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Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS)

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Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS)

This guidance is intended to assist persons submitting premarket tobacco product applications (PMTAs) for electronic nicotine delivery systems (ENDS) under section 910 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 387j). FDA’s draft guidance for industry, Applications for Premarket Review of New Tobacco Products (draft premarket review guidance), discusses the general procedures for submitting a PMTA, including who can submit a PMTA, and when and how PMTAs should be submitted. Please note that, when finalized, this guidance’s focus on ENDS products may result in more specific recommendations for an ENDS PMTA than recommendations in FDA’s draft premarket review guidance.

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