The US Food and Drug Administration (FDA) has authorized the marketing of three new e-cigarette products from Juul Labs, including the JUUL2 device and two refill pods. This decision provides adult smokers with regulated, lower-risk alternatives to traditional combustible cigarettes.
FDA Approves Menthol and Tobacco Pods
The authorization covers the JUUL2 device, a tobacco-flavored pod, and a menthol-flavored pod under the agency’s Premarket Tobacco Product Application (PMTA) pathway. The FDA noted that its review demonstrated a high rate of adult smokers switching completely from combustible cigarettes to these authorized products, with the menthol variant showing particularly strong switching rates.
Addressing youth appeal concerns, the FDA stated that the added benefit for adults who smoke cigarettes is sufficient to outweigh the risks associated with the menthol-flavored product. The authorized pods contain a nicotine concentration of approximately 1.5% to 1.6%.
Juul Labs Plans Future FDA Applications
This approval follows a turbulent regulatory history for Juul Labs. Once the dominant player in the US vaping market, Juul faced intense scrutiny over its flavored products’ popularity among teenagers. This led to a federal marketing ban in 2022, which was suspended and later overturned in 2024.
With the JUUL2 platform now authorized, Juul Labs plans to expand its product offerings. K.C. Crosthwaite, Chief Executive Officer of Juul Labs, commented: “We will build on the JUUL2 platform to submit a robust pipeline of applications to the FDA, including products with 5% nicotine and a range of flavored varieties.”
The FDA’s decision brings the total number of authorized e-cigarette products in the United States to 48.
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