FDA Orders Removal Of JUUL Products From US Market

On Thursday, June 23, the U.S. Food and Drug Administration ordered JUUL Labs Inc. to stop selling and distributing all of their products currently marketed in the United States. Any JUUL products—which include the JUUL device and four JUULpods, Virginia tobacco flavored pods and menthol flavored pods at nicotine concentrations of 5.0 percent and 3.0 percent—must be removed from the market or risk enforcement action.

The FDA orders only pertain to the commercial distribution, importation and retail sales of JUUL products, and do not restrict individual consumer possession or use. 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 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.”

According to an FDA press release, JUUL’s premarket tobacco product applications raised concerns due to insufficient and conflicting data regarding genotoxicity and potentially harmful chemicals leaching from e-liquid pods. To date, the FDA has not received clinical information to suggest an immediate hazard associated with the use of the JUUL device or JUULpods.

However, the FDA has determined there is insufficient evidence to assess the potential toxicological risks of using JUUL products. The agency said there is also 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. The FDA recommends against modifying or adding substances to tobacco products. JUUL users are encouraged to report any unexpected health problems or product problems to the FDA through the Safety Reporting Portal and to seek medical attention as necessary.

JUUL once controlled 75 percent of the national e-cigarette market, according to Business Insider. But from 2018 to 2021, the company’s value plunged from $38 billion to under $5 billion.

Consumers with questions can contact the FDA at 888-INFO-FDA.