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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FDA on bisphenol A
Agency's decision to restrict its initial toxicity analysis of bisphenol A (BPA) to food-contact applications such as infant formula packaging "severely limits the usefulness" of the agency's draft 1assessment issued in August, says a subcommittee to FDA's Science Board in a 2report posted online Oct. 29. The report says FDA should have considered the "totality of exposures," including from medical devices used in the neonatal intensive care unit, to guide more accurate calculations. The observation is one of several critiques lodged at FDA's assessment, which the subcommittee says overlooks potentially informative data and comes to questionable conclusions about the safety margins for BPA levels in food packaging. FDA has said it plans to develop a separate assessment of BPA in medical products (3"The Gray Sheet" Oct. 20, 2008, In Brief). The subcommittee presented the report at an Oct. 31 Science Board meeting
FDA splits up BPA report
FDA released a draft assessment Aug. 15 downplaying the toxicity and health risks of the chemical bisphenol A (BPA) in food-contact applications, such as baby bottles and drink containers, and will issue a separate report focused on medical products at a later date, the agency says. NIH's National Toxicology Program released a report in April on the potential for BPA to leach from plastics in consumer products and some medical products (1"The Gray Sheet" May 12, 2008, p. 6). The BPA subcommittee of FDA's science board will meet Sept. 16 to discuss the food-related report