FDA Sets Melamine Standard for Formula after Traces of Chemical Found in U.S.-Made Products

Melamine contamination of infant formula—which has killed at least three babies and sickened thousands of others in China—has reared its ugly head in the United States. 


On Nov. 26, the Associated Press (AP) reported that the U.S. Food and Drug Administration (FDA) had found traces of melamine in the infant formulas made by Nestle and Mead Johnson. FDA tests had also showed the presence of another industrial chemical related to melamine called cyanuric acid in some of the formula. The information about the contamination was not made public by the FDA until the AP filed a Freedom of Information Act request. According to the AP, in-house tests conducted by Abbott Laboratories also showed trace levels of melamine in its baby formulas. Abbott Laboratories, Nestle and Mead Johnson manufacture more than 90% of all infant formula produced in the United States, the AP reports.

On Nov. 28, two days after the AP story broke, the FDA publicized a standard allowing for higher levels of melamine in baby formula than those found in the U.S.-made batches of the product—despite two months earlier saying that it was unable to set a safety threshold for melamine in baby formula products.

The FDA set a threshold of 1 part per million of melamine in formula, provided cyanuric acid is not also present. The agency did not set a safety level for melamine if cyanuric acid is also present. 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, according to the AP.

Both the new safety level and the amount of melamine found in the U.S. formulas fall significantly below the amounts of melamine that were added to infant formulas linked to the baby deaths in China. “The concentrations of melamine [in the Chinese-made formulas] were extraordinarily high, as much as 2,500 parts per million” and were the result of melamine being “intentionally dumped into watered-down milk to trick food quality tests into showing higher protein levels than actually existed,” the AP wrote. “The concentrations detected in the FDA samples were 10,000 times smaller—the equivalent of a drop in a 64-gallon trash bin.”

In our upcoming Raw Material & Ingredient Supply issue, which will publish in December, Nutrition Business Journal provides a chronological breakdown and explanation of how the most recent melamine contamination in China occurred, a retrospective analysis of the history of supplement adulteration in China, and a look into the long-term impact these issues will have on the global ingredients market. To order your copy of the issue or to subscribe to NBJ, go to www.nutritionbusinessjournal.com.

If you are an NBJ subscriber and would like to read more of NBJ’s coverage of melamine contaminations, click the following:

Sales of Organic, Natural Pet Food Skyrocket After 2007 Recall
Top Dog: Organic and Natural Pet Food Sales Soar in Wake of China Scandal
Nutritional Raw Materials & Ingredient Supply IX Overview

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