FDA Says Enfamil Not Contaminated: Gives Safety Tips to Prepare Baby Formula

 
on December 31 2011 6:33 AM

The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), in a joint statement, have confirmed there is no need to recall the powdered infant formula manufactured by Mead Johnson Nutrition Co. The agencies tested sealed cans of the Enfamil formula and found no traces of the Cronobacter contamination it was reported to have.

The official response comes after several retailers, including Wal-Mart, pulled a specific batch of Enfamil from their shelves, following reports two babies had died of suspected Cronobacter infection; the babies were from Missouri and Florida. Two further cases were reported - from Illinois and Oklahoma; in both cases the babies recovered from the infection. The testing agencies said there was no evidence the infections in the babies were related.

The CDC conducted DNA finger-printing of the bacteria samples, taken from the infants in Missouri and Illinois. The results showed the two cases of the Cronobacter differing genetically, suggesting they were not related. The agencies, in their statement, said parents may continue to use powdered infant formula, following the manufacturer's directions on the printed label.

The agencies had earlier confirmed the finding of infections in an opened can of baby formula, in prepared formula and in an opened bottle of nursery water used by the infants. The statement, however, was unclear how the contamination occurred. It is probable it happened after the cans were opened.

Cronobacter bacteria are found in open environments and in hospitals and homes. It can also multiple in powdered infant formula after the product is mixed with water. The bacteria causes severe bacterial sepsis or meningitis in infants, which often starts with fever and usually includes poor feeding, crying or listlessness. The illness is diagnosed by a laboratory culture. 

In order to prevent further infections, the FDA and the CDC have recommended the following precautions while preparing infant formula:

  • Wash your 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.
  • Discard any leftovers.
  • Follow the manufacturer's directions on the printed label.

Parents and caregivers should always follow the safety tips below for preparing infant formula, especially for premature infants and infants under 6 weeks:

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 degrees Celsius or 158 degrees Fahrenheit 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 Fahrenheit - if it is being fed to the baby immediately. Prepare only enough formula for one feeding at a time

Cleaning: Wash your hands and all feeding equipment thoroughly with soap and water before preparing the formula.

Bottles and Nipples: Consider sterilizing bottles and nipples before first use.  After that, you can clean them in the dishwasher or wash them by hand with soapy water.

Bottled Water: If you use non-sterile bottled water for formula preparation, you should follow the same directions as described for tap water above. Some companies sell bottled water that is marketed for infants and for use in mixing with infant formula. This bottled water is required to meet general FDA quality requirements for bottled water. If the bottled water is not sterile, the label must also indicate this. Water that is marketed by the manufacturer as sterile and for infants must meet FDA's general requirements for commercial sterility.

Use by Date: This is the date after which a package or container of infant formula should not be fed to infants. It indicates that the manufacturer guarantees the nutrient content and the general acceptability of the quality of the formula up to that date. FDA regulations require this date on each container of infant formula.

Storage: Manufacturers must include instructions on infant formula packaging for storage, both before and after the container is opened. They must also include information on the storage and disposal of prepared formula.

Homemade Formula: The FDA does not regulate or recommend recipes for these. Errors in selecting and combining ingredients for homemade formula can have serious consequences affecting the nutrition and overall well-being of the infant.

Formula Changes: Always look for any changes in formula color, smell or taste. If you buy formula by the case, make sure the lot numbers and use by dates on the containers and boxes match. Also, check containers for damage and call the manufacturer's toll-free number with any concerns or questions. You may also contact the FDA.

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