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.

Got…melamine?

This week, the FDA halted the importation of all milk products from China until they are tested and proved free from melamine contamination. This action followed a string of recalls over the last couple of months:

• White Rabbit candy (September 26)
• Mr. Brown coffee mix (October 1)
• Blue Cat flavored beverages (October 3)
• YILI milk drinks (October 10)
• Koala’s March cookies (October 17)
• Fresh and Crispy Jacobina biscuits (October 29)

In 2007, melamine contamination of pet food ingredients imported from China was responsible for the deaths of cats and dogs throughout the U.S. The affected animals developed kidney stones and eventually kidney failure.

The problem resurfaced this year when thousands of Chinese babies became ill and at least four died after drinking infant formula made from milk adulterated with melamine. Just like the American pets, these children suffered from kidney stones and kidney failure.

According to news reports, many Chinese milk producers have been boosting their profits by diluting their milk with water and then adding melamine to give the illusion of a normal protein count. Recalls of products containing Chinese milk products have occurred worldwide, from Cadbury chocolate sold in Asia and Australia to chocolate coins in Canada. Two weeks ago, melamine was found in Chinese eggs and animal feed, raising the possibility that many more foods are contaminated.

The FDA claims that no illnesses linked to melamine in Chinese food products have been reported in the United States. But is it just a coincidence that doctors in the U.S. are seeing a steep rise in the incidence of kidney stones in children, some as young as 5 or 6?

“The older doctors would say in the ’70s and ’80s, they’d see a kid with a stone once every few months,” said Dr. Caleb P. Nelson, a urology instructor at Harvard Medical School who is co-director of the new kidney stone center at Children’s Hospital Boston. “Now we see kids once a week or less.”

According to that NY Times article, the increase has been attributed to high salt intake and not enough liquids. But have American kids really increased their salt consumption that dramatically in the last two or three decades? I remember loving Fritos way back in the ’60s. We here at What on Earth are We Eating are skeptical.