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FDA Orders Juul Pulled from Shelves in Blow to Vape Industry

June 23, 2022
The agency found the prominent tobacco-vaporizer company failed to provide enough evidence their products protect public health.

After years of regulatory limbo, the FDA has announced that Juul Labs Inc. must stop selling and distributing its electric cigarettes and tobacco pods. The federal agency in charge of medical and tobacco products ruled June 23 that Juul’s application to sell tobacco products had insufficient evidence to determine if selling its products—specifically, the Juul vaporizer “pen” and nicotine pods—are “appropriate for the protection of the public health.”

Juul Labs markets its electronic cigarette products as a healthier alternative to traditional cigarettes, potentially one that makes it easier for smokers to quit using tobacco altogether. According to the FDA’s latest ruling, though, the evidence for Juul’s utility as a way for smokers to kick the habit isn’t solid enough. Juul’s application to market the products, according to the company, was submitted more than two years ago.

FDA Commissioner Robert Califf, in a statement, said the ruling represented “progress” in holding electric cigarette companies accountable to public health standards. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market,” Califf said. “We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”

The FDA order is the latest travail for Juul, which, before the pandemic, unwittingly sponsored a rise in underage tobacco use as high school students picked up on disposable vaporizers with fruit or desert flavors. Juul eventually eliminated those flavors in 2019, but the trend cast a pall on its medicinal mission statements. The FDA’s latest ruling forbids the sale of the company’s remaining flavors, tobacco and menthol.

Juul Labs CEO K.C. Crosthwaite—a former COO of Altria, which has a 35% stake in Juul—acknowledged the company’s image issues in a statement posted to the company’s corporate website.

“Policymakers, regulators, and the general public must trust us to design, manufacture and market our products in ways that are consistent with the goal of offering alternatives to adult smokers, while keeping our products, and marketing of our products, away from those underage,” said Crosthwaite. “We’re quite aware of an erosion in that trust over the past few years. We’re working hard to rebuild it.”

Elsewhere, the company’s Chief Regulatory Officer Joe Murillo, indicated the company disagrees with FDA’s findings and said the company would seek a stay in the sales ban.

“In our applications, which we submitted over two years ago, 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 public health,’” said Murillo.

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