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FDA Finds Melamine in U.S. Infant Formula

Agency insists amounts were "minute" and do not pose an immediate danger

By Truman Lewis and Lisa Wade McCormick
ConsumerAffairs.com

November 25, 2008

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Melamine -- the chemical blamed for the deaths of four infants in China and countless pets in the United States -- has been found in infant formula, the U.S. Food and Drug Administration (FDA) said, according to The Wall Street Journal.

The newspaper quoted FDA official Stephen Sundlof as saying the finding is "no cause for concern." He said the chemical was at very low levels and was probably the result of contact with melamine during processing or packaging. Sundlof said the agency also found minute amounts of melamine in products such as nutritional and medical supplements made by five U.S. manufacturers of infant formula.

Melamine is a chemical used to make plastic and fertilizers. It is not allowed in human or pet food, although in the late 1960s or early 1970s, the FDA approved melamine as a "food contact substance," Sundlof said.

Sundlof said the discovery was part of a testing program that went into high gear after melamine in Chinese infant formula sickened tens of thousands of Chinese infants and killed four. Samples tested by FDA came not only from ethnic markets but also from products produced by the five major U.S. infant formula manufacturers.

Animal tests are now being conducted to determine melamine safety levels, he said.

Imports detained

Earlier this month, the FDA announced that it was detaining scores of products imported from China, including some pet food, because of possible melamine contamination.

Under this action, dozens of Chinese-imported items that contain milk products will be held at the border -- and not allowed to enter the U.S. -- until the importers can prove the items are not tainted with melamine or are not made with milk or milk-derived ingredients.

The products listed in the import alert -- a precautionary measure designed to keep food tainted with melamine from entering the country -- include candy, cereals, snack foods, cheese, ice cream, soft drinks and baby food products.

"We've continued to get information from others in the international community, and reports from China, about (melamine contamination) moving into different commodities," Steve Solomon, a senior FDA enforcement official, told The Associated Press. "Most of the products we are talking about are finished products like cookies, cakes and candies. The impact will be for various ethnic communities looking for specific products."

"The (infants') illnesses involved the formation of kidney stones and crystals and related complications," the FDA wrote in the import alert. It added that some 13,000 infants were hospitalized after drinking the tainted formula.

"The milk used in the infant formula has been implicated as the source of the melamine contamination." The FDA learned that melamine was added to the infant formula to increase the nitrogen content – and falsely inflate the protein content.

The melamine contamination, however, isn't limited to infant formula.

"FDA analyses have detected melamine and cyanuric acid in a number of products that contain milk or milk-derived ingredients, including candy and beverages," the agency wrote.

And those products were shipped to consumers around the world.

More than 13 countries -- including Asia, Europe and Australia--have discovered melamine in a variety of products made with the tainted milk ingredients from China, the FDA said. Those products include candy, yogurt, frozen desserts, biscuits, instant coffee, milk tea products, and other beverages.

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