FDA Sends 2nd Round of PMTA Warning Letters

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SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) issued warning letters to 9 manufacturers who sell unauthorized electronic nicotine delivery systems (ENDS)—the second set of its kind in January.

The manufacturers did not submit a premarket tobacco product application (PMTA) by Sept. 9, 2020, and it is illegal to sell products that lack premarket authorization, the FDA said.

Manufacturers that received warning letters were The Mad Alchemist LLC, Austin Vapor, BloVape, Bombay Vapor LLC, Chief Vapor, American Legends E-Liquid LLLP, Average Joes Juice LLC, Cloud Chasers Apothecary LLC and Carolina Vapor Mill LLC, doing business as Carolina Vapor Mill. Collectively the companies have a total of more than 100,000 products with the FDA.

Earlier in January, the FDA also sent similar warning letters to 10 firms that manufacture and operate websites selling e-liquids. Companies need to respond within 15 days of receiving a letter on how they intend to address the agency’s concerns.

A court order required applications for premarket review for deemed new tobacco products on the market as of Aug. 8, 2016, to be submitted to the FDA by Sept. 9. Companies that submitted applications by the deadline are generally allowed to continue selling those products for up to a year, pending a negative action taken by the FDA on the application.

The FDA is in the process of making a public list of which products the agency received applications for.

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