Into the Ashtray: FDA’s Previous Proposal to Ban Menthol Cigarettes

On January 21, 2025, the Trump administration withdrew FDA’s proposed ban on menthol cigarettes, which the Biden administration initially introduced in 2022.  This move is the latest step in FDA’s long, uncertain, and controversial journey to ban menthol cigarettes.

For some background (which is covered in more detail in one of our previous posts on the subject), in 2009, Congress specifically exempted “tobacco or menthol” when it prohibited all other flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA)’s “Special Rule for Cigarettes.”  The bill’s legislative history noted several unique features of menthol and mentholated cigarettes, including “the large number of Americans who smoke menthol, the disproportionate prevalence of menthol cigarettes among African Americans, the racial and ethnic differences in lung cancer incidence, and the uncertainty about the potentially negative consequences of an immediate menthol ban. . . .” H.R. Rep. No. 111-58, at 38-39 (2009).  Given these features, the TCA authorized FDA to ban or modify the use of menthol in cigarettes based on scientific evidence, and required FDA to study and report on the impact of the use of menthol cigarettes on the public health through a newly created Tobacco Product Scientific Advisory Committee (TPSAC). 21 U.S.C. § 387g.

Despite TPSAC’s conclusion in 2011 that “[m]enthol cigarettes have an adverse impact on public health in the United States,” TPSAC did not recommend, and FDA did not take, any regulatory action until 2013, when FDA issued an advance notice of proposed rulemaking (ANPRM) to obtain more information regarding the potential regulation of menthol in cigarettes. 78 Fed. Reg. 44,484 (July 24, 2013).  As an aside, TPSAC and its 2011 report were not without controversy; although later overturned by the D.C. Circuit Court, the lower court entered a scathing opinion stating, among other things, that TPSAC’s findings and recommendations were “at a minimum, suspect, and, at worst, untrustworthy” (see our posts on the District Court and Circuit Court decisions for more details).

Around five years later, in November 2018, the Trump administration announced its own plans to ban menthol cigarettes, which faced significant opposition and was ultimately abandoned.  In April 2021, in response to a citizen petition to prohibit menthol cigarettes and a court order directing FDA to respond, FDA announced its commitment to issue a proposed product standard to prohibit menthol as a characterizing flavor in cigarettes “within the next year.”

FDA met its deadline and issued its proposed rule in April 2022 (at the same time, the Agency issued a proposed rule prohibiting all characterizing flavors, other than tobacco, in cigars).  After FDA extended the comment period and missed deadlines to finalize the rule, in April 2024, the Biden administration announced that it would indefinitely delay issuance of the final rule.  However, at a House Energy and Commerce Committee hearing last September, the director of FDA’s Center for Tobacco Products stated that “FDA has not abandoned the menthol product standard…it’s presently with the White House and continues to be a priority for us.”

Since the withdrawal, public health groups and other advocacy organizations have pledged their continued commitment to achieve a ban on menthol cigarettes.  Given the new administration’s withdrawal, it seems possible that it may similarly withdraw the Biden administration’s proposed rule to establish maximum nicotine levels in combusted tobacco products (see our post on that proposed rule here).  The future of these regulatory efforts is uncertain, but for now, we wouldn’t hold our breath on either.