FDA Authorizes Fruit-Flavored E-Cigarettes for Adults, Shifting U.S. Tobacco Policy

The Food and Drug Administration approved four Glas electronic nicotine delivery systems on May 5, a move that for the first time opens the door to fruit-flavored e-cigarettes for adult smokers and signals a sharper shift in U.S. tobacco policy. The authorized pods, Classic Menthol, Fresh Menthol, Gold and Sapphire, contain 50 mg/ml, or 5%, tobacco-derived nicotine. Gold is the mango flavor and Sapphire is the blueberry flavor, and the agency said the products now bring the total number of ENDS products cleared for sale in the United States to 45.

The FDA said the authorization was not an approval or an endorsement, but a narrow decision aimed at adults trying to quit or cut back on cigarettes. It also said this was its first authorization of non-tobacco and non-menthol ENDS products, breaking from a pattern in which only tobacco- or menthol-flavored vaping products had been approved. The agency’s case rested heavily on Glas’s age-control technology: users must verify their age with a government ID on a cellphone, the device works only when paired by Bluetooth with that verified phone, and the app performs random biometric check-ins. The FDA said adults 21 and older could generally complete verification, while youth and young adults could not. Bret Koplow, the acting director of the FDA’s Center for Tobacco Products, called device-access restrictions a “potential game changer.”

The decision lands on a fault line between adult harm reduction and youth protection. The FDA said more than 25 million Americans still smoke combustible cigarettes, and that cigarette smoking remains the leading preventable source of chronic disease and premature death in the country, accounting for one in five deaths last year. Supporters of the move argue that smokers need alternatives that are less harmful than combustible cigarettes, especially as teen vaping has fallen to a 10-year low. The FDA’s marketing orders also require advertising to be aimed at adults 21 and older, another guardrail the agency says is meant to limit spillover to minors.

Critics are likely to see the ruling as a dangerous reopening of the flavored-vape market. Under the Biden administration, the FDA denied more than one million marketing applications for candy- or fruit-flavored products, and public-health groups have long argued that flavor drives youth use. The Campaign for Tobacco-Free Kids says nearly 90% of youth e-cigarette users use flavored products, with fruit the most popular flavor. In 2024, 2.25 million middle and high school students reported current use of any tobacco product, down from 2.80 million in 2023, but the politics of flavored nicotine remain fraught. Trump had promised to save vaping, and the industry had pressed for a looser line. The Glas authorization is now a test case for whether regulators can permit adult access to appealing flavors without reversing hard-won progress against youth uptake.