Web Date: December 3, 2008
Melamine In Infant Formula
In a policy reversal, FDA declared on Nov. 28 that infant formula with levels of melamine or one of its analogs below 1 ppm does not pose a risk. Previously, FDA had said it could not establish a safe level of melamine for infant formula (C&EN, Oct. 13, page 9).
The agency's new conclusion comes in response to finding trace levels of melamine in one U.S.-made infant formula and cyanuric acid—a chemical analog of melamine—in another. FDA justified its new decision by saying it previously took into account studies that showed an increase in kidney failure when melamine is combined with cyanuric acid. Because the agency has not found any U.S.-made infant formula with both melamine and cyanuric acid present, it updated its safety assessment to address health concerns in products that contain just melamine or just cyanuric acid.
Consumer groups reacted to the news by calling on FDA to request a recall of any infant formula that contains melamine or cyanuric acid. FDA responded that the levels are so low that "they do not pose a health risk to infants."
FDA has been testing U.S. infant formula samples for melamine and its analogs ever since contaminated infant formula began showing up in China in September (C&EN, Sept. 29, page 18). Of 74 samples tested so far, FDA detected 0.14 ppm melamine in one formula manufactured by Nestlé Nutrition and 0.25 ppm cyanuric acid in another formula manufactured by Mead Johnson. Those levels are up to 10,000 times lower than the levels reported in the Chinese infant formula scandal.
The source of the industrial chemicals in U.S. infant formula is unclear, but company officials suspect that food packaging or sanitizers are to blame. "FDA has approved cyanuric acid for use as a sanitizer that can be used on food-processing equipment. Minute traces of the residual might be detected with new analytical technology," Pete Paradossi, a spokesman for Mead Johnson, tells C&EN. In a written statement, Kurt Schmidt, CEO of Nestlé Nutrition USA, vowed to "do whatever is necessary to correct the situation, including finding alternative packaging" for the particular formula that was found to contain melamine.
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