WASHINGTON — The Food and Drug Administration authorized fruit-flavored vapes for the first time on Tuesday, after reports of pressure from President Trump.
The approval might sound like a move guaranteed to alarm public health experts. But the decision is instead proving divisive among researchers and anti-smoking advocates as they debate whether the potential benefits in helping people quit cigarettes outweigh the risks of youth uptake.
They do, however, share concerns about reports that politics tainted the scientific process. Political appointees have become increasingly involved in making scientific decisions across the agency.
The newly authorized e-cigarette flavors from Los Angeles-based company Glas include “Gold” and “Sapphire” — pseudonyms for “mango” and “blueberry” — along with tobacco and menthol. The FDA’s scientific review found that the company’s age-gated technology, combined with the FDA’s marketing requirements, “is expected to effectively mitigate the ability of youth to use the product,” said Andrew Nixon, a spokesperson for the Department of Health and Human Services.
FDA Commissioner Marty Makary initially opposed the move despite career staff signing off on the authorization, according to reporting from the Wall Street Journal. His office was concerned about the impact on public health. Then, the Journal reported that President Trump admonished Makary last weekend and urged him to wave the products through. The commissioner appears to have followed suit.
“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 on Wednesday. “That was their view. I was skeptical initially, but that’s their view.”
Makary did not address a question on whether he discussed the matter with the president.
He added that the larger concern is “vapes where we have no idea what’s in them,” referring to the illegal market that currently dominates convenience stores, vape shops, and gas stations.
“There’s one school security officer in Florida who said almost every month there’s somebody who’s taken to the hospital with some sort of respiratory thing that they believe is related to vapes,” Makary said. “So whatever’s going on, whatever is penetrating in, we are going to be ramping up our enforcement and prioritizing these illegal Chinese products.”
Mitch Zeller, who led the Center for Tobacco Products during Trump’s first term, said that he is “greatly concerned that a decision [from FDA scientific reviewers] was overruled by the Commissioner’s Office, and now, the politicization has been compounded by the President personally weighing in. Science-based application review should be held sacrosanct.”
The press announcement referring to the authorization stands out among the sea of press releases the agency has released in recent months. Notably, there is no quote from Makary. And the release attributes the authorization to a decision that was made “under President Trump’s leadership.”
Risks and benefits of flavored vapes
Many researchers say that e-cigarettes have potential as a tool to help people quit smoking, the No. 1 cause of preventable death in the U.S. While vapes carry their own health risks, including inhaling harmful chemicals in the aerosol they produce, they’re generally considered less harmful than cigarettes if people are able to switch over to them completely.
Flavored e-cigarettes, however, are more controversial, given that the Juul-fueled vaping crisis of the late 2010s was driven by sweet flavors that appeal to young people. Youth vaping rates have fallen significantly since their peak of 20% in 2019, thanks to factors including increased public awareness and raising the legal age to purchase tobacco products from 18 to 21. But some public health experts and researchers worry that history could repeat itself.
Fruit, candy, and dessert-like flavors already proliferate among black-market e-cigarettes. “We really want to have a regulated market so that the FDA actually has control over these products,” said Michael Siegel, a professor of public health and community medicine at Tufts University School of Medicine, noting that around 70% of the e-cigarettes now sold in the U.S. are illegal.
Siegel considers himself firmly in the anti-smoking camp, having testified against tobacco companies about 13 times in his career. “There’s very strong research to show that the use of flavored vapes is more effective in smoking cessation than switching to just tobacco or menthol vapes,” he said. The thinking is that tobacco and menthol vape flavors may be too reminiscent of smoking, making people more likely to relapse. “Going to a flavor makes it a completely different experience, and is not a constant reminder of smoking,” Siegel said.
Jonathan Foulds, co-director of the Penn State Center for Research on Tobacco and Health, noted that Glas is the first e-cigarette to be authorized in the U.S. that uses age-gating technology. Before people can use the devices, they have to pair them with a smartphone and upload a selfie along with identification. The e-cigarettes only work while they’re in close proximity to the smartphone they’ve been paired with.
“While it will effectively prevent youth use of the device, it may not be very popular with adults due to the hassle,” Foulds said via email.
Political pressure over vaping at the FDA
The FDA in March released draft guidance suggesting it was opening the door to flavors like coffee, mint, and cinnamon, but specifically said that vapes with fruit, candy, and dessert-like flavors “pose a substantial public health risk,” placing a high burden of proof on manufacturers hoping to show that the benefits outweigh the risks.
The latest FDA decision seems “out of the ordinary” given that draft guidance, said Sven Jordt, a Duke University School of Medicine professor who studies vapes.
Zeller said he frequently encountered political interference while working on broader policy issues. For example, the Biden administration suspended a rule to permanently ban menthol cigarettes, despite the public health benefits of a ban. The administration worried the move would alienate voters.
But “I never felt any pressure when it came to reviewing applications” for specific products, Zeller said.
The fact that Glas vapes are called “Gold” and “Sapphire” rather than mango and blueberry “does not change that these are fruit flavors,” Tim McAfee, a former head of the Office of Smoking and Health at the Centers for Disease Control and Prevention, said via email.
“If the administration were serious about pursuing harm reduction associated with cigarette use, it would be doing what it is doing in other arenas where it has identified what it sees as a significant public health risk: removing the ingredients or products that cause the harm,” McAfee said. Makary, for example, has sought to phase out synthetic food dyes as well as increase access to natural dyes. Simply authorizing alternative products, he said, won’t solve the health problems of the millions of Americans who continue to smoke cigarettes.
Among anti-smoking groups, the American Lung Association called the decision “reckless,” while the Campaign for Tobacco-Free Kids said it’s “risking a resurgence of youth e-cigarette use.” Truth Initiative, however, struck a more moderate tone, saying the Glas technology for flavored vapes “will be a key test case” in limiting youth vaping while providing an off-ramp for quitting cigarettes. (Campaign for Tobacco-Free Kids accepts funding from Bloomberg Philanthropies, as does STAT. Bloomberg Philanthropies does not play a role in STAT’s editorial decisions.)
Overall, Siegel said, the Glas decision offers hope that the FDA may find a way to make flavored vapes available to adults who smoke while preventing youth access. But those decisions should be made by the FDA alone, he said, without interference from the executive branch. “I think the overall result is a good one,” he said. “I’m not sure that the process by which it occurred is necessarily a good thing.”
STAT’s coverage of chronic health issues is supported by a grant from Bloomberg Philanthropies. Our financial supporters are not involved in any decisions about our journalism.