|
|
In July, 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 more than 15,300,000 products with the FDA. This includes a warning letter issued on July 28 to a single company with over 15 million tobacco products listed with the FDA.
From January through July 2021, FDA has issued a total of 140 warning letters to firms selling or distributing more than 16,800,000 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 entering “Center for Tobacco Products” in the “Issuing Office” box in the “Filter by” section of the search tool.
|
|
|
|
