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Science Board looks at BPA, contaminants

This article was originally published in The Tan Sheet

Executive Summary

The FDA advisory group receives information on current methods for detecting contaminants in agency-regulated products and plans to discuss a subcommittee's review of bisphenol A use in food contact applications at an upcoming meeting. Although FDA has determined that BPA lining food containers is safe, a September study in the Journal of American Medical Association found higher concentrations of the substance in human urine is associated with cardiovascular disease, diabetes and liver-enzyme abnormalities (1"The Tan Sheet" Sept. 22, 2008, In Brief). In an Oct. 9 Federal Register notice, FDA says the board also will discuss its 2009 agenda topics during the meeting scheduled for Oct. 31 at the Washington, DC North/Gaithersburg Hilton in Gaithersburg, Md. The agency says background material on the topics should be available at least two days before the meeting

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FDA regroups on BPA

FDA says Oct. 28 it plans to research and address the potential low-dose effects of bisphenol A, which is used in packaging for some infant formula and food products. The Science Board on Oct. 31 asked the agency to reconsider its finding that current levels of BPA that transfer to foods and are absorbed by children are safe. The board recommended this after its BPA subcommittee reported FDA overlooked multiple studies that it should have considered. Before FDA's advisory board rendered its opinion, a Journal of American Medical Association study concluded higher concentrations of BPA in human urine are associated with cardiovascular disease, diabetes and liver-enzyme abnormalities. The JAMA study prompted Congress to criticize FDA's conclusion (1"The Tan Sheet" Oct. 13, 2008, In Brief)

FDA under pressure for BPA safety

Following a Sept. 17 study in the Journal of American Medical Association that finds higher concentrations of Bisphenol A in human urine is associated with cardiovascular disease, diabetes and liver-enzyme abnormalities, Reps. Rosa DeLauro, D-Conn., and John Dingell, D-Mich., criticize FDA's determination that BPA in food lining containers is safe. DeLauro says in a Sept. 16 release that FDA's stance on BPA's safety is "perplexing and dangerous." Likewise, Dingell urged the agency to "take careful notice of this new research during its Science Board meeting on Bisphenol A" Sept. 16, according to a same-day release. The most recent JAMA study does not conclusively link BPA in food containers as a cause of the associated diseases

UK To Seek Only Limited Regulatory Alignment With EU

Despite the life sciences industry’s call for continued alignment of medicines regulation with the EU from next year and for some sort of co-operation with the European Medicines Agency, it seems the UK government is prepared to make only small concessions.

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