Juul ban put on hold as FDA starts additional review

[July 07, 2022] 

(Reuters) -The U.S. Food and Drug Administration (FDA) has put on hold its ban on sales of Juul Labs Inc's e-cigarettes, with the health agency saying late on Tuesday that it would do an additional review of the company's marketing application.

Juul had won a temporary reprieve a couple of weeks ago after a U.S. federal appeals court stayed the FDA's ban following an appeal from the company for an emergency review of the regulator's order.

The once red-hot vape company has said the FDA's decision to block sales of its products is "extraordinary and unlawful", citing, among other things, the agency's authorization of e-cigarette products made by other manufacturers.

In a series of tweets on Tuesday, the FDA said there were "scientific issues unique to the Juul application that warrant additional review".

"The stay and the agency's review does (sic) not constitute authorization to market, sell, or ship JUUL products," the agency added.

While imposing its ban on June 23, the FDA said Juul had failed to show the sale of its products would be appropriate for public health, following a nearly two-year-long review of data provided by the company.

"(The latest) announcement by the FDA would suggest that it concedes data had been overlooked and a possibility they got their decision wrong," Jefferies analysts wrote in a note, adding that Juul products are likely to spend little time, if any at all, off the market.

Juul, partly owned by tobacco giant Altria Group Inc, said it was confident its products meet the statutory standard of being appropriate for the protection of public health.

"We now look forward to re-engaging with the FDA on a science- and evidence-based process to pursue a marketing authorization for JUUL products," Joe Murillo, Juul's chief regulatory officer, said in an emailed statement.

(Reporting by Uday Sampath, Shivani Tanna and Akriti Sharma in Bengaluru; editing by Uttaresh.V, Anil D'Silva and Maju Samuel)

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