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The FDA made the announcement on Thursday, June 23, saying it has issued marketing denial orders to the company.
Officials said the decision means the products that are currently on the US market must be removed.
The products include the Juul device and four types of Juul pods, the FDA said.
“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 Califf said. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market.
"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 said after receiving Juul's premarket tobacco product applications, officials determined that the applications lacked sufficient evidence about the toxicological profile of the products to show that the products' marketing "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.
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