FDA Lifts Marketing Ban on Juul Products

On June 6, the U.S. Food and Drug Administration (FDA) revoked its June 2022 marketing denial order against Juul and put the company’s application back into the scientific review process.
After determining that certain problems in science required further review, the FDA administratively suspended the decision in July 2022. Since then, the FDA said it had conducted this additional review, as well as additional substantive reviews of applications from multiple disciplines, including toxicology, engineering, social sciences, and bedside pharmacy.
The FDA said the decision to withdraw the order against Juul Labs “was due in part to the new sentencing law and the FDA’s review of the information provided by the applicant.” However, the revocation of a marketing refusal order does not indicate whether the application is likely to be authorized or denied.
The FDA added that the results of the new lawsuit regarding other manufacturers’ denial of marketing of e-cigarette products also inform its approach to product review.
Juul Labs welcomes this decision and says it looks forward to the scientific and evidence-based process reworking with the FDA to obtain marketing authorizations for Juul in America.
It 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 products meet statutory standards appropriate to protect public health.”
During the period under review, Juul devices and Virginia tobacoo and menthol Juulpods with a nicotine concentration of 5.0% and 3.0%, respectively, will continue to be sold in America.