FDA rescinds marketing ban on Juul vaping products
By Carma Hassan and Jen Christensen, CNN
(CNN) — The US Food and Drug Administration announced Thursday it had rescinded marketing denial orders for vaping products from Juul Labs Inc., although it has not yet decided whether the products will ultimately stay on the market.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.
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.”
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The marketing denial order was stayed weeks later as “scientific issues warranted additional review,” but had not been rescinded. Juul appealed the decision and the products stayed on store shelves pending the appeal.
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.”
As of the end of May, the FDA says it has only authorized 23 e-cigarette products and devices after the products have undergone what the FDA says is “rigorous scientific review” that includes toxicologic assessments. To get the green light, the products must also be appropriate by the FDA’s product standard.
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“The Lung Association is deeply troubled that the marketing denial orders for Juul have been rescinded and urge FDA to issue marketing denial orders for all of its products.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.
Juul has remained one of the most popular e-cigarette products on the market and are also among the most popular with young people. For the past decade, the FDA and US Center for Disease Control and Prevention’s annual National Youth Tobacco Survey has found that in general e-cigarettes are the most popular tobacco products among young people.
In a statement, the Campaign for Tobacco-Free Kids cited the popularity of the brand and said, “the FDA’s continuing delays in reviewing Juul’s marketing applications are unacceptable and harmful to America’s kids.”
“The FDA should swiftly finish its review and again deny marketing applications for all Juul products given Juul’s primary role in causing the youth e-cigarette epidemic and the continuing popularity of Juul’s products among youth,” Campaign for Tobacco-Free Kids CEO and president Yolonda Richardson said in part in the statement. “There is no question that Juul fueled this epidemic by introducing a sleek, easy-to-hide product that was sold in appealing flavors including menthol, marketed in ways that appeal to kids, and delivered massive doses of nicotine that can quickly addict kids. Juul’s history shows that its products are highly appealing to kids, and it cannot be trusted to act responsibly.”
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