UPDATE from the FDA AND CDC:
FOR IMMEDIATE RELEASE: December 30, 2011, 6 p.m.
The Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and state health departments continue to investigate four recent cases of Cronobacter infection in infants in four states: Florida, Illinois, Missouri, and Oklahoma. There is currently no evidence that indicates the Cronobacter infections in these infants are related.For more information, visit www.fda.gov.
FOR SAFE INFANT FORMULA PREPARATION: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 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
- 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 before and after the container is opened. They must also include information on the storage and disposal of prepared formula.
- Homemade formula. 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 FDA.
Dec. 27, 2011:
According to the Missouri Department of Public Health, tests conducted by the FDA and CDC to determine the source of bacteria that resulted in the death of a Missouri infant are still pending, and until testing is completed it cannot be determined whether the illness is linked to Enfamil Newborn Formula 12.5 oz. cans Lot # ZP1K7G or an outside source. If you use powdered infant formula, please note the Missourt Department of Public Health's link for preparing it safely.
Mead Johnson issued the following statement Christmas day:
Mead Johnson Nutrition has conducted a new round of rigorous testing on samples of a batch of Enfamil PREMIUM® Newborn powdered formula related to a U.S. Food & Drug Administration (FDA) investigation. Drawn from samples parallel to those being tested by public health officials and following the same methodology, the new testing did not detect any presence of Cronobacter (Enterobacter sakazakii).
These new results reaffirm the testing conducted before the batch was made available to retailers and consumers. Based on both sets of tests, Mead Johnson can say with confidence that Enfamil PREMIUM Newborn formula, like every infant formula the company produces, is safe.
The company undertook the highly unusual retesting due to continuing misinformation and confusion in the marketplace. Mead Johnson recognizes that parents and health care professionals trust and rely on the Enfamil brand and takes that responsibility very seriously. The company wanted to reassure consumers - as quickly as possible and based on rigorous scientific data - of the safety and quality of all its products.
These results are consistent with independent media accounts from Reuters, CNN, the Associated Press and others, reporting that none of the formula samples relating to the case have tested positive.The U.S. FDA and the U.S. Centers for Disease Control are seeking to determine the origin of the Cronobacter involved in the Missouri case and are expected to be testing a variety of possible environmental sources. The company has shared the results from its two tests with both authorities.All Mead Johnson infant formulas undergo more than 2,300 quality tests and checks to ensure that they meet or exceed all standards set by regulatory bodies, including the World Health Organization and the U.S. FDA.
As always, Mead Johnson remains committed to its mission to nourish the world's children for the best start in life.
Consumers with questions can contact us at 1-800-BABY-123.