# Public Comment re: Flavored Nicotine Delivery Systems (ENDS) Premarket ApplicationsConsiderations Related to Youth Risk This imbalance becomes even clearer in how the guidance weighs competing public health risks. March 17, 2026 • Public Comments By [Jeffrey A. Singer](https://www.cato.org/people/jeffrey-singer) [ Download PDF ](https://www.cato.org/sites/cato.org/files/2026-03/Singer%20-%20Public%20Comment%20on%20FDA%20Flavored%20E-Cigarette%20Guidance.pdf) 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 I write to share my thoughts on the draft guidance for industry on premarket applications-considerations for youth risk. The draft guidance effectively sets an asymmetric evidentiary bar—requiring flavored products to demonstrate large, product-specific cessation benefits while presuming youth risk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. [![Singer - Public Comment - 3/17/2026 Cover](/sites/cato.org/files/styles/serial_cover_phone/public/2026-03/singer-public-comment-3-17-2026-cover.png?itok=UL8uoy4Z)](https://www.cato.org/sites/cato.org/files/2026-03/Singer%20-%20Public%20Comment%20on%20FDA%20Flavored%20E-Cigarette%20Guidance.pdf) ### Download This Public Comment ##### Public Comment re: Flavored Nicotine Delivery Systems (ENDS) Premarket ApplicationsConsiderations Related to Youth Risk [ Download PDF ](https://www.cato.org/sites/cato.org/files/2026-03/Singer%20-%20Public%20Comment%20on%20FDA%20Flavored%20E-Cigarette%20Guidance.pdf) ##### About the Author [![jeff-singer-cropped.jpg](/sites/cato.org/files/styles/author_picture/public/2024-05/jeff-singer-cropped.jpg?itok=G_0nEnx7)](/people/jeffrey-singer) ##### [Jeffrey A. Singer](/people/jeffrey-singer) Senior Fellow, Cato Institute [ ](https://x.com/dr4liberty) [ ](mailto:jsinger@cato.org) [![Creative Commons License](/build/cato_2020/images/creative-commons.svg)](http://creativecommons.org/licenses/by-nc-sa/4.0/) This work is licensed under a [Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License](https://creativecommons.org/licenses/by-nc-sa/4.0/). [ Download PDF ](https://www.cato.org/sites/cato.org/files/2026-03/Singer%20-%20Public%20Comment%20on%20FDA%20Flavored%20E-Cigarette%20Guidance.pdf)