JUUL Labs’ journey to securing FDA marketing authorization was a landmark battle, marked by initial rejection, high-stakes litigation, and a strategic pivot that ultimately paid off. The story of how JUUL’s vape devices and pods finally gained approval is a masterclass in regulatory resilience and provides a clear roadmap for the industry’s future.

In July 2020, JUUL submitted a massive Premarket Tobacco Product Application (PMTA) to the FDA, spanning over 125,000 pages. The application centered on their device paired with Virginia Tobacco and Menthol pods in 3% and 5% nicotine strengths. Supported by over 110 scientific studies, JUUL’s core argument was that these products were effective tools for helping adult smokers switch from combustible cigarettes, while posing a limited risk of attracting underage users. The company presented extensive evidence to demonstrate a net public health benefit, positioning their products as a safer alternative to traditional smoking.

However, the regulatory road ahead proved to be far from smooth. This blog post breaks down the key stages of JUUL’s multi-year struggle, from a near-fatal marketing denial order to their eventual, hard-won victory, highlighting the lessons learned along the way.

Initial Rejection and Legal Lifeline

Despite the comprehensive application, the FDA delivered a major blow on June 23, 2022. The agency issued a Marketing Denial Order (MDO) for all JUUL products, citing insufficient and contradictory toxicological data. The FDA concluded that it could not complete a full toxicological review of the potential harms, forcing JUUL to immediately remove its products from the market. This decision brought the company to the brink of collapse.

JUUL acted swiftly, appealing the decision in the D.C. Circuit Court of Appeals. The court granted an emergency stay, which was followed by an administrative stay from the FDA itself. This crucial legal maneuver prevented the immediate enforcement of the MDO, allowing JUUL products to remain on shelves while the case was reviewed. It was a critical moment that gave the company the breathing room it needed to regroup and challenge the FDA’s findings.

Navigating Legal and Financial Hurdles

While battling the FDA, JUUL also faced intense scrutiny from state attorneys general over its past marketing practices, particularly those targeting minors. This led to two significant legal settlements:

• September 2022: A $438.5 million settlement was reached with 33 states and Puerto Rico.
• April 2023: A further $462 million settlement was agreed upon with six more states, including California and New York, plus the District of Columbia. This agreement included even stricter marketing restrictions, further constraining how JUUL could promote its products.

These settlements, while costly, were necessary steps to resolve lingering legal challenges and allow the company to focus entirely on its regulatory future with the FDA.

A New Strategy: The JUUL2 and Enhanced Safety

With the initial MDO on hold, JUUL went back to the drawing board, not just to gather more data, but to innovate. On December 19, 2023, the company submitted a new PMTA for its next-generation JUUL2 device. This application was highly strategic, focusing on several key enhancements designed to address the FDA’s primary concerns:

• Menthol-Flavored Pods: The application was specifically for 18mg/mL menthol-flavored pods.
• Age Verification Technology: The new device included a built-in chip that required age verification, directly tackling the issue of youth access.
• Improved Data: The submission was backed by updated scientific data aimed at resolving the toxicological inconsistencies the FDA had previously identified.

This proactive approach demonstrated JUUL’s commitment to preventing underage use and signaled a willingness to work within a stricter regulatory framework. This move proved pivotal. On June 6, 2024, the FDA rescinded the 2022 MDO, acknowledging the need to review new evidence. This decision moved the application back into substantive review and was widely seen as a major turning point in the regulatory climate.

The Final Victory: Full Authorization

After nearly a year of providing supplementary data and engaging in continuous dialogue with the FDA, JUUL finally received the news it had been fighting for. On July 17, 2025, the FDA granted full marketing authorization for the JUUL device and both its Virginia Tobacco and Menthol flavored pods in 3% and 5% nicotine strengths.

In its decision, the FDA highlighted evidence from a two-year longitudinal study demonstrating that a significant number of adult smokers had completely switched to JUUL. The agency concluded that the benefits to adult smokers outweighed the risks to youth, especially with the enhanced safety measures in place. This ruling validated JUUL’s long-held position and marked the end of a grueling five-year process.

Our Verdict: What JUUL’s Win Means for Vaping

JUUL’s path from rejection to authorization offers invaluable lessons for the entire vaping industry. It underscores that robust scientific data is non-negotiable, legal action can provide critical time to strengthen a case, and proactively addressing youth access is essential to winning regulatory trust.

The approval, coming nearly a year after the last authorization for a similar product, doesn’t necessarily mean the FDA will start fast-tracking applications. However, it does bring much-needed clarity to the regulatory process. By repeatedly scrutinizing and ultimately approving JUUL’s application, the FDA has provided a clearer template for what it expects in terms of evidence standards and risk-benefit analysis. As the regulatory framework becomes more transparent and predictable, other manufacturers can better align their submissions with the FDA’s requirements, fostering a more stable and responsible market for all adult vapers.