FDA regroups on BPA
This article was originally published in The Tan Sheet
Executive Summary
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)
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Norris Alderson, FDA's associate commissioner for science, says in a Dec. 3 letter the agency and its Science Board agree that the draft assessment of bisphenol A use should focus on "dietary sources relevant to infants," including exposure from epoxy used in formula packaging. The letter, addressed to Barbara McNeil of the Science Board and Harvard Medical School, says that the board's peer review report recommends additional work relating to BPA exposure, health effects and proposed research. Alderson adds that FDA will work with the Centers for Disease Control and Prevention and other parties to develop additional biomonitoring data for infants and exposure assessments for infant formula packaging. The agency previously was criticized for suggesting that low levels of BPA transferred from food packaging are safe in children (1"The Tan Sheet" Nov. 10, 2008, In Brief)
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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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