Juul vape submitted PMTA

American e-cigarette brand Juul Labs announced on July 31 that it had submitted a pre-market tobacco product application for the company’s JUUL System (an electronic nicotine delivery system (ENDS) product) to the U.S. Food and Drug Administration (FDA) (PMTA).

Juul’s application products include comprehensive scientific evidence of Juul devices and Juul mainframes for Virginia tobacco and menthol cartridges with a nicotine concentration of 5.0% and 3.0%, as well as information on data-driven measures used by minors of its products. The application includes detailed scientific data containing 110 studies, a total of 125,000 pages, to evaluate the impact of the product on current users and non-users (including minors) of tobacco products.


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