FDA Poised to Crack Down on Vape Shops – Lexology

A recent Food and Drug Administration Request for Proposal indicates that the agency is poised to more aggressively ensure that vape shops are satisfying their obligations under the Family Smoking Prevention and Tobacco Control Act. The FDA has asked for bids on a third-party contract to inspect vape shops and other companies that manufacture components of electronic nicotine delivery systems (ENDS). The agency is apparently prepared to spend $23 million over a five-year period for these services.

The inspectors will be tasked with a number of duties, including specifically ensuring that companies have not impermissibly introduced so-called “new tobacco products.” Under the Tobacco Control Act, companies generally are not permitted to introduce “new tobacco products” (defined as any product introduced after February 15, 2007 or changed in any way since then) without FDA permission. However, under the Deeming Regulations, ENDS were given limited relief, such that if the product was introduced by August 8, 2016 (the effective date of the regulations) the product could continue to be sold until 2022, provided that the manufacturer submits a request for FDA premarket

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