SILVER SPRING, Md. — Juul Labs Inc. must stop selling all its electronic cigarette devices and pods in the United States, the U.S. Food and Drug Administration said Thursday.
The FDA issued marketing denial orders (MDOs) to the San Francisco-based company for its products marketed in the country including the Juul device and four types of Juulpods—Virginia tobacco-flavored pods at nicotine concentrations of 5% and 3% and menthol-flavored pods at nicotine concentrations of 5% and 3%.
Juul must stop selling and distributing these products, and any currently on the market must be removed or risk enforcement action, the agency said. Retailers should contact Juul with any questions about products in their inventory.
“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 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.”
After the FDA reviewed the company’s premarket tobacco product applications (PMTAs), it determined they lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing them would be appropriate for the protection of the public health. Some of Juul’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, the FDA said.
While the FDA said to date it has not received clinical information to suggest an immediate hazard associated with the use of the Juul device or Juulpods, the MDOs reflect the agency’s determination that there is insufficient evidence to assess the potential risks of using Juul products.
“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.”
The FDA also said there is no way to know the potential harms from using other authorized or unauthorized third-party e-liquid pods with the Juul device or using Juulpods with a non-Juul device, and it recommended against modifying or adding substances to tobacco products.
Joe Murillo, chief regulatory officer at Juul Labs, said the company respectfully disagrees with the FDA's findings and believes it has provided sufficient information and data to address all issues raised by the agency.
“In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of Juul products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being “appropriate for the protection of the public health," Murillo said.
Juul intends to seek a stay on the decision, and is exploring all of its options, including appealing the decision.
"We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide," Murillo said.
The MDOs only pertain to the commercial distribution, importation and retail sales of these products, and do not restrict individual consumer possession or use. Unauthorized electronic nicotine delivery system (ENDS) products for which no application is pending are among the agency’s highest enforcement priorities, it said.
The FDA has authorized 23 ENDS products under the PMTA pathway so far. It has cleared the way for Juul’s biggest rivals, Reynolds American Inc., Winston-Salem, N.C., and NJOY Holdings Inc., Scottsdale, Ariz., to keep tobacco-flavored e-cigarettes on the market.
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