Update on FDA’s scientific review of JUUL product applications

Today, the FDA is providing an update on the status of the agency’s review of the premarket tobacco product applications (PMTAs) submitted by JUUL Labs, Inc. On June 23, 2022, the FDA issued marketing denial orders (MDOs)External Link Disclaimer to JUUL Labs, Inc. for all of their products marketed in the United States at the time. The FDA had determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that the marketing of the products met the public health standard required by law.