“There is currently no evidence that indicates the Cronobacter infections in these infants are related.”
– Joint Statement by FDA and CDC, December 30. 2011
Although an investigation into four cases of Cronobacter sakazakii infections – one each in Missouri, Illinois, Oklahoma and Florida – is ongoing, FDA reported yesterday that the Cronobacter sakazakii strain that killed a Missouri newborn and the strain that infected an Illinois baby are genetically different from each other. Bacterial cultures from the Florida and Oklahoma babies were not available for testing.
FDA labs also have NOT found Cronobacter sakazakii in any unopened containers of Mead Johnson Nutrition’s Enfamil powdered infant formula or nursery water (used to reconstitute the formula), confirming the company’s own lab findings. Following is a portion of the FDA/CDC Joint Statement:
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.
Based on test results to date, there is no need for a recall of infant formula and parents may continue to use powdered infant formula, following the manufacturer’s directions on the printed label.
The ongoing investigation includes laboratory testing of various types and brands of powdered infant formula, nursery water and, when available, clinical samples from the infants. The investigation also includes the inspection of manufacturing facilities for infant formula and nursery water.
The following results have been confirmed from completed laboratory tests, although additional lab results are pending release:
- CDC’s laboratory conducted DNA fingerprinting of the bacteria from two recent cases of Cronobacter infection in infants (Missouri and Illinois). The results show that the Cronobacter bacteria differ genetically, suggesting that they are not related. (Bacteria from cases in Oklahoma and Florida are not available for analysis.)
- CDC laboratory tests of samples provided by the Missouri Department of Health and Senior Services found Cronobacter bacteria in an opened container of infant formula, an opened bottle of nursery water and prepared infant formula. It is unclear how the contamination occurred.
- The FDA tested factory sealed containers of powdered infant formula and nursery water with the same lot numbers as the opened containers collected from Missouri and no Cronobacter bacteria were found.
The FDA has inspected the facilities that manufactured the infant formula and the nursery water that tested positive for Cronobacter bacteria. Those manufacturers have programs that test their products before they are distributed. The lots in question were tested and found negative for Cronobacter. There is currently no evidence to conclude that the infant formula or nursery water was contaminated during manufacturing or shipping.
The FDA, CDC and state agencies continue to investigate the cause of the infections using epidemiological and laboratory methods. Currently CDC and FDA laboratories are testing infant formula, water and other environmental samples related to the ill infants from Illinois and Oklahoma; the results are pending. Additional steps include: completion of inspections of manufacturers, additional laboratory testing of samples, and additional DNA fingerprinting investigation.
Last week, following single reports of Cronobacter illness in infants in Missouri and Illinois, CDC asked public health officials around the country to look for other cases of Cronobacter infection among infants. This generated reports to CDC of two additional cases, one in Oklahoma and the fourth recent case in Florida. The illnesses in these infants occurred in late November and early December. The infants in Missouri and Florida, tragically, died as a result of their infection, while the infants in Illinois and Oklahoma have survived.
Cronobacter is a very rare cause of a severe infection in young infants, and usually occurs in the first days or weeks of life. Typically CDC is informed of about 4-6 cases of Cronobacter a year. With recent increased awareness, CDC has been informed of a total of 12 cases in 2011.
Cronobacter causes severe bacterial sepsis or meningitis in infants, which often starts with fever, and usually includes poor feeding, crying or listlessness. Cronobacter illness is diagnosed by a laboratory culture.
Any young infant with these symptoms should be in the care of a physician. There is no need to test a child that is not sick. If a Cronobacter infection is diagnosed by a laboratory culture, CDC encourages clinicians and laboratories to inform their local or state health departments.
Cronobacter bacteria is found in the environment and in hospitals and homes. It can also multiply in powdered infant formula after the powder is mixed with water.
Mead Johnson responded to the news with the following statement:
Mead Johnson Nutrition (NYSE: MJN) was notified today by the United States Food & Drug Administration (FDA) and the Centers for Disease Control (CDC) that health inspectors have completed their testing on all formula samples collected from the company. These tests confirmed that the Mead Johnson products were safe, and no presence of Cronobacter was detected. This is consistent with two rounds of testing conducted by Mead Johnson.
“We’re pleased with the FDA and CDC testing, which should reassure consumers, healthcare professionals and retailers everywhere about the safety and quality of our products. These tests also reinforce the rigor of our quality processes throughout our operations”
Mead Johnson has been informed that all samples collected from the company – and related to health investigations in Missouri and Illinois – have been found safe. Mead Johnson emphasizes these are the only incidents that led to tests on its products.
All Mead Johnson infant formulas, including Enfamil PREMIUM® Newborn, undergo approximately 2,300 quality checks and safety tests to ensure that they meet or exceed our own rigorous standards, and those set by the World Health Organization, the FDA and other regulatory bodies before they are made available to consumers.
“We’re pleased with the FDA and CDC testing, which should reassure consumers, healthcare professionals and retailers everywhere about the safety and quality of our products. These tests also reinforce the rigor of our quality processes throughout our operations,” said Tim Brown, senior vice president and general manager for North America. “We remain committed to our mission to nourish the world’s children for the best start in life.”
As a result of the FDA and CDC tests – as well as our own – Mead Johnson said parents can continue using Enfamil and other Mead Johnson products with confidence.
FDA investigations are continuing into the possible sources of the Cronobacter sakazakii strains that killed the Florida and Missouri babies and infected the infants in Illinois and Oklahoma. These include additional lab tests on infant formula from various manufacturers, nursery water samples and environmental samples. The agency also is carrying out inspections of the manufacturing facilities.
FDA and CDC offer the following recommendations for safe preparation and use of powdered infant formulas, especially for premature infants and infants under 6 weeks of age:
- 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.