SYNOPSIS

Public health groups sued the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration over their failure to prohibit the sale of menthol cigarettes.

WHY IT MATTERS FOR PUBLIC HEALTH

This case illustrates how public health groups have used the law to hold the FDA accountable for its failure for years to prohibit the sale of menthol cigarettes. The African American Tobacco Control Leadership Council (AATCLC) sued the FDA to compel it to ban menthol because African Americans account for a disproportionate amount of all menthol smokers. A federal ban on menthol would save lives. 

BACKGROUND

The Family Smoking Prevention and Tobacco Control Act prohibits the sale of flavored cigarettes, but it has expressly exempted menthol and tobacco flavor cigarettes since its enactment in 2009. The Tobacco Control Act requires the FDA to periodically reevaluate tobacco product standards, including this special rule for cigarettes. For years after the passage of the Tobacco Control Act, the FDA did not reevaluate the product standard or take any action to issue a product standard prohibiting the sale of menthol cigarettes.

On June 17, 2020, AATCLC, Action on Smoking and Health, and the American Medical Association sued the FDA, alleging that the agency delayed unreasonably in banning menthol in cigarettes. The lawsuit challenged the FDA’s failure to respond to a citizen petition that the Public Health Law Center and other public health groups submitted in 2013, asking the agency to prohibit menthol in cigarettes.

On April 29, 2021, the FDA announced that it planned to propose a rule prohibiting menthol by April of 2022. The AATCLC’s lawsuit was thus successful in motivating the FDA to add menthol to the list of banned flavors in cigarettes. On June 1, 2022, the plaintiffs announced their intent to dismiss their lawsuit in light of the FDA’s action. The FDA accepted comments on the proposed rule and expressed its intent to issue a final rule by August of 2023, a date that was then revised to March of 2024.

PROCEEDINGS

On April 2, 2024, the AATCLC, joined by the Action on Smoking and Health, the National Medical Association, and the American Medical Association, sued the FDA for a second time in the Northern District of California, after the revised deadline for the menthol rule came and went without the menthol rule being finalized. The plaintiffs argue that the FDA has unreasonably delayed the issuance of a final rule to prohibit menthol, and that in so doing the agency is violating the Tobacco Control Act and the Administrative Procedure Act. Their complaint calls on the agency to finalize the rule as soon as possible.

LITIGATION STATUS (OPEN)

The plaintiffs filed their complaint in the U.S. District Court for the Northern District of California on April 2, 2024.

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