December 9, 2008
FDA to Allow Trace Levels of Melamine in Baby Formula
WASHINGTON — The Food and Drug Administration said Friday that it will allow trace amounts of melamine in infant formula. Earlier this week, the agency said it found the industrial chemical in at least one brand of formula sold in the U.S.
The new stance partly reverses the agency’s October assessment that it was safe to consume food and beverages with melamine levels below 2.5 parts per million, with the exception of infant formula. The FDA said at the time that it couldn’t determine if there was a safe level of melamine and melamine-related compounds in infant formula.
But Friday, the FDA said it “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.” Melamine is a chemical approved for use in plastics and the liners of some food containers in the U.S. It isn’t approved for use in food. Cyanuric acid is a melamine byproduct.
Earlier this week, the FDA said it found traces of melamine in a liquid form of Good Start Supreme Infant Formula with Iron made by Nestlé SA’s Nestlé USA unit and traces of cyanuric acid in Infant Formula Powder, Enfamil LIPIL with Iron from Mead Johnson Nutritionals, a unit of Bristol-Myers Squibb Co. Both companies have said their own tests haven’t found such chemicals.
“The domestic supply of infant formula is safe,” Stephen Sundlof, head of the FDA’s food-safety division, said Friday. The agency, he said, has determined that trace amounts of melamine and cyanuric acid separately are unlikely to cause health problems in babies. The two chemicals together, however, cause crystals to form in urine and lead to kidney damage. Dr. Sundlof said no amount of the two chemicals together will be allowed in infant formula.
The combination of the chemicals in contaminated infant formula caused severe kidney problems for thousands of babies in China this year. Dr. Sundlof said melamine and cyanuric acid together also caused last year’s kidney problems and deaths in cats and dogs that ate pet food contaminated with the chemicals.
The FDA started testing U.S. infant formula after the problems in China, where milk was watered down and melamine was added. In tests, melamine appears to boost the protein content of milk.
