PMTAs: the road to FDA approval for e-cigarette products

Executive summary • Introduction • Why an electronic nicotine delivery system (ENDS) product requires a PMTA: distinction among ENDS products, components/parts, and accessories; three pathways to market approval; concerns about the grandfather date • Guidance for industry: information on premarket tobacco product applications (PMTA) and the submission process • Public health considerations: scientific evidence, comparative analysis, voluntary restrictions on sale and distribution, nicotine exposure warnings, child-resistant packaging, alternatives to new scientific studies, government-sponsored databases, non-U.S. randomised controlled clinical trials, literature reviews or reports • FDA enforcement for manufacturers and retailers: enforcement limited to finished tobacco products; independent vapour shops considered as tobacco product manufacturers • Appendix 1: definitions • Appendix 2: submitting a PMTA