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.