FDA warns of possible food-borne pathogen found in powdered infant formulas

April 17, 2002–The Food and Drug Administration (FDA) released a warning to health care professionals about the risk of subjecting newborn infants to Enterobacter sakazakii (E.sakazakii) infections.

E. sakazakii is an emerging food-borne pathogen that can cause sepsis, meningitis, or necrotizing enterocolitis in newborn infants, particularly premature infants or other infants with weakened immune systems, according to the FDA.

This warning follows the investigation of a fatal E. sakazakii meningitis case that occurred in a neonatal intensive care unit in the United States. The investigation was conducted by the Centers for Disease Control and Prevention (CDC).

"According to the CDC, the use of milk-based powdered formula was a likely factor in the infection of this child," notes an FDA spokesperson.

Those at a higher risk are premature infants or other immuno-compromised infants fed powdered infant formulas. The warning does not apply to liquid formula. Additionally, the FDA says it is "not aware of E. sakazakii infections among healthy full term infants in home settings."

Full details of CDC’s investigation will be available in an upcoming edition of the Morbidity and Mortality Weekly Report (MMWR).

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