FDA Formally Sends Flavored Cigar Rule to OMB For Review

October 16, 2023 By Matthew Tabacco

The U.S. Food and Drug Administration (FDA) has taken a significant step in addressing the issue of flavored cigars and menthol in cigarettes by sending their proposed rules to the White House Office of Management and Budget (OMB) for review. 

The proposed rules, which were sent to OMB on Friday, October 13, 2023, will now undergo a rigorous review by the Office of Information and Regulatory Affairs (OIRA) at OMB. During this process, OIRA will likely scrutinize FDA’s proposal, including asking questions about each rule’s economic impact and legal implications.

Regarding cigars, FDA began the initial rulemaking process in May 2022, when it proposed the initial rule and invited public comment on the action. On August 2, 2023, Cigar Rights of America submitted a formal comment to the record opposing the proposed rule on numerous grounds, including FDA’s failure to properly submit objective criteria for what constitutes a flavored cigar.

While premium cigars are not currently regulated by the FDA, (the result of a CRA-funded lawsuit against the agency’s authority to regulate premium cigars) CRA is still concerned about potential FDA actions regarding cigars in general and the impact these regulations could have on premium cigars in the future. 

CRA is currently evaluating the next steps in this process and analyzing the timeline for when FDA could publish a final rule.

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