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Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems; Draft Guidance for Industry
Docket No.: FDA-2015-D-2496-0001
Dates: Submit comments by July 11, 2016
Summary: The FDA is announcing the availability of a draft guidance for industry entitled “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems.” Given the relatively new presence of electronic nicotine delivery systems (ENDS) on the U.S. market and FDA's final rule deeming these products to be subject to the tobacco product authorities in the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA expects to receive premarket tobacco product application (PMTA) submissions from manufacturers of ENDS. This draft guidance is intended to assist persons with their PMTA submissions for ENDS products.
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