2FIRSTS | FDA Authorizes JUUL2, Cites Adult Switching Amid Efforts to Speed PMTA Reviews

The U.S. Food and Drug Administration on August 28 authorized the JUUL2 device and its tobacco- and menthol-flavored pods through the premarket tobacco product application (PMTA) pathway, bringing the total number of FDA-authorized e-cigarette products to 48. The FDA highlighted complete switching among adult cigarette smokers as a key factor in its decision, reporting that 28.4% to 49.3% of adults using the menthol-flavored JUUL2 pod had stopped smoking entirely at six weeks, compared with 19.9% to 34.6% for the tobacco-flavored pod. For the menthol product, the FDA determined that the added benefit to adult smokers was sufficient to outweigh its risks, including youth appeal.

The JUUL2 platform, first launched in the UK in 2021, incorporates age-verification and device-locking capabilities along with Bluetooth connectivity and pod authentication. JUUL Labs submitted its initial U.S. PMTA for JUUL2 in July 2023, followed by a menthol-flavored pod application in December 2023. The latest orders extend JUUL's U.S. marketing authorization from its original product line, which was authorized in July 2025 after a lengthy regulatory process involving initial denial orders in 2022.

The JUUL2 authorization is part of a broader acceleration of PMTA reviews at the FDA. The agency has reduced its PMTA backlog by approximately 70% during 2025, eliminated the queue for Acceptance Review, and is applying efficiency measures developed through a nicotine-pouch PMTA pilot program to other product reviews. Since the original JUUL authorization in July 2025, the number of authorized e-cigarette products has risen from 39 to 48, with additional decisions for nicotine pouches also issued throughout 2026. While faster reviews are expected to expand the authorized market, the FDA continues to prioritize enforcement against unauthorized products and emphasizes that PMTAs are reviewed on a product-specific basis.

(Source：2Firsts)