FDA’s internal review of infant formula shortage management exposes outdated system

27 Sep 2022 --- The US Food and Drug Administration (FDA) has released an internal report on its actions to address the nationwide infant formula shortage. Presenting interviews with 60 FDA employees, the report concludes that the agency’s operating system needs improvement in several areas, as well as increased authority. 

“The report identifies several areas where the FDA lacks specific authorities and resources. 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,” says Steven Solomon, director at the Center for Veterinary Medicine.

“The FDA does not have the authority to influence the market,” a spokesperson from the FDA told NutritionInsight.

Areas for improvement
The report highlighted five significant areas that need improvement. Based on responses from FDA staff members that were “directly involved,” the report stresses the need for modern information technology, allowing access and data exchange in real-time to all people involved.

The FDA needs more authority to be able to do more, Solomon stresses.The other focus areas include sufficient staffing, training, equipment and regulatory authorities to fulfill the FDA’s mission and an updated emergency response system capable of handling multiple public health emergencies co-occurring.

It stresses the need for increased scientific understanding about Cronobacter, “its prevalence and natural habitat, and how this translates into appropriate control measures and oversight and an assessment of the infant formula industry, its preventive controls, food safety culture and preparedness to respond to events,” Solomon says.

“I believe in continuous quality improvement and that we as public health officials must constantly evaluate, adapt and measure how we respond to such incidents. 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,” he adds.

What caused the formula shortage?
The shortage was partly caused by several reports of infants falling ill from consuming formula from Abbott Nutrition’s Sturgis plant in Michigan, US. The market monopolist voluntarily recalled its products.

The FDA received reports from parents and caregivers that their infants became sick from Cronobacter sakazakii and Salmonella. Four infants were hospitalized, and two cases were fatal. The investigation concluded that the bacteria was found in the plant, causing it to shut down amid a national shortage. 

A few months later, the plant was affected by extreme weather, causing flooding, forcing it to shut down one of the monopolist infant formula manufacturers once again to ensure no bacteria were found. Further reasons for the shortage are the Ukraine war, the supply chain crisis and the COVID-19 pandemic.

Systemic vulnerabilityThere is a high need for investment in expertise and tools to anticipate and approach future issues of this nature.
Solomon explains that a critical finding of the interviews is a systemic vulnerability rather than a specific event that led to the outcome. There is a high need for investment in expertise and tools to anticipate and approach future issues of this nature.

He expresses areas of improvement to be “scientific, clinical, nutritional, analytical, and inspectional expertise; legal processes; supply chain and policy considerations; and resources to support this multidisciplinary work.”

The FDA lacks authority in several areas. Although the agency is expected and needs to do more, it is unable to, the report notes.

One example is its regulation of the market for dietary supplements, often criticized by the industry for “not doing enough.” 

A spokesperson from the FDA previously told NutritionInsight that “the agency is committed to doing everything within its authorities and resources to regulate dietary supplements and to identify and remove unsafe and illegal products from the market.” 

By Beatrice Wihlander