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Monday, September 29, 2008

Infant Formula: FDA Says What's Sold Legally in the U.S. is Safe

The Los Angeles Times reports on the FDA's assurance that infant formula is safe as the tainted products that sickened Chinese babies aren't allowed in the US, where formula-making is tightly regulated.  Jill Adams writes,

Baby_bottleBabies 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.

Search of Asian markets

THIS month the FDA has dispatched investigators to look for foreign-made infant formula in small specialty stores that cater to Asian Americans. "The FDA has a national field force of inspectors. In a situation like this, we also reach out to local and state officials," Leon said. Those officials include inspectors with the Los Angeles County Department of Health Services and the California Department of Public Health.

In Los Angeles County, field inspectors started visiting Asian markets earlier this month. No Chinese infant formula has been found, either on the shelves or in storage, according to Jesus Urrutia, chief of the food and milk program within the health department's Environmental Health Program, who oversaw the investigation for L.A. County. The initial field survey consisted of 15 stores and in all but one of those, shopkeepers were aware of the contamination risk. Now Urrutia has added Chinese infant formula to the list of items to be checked by county environmental health inspectors, who monitor food markets, warehouses and restaurants for sanitation, food-handling procedures and the like. This will effectively expand the search countywide -- food establishments are inspected at least annually -- and keep it going over time.

San Francisco and Los Angeles, along with New York City, were at the top of the list of more than a dozen areas where the FDA urged store-by-store inspections, based on their large Asian populations. More than 1,000 stores across the nation have been canvassed so far and no Chinese-made infant formula has been found, Leon said.

Consumers who buy formula online could also potentially be at risk if they don't stick to U.S. companies.

Leon said her office has been flooded with e-mails and calls from consumers. "We had to let people know, unless it has Chinese writing on it, don't worry about it. If it's Similac [or similar products], you're fine."

In an update of its advisory about melamine contamination, the FDA also cautions against purchasing other products imported from China that may contain milk, such as candies, desserts and beverages.

Melamine has also been found in a frozen yogurt dessert and a canned coffee drink made in China, but so far found only in countries outside the U.S., according to the WHO.

The FDA's Leon advises that if it's made in China and contains dairy products, don't eat it. "That's the safest position that people can take right now. Nobody knows yet how far and wide this will go."

Dairy products can take many forms, including milk protein concentrate, nonfat milk powder, whey powder, lactose powder and casein. "It's not the way we usually think of milk -- as fresh cow's milk. It's derivatives and powders that get reconstituted as a milk product," she said.

The FDA continues to expand its investigation. Not only is the agency warning against Chinese foods that may contain milk, but it's also inspecting bulk shipments of milk derivatives coming into U.S. ports and not only from China -- typically powdered milk products that are used to make other things besides formula, such as baking mixes or coffee creamer. It's an extra precaution and so far, no contamination has been found.

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