US FDA rescinds market denial order for Juul products

[June 07, 2024]  (Reuters) -The U.S. Food and Drug Administration (FDA) said on Thursday it was rescinding a June 2022 order that briefly blocked sale of Juul Lab's products, including its e-cigarette device.

The latest move comes a few months after Juul sought an FDA authorization for new menthol-flavored pods meant to be used with its e-cigarette device, which was under the agency's review.

The FDA in June 2022 banned Juul's four varieties of tobacco and menthol-flavored pods and the e-cigarette device after it concluded that the company failed to show that sale of these products would be appropriate for public health.

The ban was stayed a month later after an appeal by the company.

The FDA said rescission of orders that prevent marketing of the products is not an authorization or a denial of Juul's marketing application. The revocation only returns company's applications to a pending and under-review status.

"We 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," Juul said in a statement to Reuters.

The marketing denial orders issued by the FDA have faced multiple challenges in different U.S. states by the e-cigarette makers.

Juul e-cigarettes are seen on the counter of a vape store in Santa Monica, California, U.S., June 23, 2022. REUTERS/Lucy Nicholson

"Some of these court decisions establish new case law and inform the FDA's approach to product review," the FDA said.

The agency began regulating e-cigarette devices and vapes in August 2016. So far, 23 e-cigarette products have been authorized by it for sale in the United States.

The FDA said continued review of Juul's application does not alter the fact that all e-cigarette products need its authorization to be legally marketed.

(Reporting by Juveria Tabassum, additional reporting by Emma Rumney in London; Editing by Mohammed Safi Shamsi and Vijay Kishore)

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