Juul has asked a federal appeals court to temporarily block a Food and Drug Administration ban on selling its vapor products in the US. The agency issued the warrant on Thursday, citing a lack of sufficient evidence the company has provided to show its devices are safe. The FDA acknowledged that it was not aware of “an imminent danger” associated with Juul’s vape pen or pods. “The FDA’s decision is arbitrary and erratic and lacks substantial evidence,” Juul said in an application to the U.S. Court of Appeals for the DC Circuit, according to The Wall Street Journal. The company called the ban extraordinary and illegal. It requested an administrative suspension until it can file a motion for an urgent review of the FDA’s order.
Juul claimed that without the stay, it would suffer significant and irreparable damage. The company argued in the filing that the order represents a shift from typical FDA practices, which allow for a transition period. The company makes the majority of its sales in the US. If the reprieve is granted, Juul and retailers can continue to sell their products there. “We respectfully disagree with the FDA’s findings and decision and continue to believe that we have provided sufficient information and data based on high-quality research to address all of the issues raised by the agency,” said Joe Murillo, Juul’s Chief Regulatory Officer, to Engadget after the FDA issued the statement. To order.
“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 believe that these data, together with the totality of the evidence, meet the legal standard to be suitable for the protection of public health.” In 2020, the FDA required e-cigarette makers to submit their products for review. It looked at the potential benefits of vaping as an alternative to cigarettes for adult smokers. It weighed that against concerns about the popularity of vaping among young people. The agency has authorized 23 “electronic nicotine delivery systems,” including NJOY and Vuse mother, Reynolds American products.
The FDA criticized Juul in 2019 for telling students its products are “completely safe.” The Federal Trade Commission and the state attorney general have been investigating Juul over claims it marketed its vape pens to underage users. In the past year, the company has agreed to pay at least $87 million to settle lawsuits in several states — including North Carolina, Washington state, and Arizona — alleging it targeted young people with its marketing. It has faced similar cases in other states. Our editorial team, independent of our parent company, has selected all products recommended by Engadget. Some of our stories contain affiliate links. We may earn an affiliate commission if you buy something through one of these links.
