Update on FDA’s Scientific Review of JUUL Product Applications

The FDA is providing an update on the status of the agency’s review of the premarket tobacco product applications (PMTAs) submitted by JUUL Labs, Inc.

On June 23, 2022, the FDA issued marketing denial orders (MDOs) to JUUL Labs, Inc. for all of their products marketed in the United States at the time.  The FDA had determined 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.  When the FDA announced the issuance of the MDOs, the agency stated that some of the company’s study findings raised concerns due to the insufficient and conflicting data regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods, which precluded the FDA from completing a full toxicological review of the products.

On July 5, 2022, the FDA administratively stayed the MDOs after determining that certain scientific issues warranted additional review.  Since then, the FDA has conducted this additional review and has also conducted additional substantive review of the applications in a number of disciplines, including toxicology, engineering, social science, and clinical pharmacology.

In parallel, in the time since the MDOs were administratively stayed in 2022, the FDA has gained more experience with various scientific issues regarding e-cigarette products, and there have been new litigation outcomes in cases about MDOs for e-cigarette products from other manufacturers.  Some of these court decisions establish new case law and inform the FDA’s approach to product review to maintain the agency’s commitment to issuing final decisions that are appropriate on both the scientific merits and the law.

Today, the FDA rescinded the MDOs issued in June 2022 to JUUL Labs, inc.  This 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.  Rescission of the MDOs is not an authorization or a denial and dows 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.  The FDA’s regulations significantly limit what the agency can disclose regarding the content of pending applications.

Once accepted and filed by the FDA, applications under review ultimately either receive marketing granted orders or marketing denial orders.  During any application review, additional steps may occur in the interim, such as those described on the FDA’s website.

The agency’s continued review does not alter the fact that all e-cigarette products, including those made by JUUL, are required by law to have FDA authorization to be legally marketed.

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