FDA To Revise BPA Review, Considers Independent Studies

Dow Jones , Jared A. Favole
Published December 15, 2008

WASHINGTON -(Dow Jones)- The Food and Drug Administration is revising its draft assessment on a chemical commonly found in baby bottles, saying it will reconsider some independent studies that showed Bisphenol-A, or BPA, isn't safe at current levels. The move is likely to be welcomed by academics, scientists and lawmakers who criticized the agency for saying BPA is safe at current levels despite hundreds of independent studies showing BPA isn't safe. The FDA's view on BPA, which was released in an August draft report, relied heavily on studies funded by the chemical industry. An FDA panel of outside medical experts agreed that independent studies deserve more attention. The panel said the FDA's stance on BPA wasn't supported by the available data and science. The FDA will re-evaluate some independent studies on BPA to determine whether they deserve more consideration, said Norris Alderson, the FDA's associate commissioner for science, in a Dec. 3 letter to an FDA advisory board. That doesn't mean the FDA's position on BPA will change. The letter is sure to reignite debate about the safety of BPA, and the FDA's handling of the issue. The agency has faced charges from scientists and environmentalists that it is acting too slowly. They want the agency to ban the chemical from infant products until studies prove it isn't harmful. "Right now I'm very concerned about the pace of this progress," said Sonya Lunder of the Environmental Working Group, an advocacy organization. " Considering 4 million babies are born each year, do they understand the urgency of this issue?" Lunder suggested the FDA follow the lead of Canada, which this year said it was banning baby bottles containing BPA. The FDA has resisted such a move, saying the agency can't just follow another country's lead. The chemical industry has said it is committed to phasing out the use of materials containing BPA in some infant products if the FDA suggests the chemical isn't safe. Retailers such as Wal-Mart Stores Inc. (WMT) have taken a cautionary stance and started removing baby bottles containing BPA from their shelves. The FDA is "actively" searching for newer data on BPA and has already begun reviewing two studies scientists suggested it look at, Alderson's letter said. Alderson said the agency is developing guidelines to better evaluate BPA's effect. The FDA also is considering using a statistical technique, which would allow the agency to summarize results of dozens or hundreds of studies, to determine the chemical's safety. The agency hasn't used this technique, known as meta-analysis, for regulatory decisions. The FDA has acknowledged relying on the industry-funded studies, in part because they follow strict guidelines that allow the agency to come to independent conclusions. Scientists charge that the industry studies use old- fashioned testing methods that aren't sensitive to capturing the effects of BPA. The FDA said it excluded many independent studies because they don't follow strict recording guidelines like the industry-funded studies. According to Alderson's letter, the FDA will consider some of the studies it excluded in the original August report and will more clearly explain why certain studies are included or excluded. BPA, first synthesized in 1891, appears in everything from baby bottles to sunglasses. Studies suggest BPA may be associated with a variety of problems, including Type-2 diabetes, prostate cancer, genital defects in men, early onset of puberty in women and behavioral problems.