FDA Panel Accepts Findings On BPA
Saturday, November 1, 2008
The Food and Drug Administration made mistakes when determining that a widely used chemical found in baby bottles and other plastics was harmless and the agency should redo its risk assessment, an FDA advisory panel ruled yesterday.
But the report's authors told the Science Board advisory panel that they could not say whether BPA was harmful or whether it should be banned in food and beverage containers. They left that to FDA Commissioner Andrew von Eschenbach to decide.
How von Eschenbach will respond is unclear, especially as the Bush administration winds down. The FDA said earlier this week that it plans to do more research, which will probably take years. The agency will respond in writing to the Science Board's decision and the report within 30 days, said agency spokeswoman Judy Leon.
The FDA Science Board, a group of scientists drawn from academia, government and industry that advises the FDA commissioner, voted unanimously yesterday at a meeting in Gaithersburg to accept a report done by a subcommittee that blasted the agency's recent risk assessment of bisphenol-A (BPA), a compound found in baby bottles and the lining of food and soda cans.
The report, released earlier this week, said the FDA ignored scores of government-funded studies that linked exposure to low doses of BPA to increased risk of diabetes, heart disease, hyperactivity and cancer in laboratory animals and that its margin of safety was "inadequate."
Scientists, lawmakers, and environmental and consumer groups contend the FDA should ban the substance from food and beverage containers until they are certain that it is safe.
The FDA's stance on BPA has been controversial because it is out of step with more than 100 studies as well as a finding by the National Toxicology Program, part of the National Institutes of Health, that there is "some concern" that BPA may affect the brain and behavioral development in fetuses, infants and small children. The NTP reviewed many of the studies that the Science Board subcommittee said the FDA ignored, and Martin Philbert, a University of Michigan toxicologist who headed the FDA panel that produced the critical report, said the agency should use studies the NTP relied on.
In their evaluation of BPA's risks, FDA officials relied heavily on two studies funded by the American Plastics Council, which represents BPA manufacturers. The FDA said it did so because the agency itself contributed to the design of those studies and examined the raw data. Philbert told the Science Board that while the FDA's reliance on those studies was "understandable," they were not the only ones that the agency should use because they were not designed to account for the effect on fetuses. Low doses of BPA "may put neonates at greater risk than the assessment acknowledges," Philbert said.
Philbert also said the FDA should consider what he called a "landmark study" that was published in the Journal of the American Medical Association in September. That study found that people with higher levels of BPA had higher rates of diabetes, liver abnormalities, and heart disease. Based in part on that study, Canada banned BPA from baby bottles in October.
BPA is also found in the lining of liquid infant formula cans. The Environmental Working Group, an advocacy group, yesterday called on infant formula makers to voluntarily eliminate BPA from the cans. Most of the largest formula manufacturers said they plan to phase out BPA but that the timing depends on whether they can secure FDA approval for alternatives.
"As soon as a safe alternative is identified by the chemical and packaging industry, we stand ready to bring these new containers to market as soon as they are approved by the FDA," said Mardi Mountford, executive vice president of the International Formula Council, based in Atlanta.
John Rost, chairman of the North American Metal Packaging Manufacturing Association, said it could take two years before FDA-approved alternatives could be phased in.
"There is no drop-in alternative to BPA" in can linings, he said.