The U.S. Food and Drug Administration's food program has no clear leader and must act more boldly with its budget, data sharing, and use of its mandatory recall authority, according to a report that the agency commissioned following the infant formula shortage earlier this year.
The Reagan-Udall Foundation's evaluation of the agency's Human Food Program, which was released Monday, described a lack of leadership resulting in part from a lack of clarity as to the roles of the program's Office of Food Policy and Response and the Center for Food Safety and Applied Nutrition.
"There is no clear Human Foods Program leader or decision-maker, outside of the [FDA] commissioner," the report says.
"Although the missions of CFSAN and OFPR have differences on paper, staff are often left wondering which program is responsible for decision-making. … A governance board was established in 2014 (and updated in 2019) to address this need for coordinated decision-making," the report continued. "However, this concept has not effectively addressed the structural challenges."
FDA Commissioner Robert Califf announced in July that the agency was retaining the Reagan-Udall Foundation, a nonprofit organization created by Congress to aid the FDA's mission to assess the food office, in addition to the Office of Regulatory Affairs.
The FDA's handling of an Abbott plant under investigation for bacterial contamination linked to a national shortage of infant formula drew sharp rebukes from lawmakers during a May hearing. The lawmakers said it was "unconscionable" that it took the agency months to inspect the plant despite an October 2021 whistleblower report about its conditions.
The FDA started investigating the key facility on Feb. 17, following reports of infant illnesses after consuming the formula.
While the country's food supply is safe, Califf said in July, the FDA's food program has been stressed by increasingly diverse and complex supply chain and food issues.
Monday's report came in response to this concern. Califf announced Monday that he would be making a decision as to the future of the Human Food Program after consulting stakeholders and forming a group of agency leaders to help him figure out how to "implement and operationalize" the report's 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," he said.
Monday's report included several areas in which the program should act more boldly in exercising its authority.
"FDA should use its mandatory recall authority more frequently, recognizing that a process should be in place to assure that accommodations are made for life-sustaining products that are the only source of nutrition for certain populations (e.g., infant formula)," the report said.
It also said the program should strengthen its implementation and use of its authority to collect user fees.
It also needs to act more boldly with nutritional labeling and data sharing, the report said.
"In addition to seeking new authority regarding data sharing and records access, FDA should explore applying existing authority that infant formula manufacturers must retain microbiological testing records — and that those records 'shall be made available ... for review and duplication upon request' by FDA — to require real time disclosure of final product testing results from infant formula manufacturers," the report said.