FDA Authorizes First Fruit-Flavored E-Cigarettes From Los Angeles Company

The U.S. Food and Drug Administration authorized the marketing of fruit-flavored e-cigarettes for the first time on Tuesday, approving mango and blueberry pods along with two menthol varieties from a Los Angeles-based manufacturer. The products contain 5 percent tobacco-derived nicotine and will be sold under the names Gold, Sapphire, Classic Menthol and Fresh Menthol.

The agency said the company's device access restriction technology, which requires online buyers to verify their identity with a government-issued ID and pair the device via Bluetooth to a smartphone, combined with marketing limits barring sales to anyone under 21, sufficiently mitigates youth access.

The move marks a sharp reversal from Biden-era policies under which the FDA rejected more than 26 million applications for flavored vape products. Officials had sought to keep such items away from children, citing their appeal to younger users.

The decision follows reported pressure from the Trump administration to move more quickly on flavored vape approvals. A White House spokesperson told reporters that the Biden administration had cracked down on flavored vapes despite evidence the products help adults quit smoking.

“The only factor guiding the Trump administration’s health policymaking is Gold Standard Science, and the FDA under Commissioner Makary’s trailblazing leadership will continue to make evidence-based decisions that rectify the Biden administration’s missteps and that are in the best interest of the American people,” the spokesperson said.

The FDA stated in a press release that its scientific review found the applicant's technology and required marketing restrictions expected to limit youth use effectively. The agency has now authorized 45 e-cigarette products in total.

““By helping to prevent youth use, device access restrictions are a potential game changer. The FDA said it will continue requiring strong evidence that such products benefit adult smokers seeking to quit. Anti-smoking organizations expressed disappointment with the authorization. One group said the flavors induce people, many of them children and young adults, to use a product that may result in a lifetime of addiction and other harms. Another leading public health organization stated the FDA now bears responsibility to closely monitor how the products are marketed and used to ensure they continue meeting a rigorous public health standard that weighs benefits for adult smokers against risks to youth. The agency noted that more than 25 million Americans smoke cigarettes and that smoking remains the leading preventable cause of chronic disease and premature death in the U.S., accounting for about one in five deaths.”

During his first term, President Trump supported raising the tobacco purchase age to 21 and said in 2019 that he would ban flavored vapes because youth should not be so affected. He later changed his tone after meeting with an industry lobbyist. A study published in the peer-reviewed American Journal of Preventive Medicine found that FDA efforts during Trump’s first term to crack down on sales to minors and run public education campaigns prevented just under 450,000 young people from smoking.

Last year the Supreme Court ruled unanimously that the FDA could deny authorization for products it believes may appeal to children. The current approval comes after the agency modified its approach to flavored vapes earlier this year amid industry lobbying.

Public health and parent groups have warned for years that flavored vaping products could appeal to teenagers. Advocates called on the FDA to monitor whether the new restrictions prove effective in practice. The Campaign for Tobacco-Free Kids criticized the decision, arguing it could undermine progress in reducing youth vaping.