The recent appointment of Dr. Martin Makary as Commissioner of the U.S. Food and Drug Administration (FDA) has stirred alarm within the tobacco harm reduction (THR) community, following comments that many view as deeply misleading and potentially damaging to public health policy. During a May 22nd Senate Appropriations Subcommittee hearing, Dr. Makary painted an alarmist picture of adolescent vaping, asserting that in some American high schools, “half the kids are addicted.” This claim, repeated on social media, quickly attracted criticism from public health and THR experts, who highlighted that the FDA chief’s statements vastly overstated current teen vaping rates and lack evidence-based grounding.
Framed around a call for more aggressive action against illegal Chinese-made vaping products, Dr. Makary’s remarks described these devices as being tailored to lure young users through features resembling video games. He showcased a disposable vape during the hearing and criticized the inefficacy of current regulatory enforcement, describing a situation where products banned at one port re-enter the country through another. According to Makary, this failure of border control is being rectified through collaboration with the Department of Justice and the Department of Homeland Security, with a shift from returning shipments to outright seizing them.
However, while there is widespread agreement that unauthorized and illicit vaping products should be eliminated from the market, THR proponents argue this can only happen efficiently if the FDA focuses on expanding the authorization of legitimate, lower-risk products. Unlike the U.S., which has moved at a glacial pace, regulatory bodies in the UK and EU, have authorized thousands of vaping products under clear and reasonable frameworks. This proactive approach both supports consumer safety and preserves access to adults who rely on these tools to quit smoking.
Makary’s youth vaping epidemic claim debunked
In line with this, tobacco harm reduction expert and researcher Dr. Brad Rodu, recently wrote on his blog that according to his findings, this group represents just 0.5% of the high school population. He explained that last December, he conducted an in-depth analysis of vaping trends among American high schoolers using data from the CDC’s 2023 National Youth Tobacco Survey, the most recent dataset available at the time. Rodu found that approximately 73,092 of the country’s 15.8 million high school students reported vaping frequently—defined as use on 20 to 30 days in the past month. “That represents only 0.5%, not 50%,” he said.
This kind of departure from evidence-based communication has sparked disappointment among many THR advocates who initially had high hopes for Dr. Makary’s tenure. His book, Blind Spots: Why We Fail to See the Solutions Right in Front of Us, had challenged entrenched thinking within the medical establishment. Some believed his willingness to critique conventional wisdom would extend to the FDA’s neglect of tobacco harm reduction—a critical oversight that continues to contribute to the high death toll from smoking in the U.S. As someone now positioned to fulfill former President Trump’s pledge to “save” vaping and other safer cigarette substitutes, his approach to the issue carries enormous implications.
Protecting kids without punishing adults
Within the harm reduction field, there is of course a consensus that any substance use among minors is a concern. However, nicotine—much like caffeine—must be contextualized alongside other risky behaviors such as underage alcohol and marijuana use. The issue demands proportional response, not panic-driven policy. Overstating the prevalence and dangers of youth vaping risks justifying sweeping crackdowns on nicotine alternatives that are vital for adult smokers trying to quit combustible tobacco.
Harm reduction advocates argue that the consequences of these type of innacurate claims are not just academic—they are real and immediate. Overblown narratives around youth vaping have repeatedly been used to justify sweeping restrictions on nicotine alternatives that millions of adults rely on to transition away from combustible tobacco. When top health officials conflate exagerated fears with public health data, they risk encouraging misguided policies that stifle innovation and access to less harmful products.
The broader context of this controversy points to a long-standing imbalance in U.S. nicotine policy: a heavy-handed focus on youth prevention with insufficient attention to adult smokers who could benefit from safer alternatives. While no one disputes the need to keep nicotine out of the hands of minors, this aim must be pursued alongside, not instead of, a commitment to helping adults quit smoking through effective harm reduction strategies.
Exaggerated claims also contribute to public mistrust in regulatory institutions. The FDA’s credibility has already been under scrutiny in recent years, particularly within the THR space. The agency’s prolonged delays and inconsistent decisions regarding the approval of vaping products have frustrated many in the public health community who champion evidence-based approaches. This latest backlash only adds fuel to those concerns.
Revolving doors and missed opportunities
Adding to this mistrust, is also the recent move of Dr. Brian King, former director of the FDA’s Center for Tobacco Products (CTP), to the Campaign for Tobacco-Free Kids (CTFK)—an organization known for its aggressive anti-vaping stance. King’s departure from the FDA in April and swift appointment at CTFK in May was met with skepticism by many harm reduction advocates. They see it as further evidence of a revolving door between government agencies and advocacy organizations that often sideline science in favour of ideology.
During his tenure at the FDA, King was frequently criticized for focusing more on curbing youth vaping than on facilitating access to reduced-risk products for adults. Although his time at the CTP did see some approvals of flavoured vaping products and nicotine pouches, the overall pace of progress was seen as sluggish and inconsistent. Hence, his new role at CTFK has raised fears that this trend from his end will continue, or worsen, as he aligns himself with an organization that has historically opposed tobacco harm reduction.
On a positive note, taking over from King is Bret Koplow, who seems to be in support of for tobacco harm reduction. His long tenure at the FDA means he isn’t entering the position unfamiliar with the landscape and has already been involved in CTP’s ongoing work, rather than starting from scratch. Philip Morris International CFO Emmanuel Babeau, recently told Investing.com that although Koplow still needs to be officially confirmed, early indications suggest that Koplow may prioritize a balanced approach to tobacco policy, particularly by helping smokers understand the relative benefits of reduced-risk products compared to combustible cigarettes.
Critic of medical blind spots or creator of one?
Meanwhile, Dr. Makary’s comments signal a troubling direction for FDA leadership. His portrayal of a teen vaping “epidemic” disconnected from reality may pave the way for policies that ignore the needs of adult smokers. By repeating debunked claims and relying on anecdotes rather than evidence, the FDA risks undermining not only its own legitimacy but also the broader goal of reducing smoking-related disease and death.
What’s needed now is a return to science-based policymaking—one that respects both youth protection and adult harm reduction. The path forward must be grounded in facts, not fear. Until the FDA can demonstrate consistency, transparency, and a genuine commitment to public health for all populations, its reliability will remain in doubt for many within the harm reduction movement. For the millions of Americans who have successfully used vaping and other nicotine alternatives to quit smoking, the stakes couldn’t be higher.
