On April 2, three advocacy organizations filed a complaint in the U.S. District Court for the Northern District of California seeking an order directing the U.S. Food and Drug Administration (“FDA”) to promulgate its already-proposed rule banning menthol as a characterizing flavor in combustible cigarettes. The case comes as FDA has missed several internal deadlines for promulgating a final rule on the topic.
The African American Tobacco Control Leadership Council, Action on Smoking and Health, and National Medical Association (together, the “Plaintiffs”) filed suit against the U.S. Department of Health and Human Services, FDA, FDA’s Center for Tobacco Products, and the leaders of each agency in their official capacities.
This is the second suit by these Plaintiffs to compel a prohibition of menthol in cigarettes. In 2020, the Plaintiffs filed a similar action, which the federal government was unsuccessful in dismissing. Rather than continue defending the suit, FDA issued its May 2022 Notice of Proposed Rulemaking, “Tobacco Product Standard for Menthol in Cigarettes.” This proposed rule would prohibit menthol as a characterizing flavor in cigarettes. In light of FDA publishing this notice, the Plaintiffs voluntarily dismissed the first suit in June 2022.
The Plaintiffs allege in the present suit that FDA violated both the Administrative Procedure Act (“APA”) and the Family Smoking Prevention and Tobacco Control Act (“TCA”) by delaying the promulgation of its 2022 proposed rule. The agency’s failure to promulgate a final rule banning menthol in cigarettes amounts to “undue delay” under the APA, the Plaintiffs say, because the conditions in the TCA related to promulgating a final rule on this subject have long been satisfied. On this point, the complaint emphasizes that FDA has announced and missed several self-imposed benchmarks for promulgation of the final rule. Following the end of the comment period in August 2022, FDA announced in its Agendas for Fall 2022 and Spring 2023 that a final rule would be issued in August 2023. After no final rule was promulgated by this deadline, FDA’s most recent Agenda projected March 2024, as the final rule’s publication date. To date, no final rule has been promulgated with respect to the 2022 proposal.
Further, the Plaintiffs argue that the TCA requires FDA to act on menthol in cigarettes considering the evidence available to the agency. As directed by the TCA (21 U.S.C. § 387g(e)), the Tobacco Products Scientific Advisory Committee (“TPSAC”) provided FDA with a 2011 report reviewing evidence and making recommendations regarding menthol cigarettes. This report asserted that menthol masks the throat-irritating properties of cigarettes and disproportionately appealed to youth and minorities. In light of the TPSAC menthol report and the completion of the notice and comment period for the proposed menthol ban, the Plaintiffs argue that FDA must proceed with the menthol ban under the TCA. Specifically, they highlight that the TCA provides: “[a]fter the expiration of the period for notice and comment [on a proposed rule] . . . and after consideration of comments submitted . . . and any report from [TPSAC], the Secretary shall . . . if the Secretary determines that the standard would be appropriate for the protection of the public health, promulgate a regulation establishing a tobacco product standard . . . .” (21 U.S.C. § 387g(d)(1)(A)).
Why It Matters
This lawsuit comes as the latest in a series of moves that have previously proved successful in prompting FDA to propose action on menthol—though not yet to the point of promulgating a ban. FDA has considered a ban on menthol as a characterizing flavor in combustible cigarettes for several years. From a policy perspective, a ban on menthol cigarettes would likely penalize compliant companies while driving consumers to seek such products through illegal avenues. Industry members should continue to pay close attention to any potential movement on the menthol ban by FDA in response to this renewed pressure from advocacy groups.
