FDA Allows JUUL to Remain on Shelves Amid Safety Review

FDA Allows JUUL to Remain on Shelves Amid Safety Review

Introduction

The U.S. Food and Drug Administration (FDA) has agreed to rescind its ban on JUUL e-cigarettes, signaling that it continues to review new case law and information from the manufacturer while evaluating the safety of the nicotine levels and their potential to promote teen addiction.

JUUL vape pens, which resemble USB drives, were introduced in 2015. Their discreet design allowed teens to hide their vaping habits from parents and school officials. The manufacturer aggressively marketed a variety of fruity and sweet flavors through social media influencers, leading to JUUL becoming the most widely used e-cigarette among teens in the U.S. This marketing strategy has been blamed for fueling a teen vaping crisis, creating a new generation of Americans addicted to nicotine.

In June 2022, the FDA issued a marketing denial order (MDO) affecting all JUUL products marketed in the U.S., determining that the manufacturer had failed to provide sufficient evidence to indicate that their products could be marketed safely. However, one month later, the FDA agreed to review certain scientific issues, resulting in a stay of the decision. The vaping devices remained on the market while awaiting further decisions. On June 6, the FDA provided an update, 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 stated. “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 product approval has now returned to a “pending” status and will undergo further FDA review. The initial decision to remove JUUL from the market followed the FDA's order for 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 elaborated on why it initially rejected JUUL’s application beyond noting that the company’s marketing plans failed to demonstrate how they would protect public health from the dangers posed by their nicotine-based products, which have a reputation for enticing teens and underage tobacco users.

Despite authorizing several other vaping products in recent years, the FDA previously determined that JUUL had not provided sufficient evidence to assess relevant health risks and that continuing to sell JUUL would not protect 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,” JUUL Labs stated on June 6. “These products will remain on the market during this review.”

Thousands of families, young adults, and communities, along with states, have filed individual and class action lawsuits against JUUL, alleging that the company’s actions led to teens developing lifelong nicotine addictions. Claims have also been brought by local school districts, which have incurred increased costs due to teen vaping problems in the U.S.

In response to the litigation, JUUL has reached several settlement agreements in recent years. In January 2023, the company agreed to a $1.7 billion settlement to resolve thousands of individual injury lawsuits. Additionally, JUUL agreed to a $438.5 million 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. As part of these settlements, JUUL Labs has not admitted to any wrongdoing.

The FDA’s latest decision to review JUUL’s application further underscores the ongoing scrutiny and controversy surrounding the company and its role in the teen vaping epidemic. As the review process continues, the market awaits the FDA’s final determination on the safety and regulatory status of JUUL products.