With its business growing up in the smoke, e-cigarette giant Juul filed an emergency motion on Monday against the Food and Drug Administration for refusing to authorize the company to market any of its products in the US. The verdict was effectively forced out of business.
The decision was leaked to the Wall Street Journal last Wednesday, June 22, and the regulator publicly announced the decision on Thursday. On Friday, a panel of federal appeals court judges granted Juul a temporary administrative stay, allowing the company to continue selling its products, while the court reviewed Juul’s emergency petition to block the FDA’s decision. Of. Juul had until Monday afternoon to file his petition. The judges said the administrative adjournment was in no way based on the merits of Joule’s argument.
Meanwhile, The Wall Street Journal reported Friday that in addition to fighting the FDA denial, Juul is also considering filing for bankruptcy. The report cited unidentified people familiar with the matter. Juul did not immediately respond to Ars’ request for comment regarding the potential bankruptcy filing.
On Monday, minutes before the afternoon deadline, Juul filed an emergency petition requesting a stay on the FDA marketing denial for further review. The FDA now has until July 7 to respond to Joule’s plea before the court decides on the fate.
process in question
In its petition, Juul argued that it was unfairly discredited to fuel the youth vaping epidemic and that the FDA denied authorization to do so under political and financial pressure from several lawmakers. Although the FDA said its denial was based on insufficient toxicology data, Jull argued that the data the FDA was requesting was “right there”. [Juul’s] Original submission,” although all the details relating to the data in question were modified from the petition.
Juul also claimed that the FDA reviewed its 125,000-page authorization request differently than competitors’ requests. Finally, Juul complained that the FDA did not give the company a chance to respond to concerns about insufficient data before disclosing its decision. The company said it learned of the FDA’s decision through a Wall Street Journal leak last Wednesday and the news caused chaos for its business and customers.
Overall, the company argued that the FDA overlooked its data and denied it authorization on the basis of an “unstable regulatory process” that would cause irreparable harm to the company and “eventually shutter”. [Juul’s] Business.”
The FDA has until July 7 to respond. In a comment to the Journal, Mitch Zeller, the former director of the FDA’s Center for Tobacco Products, who retired in April, said the regulator’s decision was based solely on the strength of Juul’s application, not political pressure. “It was a scientific review conducted by subject-matter experts,” he said. “That’s how the system should work.”