SILVER SPRING, Md. — The Food and Drug Administration (FDA) has finally made a decision about JUUL vapor products.
On June 23, the agency issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of its products currently on the market in the United States. With the FDA's decision on the premarket tobacco applications (PMTAs), the company must stop selling and distributing the products.
In addition, all JUUL products currently on the U.S. market must be removed.
The MDOs apply to the JUUL device and four types of JUUL pods: Virginia tobacco flavored pods at nicotine concentrations of 5.0 percent and 3.0 percent, and menthol flavored pods at nicotine concentrations of 5.0 percent and 3.0 percent.
"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.
"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," he added.
According to the agency, the MDOs only pertain to the commercial distribution, importation and retail sales of these products, and do not restrict individual consumer possession or use.
After reviewing the company's 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.
According to the FDA, 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 is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company," said Michele Mital, acting director of the FDA's Center for Tobacco 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. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders," Mital said.