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.

These MDOs only pertain to the commercial distribution, importation and retail sales of these products, and do not restrict individual consumer possession or use-the FDA cannot and will not enforce against individual consumer possession or use of JUUL products or any other tobacco products.Īfter reviewing the company’s premarket tobacco product applications (PMTAs), the FDA determined that 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. 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 agency has dedicated significant resources to review products from the companies that account for most of the U.S.

“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,” said FDA Commissioner Robert M. Retailers should contact JUUL with any questions about products in their inventory. The products include the JUUL device and four types of JUULpods: Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%. market must be removed, or risk enforcement action. As a result, the company must stop selling and distributing these products. for all of their products currently marketed in the United States.

Food and Drug Administration issued marketing denial orders (MDOs) to JUUL Labs Inc. The court notes the purpose of this administrative stay is to give the court sufficient opportunity to consider petitioner’s forthcoming emergency motion for stay pending court review and should not be construed in any way as a ruling on the merits of that motion. Circuit entered a temporary administrative stay of the marketing denial order for Juul Labs Inc.

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