Premarket Tobacco Product applications for Electronic Nicotine Delivery Systems - Guidance for Industry.

This document provides guidelines for submitting a Premarket Tobacco Product application (PMTa) for Electronic Nicotine Delivery Systems (ENDS) and other deemed tobacco products, as per the FDa regulations. The document emphasizes the importance of a static format that maintains fonts, special orientations, table formats, and page numbers, and enables accurate cross-linking to other sections. It recommends including descriptive information, product samples, labeling, environmental assessment, a summary of all research findings, and scientific studies and analyses in the PMTa. The document also suggests that a single submission may cover multiple products, following the technical specifications available on the FDa website. Moreover, it mentions the possibility of requesting meetings with the FDa to discuss PMTa development, as outlined in the Meetings with Industry guidance. The recommendations in this guidance are similar to those in the draft guidance issued in 2016.

“Premarket Tobacco Product applications for Electronic Nicotine Delivery Systems - Guidance for Industry.” FDa Center for Tobacco Products (CTP), June 2019.