Trace Levels of Melamine In Formula Called Safe
Saturday, November 29, 2008
Federal health officials have changed their guidance on the health risks of melamine in infant formula, saying trace amounts of the industrial compound alone are not harmful.
Last month, the Food and Drug Administration said it was "currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns."
FDA officials updated their interim risk assessment yesterday after finding what they described as "extremely low amounts" of melamine and cyanuric acid, a related chemical, in samples of two popular brands of domestically made infant formula.
"FDA's ongoing investigation continues to show that the domestic supply of infant formula is safe and consumers can continue using U.S. manufactured infant formula," Stephen Sundlof, a top FDA official, told reporters yesterday. Melamine or cyanuric acid alone "at 1 part per million in infant formula do not raise public health concerns."
Sundlof said the previous risk assessment was based on the combination of melamine with a melamine-related chemical and that the new assessment applies to melamine or a related chemical present alone.
Melamine is used to make fertilizer and plastic. If melamine and cyanuric acid combine, they can form round yellow crystals that can damage kidneys, destroy renal function and even lead to death. Chinese-made infant formula contaminated with melamine has killed at least three infants in China and sickened tens of thousands more. Melamine-tainted pet food also killed thousands of cats and dogs in the United States last year.
Sundlof said the new assessment was not based on new data but on existing animal studies showing that high levels of melamine alone do not harm laboratory rats. He said the FDA cannot set a safe level of infant exposure to melamine combined with cyanuric acid and other related chemicals because there hasn't been enough research.
Consumers should keep using infant formula, Sundlof said. Switching to alternatives or homemade formula could result in infants receiving inadequate nutrition.
The FDA began collecting samples of domestically made infant formula in September, when the Chinese formula scandal broke. Melamine apparently was added to watered-down milk to boost protein levels and fool quality tests. That milk was then used to make infant formula.
So far, the FDA has tested 87 infant formula products and out of 77 that it has results for so far, it has found melamine at levels of .137 and .14 parts per million in Nestle Good Start Supreme Infant Formula with Iron in liquid form and cyanuric acid at levels between 0.245 ppm and 0.249 ppm in Enfamil Lipil with Iron, made by Mead Johnson Nutritionals, a subsidiary of Bristol-Myers Squibb.
The test results came to light because of a Freedom of Information Act request by the Associated Press.
Sundlof said melamine is approved for use in food packaging such as can liners, and cyanuric acid appears in products used to clean manufacturing equipment. However, he said, the agency could not explain why melamine and cyanuric acid appeared in some samples and not others and could not rule out a contaminated food ingredient as a potential source. "I don't want to speculate on why it is in some and not in others," he said. "The real answer is, we don't know."
Canadian health officials this week also found trace amounts of melamine in infant formula sold in that country but said the levels don't pose a health risk to infants.