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FDA is stepping up its crackdown on unauthorized e-cigarettes

FDA is stepping up its crackdown on unauthorized e-cigarettes

2022-09-20

The U.S. Department of Justice is seeking a court order, threatening lawsuits, and requiring the destruction of unauthorized vaping products, Alex Norcia wrote in Filter. The move is notable given that Brian King, director of the Center for Tobacco Products, was reluctant to say in a recent interview with Politico whether the agency would be willing to take unauthorized vaping products off shelves.


Filter has confirmed that the U.S. Food and Drug Administration notified the Justice Department by September 1 that at least two open-system e-cigarette companies violated the Federal Food, Drug, and Cosmetic Act because the manufacturers did not submit premarket filings. Tobacco products apply and continue to sell their products.


"We plan to seek a court order to permanently ban you ... until your product is received and actually authorized by the FDA to sell," in a letter signed by Justice Department senior litigator Christina Palascandora wrote. Two companies known to have received letters have been ordered to destroy their products under FDA supervision.


An industry insider told Filter that the letter was a "clear escalation" -- the first time, to his knowledge, that the FDA went beyond a "warning" to explicitly "threat" to sue for unauthorized nicotine e-cigarette sales.


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