Juul Pursues FDA Approval for Innovative Vape Product

Juul Labs Inc., a prominent electronic cigarette manufacturer, is actively seeking federal authorization for an innovative high-tech e-cigarette. This unique product is designed with the capability to electronically verify a user’s age, aiming to prevent the use of illicit counterfeit and unauthorized pod refills.

The new device, already available in Canada and the UK under the name Juul2, can connect to a web or smartphone app. This app employs third-party verification to ensure users are adults, and the device includes features like device locking. The company is currently applying to sell tobacco-flavored pods in the U.S.

The introduction of this new device comes at a time when the company is awaiting a decision from the Food and Drug Administration (FDA) regarding the status of its current products on the market. Last year, the FDA ordered all Juul e-cigarette products off the market. In response, Juul appealed this decision, leading the FDA to suspend its initial order to conduct an internal review of the scientific issues in the company’s application. Juul is continuing to pursue its administrative appeal of the FDA’s decision.

The company has stated that its new next-generation product will provide a technological solution for two significant public health problems: aiding adult smokers in switching from combustible cigarettes and restricting underage access to vapor products. Juul has reported success in the UK, where initial research showed that over 32% of JUUL2 System users had switched from combustible cigarettes to the vape device within six months of purchasing the product.

This development marks Juul’s first public venture after a significant financial setback earlier this year. The company agreed to pay a $462 million settlement to six states and Washington, D.C. over claims that its devices caused addiction in minors. While the company did not admit to any wrongdoing in the settlement, the states accused Juul of illegally marketing its product to minors, asserting it was less addictive than cigarettes and using targeted advertising campaigns to appeal to a younger demographic.

Despite these challenges, Juul reported sales of $1.9 billion in 2021. However, its sales have recently declined, and it now trails behind R.J. Reynolds Vapor Company, a subsidiary of the Reynolds American tobacco company. Industry analysts have attributed this significant and recent market-share decline to the regulatory and legal uncertainty surrounding Juul products.

In a related development, Juul Labs Inc. has filed a lawsuit to compel the U.S. Food and Drug Administration to provide access to documents it used in issuing a marketing denial order of all company products. Juul alleges that the FDA intentionally omitted key toxicological evidence before announcing its intent to ban the products and failed to balance the public health benefits of Juul vaping products against the risks.

As Juul continues to navigate these legal and regulatory challenges, the future of its new high-tech vape product in the U.S. market remains uncertain. The company, however, remains hopeful and is committed to engaging with the FDA throughout the review process.