JUUL LABS’ STATEMENT ON FDA MARKETING AUTHORIZATIONS

Company News

July 17, 2025

Today the U.S. Food and Drug Administration (FDA) issued marketing granted orders (MGOs) for the JUUL System. As part of our 2020 applications, we submitted over 110 scientific studies to FDA covering nonclinical, clinical, and behavioral science. Following rigorous evaluation of the data, FDA decided that an MGO for the JUUL System was “appropriate for the protection of public health” – the standard required by statute for authorization.

This is good news for the millions of Americans who still smoke cigarettes. 

While more than two million Americans have switched completely away from combustible tobacco using JUUL, we’re focused on making the cigarette obsolete. And for us, that mission is non-negotiable: we’re the only company in the U.S. market with a vapor MGO that doesn’t also sell cigarettes. 

Smoking still accounts for one in five preventable premature deaths in the U.S. This means nearly 500,000 Americans die prematurely each year, and millions more suffer unnecessarily from smoking-related chronic diseases caused by how they get their nicotine. The U.S. spends over $240 billion annually on smoking-related healthcare costs – with an estimated 60% of these expenses covered by taxpayers through Medicare, Medicaid, and other federally-sponsored programs.

But there’s another way. Americans who use nicotine deserve a reliable marketplace where they can confidently choose from an array of FDA-authorized smokefree nicotine products. These products must be backed by rigorous research, manufactured in regularly-inspected facilities, authorized by FDA before introduction to the market, and then marketed and sold responsibly to adults. We fully support FDA in its mission to create such a market.   

America 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. Juul Labs markets responsibly and uses age-verification measures to ensure that our products are marketed to and used by adults. Currently, underage use of all vapor products is at the lowest point in more than a decade, and reported underage use of JUUL products has decreased by more than 98% since 2019. We support category-wide standards to limit access by those underage to all tobacco products.

While today marks an important milestone for our company and our consumers, we’re looking to what’s next. Over the past decade, our 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 cigarettes. Today’s authorization of the JUUL System, including the market-leading tobacco-flavored vapor product in the U.S., enables us to submit applications with updates to the device and pod hardware with the goal of improving the user experience. And our new JUUL2 platform incorporates a suite of innovative technology for an enhanced, more consistent vapor experience for adults moving away from cigarettes and built-in access control capabilities to prevent underage use. We have also developed a portfolio of adult-oriented flavors beyond Virginia Tobacco and Menthol to provide adults who smoke with an increasing variety of options. 

The end of smoking in America is within our grasp. Our team remains committed to our mission to make the cigarette obsolete.

JUUL Products Authorized by FDA

FDA issued MGOs for the on-market JUUL System, which is a closed, cartridge-based nicotine vapor product that utilizes proprietary heating technology to aerosolize and deliver nicotine without combustion. The JUUL System is comprised of the JUUL Device and JUULpods. JUULpods are pre-filled with a nicotine-containing e-liquid formulation, which varies by tobacco or menthol flavor and nicotine concentrations of 5.0% (59 mg/mL) and 3.0% (35 mg/mL). 

About FDA Authorization

In authorizing JUUL products for sale in the United States, the FDA has determined that these products are “appropriate for the protection of public health” (APPH), the statutory requirement for introducing new tobacco products onto the U.S. market. In explaining the decision, FDA noted that Juul Labs “submitted robust data—including a two-year longitudinal cohort study—demonstrating high rates of adults completely switching from cigarettes to either the tobacco- or menthol-flavored JUUL products.” FDA’s statement and supporting documents are available HERE and a list of FDA-authorized vapor products HERE. 

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 by or invested in by a cigarette manufacturer. The JUUL System, which received authorization today, launched in the U.S. in 2015.