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U.S. Department of Health and Human Services

For Consumers

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Health Information Advisory on Infant Formula

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In response to reports of contaminated milk-based infant formula manufactured in China, the Food and Drug Administration (FDA) issued a Health Information Advisory on September 12, 2008.

This is to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell infant formula in the United States.

Manufactured in China

It has been reported that a number of infants in China who have consumed Chinese manufactured infant formula are suffering from kidney stones, a condition which is rare in infants.

The Chinese manufactured infant formula may be contaminated with melamine. Melamine artificially increases the protein profile of milk and can causes kidney diseases, such as those seen in these Chinese infants.

Although no Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States, FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community.

FDA is asking state officials to work with the agency to remove Chinese infant formula found on store shelves, and to warn members of the Asian community to avoid using Chinese manufactured infant formula.

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Advice to Caregivers
    • Don't feed infant formula manufactured in China to infants.
    • Use an appropriate infant formula manufactured in the United States as mentioned below.
    • Contact your health care professional if you have questions regarding the infant's health or if you note changes in the infant's health status.

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Manufacturers That Meet FDA Requirements

FDA began investigating the reports of contamination immediately and received information from the companies who manufacture infant formula for the American market that they are not importing infant formula or source materials from China.

The following manufacturers have met the necessary FDA requirements for marketing milk-based infant formulas in the United States:

    • Abbott Nutritionals
    • Mead Johnson Nutritionals
    • Nestle USA
    • PBM Nutritionals
    • Solus Products LLC.

Also, one manufacturer, SHS/Nutricia, Liverpool, England, markets an amino acid based exempt infant formula that does not contain any milk-derived ingredients.

FDA requires that all infant formula manufacturers register with the agency and adhere to specific labeling and nutritional requirements. All properly registered manufacturers marketing infant formula in the United States undergo an annual inspection of their production facilities.

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This article appears on FDA's Consumer Update page, which features the latest on all FDA-regulated products.

Updated: October 1, 2008