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Melamine Traces Found In US Baby Formula

Posted on: Wednesday, 26 November 2008, 14:25 CST

A spokeswoman for the Food and Drug Administration said on Tuesday that U.S. health officials have found trace amounts of the chemical melamine in one sample of infant formula sold in the United States.

Last month, the FDA said it was unable to identify any melamine exposure level as safe for infants, but a top official said it would be a "dangerous overreaction" for parents to stop feeding infant formula to babies who depend on it.

"There's no basis for concern because we're talking about trace levels that are so low ... that there's absolutely no risk," FDA spokeswoman Judy Leon said.

Melamine was found in larger concentrations of Chinese infant formula earlier this year and was blamed for killing at least three babies and making at least 50,000 others ill.

The mostly plastics-based chemical has been found in milk power, wheat gluten and other Chinese-made ingredients used in products ranging from pet food to candy.

In September, the FDA sought to assure parents and said there was no similar contamination threat in the United States.

The chemical has the ability to make foods appear to have higher amounts of protein during testing and is considered a cheap but dangerous substitute that can damage the kidneys.

But Leon said that was not the case with the U.S. infant formula, which in September was determined to contain no Chinese ingredients.

“The new results are most likely a result of the manufacturing process or what comes into contact with formula in cans. It's not adulteration and it's not contamination," she said.

U.S.-approved makers include Abbott Nutrition, Bristol-Myers Squibb unit Mead Johnson Nutritionals and Nestle USA, which manufacture more than 90 percent of all infant formula produced in the United States.

However, Leon declined to name the manufacturer of the sample found to contain melamine.

The International Formula Council issued a statement to reassure consumers of the products safety.

"Infant formula manufactured in the United States remains safe and nutritious," the group said. "U.S. infant formula products meet the highest standards and specifications."

The FDA has deployed more sensitive tests in recent weeks as it has expended tests for melamine in all food products, including infant formula.

Leon said scientists at the FDA conducted two tests of the formula sample, one finding a melamine level of 137 parts per billion (ppb) and another measuring 140 ppb. A level of 250 ppb or less is considered a trace amount.

Many consumer advocates maintain that it is still too soon to say there is no risk for infants.

Sonya Lunder, a senior analyst with the Environmental Working Group, said the FDA's earlier determination that 250 ppb of melamine was a trace amount was intended for foods other than infant formula.

"We need to have a zero-tolerance policy for contaminants in infant formula," Lunder said. "Babies eat only formula for months and months on end. They are exception vulnerable."

Leon said the FDA was in the process of determining what amounts of melamine pose a risk to infants and would release a public advisory later.

She stressed that until the advisory is released parents should not change their babies' feeding habits.

"We found one positive test on one sample at a level so low that it has absolutely no impact on the health of babies whatsoever," Leon said. "So there's no reason for any parent to be concerned for any reason."

Several medical experts said trace concentrations would be diluted even in an infant, and are highly unlikely to be harmful.

"It's just a tiny amount, it's very unlikely to cause stones," said Stanford University Medical School pediatrics professor Dr. Paul Grimm.

However, Leon said the FDA was not yet ready to release results of tests of other food products, including dietary supplements.

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Source: redOrbit Staff & Wire Reports

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