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Dr. Gregory Pais, ND
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Consumers Union and the Illinois attorney general are demanding a Food and Drug Administration recall of contaminated infant formula. Laboratory test results disclosed Nov. 25 2008 have detected traces of melamine contamination in several major brands of infant formula. The FDA says the baby food is safe as the "extremely low levels of contamination" supposedly aren't a problem.

Melamine is the industrial chemical found in Chinese infant formula (in much larger concentrations) that has been blamed for killing at least three babies and making at least 50,000 others ill. According to the FDA the melamine contamination in U.S.-made formula occurred during the manufacturing process. The manufacturers insist their products are safe.

While proclaiming that the very low concentrations detected of melamine and a similar compound called cyanuric acid pose no health danger to infants, the FDA has maintained it is unable to identify any exposure level of melamine in infant formula "that does not raise public health concerns." The FDA said last month that the toxicity of cyanuric acid is under study, but that in the meantime it is "prudent" to assume that its potency is equal to that of melamine.

The FDA said there have been no reports in the United States of human illness from melamine. The chemical, which is used in product packaging and as a solution to clean manufacturing equipment, can bind with other chemicals in urine, potentially causing harmful kidney or bladder stones and, in extreme cases, kidney failure.

Illinois Attorney General Lisa Madigan has called on the state's public health department and the FDA to recall both the Nestle and Mead Johnson infant formula products - and urged the companies to take that steps regardless of what any government agency does. Madigan also criticized the FDA's handling of its test results. "The agency apparently withheld the results of its testing from the public for over three weeks, and then only disclosed the information in response to a FOIA request by The Associated Press," she wrote in a letter to Michael Leavitt, the secretary of the U.S. Department of Health and Human Services, which oversees the FDA.

Consumers Union said that the FDA's assurances are of small comfort to parents and caregivers. "The FDA originally said there was no safe level for these contaminants in infant formula. So this formula is contaminated," said Jean Halloran, the group's director of Food Policy Initiatives. "It is very disturbing to us that no recall has been requested." She urged the FDA "to immediately make public all of the results of its tests for melamine contamination in food," even those with levels below what would trigger agency action."

The FDA has told manufacturers it has taken 230 samples of various products, including pediatric supplements and ingredients used in infant formula. 87 of those samples are of infant formula, and 77 of those have been analyzed. The results were:

• Nestle's Good Start Supreme Infant Formula with Iron had two positive tests for melamine on one sample, with readings of 0.137 and 0.14 parts per million.

• Mead Johnson's Infant Formula Powder, Enfamil LIPIL with Iron had three positive tests for cyanuric acid, at an average of 0.247 parts per million.

Separately, a third major formula maker - Abbott Laboratories, whose brands include Similac - told AP that in-house tests had detected trace levels of melamine in its infant formula. Those levels were below what FDA found in the other formulas, an Abbott spokesman said.

The three firms - Abbott Laboratories, Nestle and Mead Johnson - manufacture more than 90% of all infant formula produced in the United States.


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