FDA Approves Juul’s Updated E-Cigarette with Age Verification System

Juul Labs has received federal approval to sell a new version of its e-cigarette, equipped with an optional age-verification system. The Food and Drug Administration (FDA) has granted this authorization, allowing Juul to market the updated device for the first time in over a decade of its operation.

In recent years, Juul faced significant legal challenges and financial settlements, amounting to roughly $3 billion due to lawsuits related to teen usage of its products. These legal issues have led to significant layoffs within the company. The newly launched device, called Juul2, includes updated flavors such as tobacco and menthol. They are marketed alongside discontinuing several flavors once favored by teenagers, such as mango and mint.

Juul CEO K.C. Crosthwaite announced plans to seek further authorization for additional flavors targeted at adult nicotine users.

Regulators have reiterated that approval does not endorse using Juul products by non-smokers. Research reviewed by the FDA shows adult smokers using Juul can lower exposure to carcinogens found in regular cigarettes. Studies indicate 20% to 50% of smokers using Juul products successfully quit smoking after six weeks, with the success rate depending on flavor choices.

The FDA assesses the balance of risks and benefits for the U.S. population, acknowledging benefits for adults switching to less hazardous products against risks to youth and non-users. The agency requires sufficient evidence for new products offering greater benefits than risks before granting marketing authorization.

Juul’s new device features an optional age verification system through an online app. Adult consumers can access insights on product usage, device location, battery status, and pod information. The app also enables locking of the device to prevent unauthorized use.

The FDA has approved several e-cigarettes to support adult smokers in reducing or quitting smoking. Notably, in May, authorization was given for fruit-flavored electronic cigarettes aimed at adults, marking a policy shift influenced by industry appeals.

Despite these efforts, Juul is no longer leading the U.S. e-cigarette market, lagging behind Vuse, a brand owned by Reynolds American, known for Camel and Newport cigarettes. Federal data suggests teenagers have shifted from Juul amid reduced vaping habits, often opting for unauthorized flavored disposable e-cigarettes imported from China.