FDA Authorizes Juul to Sell New E-Cigarette — Update

By Kelly Cloonan

The Food and Drug Administration gave Juul Labs the go-ahead to sell a new version of its e-cigarette and tobacco- and menthol-flavored pods, marking another win for the company after it got clearance last year to keep its vapes on U.S. shelves.

The regulator said Friday it determined that the company's new Juul2 products offer greater benefits to the health of the population than risks.

In its review of Juul's application, the FDA said it found that a substantial proportion of adult smokers completely switched from combustible cigarettes to the new products, and at a higher rate for the menthol-flavored pod than the tobacco-flavored pod.

"The added benefit to adults who smoke cigarettes is sufficient to outweigh the risks of the menthol-flavored product, including youth appeal," the FDA said.

Juul said the updated vaping device offers what it's calling a more consistent vapor and nicotine delivery experience, and is designed to compete effectively with combustible cigarettes. The new product has already been available in several international markets, including the UK.

The company said it now plans to file further applications with the FDA for other products targeted toward adult nicotine consumers, including 5% nicotine concentration products and a portfolio of flavors beyond tobacco and menthol.

"More than 2 million adult Americans have already switched completely away from deadly cigarettes using our first generation Juul products, and we hope millions more will switch with the enhanced JUUL2 platform," Chief Executive K.C. Crosthwaite said.

The FDA's decision is the latest regulatory milestone for Juul after it got clearance to keep selling the first generation of its e-cigarette last summer.

In 2022, the FDA had ordered the company to halt sales due to unresolved questions related to toxicology data it had submitted in its application to remain on the U.S. market. The ban was quickly put on hold and Juul resumed its e-cigarette sales, but it still pushed the company to the brink of bankruptcy as it settled thousands of lawsuits alleging it had marketed its addictive devices to children and teens.

Juul has denied allegations that it marketed its e-cigarettes to children and teens.

Write to Kelly Cloonan at kelly.cloonan@wsj.com

(END) Dow Jones Newswires

August 28, 2026 18:02 ET (22:02 GMT)