The U.S. Food and Drug Administration has overturned its ban on JUUL products, potentially allowing the brand to reintroduce its e-cigarettes and vapes into the market.
The FDA initially issued marketing denial orders to JUUL Labs in June 2022, preventing the company from selling devices and tobacco and menthol-flavored pods. However, after JUUL quickly appealed the decision, the products were permitted to remain on shelves.
Following a new case law and the FDA’s comprehensive review of information provided by JUUL in areas such as toxicology, engineering, social science, and clinical pharmacology, the marketing denial orders have been canceled. JUUL’s premarket tobacco product applications are now back in pending status, subject to substantive review by the FDA without a definitive market approval or denial outcome.
“The agency’s ongoing review does not change the fact that all e-cigarette products, including those from JUUL, must have FDA authorization to be legally sold,” stated the FDA.
JUUL confirmed in a statement that its device and the pods involved in the applications will remain available during the review process. The company expressed appreciation for the FDA’s decision and expressed readiness to engage in an evidence-based process to secure marketing authorization for JUUL products.
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JUUL continues to maintain its status as a leading e-cigarette brand in the market despite controversy surrounding its popularity among young users. The CDC identified it as the main driver of youth e-cigarette use in 2017 and 2018, leading to concerns raised by the U.S. Surgeon General.
In a study, it was found that in 2019, JUUL was the usual brand for 59.1% of high school students and 54.1% of middle school students who used e-cigarettes, attributed to the brand’s flavors, design, and marketing.
Despite financial challenges and legal actions, JUUL remains a key player in the increasing e-cigarette sales market. A CDC report from last year noted a significant growth in e-cigarette sales and brands, with JUUL ranking second in overall sales among 269 brands.
While only 23 e-cigarette products from three companies are currently authorized by the FDA for sale in the U.S., JUUL and other manufacturers can sell their products while awaiting review. To comply, products must meet specific standards, which JUUL contends it meets.
