Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems; Guidance for Industry; Availability

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled "Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems, Guidance for Industry." 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 guidance is intended to assist applicants to prepare PMTAs for ENDS products.