FDA Orders All Juul E-Cigarette Products Off US Market

WASHINGTON, DC — The U.S. Food and Drug Administration Thursday ordered Juul to take its e-cigarette and four pod products off the U.S. market, saying the company has played an outsized role in the rise of teen vaping, and that its application did not have enough evidence to show its marketing “would be appropriate for the protection of the public health.”

Juul Labs, which was headquartered in San Francisco before moving to Washington, D.C. in recent years, must stop selling and distributing its e-cigarette and four pod products, and remove existing products from store shelves, or face enforcement action, the FDA said.

The products include the JUUL device and the following pods: Virginia tobacco flavored pods at nicotine concentrations of 5 percent and 3 percent; and menthol-flavored pods at nicotine concentrations of 5 percent and 3 percent.

Dr. Robert Califf, the FDA commissioner, said in a statement that his agency's actions show its commitment to "ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our 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 order does not prevent consumers from having or using the products, the FDA said, only the commercial selling and importing of the products.

The agency said it reviewed Juul's premarket tobacco product applications and deemed the applications "lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health."

"In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications," the FDA said in the news release.

The agency has not received clinical information to suggest an immediate danger associated with using JUUL products, but the order reflects the agency's conclusion there was not enough evidence to assess the potential toxicological risks of using them.

"There is also no way to know the potential harms from using other authorized or unauthorized third-party e-liquid pods with the JUUL device or using JUULpods with a non-JUUL device," the agency said.

Michele Mital, acting director of the FDA’s Center for Tobacco Products, said the agency is charged with ensuring tobacco products meet health and safety standards set by the law. It is the company's responsibility to prove a product meets those standards, Mital said.

“As with all manufacturers, JUUL had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders," Mital said.

The Associated Press contributed reporting.