The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) gave the US FDA jurisdiction to regulate tobacco products. Under the Tobacco Control Act, the FDA, through the newly-created Center for Tobacco Products, established the science and evidence-based Premarket Tobacco Product Application (PMTA) process to review and authorize new tobacco products introduced into the United States after February 15, 2007. ENDS products, including those that have been on the market as of August 8, 2016, may be authorized through PMTAs.
Manufacturers seeking a PMTA must demonstrate that marketing a new tobacco product would be “appropriate for the protection of the public health” for the population as a whole. This includes evaluating the impact on both current tobacco product users and nonusers. Obtaining a PMTA marketing order means that a manufacturer is authorized to market and sell its product to consumers in the United States.
Juul Labs is fully committed to the PMTA process in the United States and to that end we have built a robust scientific research program to assess the harm-reduction potential of the JUUL System, including their impact on the individual user, their ability to move adult smokers away from combustible cigarettes, and the net-population impact on public health.