Juul has to remove its e-cigarettes from the market in the United States, the Food and Drug Administration announced today. The agency rejected the company’s application to sell tobacco- and menthol-flavored e-cigarettes.

“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,” said FDA Commissioner Robert Califf in a statement.

The FDA said that it rejected Juul’s application because there wasn’t enough evidence to evaluate any potential toxicological risks of Juul’s products.

E-cigarette and vaping companies have to get clearance from the FDA in order for their products to be marketed and sold. The agency deferred enforcing the policy, in place since 2016, for years. But after increased public scrutiny, it started reviewing applications from companies in September 2020. It’s rejected over 1 million flavored e-cigarette products and authorized a handful of tobacco-flavored vapes — including from Juul competitors the R.J. Reynolds Vapor Company and NJoy.

Juul’s application was one of the most closely tracked. It’s been a market leader among e-cigarette and vaping companies and has spent the past few years taking the brunt of the blame for vaping’s popularity with kids and teenagers. It drew federal attention as part of efforts to get control of youth vaping, which spiked in 2018. But its popularity with teens declined over the past few years, according to 2021 data from the Centers for Disease Control and Prevention. Most teens who vape said they used flavored disposable e-cigarettes.

Juul took its fruit and mint flavors (which were popular with kids) off the market in 2019 and only asked the FDA to review its tobacco- and menthol-flavored products. Now, those remaining products will have to be pulled from shelves in the US.

The FDA has said its review process for e-cigarettes and vapes focuses on whether the potential benefits to adult smokers (who may use them to quit smoking) outweigh the risks of hooking kids and teens on nicotine.

Developing...