KVSP FDA reverses order taking Juul vaping products off the market in US, opens door to possible authorization
Written by ABC Audio ALL RIGHTS RESERVED on June 6, 2024
(NEW YORK) –The U.S. Food and Drug Administration rescinded its marketing ban on Juul Labs on Thursday, opening the door to possible authorization of its products.
The reversal comes nearly two years after the federal health agency ordered the company’s e-cigarettes and vaping products be taken off the market.
The FDA had initially blocked Juul’s application to sell its vaping device and tobacco- and menthol-flavored pods in June 2022, after completing a nearly two-year review of the manufacturer’s application, finding 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.”
The company has long claimed its product can be used as a tool to stop smoking cigarettes.
The FDA subsequently paused the block just weeks later in July 2022 to conduct additional scientific review.
Since then, the FDA said Thursday it has “conducted additional substantive review of the applications in a number of disciplines, including toxicology, engineering, social science, and clinical pharmacology.”
The reversal is based on a “review of information provided by the applicant” as well as new case law stemming from court decisions involving marketing denial orders, or MDOs, for e-cigarette products, the FDA said.
“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,” the FDA said in a statement. “Rescission of the MDOs returns the applications to pending status, under substantive review by the FDA.”
Juul Labs said in a statement Thursday that they “appreciate the FDA’s decision and now look forward to re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for JUUL products.”
“We remain confident in the quality and substance of our applications and believe that a full review of the science and evidence will demonstrate that our products meet the statutory standard of being appropriate for the protection of public health,” the statement continued.
This is a developing story. Please check back for updates.
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