FDA rescinds ban on Juul products

The Food and Drug Administration (FDA) has announced that it will lift its ban on the sale of Juul e-cigarettes in light of new legal precedent.

Nearly two years ago, the FDA banned the sale and marketing of Juul’s e-cigarette products, saying at the time that the company had failed to demonstrate that allowing their products on the market was “appropriate for the protection of the public health.”

Juul products have since been available for purchase, but the FDA suspended the ban later that year, citing the need for further research. Juul also filed a lawsuit alleging that the FDA had failed to disclose documentation supporting its decision to ban Juul products.

“Today, the FDA revoked the MDO it issued to JUUL Labs in June 2022. This action is being taken in part as a result of new case law and FDA’s review of information provided by the applicant,” the FDA said in a statement Thursday.

“Cancellation of an MDO does not imply approval or denial, and is not an indication that an application will be approved or denied,” the agency said. “Cancellation of an MDO places the application back on hold pending substantive review by FDA.”

Shortly after the FDA’s decision was announced, Juul welcomed the news in a statement.

“We appreciate the FDA’s decision and look forward to working with them again on a scientific, evidence-based process to gain marketing approval for JUUL products,” the company said.

“We remain confident in the quality and content of our application and are confident that a thorough review of the science and evidence will demonstrate that our product meets the statutory standard of being appropriate for the protection of public health.”

When the FDA issued the ban in 2022, officials cited Juul’s role in increasing youth smoking. The 2023 National Youth Tobacco Survey, released in November, found that smoking among high school students decreased and smoking among middle school students increased in 2023. E-cigarettes were the most popular product among this generation for the 10th consecutive year, while cigarette and cigar use hit record lows.