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FDA move on flavored vapes sparks concern on toxicity, teen vaping

Many tobacco researchers and policy experts think e-cigarettes have potential as a tool to help people quit smoking. But they also want to prevent teenagers from taking up the habit and getting hooked on nicotine.

The tension between these two goals is at the heart of new draft guidance to e-cigarette manufacturers from the Food and Drug Administration this week on the subject of flavored vapes. The document suggests vapes in flavors like coffee, mint, or cinnamon may now have a shot at getting authorized for sale. 

Some public health experts, along with anti-tobacco advocates, worry the change could set back the progress the U.S. has made in reducing the number of underage people who use e-cigarettes. And that’s not their only worry about potential health repercussions of authorizing more flavored vapes. 

“What I’m really concerned about, as someone looking at the toxicity of flavors, is that they want to endorse spice flavors,” said Sven Jordt, a professor at the Duke University School of Medicine who researches tobacco products. Cinnamon and clove in particular, he said, are “among the most toxic flavor chemicals that have been identified in e-cigarettes.”

The FDA’s draft guidance, which was first reported by The New York Times, is not yet official policy. It’s open for comment for the next 60 days.

So far, the agency has authorized only vapes in tobacco and menthol flavors in an effort to avoid the sweet options that fueled the youth vaping crisis in the late 2010s. The document suggests the FDA is still unlikely to authorize vapes that feature fruit, candy, and dessert-themed flavors because they’re particularly enticing to young people, but that it may be more accepting of flavors that could appeal to adults trying to quit smoking.

If manufacturers want flavors like these approved, they would have to show the agency that those flavors are both more likely to get adult smokers to switch over to e-cigarettes than tobacco flavors, and that the benefits to adults “outweigh the added risk to youth.”

“If the FDA imposes a high bar for evidence, that could be a difficult needle to thread,” Benjamin Chaffee, a professor at the University of California San Francisco Center for Tobacco Control, Research, and Education, said via email.

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That’s what independent manufacturers say, too. Jim McCarthy, a spokesperson for the trade group American Vapor Manufacturers, said manufacturers would have to spend millions of dollars on longitudinal studies before submitting applications for flavored products. The guidance is “more arbitrary, imaginary, unreliable double-talk from an agency that has been misleading the public about safer nicotine products shamelessly for years,” he said.

Meanwhile, Reynolds American spokesperson Luis Pinto said in a statement that the FDA’s draft guidance “should go further.”

“We believe the biggest opportunity to reduce cigarette use is by giving adult smokers appealing flavor options beyond tobacco and menthol,” he said.

The FDA did not respond to a request for comment.

The vast majority of e-cigarettes sold in the U.S. are illegal but remain easily found in gas stations, smoke shops, and online retailers. Just 39 e-cigarettes have so far been authorized for sale from the brands Juul, Logic (owned by Japan Tobacco International), NJOY (owned by Altria), and Vuse (owned by R.J. Reynolds Vapor Company).

Dennis Henigan, vice president for legal and regulatory affairs at the Campaign for Tobacco-Free Kids, said his advocacy group worries the FDA is succumbing to pressure from the tobacco and vaping industry with its new guidance. 

“We see no good reason for FDA to deviate from how it has been assessing flavored e-cigarettes,” Henigan said. “We’re both puzzled and troubled by this apparent shift in approach.”

(Campaign for Tobacco-Free Kids is funded by Bloomberg Philanthropies, which also supports STAT’s coverage of chronic health issues. STAT is editorially independent.)

Henigan added that the guidance is “particularly concerning” in light of the booming nicotine pouch market and the FDA’s recent authorization of Zyn pouches in flavors like coffee, mint, and citrus. “There seems to be a trend toward the FDA wanting to find ways to authorize more flavored products,” he said.

The tobacco industry, which was a major donor to Trump’s presidential campaign as well as to his White House ballroom, has chalked up a number of wins since his administration took office. The federal government has withdrawn proposed FDA rules that would have banned menthol in cigarettes and reduced their level of nicotine, while budget cuts effectively shuttered the Office on Smoking and Health at the Centers for Disease Control and Prevention last year. 

“Aggressively combatting tobacco smoking does not appear to be a priority presently,” said UCSF’s Chaffee. 

Who benefits from more vaping flavors?

One of the key questions raised by the new guidance is to what extent expanded flavor options would encourage people who smoke to give up cigarettes in exchange for vapes. Harm reduction advocates note that while vapes carry health risks of their own, they’re less dangerous than cigarettes and other combustible tobacco products.

Some research does suggest a wider range of e-cigarette flavors may appeal to adult smokers. And industry advocates say it would be better for smokers trying to quit to break their association between nicotine and tobacco flavors. But “so far, the science hasn’t supported the idea that availability of diverse flavors is really efficient at making people switch and [stay] smoke-free over a long time,” said Jordt.

Then there’s the issue of whether flavors like mint or coffee are really too sophisticated to appeal to youthful palates. Mint was the third-most popular flavor choice among students who used e-cigarettes in the 2024 National Youth Tobacco Use survey, after fruit (63%) and candy (33%). “I think that’s a huge mistake, listing mint as a flavor,” Jordt said, saying it could trigger more youth uptake. Plenty of teenagers also flock to Starbucks for iced coffee drinks and chew cinnamon gum. 

The FDA’s guidance doesn’t mention the potential toxicity of additional flavors, but that was a concern raised by both Jordt and Suchitra Krishnan-Sarin, a psychiatry professor at the Yale University School of Medicine who together co-authored a 2023 paper on the subject.

“Many e-cigarette products that existed on the market earlier had very high levels of cinnamon, and cinnamon is known to be a toxicant” when inhaled, Krishnan-Sarin said. 

Manufacturers at the time recommended that cinnamon vape liquids be used with glass tanks or pods because they would melt plastic, Jordt said — “obviously that will also melt your lung.” 

Eugenol, used in clove flavors, is a potent local anesthetic, which Jordt said makes it easier to inhale more of the vapor from e-cigarettes. And vanilla, found in a wide range of flavored e-cigarettes, has been shown in some studies to promote the release of dopamine in the brain, which he said may strengthen the addictive potential of vapes.

Overall, not only are flavors appealing and palatable, they also “counteract the unpleasant sensory effects that are inherent to nicotine,” such as a bitter taste and irritation in your airways, said Adam Leventhal, director of the Institute for Addiction Science at the University of Southern California. That’s another reason many experts prefer to err on the side of caution with flavors.

Illegal vapes, many of which are imported from China, already feature lots of fruity flavors as well as extra-potent sweeteners. Yet youth vaping rates have still fallen significantly, down to 6% in 2024 compared to a high of 20% in 2019.

In light of that change, experts said they understood why the FDA might consider opening the door to more flavors as another tool in the fight against smoking, which is still the leading cause of preventable death and disease in the U.S. But Leventhal noted that enforcement against unauthorized flavored vapes probably helped lower rates of youth vaping. 

More flavors could re-start the cycle of underage vaping, Krishnan-Sarin said: “Are we repeating history?”

Youth vaping rates are top of mind for public health experts right now. In a surprise move, the FDA published the raw data results from the 2025 National Youth Tobacco Use survey late last week, without any accompanying analysis. Krishnan-Sarin and Jordt said they’re working with colleagues to understand the findings. (In past years, the CDC’s Office of Smoking and Health did the bulk of that analysis.) In the meantime, Altria put out its own analysis.

“I think they’re trying to be open to the public,” Krishnan-Sarin said of the FDA’s move to release the results. “But this is kind of an unusual way.” 

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.


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