FDA Announces ANPRM to Reevaluate Cigar Regulations

The U.S. Food & Drug Administration (FDA) is formally reevaluating whether it will continue to regulate premium cigars.

On Monday, FDA will issue an Advanced Notice of Proposed Rulemaking (ANPRM) on whether to regulate premium cigars differently from other products in the deeming regulations.

An ANPRM serves a formal document showing the agency’s thinking on a particular issue, as well as an opportunity for both the public and industry to comment on the potential changes. It is not a formal commitment to change the rule.

This ANPRM is specifically looking at what is the definition of premium cigar, whether premium cigars have different health impacts from non-premium cigars and whether premium cigars have different use patterns from non-premium cigars.

The comment period runs 90 days, meaning it will end on June 25.

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When FDA was evaluating the regulations in 2014, it asked similar questions regarding whether it should exempt premium cigars from FDA regulation, as well as what qualifies as a premium cigar. Ultimately, it chose to regulate all cigars the same, stating that it believed that all cigars are dangerous and there was no evidence that proved why premium cigars should be regulated differently.

FDA acknowledges that post-2016 there has been at least one additional study that is favorable to premium cigars. In addition, it appears the cigar industry’s multi-pronged lobbying campaign has been successful.

“Given the ongoing interest from many parties and sectors, such as industry and Members of Congress, in the regulatory status of premium cigars, FDA is issuing this ANPRM to request relevant new and different information, data, and analysis not submitted in response to FDA’s proposed deeming rule (79 FR 23142, discussed below) that could inform FDA’s regulation of premium cigars,” says the ANPRM.

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This is the third tobacco-related ANPRM FDA has issued in two weeks. One was regarding whether the agency should establish maximum levels of nicotine for cigarettes and other tobacco products; another deals with potentially increasing regulations for flavored tobacco.