The US Food and Drug Administration has been seeking comment on its Draft Guidance for Industry: Flavored ENDS Premarket Applications – Considerations Related to Youth Risk. The Regulations.gov docket is FDA-2026-D-1817
Comment by: Clive Bates, Stefanie Miller, Brad Rodu, Sally Satel, and David Sweanor.
- Available as a PDF (18 pages)
- As a Google Doc
- And at my Substack: FDA vape regulation “untethered from reality”
Summarised as follows:
Despite the importance of these policies to millions of Americans, the Draft Guidance is untethered from reality and is not fit for purpose. The public health standard, “Appropriate for the Protection of Public Health” (APPH), must reflect real-world market conditions, actual human behavior, and the most likely consequences of authorization decisions on public health.
In our view, the guidance is defective in the following seven ways, which also form the framework for the body of our response.
- A gross mischaracterization of ENDS risk to youth. For many young people who report current nicotine use, ENDS use has displaced smoking: in the absence of ENDS, they would likely be smoking today. This is a major public health benefit, yet the FDA ignores it.
- An inadequate basis for claiming that flavors cause ENDS uptake. There is no compelling evidence that flavors cause vaping uptake or that denying flavored products prevents uptake, only that young people have preferences for certain flavors. Nicotine use is driven by a wide range of psychosocial risk factors that flavor policies cannot address.
- An insufficient focus on reducing adult smoking. There are 34 times as many adult tobacco and nicotine users (≥18) as youth (<18). Adult smoking is the most urgent public health problem in terms of the number of people at immediate and severe risk and the opportunity to make health gains through switching to regulated ENDS products.
- A disturbing indifference to the vast illegal market for ENDS products. The Draft Guidance includes no accounting of the impacts of the dominant illicit market that serves users of all ages with unregulated flavored vaping products. The FDA’s effort to “protect youth” from flavored products exposes them to risky, unregulated products and to criminal activity.
- A perverse regulatory imbalance in favor of deadly combusted tobacco products. There are vastly more smoking products available for sale legally (15,000) than ENDS (45), pouches (30), or heated tobacco (19). There are two orders of magnitude more smoking products, yet smoke-free products face far higher barriers to entry and a process that takes so long that many are obsolete by international standards.
- An unworkable framework for testing comparative efficacy. The tests for comparative efficacy are so poorly specified as to be unworkable for most manufacturers. Nothing in the Tobacco Control Act requires or justifies these burdensome tests.
- The unlawful creation of a product standard outside the required rulemaking process. The Draft Guidance creates a poorly specified de facto product standard, but without the required rulemaking procedure. FDA has not subjected its own policymaking to an assessment of whether it is “appropriate for the protection of public health.”
In conclusion, we propose a range of non-marginal reforms consistent with the Tobacco Control Act and based on a recent report for the American Enterprise Institute, Regulating the Tobacco and Nicotine Market in the American Public Interest: A Reform Agenda for the FDA (September 2025). To summarize:
- Focus pre-market evaluation on product safety, packaging, branding, and marketing, and address most behavioral and population effects post-market.
- Establish market-wide surveillance, including illicit trade, to catch real-world problems as they emerge.
- Address adverse population trends through post-market corrective action (authorized products) or enforcement (illicit products) rather than pre-market guesswork.
- Give due weight to the much larger adult smoking population at far greater and more imminent risks in assessing APPH.
- Regain control of the market by crowding out illicit trade: design a process capable of authorizing c. 4,000 ENDS products, removing barriers to entry and achieving a ten-fold reduction in application costs, while meeting the statutory 180-day timetable.