The US Food and Drug Administration (FDA) has authorised JUUL2, making it the second vaping device cleared by the agency to incorporate technology designed to restrict access by young people.
The decision adds to signs that technology-based age controls could play a growing role in how the FDA weighs the benefits of vaping for adult smokers against the risk of youth use.
The FDA authorised the JUUL2 device and tobacco and menthol pods through its premarket tobacco product application process on August 28.
The agency said its review found that a substantial proportion of adult smokers completely switched away from cigarettes while using the products.
After six weeks, between 19.9 and 34.6 per cent of people using the tobacco-flavoured pod had stopped smoking cigarettes entirely. Among those using the menthol pod, the figure was between 28.4 and 49.3 per cent.
People who switched completely were also exposed to lower levels of harmful chemicals than they would have been if they had continued smoking, according to the FDA.
The agency concluded that the benefit to adults who smoke was enough to outweigh the risks associated with the menthol product, including its potential appeal to young people.
The FDA said: “Today’s authorizations are another important step to provide greater access to products that can promote switching for adults who smoke and prevent downstream health risks associated with combustible cigarettes.”
Technology in preventing youth-access
The authorisation is significant because JUUL2 incorporates age-control technology, an approach the FDA has now accepted in two separate vaping systems.
JUUL says its smartphone app is restricted to people aged 21 and over and can be paired with the JUUL2 device. Users can also lock a paired device to stop other people using it. Unlike some newer age-gated systems, however, use of the app and device-locking function is optional.
Earlier this year, the FDA authorised the Glas G2 system, which takes a more restrictive approach.
Its access-control technology requires users to verify their age and identity using government-issued identification and pair the vaping device with a smartphone via Bluetooth. The device will not operate when separated from the paired phone, while the app carries out random biometric checks to confirm the registered adult is still the user.
The FDA specifically cited those controls when it authorised four Glas pods in May, including non-tobacco and non-menthol flavours.
It said the technology, alongside marketing restrictions, was expected to “effectively mitigate the ability of youth to use the product”. The agency also said the decision demonstrated another route by which vaping products could meet its public health standard through effective age-gating.
The Cancer Letter, which highlighted the JUUL2 decision this month, described it as the second vape authorised by the FDA to incorporate age-gating features.
Balancing switching with youth protection
Under the PMTA process, the FDA must consider a product’s likely effect on the population as a whole. That includes whether it could help existing tobacco users move away from cigarettes and whether it could encourage people who do not use tobacco, particularly young people, to start.
Its marketing order for JUUL2 makes clear that the authorisation is conditional and can be withdrawn or suspended if the public health balance changes. The FDA said it would continue monitoring the products, including for significant increases in youth uptake.
Youth vaping rates have fallen substantially from their 2019 peak. The latest National Youth Tobacco Survey found that 5.2 per cent of middle and high school students, around 1.44 million young people, used vapes in 2025. Use declined between 2022 and 2025.
At the same time, combustible cigarettes continue to carry a much larger health burden. The US Centers for Disease Control and Prevention estimates that cigarette smoking and exposure to secondhand smoke cause more than 480,000 deaths in the country each year.
The JUUL2 decision brings the number of FDA-authorised vape products to 48.
