FDA reverses marketing ban on Juul e-cigarettes
What does the FDA's current review of Juul's products entail, and what are the potential outcomes?
The FDA's current review of Juul's products entails a reevaluation of the company's applications in light of new legal precedents and additional scientific review. This reevaluation process will determine whether the products will ultimately receive marketing granted orders or new marketing denial orders.
The potential outcomes of this review are:
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Marketing Granted Orders: If the FDA determines that Juul's products meet the public health standard required by law, they may grant marketing orders, allowing the company to sell and distribute their e-cigarette products in the US market16.
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New Marketing Denial Orders: If the FDA finds that the products do not meet the required public health standard, they may issue new marketing denial orders, which would require Juul to stop selling and distributing their products in the US market1.
It is important to note that this review does not guarantee that Juul's products will be fully cleared. The FDA emphasizes that the current status of the products under review is not an indication of whether they are likely to be authorized or denied.
What prompted the FDA to reverse its ban on Juul e-cigarettes recently?
The FDA reversed its ban on Juul e-cigarettes recently due to the review of new court decisions and consideration of updated information provided by the vape maker6. The FDA emphasized that this new status was not an indication that Juul's products would be fully cleared, but they are now back under agency review. The FDA has gained more experience with various scientific issues regarding e-cigarette products since the initial ban, and there have been new litigation outcomes in cases about marketing denial orders for e-cigarette products from other manufacturers. Juul said it appreciated the FDA's decision and now looks forward to re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for its products.
How has Juul managed to maintain its market presence despite the FDA's initial ban?
Juul has managed to maintain its market presence despite the FDA's initial ban due to a combination of legal appeals and ongoing reviews. When the FDA ordered the company to stop selling its products in 2022, Juul filed an emergency motion, seeking a temporary hold while it appealed the sales ban. The U.S. Court of Appeals for the District of Columbia Circuit granted Juul's request for a hold, allowing the company to continue selling its electronic cigarettes while the court reviews the case4.
Additionally, Juul has continued to engage with the FDA, providing updated information and data in support of its products. The FDA has recently reversed its ban on Juul e-cigarettes, citing new court decisions and the need to consider the updated information provided by the company. However, the FDA emphasized that this new status was not an indication that Juul's products would be fully cleared and that they are still under agency review.
Throughout this process, Juul has maintained its position as the No. 2 e-cigarette maker in the U.S., behind only Vuse. The company has expressed its appreciation for the FDA's latest decision and looks forward to re-engaging with the agency on a science- and evidence-based process to pursue marketing authorization for its products.