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In June, FDA issued a total of nine 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 nine 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 almost 200,000 products with the FDA.
Since January 2021, FDA has issued a total of 131 warning letters to firms selling or distributing more than 1,470,000 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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FDA continues to provide updates on the review process of the tobacco product applications received by the Sept. 9, 2020 deadline through the Tobacco Product Applications: Metrics and Reporting page.
The Agency has posted the latest metrics charts related to the review of all tobacco products applications. The charts now include data as of June 1, 2021 for the applications submitted through the SE, EX REQ, and PMTA pathways.
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