The agency administratively stayed its marketing denial order of the Juul Labs premarket tobacco applications.
SILVER SPRING, Md. — The Food and Drug Administration (FDA) is taking another look at the premarket tobacco applications (PMTAs) Juul Labs submitted for its vapor products.
On Tuesday, the agency put its marketing denial orders (MDOs) for the applications on hold. The decision came less than two weeks after the FDA issued the MDOs and ordered all the vapor company's products removed from the market.
"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," the FDA posted on Twitter.
The FDA's administrative stay also follows a decision by the U.S. Court of Appeal for the District of Columbia Circuit to grant Juul Labs an emergency administrative stay while the company fights the FDA's denial of its PMTAs.
"With this administrative stay from the FDA now in place, we continue to offer our products to adult smokers while we pursue the agency'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," said Juul Labs Chief Regulatory Officer Joe Murillo.
"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," he added.
On June 23, the FDA announced its MDOs for all JUUL products: the JUUL device and four types of JUUL pods: Virginia tobacco flavored pods at nicotine concentrations of 5.0 percent and 3.0 percent, and menthol flavored pods at nicotine concentrations of 5.0 percent and 3.0 percent.
The MDOs only pertain to the commercial distribution, importation and retail sales of these products, and do not restrict individual consumer possession or use.
After reviewing the company's PMTAs, the agency determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.
According to the FDA, some of the company's study findings raised concerns due to insufficient and conflicting data — including regarding genotoxicity and potentially harmful chemicals leaching from the company's proprietary e-liquid pods — that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company's applications.
In response, Murillo said the company "respectfully disagree[s] with the FDA's findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency.
"In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being 'appropriate for the protection of the public health,'" Murillo added.
Late last week NACS threw its support behind Juul Labs' bid to remain on the market when it filed an amicus brief in the U.S. Court of Appeal for the District of Columbia Circuit.
"If allowed to take effect, the order threatens NACS members with harm independent of the harm JUUL describes in its stay application," NACS wrote in the brief. "The order saddles retailers and distributors with inventory they cannot sell and contracts they cannot fulfill, waylaying a substantial portion of their business practically overnight."