- The FDA should restructure its Human Foods Program by providing a clear chain of command and governance model to do a more effective job of regulating food to protect public health, according to a report from the Reagan-Udall Foundation. The culture among employees in the program is fragmented, the report found, mainly because there is no clear vision or mission.
- The Human Foods Program also should become more prominent in the FDA, especially given the importance of its mission — as well as the large amount of federal spending and policy about diet-related diseases, the report says. The agency needs more flexibility to hire people and set their salaries and should be bolder in exercising policy and fee collection authorities.
- The Reagan-Udall report is the result of an independent investigation of the FDA that Commissioner Robert Califf announced in July. It was triggered by a massive recall and shortage of baby formula that came about because of issues with the agency’s investigative capabilities during the pandemic.
For years, people involved with the food industry and policymakers have noticed inefficiencies and confusion in the FDA’s food regulation system. But nothing has come forward that could result in real change until now.
In a statement on Tuesday, Califf said he is committed to closely reviewing the report and putting some of the recommendations it contains into action. The FDA is working on a new vision for the Human Foods Program, he said in the statement, and the agency will provide a public update at the end of January. Proposed changes to the leadership structure — which could need legislative approval, depending on what is decided — will be announced by the end of February.
Califf said any changes will take into account the findings in the Reagan-Udall report, advances in food science and an internal review of the agency’s infant formula supply chain response completed in September. The goal is to design “a system that allows us to more quickly adapt to an ever-changing and evolving environment,” he said in the statement.
Califf said he is forming a group of agency leaders to consult with on the revamp, and he pledged in the statement to give the program the “resources, tools and visibility it warrants given how critical its work is to every American.”
In a virtual press conference Tuesday, leaders from the Environmental Working Group, Consumer Brands Association and Consumer Reports, among other organizations, praised the Reagan-Udall report and its recommendations.
The organizations were glad to see such bold suggestions made and hoped Califf would be true to his word and embrace them — especially by creating a better structure for the Human Foods Program and improving the agency’s culture.
“For the expert panel to formally acknowledge that serious problems exist within the FDA Foods Program is significant because it represents an important first step toward reform,” said Brian Ronholm, director of food policy at Consumer Reports.
Roberta Wagner, vice president of regulatory and technical affairs for the Consumer Brands Association, said food and beverage companies long ago shifted their cultures because of the Food Safety Modernization Act.
The measure, signed into law in 2011, was intended to set the table for a new way that both companies and regulators looked at food safety: It’s better to prevent problems than to react to them. But while companies made big changes, the FDA did not.
“The agency has not caught up with that,” Wagner said. “They’re still inspecting the same way they did before FSMA.”