Expert Panel Completes Operational Evaluation of FDA’s Human Foods Program

Report submitted to FDA Commissioner and posted on Reagan-Udall Foundation website

(December 6, 2022) Today, the Independent Expert Panel for Foods submitted its Operational Evaluation of FDA’s Human Foods Program to Dr. Robert Califf, Commissioner for Food and Drugs. The evaluation and report were facilitated by the Reagan-Udall Foundation at Dr. Califf’s request.

Chaired by former Commissioner of Food and Drugs Dr. Jane Henney, the Independent Expert Panel for Human Foods was comprised of Francisco Diez-Gonzalez, PhD; James Jones; Barbara Kowalcyk, PhD; Shiriki Kumanyika, PhD, MS, MPH; and John Taylor, JD. Together, these researchers, former regulators, and process improvement specialists brought disciplinary expertise and experience in epidemiology, public health, food science and safety, microbiology, nutrition, and regulatory operations to the evaluation.

“We were honored to take on this challenge and worked diligently to propose changes to strengthen the operation of FDA’s Human Foods Program,” said Dr. Henney. “The report provides constructive recommendations that will take time to work through and implement, but we are confident the effort will benefit the health and safety of the American public.”

The Expert Panel addressed culture, structure/leadership, resources, and authorities to provide recommendations that would equip FDA to fulfill its regulatory responsibilities, strengthen its relationships with state and local governments, and secure the nation’s food supply for the future. The FDA-requested scope excluded cosmetic and dietary supplement responsibilities and the Center for Veterinary Medicine.

The Expert Panel used a three-phase evaluation protocol consisting of information gathering, information synthesis and analysis, and report generation. The panel heard from more than 350 stakeholders through a two-day in-person stakeholder meeting, an online stakeholder public portal, and a series of interviews.

The full human foods report is posted at

The Reagan-Udall Foundation is working with a separate Independent Expert Panel to review certain portions of the FDA’s tobacco program. That report is due for release on December 19, 2022.

About the Reagan-Udall Foundation for the FDA

The Reagan-Udall Foundation for the FDA (FDA Foundation) is an independent 501(c)(3) created by Congress to advance regulatory science to help the U.S. Food and Drug Administration accomplish its mission. The FDA Foundation works to improve health and safety through stakeholder engagement and public-private partnerships that facilitate innovation, foster the use of real-world evidence, and identify modern tools and policies to keep pace with today’s rapidly evolving science.

Media Contacts:

Lea Ann Browning-McNee
301-509-1846 (cell)  

Mary McNamara
202-276-7822 (cell)