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FDA Faulted for Stance on Chemical in Plastics

By Steve Reinberg
HealthDay Reporter

FRIDAY, Oct. 31 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel agreed Friday that the agency had erred in August when it said that a chemical widely used in baby bottles and other plastic packaging for foods and beverages posed no health risks.

On Wednesday, a panel of toxicology experts said the FDA hadn't properly assessed the potential health risks posed by the chemical bisphenol A (BPA), which some studies have linked to cancer, diabetes, heart disease and developmental delays in children. The toxicologists said the FDA had relied too heavily on studies funded by the chemical industry to make its decision, and had failed to consider other studies that questioned the safety of BPA.

The panel of toxicologists had been convened by the FDA after the agency ruled that BPA was safe at current exposure levels -- a stance that prompted criticism from some lawmakers and consumer groups.

On Friday, the FDA's Science Board, which consists of scientists from academia, government and industry and advises the FDA commissioner, seconded the toxicologists' concerns about the FDA's August ruling. The issue will now go to FDA Commissioner Dr. Andrew von Eschenbach. It's unclear how the FDA might respond, the Washington Post reported.

"Let me be clear: There's no shame for having" your hypothesis disproved, von Eschenbach said during Friday's session, referring to BPA without mentioning it by name, the Dow Jones news service reported.

The FDA's position on BPA has been controversial because it contradicted more than 100 studies, as well as a finding by the U.S. National Toxicology Program, that there was "some concern" that BPA may affect the brain and behavioral development in fetuses, infants and small children, the Post said.

Norris Alderson, associate commissioner for science at the FDA, told Dow Jones that the agency will probably start research early in 2009 to determine the toxic effects of BPA on babies less than 1 month old. Babies are considered the most susceptible group to BPA's effects. It's unclear when those studies would be done, the news service said.

In September, a study published in the Journal of the American Medical Association said that people with high levels of BPA were more likely to have heart disease, including heart attack, or diabetes. High BPA levels increased the risk for these diseases by 39 percent, the researchers reported.

Speaking at Friday's hearing, Steven G. Hentges, of the American Chemistry Council's Polycarbonate/BPA Global Group, said: "The Science Board is receiving many diverse viewpoints on bisphenol A. But the common ground we all share is a commitment to do what's right to protect the health and safety of American consumers -- adults and children alike."

Hentges called the FDA's August draft assessment "consistent with the conclusions of other scientific and government bodies worldwide, such as the European Food Safety Authority, Health Canada, the European Union, and NSF International, all of which completed or updated their assessments this year. We rely on their conclusions, which are that polycarbonate plastic and epoxy resins are safe for use in food contact applications."

Earlier this month, Canada moved to ban plastic baby bottles containing BPA. Several U.S. states are considering restricting BPA use.

Commenting on Friday's developments, Dr. Hugh S. Taylor, director of the Division of Reproductive Endocrinology and Infertility at Yale University School of Medicine, said: "While the dangers of BPA exposure are far from definitively proven, the clear and mounting evidence that BPA is very likely to be harmful should not lead to a statement from the FDA that there is no concern. The panel's recommendation was misleading and gave people false reassurance. Decisions that may affect the health of the next several generations (due to the effects on the fetus as well) should be made cautiously and with input from all interested parties. The FDA is to be commended for this re-evaluation."

More information

To learn more about BPA, visit Environment California.

SOURCES: Hugh S. Taylor, M.D., director of the Division of Reproductive Endocrinology and Infertility, and professor of obstetrics and gynecology, Yale University School of Medicine, New Haven, Conn.; American Chemistry Council, news release, Oct. 31, 2008; Washington Post; Dow Jones

Last Updated: Nov. 01, 2008

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