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FDA seeks data on BPA-containing devices

This article was originally published in The Gray Sheet

Executive Summary

FDA is requesting information on devices and other medical products that contain the chemical Bisphenol A, whether as part of the product or its packaging, the agency announces Oct. 15. NIH's National Toxicology Program released a draft report in April, finalized Sept. 3, on the potential for BPA to leach from plastics in consumer products and some medical products. After convening an agency-wide taskforce, FDA released a draft assessment Aug. 15 downplaying the toxicity and health risks of BPA in food-contact applications only (1"The Gray Sheet" Aug. 18, 2008, In Brief). But Congressional leaders are investigating a potential conflict of interest because Dr. Martin Philbert, chair of FDA's BPA advisory panel, heads a research center that received a $5 million donation from retired medical equipment manufacturer Charles Gelman, who advocates BPA's safety. Comments on the presence and risks of BPA in devices and other medical products are due Dec. 29

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