| On July 28, FDA issued a warning letter to Visible Vapors, LLC—a company based in Pennsylvania that manufactures and operates a website selling electronic nicotine delivery system (ENDS) products, including e-cigarettes and e-liquids—advising them that marketing these new tobacco products, which lack premarket authorization, is illegal, and therefore they cannot be sold or distributed in the U.S. The firm did not submit any premarket tobacco product applications (PMTAs) by the Sept. 9, 2020 deadline. Per court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-cigarettes and e-liquids—were required to be submitted to FDA by Sept. 9, 2020. While the warning letter issued today cites specific products as examples, including Visible Vapors Irish Potato 100mL and Visible Vapors Peanutbutter Banana Bacon Maple (The King) 100mL, the company has more than 15 million products listed with FDA, and must ensure all of its products comply with federal rules and regulations, which include the premarket review requirement. In line with the agency's 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 product application. From January through June 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 searching "Center for Tobacco Products" under "Issuing Office." |
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