The FDA Spent Years Rejecting Flavored Vapes. Then Trump Made a Call.

The FDA spent years building a wall against flavored e-cigarettes. Under the Biden administration, it rejected more than 26 million applications for flavored vape products, keeping them off shelves to protect children. Last year, the Supreme Court unanimously upheld the agency’s authority to deny products that might appeal to kids.

Then, over a single weekend, the wall developed a door.

On May 6, the FDA authorized four vape products from Los Angeles-based Glas Inc., including two fruit-flavored pods — mango and blueberry, branded “Gold” and “Sapphire.” It is the first time the agency has approved non-tobacco, non-menthol flavors.

FDA Commissioner Dr. Marty Makary had initially opposed the authorization despite career scientific staff signing off, according to the Wall Street Journal. Then President Trump admonished Makary and urged him to greenlight the products, the Journal reported, citing people familiar with the matter. Makary did not address whether he discussed the matter with the president when asked by STAT News.

“The feeling of the scientists at the agency was that age-gating technology is solid and that would limit the vaping to adults,” Makary told STAT, adding that he had been “skeptical initially, but that’s their view.”

The FDA’s press release credits the authorization to decisions made “under President Trump’s leadership” — phrasing that drew attention for its unusual political framing.

The scientific case isn’t trivial. Glas devices require government ID verification, smartphone pairing via Bluetooth, and random biometric check-ins to prevent youth use. Researchers at Penn State and Tufts noted the technology could represent genuine progress in balancing adult smoking cessation with child protection. Some 70% of e-cigarettes currently sold in the US are illegal and unregulated.

But the process is what concerns experts. Mitch Zeller, who led the FDA’s Center for Tobacco Products during Trump’s first term, said that while he encountered political interference on broad policy, “I never felt any pressure when it came to reviewing applications” for specific products.

“Science-based application review should be held sacrosanct,” Zeller told STAT News.

The American Lung Association called the decision “reckless.” Action on Smoking and Health said it fails Americans’ right to health. The Trump administration said its only guide is “Gold Standard Science.”

The public health community now watches to see whether that gold standard bends when the phone rings.

Sources

FDA Expands Market Access, Authorizes New ENDS Products — US Food and Drug Administration
FDA approval of fruit-flavored vapes raises political concerns — STAT News
Trump reportedly pressed FDA chief to authorize mango and blueberry vapes after years of rejection — Fortune

Discussion (6)

janne_k

Finally some common sense!! Adults should be allowed to have flavored vapes if the alternative is smoking actual cigarettes!! The Bluetooth age-gating tech sounds really impressive too - Penn State AND Tufts both said it could work!!

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TommyR81

so biden approved 26 million vape applications and nobody said anything but trump approves FOUR and suddenly it's a scandal. the media is so predictable it's sad

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Marcus_W

Biden's FDA REJECTED 26 million applications. That's the opposite of what you said. Trump's FDA approved these four. You have every single fact backwards and you're still mad about it. Incredible.

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cherbear

blueberry is the only correct answer, mango people cannot be trusted

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dawn_patrol_99

Everyone arguing about flavors is missing the real issue. Bluetooth pairing?? Government ID verification?? RANDOM biometric check-ins?? You're handing your personal data to a vape company and the government gets a nice little smoking database as a bonus. This was never about mango vs blueberry, it's about getting adults to voluntarily link their biometrics to a federal registry. Wake up.

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Linda M. Rojas

A few points worth separating here. Roughly 70% of e-cigarettes currently sold in the US are illegal and completely unregulated. That's the actual status quo — not some protected environment, but a black market. The Glas authorization covers four specific products with meaningful age-verification requirements. Whether the president should have personally pressed the commissioner is a legitimate process concern, and Mitch Zeller's comment about sacrosanct science-based review is well taken. But the underlying scientific assessment — that the technology could limit youth access — shouldn't be dismissed just because the process was imperfect. These are two different questions and we'd have a better public conversation if we treated them that way.

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