FDA Agrees to Release List of PMTA Product Applicants
SILVER SPRING, Md. — With one week to go until the deadline for companies to file premarket tobacco applications (PMTAs) for the majority of newly deemed tobacco products, the Food and Drug Administration (FDA) said it will publish a list of those products with submissions on file.
Tobacco companies and manufacturers have until Sept. 9 to file PMTAs for products included in the 2016 deeming rule, among them vapor products. Any product that does not have PMTA must be removed from the market as of Sept. 10.
Without a listing from the FDA, retailers would have to rely on their suppliers, wholesalers and distributors to inform them which products are no longer available — a concern that drew retailer groups, including NACS, to urge the agency to provide an account of the PMTAs, as Convenience Store News previously reported.
According to Bloomberg, the FDA announced it would make that list available. In a blog post on Aug. 31, Mitch Zeller, director of the agency's Center for Tobacco Products, said the FDA has received applications for about 2,000 electronic cigarettes and other newly regulated tobacco products to date. There are more than 400 million eligible items that would need to apply to stay on the market.
Once an application is submitted and accepted by the agency, the FDA has a 12-month timeline to review and approve the PMTA.
An agency spokeswoman declined to say when the list will be available, the news outlet added.