WASHINGTON – Following reports of pressure from President Trump, the Food and Drug Administration approved the first fruit-flavored e-cigarettes on Tuesday.
The approval may sound like a move sure to alarm public health experts. But the decision, which debates whether the potential benefits of helping people quit outweighing the risks of youth tobacco use, has proven to be rather divisive among researchers and smoking cessation advocates.
But they share concerns over reports that politics has tainted the scientific process. Political appointees are increasingly involved in making scientific decisions across government agencies.
Newly approved e-cigarette flavors from Los Angeles-based company Glas include tobacco and menthol, as well as “gold” and “sapphire,” pseudonyms for “mango” and “blueberry.” As a result of the FDA’s scientific review, the company’s age-restricted technology, when combined with the FDA’s marketing requirements, “is expected to effectively reduce the ability of youth to use the product,” said Andrew Nixon, a Department of Health and Human Services spokesman.
The Wall Street Journal reported that FDA Commissioner Marty McCulley initially opposed the move, even though career officials agreed to the approval. His office was concerned about the impact on public health. The paper later reported that President Trump reprimanded Mr. McCurry over the weekend and urged him to hand over the merchandise. The commissioner appears to have followed suit.
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McCurry told STAT on Wednesday that “the agency’s scientists felt that the age-restriction technology was robust and that e-cigarette use would be restricted to adults.” “That was their view. I was skeptical at first, but that’s their view.”
Mr. McCurry did not respond to questions about whether he had discussed the issue with the president.
The bigger concern, he added, is “e-cigarettes where you don’t know what’s in them,” referring to the illegal market that currently dominates convenience stores, vape shops and gas stations.
“One school security guard in Florida said that almost every month someone goes to the hospital with some sort of respiratory illness that appears to be related to vaping,” McCurry said. “So no matter what’s going on, no matter what’s coming in, we’re going to step up enforcement and prioritize these illegal Chinese products.”
Mitch Zeller, who led the Center for Tobacco Products during President Trump’s first term, said: “We are extremely concerned that the decision[by the FDA’s scientific reviewers]was overturned by the Office of the Secretary, and now the president is giving his personal opinion, making the politicization even worse. Science-based review of applications should be sacrosanct.”
The press release regarding this approval stands out among the many press releases issued by the agency in recent months. Notably, there are no quotes from McCurry. The release said the approval was a decision made “under the leadership of President Trump.”
Risks and benefits of flavored e-cigs
Many researchers say e-cigarettes have potential as a tool to help people quit smoking, the No. 1 cause of preventable death in the United States. Although e-cigarettes have their own health risks, such as inhaling harmful chemicals in the aerosols they produce, they are generally considered less harmful than cigarettes if people can switch to them completely.
But flavored e-cigs are more controversial, given that the Juul e-cig crisis of the late 2010s was sparked by sweet flavors that appealed to young people. Youth e-cigarette use rates have fallen significantly from a peak of 20% in 2019, due to factors such as increased public awareness and the raising of the legal age to purchase tobacco products from 18 to 21. But some public health experts and researchers fear history is repeating itself.
Flavors like fruit, candy, and desserts are already proliferating among black market e-cigarettes. “We really want a regulated market so that the FDA can actually control these products,” said Michael Siegel, professor of public health and community medicine at Tufts University School of Medicine, noting that about 70% of e-cigarettes currently sold in the United States are illegal.
Mr. Siegel considers himself part of the anti-smoking movement and has testified against tobacco companies about 13 times during his career. “There is strong research showing that using flavored vapes is more effective for quitting smoking than switching to tobacco or menthol vapes alone,” he said. The idea is that cigarette and menthol vape flavors may be too reminiscent of smoking, increasing the likelihood of relapse. “When you go for a particular flavor, it’s a completely different experience and doesn’t always remind you of smoking,” Siegel says.
Jonathan Falls, co-director of the Penn State Tobacco and Health Research Center, said Glas is the first e-cigarette approved in the United States to use age-restricted technology. Before users can use their device, they must pair it with their smartphone and upload a selfie along with their ID. E-cigs only work when they are in close proximity to the smartphone they are paired with.
“While it can effectively prevent youth from using the device, it may be cumbersome and may not be popular with adults,” Falls said in an email.
Political pressure on e-cigarettes at the FDA
The FDA released draft guidelines in March suggesting it would open the door to flavors like coffee, mint and cinnamon, but specifically said e-cigarettes with flavors like fruit, candy and dessert “pose a significant public health risk,” placing a high burden of proof on manufacturers who want to prove the benefits outweigh the risks.
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Sven Jolt, a Duke University School of Medicine professor who studies e-cigarettes, said the latest FDA decision appears “abnormal” given the draft guidance.
Zeller said he frequently encountered political interference while working on broader policy issues. For example, the Biden administration suspended rules permanently banning menthol cigarettes, despite the public health benefits of the ban. The administration feared 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’ e-cigs are called “gold” or “sapphire” rather than mango or blueberry “doesn’t change the fact that these are fruit flavors,” Tim McAfee, former director of the Centers for Disease Control and Prevention’s Office on Smoking and Health, said in an email.
“If the government is serious about reducing the harms associated with cigarette use, it will do the same thing it does in other areas where it identifies what it considers to be significant public health risks: remove ingredients and products that cause harm,” McAfee said. For example, Makary aims to phase out synthetic food dyes and increase access to natural dyes. He said simply approving alternative products will not 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” and the Tobacco Free Kids Campaign said it “risks a resurgence in youth e-cigarette use.” But the Truth Initiative took a more moderate tone, saying that Glas technology in flavored e-cigarettes “will be an important test case” for restricting young people’s use of e-cigarettes and providing incentives for them to quit smoking. (The Tobacco Free Kids campaign, like STAT, receives funding from Bloomberg Philanthropies. Bloomberg Philanthropies has no control over STAT’s editorial decisions.)
Overall, Siegel said, the Glas decision offers hope that the FDA may be able to find a way to make flavored e-cigarettes available to adults who smoke while blocking access for youth. But he said such decisions should be made by the FDA alone, without intervention from the executive branch. “I think the overall results are good,” he said. “I don’t know if the process by which it happened is necessarily a good thing.”
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