Limitations on the Capability of the FDA to Advise.

Abstract

Svirsky, Howard, and Berman (2022) address the U.S. Food and Drug Administration (FDA)’s oversight of tobacco products, the newest major area of regulation Congress assigned to the FDA. They discuss the role of population health in decision making about tobacco products. They also conclude that the FDA plays important roles beyond simply setting basic quality standards, including as a purveyor of advice. Debates over the FDA’s focus on individual vs. population risk, and on the FDA’s role in guiding prescribing practices, have existed since the creation of the FDA over 100 years ago in the context of widespread concern relating to the US medical products market. The evolution and current status of those controversies may help provide some insight into the future of tobacco regulation.