The US Food and Drug Administration (FDA) issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of its products currently marketed in the United States.
With this announcement, the company must stop selling and distributing its products. Also, the ones currently on the US market must be removed, or they risk being penalized.
Products include the JUUL device and four types of JUULpods: Virginia tobacco flavored capsules with 5% and 3% nicotine concentrations, as well as menthol flavored capsules with 5% and 3% nicotine concentrations. Retailers should contact JUUL with questions about the products in their inventory.
“Today’s action is a further advance in the FDA’s commitment to ensure that all e-cigarettes and electronic nicotine delivery systems currently marketed to consumers meet our public health standardssaid FDA Commissioner Robert M. Califf. “We recognize that these make up a significant portion of the products available and many have played a disproportionate role in the rise of youth vaping.”
After reviewing the company’s pre-market tobacco product applications (PMTAs), the FDA determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that the marketing of the products would be appropriate for the protection of public health.
In particular, some of the study findings raised concerns due to insufficient and conflicting data, including those related to genotoxicity and chemical leaching potentially harmful substances from the company’s proprietary e-liquid pods, which were not adequately addressed and prevented the FDA from completing a full risk assessment toxicological analysis of the products named in the company’s filings.
“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by law, but the responsibility to prove that a product meets those standards ultimately rests on the shoulders of the companysaid Michele Mital, acting director of the FDA’s Center for Tobacco Products.
“As with all manufacturers, JUUL had the opportunity to provide evidence showing that the marketing of its products meets these standards. However, the company did not provide that evidence, and instead left us with important questions. Without the data necessary to determine the relevant health risks, the FDA is issuing these marketing denial ordersMital added.
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