US FDA revokes sales denial order for JUUL and restarts review process

US FDA revokes sales denial order for JUUL and restarts review process

On June 6, the U.S. FDA announced that it would voluntarily withdraw its marketing denial order (MDOs) issued to JUUL in June 2022, returning the application to pending status.

Editor's note: On June 6, local time, the U.S. FDA announced that it would voluntarily withdraw its marketing denial order (MDOs) to JUUL, returning the application to pending status. It is understood that this is the first time that the FDA has voluntarily withdrawn a marketing denial order.

On June 6, local time, the U.S. Food and Drug Administration (FDA) issued a press release announcing an update on its review progress of the premarket tobacco product applications (PMTAs) submitted by JUUL Labs, Inc.

On June 23, 2022, the FDA issued marketing denial orders (MDOs) for all products of JUUL Labs, Inc. that were sold in the United States at the time. The FDA has determined that these applications lack sufficient evidence of the toxicological properties of the products and cannot prove that the marketing of the products meets the public health standards required by law. When the FDA announced the issuance of the MDOs, it said that insufficient and conflicting data on genotoxicity and leaching of potentially harmful chemicals from the company's proprietary cartridges prevented the FDA from completing a comprehensive toxicological review of the products.

On July 5, 2022, the FDA administratively suspended the MDOs after determining that certain scientific issues warranted additional review. Since then, the FDA has conducted additional reviews and conducted additional substantive reviews in multiple areas, including toxicology, engineering, social sciences, and clinical pharmacology.

At the same time, since the 2022 MDOs were administratively suspended, the FDA has gained more experience with various scientific issues related to e-cigarette products, and there have been new litigation results in other manufacturers' e-cigarette product MDOs. Some of these court decisions have established new case law and informed the FDA's product review approach to maintain its commitment to making scientifically and legally appropriate final decisions.

Today (June 6), the FDA rescinded the June 2022 MDOs issued to JUUL Labs, Inc. This action was in part due to new case law and the FDA's review of the information provided by the applicant. Revocation of MDOs is neither an authorization nor a denial, nor does it indicate whether an application is likely to be authorized or denied. Revocation of MDOs returns an application to pending status, subject to substantive review by the FDA. FDA regulations severely limit the information the agency can disclose about the contents of pending applications.

Once accepted and filed with the FDA, an application under review will ultimately receive a marketing authorization order or a marketing denial order. Additional steps may be taken on an interim basis during any application review, as described on the FDA website.

FDA's ongoing review does not change the fact that, under the law, all e-cigarette products, including JUUL, require FDA authorization before they can be legally marketed.