FDA Tells Firms That Didn't Submit PMTA Applications to Stop

FDA Tells Firms That Didn't Submit PMTA Applications to Stop Selling Product


FDA Tells Firms That Didn't Submit PMTA Applications to Stop Selling Product
SILVER SPRING, Md. — The Food and Drug Administration (FDA) sent warning letters to 10 companies for selling electronic nicotine delivery systems (ENDS) — specifically e-liquids — even though they did not file premarket tobacco applications (PMTAs) by the Sept. 9, 2020 deadline.
The letters are the first the agency issued since to companies that continue to sell or distribute unauthorized ENDS passed the deadline.
Per a court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016, including e-liquids, were required to be submitted to the FDA by Sept. 9, the agency explained.

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