September 4, 2020
In April 2020, the United States District Court for the District of Maryland granted FDA’s request for an extension of the premarket review submission deadline from May 12, 2020, to Sept. 9, 2020, an extension the agency sought solely due to the unexpected circumstances around the global COVID-19 pandemic. Manufacturers of certain deemed new tobacco products will therefore be required to submit premarket applications for their products by Sept. 9, 2020, consistent with the U.S. District Court for the District of Maryland’s order. Since then, FDA has received multiple requests for an additional extension of the Sept. 9, 2020 deadline from individual manufacturers and importers, as well as from certain industry groups, due to the COVID-19 pandemic, recent natural disasters, or other circumstances.
FDA has not granted the requests from individual manufacturers and importers, as it has explained to them in responsive letters. The 120-day extension granted in April reflected a balance between FDA’s critical public health priority in promptly reviewing tobacco product applications and the difficulties posed by the COVID-19 pandemic.
In its responses to the extension requests from individual manufacturers and importers, FDA stated that the Agency will determine whether each application the firm submits by the deadline meets the applicable statutory and regulatory requirements under sections 905 and 910 of the Federal Food, Drug, and Cosmetic Act to proceed to scientific review. In these responses, FDA further stated that the Agency intends to take the firm’s individual circumstances into account as it considers premarket tobacco product applications that are submitted by the deadline. Further, FDA encouraged each firm to explicitly identify any content that may be missing from their application, clearly explain how COVID-19, a recent natural disaster, or other unforeseen circumstance has prevented them from providing such information and provide a timeframe by when they will submit missing information to FDA. Finally, in these responses, FDA has stated that it would take into account relevant considerations in deciding whether to initiate enforcement action against a particular product as the one-year period for review comes to an end in September 2021.
FDA notes that in accordance with a different court order, the Agency will not enforce the premarket review requirement against manufacturers of premium cigars that do not submit premarket applications for these products by the Sept. 9, 2020 deadline. For purposes of the court’s order, a premium cigar is defined as a cigar that meets all of the following eight criteria:
- Is wrapped in whole tobacco leaf;
- Contains a 100 percent leaf tobacco binder;
- Contains at least 50 percent (of the filler by weight) long filler tobacco (i.e., whole tobacco leaves that run the length of the cigar);
- Is handmade or hand rolled (i.e., no machinery was used apart from simple tools, such as scissors to cut the tobacco prior to rolling);
- Has no filter, nontobacco tip, or nontobacco mouthpiece;
- Does not have a characterizing flavor other than tobacco;
- Contains only tobacco, water, and vegetable gum with no other ingredients or additives; and
- Weighs more than 6 pounds per 1,000 units.
If a product meets the above criteria, FDA will not enforce the premarket review requirement if a premarket application for such a product is not submitted until FDA takes future action consistent with the court’s order.