A Rule That Ran Out of Road
On April 29, 2022, the U.S. Food and Drug Administration published a proposed rule in the Federal Register that would have prohibited menthol as a characterising flavour in cigarettes. The proposal cited the agency's authority under the Family Smoking Prevention and Tobacco Control Act of 2009, which granted the FDA power to set product standards — including the elimination of flavours other than tobacco — if doing so would benefit public health. Menthol had been explicitly carved out of the 2009 Act's immediate flavour ban, left for the agency to address separately. The April 2022 notice was that address.
The proposed rule drew a substantial comment record. The FDA received hundreds of thousands of submissions , ranging from public-health organisations citing disproportionate menthol use among Black smokers to tobacco manufacturers contesting the evidentiary basis and projecting market disruption. Enforcement concerns were raised separately: critics noted that a federal ban on a widely used legal product could generate illicit trade, a complication the agency acknowledged in its regulatory impact analysis.
The proposed standard reaches the number only after hundreds of pages of preamble.
Photo: Mikhail Nilov / Pexels
The Office of Management and Budget received a final rule package for review in late 2023, a procedural step that typically precedes publication. The rule did not publish. In 2024, the Department of Health and Human Services decided not to finalise the menthol product standard , citing the complexity of the enforcement landscape and the need for further analysis. No withdrawal notice was placed in the Federal Register as a formal rulemaking action; the decision was communicated through an HHS statement, leaving the April 2022 proposed rule technically open on the docket while operationally dormant.
The episode follows a documented pattern in FDA tobacco rulemaking: proposed standards that clear the notice-and-comment stage but stall before finalisation. The agency's proposed nicotine product standard, announced in July 2017, remained unfinished years later through successive administrations. For menthol, the 2024 non-finalisation did not rescind the underlying legal authority. The FDA retained — and retains — the statutory power to propose the standard again.
