The U.S. Food and Drug Administration (FDA) has placed an administrative stay on its marketing denial order against Juul Labs Inc. On June 23, the FDA said that Juul had not sufficiently proven that its products are beneficial to the public, but it now says that the case needs further review.
"On July 5, 2022, FDA administratively stayed the marketing denial order [against Juul]," FDA's Center for Tobacco Products wrote on Twitter
As a part of its effort to bring regulations on vaping up to date, the FDA is requiring all electronic cigarette companies to prove that their products benefit public health in order to stay on the market. Only a few products have been approved through this process so far, with millions being denied.
In order to get FDA marketing approval, manufacturers have to show that their products either help adult smokers quit smoking or reduce their smoking habits. They also have to prove that their products aren't likely to cause addiction in underage users.
In its marketing denial order announcement, the FDA wrote that Juul hadn't answered all of the regulators' questions regarding the potential health risks of its vape products. However, Juul says that it has submitted sufficient information to "address all issues raised by the agency."
"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," a chief regulatory officer at Juul, Joe Murillo, said in a statement.
In a court document filed by the company and reported by The New York Times, Juul says that its products have helped two million adults stop smoking traditional cigarettes.
The order was blocked by a three-judge panel at the U.S. Court of Appeals for D.C., the day after it was put in place. The court will review Juul's application, and the FDA's administrative stay will remain in place in the meantime. However, the FDA says that the stay and block do not rescind the marketing denial order and do not "constitute authorization to market, sell or ship Juul products."
"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," Murillo said. "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."
According to the FDA, more than two million middle and high school students in the U.S. used a vape in 2021. Eight in ten students said that they had tried flavored vapes. Juul is the e-cigarette of choice for more than a quarter of all high school students in 2020, according to a National Youth Tobacco Survey.
Juul has said that one pad caries as much nicotine as 20 packs of cigarettes.
