FDA, CDC Find No Cronobacter in Infant Formula

By Brianne Moore

An ongoing investigation into four recent cases of Cronobacter infection in infants has found no connection between the infected children and no evidence that infant formula was the source of the infection, according to a CDC release. The investigations began after the infection and death of a baby in Missouri who had been fed Enfamil Newborn infant formula. The child’s death prompted Wal Mart and several other stores to pull the formula from their shelves. Based on the results, the agencies and manufacturers have decided that no recall is necessary and parents may continue to use powdered formula.

Cronobacter cases have recently been reported in Missouri, Illinois, Oklahoma and Florida. Two of the cases—Missouri and Florida—resulted in deaths.

The FDA and CDC worked with state health departments to test various types and brands of infant formula, nursery water and clinical samples from the infected infants, when available. Manufacturing facilities for the formula and water were also inspected.

CDC’s lab tests revealed Cronobacter bacteria in an opened container of infant formula and an opened bottle of nursery water fed to a baby who was infected in Missouri. FDA tested factory-sealed containers of formula and water with the same lot numbers as the opened containers and found no Cronobacter. Cronobacter also was not detected in the facilities that manufactured the infant formula and nursery water. Based on their results, FDA and CDC conclude there is no evidence to conclude the formula or the water were contaminated during manufacturing and shipping.

Tests are still being conducted on formula, water and other environmental samples related to the Cronobacter cases in Illinois and Oklahoma.

Cronobacter is a rare but serious infection in young infants. In a typical year, CDC is informed of 4-6 cases. A total of 12 cases were reported in 2011, possibly due to increased awareness. Cronobacter causes severe bacterial sepsis or meningitis, which often presents with a fever and can include poor feeding, crying or listlessness. Any infants that display these symptoms should be taken to a doctor immediately.