SILVER SPRING, Md. — The U.S. Food and Drug Administration will make public a list of the tobacco products subject to the premarket tobacco application (PMTA) deadline of Sept. 9—something NACS and other retail associations had urged the agency to do.
The move will help convenience-store retailers identify illegal products that must be pulled from shelves following the deadline.
With the PMTA deadline quickly approaching, the FDA is preparing to receive a large volume of applications, particularly from manufacturers of e-liquids, e-cigarettes and other electronic nicotine devices (ENDS), Mitch Zeller, director of the FDA’s Center for Tobacco Products (CTP) said on Aug. 31. The FDA has one year to review products that were filed on time—but it might not make that deadline.
While the FDA does not know how many applications will be submitted by Sept. 9, there are more than 400 million deemed products listed with the FDA.
Manufacturers of cigars, pipe tobacco, electronic cigarettes, vapor products, hookah, alternative nicotine products and heated tobacco products introduced after Feb. 15, 2007, were required to file substantial equivalence (SE) or PMTA marketing authorization requests by Sept. 9. The deadline was originally May 12, 2020, but the FDA asked for more time due to the COVID-19 pandemic.
The likelihood of the FDA reviewing all of the applications during the one-year review period is low, the agency said, given that this would be an unprecedented number of applications and “several orders of magnitude