The Food and Drug Administration said Friday it authorized the marketing of three new Juul e-cigarette products through its premarket tobacco product application pathway.
The products are part of the Juul 2 System made by Juul Labs Inc., Washington, D.C., and include a tobacco-flavored pod, a menthol-flavored pod and the Juul 2 device.
The tobacco- and menthol-flavored e-cigarette pods authorized are 18 milligrams/milliliters, which is the equivalent of 1.5% to 1.6% nicotine concentration, the FDA said.
The FDA said its review of data in the application found that a “substantial proportion of adults who smoke completely switched away from combustible cigarettes to the authorized Juul 2 products, with the menthol-flavored pod having a higher rate of complete switching compared to the tobacco-flavored pod.”
Specifically, 19.9% to 34.6% of those using the tobacco-flavored pod and 28.4% to 49.3% of those using the menthol-flavored pod stopped smoking cigarettes entirely at six weeks, the agency said.
“Those who completely switched to the authorized products were exposed to lower levels of harmful chemicals than they would have been had they continued smoking cigarettes,” the FDA said.
To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks.
The FDA said it determined that the added benefit to adults who smoke cigarettes is “sufficient to outweigh the risks of the menthol-flavored product, including youth appeal.”
“Today’s authorizations are another important step to provide greater access to products that can promote switching for adults who smoke and prevent downstream health risks associated with combustible cigarettes,” the FDA said. “However, it is important that these adults switch completely to e-cigarettes or other lower-risk alternatives, as dual use does not provide the same degree of health benefit.”
In July 2025, the FDA authorized several Juul e-cigarette products, including tobacco and menthol-flavored pods in 3% and 5% nicotine concentrations.
To date, the FDA has authorized 48 e-cigarette products.
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