FDA allows marketing of Juul's new e-cigarettes and flavored pods

The FDA authorized Juul Labs to market a tobacco-flavored pod, a menthol-flavored pod and the JUUL2 device through the agency's premarket tobacco product application (PMTA) process.

The agency said its review found that a substantial proportion of adult smokers completely switched from combustible cigarettes to the authorized products, with the menthol pod showing higher switching rates than the tobacco pod.

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

The U.S. Food and Drug Administration on Friday authorized the marketing of three new JUUL2 e-cigarette products, the latest in a series of approvals for nicotine products the agency says may offer a lower-risk alternative to traditional cigarettes.

Last year, FDA had cleared Juul's e-cigarette device and tobacco- and menthol-flavored refill pods after years of heightened regulatory scrutiny.

Juul, once a dominant player in the U.S. vaping market, saw its fortunes decline when its flavored products drew scrutiny for their popularity among teenagers, leading to a federal marketing ban in 2022. The company later avoided bankruptcy after the ban was stayed and subsequently rescinded in 2024.

With the latest decision, the number of FDA-authorized e-cigarette products rises to 48, the agency said.

Last week, the FDA cleared other smoke-free nicotine products, including Philip Morris' ZYN Ultra nicotine pouches.