Standard is set for infant formula

Federal regulators set a safety threshold Friday for the industrial chemical melamine that is greater than the amount of contamination found so far in U.S.-made infant formula.

Food and Drug Administration officials set a threshold of 1 part per million of melamine in formula, provided a related chemical isn’t present. They insisted the formulas were safe.

The setting of the standard comes days after FDA tests found traces of melamine in the infant formula of one major U.S. manufacturer and cyanuric acid, a chemical relative, in the formula of a second major maker. The contaminated samples, which both measured at levels below the new standard, had been analyzed several weeks ago.

The FDA had stated in early October that it was unable to set a safety contamination level for melamine in infant formula.

Dr. Stephen Sundlof, the FDA’s director of food safety, said Friday that there had been no new scientific studies since October that would give regulators more safety data, but he said the agency was confident in setting the 1 part per million level for either of the chemicals alone. Sundlof noted that neither of the two tainted samples had both contaminants.

He had no ready explanation for why the level wasn’t set earlier.

Sundlof said the lack of dual contamination was key because studies so far show dangerous health effects only when both chemicals are present.

The agency still will not set a safety level for melamine if cyanuric acid is also present, he said.

Both the new safety level and the amount of the chemical found in U.S.-made infant formula are far below the amounts of melamine added to infant formula in China that have been blamed for killing at least three babies and making thousands ill.

Reacting to news of the contaminated formulas, members of Congress, a national consumer group and the Illinois attorney general have demanded a national recall, something the FDA said made no sense because it had no evidence suggesting that the formula would be dangerous for babies at the levels of contamination found.

The FDA on Wednesday said Nestle’s Good Start Supreme Infant Formula with Iron had two positive tests for melamine on one sample, and Mead Johnson’s Infant Formula Powder, Enfamil LIPIL with Iron, had three positive tests on one sample for cyanuric acid.