My name is Jeffrey A. Singer. I am a Senior Fellow in Health Policy Studies at the Cato Institute. I am also a medical doctor specializing in general surgery and have been practicing that specialty in Phoenix, Arizona, for over 40 years. The Cato Institute is a 501(c)(3) non-partisan, non-profit, tax-exempt educational foundation dedicated to the principles of individual liberty, limited government, free markets, and peace. Cato scholars conduct independent research on a wide range of policy issues. To maintain its independence, the Cato Institute accepts no government funding. Cato receives approximately 80 percent of its funding through tax-deductible contributions from individuals. The remainder of its support comes from foundations, corporations, and the sale of books and other publications. The Cato Institute does not take positions on legislation.

I write to share my thoughts on the draft guidance for industry on premarket applications-considerations for youth risk.

The draft guidance effectively sets an asymmetric evidentiary bar—requiring flavored products to demonstrate large, product-specific cessation benefits while presuming youth risk based on broad category-level data—and, despite recent CDC data showing teen vaping has fallen to its lowest level in a decade, this approach functions less as a neutral public health balancing test and more as a de facto ban standard.

The guidance imposes an unrealistic evidentiary burden by expecting applicants to provide robust, product-specific evidence that flavored ENDS outperform tobacco-flavored products in promoting smoking cessation. In practice, this would require large-scale randomized controlled trials and long-term switching data—forms of evidence that are costly, time-consuming, and often infeasible, particularly for smaller manufacturers. At the same time, there is real-world evidence indicating that adult smokers often prefer non-tobacco flavors and are more likely to use flavored ENDS when attempting to quit or reduce cigarette consumption.2 Yet the agency is effectively demanding pharmaceutical-grade evidence for consumer products while discounting observational data and broader population-level trends showing substitution away from combustible cigarettes. As a clinician, I would note that in medicine we routinely make decisions based on imperfect but converging evidence when the alternative is continued exposure to a more dangerous product. In this case, setting an evidentiary bar that ignores real-world substitution risks impeding access to lower-risk alternatives while leaving combustible cigarette use—the most harmful form of nicotine delivery— unchallenged.

This imbalance becomes even clearer in how the guidance weighs competing public health risks.