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FDA and CDC investigations find no contamination in Enfamil infant formula

Robin Wulffson MD's picture
Cronobacter sakazakii, Enfamil, Mead Johnson, deadly bacteria

WASHINGTON, DC - On December 30, both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) reported that their investigations had found no signs of bacterial contamination in Enfamil PREMIUMĀ® Newborn Formula. The investigations were launched when hospital tests found that 10-day-old Avery Cornett died December 18 of a rare infection caused by deadly bacteria known as Cronobacter sakazakii. The bacteria is known to contaminate milk-based baby formulas; the infant had been placed on the newborn formula; thus, the investigation was launched.

The FDA and CDC tested opened containers with formula, both liquid and powdered, and bottled distilled water used to feed Avery Cornett. In addition, they tested closed bottles and cans from the lot collected from the family, the hospital and Wal-Mart, where the family bought its formula.

Mead Johnson also conducted their own investigation and reported on December 25 that the batch, which was the source of the formula consumed by infant Avery contained no contaminants. The manufacturer previously released a statement noting that all of their finished infant powdered products (including the batch implicated in the fatality) are tested for Cronobacter sakazakii (also known as Enterobacter sakazakii) prior to shipment. If an ingredient or a batch of powdered infant formula product is found to contain Cronobacter sakazakii, it is rejected and not distributed.

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The suspected product was 12.5-ounce cans of Mead Johnson's Enfamil Newborn powder with the lot number ZP1L7G. Cronobacter was found in an opened container of the formula, as well as in nursery water used to reconstitute the powdered product. Both the FDA and CDC reported that, although Mead Johnson has been cleared, the source of the contamination remains unclear. Tests of other potential sources are ongoing and the FDA plans to continue to "complete" inspections of baby-formula manufacturers' facilities.

The CDC notes that only four to six Cronobacter infections are reported to their agency each year; however, for 2011, 12 cases have been reported. In addition, a cluster of cases occurred in December, including infant Avery who was born in Missouri. Neither of the other two infants had ingested a Mead Johnson product. Earlier in the month, another Missouri infant was stricken with Cronobacter; however, the infant survived and was discharged from the hospital. In addition, this infant was not on Enfamil. On December 27, it was reported that a third infant in the United States tested positive for Cronobacter sakazakii; however, this infant was born in Illinois and had ingested several infant formulas but not Enfamil; in addition, the baby had taken a number of over-the counter products. After the CDC became aware of the three December reports, it began a search for other Cronobacter infections. Two additional reports surfaced. An Oklahoma infant survived, while a Florida infant died.

Genetic testing of bacteria samples taken from the Illinois and Missouri infants revealed differences in DNA; this finding suggests that the specimens are not related, and raises the possibility that there may be multiple sources of the infections.

To minimize the risk of contamination, the FDA and CDC advise parents using powdered formula to wash their hands with soap and water before preparing the formula, clean all feeding equipment in hot, soapy water, prepare only enough formula for one feeding at a time, and give it to the baby right away.

In a statement, Mead Johnson said that the results of the government testing confirm two rounds of internal company testing. The company said parents could continue to use their infant formula "with confidence."