With its business going up in smoke, e-cigarette giant 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 products in the US, effectively forcing it out of business.
The decision was leaked to The Wall Street Journal last Wednesday, June 22, and the regulator publicly announced the decision Thursday. On Friday, a panel of federal appeals court judges granted Juul a temporary administrative stay, allowing the company to continue to sell its products while the court reviews Juul’s emergency petition to halt the FDA’s decision. Juul had until noon Monday to submit its petition. The administrative stay is not based on the merits of Juul’s argument in any way, the judges noted.
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 unnamed people familiar with the matter. Juul did not immediately respond to Ars’ request for comment regarding a possible bankruptcy filing.
On Monday, minutes before its noon deadline, Juul filed an emergency petition requesting a stay of the FDA marketing denial, pending further review. The FDA now has until July 7 to submit a response to Juul’s petition before the court will decide on its fate.
Process in question
In its petition, Juul argued that it was wrongfully vilified for sparking the youth vaping epidemic and that the FDA denied its authorization while under political and financial pressure to do so from multiple lawmakers. Though the FDA said that its denial was based on insufficient toxicology data, Juul argued that the data the FDA was requesting was “right there in [Juul’s] original submission,” though all of the details related to the data in question were redacted from the petition.
Juul also claimed that the FDA reviewed its over 125,000-page authorization request differently than it did competitors’ requests. Lastly, Juul complained that the FDA did not give the company a chance to respond to concerns about insufficient data before revealing its decision. The company said that it learned of the FDA’s decision through The Wall Street Journal leak last Wednesday and that the news created chaos for its business and customers.
Overall, the company argued that the FDA overlooked its data and denied it authorization based on a “haphazard regulatory process,” which will cause the company irreparable injuries and “ultimately shutter [Juul’s] business.”
The FDA has until July 7 to submit a response. In a comment to the Journal, Mitch Zeller, 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. “This was a scientific review conducted by subject-matter experts,” he said. “That’s the way the system is supposed to work.”
https://arstechnica.com/?p=1863071