Melamine found in U.S. infant formula

The AP reported yesterday that melamine or the related chemical cyanuric acid were found in infant formula sold by the three largest U.S. producers—Abbott Laboratories, Nestle, and Mead Johnson. Melamine and cyanuric acid killed pets in the U.S. last year and children in China recently. The affected animals and children suffered from kidney stones and kidney failure.

According to the AP report, the FDA and other experts claim that the chemicals’ presence in U.S.-manufactured infant formula is not related to the Chinese incident, but is a consequence of normal manufacturing processes:

Melamine is used in some U.S. plastic food packaging and can rub off onto what we eat; it’s also contained in a cleaning solution used on some food processing equipment and can leach into the products being prepared.

The AP filed a Freedom of Information Act request to get data on two of the companies from the FDA. Those companies and their products [note: see update with correction below] are:

• Mead Johnson’s Enfamil LIPIL with Iron, which contained 0.14 parts per million (ppm) melamine.
• Nestle’s Good Start Supreme Infant Formula with Iron, which contained 0.247 ppm cyanuric acid.

A spokesman for the third company, Abbott Laboratories, said that the company’s own tests detected melamine in some of its products at levels “far below the health limits set by all countries in the world, including Taiwan, where the limit is 0.05 parts per million.” Abbott, the maker of Similac, did not say in which of its products the melamine was detected.

Last month, in updating its “Interim Safety and Risk Assessment of Melamine and its Analogues in Food for Humans,” the FDA said that it “cannot establish a level of melamine and its analogues in these products [infant formula] that does not raise public health concerns.” (In contrast, the FDA’s safe level for these chemicals in all other food products besides infant formula is 2.5 ppm.) In other words, back on October 3, the FDA said that any amount of melamine or its related chemicals in infant formula was a problem.

Today, however, the FDA contradicted itself. Agency spokeswoman Judy Leon said that the FDA allows anything below 250 parts per billion [0.25 ppm] of melamine in infant formula, and that “there’s no cause for concern or no risk from these levels.”

But considering that the incidence of kidney stones in U.S. children is skyrocketing and no one knows why, we here at What on Earth Are We Eating can’t help but be concerned.

Updated Thursday, 11/27/08: According to a new AP report, the spreadsheet with test results that the FDA provided on Tuesday contained an error. On Wednesday, FDA spokeswoman Judy Leon said that the FDA had incorrectly switched the names of the Mead Johnson and Nestle products on the spreadsheet. Thus Nestle’s Good Start had the melamine while Mead Johnson’s Enfamil had the cyanuric acid. The corrected data:

• 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.

Update II, Friday, 11/28/08: The FDA sets a new “safe” level for melamine and cyanuric acid in infant formula of 1 ppm. This contradicts both FDA spokeswoman Judy Leon’s statement the previous day that the safe level was 0.25 ppm and the FDA’s October 3 statement that there is no safe level of these substances in infant formula. Since the only thing that has changed since October 3 is that melamine and cyanuric acid were found in U.S. infant formula at levels below 1 ppm, it’s obvious that these new standards (both the 0.25 ppm level mentioned on November 27 and the 1 ppm level set on November 28) were not based on adequate science. (In fact, in the FDA’s updated risk analysis, the only study referenced is a 13-week rat study.)

This is the FDA’s explanation for how the formula became contaminated:

Melamine is not naturally occurring and is not approved to be directly added to food in the United States. However, melamine is approved for use as part of certain food contact substances. Low levels of melamine are present in the environment and trace amounts may occur in certain food commodities as a result of approved uses.

But there’s another possible source of the melamine contamination: the milk used in the infant formula may have come from cows that ate animal feed containing melamine. We have previously reported on the presence of melamine in U.S. animal feed, and it has also been found in Chinese animal feed.