December 15, 2008 / 8:47 PM / 11 years ago

FDA plans more studies on baby bottle chemical

WASHINGTON (Reuters) - U.S. regulators are planning more research into a controversial chemical found in many plastic products, including baby bottles, indicating they have no immediate plans to curb bisphenol A.

A letter signed by a Food and Drug Administration official, released on Monday, stated that the agency planned “a large research effort,” with studies lasting years that will assess the effects of the chemical, also called BPA, in laboratory animals including rodents and monkeys.

Consumer advocates condemned the regulatory agency’s refusal to take steps now to curb the use of bisphenol A, a chemical used for decades to harden plastic products.

“FDA is planning to conduct these studies in its laboratories using representative dose ranges and multiple animal models,” according to the letter signed by Norris Alderson, the FDA’s associate commissioner for science.

This indicates that the issue of what to do regarding BPA will fall to the incoming administration of President-elect Barack Obama to decide.

The letter represented the initial response to an October report by a panel of outside experts convened by the agency. The panel found the FDA failed to consider existing studies calling into question BPA’s safety when it issued a draft conclusion in August that BPA is safe at current exposure levels.

The advisory panel’s report concluded that “the margins of safety defined by FDA as ‘adequate’ are, in fact, inadequate.”

“More years of research by FDA to determine what thousands of scientists worldwide already know about the toxic chemical is a waste of time, taxpayer dollars and will place millions of babies yet to be born at risk,” said Alex Formuzis of the activist organization Environmental Working Group.

BPA is used in many food and beverage containers, the coating of food cans and some medical devices. It mimics the hormone estrogen in the body. People consume it when it leaches from plastic into baby formula, water or food in a container.

U.S. government toxicologists at the National Institutes of Health this year concluded BPA presents concern for harmful effects on development of the prostate and brain and for behavioral changes in fetuses, infants and children.

“FDA is re-evaluating available data and planning for the acquisition of additional data that will strengthen the exposure estimates from all dietary sources of BPA, with particular attention to dietary sources relevant to infants and children,” the FDA letter said.

Formuzis said the FDA should either immediately ban BPA from use in products for babies and young children or let the Obama administration deal with the matter.

Steven Hentges of the American Chemistry Council industry group welcomed the FDA comments, saying: “We share with FDA their concern for public health and particularly the health of infants and children. We look forward to the outcome of their evaluation. We are prepared to following their guidance when they complete their evaluation.”

A study by British researchers published in September showed that people with the highest levels of BPA in their body were much more likely to have heart disease, diabetes and liver-enzyme abnormalities than those with the lowest levels.

Canada said this month it will move to limit sales of baby bottles made with BPA due to health concerns.

Environmentalists and some U.S. lawmakers have said the FDA has relied too heavily on two industry-funded animal studies to dismiss safety concerns about BPA.

FDA officials previously have said they did not ignore evidence showing possible harm from BPA.

Editing by Bill Trott

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below