FDA, HHS Ask Court to Dismiss Menthol Cigarette Ban Lawsuit

Attorneys representing the government in a lawsuit that seeks to force the FDA to ban menthol cigarettes have informed a federal court that they will seek to have the lawsuit dismissed.

Yesterday, the government filed a motion to dismiss in African American Tobacco Control Leadership Council et al. v. U.S. Department of Health and Human Services et al., a federal lawsuit filed by four public health groups against the U.S. Food & Drug Administration (FDA) and the Department of Health and Human Services (HHS) in a federal court in California. In its motion, the government argues two main points: first, the plaintiffs do not have grounds to sue because they have suffered no harm, and second, the FDA hasn’t delayed acting because Congress did not create a deadline.

In April, the plaintiffs sued, arguing that FDA’s repeated delays in enacting a ban on menthol cigarettes is in violation of the Tobacco Control Act. The government has countered by pointing out that when Congress passed the Tobacco Control Act in 2009, all flavored cigarettes were ban except for menthol cigarettes. There was no deadline set for when HHS, which then delegated the matter to the FDA, needed to act.

In 2022, FDA opened a federally-required comment period that allowed individuals, groups and companies to speak in favor or against its upcoming proposals to ban the sales of menthol cigarettes and flavored cigars. Technically, these are two different proposals, though the two have gone through the regulatory process using identical timelines. This lawsuit only focuses on menthol cigarettes, though if the plaintiffs win, it would likely induce action on a flavored cigar ban.

In April 2024, Xavier Becerra—the secretary of HHS—announced that the menthol cigarette ban—and presumably the flavored cigar ban—was placed on hold. Previously, the FDA repeatedly said that the rules would be announced before the end of 2023.

“This rule has garnered historic attention and the public comment period has yielded an immense amount of feedback, including from various elements of the civil rights and criminal justice movement. It’s clear that there are still more conversations to have, and that will take significantly more time,” said Becerra. Those comments were reiterated in yesterday’s filing in federal court.

This lawsuit was filed three weeks before the Biden administration announced that it was delaying the menthol cigarette ban.

“Plaintiffs have not alleged any concrete injury from the alleged delay in promulgating a final rule prohibiting menthol as a characterizing flavor in cigarettes, such as an impediment to their operations. At most, they have alleged a setback to their abstract social interests, which is insufficient to establish standing,” wrote attorneys representing the government.

Those attorneys cite a Supreme Court decision made last month, FDA v. Alliance for Hippocratic Medicine, when the court unanimously held that a group of doctors did not have standing to sue over FDA’s approval of mifepristone, an abortion pill, because the doctors had not suffered any harm.

In this menthol cigarette case, the government alleges that the only harms these groups have suffered are their own beliefs against the sale of menthol cigarettes and that the groups have had to divert resources that could be used for other programs to ones focused on menthol cigarettes. The attorneys argue the Supreme Court recently found this type of harm was insufficient as it “would mean that all the organizations in America would have standing to challenge almost every federal policy that they dislike, provided they spend a single dollar opposing those policies.”

The second part of the argument is more straightforward: Congress never set a deadline to ban menthol cigarettes; in fact, it never required HHS—or FDA—to ban menthol cigarettes.

The lawsuit didn’t shed much additional light as to the current delay, which many have speculated is related to concerns over support from Black voters in the upcoming election. Yesterday’s motion indicates the “the draft rule is still with OIRA for interagency review and the agency has not made the requisite determination in subsection (A) of the statute, the agency is not required to promulgate a final rule.” This would confirm what is already publicly confirmed: the FDA submitted its rule to the White House Office of Management and Budget Office of Information and Regulatory Affairs (OIRA), which has held nearly 13,000 meetings over the rule.

A hearing for the matter is scheduled for Sept. 12, 2024, at a federal court in Oakland.

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.