The U.S. Food and Drug Administration’s (FDA’s) proposed reorganization package for a unified Human Foods Program (HFP) and new Office of Regulatory Affairs (ORA) model is now under review at the U.S. Department of Health and Human Services (HHS), which begins the formal external review process. Following several remaining critical steps, the agency is hopeful that implementation of the new structure will occur sometime in calendar year 2024.
In addition to previous announcements, FDA’s proposed reorganization package includes the following new updates that not only shift how the agency’s foods and field work is conducted, but also impact a number of additional FDA offices outside of these programs. The proposed changes highlight the agency-wide nature of the proposed reorganization package, including: