U.S. Food and Drug Administration Authorizes Juul Labs' Next Generation JUUL2 System

FDA determines JUUL2 System meets statutory standard of being "appropriate for the protection of public health" 

JUUL2 System incorporates a suite of innovative technology to better serve adults who smoke 

WASHINGTON, Aug. 28, 2026 /PRNewswire/ -- Yesterday, the U.S. Food and Drug Administration issued marketing granted orders for Juul Labs' next generation JUUL2 System with tobacco- and menthol-flavored pods. Juul Labs submitted JUUL2 System Premarket Tobacco Product Applications to FDA in 2023, and provided tens of thousands of pages of scientific evidence, including nonclinical, clinical, behavioral, and population science data. Following rigorous evaluation of the data, FDA determined that the JUUL2 System is "appropriate for the protection of the public health" ––the statutory standard required for market authorization. 

As the FDA stated in its newsroom post today, "FDA's review of data in the application found that a substantial proportion of adults who smoke completely switched away from combustible cigarettes to the authorized JUUL2 products, with the menthol-flavored pod having a higher rate of complete switching compared to the tobacco-flavored pod…The FDA determined that the added benefit to adults who smoke cigarettes is sufficient to outweigh the risks of the menthol-flavored product, including youth appeal."

"FDA authorization of the JUUL2 System is a win for American innovation and another important step towards eliminating cigarettes. The JUUL2 platform demonstrates our company's commitment to responsible product development and investment in high-quality US design and manufacturing. We agree with FDA's assessment that these 'authorizations are another important step to provide greater access to products that can promote switching for adults who smoke,'" said K.C. Crosthwaite, Chairman and CEO, Juul Labs. "We will build on the JUUL2 platform with a robust series of FDA filings, including 5% nicotine concentration products and a portfolio of flavors — beyond tobacco and menthol — that are targeted to adult nicotine consumers. More than two million adult Americans have already switched completely away from deadly cigarettes using our first generation JUUL products, and we hope millions more will switch with the enhanced JUUL2 platform." 

The JUUL2 System, designed by Juul Labs' team of US-based engineers and scientists, incorporates a suite of innovative technology aimed at providing adults who smoke with an appealing, smokefree alternative. The JUUL2 System has been available in a number of other international markets, including the United Kingdom, and FDA's marketing order allows Juul Labs to now bring this enhanced vapor technology to US adult consumers. Juul Labs proudly assembles and fills JUUL2 pods in high-quality US manufacturing facilities in Tennessee and Wisconsin with e-liquids made in Maryland.

Key features of the JUUL2 platform include:

• Enhanced Vapor Experience: A more consistent vapor and nicotine delivery experience designed to compete effectively with combustible cigarettes.
• Advanced Thermal Technology: An innovative heater control system improves temperature-control precision.
• PodID: Each pod contains a unique, secure Pod ID chip that improves vapor performance and prevents the use of illegal counterfeit pods.
• Smartphone App: The 21+ age-gated JUUL App pairs with the connected JUUL2 device and provides adult consumers insights into their product use, device location, real-time battery and pod-level information.
• Device Lock: Using the JUUL App, adult consumers have the ability to lock a paired JUUL2 device to prevent use by others.
• US Manufacturing: Juul Labs proudly assembles and fills JUUL2 pods in high-quality US manufacturing facilities with U.S.-made e-liquid.

More information is available via Juul Labs' Newsroom. 

Media contacts: [email protected]

About Juul Labs 

Juul Labs is a privately held company headquartered in Washington, DC. We continue to drive innovation in the vapor industry through our in-house product design, research and development, and science teams in Silicon Valley and North Carolina. We are proud of the quality control capabilities we enjoy with Maryland-sourced e-liquid and pod filling in Wisconsin and Tennessee. 

Juul Labs is the only major U.S.-based vapor company not owned by or invested in by a cigarette manufacturer. Juul Labs received FDA authorization for its original JUUL System in July 2025 and for the JUUL2 System in August 2026. 

SOURCE JUUL Labs