The Food and Drug Administration (FDA) announced that it has rescinded the MDOs issued to Juul Labs in 2022.
This action by the FDA 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, the agency stated.
“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,” the FDA wrote in a statement. “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.”
On June 23, 2022, the FDA issued MDOs to JUUL Labs for all of its products marketed in the U.S. 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 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, the agency stated.
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,” the statement continued.
Once accepted and filed by the FDA, applications under review ultimately either receive marketing granted orders or marketing denial orders.
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.
Statement from Juul Labs:
“Today, the FDA rescinded its June 2022 Marketing Denial Orders (MDOs) for the Juul System and placed our applications back into scientific review. 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.
“These products (the Juul device and Virginia Tobacco and Menthol Juul pods in 5% and 3% nicotine concentration) will remain on the market during this review.”
