FDA Sued for Second Time Over Delay in Banning Menthol Cigarettes

A coalition of medical and civil rights organizations announced it is filing a second lawsuit against the Food and Drug Administration (FDA) for failing to meet deadlines to implement the U.S. ban on menthol cigarettes.[1].

The African American Tobacco Control Leadership Council (AATCLC), Action on Smoking and Health (ASH) Washington, and the National Medical Association (NMA) have filed a second lawsuit against the U.S. Food and Drug Administration (FDA) for its failure to publish the text banning menthol cigarettes. The lawsuit comes more than seven months after the deadline for publication. The FDA has two months to respond.

Menthol cigarettes delayed by more than 10 years

In 2020, AATCLC and ASH had already jointly filed a complaint against the FDA health authorities. By not banning menthol in the same way as other flavors, the complaint pointed to the lack of action by the competent authorities to protect the lives of thousands of Americans, particularly African-Americans, from premature deaths and diseases linked to the consumption of these tobacco products.

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act which establishes a ban on flavors in cigarettes but excludes menthol from the scope of this ban, subject to additional research. In 2011, the FDA advisory committee concluded after a review of scientific knowledge that " Removing menthol cigarettes from the market would benefit public health in the United States " Two years later, a report from the same institution established that if menthol cigarettes had been withdrawn from the market in 2010, approximately 17,000 premature deaths would have been avoided over the period up to 2020 and approximately 2.3 million people would not have started smoking.

Following the plaintiffs’ initial lawsuit, the FDA made the historic decision to add menthol to the list of prohibited characteristic flavors in cigarettes. The FDA then issued a notice of proposed rulemaking to ban the sale of menthol cigarettes on the market. The plaintiffs subsequently withdrew their initial lawsuit. However, three years later, the FDA has yet to formally promulgate and publish the ban. After initially setting an August 2023 publication date, the White House updated its Office of Information and Regulatory Affairs website to March 2024. That deadline has once again been missed.

Tobacco Industry Pressure on the White House

Health groups are lamenting the delay and denouncing the Biden administration for caving to pressure from the tobacco industry. The Campaign for Tobacco-Free Kids reported last December that the announcement of the March 2024 deadline came just two weeks after the tobacco industry and several of its lobbyists had encounter senior White House officials. The Biden administration’s public schedule of meetings on regulatory action shows that during the month of November 2023, 41 meetings have been scheduled regarding menthol regulation; 38 were with representatives of the tobacco industry and its allies, while the other three were with representatives of public health organizations.

Keywords: FDA, menthol, ban, Action for smoking and health, lawsuit, interference, lobby

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AE

[1] Press release, Health groups file second lawsuit against the US FDA, Action for smoking and health, published on April 2, 2024,