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![Packages of Juul e-cigarettes are displayed for sale in the Brazil Outlet shop on June 22, 2022 in Los Angeles, California.](https://cdn.arstechnica.net/wp-content/uploads/2022/06/GettyImages-1404506917-800x598.jpeg)
With its enterprise going up in smoke, e-cigarette big Juul filed an emergency motion Monday to halt the Food and Drug Administration’s decision to deny the company authorization to market any of its merchandise within the US, successfully forcing it out of enterprise.
The choice was leaked to The Wall Road Journal final Wednesday, June 22, and the regulator publicly announced the decision Thursday. On Friday, a panel of federal appeals court docket judges granted Juul a short lived administrative keep, permitting the corporate to proceed to promote its merchandise whereas the court docket critiques Juul’s emergency petition to halt the FDA’s choice. Juul had till midday Monday to submit its petition. The executive keep just isn’t primarily based on the deserves of Juul’s argument in any approach, the judges famous.
In the meantime, The Wall Road Journal reported Friday that along with combating the FDA denial, Juul is also considering filing for bankruptcy. The report cited unnamed folks accustomed to the matter. Juul didn’t instantly reply to Ars’ request for remark relating to a attainable chapter submitting.
On Monday, minutes earlier than its midday deadline, Juul filed an emergency petition requesting a keep of the FDA advertising and marketing denial, pending additional assessment. The FDA now has till July 7 to submit a response to Juul’s petition earlier than the court docket will resolve on its destiny.
Course of in query
In its petition, Juul argued that it was wrongfully vilified for sparking the youth vaping epidemic and that the FDA denied its authorization whereas underneath political and monetary stress to take action from a number of lawmakers. Although the FDA stated that its denial was primarily based on inadequate toxicology information, Juul argued that the information the FDA was requesting was “proper there in [Juul’s] unique submission,” although the entire particulars associated to the information in query had been redacted from the petition.
Juul additionally claimed that the FDA reviewed its over 125,000-page authorization request otherwise than it did opponents’ requests. Lastly, Juul complained that the FDA didn’t give the corporate an opportunity to reply to considerations about inadequate information earlier than revealing its choice. The corporate stated that it discovered of the FDA’s choice by The Wall Road Journal leak final Wednesday and that the information created chaos for its enterprise and prospects.
General, the corporate argued that the FDA neglected its information and denied it authorization primarily based on a “haphazard regulatory course of,” which is able to trigger the corporate irreparable accidents and “in the end shutter [Juul’s] enterprise.”
The FDA has till July 7 to submit a response. In a remark to the Journal, Mitch Zeller, former director of the FDA’s Heart for Tobacco Merchandise, who retired in April, stated the regulator’s choice was primarily based solely on the energy of Juul’s utility, not political stress. “This was a scientific assessment performed by subject-matter consultants,” he stated. “That’s the way in which the system is meant to work.”
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