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FDA Sets Melamine Standard For Baby Formula

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WASHINGTON — Two months ago, federal food regulators said they were unable to set a safety threshold for the industrial chemical melamine in baby formula. Now, however, they found a way to settle on a standard that allows for higher levels than those found in U.S.-made batches of the product.

Food and Drug Administration officials on Friday set a threshold of 1 part per million of melamine in formula, provided a related chemical is not present. They insisted the formulas are safe.

The development comes days after The Associated Press reported that FDA tests found traces of melamine in the infant formula of one major U.S. manufacturer and cyanuric acid, a chemical relative, in the formula of a second major maker. The contaminated samples, which both measured at levels below the new standard, were analyzed several weeks ago.

The FDA had said in early October it was unable to set a safety contamination level for melamine in infant formula.

Dr. Stephen Sundlof, the FDA's director of food safety, said Friday the agency was confident in the 1 part per million level for either of the chemicals alone, even though there have been no new scientific studies since October that would give regulators more safety data. He had no ready explanation for why the level was not set earlier.

The standard is the same as the one public health officials have set in Canada and China, but is 20 times higher than the most stringent level in Taiwan.

The problem of melamine in infant formula first surfaced in China in September.

Sundlof said the lack of dual contamination was key because studies so far show dangerous health effects only when both chemicals are present. He emphasized that neither of the two tainted samples had both contaminants.

The agency still will not set a safety level for melamine if cyanuric acid is also present, he said.

Both the new safety level and the amount of the chemical found in U.S.-made infant formula are far below the amounts of melamine added to infant formula in China that have been blamed for killing at least three babies and making thousands ill.

"The levels were so low ... that they do not cause a health risk to infants," Sundlof said. "Parents using infant formula should continue using U.S.-manufactured infant formula. Switching away from one of these infant formulas to alternate diets or homemade formulas could result in infants not receiving the complete nutrition required for proper growth and development."

A scientist for a national consumer group said it was irresponsible of FDA to assure the public that infant formula is safe based on tests of only 74 samples, especially since cyanuric acid is a byproduct of melamine, making it likely that they will be found together.

"This is a slippery slope of rationalization by FDA," said Urvashi Rangan, a senior scientist with the Consumers Union in New York. "FDA needs to get a handle on how widespread the problem is and, most important, if both these chemicals are occurring in any products. They just haven't tested enough to know that yet."

Earlier this week, members of Congress and the Illinois attorney general demanded a national recall, something FDA said made no sense because it had no evidence suggesting that the formula would be dangerous for babies at the levels of contamination found.

After saying it made an error in its data, the FDA on Wednesday produced these results: Mead Johnson's Infant Formula Powder, Enfamil LIPIL with Iron found melamine at levels of 0.137 and 0.14 parts per million. Three tests of Nestle's Good Start Supreme Infant Formula with Iron detected an average of 0.247 parts per million of cyanuric acid.

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, and below any national safety guidelines.

Abbott Laboratories, Nestle and Mead Johnson make more than 90 percent of all infant formula produced in the United States

The agency had left the impression of a zero tolerance 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."

The FDA and other experts said they believe the melamine contamination in U.S.-made formula had occurred during the manufacturing process, rather than intentionally. The U.S. government quietly began testing domestically produced infant formula in September, soon after problems with melamine-spiked formula surfaced in China.

Melamine can legally be used in some food packaging, and can rub off into food from there. It's also part of a cleaning solution used on some food processing equipment.

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Pritchard reported from Los Angeles.

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On the Net:

FDA: http://www.fda.gov/oc/opacom/hottopics/melamine.html