FDA Sued Over Menthol Cigarette Ban Delay

Three public health groups have filed a lawsuit against the U.S. Food & Drug Administration (FDA), claiming that the agency has unlawfully delayed introducing a ban on menthol cigarettes.

The lawsuit was filed in the U.S. District Court for the Northern District of California by the African American Tobacco Control Leadership Council, Action on Smoking on Health, and National Medical Association. The lead plaintiff—the African American Tobacco Control Leadership Council (AATCLC)—is based in San Francisco.

This lawsuit hopes to get FDA’s proposed final rule that would ban the sale of menthol cigarettes enacted and enacted quickly. That proposal—along with a separate proposal to ban the sale of flavored cigars—was unveiled in April 2022. FDA opened a federally-required comment period that allowed individuals, groups and companies to speak in favor or against the proposals. If either ban becomes a finalized rule—i.e., the law—FDA will need to reply to those comments when it unveils the finalized rule(s).

The two proposals—the menthol cigarette ban and flavored cigar ban—are separate, though the agency has kept the timelines for both on the same schedule. The word “cigars” is mentioned in less than a dozen places throughout the document. Technically, this lawsuit only pertains to the menthol cigarette proposal.

Both finalized rules were expected to be announced sometime in the second half of 2023, though they were delayed in December. On Dec. 6, the White House Office of Management and Budget Office of Information and Regulatory Affairs unveiled its Fall 2023 Unified Agenda of Regulatory and Deregulatory Actions, a semi-annual update of various planned rules and regulations. That update confirmed what had been speculated: despite many public promises to enact the bans in 2023, they were being delayed until—at least—2024. Neither the FDA nor the Biden administration have given a reason for the delay.

The updated calendar listed both proposals as having a final rule date of “03/00/2024” though that date wasn’t binding. March came and went without any new final rules, so these groups sued.

Interestingly, this is not the first time the lead plaintiff has sued FDA over inaction on menthol. AATCLC was one of more than a dozen groups that created a formal Citizen Petition urging FDA to ban the sale of menthol cigarettes. That petition was unveiled in April 2013. After feeling like the agency had not met the legal requirements for responding to this formal petition, the groups sued the FDA in 2020. A judge ruled against the FDA and told the agency that it had until April 29, 2021 to respond to the groups.

On April 29, 2021, the agency responded.

The agency said that it would work on a finalized rule and announce it within a year. On April 28, 2022, it unveiled the proposed rules to ban the sales of menthol cigarettes and flavored cigars.

Part of what the three plaintiffs are complaining about has been that FDA has dragged out the process of announcing a menthol cigarette ban. The groups contend that Congress directed FDA to study the issue and make a determination about whether menthol cigarettes should be banned as part of the Family Smoking Prevention and Tobacco Control Act, which was signed into law in June 2009. The Tobacco Control Act—which, amongst other things, gave FDA the authority to regulate cigars—banned all flavored cigarettes except menthol, a specific carveout that is widely believed to have helped the bill pass in Congress.

It’s unclear what effect this particular lawsuit will have, partially because it’s unclear how close FDA is to announcing the finalized rules. Similarly, it’s still unknown as to why the two rules got delayed. It has been widely speculated that the Biden administration is hesitant to announce the menthol cigarette ban ahead of November’s election, though it’s unclear how real those concerns are. That said, the FDA has had a track record of getting sued by health advocates claiming that the agency is not living up to its mandate when it comes to tobacco regulations, and then losing those cases.

If the lawsuit has an effect in accelerating the menthol cigarette ban, it is likely also to accelerate a ban on flavored cigar sales. Given that FDA has treated these two proposals in tandem, that seems likely to continue, though—in theory—FDA could respond to this lawsuit by announcing the menthol cigarette ban but not the flavored cigar ban.

Whenever the finalized rules are announced, it is widely expected that tobacco companies will sue FDA.

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.