FDA says it's unable to regulate BPA

As 'indirect food additive,' substance is exempt from scrutiny

By Meg Kissinger, Journal Sentinel

U.S. Food and Drug Administration officials say they are powerless to regulate BPA, although they have declared the chemical to be a safety concern for fetuses, babies and young children.

A quirk in the rules allows BPA makers to skirt federal regulation.

"We may have to go after legislation to change it," Joshua Sharfstein, the FDA's principal deputy director, told the Journal Sentinel. The newspaper has been investigating the government's lack of regulation regarding BPA for three years.

FDA officials announced Friday that they had reversed their position that bisphenol A is safe. The chemical, used to line most food and beverage cans, has been found in the urine of 93% of Americans tested.

The agency now considers BPA to be of some concern for effects on the brain, behavior and prostate glands of fetuses and the very young. Scientific studies have raised concerns about the chemical's link to breast and prostate cancer, diabetes, obesity, heart disease, reproductive failures and behavioral problems.

The FDA did not ban the chemical, although top scientists, including Linda Birnbaum, director of the National Toxicology Program, say they consider the safety of BPA to be uncertain. An agency source says some from within the FDA wanted to follow Canada's lead and ban it from baby bottles - or from the lining of infant formula cans - but administration officials have resisted, concerned that babies who rely on bottled formula would be left without healthy alternatives.

"They couldn't take it off the shelves when there aren't substitutes in place," said the source, who asked not to be identified because the issue is so politically charged in the agency.

FDA officials - including Sharfstein; Lynn Goldmann, a consultant to the FDA; and Jesse Goodman, the FDA's acting chief scientist - told the Journal Sentinel they were frustrated by the antiquated framework of the FDA's regulatory process.

Officials say they would like chemical manufacturers to report information about the chemical to them, including how much BPA they produce and where and how it is used.

But because BPA was classified years ago as an indirect food additive, it is not subject to the kind of scrutiny that other chemicals are. Without critical data about BPA, it is impossible to regulate the chemical, officials said.

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See also, FDA reverses ruling after evidence, pressure mounted

Bisphenol A was developed as an estrogen replacement more than 100 years ago but came into wide use to make hard, clear plastic in the 1960s. The chemical, now used to line most food and beverage cans, has increasingly been the subject of safety concerns. Here is a look at key dates:

1998: Patricia Hunt, a scientist at Case Western Reserve University investigating the connection between maternal age and Down syndrome, notices that her untreated laboratory mice, stored in polycarbonate cages, are developing chromosomal abnormalities. Scientists begin to look at the connection between BPA and diseases such as breast and testicular cancers. Subsequent studies link BPA to heart disease, diabetes and behavioral problems in lab animals. ...