FDA rescinds marketing ban on Juul vaping products | CNN

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The US Food and Drug Administration announced Thursday it had rescinded marketing denial orders for vaping products from Juul Labs Inc., although it has not yet decided whether the products will ultimately stay on the market.

Juul said Thursday its products will remain on the market during scientific review.

In 2022, the FDA issued a marketing ban on Juul products, including devices and tobacco and menthol-flavored pods. The marketing denial order was stayed weeks later as “scientific issues warranted additional review,” but had not been rescinded.

On Thursday, the FDA said court decisions since then “establish new case law and inform the FDA’s approach to product review to maintain the agency’s commitment to issuing final decisions that are appropriate on both the scientific merits and the law.”

Recission of the marketing ban “is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied,” the FDA said Thursday.

“The agency’s continued review does not alter the fact that all e-cigarette products, including those made by JUUL, are required by law to have FDA authorization to be legally marketed.”

In a statement, Juul said it looks forward to “re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for JUUL products.”

The American Lung Association said on Thursday that it was “deeply troubled” by the FDA’s decision.

“The Lung Association is deeply troubled that the marketing denial orders for Juul have been rescinded and urge FDA to issue marketing denial orders for all of its products. Juul is largely responsible for the youth e-cigarette epidemic from 2017-2019. These products and its manufacturer clearly do not meet the standard for protecting the public health. FDA must follow the law and not permit any Juul product or other tobacco product to be sold in the U.S. prior to it receiving a premarket authorization,” said Erika Sward, the association’s assistant vice president of nationwide advocacy, in a statement.