FDA Updates Public On PMTA Application Progress
The FDA Center for Tobacco Products (CTP) released new information regarding the number of premarket tobacco product applications (PMTA) it received by the September 9, 2020 deadline.
Unfortunately, the FDA has yet to publish a list of all products for which PMTAs were received by the September deadline.
According to the FDA, it has processed PMTAs for more than 4.8 million products from 230 companies and processing is still ongoing given the size, complexity and diversity of applications it received.
Meanwhile, the FDA completed the processing step for all exemptions from substantial equivalence requests (EX REQ) and substantial equivalence (SE) reports.
Click Here for the deemed new tobacco product applications list that were on the market as of August 8, 2016, are currently marketed and submitted via the SE or EX REQ pathways by the September deadline.
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 PMTA’s for the FDA to review and approve by the September 9, 2020 deadline.
PMTA’s require a product to meet a regulatory hurdle that can be complex and costly.
E-cigarette products will be permitted to stay on the market for one year while the agency reviews the applications, or until the agency rejects them.
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, the Society of Independent Gasoline Marketers of America and the Food Industry Association submitted a letter to the FDA urging it to release a list of approved e-cigarette products.