FDA Permits Small Amount of Melamine in US Baby Formula

December 01, 2008 11:05 AM
by findingDulcinea Staff
After the baby formula scare in China sickened thousands of infants, trace amounts of the chemical responsible will be allowed in formulas sold in the United States.

U.S. Baby Formulas and Melamine

The Food and Drug Administration has determined that trace amounts of the industrial chemical melamine are safe and allowable in baby formula sold in the United States.

Melamine is the substance that has contributed to kidney problems in thousands of babies in China, according to Jennifer Corbett Dooren of The Wall Street Journal.

When the problems in China developed, the FDA began testing domestic baby formulas to determine whether they were safe. Initially, the FDA said it was uncertain whether there was a permissible amount of melamine for baby formula.

After testing, the agency has now stated that "levels of melamine alone or cyanuric acid alone, at or below 1 part per million (ppm) in infant formula do not raise public health concerns."

According to The Wall Street Journal, cyanuric acid is a melamine by-product. Separately, the substances are not likely to harm babies, but they can cause kidney damage when combined. 

Formulas were tested from the five approved U.S. infant formula manufacturers: Abbott Laboratories, Bristol-Myers, Solus Products LLC, PBM Products LLC and Nestlé. Corbett Dooren reported that most tests came back negative for melamine and cyanuric acid.

Dr. Stephen Sundlof, who heads the food safety division for the FDA, said melamine and cyanuric acid will not be allowed together in infant formula, and that the U.S. baby formula supply is safe.

Background: Melamine causes problems in food supply

China's state media recently reported that the industrial chemical melamine is "probably being routinely added" to animal feed, according to the BBC. Some have viewed the report as a confession that melamine may be present in much more than milk, which has been blamed for sickening thousands of babies and killing at least four.

Investigators recently traced melamine in four brands of Chinese eggs, prompting speculation that animals in China are eating melamine-contaminated feed.

Chinese authorities have destroyed more than 3,600 tons of animal feed contaminated with melamine, and closed 238 illegal feed makers, according to the International Herald Tribune.

While some of China's state newspapers suggested there is a widespread practice of adding melamine to feed, the China Daily newspaper said, "We cannot say for sure if the same chemical has made its way into other types of food."

China is one of the largest food exporters in the world, making concerns over food safety even more troubling to some individuals.

"It is illegal for any individual or any enterprise to add melamine into feed, and we will crack down uncompromisingly on melamine," Wang Zhicai, director of the animal husbandry and livestock bureau at the Agriculture Ministry, said at a news conference.

Melamine was the culprit in the poisoning of thousands of babies in China. In October, the Chinese ministry offered a partial update of its official victim figures for the milk scare. As of Sept. 21, the official number of children hospitalized for melamine poisoning was at 13,371, reported Agence France-Presse. There were 10,666 children who remained hospitalized by Oct. 9, while 36,144 had been in the hospital but were allowed to return to their homes.

Thousands of others have received outpatient care, but a health ministry spokeswoman told AFP that they did not have updated figures on outpatients. On Sept. 21, it was reported that 39,965 children received outpatient care.

Ministry officials also said that while they did have updated figures for the total number of children affected so far by the milk scare, they would not make the information public.

Reuters reported that according to its analysis of local media reports across China, the number of affected children reached almost 94,000—almost double the number of the ministry's last official count.

Despite the alarming numbers coming from all parts of the country, Chinese officials say that the epidemic is under control and that melamine has not been found in liquid milk in recent tests.

Related Topic: FDA heading to China

Repeated safety scares from Chinese-made products have prompted the Food and Drug Administration to set up three offices in China, according to the Associated Press.

The offices will try to curb the problems that have plagued consumers over the last several months.

The AP reported that the office of U.S. Health and Human Services Secretary Mike Leavitt released a statement saying, "Establishing a permanent FDA presence in China will greatly enhance the speed and effectiveness of our regulatory cooperation and our efforts to protect consumers in both countries."

In 2007, consumers were troubled to learn that Chinese-made pet food had been contaminated with the industrial chemical melamine. Later that year, the concerns grew when lead paint and other harmful chemicals were detected in Chinese-made toys.

Earlier in 2008, tainted heparin, a medication that prevents blood from clotting, also found its way from China to the United States.

These will be the first internationally-based FDA offices.

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