The US Food and Drug Administration (FDA) is undergoing significant changes to modernize and consolidate its programs, including building a more robust regulatory program. 

Robert M. Califf, commissioner of food and drugs at the FDA, has put forward sweeping changes such as boosting food safety programs, firming up the US food supply chain and boosting nutrition.

The changes come following an external evaluation conducted by the Reagan-Udall Foundation and an internal review of the agency’s infant formula supply chain response. They propose a new structure for the Human Foods Program which handles inspections, laboratory testing, import and investigative operations.

Califf unveiled “a new, transformative vision” for the FDA Human Foods Program and for the Office of Regulatory Affairs (ORA, the FDA’s field-based operations) to support the FDA organization as a whole. 

Responding to calls for action
The FDA has recently come under fire from former FDA and 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 internal and external evaluations, which identified issues surrounding culture, structure, resources and authorities. They also noted areas of need, including modernizing data systems, providing more resources and authorities, improving emergency response systems and building a more robust regulatory program.

The 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 ORA.Consolidation approach
Under the new plan, the 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 ORA. The program will be unified under a single leader who reports directly to the commissioner. 

“Creating a Human Foods Program under a single leader who reports directly to the commissioner unifies and elevates the program while removing redundancies, enabling the agency to oversee human food in a more effective and efficient way,” states Califf.

The commissioner will conduct a national search for a deputy commissioner for Human Foods who will oversee the program and make decisions on policy, strategy and resource allocation.

The deputy commissioner will be charged with leading a unified Human Foods Program that keeps the foods regulated, safe and nutritious while ensuring the agency remains abreast of the latest advancements in science, technology and nutrition. 

The deputy commissioner will also have decision-making authority over policy, strategy and regulatory program activities within the Human Foods Program, as well as resource allocation and risk-prioritization.

Helping consumers make informed choices
The FDA will establish a Center for Excellence in Nutrition that prioritizes the agency’s efforts to help American consumers make informed food choices. The Center will include an Office of Critical Foods, as directed by the 2023 Consolidated Appropriations Act. 

Moreover, an Office of Integrated Food Safety System Partnerships will focus on elevating and integrating food safety activities with state and local regulatory partners as envisioned in the FDA Food Safety Modernization Act of 2011. 

This newly proposed structure will ensure greater collaboration and support of state-level inspectional activities. 

“We know that we cannot be everywher, at all times, and our relationships with our state and local regulatory partners will be more important than ever going forward,” says Califf.

Establishing a Human Foods Advisory Committee
A Human Foods Advisory Committee will be established to support scientifically grounded decision-making activities. This committee will consist of external experts who will advise on food safety, nutrition and innovative food technologies. 

The FDA will also emphasize strengthening its information technology and analytical capabilities to support the work of the Human Foods Program and to fulfill the promise described in the New Era of Smarter Food Safety. 

This area of focus will enable more facile communication, more efficient operations and enhanced empirical risk algorithms to guide the program’s priorities and the work in the field.

Transforming the Office of Regulatory Affairs
Lastly, the operating structure of the ORA will be transformed into an enterprise-wide organization that supports all FDA regulatory programs. 

This realignment will allow the ORA to focus on inspections, laboratory testing, imports and investigative operations.

This will optimize the ORA’s operations in line with the FDA’s public health and prevention-oriented goals. Certain other functions of the ORA will be aligned with other parts of the FDA in an attempt to create an overall stronger agency.