Proposed FDA Rules Banning Menthol Cigarettes and Flavored Cigars Delayed Again

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With the calendar turning to April, the Food and Drug Administration’s (FDA) most recent estimated timeline for finalization of the proposed rules that would ban menthol cigarettes and flavored cigars has passed. In December 2023, FDA targeted issuance of final rules in March 2024. So where do things stand, and what is the outlook?

The final rules have been under review by the White House’s Office of Management and Budget (OMB) since October 2023. This is step eight of the nine-step federal rulemaking process. During the review process, OMB evaluates whether to clear the rule for final publication or send it back to the FDA for further review. Usually, this review process lasts 30 to 90 days and includes meetings between interested stakeholders and the OMB’s Office of Information and Regulatory Affairs (OIRA).

According to the OIRA dashboard, it has engaged in over 150 meetings with tobacco retailers, manufacturers, wholesalers, and trade associations as well as policy groups and tobacco control organizations. The National Association of Tobacco Outlets (NATO) meeting took place in December 2023. Additionally, more than 250,000 comments were submitted to FDA during the proposed rules’ public comment period, with the overwhelming majority opposing the implementation of these rules.

The FDA’s Center for Tobacco Products (CTP) has continually said that finalizing these rules is a top priority for the Agency. Due to all of the engagement in opposition to these proposals, they have become an election issue, and as a result one of the possible scenarios is that the rules will not be finalized until at least after the November election, if at all. Just last week, tobacco control groups in response to the delay filed a lawsuit claiming that the FDA has unlawfully delayed finalizing the rule to ban menthol cigarettes. It remains to be seen if this will spur action by the FDA before the election.

Of note, if these rules are finalized in the coming weeks or months, and if FDA follows through on its initial proposals, they will not take effect for at least one year from the date of each final rule’s publication. Courts reviewing industry challenges to the rules could also further delay these effective dates. 

The delay in the finalization of the menthol and flavored cigar rules also likely affects the timeline of proposing a rule that would require lowering the amount of nicotine in cigarettes. As FDA has not even published a proposed rule relating to reducing nicotine in cigarettes, this rulemaking is in the very early stages of the nine-step rulemaking process, and it will therefore be years before it makes its way through the regulatory process, if at all.

NATO encourages all stakeholders who have a position on these rules to continue to engage their federal elected officials.

David Spross is the executive director of NATO, a tobacco retailing association based in Lakeville, Minnesota. Reach him at david.spross@natocentral.org.  To learn more about NATO, visit www.natocentral.org.

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