Personal Injury Law

Panel Says FDA Failed To Assess BPA Risk

By Chrissie Cole

A scientific advisory panel has concluded the Food and Drug Administration (FDA) underestimated scientific evidence and employed flawed methods when deciding a chemical widely used in baby bottles and in the lining of cans is not harmful.

The report, released today, finds the FDA did not take into account a host of studies linking bisphenol-A (BPA) to diabetes, prostate cancer and other health problems when finalizing its first draft risk assessment in September.

The U.S. government's National Toxicology Program, reviewed animal studies this year that also linked the chemical to developmental changes in fetuses and young children. The group, ranked the risk level for children in the middle of a five-point scale.

After considering those studies the panel determined the FDA’s margin of safety is “inadequate.” The panel, part of the Science Board, is made up of a committee of advisers to the FDA commissioner, and was initially assembled to review the FDA’s risk evaluation of BPA.

“The FDA agrees that in light of concerns raised in several studies relating to potential effects of low doses of BPA, that additional research will prove valuable,” said July Leon, a spokeswoman for the FDA.

The agency is moving forward with planned research aimed at addressing the potential low-dose effects of BPA. They plan to carefully assess the findings of these studies, said the agency in a recent statement.

The report adds more controversy to an already heated debate over whether BPA use should be banned. Bisphenol-A is a chemical used to harden plastic, particularly in baby bottles and cans of baby formula.

“Current exposure levels are unsafe,” says Sarah Janssen, a reproductive biologist with the environmental advocacy group, Natural Resources Defense Council (NRDC). “We should rid all food containers of BPA.”

John D. Dingell (D-Mich.) Chairman of the House Committee on Energy and Commerce and Rep. Bart Stupak (D-Mich.) along with many other state attorneys generals have called on formula-makers to ban the use of bisphenol-A in their products.

Conflict of Interest

Lawmakers, including Rep. Rosa DeLauro (D-Conn), have raised question about the connection between Martin Philbert, acting director of the Risk Science Center at the University of Michigan and the chemical industry after his center received a total of $15 million in grants from Dow Chemical, a manufacturer of BPA.

Philbert is head of the advisory panel that issued the report criticizing of the FDA.

Philbert is also the focus of a FDA probe into a conflict-of-interest after he took $5 million from a wealthy businessman with ties to the medical industry, than failed to disclose it. #

Full post as published by InjuryBoard on October 29, 2008 (boomark / email).