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What is a PMTA?

FDA evaluates new tobacco products, including electronic nicotine delivery systems (ENDS), under the current regulatory framework

The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) gave the FDA authority to regulate tobacco products. Under the Tobacco Control Act, the FDA, through the Center for Tobacco Products, established the Premarket Tobacco Product Application (PMTA) process to review and authorize new tobacco products. 

Manufacturers seeking a PMTA must demonstrate that marketing a new tobacco product would be “appropriate for the protection of the public health”. This includes evaluating the health risks of the new tobacco product compared to cigarettes and the impact on both current tobacco product users and nonusers. Obtaining a PMTA marketing order means that a manufacturer is authorized to sell its product to consumers in the United States.

The PMTA process enables the FDA to assess the public health impact of new tobacco products.

Juul Labs is fully committed to the PMTA process.  We have a robust scientific research program to assess the harm-reduction potential of JUUL products, 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.