The U.S. Food and Drug Administration announced it has authorized three products in the Juul2 e-cigarette system made by Juul Labs through the premarket tobacco product application pathway. The authorization covers the Juul2 device and 18 mg/mL tobacco- and menthol-flavored pods, equivalent to roughly 1.5% to 1.6% nicotine concentration. The FDA previously authorized several Juul products in tobacco and menthol flavors at 3% and 5% nicotine concentrations in July 2025.
The FDA said its review found that a substantial proportion of adults who smoke completely switched from cigarettes to the authorized Juul2 products. At six weeks, 19.9% to 34.6% of users of the tobacco-flavored pod and 28.4% to 49.3% of users of the menthol pod had stopped smoking completely, with the menthol product showing the higher switching rate. Adults who switched completely were exposed to lower levels of harmful chemicals than if they had continued smoking.
The FDA determined that the population-health benefits for adults who smoke outweighed the risks of the menthol product, including its potential appeal to youth. The agency stressed that complete switching provides greater health benefits than dual use of cigarettes and e-cigarettes. The three authorizations bring the total number of e-cigarette products authorized by the FDA to 48.
