FDA Authorizes Juul2 E-Cigarette

The FDA has authorized Juul Labs to market a new Juul2 e-cigarette system, including a device and tobacco- and menthol-flavored pods with nicotine concentrations around 1.5% to 1.6%, as part of the premarket tobacco product application pathway. The agency said a substantial proportion of adult smokers switched completely from cigarettes to the authorized Juul2 products, with higher switching rates for the menthol pod than the tobacco pod, and that complete switching is associated with lower exposure to harmful chemicals. Regulators emphasized that the population health benefits for adults who smoke outweighed the risks, though they acknowledged potential youth appeal and stressed the importance of complete switching rather than dual use. Juul has signaled plans to pursue additional FDA approvals for other adult-focused products, including higher nicotine concentrations and a broader portfolio of flavors. With these latest authorizations, the total number of FDA-approved e-cigarette products rises to 48, reflecting continued regulatory permission for devices positioned as lower-risk alternatives to smoking.