By Timothy S. Donahue
Top Takeaways:
- New authorization: FDA authorized the JUUL2 device and two 18 mg/mL pods.
- Switching evidence: Up to 49.3% of menthol-pod users completely switched from cigarettes at six weeks.
- More coming: Juul Labs says it plans PMTAs for 5% JUUL2 products and flavors beyond tobacco and menthol.
It was only a matter of time.
The U.S. Food and Drug Administration today authorized the marketing of three new JUUL vaping products through the premarket tobacco product application (PMTA) pathway. The authorized products are part of the JUUL2 e-cigarette system made by Juul Labs Inc. and include a tobacco-flavored pod, a menthol-flavored pod, and the JUUL2 device.
“As part of its thorough scientific review of new tobacco products, the FDA considers the risks and benefits to the U.S. population as a whole — including the benefits to adults who currently use tobacco products and switch to a potentially lower-risk product, as well as the risks posed to youth and non-users of tobacco products,” the regulatory agency stated.
The JUUL2 is a Bluetooth-enabled e-cigarette platform from Juul Labs designed with advanced safety and tech features, including as age-gating. K.C. Crosthwaite, Chairman and CEO, Juul Labs, said that more JUUL products are coming.
“FDA authorization of the JUUL2 System is a win for American innovation and another important step towards eliminating cigarettes. The JUUL2 platform demonstrates our company’s commitment to responsible product development and investment in high-quality US design and manufacturing,” said Crosthwaite. “We agree with FDA’s assessment that these ‘authorizations are another important step to provide greater access to products that can promote switching for adults who smoke.
“We will build on the JUUL2 platform with a robust series of FDA filings, including 5% nicotine concentration products and a portfolio of flavors — beyond tobacco and menthol — that are targeted to adult nicotine consumers.
“More than two million adult Americans have already switched completely away from deadly cigarettes using our first generation JUUL products, and we hope millions more will switch with the enhanced JUUL2 platform.”
To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks.
The FDA’s review of data in the application found that a substantial proportion of adults who smoke completely switched away from combustible cigarettes to the authorized JUUL2 products, with the menthol-flavored pod having a higher rate of complete switching compared to the tobacco-flavored pod.
Specifically, 19.9% to 34.6% of those using the tobacco-flavored pod and 28.4% to 49.3% of those using the menthol-flavored pod stopped smoking cigarettes entirely at six weeks.
“Those who completely switched to the authorized products were exposed to lower levels of harmful chemicals than they would have been had they continued smoking cigarettes,” the agency stated.
The FDA determined that the added benefit to adults who smoke cigarettes is sufficient to outweigh the risks of the menthol-flavored product, including youth appeal.
In July 2025, the FDA authorized several JUUL e-cigarette products, including tobacco and menthol-flavored pods in 3% and 5% nicotine concentrations. The tobacco and menthol-flavored e-cigarette pods authorized today are 18 mg/mL, which is the equivalent of 1.5 to 1.6% nicotine concentration.
“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, the agency stated. “However, it is important that these adults switch completely to e-cigarettes or other lower-risk alternatives, as dual use does not provide the same degree of health benefit.”
To date, the FDA has authorized 48 e-cigarette products. These products are listed at www.fda.gov/authorizedecigarettes
