The FDA has canceled its previous orders denying Juul the ability to market its e-cigarette products in the US, allowing the vaping giant to re-enter the regulatory review process.

RT’s Three Key Takeaways:

  1. FDA Rescinds Juul’s Marketing Denial Orders: The FDA has rescinded the marketing denial orders (MDOs) issued to Juul Labs in June 2022, which previously required the company to remove its products from the US market due to insufficient toxicological data.
  2. Additional Review and New Legal Precedents: The decision to rescind the MDOs was influenced by additional scientific review and new legal precedents from recent court cases involving e-cigarette products. These developments informed the FDA’s updated approach to product review.
  3. Pending Status for Juul Applications: Rescinding the MDOs returns Juul’s applications to pending status, meaning they are now under substantive review by the FDA. This process will determine whether the products will ultimately receive marketing granted orders or new marketing denial orders.

The US Food and Drug Administration (FDA) has rescinded the marketing denial orders (MDOs) it issued to Juul Labs in June 2022, which previously required the company to stop selling its products in the US market.

When issuing the MDOs, the FDA determined that the applications lacked sufficient evidence regarding the products’ toxicological profile to demonstrate that the marketing of the products met the public health standard required by law, according to an update from the FDA. 

The FDA notes in the update that when it 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 review of the applications in a number of disciplines, including toxicology, engineering, social science, and clinical pharmacology, according to the update.  

In parallel, in the time since the MDOs were administratively stayed in 2022, the FDA says it 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, according to the FDA’s update.   

Current Status and Future Steps

Today, the FDA rescinded the MDOs issued in June 2022 to Juul Labs. 

“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,” says the FDA in the update. “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.”

Rescission of the MDOs returns the applications to pending status, under substantive review by the FDA. 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,” reads the FDA’s update.

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