WASHINGTON — For the first time, the U.S. Food and Drug Administration has approved the marketing of fruit-flavored e-cigarette products.
The products, made by Los Angeles-based manufacturer Glas Inc., come in mango, blueberry and two menthol varieties. They will be sold under the names Gold, Sapphire, Classic Menthol and Fresh Menthol. Each pod contains 5% nicotine derived from tobacco.
The decision comes amid ongoing concerns about youth vaping, with critics long pointing to flavored products as a key factor driving use among teens. The Campaign for Tobacco-Free Kids criticized the move, warning it could reverse progress made in reducing youth vaping.
In a statement, the FDA said its review found the company’s age-restriction technology, combined with strict marketing rules, should help limit access by minors.
“The FDA’s rigorous, scientific review of these products found that the applicant sufficiently demonstrated that Glas’s device access restriction technology, combined with FDA-required marketing restrictions, is expected to effectively mitigate the ability of youth to use the product,” the agency said.
The system requires users to verify their age with a government-issued ID and connect the device to a smartphone via Bluetooth. The device will not function without the paired phone, and the FDA says the app includes random biometric check-ins to confirm the authorized user.
FDA officials say that kind of technology could play a key role in balancing adult access with youth prevention.
“By helping to prevent youth use, device access restrictions are a potential game changer,” said Bret Koplow, acting director of the FDA’s Center for Tobacco Products. “This technology is also an indication of the role innovation may serve in the effort to protect young people from threats posed by nicotine use and addiction while helping to enable availability of an expanded array of flavored options for adults who smoke who may use these products to completely switch away from regular cigarettes.”
The approval follows reporting that the Trump administration had pushed for faster authorization of flavored vaping products. A Wall Street Journal report said President Donald Trump had recently criticized FDA leadership over delays.
Federal regulators have historically been cautious about approving flavored vaping products due to their appeal to younger users. The FDA says it will continue requiring strong evidence that such products provide a benefit to adults while minimizing risks to youth.
The agency also says the products will face strict marketing requirements, including limits on how they are advertised and who they target. The company must also track and report whether its youth-prevention measures are working.
The FDA emphasized that no tobacco product is considered safe and warned that people who do not currently use tobacco should not start.
With this decision, the FDA has now authorized 45 electronic nicotine delivery system products for sale in the United States.
According to the agency, more than 25 million Americans still smoke cigarettes, which remain the leading preventable cause of disease and death nationwide.
