On April 2, 2024, three tobacco control groups filed a lawsuit requesting a federal district court to issue an order directing the U.S. Food and Drug Administration (FDA) to promulgate (i.e., finalize) the agency’s proposed regulation banning the use of menthol in cigarettes and publish the final regulation in the Federal Register, all “within a reasonable timeframe.” The three groups that filed the lawsuit include the African American Tobacco Control Leadership Council, the Action on Smoking and Health, and the National Medical Association. This lawsuit names the U.S. Department of Health and Human Services (HHS), the FDA, and the FDA’s Center for Tobacco Products (CTP) as defendants.
As background, these same tobacco control groups, plus the American Medical Association, filed a lawsuit in June of 2020 against the HHS, FDA and CTP to compel the FDA to: (1) make a formal determination about whether menthol should be added to the list of banned characterizing flavors in cigarettes, and (2) respond to the plaintiffs’ Citizen Petition, which requested the FDA to promulgate a final rule banning menthol as a characterizing flavor in cigarettes. This first lawsuit was voluntarily dismissed by the plaintiffs on June 1, 2022, after the FDA published a formal proposed regulation banning the use of menthol in cigarettes.
However, the plaintiff’s state that the reason this second suit has been filed is due to the FDA’s continued delay in the finalization and publication of the menthol cigarette ban regulation.
Under federal law, an agency must follow a nine-step process when proposing and finalizing a new federal regulation. The chart
shown here
lists these nine steps. The FDA’s proposed regulation banning the use of menthol in cigarettes is currently in Step 8, which requires the White House Office of Management and Budget (OMB) to review and either approve, modify, or not approve the proposed regulation. Step 9 involves the publication of a final regulation in the Federal Register.
Last fall, the Office of Information and Regulatory Affairs within the OMB included in the federal government’s “Unified Agenda of Regulatory and Deregulatory Actions” a statement that the FDA’s proposed ban on the use of menthol in cigarettes should be finalized by March of 2024. Since this deadline has now passed without final action on the proposed menthol ban regulation by the OMB, the plaintiffs have filed this second lawsuit to compel the finalization and publication of the menthol regulation.
A copy of the new lawsuit complaint filed by the plaintiffs against the HHS, FDA and CTP can be found
here.