Companies File Joint Comments Seeking Premium Cigar Exemption from FDA

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Six of the world’s largest cigar companies have filed joint comments regarding the FDA’s regulation of premium cigars, advocating that the agency is not able to justify the costs of regulation against its public health mission.

Those companies include Davidoff, Drew Estate, General Cigar Co., Tabacalera Perdomo, Tabacalera Unidas (CLE) and Tabacalera USA (Altadis U.S.A.) Those companies are all members of the Cigar Association of America (CAA), a group that includes mass market cigar makers as well. Of note, the joint comments are only on behalf of these companies and not on behalf of CAA itself.

To learn more about the FDA’s regulation of cigars, click here.

THE BASICS

The comments are filed as part of the U.S. Food & Drug Administration’s (FDA) comment period on substantial equivalence, one of the pathways manufacturers can use to gain approval for tobacco products from the agency. FDA is in the process of redoing its substantial equivalence process in order to make it more streamlined for both manufacturers who apply for substantial equivalence and the agency itself. As part of that overhaul, the agency is required to solicit comments from the public and industry about what it should do.

That being said, the comments aren’t about how to streamline the substantial equivalence process. Rather, they call for FDA to exempt premium cigars from having to go through the approval process. Technically, the comments do not specifically argue for an exemption from warning labels, though they do disagree with the regulatory process for premium cigars as a whole.

Due to a recent court case, substantial equivalence is set to be due on May 12, 2020, a date that the cigar industry is appealing in separate court filings. Up until that court decision, the reports were not due until August 2021.

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