Aug 28 (Reuters) – The U.S. Food and Drug Administration on Friday authorized the marketing of three new ‘JUUL2’ e-cigarette products, the latest in a series of approvals for nicotine products the agency says may offer a lower-risk alternative to traditional cigarettes.
Here are some details:
• The FDA authorized Juul Labs to market a tobacco-flavored pod, a menthol-flavored pod and the JUUL2 device through the agency’s premarket tobacco product application (PMTA) process.
• The agency said its review found that a substantial proportion of adult smokers completely switched from combustible cigarettes to the authorized products, with the menthol pod showing higher switching rates than the tobacco pod.
• “The added benefit to adults who smoke cigarettes is sufficient to outweigh the risks of the menthol-flavored product, including youth appeal,” FDA said.
• Last year, FDA had cleared Juul’s e-cigarette device and tobacco- and menthol-flavored refill pods after years of heightened regulatory scrutiny.
• Juul, once a dominant player in the U.S. vaping market, saw its fortunes decline when its flavored products drew scrutiny for their popularity among teenagers, leading to a federal marketing ban in 2022. The company later avoided bankruptcy after the ban was stayed and subsequently rescinded in 2024.
• With the latest decision, the number of FDA-authorized e-cigarette products rises to 48, the agency said.
• Last week, the FDA cleared other smoke-free nicotine products, including Philip Morris’ ZYN Ultra nicotine pouches.
(Reporting by Neil J Kanatt in Bengaluru; Editing by Vijay Kishore)
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