The US Food and Drug Administration (FDA) has on Thursday rescinded its June 2022 marketing denial orders for the JUUL System and placed the company’s applications back into scientific review.
The FDA has administratively stayed the decision in July 2022 after determining that certain scientific issues warranted additional review.
Since then, the FDA said it has conducted this additional review and has also conducted additional substantive review of the applications in a number of disciplines, including toxicology, engineering, social science, and clinical pharmacology.
The regulator added that the new litigation outcomes in cases about marketing denial orders for e-cigarette products from other manufacturers has also informed its approach to product review.
The FDA said the decision to rescind the orders against Luul Labs is “being taken, in part, as a result of the new case law, as well as the FDA’s review of information provided by the applicant.”
The regulator added that rescission of the marketing denial orders does not indicate whether the applications are likely to be authorized or denied.
Welcoming the decision, Juul Labs said it looks forward to “re-engaging with the agency on a science- and evidence-based process” to pursue a marketing authorisation 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 company added.
These products 0 the JUUL device and Virginia Tobacco and Menthol JUULpods in 5.0% and 3.0% nicotine concentration - will remain on the market during this review.
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