FDA authorized the JUUL2 device, marking the company’s first new device approval in more than a decade and a key step in Juul’s return to the US market after years of regulatory challenges. Photo credit: Juul Labs Inc.
The US Food and Drug Administration (FDA) has authorized Juul Labs to market its updated JUUL2 e-cigarette system in the US, including tobacco- and menthol-flavored pods.
FDA issued marketing granted orders for the three products on August 28. The authorization came through the agency’s premarket tobacco product application (PMTA) pathway.
JUUL2 includes an optional age-verification feature that can require users to verify their age through an online app before unlocking the device. The system also uses technology designed to work only with authorized pods.
The newly authorized tobacco and menthol pods contain 1.6% nicotine, or 18 mg/mL. Juul already received FDA authorization in July 2025 to market its original e-cigarette device and tobacco- and menthol-flavored pods in 3% and 5% nicotine concentrations in the US.
FDA said manufacturers seeking marketing authorization must provide sufficient evidence showing that a product’s potential benefits to the population outweigh its risks. In its review of JUUL2, the agency found that the products met the statutory standard for marketing authorization.
The decision marks the first FDA authorization for a new Juul device in more than a decade and represents another step in the company’s return to the US market following years of regulatory challenges.
Juul c.e.o. K.C. Crosthwaite said, “We look forward to continuing to work with the FDA as we seek authorization for a portfolio of flavors — beyond tobacco and menthol — that are targeted to adult nicotine consumers.”
According to FDA’s assessment, adult smokers who completely switch from combustible cigarettes to Juul products may reduce their exposure to harmful chemicals found in cigarette smoke. The agency also reviewed studies showing that some adult smokers using Juul products stopped smoking during the research periods, with results varying between products and flavors.