(HealthDay News) — (Tasrir) — Why? The agency said it needs to review both new court decisions and updated data from the vape maker. While the company’s e-cigarettes are back under review, they have not been fully cleared for sale in this country, the FDA said in its announcement.
Juul was first banned from selling its vaping devices in the U.S. market back in June 2022, but the firm’s products have remained on store shelves while the company appealed the ban.
Reaction to the news was swift.
“The FDA’s continuing delays in reviewing Juul’s marketing applications are unacceptable and harmful to America’s kids as Juul remains one of the most commonly used e-cigarette brands among youth [according to the 2023 National Youth Tobacco Survey],” Yolonda Richardson, president and CEO of the Campaign for Tobacco-Free Kids, said in a statement. “It is inexplicable that Juul’s applications remain pending nearly four years after they were first filed and nearly two years after the FDA initially denied them.”
“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,” Richardson added. “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.”
Meanwhile, Juul Labs welcomed the reversal of the ban.
“We appreciate the FDA’s decision and now look forward to re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for Juul products,” the company said in a statement. “We remain confident in the quality and substance of our applications and believe that a full review of the science and evidence will demonstrate that our products meet the statutory standard of being appropriate for the protection of public health.”
Juul became one of the biggest industry success stories as millions turned to vaping, even as health experts expressed concerns that e-cigarettes were hooking a new generation on nicotine. In 2019, roughly 28% of all high school students vaped, according to data from the U.S. Centers for Disease Control and Prevention.
That trend has only continued: Last year, the CDC reported e-cigarette use had grown nearly 50% between January 2020 and December 2022. During that period, Juul trailed only Vuse among e-cig brands.
To date, the FDA has only approved 23 e-cigarette products made by just three companies.
