FDA Human Foods Program Evaluation Completed

In December, 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, Ph.D.; James Jones; Barbara Kowalcyk, Ph.D.; Shiriki Kumanyika, Ph.D., 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 panel addressed culture, structure/leadership, resources and authorities to provide recommendations for FDA to fulfill regulatory responsibilities, strengthen relationships with state and local governments and secure the nation’s food supply. The FDA-requested scope excluded cosmetic and dietary supplement responsibilities and the Center for Veterinary Medicine.

The panel’s evaluation protocol included information gathering, information synthesis, analysis and report generation. It heard from more than 350 stakeholders through a two-day in-person stakeholder meeting, an online stakeholder public portal and a series of interviews.

Califf released a statement shortly after the 51-page report was published: “The work of these independent evaluators will help to inform a new vision for the FDA Human Foods Program. The agency is committed to providing a public update on the new vision at the end of January 2023 and additional public updates by the end of February 2023, including the planned leadership structure and any changes to key internal processes and procedures. This new vision and structure will be built on the external evaluation being released today; the internal review of the agency’s infant formula supply chain response completed in September, which has already resulted in noticeable improvements in our operations across the Foods Program; and ongoing work that allows the agency to take advantage of emerging advances in food science, with a goal of designing a system that allows us to more quickly adapt to an ever-changing and evolving environment.

“I will be making final decisions regarding the future of the FDA Human Foods Program after reviewing the report and consulting with stakeholders both externally and internally. To assist me in this effort, I am forming a group of agency leaders to advise me on how best to implement and operationalize these findings. I expect this leadership group to be bold and focused on the transformative opportunities ahead for the FDA’s food program — by fully realizing the preventive vision laid out in the Food Safety Modernization Act, elevating the importance of nutrition given declining life expectancy in the U.S., due in large part to chronic diseases, strengthening our state partnerships, and embracing innovative food and agricultural technologies that will allow us to supply the nation — and the globe — with ample safe and nutritious food in the decades ahead.

“I will closely oversee the Human Foods Program until a determination is made on how we will strengthen and modernize the program. I will be fully engaged to ensure that the program comes out of this transition with the resources, tools and visibility it warrants given how critical its work is to every American.”

View the full report at reaganudall.org.