A federal appeals court on Friday froze the FDA’s ban on Juul products after the company filed for an emergency administrative reprieve. On Thursday, the US regulator took drastic measures against the e-cigarette manufacturer, effectively destroying access to the US market.
The temporary suspension will essentially be in place to buy time until the case can be duly heard by the court, although according to court documents it “should not be construed in any way as a judgment on the merits”.
The FDA took action against Juul after the company failed to provide sufficient evidence that its products were sufficiently safe alternatives to smoking. The regulatory agency said Juul’s documentation left it with “important questions.”
According to a report from the Wall Street Journal, Juul is considering filing for bankruptcy if it cannot reverse the FDA’s order.
Following the FDA order, Juul’s Chief Regulatory Officer Joe Murillo said the company would pursue a stay and planned to appeal the regulator’s decision.
“In our filings, which we submitted more than two years ago, we believe that we have appropriately characterized the toxicology profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and we believe that these data , along with the totality of the evidence, meet the legal standard to be “fit for the protection of public health,” Murillo said.
Juul rivals Reynolds American and NJOY Holdings will continue to sell their own vape products in the US after previously receiving FDA authorization that Juul was unable to secure on its own.