There is no evidence linking four ongoing Cronobacter sakazakii infections in infants across four states, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) announced in a joint news release Friday.

Based on their investigation, the agencies see no need for a recall of infant formula. Parents may continue to feed powdered formula to their infants, the news release said.

In a precautionary move, Walmart recalled Enfamil-brand powdered baby formula from its stores nationwide on December 22, after a 10-day old boy died from Cronobacter infection in Missouri. According to Mead Johnson Nutrition, the formula manufacturer, the recalled batch tested negative for the bacteria before it went to stores.

The CDC said it found Cronobacter bacteria in an opened container of infant formula, an opened bottle of nursery water and prepared infant formula provided by the Missouri Department of Health, but was not certain how the foods became contaminated. In a follow-up, the FDA tested factory-sealed containers of formula and nursery water from the same batches and found no Cronobacter.

The other three infections have occurred in Florida, Illinois and Oklahoma. The infant in Florida died.

The CDC found that the Cronobacter bacteria in the Missouri and Illinois cases differ genetically, which suggests they are not related. The agency said it could not obtain bacteria from the Oklahoma or Florida cases to analyze.

After inspecting the facilities that manufactured the formula and nursery water, the FDA said it found no Cronobacter there, either.

The news release described Cronobacter (also referred to as C. sakazakii, and formerly called Enterobacter sakazakii) as “a very rare cause of a severe infection in young infants,” saying that the CDC is typically informed of 4 to 6 cases each year. The agency knows of 12 cases that occurred in 2011.

“Cronobacter needs to be a reportable illness like E. coli and Salmonella,” said Bill Marler, food safety attorney and publisher of Food Safety News. “We then would have a far better understanding of the cause of these clusters or individual cases.”

In a December 27 Food Politics post about the infant illnesses, New York University food studies professor Marion Nestle pointed out that unlike their liquid counterparts, powdered formulas are not sterile. Nestle wrote that in 2002, “the FDA warned pediatricians that powdered milk formulas could be contaminated with Enterobacter sakazakii, a type of bacteria that causes rare but terrible and sometimes fatal infections in infants.”

Nestle went on to point out that in 2001, the CDC determined that 50 to 80 percent of E. sakazakii cases came from powdered formula.

The CDC said that Cronobacter may multiply in formula after the powder is mixed with water, and the agency recommends mixing fresh formula for each feeding session. The agency also recommends breastfeeding whenever possible.

The news release concluded with a number of recommendations for preparing powdered infant formula:

– Wash hands with soap and water before preparation

– Clean all feeding equipment with hot, soapy water

– Prepare only enough formula for one feeding at a time and give it to the baby right away

– Follow the manufacturer’s directions on the printed label

  • doc raymond

    Let’s do the math. 4 cases of C sakazakii per year, Nestle says 50% are from formula, so that is 2 cases per year. There are 4 million births in the US per year. Let’s just guess that at the very least 3 million of these infants consume formula 6 times per day for 6 months (conservative). That would be over 3 billion servings per year and 2 infections because powdered formula, made from pasteurized milk, “are not sterile”. Pretty damned close to sterile, Marion.

  • Conventional pasteurized, refrigerated liquid milk is also not sterile; the heat treatment controls organisms of public health significance. Likewise the heat treatments in spray drying would also control organisms of public health significance including cronobacter. Potential contamination could occur after this due to addition of other dry ingredients or incidental contamination. Possibly the organism is better able to survive and compete in the lower water activity powder. As FDA points out mothers should understand that if they boil the water and use water above 160F to reconstitute the powder, they will kill the organism.

  • Anthony Boutard

    I am not sure what the point of the math is. Sterile is typically a defined result, not a matter of probability. With living organisms, especially for pathogens in baby formula which provides a rich environment for growth, nearly sterile is meaningless. Nestle is right, we need data to understand this pathogen, and mandatory reporting seems a logical first step, along with some precautionary advice.
    Moreover, the statistic that stands out in this episode is one death in three infections. That is a high mortality rate by any measure. As we have seen with other food borne pathogens that have emerged recently, there may be a very short grace period before Cronobacter insinuates itself in our food chain.
    Anthony Boutard
    Ayers Creek Farm

  • doc raymond

    I have never seen any advice from FDA to boil water and add the dry formula while still hot to sterilize the powder. To the contrary, I have seen advice that adding powdered formula to boiling hot water will denature much of the necessary protein in the milk. This pathogen has such a high mortality rate because it is diagnosed mainly in neonates, who have very limited immune systems and almost zero tolerance for dehydration. Mothers are advised not to feed cow’s milk to children until at least one year of age, so you cannot compare cow’s milk and powdered formula. The point of the math is simple. Two infections per year (maybe) out of over 3 billion servings. If the powdered formula was contaminated in the plant, there would be hundreds of illnesses in these very vulnerable young children. I am just becoming very weary of people seeking headlines by declaring our food is killing us.

  • From the FDA website,
    “Formula preparation. In most cases, it’s safe to mix formula using ordinary cold tap water that’s brought to a boil and then boiled for one minute and cooled. According to the World Health Organization, studies suggest that mixing powdered formula with water at a temperature of at least 70 degree C—158 degrees F—creates a high probability that the formula will not contain Cronobacter sakazakii. Remember that formula made with hot water needs to be cooled quickly to body temperature—about 98 degrees F—if it is being fed to the baby immediately. Prepare only enough formula for one feeding at a time”