Thu, Jun 23, 2022 8:23 AM
By Richie Malouf, The Center Square
The U.S. Food and Drug Administration announced Thursday its decision to issue a marketing denial order to Juul Labs Inc. for all their U.S. marketed products.
Marketing denial orders require a company to stop selling and distributing the relevant products. In this case, all Juul products can no longer be sold or distributed throughout the U.S.
The FDA order requires Juul to pull its electronic cigarettes from the U.S. market or face the risk of law enforcement action.
“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. Califf, M.D. “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 company can no longer sell the Juul electronic vaping device or any flavored pods to accompany it in the U.S.
The FDA’s order applies to commercial distribution, importation, and retail sales of the products.
The order does not restrict individual possession or use of Juul products.
The FDA made its decision after it determined that there was insufficient evidence to assess the potential toxicological risks of using the JUUL products.
“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,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products.
“Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”