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Infant deaths lead to FDA reorganization
A slew of illnesses has forced FDA to reexamine the way it oversees critical food systems such as baby formula production.
2 Min Read
.jpg?width=1280&auto=webp&quality=95&format=jpg&disable=upscale "Powdered baby formula in a can.")
At a Glance
- In late 2021 and early 2022, at least four infants became ill due to contaminated powdered baby formula.
- FDA has been formulating a plan for reorganization that involves internal restructuring and creating several new teams.
- How this reorganization will affect food supply chains and improve crisis prevention efforts remains to be seen.
Dec. 15 update: Marianna Naum, acting director of communications and public engagement staff at FDA, states that Commissioner Robert Califf has a new vision for "the way FDA oversees the U.S. human food supply that elevates key focus areas, streamlines processes, and consolidates activities under an empowered single leader." The agency claims to have made meaningful progress related to its infant formula response, but their examples only highlighted efforts already mentioned in this article. Follow their progress on FDA's website.
On Dec. 13, FDA published an update about its planned Human Foods Program (HFP) and new Office of Regulatory Affairs (ORA) model. Announced in January 2023, this proposal seeks to address findings and recommendations from internal and external stakeholders related to a recent infant formula response.
FDA began to receive reports of illnesses and eventually two deaths linked to Abbott Nutrition’s powdered infant formula in September 2021, and the resulting recall and shortage in February 2022 “created hardships for parents and caregivers who rely on infant and specialty formulas to feed their babies,” according to the review.
Now, the proposed reorganization has entered the formal review process at the Department of Health and Human Services (HHS). If all goes well, FDA believes agencywide implementation could occur in 2024, but several steps remain, including another review by the Office of Management and Budget and negotiations with unions representing affected staff.
The proposal will result in the following changes to FDA’s procedures and structure:
HFP and product centers will become solely responsible for consumer and whistleblower complaints, speeding up problem detection and complaint processing.
ORA, to be renamed the Office of Inspections and Investigations (OII), will increase its role in field-based inspections, investigations and imports.
A new Office of the Chief Medical Officer (OCMO) will strengthen coordination of cross-agency medical issues, including concerns related to special populations such as children.
A new Office of Public Health Preparedness and Response will coordinate within FDA to resolve medical product shortages, prepare for emergencies and deploy countermeasures.
The Office of Counterterrorism and Emerging Threats (OCET) will merge with the Office of Regulatory Science and Innovation (ORSI) to support regulatory science and preparedness research.
A new Office of Enterprise Transformation will manage process improvement efforts across FDA to ensure more strategic and efficient use of resources.
In addition, FDA has begun reevaluating its infant formula staffing needs and providing input on the Food and Drug Omnibus Reform Act of 2022, which authorized creation of the Office of Critical Foods (OCF) to oversee infant formula, among other products. The agency has also established a critical foods investigator cadre focused on the inspection and oversight of critical foods industries.
We're awaiting a response from FDA, so it remains to be seen how this reorganization will affect food supply chains and whether these efforts will improve crisis prevention in addition to response efforts.
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