The end of the saga, or just another twist?
It is a saga that began more than ten years ago. In 2015, Juul Labs launched its pod system in the United States. The device proved hugely successful, both among adult smokers and some minors with no previous history of smoking. Under regulatory and media pressure, Juul voluntarily withdrew several of its flavored pods from the U.S. market. Flavors such as mango and crème disappeared, leaving only tobacco and menthol.
As the years passed, lawsuits against Juul continued to pile up. Several states notably accused the manufacturer of being directly responsible for the large number of minors vaping in the United States. An “epidemic of e-cigarette use among teenagers”, as then-Food and Drug Administration (FDA) Commissioner Scott Gottlieb had described it a few years earlier.
In mid-2022, the FDA banned all Juul products in the United States, citing insufficient data on their health effects and conflicting data regarding their genotoxicity. But just twelve days later, the regulator itself reversed the decision, stating simply that certain scientific questions concerning Juul pods warranted further review. The products were allowed back onto the market in the meantime.
Between 2022 and 2024, the FDA conducted an in-depth review of all the data it held on Juul products. During those two years, the regulatory agency faced numerous lawsuits from manufacturers whose products had been denied authorization. The FDA lost several of these cases, with some rulings describing its actions as “arbitrary and capricious”, or finding that it had imposed certain evaluation criteria that were inconsistent with the guidance it had itself provided manufacturers on how to obtain authorization for their products.
In mid-2024, the FDA formally rescinded the bans imposed on Juul products two years earlier. It stressed, however, that this did not amount to an authorization, but simply meant that its review of the products for which Juul had applied for marketing authorization would resume. The agency also noted that its decision took into account several recent court rulings. Ironically, the January 2024 ruling that apparently influenced this reversal would itself be overturned a year later. On April 2, 2025, the U.S. Supreme Court unanimously sided with the FDA in the case, by nine votes to zero, finding that the agency had not acted arbitrarily when denying the marketing applications. The FDA had therefore softened its position under pressure from a legal precedent that, a year later, would no longer stand.
In 2025, the Food and Drug Administration finally authorized five Juul products for legal sale in the United States. Then, on August 28, 2026, it authorized three additional products: the Juul2 device and two tobacco- and menthol-flavored pods containing 18 mg/mL of nicotine. Juul had been seeking authorization to market these products since 2023.
Juul has already indicated that it intends to submit further marketing applications for pods containing higher nicotine concentrations and additional flavors.
