In late January, the U.S. Food and Drug Administration (FDA) withdrew its proposed rules to prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars. Although either proposal could be revived under a future administration, the withdrawal ends both of the current rulemaking processes. The move also strongly indicates shifting FDA priorities under the second Trump administration. Amid these changes, industry may find the agency more receptive to its arguments—particularly those submitted in comments to proposed rulemaking.

Background on Proposed Rules

In May 2022, FDA issued a notice of proposed rulemaking (NPRM), “Tobacco Product Standard for Menthol in Cigarettes.” This proposed rule would have prohibited menthol as a characterizing flavor in cigarettes. FDA received over 175,000 comments from stakeholders on all sides of the issue. Following the end of the comment period, FDA announced and missed several self-imposed deadlines for publishing the final rule. FDA’s Agendas for Fall 2022 and Spring 2023 stated that a final rule would be issued in August 2023. After FDA missed this deadline, its Fall 2023 Agenda stated that a final rule would be issued in March 2024. However, the Spring 2024 Agenda indicated that the final rule’s issue date was “to be determined,” and then-Secretary of Health and Human Services Xavier Becerra announced the final rule “will take significantly more time.”

On the same day in May 2022, FDA issued another NPRM, “Tobacco Product Standard for Characterizing Flavors in Cigars.” This proposed rule would have prohibited all characterizing flavors other than tobacco in all cigars. “Characterizing flavors” would include any artificial or natural flavor (other than tobacco), herb, or spice. FDA received roughly 71,000 comments on the proposal and, as with the menthol cigarette NPRM, announced and missed its self-imposed deadlines. FDA’s Fall 2022 agenda stated that a final rule would be issued in August 2023. The following year, FDA’s Fall 2023 agenda pushed the estimated finalization date to August 2024, but the agency missed this deadline as well.

Political pressure from key constituencies likely explains the Biden administration’s delay in issuing final rules ahead of the 2024 presidential election. Some organizations cautioned that prohibiting menthol cigarettes and flavored cigars, which are popular with Black smokers, would ultimately harm the Black community. For instance, the American Civil Liberties Union published an open letter to then-Secretary Becerra warning that the proposed menthol cigarette ban would “disproportionately impact communities of color, result in criminalization of the market, and exacerbate mass incarceration.” Similarly, the National Association of Black Law Enforcement Executives commented that both proposed flavor bans would “further add to the increase of negative law enforcement interactions which would lead to the continued mistrust of law enforcement in the black and brown communities.”

Shifting FDA Perspectives and the Importance of Comments

The recent withdrawal of both proposed federal flavor bans is compelling evidence that the Trump administration is taking a less aggressive rulemaking posture compared to the Biden administration. The Office of Information and Regulatory Affairs withdrawal filings do not detail the reasoning behind the decision. However, several comments submitted during each proposed rule’s comment period detail ample justifications for withdrawing the proposals.

For instance, with respect to the menthol cigarette ban, industry argued that illicit markets would proliferate, fed by consumer demand for menthol cigarettes despite the proposed prohibition.

Comments to the flavored cigar ban raised similar concerns about facilitating illicit markets. Regarding both proposals, commenters also highlighted the fact that youth use of menthol cigarettes and flavored cigars had already reached historic lows without federal prohibition.

The comment process is the most direct method for stakeholders to provide their perspective to the agency during formal rulemaking. On the one hand, when an agency is insistent on establishing a policy, submitting comments allows opposing stakeholders to document important evidence. For instance, in the context of FDA’s Deeming Rule, a federal district court vacated the rule as to premium cigars, finding that FDA was arbitrary and capricious when it asserted that it received “no data” to support differential use patterns resulting in lower health risks for premium cigars. The agency had, in fact, received such data in comments from the industry. The district court’s reasoning was recently affirmed by the U.S. Court of Appeals for the District of Columbia Circuit.

On the other hand, when an agency may be receptive to stakeholders’ perspectives, the comment process allows stakeholders to provide evidence and arguments supportive of the desired agency action. Under both scenarios, the submission of comments is critical for industry members seeking an informed regulatory process.

Why It Matters

Another Biden-era proposal—to drastically limit the nicotine content of cigarettes and certain other combustible tobacco products—remains pending and open for comments until September 15, 2025. As we recently discussed here, the proposal would set a maximum nicotine content for combusted cigarettes, cigarette tobacco, roll-your-own tobacco, cigars (excluding premium cigars), and pipe tobacco (excluding waterpipe tobacco). To lawfully market such products, manufacturers would be required to reformulate their products and receive premarket authorization within two years of the final rule’s publication.

Our team regularly supports clients in preparing comments on agency rules. If you have questions about the implications of the nicotine content limit NPRM as it pertains to your business, our team is happy to assist.