FDA Says Enfamil Baby Formula Not to Blame for Infant Deaths

The Food and Drug Administration (FDA) announced over the weekend Enfamil baby formula was not the cause of four infants contracting Cronobacter bacteria poisoning in recent weeks. Two of those infants died as a result of their infection.

According to a Chicago Tribune report, regulators from the FDA and Centers for Disease Control and Prevention said “there is no need for a recall of infant formula” based on their round of tests and investigation into a possibly contaminated batch of Enfamil. The FDA commenced an investigation shortly after reports surfaced that each of the babies who contracted the bacterial infection had been fed Enfamil shortly before getting sick.

Last week, Mead Johnson (makers of Enfamil) confirmed that FDA investigators had visited the company’s production facility in Michigan where it manufactures the leading baby formula product. Inspectors took samples of the product in question and also scoured safety and testing records conducted by the company. The results of those and the agency’s testing found no traces of Cronobacter in the suspected supply of Enfamil.

After 10-day-old Avery Cornett, of Missouri, died of Cronobacter poisoning just a few days after being fed Enfamil, the news reports caused Walmart Inc. to pull select batches of the baby formula from its shelves and prompted a nationwide panic. Walmart said the move was a precaution but the knee-jerk move caused several other leading national retailers to pull the questionable batch of Enfamil from its shelves, too.

Following those announcements, Mead Johnson maintained its stance that its product was not responsible for the bacterial infections and produced two separate results of tests showing its product was safe and free of Cronobacter bacteria.

The Tribune report indicates the FDA investigation did not focus solely on Mead Johnson’s production facility as regulators continued to find a source of the bacteria. The agency visited the homes of the families affected by the infections. There, they found traces of the bacteria in “an open can of infant formula, an open bottle of nursery water and prepared infant formula.”

Despite finding evidence of contamination in the homes and in open containers of the formula, the FDA still is unsure of the source of the contamination but indicated it likely occurred after Enfamil was purchased and opened at home. It also said there is no connection between any of the four infections.

Two of the infants reportedly were fed Enfamil formula but two others may not have been fed the same brand of formula. Infants who died as a result of their Cronobacter infections were from Missouri and Florida. The two who have since recovered from their infections are from Illinois and Oklahoma.

Cronobacter poisoning among infants is rare despite it being a common bacteria.

The Enfamil formula had been suspected because when it is mixed with water, Cronobacter bacteria can multiply. In infants, Cronobacter poisoning can lead to blood infections and meningitis. Obviously, as is the case with these poisonings, some cases can be fatal. The CDC said in its statement with the FDA that about a half-dozen cases of Cronobacter poisoning are reported annually. In 2011, the CDC confirmed 12 cases of Cronobacter infections.

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