Outside report calls for changes in FDA food program

December 8, 2022

The Food and Drug Administration’s human foods program has serious cultural and structural problems compromising its ability to protect public health, an outside review requested by the agency found.

The report, “Operational Evaluation of the FDA Human Foods Program,” was prepared by the Reagan-Udall Foundation, a non-profit created by Congress to advance FDA’s programs. FDA Commissioner Robert Califf requested the report, responding in part to controversy over the agency’s handling of the infant formula shortage and slow response to food safety problems in that industry.

However, the report goes beyond the formula crisis to indict the agency’s culture and management structure. One of the report’s central recommendations is that there should be a single official in charge of food at FDA. Under the Trump administration, the deputy commissioner position that previously oversaw all food activities at the agency was removed from direct oversight of the Centers for Food Safety and Applied Nutrition.

“The lack of a clear overarching leader of the Human Foods Program has contributed to a culture of indecisiveness and inaction and created disincentives for collaboration,” according to the report. The current setup has “led to overlapping roles and competing priorities that result in what is perceived as constant turmoil.”

Options for reorganizing the human foods program include breaking out foods as an entirely separate federal agency within the Department of Health and Human Services, but that would likely require legislation. The most likely fix may be to re-establish a deputy commissioner for foods within FDA and give them line authority over CFSAN, the Center for Veterinary Medicine and the food inspection activities of FDA’s Office of Regulatory Affairs. The report also calls for more emphasis on nutrition, and one option would separate nutrition and food safety into two separate centers.

Morale within the agency’s food programs has reportedly been low for some time, a direct result of the cultural and structural problems identified in this report.

In response to the report, Califf said: “I am forming a group of agency leaders to advise me on how best to implement and operationalize these findings.”