On June 6, the U.S. Food and Drug Administration (FDA) rescinded its June 2022 marketing denial order against Juul and put the company's application back into the scientific review process.

After determining that certain scientific issues required further review, the FDA put the decision on administrative stay in July 2022. Since then, the FDA said it has conducted this additional review and has also conducted additional substantive reviews of applications in several disciplines, including toxicology, engineering, social sciences, and clinical pharmacology.

The FDA said its decision to rescind the order against Juul Labs was "due in part to new case law, as well as FDA's review of the information provided by the applicant." However, the revocation of the marketing denial order does not indicate whether the application is likely to be authorized or rejected.

The FDA added that new litigation results in cases involving other manufacturers' marketing denial orders for e-cigarette products also inform its approach to product review.

Juul Labs welcomed the decision and said it looks forward to a science - and evidence-based process to re-engage with the FDA to obtain marketing authorization for Juul products in the United States.

The company added: "We remain confident in the quality and content of our application and are confident that a full review of the science and evidence will demonstrate that our product meets the statutory standards appropriate to protect public health."

During this review period, Juul devices and Virginia Tobacco and menthol Juul pods with nicotine concentrations of 5.0% and 3.0%, respectively, will continue to be sold in the U.S. market.