FDA Changes Mind on Baby Formula, Says Some Melamine SafeDec 1, 2008 | Parker Waichman LLP U.S. health regulators are on record as stating no amount of melamine in infant formula is safe. But after confirming that "trace" amounts of melamine had been detected in some U.S.-made baby formula, officials at the Food & Drug Administration (FDA) have apparently changed their minds. Late last week, the agency said such small amounts posed no risk.
Melamine is a renal toxin that can cause kidney stones and acute renal failure if ingested in large amounts. In China, melamine-tainted formula has sickened over 50,000 children, killing at least four. The melamine was apparently added to milk powder by manufacturers to make it appear that their watered-down baby formula was more nutritious than it really was.
According to the FDA, U.S. formula makers do not obtain ingredients for their products from China. But last week, it was learned that tests run by the agency had detected “trace” amounts of melamine in one sample. According to a report in the Associated Press, the melamine was found in Nestle’s Good Start Supreme Infant Formula with Iron. That formula had two positive tests for melamine on one sample, with readings of 0.137 and 0.14 parts per million.
The Associated Press also reported that another brand, Mead Johnson’s Infant Formula Powder, Enfamil LIPIL with Iron, had three positive tests for cyanuric acid (an analogue of melamine), at an average of 0.247 parts per million. 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.
Back in October, the FDA issued a public statement that levels of melamine and its analogues below 2.5 ppm in foods other than infant formula do not raise public health concerns." According to CNN.com, the agency said then that it did not have enough data to determine a safe level of melamine and its analogues in infant formula.
CNN.com is reporting that on Friday, FDA official said it was still not possible to determine a safe level for infant formula containing both melamine and cyanuric acid compounds, but officials "believe that at very low levels there should not be any health concerns."
"Amounts of the industrial chemical melamine or the melamine-like compound called cyanuric acid that are below 1.0 ppm [1,000 parts per billion] do not raise public health concerns," Stephen Sundlof, the FDA's director of the Center for Food Safety and Applied Nutrition, told CNN.com.
The agency's reassurances are not setting well with many consumer advocates, and calls for a nationwide baby formula recall have continued. Last week, the Associated Press said Illinois Attorney General Lisa Madigan called on the state’s public health department and the FDA to recall both the Nestle and Mead Johnson products. She also criticized the FDA’s handling of the melamine information, the Associated Press said.
“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.
The group Consumers Union and at least one member of Congress have also called for a baby formula recall.