FDA Greenlights Juul’s New E-Cigarette with Age-Verification Feature

POLICY WIRE — Washington, D.C. — Juul Labs has been granted federal authorization to market an upgraded e-cigarette equipped with an optional age-verification system, aimed at preventing use by minors.

The Food and Drug Administration’s decision permits Juul to introduce a new iteration of its popular vaping device, marking the first such launch in over a decade. The company has faced significant challenges in recent years, including layoffs of hundreds of employees and settlements totaling approximately $3 billion to resolve lawsuits related to teenage vaping.

The new device, to be sold under the brand name Juul2, will be accompanied by refreshed versions of tobacco and menthol-flavored cartridges. Juul discontinued several flavors in 2019, such as mango, mint, and creme, which were popular among teens but accounted for a large portion of sales.

Juul CEO K.C. Crosthwaite announced plans to seek approval for a broader range of flavors targeted at adult nicotine consumers. The FDA emphasized that this authorization is not an endorsement and advised non-smokers against using Juul or any e-cigarettes.

The FDA highlighted that smokers who fully transition to Juul may reduce their exposure to harmful carcinogens and chemicals found in traditional cigarettes. Company studies, reviewed by the FDA, indicated that 20% to 50% of smokers using Juul products were able to quit within six weeks, with varying success rates depending on the flavors used.

The agency considers the risks and benefits to the U.S. population, including the advantages for adult tobacco users switching to potentially lower-risk products and the risks to youth and non-tobacco users. The FDA requires substantial evidence that new products provide greater health benefits than risks to obtain marketing authorizations.

The new Juul device offers an optional age-verification feature through an online app, which must be used before the e-cigarette can be activated. The app provides adult users with insights into their usage patterns, device location, battery status, and pod information, and allows them to lock the device to prevent unauthorized use.

The FDA has authorized several e-cigarettes to assist adult smokers in quitting or reducing cigarette use. In May, the agency approved the first fruit-flavored electronic cigarettes for adult smokers, marking a significant policy change following industry appeals to President Trump.

Juul is no longer the leading e-cigarette brand in the U.S., having been surpassed by Vuse, sold by tobacco company Reynolds American. Teen vaping has declined , with those who continue to vape primarily using unauthorized disposable e-cigarettes from China, often in fruit and candy flavors.

Reporting by Policy-Wire (PW)