The FDA Center for Tobacco Products (CTP) released a list of deemed new tobacco products for which a premarket tobacco product applications (PMTA) was submitted to FDA by September 9, 2020.
The lists include deemed new tobacco products for which a premarket tobacco product applications (PMTA) was submitted to FDA by September 9, 2020. A court order provided for a one-year period during which time such products might remain on the market pending FDA review. If a negative action is taken by the FDA on the application prior to September 9, 2021, the product must be removed from the market or risk FDA enforcement. If a positive order is issued by the FDA on a product in the lists, the product will be listed on the positive marketing orders page and may continue to be marketed according to the terms specified in the order letter. It is important to keep in mind that the lists are only one source of information. For example, retailers should discuss with their suppliers about the status of any particular tobacco product’s application or any product’s marketing authorization.
Under a court order from the District Court of Maryland, e-cigarette products that were on the market prior to August 8, 2016, were required to submit PMTAs for the FDA to review and approve by the September 9, 2020 deadline. PMTAs require a product to meet a regulatory hurdle that can be complex and costly. By the FDA providing a public list of e-cigarette products that meet the proper requirements, retailers of these products will be informed as to which they can sell legally in their stores. The Energy Marketers of America, the National Association of Convenience Stores (NACS), the National Association of Truckstop Operators (NATSO), the Society of Independent Gasoline Marketers of America (SIGMA) and the Food Industry Association (FMI) submitted a letter earlier this year to the FDA urging it to release a list of approved e-cigarette products.