Litigation Update: FDA Begins Review of JUUL Labs’ Premarket Tobacco Product Applications

by | Aug 20, 2020

The FDA announced on Tuesday, August 18th, that it is beginning the review of the application submitted by JUUL Labs on an electronic nicotine delivery system (ENDS) product. JUUL Labs submitted the application in order to receive approval to continue selling its products.

In the company’s announcement, JUUL stated that included with their application, is a full scientific study that provides evidence that their JUUL devices and JUUL pods in Virginia Tobacco and Menthol flavors at nicotine concentrations of 5.0% and 3.0% are appropriate for the protection of public health, meaning they can benefit adult smokers without attracting minors or nonsmokers. Additionally, the application includes data-driven measurement mechanisms to be incorporated in order to monitor and address the usage of their products by young people.

The FDA has a deadline of September 9th for e-cigarettes manufactures to submit their applications for product review.

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