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

This document provides guidance on the premarket tobacco product applications (PMTa) for newly deemed electronic nicotine delivery system (ENDS) products, as required by the Food and Drug administration (FDa). The PMTa should include static documents that maintain their formatting, enable page-by-page printing, and allow for electronic copying of text, images, and data. For any health risk studies conducted, full study reports and data should be submitted, along with a summary of results and methods. The summary should include details such as the study objective, design, statistical analysis plan, and findings. additionally, the PMTa should include information on the product's composition, literature reviews, analysis of published literature and datasets, and master files. The document also outlines the definitions of certain terms used in the guidance.

“Premarket Tobacco Product applications for Electronic Nicotine Delivery Systems Guidance for Industry: DRaFT GUIDaNCE.” FDa Center for Tobacco Products (CTP), May 2016.