The U.S. Food and Drug Administration’s (FDA’s) Center for Tobacco Policy issued a statement on Aug. 31 indicating the agency plans to publish a list of electronic nicotine delivery system (ENDS) products for which it has received a premarket tobacco product application (PMTA). FDA’s announcement is a win for the travel center industry. Without a publicly available list, retailers – including travel centers – will not know which products are legal for them to sell.
Manufacturers of ENDS products must submit a PMTA to FDA by Sept. 9, 2020, to remain on the market. Once a PMTA is submitted, a product can be sold for up to 12 months while the application is being considered. NATSO joined a recent letter to FDA urging the agency to publish a list of ENDS products for which it has received a PMTA by the Sept. 9, 2020, deadline.
FDA announced Aug. 31 that it will publish such a list as NATSO requested, but there may be a delay while the agency processes the PMTAs before the list is made available. In the meantime, FDA encouraged retailers to reach out to the manufacturers directly or refer to public statements made by the ENDS manufacturers so they can know which products are legal to sell.
In addition, FDA noted it is unlikely the agency will be able to process all of the PMTAs it receives during the one-year review period. NATSO will continue to monitor these developments for the industry.
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