FDA Will Reject JUUL PMTA, Insiders Say

The FDA will reject Juul Labs’ Premarket Tobacco Applications (PMTAs) and issue Marketing Denial Orders (MDOs) for the company’s JUUL device and refill pods, according to the Wall Street Journal.

The announcement could come as early as today. The Journal did not report the FDA's reasoning for the denial.

The news was apparently leaked by the agency, and comes just a day after the FDA announced it will pursue a plan to remove most nicotine from cigarettes. Many observers believe such a policy would require the agency to allow sales of a variety of attractive non-combustible products to prevent a huge cigarette black market.

The agency has so far authorized just a handful of vaping products, and just one—the NJOY Ace—that is a modern pod-style vape like Juul Labs’ flagship device. Juul submitted PMTAs for its original JUUL device and refill pods in July 2020, and reportedly spent tens of millions of dollars on the applications.

The FDA recently stated in a court filing it would take the agency another year—until June 30, 2023—to make decisions on the remaining 240 PMTAs submitted by the top 10 vaping manufacturers (measured by share of the convenience store/gas station vape market). Juul Labs and RJ Reynolds’ Vuse brand are the top two brands on the market, with the JUUL and Vuse’s Alto device making up more than 60 percent of total sales.

The agency has been under intense pressure from Democrats in Congress to reject Juul Labs' applications and remove the products from the market.

Once the MDO is issued, Juul Labs will be able to challenge the denial in a federal circuit court, or file an administrative appeal with the FDA. The company could be issued a stay of the denial order, which would allow it to be sold while the MDO is reviewed.

Juul Labs is also believed to have a second product under FDA review that is either the same or very similar to its JUUL2, a so-called "smart vape" that launched in the UK last fall. Some observers believe a Juul device with age verification technology is more likely to be authorized by the agency.