The U.S. Food and Drug Administration (FDA) has issued a stay on its previous Juul marketing denial order (MDO), suspending its ban on the products while Juul appeals the FDA’s original decision in court.
The FDA noted in a tweet that there are “scientific issues unique to the Juul application that warrant additional review.” As a result, Juul products can stay on the U.S. market while the ban is being reviewed. The FDA has noted that this order only suspends the MDO temporarily, it does not rescind the ban.
“All electronic nicotine delivery systems, or ENDS products, including those made by JUUL, are required by law to have FDA authorization to be legally marketed. The stay and the agency’s review does not constitute authorization to market, sell, or ship JUUL products,” the agency noted on Twitter.
The stay on the MDO comes as a new development in the ongoing battle by Juul to receive official premarket tobacco product application (PMTA) authorization under rules that required the company to prove that it provides more benefit to the public than harm.
The company was previously ordered by the FDA to stop the sale of all e-cigarette products in the U.S., with the agency stating that Juul’s application to remain on the market lacked scientific evidence that its products would benefit the overall health of consumers. At the end of June, Juul Labs was granted an emergency administrative stay of enforcement by the U.S. Court of Appeals for the D.C. Circuit. The stay temporarily blocks the FDA’s marketing denial order.
The New York Times reported that in a brief last week Juul argued that it has helped two million adult smokers quit smoking traditional cigarettes. This, among others, is one of the arguments by Juul for the authorization of its vape products.