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Some Melamine in Infant Formula is OK, FDA Says

Agency reverses course after declaring chemical unsafe

By Mark Huffman
ConsumerAffairs.com

December 1, 2008

• Chinese Companies Pay $160 Million Over Melamine Scandal • Topaz Wafer Rolls Recalled on Melamine Fears • Melamine Triggers Recall of Cocoa from Canada • Vietnam Company Recalls Biscuits Due to Melamine • USDA Will Test Meat Products for Melamine • Melamine Found in Walgreens Chocolate Bars • Chinese Infant Death Toll from Tainted Formula Rises • Some Melamine in Infant Formula is OK, FDA Says • FDA Finds Melamine in U.S. Infant Formula • FDA Blocks Chinese Products Over Melamine Fears • Melamine Scandal Continues to Expand • FDA's Melamine Decision Scares Consumers • DeLauro Raps FDA On Melamine Risk Guidelines • FDA Issues Report On Melamine and Food Safety • Melamine-Tainted Chinese Candy Shows Up in U.S. • Hershey's Says Chocolates Are Safe from Chinese Melamine Scandal • Cadbury Recalls Chinese-Made Chocolates Due to Melamine • Melamine Scare Spreads to Mr. Brown Coffee • Chinese Gorillas Fall Ill as Melamine Scandal Widens • FDA Updates Chinese Infant Formula Warning • Asian Baby Death Toll From Infant Formula Rises • FDA Issues Warning on Chinese-Made Infant Formula

Within days of disclosing that it had found the chemical melamine in some U.S. infant formula, the Food and Drug Administration said trace amounts of the substance in baby food is acceptable.

That's at odds with the agency's declaration less than two months ago that it would allow no melamine in infant formula. All other food, it said, could have up to 2.5 parts per million of the substance without causing harm.

The FDA now says it has concluded that "levels of melamine alone, or cyanuric acid alone, at or below one part per million in infant formula, do not raise public health concerns."

Last week the agency said it had found trace amounts of the substance in Good Start Supreme Infant Formula with iron, made by Nestle. Trace amounts of cyanuric acid were found in Infant Formula Powder, Enfamil LIPIL with Iron, from Mead Johnson Nutritionals, a subsidiary of Bristol-Myers Squibb.

Melamine is a chemical approved for use in production of some plastics in the U.S., but is not approved for use in food. It has shown up in food products imported from China with some frequency, causing numerous pet injuries and deaths in 2007, and prompting recalls of some milk products this year. Over the summer a number of Chinese babies were killed or injured after drinking infant formula containing melamine, but the affected brands were not imported into the U.S.

The FDA's Stephen Sundlof, head of the food safety division, says the agency draws a distinction between food products containing trace amounts of melamine and products containing trace amounts of cyanuric acid, a melamine by-product.

Separately, he says, trace amounts of the chemicals cause no harm. However, when the two chemicals are combined they cause crystals that can lead to kidney damage. No amounts of the two chemicals together, he said, will be allowed in infant formula.

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