FDA Allows JUUL Vap Pens To Remain on Store Shelves While Continuing To Review Safety, Teen Addiction Risks

JUUL addiction risks and illegal marketing to teens previously led the FDA to call for a ban of the vape pens, and the manufacturer has paid nearly $3 billion to settle lawsuits brought by families, states and school districts nationwide.

The U.S. Food and Drug Administration (FDA) has agreed to rescind a ban on JUUL e-cigarettes, indicating that it is continuing to review new case law and information from the manufacturer, as it continues to evaluate whether the nicotine levels are safe or pose an unreasonable risk of promoting teen addiction.

JUUL vape pens were introduced in 2015, and were designed to look like USB drives, allowing teens to hide their vaping habit from parents and school officials.

After the manufacturer aggressively marketed a variety of fruity and sweet JUUL flavors through social media influencers, the e-cigarette quickly became the most widely used among teens through the U.S., and have been blamed fueling a teen vaping crisis, creating a new generation of Americans addicted to nicotine.

The FDA issued a JUUL marketing denial order (MDO) in June 2022, affecting all JUUL Labs products marketed in the U.S. after determining the manufacturer failed to provide sufficient evidence indicating that they could be marketed safely. The decision was stayed one month later after the agency agreed to review certain scientific issues, and the vaping devices stayed on the market awaiting further decisions.

However, on June 6, the FDA issued an update on its review of JUUL product applications, rescinding the MDO.

“This action is being taken, in part, as a result of the new case law, as well as the FDA’s review of information provided by the applicant,” the FDA update states. “Rescission of the MDOs is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied.”

JUUL’s application for approval of its products has been returned to the “pending” status, and will undergo further FDA review, the agency indicates.

The decision to remove JUUL from the market came after the FDA ordered all vape manufacturers to submit premarket tobacco product applications (PMTAs) for any nicotine based e-cigarette and vaping products in September 2021. The FDA has not explained why it rejected JUUL’s application for approval, beyond saying that the company’s marketing plans failed to show how the company would protect public health from the dangers of its nicotine-based products, which have already gained a reputation as an enticement for teens and underage tobacco users.

While a number of other vaping products have been authorized by the agency in recent years, the FDA previously determined that JUUL failed to provide sufficient evidence to determine relevant health risks and that continuing to sell JUUL would be appropriate for the protection of public health.

“We remain confident in the quality and substance of our applications and believe that a full review of the science and evidence will demonstrate that our products meet the statutory standard of being appropriate for the protection of public health,” according to a statement by JUUL Labs issued on June 6. “These products will remain on the market during this review.”

JUUL E-Cigarette Lawsuit Settlements

Thousands of families and young adults, as well as communities and states, have filed individual and class action JUUL lawsuits, alleging that the company’s actions left teens with a life-long nicotine addiction. Claims have also been brought by local school districts, which have been left with increased costs dealing with teen vaping problems in the United States.

JUUL reached a string of agreements to resolve the litigation over the last couple years, including a $1.7 billion settlement to resolve thousands of individual injury lawsuits in January 2023, a $438.5 billion settlement to resolve claims filed by 40 different states, and a separate $462 million agreement to resolve claims by six other states and the District of Columbia.

JUUL Labs has not admitted wrongdoing as part of any of the settlement agreements.