FDA responds to BPA review
This article was originally published in The Tan Sheet
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 agency is formulating a response to its Science Board's review of FDA's draft assessment of bisphenol A's safety in food contact applications. Associate Commissioner for Science Norris Alderson initially replied to the board in a December 2008 letter, agreeing that FDA should focus on BPA applications that might impact infants, including formula packaging (1"The Tan Sheet" Jan. 5, 2009, In Brief). According to a Feb. 9 release, FDA and Health Canada officials held a forum Jan. 30 with manufacturers from both countries to discuss ongoing BPA reduction efforts. FDA says an international regulatory consensus holds that BPA exposure through food packages does not pose a risk to the general population, but the agency continues to review research on the potential low-dose effects of 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)
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