The FDA’s Center for Tobacco Products reviewed Juul’s applications for its menthol and tobacco-flavored vapes with 3 and 5 percent nicotine pods. Regulators found that the company’s data on the toxicity of its products was lacking and conflicting, which impeded the agency from fully assessing the vapes and their accompanying pods’ potential risks. Regulators also noted that to date, there is no way to know what harm could come from using third-party vape juice in Juul pods. However, there is no data showing that Juul pods are immediately harmful to users.

“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,” said Joe Murillo, the chief regulatory officer at Juul Labs, in a statement. “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.’”

Juul must immediately discontinue sales of its products. If it doesn’t, it risks enforcement actions from the FDA.

Murillo added that the company is going to be seeking a stay and is exploring appealing the decision and engaging the FDA.

Reactions

Cliff Douglas, the director of the University of Michigan’s Tobacco Research Network, estimates that roughly 3 million adults use Juul vapes. “As a public health person … all I’m concerned about is that that affects millions of people,” he said. “Winnowing the market down in ways that may limit access or appeal … is a concern.”

Vaping advocates were unsettled by the news. “[This] is the latest sorry example of the agency’s campaign of regulatory arson against the nicotine-vaping products that millions of Americans rely on as an alternative to cigarettes,” said Amanda Wheeler, president of the American Vapor Manufacturers Association, in a statement.

Those most concerned with youth vaping, however, saw the regulation as a positive force. “Juul, more than any other product and any other company, has been responsible for creating and fueling the youth e-cigarette epidemic,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids, in a statement. “This would be the most significant action the FDA has taken to date to end the youth e-cigarette epidemic and stop tobacco companies from using these nicotine-loaded products to addict another generation of kids.”

Senate Majority Whip Dick Durbin (D-Ill.) endorsed the FDA’s action as well, calling it a “dramatic, historic step forward to protect the children across America from e-cigarette and vaping products.”

“When I spoke to Dr. Califf this morning ... he made it clear that tobacco, smoking and nicotine products were a major threat to the health of children across this country and to Americans,” Durbin said in a statement. “Tobacco regulation, as he noted, is the major step forward in reducing the number of cancer deaths in America and heart disease.”

Background

The FDA has granted marketing orders to a handful of tobacco-flavored e-cigarettes, including some from Vuse, NJOY and Logic. It has denied millions of other e-cigarette applications, many of which had fruity or sweet flavors. It is still deciding the fate of multiple menthol-flavored vapes.

The FDA’s deadline to decide the fate of vapes was initially set for September 2021. The agency recently estimated that it would not be finished reviewing all major e-cigarette applications until June 2023.

What’s next

The FDA is already facing lawsuits from dozens of smaller vape companies whose product applications have been denied.