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Advisory Panel Blasts FDA Over Bisphenol-A Stand

Critics say agency is making decisions about chemical without enough data

October 30, 2008

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It's one thing when a consumer group issues a blistering critique of the Food and Drug Administration. It's quite another when the criticism comes from a panel appointed by the agency itself.

In a report, a scientific panel assembled by the FDA to study the agency's position on the controversial chemical bisphenol-A found a lot to criticize. While not taking a position on whether the chemical, also known as BPA, is safe, the panel criticized the FDA for allegedly ignoring studies that claim BPA is dangerous.

In ignoring that research, the panel said, the FDA is creating what it called a false sense of security among consumers, who assume products containing BPA pose no threat because the FDA says its safe.

Some retailers, including Wal-Mart, have taken those studies very seriously, pulling products containing BPA from their shelves, if the products are intended to be used by children.

BPA is widely used in plastic manufacturing, since it is added to plastic to make it more rigid. It's used in clear, plastic water bottles, for example. It's also sound in infant formula bottles.

Studies have suggested that's not a safe use, since the animal studies involving the chemical have linked it to changes in body chemistry, and in some cases an increased cancer risk.

At present, the FDA's position is that the levels of BPA in products used by both adults and children are not high enough to cause a health risk in humans. In taking issue with that position, the panel said the FDA does not have an adequate number of infant formula samples and relies too heavily on averages, rather than accounting for variability in the samples.

It also noted that new research on BPA in adult humans and animals was published after the FDA draft report, but were not included in the final report. It took issue with the margins of safety for BPA exposure, cited by the agency, as being inadequate.

The FDA said the advisory panel "raised important questions" and said the whole issue needs more study.

The American Chemistry Council, meanwhile, said it is ready to make changes in its manufacturing process, but needs direction from the FDA.

"If the agency determines that existing margins of safety are insufficient in infant applications, our member companies that manufacture BPA will put processes in place to promptly phase out the use of materials containing BPA in baby bottles and infant formula packaging," the group said in a statement.

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