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FDA Maintains BPA Safety Assessment

Posted on: Wednesday, 17 September 2008, 12:30 CDT

The U.S. Food and Drug Administration (FDA) defended its position on Tuesday that bisphenol A, a chemical found in plastic baby bottles and other food packaging, is safe.

"Right now, our tentative conclusion is that it's safe, so we're not recommending any change in habits," said Laura Tarantino, who leads the FDA's office of food additive safety.

BPA is a chemical used in hardened plastics in a wide range of consumer products, such as food containers, eyeglass lenses and compact discs.

The agency made its comments during a scientific hearing on Tuesday, amid the first major study of bisphenol A’s health effects, which found the chemical linked with possible risks for diabetes and heart disease.

Scientists have been at odds over the safety of bisphenol A, or BPA, for some time, a debate that could continue for years.

Tarantino said that "there are a number of things people can do to lower their exposure," such as avoiding plastic containers imprinted with the recycling number ‘7’, which often contain BPA.  She also said consumers can avoid warming food in these containers, because heat serves to release the chemical.

More than nine in ten  Americans have trace levels of the ubiquitous chemical in their bodies, but the agency said they are too low to pose a health risk, even in infants and children.

However, new research released Tuesday by the Journal of the American Medical Association (JAMA) suggested possible public health implications of BPA, and the study’s authors have said the results "deserve scientific follow-up”.

The study, released to coincide with the FDA’s hearing, reviewed health surveys of roughly 1,500 adults, and found that those exposed to higher amounts of BPA were more likely to report having diabetes and heart disease.

However, the preliminary study is far from conclusive that BPA caused the health problems, and some analysts have said it provides no answers about whether BPA is harmful.

FDA officials conceded that further research is needed, and said they are not dismissing the findings.

"We recognize the need to resolve the concerning questions that have been raised," said Tarantino.

But the agency maintains that the rat and mice studies it relied upon for its assessment are more thorough than some of the human research that has raised concerns.

Although the FDA has the authority to limit use of BPA in food containers and medical devices, its internal report released last month concluded that BPA exposure is not enough to warrant such action.

However, since that time another government agency released a separate report finding that human risks, especially in children and infants, cannot be ruled out.

Previous studies with animals have suggested reproductive and hormone-related problems associated with BPA.  The JAMA study is the largest to date in looking at BPA’s possible effects in people, and the first to suggest a direct link to heart disease, according to scientists John Peterson Myers and Frederick vom Saal, both longtime critics of BPA.   However, they acknowledge more rigorous studies are needed to confirm the study’s results.

Vom Saal, a biological sciences professor at University of Missouri who has served as an expert witness and consultant on BPA litigation, and Myers, chief scientist at Environmental Health Sciences, a Charlottesville, Va., nonprofit group, authored an accompanying editorial in the JAMA study.

Many scientists believe BPA can simulate the hormone estrogen, and animal studies have linked the chemical with reproductive system problems and prostate, breast and other cancers.

Researchers from Britain and the University of Iowa examined a U.S. government health survey of 1,455 American adults.  The participants provided urine samples in 2003-04 and reported whether they had any common diseases.

The participants were divided into four groups according to their BPA urine amounts.  More than 90 percent were found to have detectable levels of the chemical in their urine.

A total of 79 reported having had a heart attack, chest pain or other types of cardiovascular disease, while 136 had diabetes.  The researchers found that the highest BPA group had more than twice as many people with heart disease or diabetes compared with the lowest BPA group.  The study showed no link between BPA and other illnesses, including cancer.
None of the participants had BPA urine amounts higher than the recommended exposure levels, according to University of Exeter researcher Dr. David Melzer, the study’s co-author.
 
Drs. Lisa Schwartz and Steven Woloshin of the Dartmouth Institute for Health Policy and Clinical Practice said the study did not present a clear indication about what might have caused the participants’ heart disease and diabetes.

"Measuring who has disease and high BPA levels at a single point in time cannot tell you which comes first," Schwartz told the AP.

The researchers acknowledge that they cannot rule out that people who already have heart disease or diabetes may be more vulnerable to having BPA show up in their urine.

The industry group American Chemistry Council said the study had substantial limitations, and called it flawed and inconclusive.

However, others say it raises enough concern to warrant limits on BPA exposure.

"We shouldn't wait until further studies are done in order to act in protecting humans," Dr. Ana Soto of Tufts University told the Associated Press.

A previous laboratory test involving human fat tissue found that BPA could interfere with a hormone involved in protecting against diabetes, heart disease and obesity.   That study was published online last month in the journal Environmental Health Perspectives, a monthly publication by the U.S. National Institutes of Health.

Government toxicology experts recently concluded their own report based on earlier animal studies, which concluded that there was no strong evidence of health hazards from BPA.  However, they acknowledged there is "some concern" about possible effects on the brain in fetuses, infants and children.

Several states are looking at BPA restrictions, and  some manufacturers are now promoting BPA-free baby bottles.  The European Union has said that products with BPA are safe, however the Canadian government has proposed prohibiting the sale of baby bottles with BPA as a precautionary measure.

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• Journal of the American Medical Association

Source: redOrbit Staff & Wire Reports

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