On May 30, FDA announced that it has received approval for its planned reorganization to establish the Unified Human Foods Program. FDA has targeted Oct. 1, 2024 for the reorganization implementation, which will impact 8,000 FDA employees. The impact of the FDA’s reorganization on FDA-regulated consumer products like foods, dietary supplements and cosmetics is likely to be significant in the coming months and years. Here is a refresher on the planned changes and what to expect next.
What is FDA planning?
Over the coming months, FDA expects to complete a transformative realignment of its disparate food centers and offices into a Unified Human Foods Program (“HFP”). FDA is betting that this reorganization will enable more effective, centralized management of the Agency’s food oversight plus swifter response to emergencies.
FDA is dismantling two major scientific and regulatory centers and merging them into a single organization under a single leader – Deputy Commissioner Jim Jones – who reports directly to FDA Commissioner Robert M. Califf. This new organization will also absorb certain food-related activities of the Office of Regulatory Affairs, which itself will be transformed into a new field organization focused solely on inspections, investigations, and imports.
Why is FDA taking these steps?
FDA’s current Center for Food Safety and Applied Nutrition has developed an unfortunate reputation among both industry and consumers as being slow, non-responsive, and somewhat ineffective. FDA developed the proposed organizational changes after a year of gathering feedback, criticism, and advice about its slow and fragmented response to the infant formula outbreak in February 2022. This emergency saw a large-scale, voluntary recall of contaminated infant formula and severe shortages.
