The new stance partly reverses an October assessment determined was safe to consume food and drink with melamine below 2.5 parts per million with the exception of infant formula. At the time the FDA said it couldn't determine if there was a safe level of melamine and melamine-related compounds that be contained in infant formula.
But Friday, the FDA said it's "concluded that levels of melamine alone or cyanuric acid alone, at or below 1 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. The chemical itself is not approved for use in food.
Stephen Sundlof, the head of FDA's food safety division, said the agency has since determined that trace amounts of melamine and trace amounts of cyanuric acid, which is a byproduct of melamine, separately is unlikely to cause any health problems in babies.
He said the combination of the two chemicals is what caused last year's kidney problems and deaths in cats and dogs who ate pet food contaminated with the chemicals. The two chemicals together caused crystals in the urine and kidney damage. He said no amount of the two chemicals would be allowed in infant formula.
Earlier this week the FDA said it found traces of melamine in a liquid form of Nestle's Good Start Supreme Infant Formula with Iron and traces of cyanuric acid in Infant Formula Powder, Enfamil LIPIL with Iron made by Mead Johnson, a unit of Bristol Myers Squibb Co. (BMY). Both companies have said their own tests have not found such chemicals.
"The domestic supply of infant formula is safe," Sundlof said.
The FDA started testing U.S. infant formula after Chinese babies were sickened earlier this year from formula that was found to be contaminated with melamine.
The FDA tested products from the nation's five FDA-approved makers of milk-based infant formulas: Abbott Laboratories (ABT), Bristol-Myers Squibb, Nestle SA's Nestle USA unit, PBM Products LLC and Solus Products LLC.
The FDA said the bulk of tests in 87 formula samples have come back negative for both melamine and cyanuric acid. The agency is still waiting for results from 13 samples.
Sundlof said the amount of melamine found in one sample of Good Start formula - at 0.137 parts per million - is 10,000 times below the amount of levels found in Chinese infant formula and well below the 1 part per million level set by the U.S. on Friday for formula. The 2.5 parts per million level set in October for melamine and melamine-related compounds for other food and drinks that doesn't raise health concerns remains unchanged.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com
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(END) Dow Jones Newswires
November 28, 2008 17:37 ET (22:37 GMT)
Publié le 28 novembre 2008 Copyright © 2008 Dowjones





