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FDA finds traces of melamine in US infant formula
(Agencies)
Updated: 2008-11-26 22:42

Sundlof told the AP the positive test results "so far are in the trace range, and from a public health or infant health perspective, we consider those to be perfectly fine."

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That's different from the impression of zero tolerance the agency left on Oct. 3, when it stated: "FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns."

FDA scientists said then that they couldn't set an acceptable level of melamine exposure in infant formula because science hadn't had enough time to understand the chemical's effects on infants' underdeveloped kidneys. Plus, there is the complicating factor that infant formula often constitutes a newborn's entire diet.

The agency added, however, that its position did not mean that any exposure to a detectable level of melamine and melamine-related compounds in infant formula would result in harm to infants.

Still, the announcement was widely interpreted by manufacturers, the news media and Congress to mean that infant formula that tested positive at any level could not be sold in the United States.

The Grocery Manufacturers Association, for example, told its members: "FDA could not identify a safe level for melamine and related compounds in infant formula; thus it can be concluded they will not accept any detectable melamine in infant formula."

It was not until the AP inquired about tests on domestic formula that the FDA articulated that while it couldn't set a safe exposure for infants, it would accept some melamine in formula - raising the question of whether the decision to accept very low concentrations was made only after traces were detected.

On Sunday, Sundlof said the agency had never said, nor implied, that domestic infant formula was going to be entirely free of melamine. He said he didn't know if the agency's statements on infant formula had been misinterpreted.