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FDA’s Human Foods Program to be Redesigned Following Criticism

FDA’s Human Foods Program to be Redesigned Following Criticism

The new Human Foods Program will combine the functions of the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response and certain functions of the Office of Regulatory Affairs.

The US Food and Drug Administration (FDA) recently announced that it will be undergoing significant changes to modernize and consolidate its Human Foods Program. The proposed changes will include building a more robust regulatory program, protecting the US food supply and promoting better nutrition.

Robert M. Califf, commissioner of food and drugs at the FDA, proposed new structures for the Human Foods Program, saying that it will be led by a single director who would oversee food safety, policy and some regulatory duties and report to the head of the agency. The changes would also create a Human Foods Advisory Committee made up of external experts of food safety, nutrition and technology. 

“The proposed structures for both groups will have clear priorities that are focused on protecting and promoting a safe, nutritious US food supply that more quickly adapts to an ever-changing and evolving environment,” Califf said in a statement.


Related: Here’s Why the USDA Updated its Organic Food Regulations


The changes come following an external evaluation conducted by the Reagan-Udall Foundation and an internal review of the agency’s baby formula supply chain response. The external evaluation identified several concerns, 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. 

The panel also found that the FDA Human Foods Program was ill defined with multiple agencies working independently of each other, often with separate leadership and little sharing of information. It recommended creating a new Federal Food Administration that would operate parallel to, rather than under the auspices of, the FDA.

In the internal review, the FDA was scrutinized by former FDA and US Department of Agriculture (USDA) officials who advocated for consolidation measures to boost food safety, security and nutrition in the US. Califf responded to criticism by saying that the Human Foods Program was its number one priority.

The new strategy will address findings from these internal and external evaluations, which identified broader issues surrounding culture, structure, resources and authorities. They also noted areas of need, including improving emergency response systems, modernizing data systems, providing more resources and authorities and building a more robust regulatory program.

Mitzi Baum, CEO of the advocacy group STOP Foodborne Illness, told FoodDive that while there are many details left unannounced, the group anticipates the restructuring “will facilitate accelerating decision-making, create seamless communication within a still fragmented agency and forge consequential cultural changes.”

However, the revamp wasn’t as well-received by others. “While today’s announcement is a positive first step, it fails to provide the deputy commissioner with direct line authority over all major foods program components or fully integrate the agency’s policymakers with its inspection force” Roberta Wagner, Consumer Brands Association vice president for regulatory and technical affairs, said in a statement.

Further, the redesign doesn’t propose a budget, nor does it lay out a plan to combat acute and chronic food illness. Rather, the plan prioritizes the regulation of nutrition, which is currently listed equally with food safety. However, time will tell whether the FDA’s new Human Foods Program will solve the concerns that were identified with the previous one.