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FDA to Finally Review BPA

Jun 9, 2008 | Parker Waichman LLP Although the US Food and Drug Administration (FDA) has long maintained - even in the face of much evidence to the contrary - that the chemical bisphenol A (BPA) is safe, the agency is finally taking steps to review the issue further.  An FDA Science Board subcommittee will hold a public meeting on the safety of BPA in plastics, review an Agency Task Force report, and deliver findings to the Board's annual meeting this fall.  This week, Frank M. Torti, M.D., M.P.H., the FDA's principal deputy commissioner and chief scientist asked Science Board Chairwoman Barbara J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical School, to establish a subcommittee to assess BPA.

BPA is a ubiquitous chemical that has been under debate and in the news in recent months.    BPA is a chemical compound that mimics estrogen and is found in polycarbonate plastics and epoxy resin.  Studies confirm BPA is chemically similar to diethylstilbestrol, a synthetic estrogen linked to the development of vaginal cancer in the daughters of women who took the drug in the 1950s-1960s to prevent miscarriage.  BPA has been in commercial use since the 1950s and is found in a wide variety of everyday items including water bottles, food and drink packaging, food can linings, dental sealants, CDs and DVDs, eyeglasses, and automobiles.

According to an FDA release, “In April 2008, the FDA formed an agency-wide BPA Task Force to facilitate review of current research and new information on BPA.  ‘The FDA Task Force is assembling an inventory of FDA-regulated products that contain BPA and we are exploring what is known about the safety of this substance in those products,’ said Torti.”  Once the review is complete, the Task Force will provide recommendations to Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D.

While the FDA now says it has been reviewing emerging literature on BPA on a continuous basis for years and its Center for Food Safety and Applied Nutrition initiated a formal reexamination of the safety of BPA in early 2007, as recently as last month, the FDA agreed with the chemical industry in defending its safety, announcing it saw no reason to advise consumers to stop using products made with the controversial chemical.  Norris Alderson, the FDA's associate commissioner for science said although the FDA is reviewing concerns about BPA, "a large body of available evidence" indicates products such as liquid or food containers made with BPA are safe.  In testimony before a Senate subcommittee, Alderson defended the FDA's reliance on two industry-funded studies in making this determination.

This April, the National Toxicology Program (NTP) of the National Institutes of Health published a Draft Brief stating that some studies suggest BPA may raise “some concerns” for “neural and behavioral effects in fetuses, infants, and children at current human exposures” and also had "some concern" for exposure in these populations “based on effects in the prostate gland, mammary gland, and an earlier age for puberty in females.”  The NTP is collecting public comments and scheduled a June 11 peer review meeting for its brief.

Critics have accused the FDA of failing to act on BPA concerns and have accused them of acquiescing to industry.


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