PUBLISHED Aug 28, 2026, 7:51 PM ET
The U.S. Food and Drug Administration has authorized Juul Labs to market its JUUL2 e-cigarette system, including tobacco- and menthol-flavored pods, marking the company’s first new device authorization in more than a decade. The FDA issued marketing granted orders dated Aug. 27, while announcing the decision publicly Aug. 28. The authorized pods contain 18 milligrams of nicotine per milliliter, equivalent to about 1.5% to 1.6%. FDA said its review found complete smoking cessation at six weeks among 19.9% to 34.6% of tobacco-pod users and 28.4% to 49.3% of menthol-pod users in company-submitted studies. The agency said benefits for adult smokers outweighed youth-related risks for the menthol product, while stressing authorization is not an endorsement or safety approval. JUUL2 also offers optional app-based age verification. Juul plans additional applications for flavors and nicotine strengths. Juul faced a 2022 marketing denial order, rescinded in 2024, before receiving original-product authorization again in 2025.
By Lauren Mitchell | JQJO News
Left: Coverage emphasizes youth risks, addiction concerns, and regulatory safeguards. Center: Coverage emphasizes authorization, evidence, restrictions, and unresolved youth risks. Right: Coverage emphasizes adult choice, smoking alternatives, and regulatory relief.
On August 27, 2026, FDA issued JUUL2 marketing granted orders. https://www.accessdata.fda.gov/Static/searchtobacco/juul/JUUL2%20PMTA%20Marketing%20Granted%20Letter%20OCC%20Clearance%20R3%208.17_Updated%208.21%20OCCrev_Redacted.pdf
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