Industry News

FDA update the review of JUUL’s PMTA application


The U.S. Food and Drug Administration (FDA) issued a press release on June 6, local time, announcing the updated assessment of JUUL Labs, Inc.'s premarket tobacco product applications (PMTAs).

On June 23, 2022, the FDA issued a ruling against JUUL Labs, Inc., which was then marketed in the United States. All products are issued with Marketing Denial Orders (MDOs). The FDA has determined that these applications lack sufficient evidence regarding the toxicological properties of the products to demonstrate that the marketing of the products meets the public health standards required by law. When the FDA announced the issuance of the MDOs, it stated that insufficient and contradictory data regarding genotoxicity and leakage of potentially harmful chemicals from the company's proprietary smoke bombs prevented the FDA from completing a full toxicology review of the product.

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

At the same time, since the administrative suspension of MDOs in 2022, the FDA has gained more experience in various scientific issues regarding e-cigarette products, and there have been new litigation outcomes in cases involving MDOs of e-cigarette products from other manufacturers. Some of these court decisions have established new case law and informed FDA's approach to product review to maintain its commitment to making appropriate final decisions, both scientifically and legally.

Today (June 6), the FDA rescinded its June 2022 decision to grant JUUL Labs, Inc. Issued MDOs. This action is due in part to new case law as well as FDA's review of information provided by applicants. Revoking an MDOs is neither an authorization nor a denial, and does not indicate whether the application is likely to be authorized or denie

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