JUUL LABS’ PREMARKET TOBACCO PRODUCT APPLICATIONS (PMTA) HAVE BEEN FILED BY FDA FOR SUBSTANTIVE REVIEW

Company News

August 18, 2020

Juul Labs today announced that it received notice from the Food and Drug Administration (FDA) that the company’s Premarket Tobacco Product Applications (PMTA) will enter the substantive review phase.

Last month, Juul Labs submitted PMTAs to the FDA for the company’s JUUL System — an electronic nicotine delivery system (ENDS) product. The company’s submission includes comprehensive scientific evidence for the JUUL Device and JUULpods in Virginia Tobacco and Menthol flavors at nicotine concentrations of 5.0% and 3.0%, as well as information on data-driven measures to address underage use of our products. The FDA will now begin a substantive scientific review of the applications.

Joe Murillo, Chief Regulatory Officer at Juul Labs said: “We will continue to follow the PMTA process and look forward to this next step as the FDA commences substantive review of the application.”

Late last year, the company, under new CEO K.C. Crosthwaite’s leadership, committed to resetting the vapor category and seeking to work cooperatively with regulators, legislators, attorneys general, public health officials, and other stakeholders to combat underage use and transition adult smokers from combustible cigarettes. As part of that process, the company reduced its product portfolio, halted television, print, and digital product advertising, built up its science and evidence-based capabilities, and supported the U.S. Administration’s final flavor policy for ENDS products, while taking a methodical approach to its global presence.