The Program redesign follows an external evaluation by the Reagan-Udall Foundation and an internal assessment of FDA's oversight of several key areas of food regulation. Both reviews identified deficiencies in FDA's culture, structure, resources, and authorities. In particular, the external evaluation indicated that the current structure suffers role duplication and allows for "siloed work." The internal review determined the Program needs better data systems, more resources and training, and updated emergency response systems.
To address these deficiencies, FDA's redesign vision includes combining the Center for Food Safety and Applied Nutrition ("CFSAN"), Office of Food Policy and Response, and certain functions of the Office of Regulatory Affairs ("ORA") to form a unified Human Foods Program with a single leader—the deputy commissioner for human foods—who will report directly to FDA's commissioner. The deputy commissioner will have decision-making authority over the Program's policy, strategy, regulatory program activities, resources, and risk priorities. FDA will also expand the Program's executive team to support the deputy commissioner.
Within the unified Program, FDA will establish a Center for Excellence in Nutrition and an Office of Integrated Food Safety System Partnerships and will create a Human Foods Advisory Committee composed of external experts to advise the agency on issues in food safety, nutrition, and food technologies. Notably, FDA's announcement was silent on how the Program's creation may impact the agency's regulation of dietary supplements or cosmetics, both of which are handled out of CFSAN. FDA indicated cosmetics "need to find the right home," an impactful statement considering the impending changes represented by the Modernization of Cosmetics Regulation Act.
Other aspects of FDA's redesign include integrating ORA to support all FDA regulatory programs and focusing ORA on its core mission of inspections, laboratory testing, import, and investigative operations; and coordinating a close collaboration between the Center for Veterinary Medicine and the Deputy Commissioner of the Human Foods Program.
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