FDA Set to Reorganize Food Regulatory Offices Into 'Human Food Program'
FDA plans to create a new, integrated food safety and nutrition “program” that will combine aspects of its existing organization structure to allow FDA to “oversee human food in a more effective and efficient way,” FDA Commissioner Robert Califf said in a Jan. 31 statement. The “Human Foods Program” will be led by a new deputy commissioner that reports directly to the FDA commissioner, and will be charged with keeping “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,” Califf said.
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Under the proposed reorganization, the unified Human Foods Program will be created by combining the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response and some functions of the Office of Regulatory Affairs under one leader, FDA said in a fact sheet. A Center for Excellence in Nutrition will be created.
The realignment also will see a shift in the portfolio of FDA’s Office of Regulatory Affairs, though details were scant. “ORA’s operating structure will be transformed into an enterprise-wide organization that supports the Human Foods Program and all other FDA regulatory programs (e.g., agency centers) by focusing on its critical activities,” Califf said. “This realignment will allow ORA to be singularly focused on excellence in its core mission -- inspections, laboratory testing, import, and investigative operations,” he said.
“Certain other functions of ORA will be aligned in other parts of the FDA to create an overall stronger agency,” Califf said. For example, state and local food safety partnership functions will be shifted to the new Human Foods Program, the FDA fact sheet said.
The proposal follows an external study commissioned by FDA on the “culture, structure and leadership, resources, and authorities” of the agency’s human food regulation, as well as an internal study on FDA’s response to the recent infant formula crisis.
“As a next step, the FDA will need to develop the vision announced today into a concrete reorganizational proposal in close coordination and communication with internal and external stakeholders while ensuring we meet our labor obligations,” Califf said. “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.”