In May, FDA issued a total of 19 warning letters to firms who manufacture and sell unauthorized e-liquids

FDA Issues 19 Warning Letters in May for Unauthorized ENDS In May, FDA issued a total of 19 warning letters to firms who manufacture and sell unauthorized e-liquids, advising them that selling products which lack premarket authorization is illegal and therefore they cannot be sold or distributed in the U.S. The companies did not submit a premarket tobacco product application (PMTA) by the Sept. 9, 2020 deadline. While each of these 19 warning letters cites specific products as examples of tobacco products that lack the required premarket authorization, collectively these firms have listed a combined total of more than 378,000 products with the FDA. Since January 2021, FDA has issued a total of 122 warning letters to firms selling or distributing more than 1,280,000 unauthorized ENDS and that did not submit premarket applications by the Sept. 9 deadline. On FDA's Warning Letters page, you can find these warning letters by filtering the "Issuing Office" and selecting the "Center for Tobacco Products."

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