As a physician and former 11-term member of Congress who focused on health policy, I have devoted my career to advancing health for Americans. The most persistent health issue I have encountered was reducing smoking rates. Even today, smoking is still the leading preventable cause of disease. The good news is that we now have a tested pathway to dramatically impact, if not eliminate, smoking and avoid its needless health toll and associated health costs.
In 2009, Congress gave the Food and Drug Administration responsibility for tobacco regulation with the charge to reduce smoking and smoking-related disease while preserving the right of adults to use tobacco if they chose to do so. As a member of Congress at the time, I was concerned that the FDA would hamper, not foster, access to reduced-risk alternatives to cigarettes. Since then, innovative products such as e-cigarettes and nicotine pouches were developed, are dramatically less risky than cigarettes (many in public health estimate the risk reduction to be 95% or greater), and help smokers quit. In short, spot on for the FDA’s core tobacco mission.
And yet, FDA mismanagement led to a result that defies both common sense and good public health policy. The FDA rejected 99% of vapor product applications, thereby ceding the market to illicit sellers (now accounting for 70% to 80% of total vapor sales). No one knows the content of illicit vapes, and many are marketed to kids. These were all problems of the FDA’s own making. The agency never set clear standards to guide product approvals. Compounding the problem, it created an application process that takes too long and costs too much.
Thankfully, times are changing. The FDA now embraces the “historic” (their word) opportunity to reduce smoking offered by reduced-risk nicotine products such as vapes and nicotine pouches. At the same time, the agency has bolstered enforcement against the out-of-control illicit vape market driven by unregulated Chinese manufacturers and the outlaw smoke shops that sell these products.
The FDA has recently authorized flavored vapes and nicotine pouches. This is critical because harm reduction requires products that adult smokers are willing to use (as evidenced by the failure of nicotine replacement therapies — many around for decades — to eliminate smoking). Moreover, as acceptable products become available, demand for illicit products will invariably fall. This is a win-win for adult smokers, a well-regulated marketplace, and public health broadly.
Next, the FDA must adopt science-based, transparent product standards to simplify and expedite the product review process while ensuring that authorized products are marketed only to adults. Second, it must begin educational outreach to adult smokers and clinicians to remedy alarmist and widespread misunderstanding of the harm reduction and smoking cessation opportunities these products offer.
To be sure, the common retort from critics of the FDA authorizing these (or any) reduced-risk choices for smokers is youth use, but that argument is not fact-based. First, youth vaping is actually rare — about 2% of youth vape regularly, and just 5% have had as little as a single puff on a vape in the past month. Eighty-five percent of youth have never tried one at all, despite the widespread availability of illicit flavored vapes. Youth use of nicotine pouches is also rare. Use of alcohol and marijuana is much more common among youth.
Second, youth use has declined 75% since 2019 despite the widespread availability of illicit flavored vapes.
Third, when asked why they started vaping, 90% of all youth who ever tried vaping did not agree that flavors mattered. What mattered was peer use and other risk factors common to most youth risk behaviors.
Fourth, of the few youth who indicate flavors were a reason, virtually all (98%) also identify those other reasons as well. In fact, only 0.25% of youth who have ever vaped said that flavors were the only reason they did so.
THE FDA’S STRATEGY ON VAPING IS GOING UP IN SMOKE — NOW AMERICANS ARE PUT AT RISK
We can work to better protect the small remaining percentage still at risk by ensuring responsible retailers are trained to scan IDs and educating the retail workforce through programs like WeCard. We must also recognize how underage users obtain these products. Social sourcing remains the primary pathway, which means adults have a responsibility to never purchase adult-only nicotine products for someone underage.
Here is the simple truth: If one does not offer adult smokers acceptable lower-risk alternatives, two things happen — many smokers continue smoking, and many others resort to illicit market products. Neither of these outcomes promotes public health or advances a well-regulated market. As a licensed physician and a former lawmaker, I support the FDA’s action to leverage the “historic” opportunity reduced-risk products offer to meaningfully reduce the health burden of smoking for the benefit of the 28 million adults who currently smoke cigarettes and encourage others to do so as well.
Dr. Michael C. Burgess is a senior adviser to the nonprofit organization Communities United for Smart Policy. He represented the 26th District of Texas in Congress from 2002 to 2024 and practiced medicine as an obstetrician for 30 years.