On May 30, the U.S. Food and Drug Administration (FDA) announced that the Secretary of Health and Human Services had approved its reorganization plan to create a unified Human Foods Program (HFP) and introduce other modernization efforts. This latest development has been hailed as “a significant milestone” by the FDA. It caps a months-long process that began after the agency’s highly criticized response to the 2022 infant formula crisis was attributed to issues arising from its existing structure.
Context
Following the infant formula shortage, the FDA launched a multifaceted review of its structure to determine the necessary steps to create an efficient, agile agency. This included commissioning the Reagan-Udall Foundation to conduct an independent evaluation and provide recommendations to strengthen the FDA’s food regulatory role, conducting an internal review of the FDA’s infant formula response, and gathering feedback from internal and external stakeholders.
As a result, the FDA developed a reorganization proposal that aligned the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Policy and Response (OPR), and key functions of the Office of Regulatory Affairs (ORA) under one unified Human Foods Program. The proposed reorganization package was completed in December 2023 and received congressional approval in May 2024.
Key details
The FDA outlined several goals it hopes to achieve with a modernized HFP, which include fully realizing the preventative vision laid out in the FDA Food Safety Modernization Act (FSMA), elevating the importance of nutrition, positioning the FDA to regulate innovative food and agricultural products more effectively, upholding the safety of the nation’s food supply, and strengthening local, state, and international partnerships. The unified HFP will incorporate all functions of CFSAN and OPR, as well as the Human and Animal Laboratories, state partnership, and human foods compliance functions of the ORA.
The ORA’s compliance and laboratory safety functions will be realigned to other offices within the HFP, and the ORA will be retitled as the Office of Inspections and Investigations (OII). The OII will be led by an Associate Commissioner for Inspections and Investigations and new offices will be established within the agency to focus on inspections, investigations, and imports. Creating a dedicated office for inspections suggests that food inspections are likely to become more frequent and that the FDA will address recalls and other food safety issues more quickly.
Next steps
The FDA is targeting October 1, 2024, for implementation of the HFP reorganization, although there is much work to be done before then. It is expected that the reorganization will impact almost 8,000 FDA employees, and the breadth of the changes may mean it will be months before the HFP is functioning fully. However, the food and beverage industry should begin preparing immediately for a more efficient and unified FDA that responds quickly to product emergencies and more closely scrutinizes food safety. Now is also the time to review the final plan and determine if any reporting structures for FDA issues will have changed for companies and if recall and crisis plans need to be updated.
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