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FDA Alerts Consumers Not to Feed Infants Chinese Infant Formula

July 7, 2004
FDA News

The Food and Drug Administration is warning consumers not to feed their infants infant formula from China because the safety and nutritional adequacy of infant formula from China is unknown. Recently, infant formula from China by the name of Guan Wei Yuan was found for sale in an Asian retail market in New York.

To date, FDA is not aware of any illnesses or injuries associated with Chinese infant formula, Guan Wei Yuan. However, the analysis of certain Guan Wei Yuan powdered formulas by the New York State Department of Agriculture and Markets food laboratory found the formula to contain less than 1/7 of the federally required minimal amount of protein per serving, approximately 1/4 the required amount of fat and only minute amounts of declared calcium and magnesium. There is no guarantee that this product, as a potential sole source of nutrition, would provide adequate nutrients for an infant. Consumption by infants, under conditions of use described on the label and labeling, could result in outcomes including severe illness or death.

The federal law requires that any infant formula marketed in the U.S. must be registered with the FDA at least 90 days before marketing. Manufacturers are required to provide assurances that they are following good manufacturing practices and quality control procedures and that the formula will allow infants to thrive. Such assurances have not been provided for any infant formulas from China. Therefore, the agency is warning consumers that the safety and nutritional adequacy of infant formula from China is unknown.

FDA will continue to investigate and work with New York State Department of Agriculture and Markets and alert other states of the findings.

Consumers are advised to report any adverse reactions related to infant formula immediately to your health care provider as well as the FDA and state and local agencies.

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