As part of our Premarket Tobacco Product Applications submitted in 2023, we provided tens of thousands of pages of scientific data, including nonclinical, clinical, behavioral, and population science. Following rigorous evaluation of the data, the FDA determined that the JUUL2 System is “appropriate for the protection of the public health”––the statutory standard required for market authorization.

As FDA noted, “Today’s authorizations are another important step to provide greater access to products that can promote switching for adults who smoke.”   

Twenty-five million Americans still smoke cigarettes and millions of adults use illicit vapor products. Smoking accounts for one in five preventable premature deaths in the United States. American adults who use nicotine deserve a reliable marketplace where they can confidently choose from an array of smokefree nicotine products that are backed by rigorous research, made in high-quality manufacturing facilities, and marketed responsibly.

Scientific Evidence Supporting APPH Determination

In authorizing the JUUL2 System, FDA noted: “The 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.”

As part of the PMTA process, FDA evaluated robust data demonstrating the JUUL2 System’s ability to transition adults who smoke, including:

• Adult Switching Success: Behavioral studies of JUUL2 users found that up to 34.6% who use tobacco flavored pods switch (no past 30-day smoking) after only six weeks of JUUL2 use.  
• Menthol Impact: Behavioral data demonstrating that adult smokers who used menthol-flavored JUUL2 pods achieved higher rates of 30-day switching (up to 49.3%) vs. those who use tobacco-flavored pods.

JUUL2: American Innovation

The JUUL2 System, designed by our team of US-based engineers and scientists, represents the next generation of our product portfolio. The JUUL2 platform incorporates a suite of innovative technology aimed at providing adults who smoke with an appealing, smokefree alternative. 

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 optional 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.

Eliminating Combustible Cigarettes 

Juul Labs is focused on making the combustible cigarette obsolete, and we support a robust science- and evidence-based review process for authorizing new tobacco and nicotine products. The FDA must use all the tools it has to accelerate providing regulated, less harmful smokefree products to the 25 million Americans who still smoke and the millions of adults who are using illicit vapor products. To displace the current $11 billion illegal market, adult consumers must have access to a fully regulated marketplace of appealing, scientifically-validated smokefree alternatives made by companies committed to following the law. Americans deserve an orderly and legal marketplace and FDA has the regulatory authority to achieve this. 

The United States must continue to build on the substantial progress made to reduce underage use of nicotine products, and Juul Labs remains committed to doing our part. Underage use of JUUL products has decreased by more than 99% since 2019, and currently, underage use of all vapor products is at the lowest point in more than a decade.

Juul Labs remains committed to our mission to make the cigarette obsolete, and we continue to innovate in pursuit of that goal. The JUUL2 System is a platform on which we will build. We have a robust series of filings planned, including submissions for 5% nicotine concentration products and a portfolio of flavors, beyond tobacco and menthol, that are targeted to adult consumers. We are confident that the JUUL2 Platform – along with the original JUUL System – are part of the solution to provide adults who smoke with an increasing variety of appealing and satisfying smokefree alternatives that have been scientifically validated by FDA. More than two million adult Americans have already switched completely away from deadly cigarettes using our first generation JUUL products, and we hope to serve millions more with the enhanced JUUL2 platform.

Today’s complaints are the latest in a series of disputes between the two companies since 2023, when Altria divested its interest completely in Juul Labs and chose not to secure a license to Juul Labs’ robust intellectual property. Altria subsequently acquired NJOY and its Chinese-developed products, which infringed Juul Labs’ patented technology. 

These new complaints follow Juul Labs’ successes earlier this year before the ITC when the ITC found that Altria’s Chinese-developed NJOY ACE vapor product infringed four patents asserted by Juul Labs and banned ACE’s importation into the United States. That same month, the ITC also terminated Altria’s separate patent infringement action against Juul Labs based on the commission’s finding that the patents asserted by Altria had not been infringed. Altria recently informed Juul Labs that it plans to re-activate federal court litigation against Juul Labs on the basis of the same patents from its failed ITC action against Juul Labs.

Juul Labs’ in-house U.S. product innovation team designed and developed the JUUL System, which has switched more than two million American adults who smoked completely away from combustible cigarettes. Over the past decade, Juul Labs’ product design team in Silicon Valley has been working on the next generation of JUUL products to provide adults who smoke with preferred alternatives to accelerate our mission to eliminate deadly cigarettes.

Juul Labs welcomes fair, and robust, competition in our mission to eliminate combustible cigarettes and is committed to defending its technology, protecting American innovation, and ensuring a level playing field in the market.

About Juul Labs

Juul Labs is a privately held company headquartered in Washington, DC. We will 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 vapor company not owned or invested in by a cigarette manufacturer. The JUUL System, which received authorization in July 2025, launched in the U.S. in 2015. Juul Labs’ technology – including the JUUL System – is developed in the United States, and is protected by a robust portfolio of American patents and intellectual property.