FDA Reorganization Officially Approved, Will be Implemented by October 1
Credit: Joshua Sukoff, FDA
The U.S. Food and Drug Administration’s (FDA’s) proposed reorganization for a new, unified Human Foods Program (HFP) has been approved by the U.S. Department of Health and Human Services, and full implementation of the reorganization is set for October 1, 2024.
The creation of a unified HFP will allow the agency to more effectively realize the preventive vision laid out in FDA’s Food Safety Modernization Act; elevate the importance of nutrition; strengthen local, state, and international partnerships; and position FDA to regulate innovative food and agricultural products more effectively. In addition, the agency will be better positioned to uphold the safety of the nation’s food supply, and respond to food-related emergencies like the infant formula shortage that occurred in 2022.
The reorganization establishes the HFP by realigning the functions of the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy and Response (OFPR), and key functions from the Office of Regulatory Affairs (ORA) under one program. Additionally, the restructuring of ORA will enable FDA’s field operations unit to focus on inspections, investigations, and imports as its core mission. FDA is changing the name of ORA to the Office of Inspections and Investigations (OII) to better convey the organization’s role as the frontline of FDA, providing real-time insights and science-based evidence required to ensure the safety and quality of the U.S. food supply.
FDA is committed to a modernized agency that optimizes resources to help meet public health goals; provides employees with clearer priorities and greater career opportunities; and complies with the recently enacted Food and Drug Omnibus Reform Act of 2022, which mandates the establishment of the Office of Critical Foods, and the Modernization of Cosmetics Regulation Act of 2022.
“This is a distinctive moment for FDA. I’m very pleased to see that after a year and a half of arduous work and effort put into this transformative vision for the FDA Human Foods Program and the architecture of the agency, we are a step closer to seeing the largest reorganization of the agency in recent history come to life this fall,” said FDA Commissioner Robert M. Califf, M.D. “This reorganization has been a major undertaking for FDA, and I am proud of what we will be able to accomplish more efficiently and collaboratively to better meet our public health mandate.”
"We appreciate Commissioner Califf’s commitment to improving the FDA human foods program," says Steven Mandernach, J.D., Executive Director of the Association of Food and Drug Officials (AFDO). "Deputy Commissioner Jim Jones has been engaging and making excellent steps to move the program forward. The approval of the reorganization allows for a much fuller implementation of the vision of the broad human food stakeholder community. We look forward to collaborating with the Deputy Commissioner and his team to help make human foods even safer in the U.S."
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