The reorganization was approved by the Department of Health and Human Services in March and is planned to begin in October.

The proposal, sent to the HHS in December to start the review process, also was submitted to the Office of Management and Budget and provided to Congress. When HHS and other federal departments approve restructuring by included agencies, they notify Congress of the plans; members’ approval is not required, but they have 30 days to object. (Also see "HHS First Stop For External Review Of US FDA’s Planned Human Foods Program Reorganization" - HBW Insight, 13 December, 2023.)

Califf asked for the review in response to a catastrophic disruption to US infant formula supply caused by the shutdown of one of the largest manufacturing plants due to unsafe levels of bacterial contaminants. (Also see "Supply Chain: A Science Food, Drug And Device Industries And US FDA Should Study – Califf" - HBW Insight, 16 June, 2022.)

The FDA expanded the reorganization along analysis its chief science officer provided and agency employees’ input. It also aligns with instructions for the agency Congress stated in the Food Safety Modernization Act passed in 2011 and the agency’s New Era of Smarter Food Safety strategy document.

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