Infant Formula and Melamine

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Statement on Melamine and Cyanuric Acid

International Formula Council Statement on Melamine and Cyanuric Acid and Infant Formula

ATLANTA (Jan. 14, 2009) – The International Formula Council (IFC) and its members applaud the recent efforts of the U.S. Food and Drug Administration (FDA), the World Health Organization (WHO), and Health Canada to establish a safe level of melamine in food that does not pose a health risk.These safety limits will help clearly distinguish between products that are intentionally adulterated with melamine, versus the very low background levels commonly found in the environment that do not impact product safety.  Furthermore, the recommendations for safe melamine levels in infant formula set forth by these authorities will reassure parents and health professionals that infant formula manufactured in the United States remains safe and nutritious.  An FDA spokesperson stated on November 28, 2008: "There's no basis for concern because we're talking about trace levels that are so low…that there's absolutely no risk."

The trace levels of melamine or cyanuric acid recently found in some U.S. infant formulas – based on testing conducted by the FDA – were far below established safety limits for infant formula in the U.S., as well as safety limits set by the WHO, and numerous other governments around the world.  It is important to note that detectable levels of melamine and cyanuric acid have never been reported to occur together within the same infant formula product.  It is also important to note that the very low background levels of melamine found in some infant formulas tested by the FDA are orders of magnitude lower than the amount of melamine found in intentionally contaminated Chinese milk products in 2008.  Dr. Stephen Sundlof, Director of FDA’s Center for Food Safety and Applied Nutrition, explained that the trace amounts found by the FDA in U.S. formulas are “10,000 fold less than the amounts associated with the Chinese infant formula contamination.”

U.S. infant formulas meet the highest safety standards and specifications and are manufactured with strict adherence to Good Manufacturing Practices using high-quality ingredients.  Each component in the manufacturing process is carefully assessed to ensure that it complies with strict industry standards, and finished products are tested to meet or exceed all FDA standards for infant formula.  The IFC and its members are committed to the continued high standards of food safety we have established.  IFC also would welcome the opportunity to help further implement standards for melamine and cyanuric acid on a global basis.

To view FDA's updated statement on melamine and its analogues, visit: http://www.cfsan.fda.gov/~dms/melamra4.html.

To view the USDA's statement on melamine and infant formula, visit http://www.fns.usda.gov/cga/PressReleases/2008/Johner_120308.pdf

To view the World Health Organization's Press Release on Melamine and Infant Formulas visit: www.who.int

To view FAQ's published by Health Canada visit: http://www.hc-sc.gc.ca/fn-an/securit/chem-chim/melamine/qa-melamine-qr-eng.php

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