FDA Authorizes Juul 2 E-Cigarette Device and Tobacco- and Menthol-Flavored Pods
核心洞察
The FDA authorized marketing of three new Juul 2 System products—a device plus tobacco- and menthol-flavored pods—through its premarket tobacco product application pathway.
Review data showed 19.9% to 34.6% of tobacco-pod users and 28.4% to 49.3% of menthol-pod users completely switched away from combustible cigarettes at six weeks.
The FDA determined the added benefit to adults who smoke outweighs the risks of the menthol-flavored product, including youth appeal.
The Food and Drug Administration (搜索) on Friday authorized the marketing of three new Juul e-cigarette products through its premarket tobacco product application pathway. The products are part of the Juul 2 System made by Juul Labs Inc. (搜索) of Washington, D.C., and include a tobacco-flavored pod, a menthol-flavored pod, and the Juul 2 device.
The tobacco- and menthol-flavored e-cigarette pods authorized are 18 milligrams/milliliter, equivalent to 1.5% to 1.6% nicotine concentration, according to the FDA.
Switching Data and Health Rationale
The FDA said its review of data in the application found that a "substantial proportion of adults who smoke completely switched away from combustible cigarettes to the authorized Juul 2 products, with the menthol-flavored pod having a higher rate of complete switching compared to the tobacco-flavored pod."
Specifically, 19.9% to 34.6% of those using the tobacco-flavored pod and 28.4% to 49.3% of those using the menthol-flavored pod stopped smoking cigarettes entirely at six weeks, the agency said.
"Those who completely switched to the authorized products were exposed to lower levels of harmful chemicals than they would have been had they continued smoking cigarettes," the FDA said.
Regulatory Determination
To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks. The FDA said it determined that the added benefit to adults who smoke cigarettes is "sufficient to outweigh the risks of the menthol-flavored product, including youth appeal."
"Today's authorizations are another important step to provide greater access to products that can promote switching for adults who smoke and prevent downstream health risks associated with combustible cigarettes," the FDA said. "However, it is important that these adults switch completely to e-cigarettes or other lower-risk alternatives, as dual use does not provide the same degree of health benefit."
Company Outlook and Product Development
Juul said the updated vaping device offers what it describes as a more consistent vapor and nicotine delivery experience, designed to compete effectively with combustible cigarettes. The new product has already been available in several international markets, including the UK.
The company said it now plans to file further applications with the FDA for other products targeted toward adult nicotine consumers, including 5% nicotine concentration products and a portfolio of flavors beyond tobacco and menthol.
"More than 2 million adult Americans have already switched completely away from deadly cigarettes using our first generation Juul products, and we hope millions more will switch with the enhanced JUUL2 platform," Chief Executive K.C. Crosthwaite said.
Regulatory Context
The FDA's decision marks the latest regulatory milestone for Juul after it received clearance last summer to keep selling the first generation of its e-cigarette. In July 2025, the FDA authorized several Juul e-cigarette products, including tobacco- and menthol-flavored pods in 3% and 5% nicotine concentrations. To date, the FDA has authorized 48 e-cigarette products.
In 2022, the FDA had ordered the company to halt sales due to unresolved questions related to toxicology data submitted in its application to remain on the U.S. market. The ban was quickly put on hold and Juul resumed its e-cigarette sales, but it still pushed the company to the brink of bankruptcy as it settled thousands of lawsuits alleging it had marketed its addictive devices to children and teens. Juul has denied allegations that it marketed its e-cigarettes to children and teens.