An Update On The Cigar Industry's Lawsuit

It's been a few months since we last did an update on the cigar industry's lawsuit against the FDA. The last time we checked in, Judge Mehta sided with the cigar industry and threw out the FDA's Deeming Rules after he concluded that the FDA had made errors in its approach to regulating premium cigars.

The Department of Justice (who represents the FDA in court) has since filed an appeal of that ruling. Nothing in this appeal process disputes Mehta’s core finding: The FDA had failed to properly evaluate comments submitted prior to enacting the deeming rule. Rather, this lawsuit is about the path moving forward for the FDA and how long it will be before regulation can again be implemented. 

The government's appeal presents two main arguments: 

1:  The FDA reasonably believed there's no public health justification for leaving premium cigars entirely unregulated.

2: If the court finds flaws in the FDA's decision regarding premium cigars, the appropriate remedy should involve remanding without vacating (where Mehta instructs the FDA to fix the issues he has found with the regulations instead of starting the regulatory process all over again). 

While the lawsuit emphasizes the distinction between "cigars" and "premium cigars," the appeal often interchanges these terms. It does however, try to address some of the issues Mehta pointed out regarding the March 2022 NASEM report concerning the usage patterns and health effects of premium cigar smoking. The final part of the appeal debates over the definition of "premium cigar" used by the judge, which, funny enough, was actually formulated by the FDA in August 2020. 

Ultimately, the appeal asserts that the lack of consensus on the definition of "premium cigars" and the absence of clear standards highlight the district court's error, suggesting a remand without vacatur to allow the FDA to determine an appropriate definition.

In response to the appeal, the cigar industry has submitted and been granted an extension to allow for more time to respond. This extension was granted for 3 reasons.

1. To provide additional time for the cigar industry to review and respond to both the government’s filing and a brief which was filed by other public health organizations.

2. To allow the three plaintiffs and their respective member companies—cigar manufacturers, retailers, and suppliers—to collaborate on a unified legal strategy.

3. To allow for the filing of any briefs in support of the cigar industry.

This has been a drawn out appeals process already. The District Court vacated the rule for premium cigars on Aug. 9, 2023 after which the government waited 50 days to announce its appeal. It then immediately requested an extension for its own filing, which was granted on Dec. 20, 2023.

Ultimately, the FDA has made clear that it plans on attempting to further regulate premium cigars at some point.

While in my mind, this appeal is baseless and the FDA grasping at straws (again they are not disputing Mehta’s core finding) the legal process has to play out. Thankfully, because of Judge Mehta, we can now do so with "premium cigars" being exempt from testing requirements, user fees, and bans on retail promotions or charitable donations in the meantime. 

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