Will the FDA Adopt an Arbitrary and Capricious Ban on Menthol Cigarettes?

The research the FDA relies upon to claim banning menthol cigarettes would improve public health is not aligned with the agency's approach to tobacco regulation.

The U.S. Food & Drug Administration is considering whether to ban menthol-flavored cigarettes. The agency first proposed a ban in 2022, but it has yet to finalize the proposal, prompting some activist groups to sue. (Query whether these groups have standing.)

The FDA and those groups calling for a ban on menthol cigarettes claim that this will benefit public health, but it's not clear the relevant medical research supports this claim, as it is not clear that such a ban will do much to reduce smoking rates or smoking initiation. This is particularly true as some relevant research assumes that users of menthol cigarettes would be able to switch to menthol (or other) flavored e-cigarettes. This is a problem as the FDA has refused to approve any non-tobacco-flavored e-cigarettes to date.

Over at Slate, Jacob Grier looks at the politics of a potential menthol ban, but also discusses the legal peril of the FDA relying upon such research to support a ban on menthol cigarettes.

The FDA's proposed menthol rule relies heavily on a study published in 2021 projecting that a federal ban would avert about 650,000 premature deaths by the year 2060, demonstrating a substantial benefit to public health. However, the modeling in that study assumes that many smokers of menthol cigarettes would switch to e-cigarettes rather than to regular, unflavored cigarettes, and that this switch is most likely to occur if e-cigarettes are available in menthol flavors. The catch? So far, the FDA hasn't authorized a single e-cigarette for sale in menthol or any other nontobacco flavor. . . .

Cliff Douglas, an adjunct professor at the University of Michigan and the president of the Foundation for a Smoke-Free World, is one of the co-authors of the 2021 study mentioned above. "Our modeling on which the FDA depends found that the menthol cigarette ban will be significantly less effective if the agency hasn't provided for a legal, authorized market for alternative products to which smokers of menthol cigarettes can turn," says Douglas. Authorized e-cigarettes are currently a "minuscule percentage of the marketplace," limited to just a handful of products, he notes. Since Biden's 2022 appointment of Brian King as director of the FDA's Center for Tobacco Products, the agency hasn't authorized any e-cigarettes at all.

That doesn't merely make a federal menthol ban less effective; it also opens it up to legal challenge. "If the FDA relies on science, including what we generated, they can't cherry-pick it and just give it partial credence and ignore the rest," says Douglas. "That creates a target for legal challenge for being arbitrary and capricious." This is a reasonable concern given the FDA's recent track record in other tobacco cases: The agency's regulation of premium cigars was struck down last year for being arbitrary and capricious, and e-cigarette makers have prevailed on challenges to its regulatory processes in the U.S. Court of Appeals for the 5th Circuit, producing a circuit split that may reach the Supreme Court.

I've noted before that the FDA has a vaping problem, but it seems the agency's difficulties may extend to combustible tobacco products as well.