The US FDA is preparing a plan to improve the monitoring of Cronobacter bacteria in Infant formula. In a statement released on Tuesday, the organization said that they would like to have cronobacter infections added to the Centers for Disease Control and prevention’s list of nationally notifiable diseases.
Minnesota was the first state to notify federal regulators of a potential issue with powdered infant formula. This state mandates physicians to notify the state health department of cronobacter infections. In 2021, The FDA received 4 reports of this infection in newborns including 2 fatalities. And all of them have taken formula made of powder at an Abbott Nutrition production facility in Sturgis, Michigan. Although Cronobacter infections are uncommon, they can be dangerous and fatal, especially in neonates.
The FDA examination and recall of products manufactured exacerbated the shortage of infant formula nationwide. Census data reveals that families are having difficulty finding infant formula. FDA detected cronobacter bacteria in the plant, yet DNA testing was unable to establish a connection between them.
Abbott said in a written statement to CNN that Since our voluntary recall in Feb, investigations by the FDA, the Centers for Disease Control and Prevention (CDC), and Abbott, including genetic sequencing, retained product samples, and available product from the four complaints, did not find any conclusive link between the company’s products and illnesses in children. No recalled product samples that were kept under test were Cronobacter positive. Cronobacter sakazakii tests on unopened formula containers in the newborn homes came up negative in all four cases.
Although the FDA’s statement provides significant support to the effort to add Cronobacter to the list of notifiable diseases, the Council of State and Territorial Epidemiologists, a nonprofit organization, will eventually decide whether to do so.
If FDA calls for it and endorses it, I think that gives a lot of support to carry the matter ahead with the State and Territorial Epidemiologists, said Mitzi Baum, CEO of Stop Foodborne Illness. It is a nonprofit organization that fights for the rights of people who get food poisoning. The FDA’s framework, according to Baum, has a number of intriguing ideas, but because there is no deadline specified, Baum feels that it is only a partial solution. Since this problem mostly affects the most vulnerable population, there isn’t a sense of urgency about it.
Over the coming months, the agency said it will meet with stakeholders and continue to polish its ideas. Similar action plans have been prepared by the FDA for other foods that have a history of particular forms of contamination. The organization unveiled plans in September to stop listeria and salmonella infections linked to wood ear mushrooms and infections brought on by tainted bulb onions.
The FDA contemplating additional actions, such as: