigar groups’ request to push back three deadlines regarding a motion for an injunction against the deeming rules. The plaintiff’s reply and opposition have been pushed back one week, while the two following dates have been delayed as well.

  • 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. 14 — Plaintiff’s reply and opposition
  • Dec. 4 — Defendants’ reply
  • Dec. 7 — Plaintiffs appendix of excerpts of the administrative record

It’s unclear whether the oral arguments regarding the motion(s) will still take place on Dec. 14 as originally scheduled.

American Academy of Pediatrics American Cancer Society Cancer Action Network American Heart Association American Lung Association Amit P. Mehta Campaign for Tobacco-Free Kids Cigar Association of America Cigar Association of America et al. v. United States Food and Drug Administration et al. Cigar Rights of America Deeming Lawsuit Deeming Regulations International Premium Cigar & Pipe Retailers Association Public Health Intervenors Truth Initiative
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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.

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