A Message About the Safety of Enfamil Products
We'd like to provide some information in response to questions about our powdered infant formulas.
The story of an infant in Michigan who tested positive for Cronobacter spp. was recently publicly shared on our Facebook page. We are tremendously saddened to learn of this family's loss. We understand that this information has raised some concern for parents and that you may have questions. While privacy considerations limit what we can say, we want to provide as much information as possible to reassure you of the quality and safety of our products.
We can confirm that on June 24th, 2016, we were contacted by the U.S. Food and Drug Administration (FDA) and informed that they were investigating a customer complaint. As part of their investigation, the FDA reviewed environmental and batch record reports. We also provided cans of retained products related to Enfamil® Gentlease® formula reportedly consumed by the baby (and appearing to match the batch number indicated in a Facebook posting). We cooperated fully with the FDA's investigation into this matter and the FDA had full access to our manufacturing facility. The FDA has confirmed that testing on a total of 57 cans of product was negative for Cronobacter. These test results are consistent with negative results obtained by Mead Johnson. Before releasing any product, Mead Johnson tests twice the amount of formula required by law. It also tests ingredients before they are added to its formulas.
We believe the FDA investigation and the Facebook post are related. Batch numbers, geographic location, and date of birth of the baby involved are consistent.
Our highest priority is the health and safety of babies that consume our products. We can assure you that there is no recall on any of our products. We know many families rely on us to provide nutrition for their children and we encourage parents who have any concerns to contact us by calling 1-800-222-9123 or emailing EnfamilResourceCenter@Enfamil.com.
Below are a few commonly asked questions:
- What is Cronobacter?
Cronobacter is a microorganism found naturally in the environment, and can be found in or on household surfaces – including food preparation surfaces – dust, kitchen areas and many kinds of foods. It has also been found in bottled water used to reconstitute infant formula. Most cases of Cronobacter illness occur in the elderly and in people with immune problems. Cronobacter is a rare but serious cause of illnesses in young infants, and illness has been reported in breastfed as well as formula fed babies.
- What measures do you take to ensure the safety of your products?
Infant formulas, including our products, are produced under stringent hygienic conditions and comply with strict international microbiological specifications. Powdered infant formulas cannot undergo a final sterilization process in the container because this would adversely affect the product, but they are heat-treated and manufacturers rigorously monitor the microbiology of their products by thorough testing of each batch.
Mead Johnson's testing of ingredients and all finished powdered infant formula products includes tests for Cronobacter at double the FDA requirements. No batch would be released if it didn’t meet our high standards for safety and quality.
Additionally, Mead Johnson provides explicit instructions on how to mix, store and use infant formulas correctly on our labels, educational materials, and website. Parents are encouraged to read, understand and practice safe formula preparation, usage, and storage according to label instructions and their physician’s guidance.
- Is Mead Johnson recalling any products as a result of this incident?
No. It is important to know that none of our products have been recalled. Our testing of ingredients and all finished powdered infant formula products includes tests for Cronobacter. No ingredient or batch of powdered infant formula would be released if it didn't meet our high standards for safety and quality. Our testing, as well as the tests completed by the FDA, confirm that no presence of Cronobacter was found in the batches of product consumed by the baby in Michigan.