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FDA to Investigate BPA

Apr 29, 2008 | Parker Waichman Alonso LLP

The Food & Drug Administration (FDA) is finally looking into concerns about the safety of bisphenol A—BPA—a chemical that imitates the hormone estrogen and which is found in polycarbonate plastic.  BPA is found in some baby bottles; water bottles; some food and drink packaging; epoxy resins, which line some metal products including canned foods; dental sealants, CDs and DVDs, eyeglasses, and hundreds of household goods.  Over 90 percent of Americans are exposed to BPA, according to the Centers for Disease Control and Prevention (CDC) and BPA has been found in the urine of 95% of Americans tested.

The FDA just formed an agency-wide BPA task force to review concerns noted in a “Bisphenol A Draft Report” recently issued by scientists from the National Toxicology Program and in a separate risk assessment by Canadian health officials.  The FDA states that based on its ongoing review, "we believe there is a large body of evidence that indicates that FDA-regulated products containing BPA currently on the market are safe and that exposure levels to BPA from food contact materials, including for infants and children, are below those that may cause health effects. However, we will continue to consider new research and information as they become available."

The FDA says it isn't recommending anyone discontinue using BPA-containing products; however, "concerned consumers should know that several alternatives to polycarbonate baby bottles exist, including glass baby bottles."  The American Chemistry Council, an industry group, also maintains potential human exposure to BPA is minimal and poses no known risk to human health.

Despite the FDA’s statements to the contrary and industry’s defense of the chemical, legislation has been proposed in several states to limit or ban BPA use, New Jersey lawmakers passed a bill to ban the sale of all BPA-containing products, Canada’s health agency is examining BPA health risks, a major Canadian retailer removed Nalgene and other polycarbonate containers from shelves, and Canada proposed a BPA ban in baby bottles.  Toys 'R' Us, Wal-Mart, Playtex, and CVS have all announced that they are phasing out bottles and other baby feeding products containing BPA; Nalgene said it would stop using BPA; and Senator Charles Schumer, Democrat-N.Y., introduced legislation to ban BPA from all baby bottles.  

Low BPA levels have been found to cause changes in behavior; in the brain, prostate gland, and mammary gland; and the age at which girls enter puberty.  In the lab, BPA is linked to sex-hormone-imbalances, including breast and prostate cancer, early puberty, miscarriage, low sperm count, and immune-system changes.  The National Toxicology Program's Center for the Evaluation of Risks to Human Reproduction found BPA risk and exposure causes neural and behavioral effects in children.  A group of scientists from the Centers for Disease Control (CDC), the FDA, and the Institutes of Health (NIH) warned that very low doses of BPA cause profound effects on laboratory animals, particularly during pregnancy and infancy and that BPA can permanently rewire genetic programming before birth.  The federal National Toxicology Program said experiments on rats found precancerous tumors, urinary tract problems, and early puberty when animals were fed or injected with low BPA doses.