The U.S. Food and Drug Administration (FDA) has authorized the marketing of Juul Labs' next-generation JUUL2 System, clearing the way for the device and its tobacco- and menthol-flavored pods to be sold legally to adult consumers in the United States.
The FDA issued marketing granted orders following a review of Premarket Tobacco Product Applications (PMTAs) submitted by Juul Labs in 2023. The agency determined that the JUUL2 System meets the statutory standard of being "appropriate for the protection of the public health."
FDA Finds JUUL2 Benefits Outweigh Youth Risks
According to the FDA, "FDA's review of data in the application found that a substantial proportion of adults who smoke completely switched away from combustible cigarettes to the authorized JUUL2 products, with the menthol-flavored pod having a higher rate of complete switching compared to the tobacco-flavored pod."
The agency concluded that these switching benefits outweigh the potential risks of the menthol-flavored product, including youth appeal. The decision marks a step forward for the brand, which has faced regulatory hurdles with its first-generation products.
Juul Labs Plans Further Filings for US Market
Juul Labs CEO K.C. Crosthwaite welcomed the decision, stating: "FDA authorization of the JUUL2 System is a win for American innovation and another important step towards eliminating cigarettes."
Crosthwaite added that the company plans to build on the platform with future FDA filings, including 5% nicotine concentration products and additional flavors targeted at adult consumers. "More than two million adult Americans have already switched completely away from deadly cigarettes using our first generation JUUL products, and we hope millions more will switch with the enhanced JUUL2 platform," he said.
The JUUL2 platform has already been sold in international markets, including the United Kingdom. The pods are assembled and filled in US manufacturing facilities in Tennessee and Wisconsin, utilizing e-liquids manufactured in Maryland.
Technical Features of the JUUL2 Platform
The updated system introduces hardware and software updates designed to improve performance and prevent unauthorized use:
- Advanced Thermal Control: An updated heater control system improves temperature precision to deliver a consistent vapor experience.
- PodID Counterfeit Prevention: Each pod contains a secure ID chip that improves performance and blocks the use of counterfeit pods.
- Age-Gated App Integration: An age-gated smartphone app allows adult users to track usage, locate their device, and view real-time battery and pod levels.
- Device Locking: Users can lock the paired JUUL2 device via the app to prevent underage access or unauthorized use.
