The U.S. Food & Drug Administration is considering whether to ban menthol-flavored cigarettes. The agency first proposed a ban in 2022, but has yet to finalize the proposal, prompting some activist groups to sue. (Ask if these groups are standing.)
The FDA and groups calling for a ban on menthol cigarettes claim that this will benefit public health, but it is unclear whether the relevant medical research supports this claim, as it is unclear whether such a ban will do much to reduce smoking rates or smoking initiation. This is especially true as some relevant research assumes that menthol cigarette users would be able to switch to menthol (or other) flavored e-cigarettes. This is a problem since to date the FDA has refused to approve any non-tobacco flavored e-cigarettes.
At Slate, Jacob Grier examines the politics of a potential menthol ban, but also discusses the legal danger of the FDA relying on such research to support a ban on menthol cigarettes.
The FDA’s proposed menthol rule is based largely on a study published in 2021 that predicts a federal ban would prevent approximately 650,000 premature deaths by 2060, demonstrating a substantial public health benefit. However, that study’s model assumes that many menthol cigarette smokers would switch to e-cigarettes rather than regular, unflavored cigarettes, and that this shift is more likely to occur if e-cigarettes are available in menthol flavors. The socket? So far, the FDA has not authorized the sale of a single e-cigarette with menthol or any other non-tobacco flavor. . . .
Cliff Douglas, an adjunct professor at the University of Michigan and president of the Foundation for a Smoke-Free World, is one of the co-authors of the 2021 study mentioned above. “Our modeling that the FDA depends on found that banning menthol cigarettes will be significantly less effective if the agency does not provide a legal, authorized market for alternative products that menthol cigarette smokers can turn to,” he says Douglas. Licensed e-cigarettes currently represent a “tiny percentage of the market,” 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 has not authorized any e-cigarettes.
This doesn’t simply make the federal menthol ban less effective; it also exposes him to legal challenges. “If the FDA relies on science, including what we have generated, it cannot cherry-pick it and give it only partial credit and ignore the rest,” Douglas says. “This creates a target for legal challenge to be arbitrary and capricious.” That’s a reasonable concern considering the FDA’s recent track record in other tobacco cases: The agency’s regulation of premium cigars was struck down last year as arbitrary and capricious, and e-cigarette makers have prevailed over challenges to its trials regulations in the United States courts. of the 5th Circuit, producing a circuit split that could reach the Supreme Court.
I’ve noted before that the FDA has a problem with vaping, but it appears the agency’s difficulties may extend to combustible tobacco products as well.