The Food and Drug Administration has authorized the JUUL2 device and two 18 mg/mL JUUL2 pods, giving JUUL Labs Inc. three more products it can legally market in the United States.
The agency announced the three marketing-granted orders on Aug. 28. They cover the JUUL2 device, a Virginia Tobacco pod, and a Polar Menthol pod. JUUL says the orders themselves were issued Aug. 27.
The authorization is significant for more than JUUL. FDA said its review found substantial rates of complete switching from cigarettes among adults using both pods—and higher rates among those using menthol. Between 19.9 and 34.6 percent of tobacco-pod users stopped smoking completely at six weeks, compared with 28.4 to 49.3 percent of menthol-pod users.
FDA said people who switched completely were exposed to lower levels of harmful chemicals than if they had continued smoking. The agency concluded that the benefits to adults who smoke were sufficient to outweigh the risks of the menthol product, including youth appeal. That conclusion is notable because menthol has often faced a steeper regulatory climb than tobacco flavor in FDA's premarket tobacco application (PMTA) process.
The authorized pods contain 18 mg/mL nicotine. In JUUL Labs' Aug. 28 statement, the company said it submitted the JUUL2 PMTAs in 2023 and plans additional applications for 5 percent nicotine products and flavors beyond tobacco and menthol.
The new orders arrive after years of regulatory whiplash for JUUL. FDA issued marketing denial orders (MDOs) for the company's original products in June 2022, then administratively stayed them less than two weeks later. In June 2024, the agency rescinded those denials and returned the applications to scientific review, citing both additional review and new case law.
That process finally produced five authorizations in July 2025: the original JUUL device and 3- and 5-percent tobacco- and menthol-flavored pods. FDA said those applications included a two-year cohort study showing high rates of adults switching completely from cigarettes. The agency's 2025 authorization marked a sharp reversal from the blanket denial three years earlier.
With the JUUL2 orders, FDA's current authorized e-cigarette list contains 48 products. As always, a marketing authorization is not an FDA "approval" or a declaration that a product is safe. It means the agency determined that allowing the product on the market meets the statutory public-health standard.
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