FDA Moves Juul System to Substantive Review Phase

Administration will now evaluate if ENDS product is appropriate for protection of public health
Juul, and Juul pods
Photograph: Shutterstock

SAN FRANCISCO — The U.S. Food and Drug Administration (FDA) told Juul Labs Inc. that its premarket tobacco product applications (PMTA) will enter the substantive review phase.

This means the FDA will evaluate whether marketing the Juul System, an electronic nicotine delivery system (ENDS) product, is appropriate for the protection of public health. The submission includes scientific evidence for the Juul Device and Juulpods in Virginia Tobacco and Menthol flavors at nicotine concentrations of 5% and 3% and information on measures to address underage use of Juul products.

The FDA will begin a substantive scientific review of the applications, Juul said, which include data from more than 110 studies totaling more than 125,000 pages evaluating the product’s effect on tobacco product users and nonusers, including those who are underage.

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

Controversy surrounding Juul, in which Richmond, Va.-based Altria has a stake, surfaced amid teen illnesses allegedly connected to the e-cigarette devices. In response, the FDA halted sales of flavored vaping pods.

Now tobacco manufacturers who have released products within a certain time frame must turn in PMTAs, which would allow them to continue selling vaping and other new products in the United States. The PMTA deadline was pushed to Sept. 9 amid the coronavirus crisis.

In 2019, San Francisco-based Juul worked to combat underage use of its products by measures including pulling flavored pods; halting TV, print and digital product advertising; building up its science and evidence-based capabilities; and supporting the flavor policy for electronic nicotine delivery system (ENDS) products.

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