(This Aug 28 story has been repeated with no changes to text.)
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 a substantial share of adult smokers switched from combustible cigarettes to the authorized products, with the menthol pod outperforming 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 in 3% and 5% nicotine concentrations.
• 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for their popularity among teenagers, leading to a federal marketing ban in 2022, which was stayed and subsequently rescinded in 2024.
• “We will build on the JUUL2 platform with a robust series of FDA filings, including products with a 5% nicotine concentration and a portfolio of flavored varieties,” Juul Labs CEO K.C. Crosthwaite said.
• The pods cleared on Friday contain roughly 1.5% to 1.6% nicotine, the FDA said, bringing the total number of authorized e-cigarette products to 48.
• The decision comes days after the agency authorized Philip Morris’ ZYN Ultra nicotine pouches.
(Reporting by Neil J Kanatt in Bengaluru and Emma Rumney in London; Editing by Vijay Kishore)
