FDA sets higher melamine standard for baby formula

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FDA sets melamine standard for baby formula

By JOAN LOWY and JUSTIN PRITCHARD Associated Press Writers

Updated: 11/29/2008 05:28:16 AM MST

http://www.denverpost.com/healthcare/ci_11101301

WASHINGTON---Less than two months after federal food regulators said

they were unable to set a safety threshold for the industrial chemical

melamine in baby formula, they announced 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

isn't present. They insisted the formulas are safe.

The setting of the standard 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 stated in early October that it was unable to set a safety

contamination level for melamine in infant formula.

Dr. Sundlof, FDA's director of food safety, said Friday the

agency was confident in setting the 1 part per million level for either

of the chemicals alone. although there has been no new scientific

studies since October that would give regulators more safety data. He

had no ready explanation for why the level wasn't set earlier.

The standard is the same as the one public health officials have set in

Canada and China where in September the problem of melamine in infant

formula first surfaced. But it is 20 times higher than the most

stringent level in Taiwan.

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. "

Reacting to news of the contaminated formulas, members of Congress, a

national consumer group and the Illinois attorney general have demanded

a national recall, something the 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: Nestle's Good Start Supreme Infant Formula with Iron had

two positive tests for melamine on one sample; Mead 's Infant

Formula Powder, Enfamil LIPIL with Iron had three positive tests on one

sample for cyanuric acid.

Separately, a third major formula maker, Abbott Laboratories, told the

AP that in-house tests had detected trace levels of melamine in its

infant formula.

Those three formula makers manufacture more than 90 percent of all

infant formula produced in the United States.

The FDA said it had analyzed 74 samples and was continuing to examine 13

more.

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.

There is a gap between the concentration that the FDA detected in

formula and the agency's estimate of how much melamine could contaminate

food from the manufacturing process. The expected contamination from

processing---15 parts per billion---is about one-tenth the amount that

the agency has detected in infant formula. FDA officials have not

responded to questions from the AP this week about how that gap might be

explained.

The agency said it is continuing research on animals to see the effects

of ingesting both melamine and cyanuric acid.

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Associated Press writer Pritchard reported from Los Angeles.

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