FDA clears Juul2 e-cigarette with age verification for U.S. market
The Food and Drug Administration on Friday cleared Juul Labs to sell Juul2, a redesigned version of its e-cigarette equipped with optional age-verification technology aimed at keeping the device out of underage hands.
The marketing authorization covers the Juul2 device along with updated tobacco- and menthol-flavored cartridges. It lets the company sell a new generation of its once-dominant vaping product in the United States for the first time in more than a decade.
For Juul, the decision is a rare piece of positive news after a punishing stretch. The company has laid off hundreds of employees and paid roughly $3 billion to settle a wave of government and private lawsuits tied to teenage use of its products. The new device is central to Juul's effort to rebuild around stricter age controls and to position itself as a lower-risk option for adults who already smoke.
In a statement Friday, Juul CEO K.C. Crosthwaite said the company plans to seek authorization for "a portfolio of flavors — beyond tobacco and menthol — that are targeted to adult nicotine consumers."
The FDA was careful to frame the action as a marketing authorization, not an endorsement. Regulators said people who do not smoke should not use Juul or any other e-cigarette. For adult cigarette smokers who switch completely, the FDA said, Juul products can reduce exposure to the toxic chemicals and cancer-causing substances found in traditional cigarettes.
In its review, the FDA examined company studies showing that between 20% and 50% of smokers who used Juul products stopped smoking at the end of six weeks, depending on which flavors they used. The agency said its decision weighed the risks and benefits to the U.S. population as a whole, including adults who switch from cigarettes and the potential risks to young people and nonusers.
"To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks," the agency said Friday in a news release.
The Juul2 device also includes a feature designed to address one of the biggest criticisms of the original Juul: it can be locked unless the user verifies their age through an online app. According to Juul Labs, the optional 21-and-up app pairs with the connected device and gives adult consumers details about their product use, device location, battery life and pod-level information. It also allows consumers to lock a paired device to prevent others from using it.
The FDA has authorized only a small number of e-cigarettes in recent years, largely through a process meant to help adult smokers cut back or quit. In May, the agency authorized the first fruit-flavored electronic cigarettes intended for adult smokers, a major policy shift that followed months of industry appeals to President Trump.
Juul no longer leads the U.S. e-cigarette market; it trails Vuse, a brand owned by tobacco giant Reynolds American, which also makes Camel and Newport cigarettes. Federal data shows teenagers have largely moved away from Juul as overall youth vaping has declined, and many teens who still vape now use unauthorized disposable devices imported from China, often in fruit and candy flavors.
Friday's authorization gives Juul a foothold in a rapidly changing market, but it does not settle the broader debate over vaping policy. Public-health concerns around youth use remain a central issue for the agency and the industry, and Juul's next moves will be watched closely as it tries to rebuild its adult customer base without reopening the door to underage use.