July has asked a federal appeals court to temporarily block a Food and Drug Administration ban on sales of its vaping products in the US. The agency issued the order on Thursday, citing a lack of sufficient evidence provided by the company to show its devices are safe. The FDA acknowledged that it was not aware of “an immediate hazard” linked to Juul’s vape pen or pods.
“FDA’s decision is arbitrary and capricious and lacks substantial evidence,” Juul said in a filing with the US Court of Appeals for the DC Circuit, according to The Wall Street Journal. The company called the ban extraordinary and unlawful. It requested an administrative stay until it can file a motion for an emergency review of the FDA’s order.
Juul claimed that, without the stay, it would suffer significant and irreparable harm. The company makes the lion’s share of its revenue in the US. If the stay is granted, Juul and retailers will be able to keep selling its products there. The company argued in the filing that the order marked a move away from the FDA’s typical practices, which allow for a transition period.
“We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency,” Juul’s chief regulatory officer Joe Murillo told Engadget after the FDA issued the order. “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 public health. “
Murillo said Juul was exploring all of its options in the wake of the ruling. Among those, according to the Journalis a possible bankruptcy filing if the company is unable to secure a stay or successfully appeal the ban.
In 2020, the FDA required makers of e-cigarettes to submit their products for review. It looked at the possible benefits of vaping as an alternative to cigarettes for adult smokers. It was weighing those up against concerns about the popularity of vaping among young people. The agency has authorized 23 “electronic nicotine delivery systems,” including products from NJOY and Vuse parent Reynolds American.
The FDA slammed July in 2019 for telling students that its products are “totally safe.” The Federal Trade Commission and state attorney generals have investigated Juul over claims it marketed its vape pens to underage users. In the last year, the company has agreed to pay at least $ 87 million to settle lawsuits in several states – including North Carolina, Washington state and Arizona – which allegedly that it targeted young people with its marketing. It has faced similar suits in other states.
Update 6/24 12:51 PM ET: Added a note about the possible bankruptcy filing.
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