FDA: A ‘Confluence of Systemic Vulnerabilities’ during Infant Formula Shortage

September 22, 2022

The nation’s response to the infant formula shortage faced several challenges, as officials struggled to collect real-time data, address staffing shortages, and strengthen the national supply chain.

A new federal report released this week evaluated the “confluence of systemic vulnerabilities” surrounding the nation’s response to the infant formula shortage. The report “illustrates the importance for the agency to continuously reassess conditions and make necessary adjustments to keep pace with the constantly evolving public health challenges the agency tackles.”

“We recognize the impact the formula shortages have had on parents, caregivers, and the children and individuals who rely on these products,” FDA Commissioner Robert M. Califf, MD, MACC, said in a statement.

During February, the FDA warned consumers about a recall of certain powdered infant formula products from Abbott Nutrition’s Sturgis, Michigan facility. Prior to the recall, these products were increasingly hard to find on store shelves due to supply chain issues from COVID-19.

The report focused on five key areas:

• Modern information technology:  The FDA had multiple platforms for safety and quality complaints, adverse event reports, and product manufacturing concerns. A single system “to receive, track, and process information” could be beneficial.
• Staffing strategies:  The shortage required a “complex coordination of staff.” The agency needs to reassess its roles and standard procedures to bring clarity and speed to its response, the report said.
• Remote challenges:  The pandemic created new challenges to obtain remote access to records or other information for many food related products.
• Testing capacity:  The FDA dealt with hurdles testing samples taken from the Michigan facility. The agency should evaluate procedures for shipping and testing samples sent to regulatory laboratories and identify areas to expand capacity, the report said.
• Supply chain woes:  The report recommended the FDA “conduct an analysis of its capabilities related to supply chain management for critical food products.”

“While infant formulas, and particularly specialty and metabolic formulas, are regulated by the FDA as food, they are in many ways comparable to life-saving medications,” the report noted. “Therefore, the FDA’s foods program had to balance considerations of product safety and product availability in a way it has never had to before.”

HAP continues to monitor the latest public health developments and will provide updates to members. The full report is available to review online.