In March, FDA issued warning letters to 31 firms who manufacture and sell unauthorized e-liquids

FDA Warns Additional Firms for Making and Selling Unauthorized E-Liquids In March, FDA issued warning letters to 31 firms who manufacture and sell unauthorized e-liquids, advising them that selling new tobacco products that  lack premarket authorization is illegal, and therefore they cannot be sold or distributed in the U.S. The firms did not submit a premarket tobacco product application (PMTA) by the Sept. 9, 2020 deadline. Warning letters to 13 firms were previously announced on March 12, and through the end of the month, an additional 18 companies received warning letters. While each of these 18 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 90,000 products with the FDA. 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 FDA by Sept. 9, 2020. For companies that submitted applications by that deadline, FDA generally intends to continue to defer enforcement for up to one year pending FDA review, unless there is a negative action taken by FDA on the application. In line with the agency's stated enforcement priorities, after Sept. 9, 2020, FDA is prioritizing enforcement against any ENDS product that continues to be sold and for which the agency has not received a timely product application. FDA recently published an update on its progress on the processing and review of the applications received by Sept. 9, including a list of companies that submitted timely applications.

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