On December 6, the Independent Expert Panel for Human Foods submitted its Operational Evaluation of FDA’s Human Foods Program report to Dr. Robert Califf, FDA Commissioner for Food and Drugs. The evaluation and report, which addressed culture, structure/leadership, resources, and authorities, were facilitated by the Reagan-Udall Foundation at Dr. Califf’s request.
The panel, chaired by former Commissioner of Food and Drugs Dr. Jane Henney, highlighted several concerning findings in their report, including lack of communication, lack of a clear vision and mission, lack of a clear, overarching leader, and siloed workers within the FDA’s Human Foods program. Its recommendations to improve both food safety and nutrition in the U.S. included creating a new Federal Food Administration under HHS that would operate parallel to, rather than under the auspices of, the FDA.
Notably, the panel found that the FDA Human Foods program was ill defined with multiple agencies, including CFSAN, OFPR and OVA, working independently of each other, often with separate leadership and little sharing of information.
“The current structure of the FDA Human Foods Program reinforces duplicative or competing roles and responsibilities, siloed work, and inadequate internal and external engagement. This reality impedes the Human Foods Program move toward a prevention paradigm. While a change in structure cannot address all the challenges identified through this Human Foods Program review, changing the current organizational configuration will assist the Agency in advancing its mission,” the panel wrote.
In addition to Dr. Henney, the panel included Francisco Diez-Gonzalez, PhD, James Jones, Barbara Kowalcyk, PhD, Shiriki Kumanyika, PhD, MS, MPH, and John Taylor, JD. The team of researchers, former regulators, and process improvement specialists 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.
“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.”
Read the full report here.