It appears that the learning curve at the FDA is extremely shallow. In September 2022, the manufacturers of Enfamil infant formula detected the presence of a pathogen, Cronobacter sakazakii, in produced manufactured at the Reckitt, Inc. Zeeland, MI. plant. In accordance with FDA rules, the Agency was informed of the finding and decontamination of the facility was implemented. On February 20th 2023, the company recalled 145,000 cans of the formula over the “possibility of cross-contamination with the pathogen”.
FDA apparently remained inert between November 2022 and February 2023, consistent with their lack of action during the 2021 episode of contamination associated with the Sturgis, MI. plant operated by Abbott Nutrition. This dereliction of responsibility spiraled into a national crisis involving the need to import infant formula to satisfy demand.
According to an article authored by Meredith Lee Hill in Politico, Mitzi Baum, the CEO of STOP Foodborne Illness, stated “FDA continues to be reactive, it’s the internal processes that have not been fixed and this is happening again.” She added, “Lessons are not being learned.”
During the past 12-momnths, there have been four recalls of infant formula as a result of contamination with Cronobacter, suggesting either enhanced surveillance for the pathogen or more regular reporting by manufacturers. It is evident this pathogen together with Salmonella can contaminate the environment and equipment in food-manufacturing plants and requires more intensive and structured decontamination and monitoring to ensure that product especially for infants is wholesome. Proactive surveillance by the FDA is inherent to a national program of food safety. We are currently not protected by the Agency.