FDA Defends U.S. Infant Formula

12/1/2008 11:20:56 AM
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WASHINGTON—The U.S. Food and Drug Administration (FDA) defended the safety of infant formula sold in the United States despite tests that found the chemical melamine in one brand and a related compound in another.

The amounts found are far less than levels found in infant formula in China earlier this year and "do not raise public health concerns," said Stephen Sundlof, director of the FDA's Center for Food Safety and Applied Nutrition. "The domestic supply of infant formula is safe."

FDA tests found "very low levels" of the industrial chemical melamine in Nestlé's Good Start Supreme with Iron formula, Sundlof said during a conference call. Low levels of cyanuric acid were found in Bristol-Myers Squibb unit Mead Johnson's Enfamil Lipil with Iron.

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steven 12/01/2008 16:44

FDA actions on melamine in U.S. infant formula are irresponsible. Trace level is misleading. In some scientific areas, ppm (parts per million) is not a trace level at all. ppb (parts per billion) is more generally referred to a trace level. For example, air pollution, most federal air quality standards are ppb level. So, these current melamine concentrations may be harmful if just based on concentration levels.


Current China and Hong Kong infant formula standards are 1 ppm and Taiwan's is 0. However, those standards all are developed based on FDA 2.5 ppm melamine adult standard. It is questionable to say that current melamine concentrations in infant formula (0.2 ppm) are low as FDA implied.


Which level of melamine is safe? As FDA indicated "FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns." It is clear to state that any levels of melamine is possible to be harmful. Since melamine is a new food safety issue, the long term effects of melamine, especially on baby, is totally unknown and will need a long time to determine. As a parent of baby and a person in science for 20 years, I strongly disagree with any "scientists" who claim that current level of melamine in U.S. in infant formula (0.1 ppm) is safe, especially for infants. Where are their scientific data to demonstrate such safety? FDA should publish these data immediately. I am very disappointed that FDA only disclosed such data because of the request of The Associated Press under the Freedom of Information Act. Since FDA cannot determine the safety level of infant formula, they should let parents decide what actions they should take. FDA actions are irresponsible. Melamine can be controlled no matter that it comes from intentional addition and formula produce processes. China, Taiwan, and Hong Kong all demonstrate that. Most of China, Taiwan and Hong Kong infant formula are much lower than 0.1 ppm now. Because FDA did not take any action, all American baby might still eat such formula with higher melamine concentration, which is possible to be harmful and can be removed.


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