A federal appeals court froze the FDA’s ban on Juul products Friday after the company sought an emergency administrative stay. On Thursday, the U.S. regulator took sweeping action against the e-cigarette maker, effectively killing its access to the U.S. market.
The temporary stay will be in place essentially to buy time until the case can properly be heard by the court, though it “should not be construed in any way as a ruling on the merits,” according to the court documents.
The FDA took action against Juul after the company failed to provide adequate evidence that its products were safe enough alternatives to smoking. The regulatory agency said that Juul’s documentation left it with “significant questions.”
According to a report from the Wall Street Journal, Juul is considering filing for bankruptcy if it can’t get the FDA’s order reversed.
Following the FDA order, Juul’s chief regulatory officer Joe Murillo said that the company would pursue a stay and planned to appeal the regulator’s decision.
“In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being ‘appropriate for the protection of the public health,’” Murillo said.
Juul rivals Reynolds American and NJOY Holdings will continue to sell their own vape products in the U.S. after previously receiving the FDA authorization that Juul itself failed to secure.
Source: Read More