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FDA Tests Find Melamine Traces in Baby Formula

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Wall Street Journal: The Food and Drug Administration said it found "trace levels" of the industrial chemical melamine in one sample of U.S.-made infant formula and in a few samples of other products like nutritional and medical supplements made by U.S. manufacturers of infant formula.

The FDA said, however, the formula and the supplements were safe to consume. "These are extremely low levels," Stephen Sundlof, director of the FDA's Center for Food Safety and Applied Nutrition, said. "It didn't cause any concern at all, not from a health standpoint."

The agency said it tested products from the nation's five FDA-approved makers of milk-based infant formulas: Abbott Laboratories, Bristol-Myers Squibb Co., Nestlé SA's Nestlé USA unit, PBM Products LLC and Solus Products LLC.

Dr. Sundlof said the melamine traces stemmed from the products coming in contact with the chemical during processing. The FDA approved melamine as a "food contact substance" about four decades ago.

The melamine traces were detected by a testing program the FDA began this year after Chinese-made infant formula contaminated with much higher levels of melamine sickened tens of thousands of babies in China and led to the deaths of at least four. The agency used a new technology that is able to detect minute amounts of melamine.

Dr. Sundlof said the agency didn't find the combination of melamine and cyanuric acid in any infant formula sample. Together, the two substances cause kidney stones, among other illnesses, and sickened the Chinese infants.

The FDA said last month that it's safe for consumers to eat most food with melamine below 2.5 parts per million, but infant formula was the exception. "FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns," it said.

The FDA said melamine was found in Mead Johnson's Infant Formula Powder, Enfamil LIPIL with Iron, and a byproduct, cyanuric acid, was found in Nestlé's Good Start Supreme Infant Formula with Iron. The companies were first identified by the Associated Press.

A spokesman for Nestlé USA said none of its infant formula contained cyanuric acid, and company testing didn't detect melamine.

A spokesman for Mead Johnson Nutritionals, owned by Bristol-Myers, said the company's own tests haven't turned up any melamine, and the FDA tests turned up melamine levels "lower than the 0.25 parts per million limit that can be measured by the published FDA test method." Mead Johnson, he said, maintains "stringent standards at all our manufacturing sites to ensure the high quality and safety of our products that our customers have come to expect."

Dr. Sundloff said the melamine detected was tiny. Out of 87 samples, it found one sample with 0.137 parts per million and 0.140 parts per million on a verification test.

Even so, the findings are likely to upset parents who feed formula to their babies. But just how much is at stake for the manufacturers isn't certain. Infant nutritional businesses are lucrative properties for some big U.S. drug makers, including Abbott, Wyeth and Bristol-Myers, though Wyeth doesn't make or market its infant formula in the U.S. Mead Johnson's revenue from its Enfamil infant formula has totaled $872 million so far this year.

Abbott spokesman Colin McBean said that results from its own tests found "undetectable or far less than the lowest tolerance level established by regulatory agencies around the world." Abbott, maker of Similac formula and related products, had $3.6 billion in world-wide nutritional sales during the first nine months of the year.

PBM Products and Solus Products couldn't be reached for comment.

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