In May 2022, FDA Commissioner Robert M. Califf, M.D., asked that I conduct an internal agency review of the agency’s actions related to multiple reports of Cronobacter illness in infants, the Abbott’s infant formula manufacturing plant in Sturgis, Michigan, and confounding issues that led to a shortage of infant formulas.
Today we released our report, which is the result of information collected from more than 40 interviews with more than 60 FDA staff and leadership directly involved with the events that transpired. The report focuses on aspects of the response that are within the agency’s purview: other factors, including the limited number of infant formula manufacturers, needed improvements in the ingredient supply chain, and better control of product distribution, must be addressed by other external stakeholders.
I believe strongly in continuous quality improvement and that we as public health officials must constantly evaluate, adapt and measure how we respond to incidents such as this. Although the limitations uncovered in our evaluation were magnified by the nature of infant formula as the sole source of nutrition for vulnerable populations, the lessons learned can be applied across the entire FDA portfolio.
The information that came out of these interviews allowed us to identify five major areas of need, with several specific findings as detailed in the report:
- Modern information technology that allows for the access and exchange of data in real time to all the people involved in response.
- Sufficient staffing, training, equipment and regulatory authorities to fulfill the FDA’s mission.
- Updated emergency response systems that are capable of handling multiple public health emergencies occurring simultaneously.
- Increased scientific understanding about Cronobacter, its prevalence and natural habitat, and how this translates into appropriate control measures and oversight.
- Assessment of the infant formula industry, its preventive controls, food safety culture and preparedness to respond to events.
One key finding from our interviews is that there is no single action to explain the events that occurred; rather the report identifies a confluence of systemic vulnerabilities that demonstrate the need to focus on continued modernization and investment in the expertise and tools needed to better anticipate and address future public health challenges in this area.
This incident demonstrated the need for an integrated, multidisciplinary approach that included scientific, clinical, nutritional, analytical, and inspectional expertise; legal processes; supply chain and policy considerations; and resources to support this multidisciplinary work.
The report also identifies several areas in which the FDA lacks specific authorities and resources. Simply put, if the FDA is expected to do more, it needs more. As the agency evaluates its workforce needs related to infant formula regulation and oversight, we recommend that it utilize the appropriations process to help secure the authorities and resources needed.
As the agency works to address the recommendations stated in the report, I would like to thank the FDA employees who participated in the review process. Their willingness to engage in an after-action assessment and speak candidly about opportunities for improvements in the system speaks to their level of professionalism and commitment, both to the agency’s mission and to continued improvement in ensuring the safety of our food supply.
As public health servants, our commitment to protecting the nation’s food supply should be never-ending. It requires continued testing and reassessment to fine-tune our approaches to meet new public health threats, evolving scientific developments and a changing marketplace.
As we implement these changes, we must ensure that they address the issues that led to the shortage of safe, wholesome food supply for our most vulnerable populations. This is one of our most important obligations.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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