JUUL Labs Submits PMTA to FDA for the JUUL System

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JUUL Labs Submits PMTA to FDA for the JUUL System

JUUL Labs has submitted a Premarket Tobacco Product Application (PMTA) to the U.S. Food and Drug Administration (FDA) for the company’s JUUL System, an electronic nicotine delivery system (ENDS) product.

JUUL’s PMTA application included comprehensive scientific evidence for the JUUL device as well as its Virginia Tobacco and Menthol flavored JUULpods. Both of these pod products have nicotine concentrations of 5 percent and 3 percent. After much scrutiny in the past two years over its marketing practices and the appeal of JUUL to underaged consumers, JUUL also included data-driven measures to address underage use of its products. By submitting its PMTA applications, JUUL feels it has now provided a “scientific foundation for the FDA to evaluate whether these products are ‘appropriate for the protection of the public health’ with respect to the risks and benefits to the population as a whole.” The submitted application includes detailed scientific data from over 110 studies, totaling over 125,000 pages evaluating the product’s impact on both current users of tobacco products as well as nonusers, and includes those who are underage.

“In order to earn a license to operate in society, we need to be a science and evidence-based company, engage in open and transparent dialogue with our stakeholders, and take methodical and responsible actions to advance the potential for harm reduction for adult smokers while combating underage use. Our PMTA submission is a key part of that approach,” said Juul Labs CEO K.C. Crosthwaite.