FDA forces all Juul products off the US market [Updated]

Enlarge / Mint and menthol pods for Juul Labs Inc. e-cigarettes. (credit: Getty | Bloomberg)

Update 6/23/2022 11:15am ET: The Food and Drug Administration this morning denied marketing authorization for all Juul products currently sold in the US, effectively shuttering the e-cigarette giant that once dominated the US market. The authorization denial specifically applies to the Juul device and the company's four types of Juul pods: Virginia tobacco flavored pods and menthol flavored pods, both at nicotine concentrations of 5.0 percent and 3.0 percent.

In a statement Thursday, the FDA said the reason for the denial was that Juul failed to provide sufficient toxicology data to demonstrate the products were safe. "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," the FDA wrote.

Michele Mital, acting director of the FDA’s Center for Tobacco Products, added that it is Juul's responsibility to demonstrate to the FDA that its products meet all legal standards. "As with all manufacturers, Juul had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards," Mital said. "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."