There’s an important compliance deadline coming up on June 30, 2018. For some manufacturers of deemed tobacco products, the U.S. Food and Drug Administration will be expecting a listing of their tobacco products come June 30. This all stems from the Family Smoking Prevention and Tobacco Control Act of 2009 that required owners and operators in the U.S. who manufacture tobacco products to register with the FDA and submit their product listings. If you are a U.S. manufacturer who makes e-cigarettes, electronic nicotine delivery systems (ENDS), cigars, pipe, hookah tobacco, nicotine gel, and dissolvable nicotine products, this compliance deadline applies to you and your business. Under the 2016 deeming rules, these manufacturers are expected to report changes to their tobacco product listings to the FDA twice a year: once during June and again in December.
The June 30, 2018 deadline applies to those businesses that are manufacturing, preparing, compounding, and processing newly deemed finished tobacco products before Aug. 8, 2016, and those that are continuing to do so and are still in business after the same date. For those confused by the term “finished tobacco product,” the FDA defines that as a tobacco product–including all of its components and parts–that’s sealed in final packaging intended for customer use.
