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The Meals and Drug Administration introduced Thursday it had formally withdrawn advertising and marketing denial orders it had issued to Juul Labs in 2022, making it attainable for the once-dominant e-cigarette producer to pursue authorization for its gross sales.
The advertising and marketing denial orders have been successfully paused by the company not lengthy after they have been issued, leaving the product in limbo for years amid courtroom litigation and “extra evaluation” the FDA mentioned it was conducting of Juul’s functions.
On the time, the FDA had raised issues over “doubtlessly dangerous chemical substances” in Juul’s e-cigarettes and “inadequate and conflicting knowledge” it mentioned the corporate had submitted.
“In parallel, within the time for the reason that MDOs have been administratively stayed in 2022, the FDA has gained extra expertise with numerous scientific points concerning e-cigarette merchandise, and there have been new litigation outcomes in instances about MDOs for e-cigarette merchandise from different producers,” the FDA mentioned in an announcement.
The company mentioned that rescinding the advertising and marketing denial orders was not the identical as a brand new determination on whether or not to formally authorize gross sales of the e-cigarettes. Juul’s functions have been returned to “pending standing,” the FDA mentioned.
The FDA has issued greater than 300 advertising and marketing denial orders for brand new tobacco merchandise since 2021. A handful have since been rescinded by the company or blocked by federal courtroom rulings.
“We recognize the FDA’s determination and now sit up for re-engaging with the company on a science- and evidence-based course of to pursue a advertising and marketing authorization for JUUL merchandise,” Juul mentioned in an announcement.
Juul’s merchandise will proceed to be in the marketplace throughout the FDA’s renewed evaluation of the appliance, the corporate mentioned.
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