Califf Orders External Review of FDA Tobacco Regulation Office

Dr. Robert Califf

The U.S. Food and Drug Administration’s (FDA) recent handling of e-cigarette regulation is leading to an external review of the agency. On July 19, 2022, FDA commissioner Robert Califf announced that he had ordered an external review of the FDA’s office of tobacco regulation in addition to the office on food safety.

In a statement, Califf stated: “The agency has confronted a series of challenges that have tested our regulatory frameworks and stressed the agency’s operations, prompting me to take a closer look at how we do business.”

The FDA has tapped the Reagan-Udall Foundation and other unnamed experts to conduct a review of key offices on food and tobacco. The foundation will be asked to advise the FDA and help it improve its regulatory and oversight processes while also reviewing its resources, procedures and organization of the tobacco and food safety offices. The foundation will also review the Office of Regulatory Affairs, which is the division responsible for conducting inspections. It should be noted that the Reagan-Udall Foundation has no statutory authority over the FDA–it has a close relationship to some of the agency’s high-ranking officials and has helped shape the FDA commissioner’s priorities.