On January 31, Robert M. Califf, M.D., MACC, FDA Commissioner of Food and Drugs shared a proposal for a unified Human Foods Program that would combine the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR) and certain functions of the Office of Regulatory Affairs (ORA) under one leader.

The new model was proposed in response to the findings of an external evaluation of the FDA Foods program conducted by an expert panel of the Reagan-Udall Foundation and a separate internal review of the agency’s infant formula supply chain response completed last year.

The Reagan Udall 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, including CFSAN, OFPR and OVA, working independently of each other, often with separate leadership and little sharing of information. It recommended creating a new Federal Food Administration under HHS that would operate parallel to, rather than under the auspices of, the FDA.

In his statement announcing the proposal for a more unified Human Foods program, Califf highlighted the issues identified by these independent reviews, including problems with the current culture, structure, resources, and authorities in the FDA Human Foods program.

“Today I am announcing a new, transformative vision for the FDA Human Foods Program. I am also announcing a transformative vision for the Office of Regulatory Affairs (ORA, the FDA’s field-based operations) to support the FDA organization as a whole. The proposed structures for both groups will have clear priorities that are focused on protecting and promoting a safe, nutritious U.S. food supply that more quickly adapts to an ever-changing and evolving environment,” said Califf.

The “Vision for a Reimagined Human Foods Program” includes the recommendation to create a Human Foods Program under a single leader who reports directly to the Commissioner. Under this plan, the functions of the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR), as well as certain functions of ORA will be unified into a new organization called the Human Foods Program.

“The FDA will conduct a competitive national search for a Deputy Commissioner for Human Foods, who will oversee the Program. The person in this position will report directly to me and will be charged with leading a unified Human Foods Program that keeps the foods we regulate safe and nutritious, while ensuring the agency remains on the cutting edge of the latest advancements in science, technology, and nutrition,” said Califf. “The Deputy Commissioner will have decision-making authority over policy, strategy, and regulatory program activities within the Human Foods Program, as well as resource allocation and risk-prioritization.”

Other key elements of the proposed new Human Foods Program include:

• Creation of a Center for Excellence in Nutrition that prioritizes the agency’s ongoing efforts to help American consumers make more informed food choices, including by working with industry to offer healthier, more nutritious food products.
• Establishment of an Office of Integrated Food Safety System Partnerships that will focus on elevating, coordinating and integrating the FDA’s food safety and response activities with state and local regulatory partners to more effectively meet the vision of an Integrated Food Safety System in the FDA Food Safety Modernization Act of 2011.

The proposed program would also include the establishment of a Human Foods Advisory Committee made up of external experts who will advise the agency on challenging and emerging issues in food safety, nutrition and innovative food technologies.

“Finally, there will be an emphasis on strengthening our enterprise information technology and analytical capabilities to fulfill the promise described in the New Era of Smarter Food Safety and support the improvement in workflow that will accompany these changes,” said Califf. “This area of focus will support the work of the Human Foods Program by enabling more facile communication, more efficient operations and enhanced empirical risk algorithms to guide the priorities of the program and the work in the field.”

To execute this new plan, the FDA has formed an Implementation and Change Management Group that will be charged with developing a detailed plan for implementation of the newly organized agency. “While details of this proposal continue to be developed, CFSAN, ORA, and OFPR will continue to operate under their current structures, with my direct oversight. I look forward to providing additional public updates by the end of February on our progress, organizational design and timeline,” said Califf.