WASHINGTON (Reuters) - U.S. health officials have found trace amounts of the chemical melamine in one sample of infant formula sold in the United States, a Food and Drug Administration spokeswoman said on Tuesday.
"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-tainted formula was found earlier this year in China, where thousands of children fell ill and several died. In September, the FDA sought to assure parents and said there was no similar contamination threat in the United States.
The chemical, normally used to make plastics, has been found in milk power, wheat gluten and other Chinese-made ingredients used in products ranging from pet food to candy.
Melamine's ability to make foods appear to have higher amounts of protein during testing has made it 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 not to be made with any 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.
Leon declined to name the manufacturer of the sample found to contain melamine. U.S.-approved makers include Abbott Nutrition, Bristol-Myers Squibb unit Mead Johnson Nutritionals and Nestle USA.
Industry trade group the International Formula Council sought to reassure consumers.
"Infant formula manufactured in the United States remains safe and nutritious," the group said in a statement. "U.S. infant formula products meet the highest standards and specifications."
Mead Johnson Nutritionals, the maker of Enfamil baby formula, said that by testing samples of its products and raw materials using published FDA methodology, it had not detected any level of melamine.
"We maintain stringent standards at all our manufacturing sites to ensure the high quality and safety of our products," Mead Johnson spokesman Pete Paradossi said.
'OUT OF STEP'
Leon said the FDA has deployed more sensitive tests in recent weeks as it has expended tests for melamine in all food products, including infant formula.
FDA scientists 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, Leon said.
But some consumer advocates said it was premature to say there was no risk for infants.
The FDA's earlier determination that 250 ppb of melamine was a trace amount was intended for foods other than infant formula, said Sonya Lunder, a senior analyst with the Environmental Working Group.
"This is out of step with what the FDA said earlier," she told Reuters.
"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. In the meantime, parents should not change their babies' feeding habits, she said.
"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."
The FDA was not yet ready to release results of tests of other food products, including dietary supplements, Leon said.