On Friday, Juul Labs received approval from the Food and Drug Administration to sell a newly updated version of its e-cigarette, featuring an optional age-verification system aimed at curbing underage use. This marks the first permission granted to the company to sell a new version of its popular vaping device since its initial launch over ten years ago.
In recent years, Juul faced challenges that led to laying off hundreds of employees and spending approximately $3 billion to settle multiple lawsuits related to underage use of its products. With the new device, marketed under the name Juul2, the company will also offer updated tobacco- and menthol-flavored cartridges. In 2019, Juul had ceased selling flavors like mango, mint, and creme, which appealed largely to teenagers.
Juul CEO K.C. Crosthwaite stated the company intends to seek validation for a wider range of flavors aimed at adult nicotine users. The FDA decision does not equate to an endorsement, and regulators warn against the use of Juul or other e-cigarettes by non-smokers.
The FDA emphasizes the importance of weighing the overall risks and benefits to the U.S. population, considering adult smokers who might switch to Juul as a potentially lower-risk option. Studies reviewed by the FDA indicate that 20% to 50% of smokers using Juul managed to quit smoking within six weeks, with results varying depending on the flavors used.
For marketing authorizations, the FDA requires substantial evidence demonstrating that the products present more benefits than risks to population health. The newly authorized device allows users the option of enforcing age verification through an online app before unlocking the e-cigarette.
Juul Labs notes that the optional app, designed for adults over 21, pairs with the e-cigarette to provide insights into product usage, device location, real-time battery, and pod information. It also offers a feature to lock the device to prevent unauthorized use.
The FDA has authorized selected e-cigarettes to assist adult smokers in quitting or reducing cigarette consumption. In May, the agency approved the first fruit-flavored e-cigarettes for adult smokers, signaling a policy shift following industry pressure. Currently, Juul has fallen behind Vuse, a brand by Reynolds American, which leads the U.S. e-cigarette market. Federal data indicate a decline in teen use of Juul, with most opting for unauthorized disposable e-cigarettes from China, often flavored with fruit or candy.