The Food and Drug Administration (FDA) on Thursday banned the sale of Juul vaping products in the United States, effective immediately. The agency said it is on a drive to regulate e-cigarettes to meet public health standards, and that Juul vapers lack sufficient evidence to banish health risks.
The FDA said Juul’s vaping devices and pods have not been proven yet to pose an immediate health hazard to users, but that the brand is among those responsible for rising youth vaping in the country. The agency clarified that it issued a marketing denial order (MDOs) against Juul because “there is insufficient evidence to assess the potential toxicological risks” of its products.
“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” FDA Commissioner Robert Califf announced. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market.”
Juul’s chief regulatory officer, Joe Murillo, said the FDA is wrong in banning its products based on supposed insufficient data, adding that his company has furnished the health agency with all required information and that Juul will go legal to address the issue.
“We respectfully disagree 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,” Murillo declared. “We 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.”
On Friday, Juul filed an emergency administrative stay at the US Court of Appeals for the DC Circuit, until it can file a motion for a stay pending review on Monday afternoon. If the court grants the application, Juul will continue to market its vaping device and menthol, as well as tobacco-flavored nicotine pods until the court reviews the FDA’s directive.
The vape company criticized the federal health agency for being selective in targeting e-cigarette manufacturers. They said that instead of the usual warning and transition period imposed on companies for compliance, the FDA imposed immediate enforcement of its order even where the products in question do not pose an immediate health hazard to users.
“FDA’s decision is arbitrary and capricious and lacks substantial evidence, and an immediate administrative stay is critical to protect [Juul Labs Inc.], its commercial partners, and its customers,” Juul said.