(Source – The New York Times)
The US Food and Drug Administration (FDA) announced on Thursday that it has rescinded its marketing denial orders for vaping products from Juul Labs Inc. However, the agency has not yet made a final decision on whether these products will remain on the market.
Juul Labs stated that its products will continue to be available while undergoing further scientific review. The FDA explained that recent court decisions have influenced their approach to product review, ensuring final decisions are based on both scientific and legal standards. In 2022, the FDA issued a marketing ban on Juul products, including devices and tobacco and menthol-flavored pods. This order was stayed shortly after, citing the need for additional scientific review, but it was not officially rescinded until now. Juul appealed the decision, allowing their products to remain on store shelves during the appeal process.
Continue working with the FDA
Ban on Juul products: The FDA clarified that the rescission of the marketing ban does not equate to an authorization or denial of Juul’s products. “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,” the FDA stated.
As of the end of May, the FDA has authorized only 23 e-cigarette products and devices after rigorous scientific reviews, which include toxicological assessments. To receive approval, products must meet the FDA’s product standards.
In response, Juul expressed its eagerness to continue working with the FDA through a science- and evidence-based process to pursue marketing authorization for its products.
Youth e-cigarette epidemic
The American Lung Association voiced strong concerns about the FDA’s decision to rescind the marketing denial orders for Juul. Erika Sward, the association’s assistant vice president of nationwide advocacy, stated, “The Lung Association is deeply troubled that the marketing denial orders for Juul have been rescinded and urge the FDA to issue marketing denial orders for all of its products.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 their manufacturer clearly do not meet the standard for protecting public health. The FDA must follow the law and ban on Juul products or other tobacco products from being sold in the U.S. before receiving premarket authorization.”
Despite the controversies, Juul remains one of the most popular e-cigarette brands, especially among young people. Over the past decade, the FDA and the US Centers for Disease Control and Prevention’s annual National Youth Tobacco Survey have consistently found that e-cigarettes are the most popular tobacco products among youth.
The ongoing review and final decision by the FDA will be closely watched, as it will have significant implications for public health, especially in terms of youth vaping and tobacco use.
