SILVER SPRING, Md. — The U.S. Food and Drug Administration has stayed a marketing denial order (MDO) that prohibited electronic-cigarette maker Juul Labs Inc. from selling its products, the agency has announced on Twitter.
“On July 5, 2022, FDA administratively stayed the marketing denial order. The agency has determined that there are scientific issues unique to the Juul application that warrant additional review,” it tweeted.
The administrative stay temporarily suspends the MDO during the additional review, but does not rescind it, the FDA said.
"All electronic nicotine delivery systems, or ENDS products, including those made by Juul, are required by law to have FDA authorization to be legally marketed. The stay and the agency’s review does not constitute authorization to market, sell, or ship Juul products," the FDA said on Twitter.
With Juul having already received a temporary stay from court, the followup from the FDA doesn’t materially change the competitive landscape as Juul will remain on the market, according to a research note from New York-based investment bank Cowen.
“That said, it does extend (at a minimum) the time that Juul will have on the market to defend its PMTA application, which now seems they'll do with the agency first, as opposed to going directly to the courts, which had been the originally announced pathway following the adverse initial findings from the [premarket tobacco product application] PMTA review,” Cowen analyst Vivien Azer said.
Joe Murillo, chief regulatory officer at Juul, said the company will continue to offer its products to adult smokers while it pursues the FDA's internal review process.
“We remain confident in the quality and substance of our applications and believe that ultimately we will be able to demonstrate that our products do in fact meet the statutory standard of being appropriate for the protection of the public health,” he said. “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.”
On June 23, the FDA told retailers that the Juul device and four types of Juulpods—Virginia tobacco-flavored pods at nicotine concentrations of 5% and 3% and menthol-flavored pods at nicotine concentrations of 5% and 3%—had to be removed from retail shelves.
The U.S. Court of Appeals for the D.C. Circuit granted Juul Labs an emergency stay on June 24, temporarily blocking the order and allowing the San Francisco-based company's e-cigarettes to remain on the market.
The agency said Juul’s PMTA lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing them would be appropriate for the protection of the public health.
In a June 28 filing for a formal stay, Juul Labs claimed that the FDA denied the company’s applications for “deeply flawed reasons.”
“Having received the emergency temporary stay, we are now seeking the ability to continuously offer our products to adult smokers throughout our appeal with the court and science- and evidence-based engagement with our regulator,” Murillo said.
Juul’s PMTAs included more than 110 scientific studies and 125,000 pages of data and analysis demonstrating the substantial public health benefits its electronic nicotine delivery system products provide, the company said. It claimed that a drawn-out regulatory process produced an erroneous decision. PMTAs for all new tobacco products were due Sept. 9, 2020, and the FDA was supposed to review applications a year later—but the process is still ongoing.
While the FDA’s order acknowledges that “exposure to carcinogens and other toxicants present in cigarette smoke were greatly reduced with exclusive use” of Juul products compared with combustible cigarettes, it also claimed Juul did not provide aerosol data measuring the toxicological effect of four chemicals.
“But [Juul Labs Inc.] did provide that data—6,000 pages of it. Had FDA done a more thorough review (like it did for other applicants), it would have seen data showing that those chemicals are not observable in the aerosol that Juul users inhale,” Juul wrote in its filing for the formal stay.
Juul also said the FDA reached these decisions amid “immense political pressure,” as members of Congress have pressed the FDA to commit that Juul products would not be authorized. Juul claimed that consumers will switch to other products or return to cigarettes if its products are ordered off the market, posing a significant public-health risk.
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