The FDA is calling for enhanced safety steps in powdered infant formula in the wake of the cronobacter crisis in that industry in 2022. Back then, Abbott Nutrition had to close their plant in Sturgis, Michigan that manufactured that formula after cronobacter contamination was found.
The whole issue started when four infants were sickened and two died in 2021 and 2022. Those infants were fed powdered infant formula made by Abbott Nutrition. Although cronobacter was found in the Abbott facility, the FDA did not find a connection between the illnesses and the facility. In addition, the FDA found insanitary conditions at that facility.
The Abbott facility closed for months after the contamination was found, causing a severe shortage in the infant formula products they made. The FDA increased availability of the formula by issuing guidance documents and approving more manufacturers for sale of this product in the country.
Now, the FDA is developing a cronobacter prevention strategy, is undertaking enhanced inspectional activities, increasing engagement with the industry and pursuing regulatory action when appropriate. The staff have been meeting regularly with manufacturers to develop this strategy to help prevent cronobacter illnesses with the consumption of powdered infant formula.
The strategy states that the FDA is considering whether the agency should develop a “dedicated cadre” of investigators to conduct infant formula inspections, may realign staff to support regulatory oversight of these products, and reviewing and updating the Infant Formula Compliance Program to reflect current science on cronobacter.
They will also evaluate current testing requirements, work with partners to strengthen the ability of officials to identify and investigate cronobacter illnesses, and conduct and support research to fill knowledge gaps in the scientific understanding of this pathogen. This research will improve the public health community’s ability to protect the health of infants who consume powdered infant formula and drive improvements in industry practices.
Finally, the FDA is asking that firms notify the Agency whenever a product sample is positive for cronobacter or Salmonella species, even if the lot the sample comes from has not been distributed.
