A week ago, the Food and Drug Administration (FDA) approved the marketing of electronic nicotine delivery systems (ENDS) made by Glas, a Los Angeles company that specializes in devices that incorporate age verification technology. “The authorized pods include Classic Menthol, Fresh Menthol, Gold, and Sapphire,” the FDA noted. “This action marks the FDA’s first authorization of non-tobacco and non-menthol ENDS products.”
That decision was significant because the FDA had previously frowned upon nicotine vaping products in flavors other than tobacco and menthol, viewing them as dangerously appealing to minors. It was also too much for FDA Commissioner Marty Makary, who resigned on Tuesday, reportedly because he disapproved of the policy shift.
While running for president in 2024, Donald Trump bragged that he “saved flavored vaping” during his first term and promised that he would “save vaping again.” But from the beginning, Makary did not seem on board with that agenda.
Testifying before a Senate appropriations subcommittee in May 2025, Makary hyped the threat posed by underage vaping. In comments he highlighted on his official X account, Makary averred that “there are high schools in America now where kids are saying half of the kids in high school are addicted to these vaping products.”
Whatever those students might have been saying, that statement was hard to reconcile with data from the National Youth Tobacco Survey (NYTS). In the 2024 NYTS, 7.8 percent of high school students reported that they had used e-cigarettes during the previous 30 days. Yet Makary implied that 50 percent of students at certain high schools are “addicted to these vaping products,” which is more than six times the nationwide prevalence of past-month use in the 2024 NYTS and about 22 times the rate of daily use (assuming 30 percent of past-month users were daily users, as in the 2023 survey).
Contrary to the impression that Makary left, underage vaping has fallen sharply in recent years. The prevalence of past-month use among high school students in 2024 was down from 10 percent in 2023 and about 72 percent lower than the peak of 27.5 percent recorded in 2019. The rate fell again last year, from 7.8 percent to 5.2 percent.
Makary did not even acknowledge that downward trend. “There are kids in America today who are addicted, they know they’re addicted, they come from good families, they’re good kids, and they can’t stop,” he said. “And that is something that we have to address.”
Given Makary’s unsupported alarm about supposedly rampant adolescent nicotine addiction, it is perhaps not surprising that he resisted delivering on Trump’s promise. But it is still hard to understand his reaction to the Glas approvals, which involved products designed to prevent underage use.
“The FDA’s rigorous, scientific review of these products found that the applicant sufficiently demonstrated that Glas’s device access restriction technology, combined with FDA-required marketing restrictions, is expected to effectively mitigate the ability of youth to use the product,” the agency said last week. “The technology requires the user to verify their age and identity with a government-issued ID and pair the device with a smartphone via Bluetooth. Following verification, the device will not operate if separated from the phone. The app also conducts random biometric check-ins to periodically confirm the registered user is the one using the device.”
Bret Koplow, acting director of the FDA’s Center for Tobacco Products, hailed that technology as “a potential game changer.” Koplow, who joined the FDA in 2011 and served as senior counselor to the commissioner during the Biden administration, is hardly an industry pawn or vape-loving radical. Yet he thought the Glas products illustrated “the role innovation may serve in the effort to protect young people from threats posed by nicotine use and addiction while helping to enable availability of an expanded array of flavored options for adults who smoke [and] who may use these products to completely switch away from regular cigarettes.”
From the FDA’s perspective, such behavior changes are desirable. The agency has repeatedly acknowledged the evidence that vaping is a much less dangerous form of nicotine consumption than smoking. But by refusing to approve the flavors that former smokers overwhelmingly prefer, the FDA undermined the harm-reducing potential of vaping products.
Koplow implicitly conceded that point, recognizing the tradeoff between making vapes less appealing to teenagers and encouraging adult smokers to make a switch that could literally save their lives. One might question his premise that newfangled devices—as opposed to, say, age-restricted sales in shops that are open only to adults—are necessary to stop teenagers from vaping, especially since underage consumption has fallen dramatically since 2019. One might also note that cigarettes, a far more hazardous product, do not incorporate any such technology. But at least Koplow understands that the FDA is supposed to be balancing two different goals.
During his Senate testimony, by contrast, Makary did not even acknowledge vaping’s promise as an alternative to smoking, let alone the tension between the goals that the FDA later tried to reconcile by greenlighting Glas. His obliviousness to such tradeoffs made him ill-suited for the job of deciding which nicotine products adults are allowed to consume, even if you take it for granted that federal bureaucrats should be making such decisions in the first place.
Makary was commendably open-minded in his approach to psychedelic therapy. But on the issue of tobacco harm reduction, he let his emotions override his avowed commitment to following the science.
The post Marty Makary's Irrational Resistance to Flavored Nicotine Vapes Drove His FDA Resignation appeared first on Reason.com.
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