FDA vape regulation "untethered from reality"
May 08, 2026 by substack.com
FDA vape regulation "untethered from reality"
This is a long article; a comment on the FDA’s Draft Guidance for Industry: Flavored ENDS Premarket Applications – Considerations Related to Youth Risk. Comment by: Clive Bates, Stefanie Miller, Brad Rodu, Sally Satel, and David Sweanor. The Draft Guidance regulating safer alternatives to smoking, including flavored ENDS, directly impacts the health and well-being of more than 60 million Americans, most of whom are adults. Despite its importance, the guidance is considered disconnected from real-world conditions and unfit for its intended purpose. The public health standard “Appropriate for the Protection of Public Health” (APPH) should take into account actual market conditions, real human behavior, and the likely public health consequences of authorization decisions.
