The FDA has rescinded the marketing denial orders (MDOs) issued to JUUL Labs Inc., partially due to new case law and further information provided by JUUL.
This rescission returns the applications to pending status and does not indicate whether they will be authorized or denied.
The FDA continues its substantive review of the applications, adhering to its regulations, which limit the disclosure of pending application content.
Related: E-Cigarette Maker Juul's Financial Rescue Marred by Allegations Against Key Directors' Self-Interest.
In June 2022, the FDA announced it would ban Juul brand e-cigarettes in the country, wiping away a significant chunk of the $21.63 billion industry, of which Juul owns 41%.
The agency cited insufficient evidence regarding the toxicological profile of JUUL's products, raising concerns over conflicting data about genotoxicity and harmful chemicals leaching from e-liquid pods.
This lack of conclusive data prevented the FDA from completing a full toxicological review, leading to the initial denial.
By July 2022, the FDA had administratively stayed the MDOs, recognizing the need for further scientific review.
Since then, the FDA has conducted additional evaluations in toxicology, engineering, social science, and clinical pharmacology.
This continued review process underscores the requirement that all e-cigarette products, including those by JUUL, must have FDA authorization to be legally marketed.
The rescission follows the FDA's updated understanding of e-cigarette products and recent litigation outcomes involving other manufacturers' MDOs.
These court decisions have provided new case law influencing the FDA's product review process. The agency remains dedicated to issuing final decisions that are scientifically sound and legally appropriate.
Although the FDA ban was put on hold, it sent Juul into a financial tailspin. The company also considered filing for bankruptcy.
Juul Labs seeks FDA approval for its next-generation vaporizer, which is already available in the U.K. and Canada. The company is waiting for word on whether its current products can stay on the market.
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