FDA Asked to Rethink Bisphenol A Safety

Panel Says FDA Should Reconsider Earlier Conclusion That Plastic Chemical Is Safe

From the WebMD Archives

Oct. 31, 2008 -- A scientific panel has formally urged the FDA to rethink a recent conclusion that a chemical used in baby bottles and infant formula packing is safe at current levels.

The chemical, called bisphenol A (BPA), is an ingredient in hard plastics and in the lining of many food cans. Consumer and environmental groups and several foreign regulatory bodies have called for the chemical to be banned over concerns that it may pose a health risk.

BPA is a known toxin. But the vast majority of studies are in animals. That forces scientists in many cases to take studies in mice or rats and extrapolate the results to humans.

The FDA concluded in August that the levels humans typically consume are safe. Earlier this week, a scientific subcommittee rejected that view, saying the agency ignored several studies and that it was premature to declare the chemical safe for human consumption.

On Friday, a scientific advisory board signed off on that report, in effect urging the agency to reconsider its conclusion.

The agency has until February to officially respond to the report. But a response is likely to come more quickly than that, says Stephen Sundlof, PhD, director of the FDA's Center for Food Safety and Applied Nutrition.

"We don't feel like we have to wait until February," Sundlof tells WebMD.

The agency has not urged consumers to avoid BPA-containing bottles or stop buying formula packaged in cans containing the chemical.

Still, some of the panel's members urged the agency to take immediate steps limiting infants' exposure to BPA.

Panel member Larry Sasich of the Lake Erie College of Medicine School of Pharmacy says the FDA is "losing credibility with the public" by failing to take clear steps limiting BPA exposure. "They expect us to come up with some solutions to this problem," Sasich says.

The FDA -- although revisiting its assumptions about safe BPA levels -- is still not recommending any change in consumer behavior. The agency is concerned that switching away from formula could pose a nutritional risk to infants that outweighs any benefit of avoiding BPA.


"We're very concerned that mothers will find and create their own infant formula," he says.

Groups representing formula manufacturers and packaging companies maintain that BPA is safe.

"They're not saying this is an imminent risk. They're just saying FDA needs to revisit its process," says John M. Rost, CEO of the North American Metal Packaging Alliance.

Consumer groups have urged the FDA to warn the public against potential BPA dangers while it searches for more conclusive scientific data about its safety. A number of major retailers, including Wal-Mart and Target, have said they would stop selling baby bottles that contain bisphenol A.

"The FDA should not draw conclusions that are biased and premature," says Diana Zuckerman, PhD, president of the National Research Center for Women and Families. "While the FDA is deciding what to do about BPA in food containers, they should at the very least empower consumers by requiring that food and beverage containers list whether or not they contain BPA."

WebMD Health News Reviewed by Brunilda Nazario, MD on October 31, 2008



Stephen Sundlof, PhD, director, center for Food Safety and Applied Nutrition, FDA.

Larry Sasich, Lake Erie College of Medicine School of Pharmacy; member, FDA advisory panel.

John M. Rost, CEO, North American Metal Packaging Alliance.

Diana Zuckerman, PhD, president, National Research Center for Women and Families.

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