U.S. Appeals Court Delays FDA’s Ban on Juul
Credit: Tanasin
A federal appeals court today granted Juul Labs Inc. a temporary stay of the U.S. Food and Drug Administration’s order for the vaping company to pull its e-cigarettes off the U.S. market.
“The purpose of this administrative stay is to give the court sufficient opportunity to consider petitioner’s forthcoming emergency motion for stay pending court review and should not be construed in any way as a ruling on the merits of that motion,” the court wrote.
The e-cigarette maker had earlier asked the court to pause what it calls an “extraordinary and unlawful action by the regulatory agency that would require it to immediately halt its business.
The company filed an emergency motion with the U.S. Court of Appeals in Washington as it prepares to appeal the FDA´s decision.
Juul said that the FDA cannot argue that there was a “critical and urgent public interest” in immediately removing its products from the market when the agency allowed them to be sold during its review.
The company noted that the FDA denied its application while authorizing those submitted by competitors with similar products.
The order sets a briefing schedule of June 27 for the petitioner’s emergency motion; July 7 for the respondent’s response, and July 12 for the reply.
The request for an emergency stay while waiting to file an appeal was expected.
“We respectfully disagree with the FDA’s findings … intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator,” said Joe Murillo, chief regulatory officer at Juul Labs, said in a statement. “We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.”
The marketing denial order, which concerns the FDA’s analysis of Juul products has not been released to the public. “Any portion of the record that was placed under seal . . . before an agency remains under seal in this court unless otherwise ordered,” the emergency motion states.
