An internal review published by the U.S. Food and Drug Administration (FDA) on Tuesday found that multiple factors hindered the agency’s response this year to the nationwide shortage of baby formula.
Steven Solomon, the head of the FDA’s veterinary division who conducted the internal review, said he found five “major areas of need” and 15 specific findings, and provided recommendations to improve the agency’s infant formula regulation and oversight.
“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,” he stated.
Baby formula had been in short supply in the United States amid supply chain pressures and a shortage of workers, but the ongoing shortage was further exacerbated after an FDA investigation of bacterial contamination in the baby formula in January.
The probe came after four infants who had consumed formula produced at the Sturgis, Michigan, facility were reported to have fallen sick with Cronobacter, a germ that can live in very dry places. Two of them ultimately died.
The investigation resulted in Abbott Nutrition, the biggest U.S. supplier of powder baby formula, recalling some products in February 2022. The products included those under the brand Similac. Abbott also temporarily shut down its manufacturing facility in Sturgis, which was producing up to one-quarter of the United States’ baby formula.
FDA Commissioner Robert Califf had asked Solomon in May to conduct an internal review of the agency’s actions related to the baby milk formula shortage situation.
Solomon found that there is “no single action to explain the events that occurred.” The review found that a “confluence of systemic vulnerabilities” show that more expertise and tools are needed to better handle future public health challenges related to baby formula.
Problems Found
Solomon said inadequate processes and lack of clarity related to whistleblower complaints “may have delayed the FDA’s response to those complaints,” in reference to a whistleblower (pdf) alleging contamination concerns at Abbott’s Sturgis plant in October 2021. The complaint was later released in late April 2022 by Rep. Rosa DeLauro (D-Conn.).Solomon identified other problems, including outdated technology being used to submit product safety and quality complaints; a need for improved coordination of FDA staff; limited infant formula-specific training among FDA investigators; and limitations in funding that hampered FDA efforts to regulate infant formula and inspect formula manufacturing facilities.
Other reasons that hindered the FDA include: scientific gaps in understanding Cronobacter contamination and illness; COVID-19 cases at the plant, which delayed the FDA’s in-person response to complaints raised there; third-party delivery companies delayed in transporting samples taken from Abbott’s Sturgis plant to get tested for Cronobacter; and dated technology and record keeping practices that may have contributed to delays in recalls.
“While domestic infant formula manufacturers have stepped up to meet the call to increase their production capacity and are working diligently, the long-term resiliency of the infant formula supply chain will rely on greater diversification of manufacturers, including new entrants to the U.S. marketplace, investment in new manufacturing facilities by infant formula producers and a commitment by these companies to consistently and continuously adhere to the FDA’s quality and safety standards,” he said.
