FDA Denies Authorization to Market JUUL Products, Court Orders Temporary Stay

On June 23, the U.S. Food and Drug Administration (FDA) issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of its products currently marketed in the U.S. The order would force JUUL to take all its e-cigarettes off the U.S. market. On June 24, 2022, the U.S. Court of Appeals for the D.C. Circuit entered a temporary administrative stay of the MDOs. JUUL's Chief Regulatory Officer Joe Murillo said, “Having received the emergency temporary stay, we are now seeking the ability to continuously offer our products to adult smokers throughout our appeal with the court and science- and evidence-based engagement with our regulator. We remain confident in our science and evidence and believe that we will be able to demonstrate that our products do in fact meet the statutory standard of being “appropriate for the protection of the public health.” JUUL is asking the court for a longer stay to delay the marketing denial order until the appeal process has concluded. The FDA has until July 7 to respond to JUUL's motion, and JUUL has until July 12 to reply. Read more here.