The U.S. Food and Drug Administration (FDA) has withdrawn a Unified Agenda Entry relating to the Advance Notice of Proposed Rulemaking (ANPRM) for premium cigars.
On June 11, 2021, the FDA revealed that the entry had been withdrawn and that no further action or updates on premium cigar regulation would come until the assessment conducted by the National Academics of Sciences, Engineering, and Medicine (NASEM) had been completed. The NASEM review is expected to provide an analysis of data on how premium cigars impact health, premium cigar patterns of use and other factors. The short and long-term health effects of premium cigars is vital to the FDA’s regulations for premium cigars and with that review by the NASEM still be ongoing, the FDA has opted to pull the entry related to premium cigars from the Spring 2021 edition of the Unified Agenda of Regulatory and Deregulatory Actions.
The FDA’s handling and regulation of premium cigars has been a process of twists and turns. The ANPRM issued in 2018 sought out new information that could help shape the FDA’s final regulation of premium cigars. This came after the deeming rule that stated the FDA’s overall view of the premium cigars: “[a]ll cigars pose serious negative health risks; (2) the available evidence does not provide a basis for FDA to conclude that the patterns of premium cigar use sufficiently reduce the health risks to warrant exclusion, and (3) premium cigars are used by youth and young adults.” The FDA received comments to its premium cigar ANPRM that should be of interest to tobacco businesses that make or sell premium cigars including the known health effects of cigar use, the alleged “rise of cigar use among youth,” the evolving tobacco market, and what it refers to as the “potential for market manipulation to avoid regulation if FDA were to treat premium cigars more favorably than other tobacco products.”