Infant formula: FDA says what's sold legally in the U.S. is safe

BABIES in China are obviously at risk from tainted infant formula. More than 54,000 children in that nation have been sickened and at least four have died in recent weeks after drinking contaminated milk products. But despite recent contamination of other Chinese products consumed by Americans, the threat from such products to children and infants in the U.S. appears minimal.

The Chinese formula in question is contaminated with melamine, a chemical powder high in nitrogen that is used in making fertilizers and durable plastics, including the unbreakable dinnerware known as melamine. The investigation in China is ongoing, but evidence suggests that melamine was deliberately added to boost, in lab tests, the apparent protein content of milk products used to make formula. The compound can cause kidney failure if ingested in large quantities.

Last week, more contaminated products turned up beyond mainland China, in Hong Kong and Macau, creating concern about how far afield contaminated goods might have traveled. The International Food Safety Authorities Network, an arm of the World Health Organization, is working to track the export of suspect products and to inform recipient countries.

Americans who rely on U.S.-made formula have little to worry about. Although pet food and toothpaste made in China and sold to Americans have been found to be contaminated, the formula bought by American consumers is more tightly regulated by the U.S. Food and Drug Administration than those products.

The FDA issued an advisory earlier this month saying that infant formula sold in the U.S. is safe. The big names, such as Similac and Enfamil, are manufactured here and they have met FDA standards for what goes into them and how they are made. Further, in response to the situation in China, the FDA has examined where formula makers get their ingredients and found none from China, said FDA spokeswoman Judy Leon.

A total of five companies are licensed to sell milk-based formula products in the U.S., and all are U.S.-based. In addition to nutritional content of infant formula, the FDA regulates the manufacturing process and record-keeping by the companies. The FDA also performs annual facilities inspections and product analyses.

That's not to say consumers couldn't get their hands on tainted formula. Federal officials remain concerned about imported formula that has not met FDA regulations. Technically it's illegal to sell Chinese formula in the U.S., but that doesn't mean it can't happen. An investigation turned up a can of Chinese-made infant formula in 2004, but at that time, low protein content was the concern, not contamination.