On May 20, 2021 the U.S. Food and Drug Administration (FDA) finally released the Premarket Tobacco Product Application (PMTA) list to the public in order to increase transparency and stakeholder knowledge of newly deemed tobacco products. Incredibly, the list included over 6 million deemed new tobacco products. Due to the length of the list, the FDA has separated products into 16 files to decrease file size. FDA has stated that generally, the agency intends to defer enforcement of deemed new tobacco products which were submitted prior to the September 9th deadline.
FDA’s published list is by no means comprehensive and does not cover all newly deemed tobacco products which are currently on the market.
Importantly, as many in the industry likely know, FDA has not included premium cigars in the list due to a favorable 2020 ruling in Cigar Association of America et al. v. U.S. Food and Drug Administration (2016) which removed premium cigars from the FDA deeming rule. This exclusion was made due to the need for the FDA to more appropriately respond with criteria specifically for the regulation of premium cigars that would mirror the decision. We will be sure to update when FDA publishes its updated approach to premium cigars.
Readers should note that FDA will regularly update the list when positive or negative actions regarding products are issued. If a negative action is issued against a product within that year, the product in question must be removed from the market to avoid FDA enforcement. Deemed new tobacco products may have also been issued a warning letter by the FDA if they were found to be in violation of the Federal Food, Drug, and Cosmetic Act, as amended by the Tobacco Control Act. Products which receive warning letters must have their issues corrected promptly and adequately or risk FDA enforcement. Products with active warning letters are listed on the FDA’s warning letters webpage.
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