A federal court has granted Juul Labs a temporary stay preventing the FDA from enforcing its Marketing Denial Order (MDO) that ordered all Juul products off the market. The court also gave Juul permission to file a motion for an emergency stay that would put the FDA denial on hold while the court hears a full appeal.
The MDO, issued yesterday, is now on hold pending further order of the court, which allows Juul to continue selling products for the time being. The stay was granted by a three-judge panel of the D.C. Circuit Court of Appeals, which will also hear Juul Labs’ petition for review (appeal) of the FDA’s denial order.
The temporary stay is intended to give the court time to study Juul’s request for an emergency stay, said the judges, and is not an indication of how the court will rule on Juul’s motion, which is due by June 27 at noon. The FDA will have until July 7 to respond to Juul’s motion, and Juul will have until July 12 to respond to the FDA.
Juul filed the motion for a temporary stay this morning, according to the Wall Street Journal. The company also petitioned the court to review the FDA’s denial order, which ordered all currently sold Juul products—including the JUUL device and four varieties of refill pod—off the market.
Juul’s court filing called the MDO “extraordinary and unlawful,” and said the company would suffer irreparable harm without a stay from the circuit court.
Juul Labs argued that the FDA decision was “arbitrary and capricious and lacks substantial evidence.” The marketing denial was issued, Juul said, after “immense political pressure from Congress once it became politically convenient to blame [Juul] for youth vaping, even though several of its competitors now have a larger market share and much higher underage-use rates.”
The Juul filing questioned the surprise nature of the FDA order, noting that the agency usually offers manufacturers a transition period. The company also complained that news of the MDO was originally broken through a leak to the Wall Street Journal, rather than direct communication with Juul.
“Regulation through leaks and press releases is no way to handle agency action, much less to order a company to cease essentially all business operations,” the company told the court.
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