The strategy follows a major incident in early 2022 when the FDA and the Centers for Disease Control and Prevention (CDC) launched an investigation into Abbott’s powdered infant formula after several infants fell ill due to Cronobacter sakazakii contamination. Two infants died, with all affected having consumed Abbott’s Similac PM 60/40 formula. The pathogen, Cronobacter sakazakii, can lead to severe sepsis and infections, as well as bowel damage.
The FDA faced scrutiny during a May 2022 hearing, where lawmakers expressed concerns about the agency’s delayed response to the contamination at Abbott’s Sturgis, Michigan, plant, despite a whistleblower report in October 2021. The incident contributed to the national shortage of infant formula.
To improve supply chain resilience, the FDA outlined its efforts to work closely with manufacturers and leverage data sources to enhance visibility into the infant formula market. This includes identifying vulnerabilities in the supply chain and promoting a diverse production base to reduce risks of future shortages.
