FDA Authorizes First Fruit-Flavored E-Cigarettes for Adult Smokers

The Food and Drug Administration on Tuesday authorized the marketing of fruit-flavored e-cigarettes for the first time, clearing four products from a Los Angeles manufacturer intended for adult smokers trying to quit combustible cigarettes. , come in mango, blueberry, Classic Menthol and Fresh Menthol varieties and will be marketed under the brand names Gold and Sapphire.

The decision marks a policy shift after months of appeals from the vaping industry to the Trump administration. Regulators emphasized that the authorization is not an endorsement and applies only to adults 21 and older. The products must be paired via Bluetooth with a smartphone after the user verifies age with a government-issued ID on their cellphone.

The device will not function if separated from the verified phone.

The FDA stated that its scientific review found the company's device access restriction technology, combined with required marketing limits, is expected to effectively mitigate youth access. Officials said they will closely monitor how the products are marketed and can suspend or withdraw authorization if youth use rises or if the benefits no longer outweigh the risks.

>"By helping to prevent youth use, device access restrictions are a potential game changer. " — Bret Koplow, acting director of the FDA’s Center for Tobacco Products (New York Post) The newly authorized products will serve as a key test case for whether such restrictions can limit underage vaping while offering alternatives to smokers.

Vaping devices have been sold in the United States since 2007, but their potential to help adults quit smoking has been overshadowed by uptake among middle and high school students.

Teen vaping rates have fallen to a 10-year low, even as the vast majority of adolescents who vape continue to use unauthorized fruit- and candy-flavored products that remain widely available despite being technically illegal. Previously, the FDA had only granted marketing permission to tobacco or menthol-flavored vaping products, denying more than a million applications for candy or fruit flavors during the prior administration.

Vaping companies have argued their products can help reduce the toll of smoking, which is blamed for 480,000 U.S. deaths each year from cancer, lung disease and heart disease. Most e-cigarettes previously authorized by the agency come from large manufacturers including Juul and Altria.

Public health groups expressed opposition to the new authorization. The Campaign for Tobacco-Free Kids criticized the decision, saying it could undermine progress in reducing youth vaping. The Truth Initiative, an anti-tobacco nonprofit, called the authorization a key test case and urged close monitoring.

In recent weeks, industry groups including the Vapor Technology Association met with administration officials to press for action on flavors. In March the FDA released its first-ever guidance to industry on flavors, stating that menthol, coffee, mint and spice varieties could appeal to adult smokers while reiterating the risks of sweeter flavors that tend to attract teenagers.

The agency has now authorized 45 e-cigarette products in total. The FDA reiterated that smoking remains the leading preventable cause of chronic disease and premature death in the U.S., accounting for about one in five deaths. More than 25 million Americans smoke cigarettes.

The newly authorized products are restricted to marketing aimed at adults interested in quitting or cutting back on smoking.