The U.S. Food and Drug Administration has announced a new, transformative vision for the agency’s Human Foods Program, as well as for the Office of Regulatory Affairs (ORA) to better support FDA as a whole. The plan includes creating a unified Human Foods Program under a single leader who reports directly to the Commissioner of FDA, removing redundancies and enabling the agency to oversee human food in a more effective and efficient way.
The agency’s decision comes after reviewing the findings and recommendations from an external evaluation conducted by the Reagan-Udall Foundation, as well as a separate internal review of the agency’s infant formula supply chain response completed last year. The findings and recommendations from these reviews identified issues surrounding culture, structure, resources, and authorities at FDA. They also noted several areas of need, including modernizing data systems, providing more resources and authorities, improving emergency response systems, and building a more robust regulatory program.