News & Events
Investigation of Cronobacter Bacteria Illness in Infants
UPDATE: Joint Statement by the FDA and CDC on Cronobacter Investigation
FOR IMMEDIATE RELEASE: December 30, 2011, 6 p.m.
FDA and CDC Update: Investigation of Cronobacter Bacteria Illness in Infants
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.
CDC recommends breastfeeding whenever possible. When using powdered infant formula, CDC and FDA advises that caregivers make up fresh formula each time they feed the baby and discard any leftovers. In addition, recommendations for how to prepare and use powdered infant formula more safely include:
- 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, and
- 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 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.
You can report a general complaint or concern about an infant formula in writing or by telephone, or by the Internet at Report a Problem.
If you think your infant has suffered a serious harmful effect or illness from an infant formula, your health care provider can report this by calling FDA's MedWatch hotline at 1-800-FDA-1088 or by using Reporting by Health Professionals.
In addition, health care providers should report infectious diseases in infants associated with use of infant formula to CDC's Division of Healthcare Quality Promotion (1-800-893-0485).
Consumers may also report an illness, injury or other problem they believe to be related to the use of an infant formula by calling FDA at 1-800-FDA-1088 or using Reporting serious problems to the FDA.
FDA wants to know when a product may have caused a problem even if you are unsure the product caused the problem or even if you and the baby do not visit a doctor or clinic.
Infant formula manufacturers provide toll-free telephone numbers on the labels of their products and should be notified about problems, complaints, or injuries caused by their products.
- FAQs about FDA’s Regulation of Infant Formula
- Food Safety for Moms-to-Be: “Once Baby Arrives”
- CDC Morbidity & Mortality Weekly Report - "E. sakazakii" Infections Associated With Use of Powdered Infant Formulas" April 12, 2002 (PDF)
- FDA 101: Infant Formula
- Health Professionals Letter on Enterobacter sakazakii Infections Associated With Use of Powdered (Dry) Infant Formulas in Neonatal Intensive Care Units. April 1, 2002; Revised October 10, 2002