The U.S. Food and Drug Administration on Thursday ordered Juul Labs Inc.'s e-cigarettes off the market, saying the products play an outsized role in the rise in youth vaping.
The sales ban follows nearly two years of back and forth between the regulator and the San Francisco-based company, which had requested authorization for its tobacco and menthol-favored products to remain on the market.
The company failed to provide evidence their products meet legal standards, Michele Mital, acting director of the FDA's Center for Tobacco Products, said in a statement.
"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," she said.
"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.
The FDA previously banned the sale of fruit- and sweet-flavored e-cigarettes after critics contended the products were aimed at minors. The agency earlier this year cleared some products made by Juul competitor NJOY to stay on the market, and authorized British American Tobacco's e-cigarette Vuse.
Marketed as an alternative for smokers trying to kick the habit, e-cigarettes have helped some adults do exactly that. However, the products have also ushered in an epidemic of youth vaping.
More than 2 million U.S. middle and high school students reported using e-cigarettes in 2021, according to a study released in September by the FDA and the U.S. Centers for Disease Control and Prevention.
Juul's regulatory defeat is the second dealt to the tobacco industry in recent days. The Biden administration this week saying it would order cigarette makers to cut nicotine levels in an attempt to cut smoking-related deaths.
Partially owned by tobacco giant Altria Group, Juul did not immediately respond to a request for comment.