U.S. FDA Allows Sale of JUUL Tobacco and Menthol Vaping Products After Scientific Review

U.S. FDA Allows Sale of JUUL Tobacco and Menthol Vaping Products After Scientific Review

On July 17, the U.S. Food and Drug Administration (FDA) authorized the marketing of five JUUL Vaping products via the Premarket Tobacco Product Application (PMTA) pathway. The authorized products include the JUUL device, as well as Virginia Tobacco and Menthol flavored JUULpods in 3% and 5% nicotine concentrations.

Following a rigorous scientific review, the FDA concluded that the evidence submitted by JUUL Labs—including additional materials provided in response to a prior deficiency letter—satisfies the standards set by the Family Smoking Prevention and Tobacco Control Act of 2009. This legal framework requires the agency to evaluate whether the marketing of a new tobacco product is appropriate for the protection of public health, considering the net impact on the entire U.S. population.

Key data submitted by JUUL included a two-year longitudinal study showing a significant number of adult smokers completely switched from combustible cigarettes to JUUL’s tobacco- and menthol-flavored products. These findings helped demonstrate potential benefits for adult smokers in terms of harm reduction or reduced cigarette consumption.

It’s important to note that FDA authorization does not equate to approval or safety endorsement. The FDA explicitly states that no tobacco product is safe, and those who do not currently use tobacco products—especially youth—should not start. These products are legally allowed for sale to adults aged 21 and older in the U.S.

Source: FDA Announcement

Brands Approved Under PMTA So Far

As of now, the brands that have received PMTA authorization include:

• NJOY

• VUSE

• Logic

Additionally, Philip Morris International has had three tobacco-flavored heat-not-burn (HNB) products approved under the PMTA framework.

About JUUL Labs

Founded in 2015 by Stanford University graduates James Monsees and Adam Bowen, JUUL Labs is headquartered in San Francisco, California. Motivated by their personal experiences as long-time smokers, the founders aimed to reinvent the smoking experience using industrial design and science. Their mission is to “improve the lives of the world’s 1 billion adult smokers” by offering alternatives to combustible tobacco.

Core Innovation: Nicotine Salt Technology

JUUL’s standout innovation lies in its patented nicotine salt formulation. Unlike the freebase nicotine used in early e-cigarettes, JUUL’s formula modifies the pH level of e-liquid to reduce throat irritation while maintaining high nicotine strength (up to 5%). This results in a smoother inhalation experience and more closely mimics the nicotine absorption curve of traditional cigarettes.

This advancement solved a major issue for early vapes—insufficient satisfaction—and triggered a global shift from large mod devices to compact, portable pod systems. JUUL’s minimalist, flat design became iconic, reshaping the industry and even inspiring the term “Juuling”, a cultural reference to its influence.

At its peak in 2018, JUUL held 72% of the U.S. e-cigarette market, accelerating the transition toward user-friendly, high-nicotine small devices and redefining the industry landscape.

Commitment to Adult Smokers and Age Verification

JUUL remains focused on providing alternatives for adult smokers, backed by strict age-verification protocols, such as requiring 21+ age confirmation on its official website.

As one of the early adopters of nicotine salt technology, JUUL has become a benchmark for innovation in the vaping space. It has helped promote public health discussions around harm reduction and smoking alternatives and continues to be a major player in regulatory, technological, and cultural conversations around e-cigarettes.

As of 2024, JUUL maintains a valuation of approximately 26 billion RMB, reinforcing its position as a resilient and influential brand in the global vaping industry.