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US FDA rescinds market denial order for Juul products
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US FDA rescinds market denial order for Juul products
Jun 6, 2024 8:55 AM

June 6 (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 ( MO ) 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.

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