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Three tests of Nestle's Good Start Supreme Infant Formula with Iron detected an average of 0.247 parts per million of cyanuric acid, a melamine byproduct.
The FDA said last month that the toxicity of cyanuric acid is under study, but that meanwhile it is "prudent" to assume that its potency is equal to that of melamine.
And while the FDA said tests of 18 samples of formula made by Abbott Laboratories, including its Similac brand, did not detect melamine, spokesman Colin McBean said some company tests did find the chemical. He did not identify the specific product or the number of positive tests.
McBean did say the detections were at levels far below the health limits set by all countries in the world, including Taiwan, where the limit is 0.05 parts per million.
"We're talking about trace amounts right here, and you know there's a lot of scientific bodies out there that say low levels of melamine are always present in certain types of foods," said McBean.
Mead Johnson spokeswoman Gail Wood said her company's in-house tests had not detected any melamine, and that the company had not been informed of the FDA test results, even during a confidential agency conference call Monday with infant formula makers about melamine contamination.
The FDA tests also detected melamine in two samples of nutritional supplements for very sick children who have trouble digesting regular food. Nestle's Peptamen Junior medical food showed 0.201 and 0.206 parts per million of melamine while Nestle's Nutren Junior-Fiber showed 0.16 and 0.184 parts per million.
The agency said that while there are no established exposure levels for infant formula, pediatric medical food -- often used in feeding tubes for very sick, young children -- can have 2.5 parts per million of melamine, just like food products other than infant formula.
The head of manufacturing for Nestle Nutrition in North America, Walter Huber, said in an interview that the company took samples alongside FDA officials who visited a manufacturing plant, and that those samples showed similar results to what FDA found for the two pediatric medical foods. Huber added that Nestle didn't fund cyanuric acid in any of the samples.
The FDA shared its results with Nestle a few weeks ago, Huber said. He said he wasn't sure whether Nestle had tested other of its products beyond what it did related to the FDA.
Rep. Rosa DeLauro, D-Conn., who heads a panel that oversees the FDA budget, said the agency was taking a "marketplace first, science last" approach.
"The FDA should be insisting on a zero-tolerance policy for melamine in domestic infant formula until it is able to determine conclusively based on sound independent science that the trace levels would not pose a health risk to infants," DeLauro said.
Rep. Bart Stupak, D-Mich., a frequent critic of the FDA, said: "If no safe level of melamine has been established for consumption by children, then the FDA should immediately recall any formula that has tested positive for even trace amounts of the contaminant."
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.
Dr. Jerome Paulson, an associate professor of pediatrics at Children's National Medical Center in Washington, D.C., said he didn't think the FDA's decision was unreasonable. He added, however, that the agency should research the impacts of long-term, low-dose exposure, "and not just assume it's safe, and then 15 years from now find out that it's not."
On the Net:
The FDA's melamine guidance:
Copyright 2008 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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