FDA lifts marketing ban on Juul e-cigarettes

On June 6, the U.S. Food and Drug Administration (FDA) rescinded its June 2022 marketing denial order for Juul and placed the company's application back into the scientific review process.

Author:

Electronic Cigarette Public

On June 6, the U.S. Food and Drug Administration (FDA) rescinded its June 2022 marketing denial order for Juul and placed the company's application back into the scientific review process.

The FDA administratively stayed that decision in July 2022 after determining that certain scientific issues required further review. Since then, the FDA has indicated that it has conducted this additional review and has also conducted additional substantive review of the application in a number of disciplines, including toxicology, engineering, social sciences, and clinical pharmacology.

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

The FDA added that the results of new litigation in cases regarding marketing denial orders for e-cigarette products from other manufacturers have also informed 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 thorough review of the science and evidence will demonstrate that our product meets the statutory standards appropriate to protect public health."

The Juul device, as well as Virginia tobacco and menthol Juul pods with nicotine concentrations of 5.0% and 3.0%, respectively, will continue to be marketed in the U.S. during this review.

Key words:

JUUL LABS,JUUL

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