FDA Rescinds Ban on Juul Products

The e-cigarettes are back under pending review.

June 07, 2024

The Food and Drug Administration has rescinded its 2022 ban on Juul Labs’s e-cigarettes. While this opens the possibility for federal clearance of the product in the future, the FDA noted “Rescission of the MDOs is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied. Rescission of the MDOs returns the applications to pending status, under substantive review by the FDA,” in a statement from FDA’s Center for Tobacco Products.

This move essentially places Juul products back under review. The products have remained on the market. According to the Wall Street Journal, Juul is the No. 2 e-cigarette maker in the United States. The FDA didn’t give a timeline for a final decision on whether Juul products can stay on the market.

In a public statement, Juul said: “We appreciate the FDA’s decision and now look forward to re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for Juul products. We remain confident in the quality and substance of our applications and believe that a full review of the science and evidence will demonstrate that our products meet the statutory standard of being appropriate for the protection of public health.”

In 2022, the FDA issued marketing denial orders (MDOs) to JUUL Labs for all of their products, saying that “the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that the marketing of the products met the public health standard required by law,” according to the FDA’s Center for Tobacco Products.

The FDA stayed the MDOs shortly after, saying that certain “scientific issues” required additional review.

FDA said the recission action is “being taken, in part, as a result of the new case law, as well as the FDA’s review of information provided by the applicant.”