FDA ignored evidence when calling BPA safe

By Liz Szabo, USA TODAY
USA Today
Nov. 01, 2008

The Food and Drug Administration ignored evidence when concluding that a chemical in plastic baby bottles is safe, according an expert panel asked to review the agency's handling of the controversial substance.

The Food and Drug Administration ignored evidence about the danger posed by a chemical in plastic baby bottles, according a report released Wednesday.

The excluded studies suggest bisphenol A, or BPA, could pose harm to children at levels at least 10 times lower than the amount the agency says is safe, according to the report written by outside scientists asked to review the agency's handling of the controversial substance.

Excluding evidence of harm "creates a false sense of security" about BPA, the panel's report says.

The scientists took the FDA to task for basing its safety decision in August on three industry-funded studies. Another government agency, the National Toxicology Program, decided many other independent studies deserved consideration. The toxicology program concluded last month there is "some concern" that BPA alters development of the brain, prostate and behavior in children and fetuses.

The expert panel also found the FDA underestimated how much BPA babies ingest on several counts. For one, the agency failed to consider the cumulative effect of being exposed to BPA from dozens of products, a fundamental error that "severely limits the usefulness" of the FDA's safety estimate.

An advocacy group, the Natural Resources Defense Council, believes BPA is too toxic to use in baby products at all. The group formally has asked the FDA to remove BPA from food and beverage containers.

The new report was written by a subcommittee of the FDA's outside science board, experts who advise the FDA on complex issues. The full science board, scheduled to meet Friday, can endorse the subcommittee's report or write its own.

In a statement, the FDA said the subcommittee's report "raises important questions" and says it is planning to do additional research on BPA.

In a statement, the American Chemistry Council, an industry group, said members will comply with the FDA's final decision, even if that means phasing out BPA.

The subcommittee has attracted controversy itself. The FDA's deputy commissioner for policy, Randall Lutter, has recommended the subcommittee chairman refrain from voting because of allegations of conflict of interest. Lutter said there is no reason the chairman, Martin Philbert of the University of Michigan, should step down. Philbert heads a research center that has accepted funding from the chemical industry.

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