Tobacco

FDA Withdraws Premium Cigar Entry From Unified Agenda

Agency will wait on results of a study to give guidance on further premium cigar regulation
FDA building
Photograph: Shutterstock

SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) withdrew its entry related to premium cigars from the federal government’s Spring 2021 Unified Agenda of Regulatory and Deregulatory Actions. The FDA will instead wait for the results of an ongoing study before providing information on potential future regulations related to premium cigars.

The Unified Agenda, published twice a year, provides information about regulations the federal government is considering or reviewing. The fall 2020 Unified Agenda included an entry for a request for information that would seek broad public comment on the FDA’s research effort specific to premium cigars and their health effects, patterns of use and other factors.

Since that entry, however, the FDA has contracted with the National Academies of Sciences, Engineering and Medicine (NASEM) to conduct a comprehensive and systematic assessment and review of the scientific literature on premium cigars and provide a final report of the study results. The FDA said NASEM expects to conclude the research in spring 2022.

“FDA expects that the results of the ongoing NASEM review and assessment will further inform the agency’s regulatory policy,” the agency said in a June 11 statement on its website.

At this time, though, it no longer intends to request information about conducting additional possible studies before reviewing the results of the ongoing NASEM research, as such additional studies may be unnecessary, the FDA said. Given this and the high interest in potential future regulations related to premium cigars, the FDA withdrew its entry from the Unified Agenda.

The agency said it expects to update the public following the completion of the NASEM review.  

Premium cigars are defined, in part, as cigars that are wrapped in whole tobacco leaf, contain a 100% leaf tobacco binder, are handmade or hand rolled and do not have a characterizing flavor other than tobacco.

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