U.S. – The Food and Drug Administration (FDA) has developed a prevention plan to stop the diseases caused by Cronobacter sakazakii linked to the intake of powdered infant formula.
The FDA received reports between September 2021 and February 2022 regarding four instances of infants who consumed powdered infant formula becoming ill or dying.
They started an onsite inspection at the facility and launched an investigation after learning that each of these infants had consumed powdered infant formula made by Abbott Nutrition in Sturgis, Michigan.
The inspection revealed unsanitary conditions, including the presence of five different strains of Cronobacter sakazakii inside the facility, prompting the company to issue a voluntary recall.
According to the Centers for Disease Control and Prevention (CDC), Cronobacter sakazakii is a germ that is found naturally in the environment, but it can live in dry foods such as powdered infant formula, powdered milk, and herbal teas.
The CDC has stated that although Cronobacter sakazakii diseases are uncommon when they do occur, they can be fatal to infants.
In addition to meningitis, a disorder that causes the linings surrounding the brain and spinal cord to swell, the germs can also cause sepsis, a potentially fatal blood infection.
Infant infections typically start in the first few days or weeks of life.
The CDC has said that only two to four instances are reported annually, although the actual number of illnesses may be higher given that most hospitals and laboratories are not obligated to notify health departments of Cronobacter sakazakii infections.
Even though the FDA claims that by closely collaborating with manufacturers to maximize output and replenish shop shelves, the supply of infant formula products has been continuously expanding, the unique plan will describe the Federation’s road to improving the safety of these goods.
The agency intends to review and update current guidelines and rules applicable to the production of powdered infant formula, as appropriate.
They also plan to conduct and support research to help fill knowledge gaps in the scientific understanding of Cronobacter.
Such research, according to the FDA, will improve the public health community’s ability to help protect the health of powdered infant formula consumers and will drive improvements in industry practices that can enhance the safety of these products.
The FDA has stated that the framework made public on November 15 is meant to serve as a discussion point as the FDA’s plan to prevent Cronobacter sakazakii infections linked to the intake of powdered infant formula is further developed.
Teams from across the FDA will meet with stakeholders in the coming weeks to further develop and finalize the prevention approach.
These meetings will be used to provide information for an updated summary of the powdered baby formula strategy, which will outline the initiatives the Federation is working on to ensure the safety of newborn formula.