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FDA orders all Juul e-cigarettes off the market

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The FDA’s Center for Tobacco Products reviewed Juul’s applications for its menthol and tobacco flavor vapes with 3 and 5 percent nicotine pods. Regulators found that the company’s data on the toxicity of its products was lacking and contradictory, preventing the agency from fully assessing the potential risks of the vapes and associated pods. Regulators also noted that to date there is no way of knowing what damage could be caused by using third-party vape juice in Juul pods.

Juul must immediately stop selling its products. If not, it risks FDA enforcement action.

reactions: Cliff Douglas, the director of the University of Michigan’s Tobacco Research Network, estimates that approximately 3 million adults use Juul vapes. “As a public health person…I’m just concerned that millions of people are being affected,” he said. “Bringing the market down in ways that could limit access or appeal…is a concern.”

Proponents of vaping were alarmed by the news. †[This] is the latest sad example of the agency’s regulatory arson targeting the nicotine vaping products that millions of Americans rely on as an alternative to cigarettes,” Amanda Wheeler, president of the American Vapor Manufacturers Association, said in a statement.

However, those most involved in youth vaping saw the regulation as a positive force. “Juul, more than any other product or company, has been responsible for creating and fueling the e-cigarette epidemic among young people,” Matthew Myers, president of the Campaign for Tobacco-Free Kids, said in a statement. “This would be the most important action the FDA has taken to date to end the youth e-cigarette epidemic and prevent tobacco companies from using these nicotine-containing products to addict a new generation of children.” to make.”

Background: The FDA has awarded marketing orders to a handful of tobacco-flavored e-cigarettes, including some from Vuse, NJOY, and Logic. It has denied millions of other uses of e-cigarettes, many of which had fruity or sweet flavors. It still determines 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 finish reviewing all major e-cigarette uses until June 2023.

What’s next: Juul may decide to appeal the FDA’s decision, which could lead to lawsuits. The FDA is already facing lawsuits from dozens of smaller vape companies whose product applications have been rejected.

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