Personal Injury Law

FDA Plans More Studies On Bisphenol A

By Chrissie Cole

U.S. regulators are planning more research into bisphenol A, or BPA, a controversial chemical that is found in many plastic products, indicating they have no immediate plans to amend its position.

The U.S. Food and Drug Administration (FDA) released a letter on Monday, stating the agency has planned a “large research effort” with studies spanning several years intended to assess the effects of the chemical in laboratory animals including monkeys and rodents.

Consumer advocates have criticized the agency’s refusal to take steps now to amend use of bisphenol A, a chemical used to harden plastic found in a wide variety of products, from baby bottles to the lining of canned goods and compact discs.

“The agency plans to conduct these studies in a laboratory environment using representative dose ranges and multiple animal models,” said a letter signed by Norris Alderson, the FDA’s associate commissioner for science.

The letter represents the agency’s initial response to an October report by an external scientific advisory panel of experts convened by the agency. The panel concluded the agency failed to take into account a host of studies linking bisphenol-A to diabetes, liver abnormalities, cancer and other health problems when finalizing its first draft risk assessment in September.

After considering those studies the panel determined the FDA’s margin of safety is “inadequate.”

“It’s a waste of taxpayer dollars and places millions of babies yet to be born at risk, for the agency to spend more years of research to conclude what thousands of scientists already know about the toxic chemical,” said Alex Formuzis of the Environmental Working Group (EWG), an activist organization.

The chemical is used in thousands of everyday consumer items including food and beverage containers, shower curtains as well as in some medical devices. BPA mimics the hormone estrogen and may disrupt the body's endocrine system. People ingest it when it leaches from plastics into water, food or baby formula.

More than 130 studies, over the last decade, have linked BPA to diabetes, obesity, breast cancer, neurological problems and other health disorders. Much of the newest research suggests that chemical can have an effect even at very low doses – lower than those currently set by the FDA.

Most recently, the National Institutes of Health determined that BPA presents concern for harmful effects on the development of the brain, prostate and behavioral changes in fetuses, infants and children.

The FDA should ban the use of BPA immediately from products for babies and children or let the Obama administration deal with the issue, said Formuzis.

The agency has maintained the chemical is safe, relying largely on two animal studies funded by the chemical industry.

Political pressure on the agency to ban bisphenol A is mounting. 13 states have introduced BPA bans in several products. When Congress convenes in January, Sen. Charles E. Schumer (D-NY) and Rep. Edward J. Markey (D-Mass.) plan to reintroduce bills to ban the chemical.

A coalition of environmental and health groups meeting with President-elect Barack Obama’s transition team are pushing to make a BPA ban top priority.

Canada has declared BPA a “toxic substance” and plans to ban it from all baby bottles.

Many retailers and manufacturers including Target and Wal-Mart have already begun offering BPA-free alternatives. #

Full post as published by InjuryBoard on December 16, 2008 (boomark / email).