While the infant formula recall ended in June 2022, supplies currently still remain below normal levels. Robert M. Califf, MD, FDA commissioner, requested that an internal agency review of the situation be conducted, and assigned the task to Steven M. Solomon DVM, MPH, director of FDA’s Center for Veterinary Medicine and a 32-year veteran of the agency, including 23 years in the agency’s Office of Regulatory Affairs (ORA), which, among other functions, houses FDA’s inspectional programs.
Dr. Solomon was charged with identifying the challenges encountered in addressing the circumstances that led to a nationwide shortage of infant formulas that serve as the sole source of nutrition for many infants and for people with certain metabolic conditions that require specialty formulas. He was also tasked with providing recommendations to prevent similar events in the future.
The evaluation team, led by Dr. Solomon, conducted 43 interviews with a total of 61 employees. The employees included many with a lengthy history with the agency. The findings of this internal evaluation were published on September 20, and identified five major areas of need in the agency:
- 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; and
- Assessment of the infant formula industry, its preventive controls, food safety culture, and preparedness to respond to events.
Some of these findings will come as no surprise to most. FDA has operated shorthanded and in need of additional resources for many years. There were 15 specific findings in the report that shed more light on these concerns, with emphasis on findings 8 and 9 to address some of the resource shortages:
Finding 8: The FDA’s foods workforce maintains expertise across the 80% of the food supply regulated by FDA. However, funding limitations have stalled the growth of the foods program, hindering the agency’s ability to keep pace with the growing workload, increased complexity of supply chains, and scientific and technological changes in food manufacturing. FDA’s shortage of investigators, subject matter experts, and compliance personnel with infant formula expertise hinders the agency’s ability to comprehensively inspect infant formula manufacturing facilities, review and evaluate new products, and respond to product concerns or complaints in a rapid manner.
Recommendation: FDA should evaluate its workforce needs related to infant formula regulation and oversight and utilize the appropriations process to help secure the resources needed
Finding 9: The critical nature of infant formula products as a sole source of nutrition posed unique challenges to public health complicating compliance actions compared to typical food compliance actions. This incident required an unusual level of agency leadership involvement to assess and weigh risks associated with potential product contamination against risks of essential products being unavailable due to a shortage. Typically, product safety is the primary driver during food safety incidents and product availability does not impact compliance actions.
Recommendation: FDA should review its compliance procedures for critical food products and determine whether there is a need to clarify roles and responsibilities, consider the need for a decision matrix, and consider alternative activities to minimize product availability concerns when the product is a sole source of nutrition.