(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’s products, including its device for e-cigarettes.
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-cigarettes device, which was under the agency’s review. Altria Group is a former investor of the company.
The FDA had 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 after it was issued as a result of 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.
The marketing denial orders issued by the FDA have faced multiple challenges in different U.S. states by the e-cigarette makers.
“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)
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