The U.S. FDA Reaffirms the Safety of Enfamil® Infant Formula
EVANSVILLE, Ind., December 1, 2008 — The U.S. Food and Drug Administration (FDA) has confirmed that no melamine has been detected in Enfamil infant formula products and that recent media reports indicating that trace levels had been detected were inaccurate.
Mead Johnson remains confident in the safety of our products and so should parents and health care professionals. We maintain stringent standards at all our manufacturing sites around the world to ensure high quality, safe products that parents and healthcare professionals have come to expect from us for over 100 years.
The U.S. FDA issued a statement on November 28, 2008, that said, "FDA's ongoing investigation continues to show that the domestic supply of infant formula is safe and that consumers can continue using U.S. manufactured infant formulas." » See FDA Statement
The U.S. FDA reported that minute levels of cyanuric acid were detected in Enfamil products. At this time we are unable to duplicate those test results. We are continuing to investigate. That said, the FDA confirmed that their reported levels of cyanuric acid are so low that they do not pose a health risk to infants.Frequently Asked Questions About Cyanuric Acid Media Reports
The Associated Press incorrectly reported that Enfamil LIPIL contained minute traces of melamine. The U.S. Food and Drug Administration has since confirmed that no melamine has been detected in Enfamil LIPIL infant formula products and that recent media reports indicating that trace levels had been detected were inaccurate. The U.S. FDA issued a statement on its website confirming that infant formulas in the US are safe. » See FDA StatementWhy did the media report this misinformation?
The U.S. FDA received a request for the testing data from the Associated Press media outlet. A preliminary report was provided to a reporter under the Freedom of Information Act. It appears that the data reported from the preliminary report were not correct.Melamine and Cyanuric Acid
Mead Johnson's own testing, conducted by a third party laboratory using a published US FDA testing methodology, as well as tests conducted by the FDA, have never detected the presence of melamine in any of Mead Johnson's products. We maintain stringent standards at all our manufacturing sites around the world to ensure the high quality and safety of our products that our customers have come to expect from Mead Johnson for over 100 years.Melamine was not found in your product but cyanuric acid was. What is that?
Cyanuric acid is a substance that has several useful benefits. It is a component of some sanitizers used in food manufacturing sites and it may be found in chemically purified drinking water following the World Health Organization (WHO) guidance for safe drinking water.Are the trace quantities of cyanuric acid in food a health risk?
No. Due to the extremely large margin of safety and the recognized positive public health benefit for use of cyanuric acid salts, there is no reason questioning the safety of a trace amount of cyanuric acid found in foods or formula products.Is cyanuric acid present in other foods?
Yes. In the World Health Organization Guidelines for Drinking-Water, the typical concentration of cyanuric acid resulting from maintaining microbiological safety is approximately 40 mg/L of water. That, for comparison, is approximately 80 times greater than the minute levels of cyanuric acid reported to have been found by the FDA.Are there safe limits for cyanuric acid and melamine?
A report issued by the World Health Organization (WHO) addresses the risk assessment of melamine and cyanuric acid. The WHO report summarizes tolerable daily intakes ("TDI") for total melamine and cyanuric acid for infants from several regulatory bodies around the world. Significantly, under WHO's risk assessment, the minute level of cyanuric acid reportedly found in Mead Johnson's products (0.247 ppm) was far below that thought to present any risk to infant health.How could trace quantities of cyanuric acid be found in infant formula?
Minute quantities (parts per billion) of residual sanitizer used to clean formula-processing equipment and utensils could be detected with modern analytical technology that is capable of measuring ultra trace quantities of chemical substances. Concentrations at these extremely low levels, if they occur at all, are not a food safety concern and have no effect on the final product, similar to finding water spots on dishes.Why did the US FDA find cyanuric acid and Mead Johnson's testing did not?
At this time we are unable to duplicate test results reported by the FDA that minute trace levels of cyanuric acid were detected in a sampling our infant formula. We are continuing to investigate. That said, the FDA confirmed that their reported levels of cyanuric acid are so low that they do not pose a health risk to infants.Does the presence of cyanuric acid mean that melamine is present?
No. Melamine and cyanuric acid are compounds in the same chemical family. The FDA- approved uses of cyanuric acid can result in ultra-trace amounts of cyanuric acid in food products. It does not mean that melamine is present. This is especially true if the product is tested for the presence of melamine and none is found. Mead Johnson tests its products for the presence of melamine and none has been found.Do you test for Cyanuric Acid? If so, have you found it in your product?
Yes. Mead Johnson tests for the presence of cyanuric acid. Mead Johnson's own testing, conducted by a third party laboratory using a published U.S. FDA testing methodology, has never detected the presence of cyanuric acid in our products.What are the uses for cyanuric acid?
Among the many approved beneficial use for cyanuric acid, the FDA has approved it for use as a sanitizer that may be safely used on food-processing equipment and utensils used in the manufacture of infant formula. Routine sanitizing of processing equipment is an important step to our commitment to the quality and safety of our products and is part of Good Manufacturing Practice requirements.Does the FDA have a position on melamine and cyanuric acid found infant formula?
Yes, on November 28, 2008, the FDA stated that the "FDA's ongoing investigation continues to show that the domestic supply of infant formula is safe and that consumers can continue using U.S. manufactured infant formulas. FDA has concluded that levels of melamine alone or cyanuric acid alone, at or below 1 part per million (ppm) in infant formula do not raise public health concerns."
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