NATSO joined a letter to the U.S. Food and Drug Administration (FDA) on Aug. 25 urging the agency to publish a list of electronic nicotine delivery system (ENDS) products for which it has received a premarket tobacco product application (PMTA) by the Sept. 9, 2020, deadline. Without a publicly available list, retailers – including travel centers – will not know which products are legal for them to sell.
On Aug. 8, 2016, all ENDS products became subject to the FDA’s tobacco authorities, including the premarket authorization requirements. This means all e-cigarettes and other ENDS products on the market at that time needed to have authorization from the FDA to be legally marketed. To date, only one ENDS product has been authorized by the FDA — meaning all other ENDS products currently on the market are considered illegally marketed and are subject to enforcement, at any time. To remain on the market, manufacturers of ENDS products must submit a PMTA to FDA by Sept. 9, 2020. Once a PMTA is submitted, a product can be sold for up to 12 months while the application is being considered.
If manufacturers do not submit their PMTAs by this date, retailers cannot continue to sell their products. FDA, however, has not created a process to make available a list of products for which it has received a PMTA. That leaves retailers in a difficult position because they do not know which products are legal to sell. NATSO urged FDA to disclose which ENDS products have PMTAs submitted on their behalf by their manufacturers to better facilitate enforcement of the premarket authorization requirements.
NATSO was joined by FMI, the Food Industry Association, the National Association of Convenience Stores, the Petroleum Marketers Association of America, and the Society of Independent Gasoline Marketers of America in sending the letter.
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