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FDA Steps Back From JUUL MDOs

The decision to rescind the previous marketing denials returns the products under review to pending status with future approval now possible.
E-cigarette user

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) rescinded the marketing denial orders (MDOs) it issued against the premarket tobacco product applications (PMTAs) submitted by JUUL Labs Inc., adding another twist to a nearly two-years-old saga.

On June 23, 2022, the FDA initially issued its MDOs for all of Juul's 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.  

However, the following month, the agency administratively stayed the MDOs after determining that certain scientific issues warranted additional review. Since then, the FDA has conducted substantive reviews of the applications in a number of disciplines, including toxicology, engineering, social science and clinical pharmacology.  

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In parallel, the FDA has also 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.  

In light of both the new reviews and case law, the FDA rescinded the MDOs issued to JUUL. Rescission is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied, however the new orders return 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. Further information on legal tobacco products, including vapes and e-cigarettes, is available in the FDA's new Searchable Tobacco Products Database.

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