FDA orders all Juul e-cigarettes off the market

Source: Politico | June 23, 2022 | Katherine Ellen Foley

The agency decided the company’s applications fail to show that their products are appropriate for the protection of public health.

The Food and Drug Administration on Thursday ordered Juul to take all of its vapes off the market, eliminating a major player from the market.

“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 M. Califf said in a statement. Juul did not have an immediate comment on the decision.

Juul, which is owned in part by tobacco giant Altria, is a large market player in the e-cigarette space. The company rose to infamy among public health experts as one of the brands responsible for getting teenagers hooked on e-cigarettes in 2018 and 2019 as youth vaping rates ballooned. In 2019, in a response to criticism, the company discontinued sales of its fruity flavors popular among children, continuing to market only menthol and tobacco-flavored products. Though the rates have since dropped significantly, in a 2021 federal survey, high school and middle school students who regularly vape named Juul as one of the top brands they use.

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.

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

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