FDA Denies Petition to Ban BPA, Questions Studies Showing Harm
By Daniel J. DeNoon
WebMD Health News
Reviewed by Louise Chang, MD
March 30, 2012 -- The FDA today said it will not ban BPA -- not yet, and maybe not ever.
Forcing today's FDA statement was a lawsuit by the environmental group Natural Resources Defense Council (NRDC). That lawsuit demanded that the FDA rule on the NRDC's 2008 petition asking the FDA to ban BPA.
To settle the legal action, the FDA agreed on a March 31 deadline for the ruling. Today the NRDC got its response in a 15-page letter.
"FDA is denying your citizen petition in its entirety," the letter states. "FDA has determined that its continued scientific study ... and review of all new evidence as it becomes available is the most appropriate course of action at this time."
Sarah Janssen, MD, PhD, an NRDC senior scientist, says the FDA has missed a chance to improve public health.
"BPA is a toxic chemical that has no place in our food supply. We believe FDA made the wrong call," Janssen says in a statement. "The agency has failed to protect our health and safety -- in the face of scientific studies that continue to raise disturbing questions about the long-term effects of BPA exposures, especially in fetuses, babies, and young children."
Jean Halloran, the director of food policy initiatives at Consumers Union, the policy arm of Consumer Reports, says in a statement, "We're disappointed with the FDA's decision because we think there's ample scientific evidence about the health risks of BPA for the agency to take action now and ban it from food and drink packaging."
In a statement provided to WebMD, the FDA stresses that its ruling "is not a final safety determination and the FDA continues to support research examining the safety of BPA."
Is BPA a Threat?
BPA is used to make the hard, clear plastic called polycarbonate. Except for those labeled "BPA-free," reusable plastic water bottles and plastic baby bottles are made from this polycarbonate. Cash-register receipts, toilet paper, and even U.S. cash is tainted with BPA. But most of our exposure comes from the BPA-containing epoxy resins in the protective lining of metal food and beverage cans.
Is BPA really bad for you? It's an important issue, as nearly all Americans have detectable BPA in their urine and, to a lesser extent, in their blood.
Just about everyone agrees that BPA is toxic in large enough amounts. But the real question is whether people are exposed to toxic amounts of BPA.
Animal studies show that BPA can cause cancer. Human studies link high blood levels of BPA to obesity, thyroid problems, reproductive abnormalities, heart disease, childhood behavior problems, and neurologic disorders in humans. These studies only suggest a possible problem -- they do not prove that BPA actually causes any of these harms. BPA has not been proven to cause any human disease or condition.
The NRDC correctly notes that BPA acts in the body as an estrogen-like hormone, and that even low-level estrogen activity can disrupt normal body functions in adults and normal development in fetuses and in young children.
Moreover, there's the issue of environmental exposure. BPA is everywhere. While individual exposures may be tiny, and while the body may quickly clear BPA from the blood, we're constantly being re-exposed.
But is this enough to make a difference in people's health? The NRDC says the FDA should err on the side of safety and ban BPA. The FDA isn't convinced.
"While evidence from some studies have raised questions as to whether BPA may be associated with a variety of health effects, there remain serious questions about these studies, particularly as they relate to humans and the public health impact of BPA," the FDA says in its letter to the NRDC.
The FDA says it's working on a new safety review of BPA this year. And it notes that another federal agency, the National Institute of Environmental Health Sciences, is funding $30 million worth of new BPA research.
So far, it looks like this research is persuading the FDA that current levels of BPA exposure are safe. The FDA says its research shows that:
- Exposure to BPA in human infants is from 84% to 92% less than previously estimated.
- Pregnant animals fed huge amounts of BPA passed very little of the chemical to their unborn babies.
- People of all ages process and rid their bodies of BPA faster than the rodents used as test animals do.
The NRDC's Janssen says the FDA is misreading the scientific research.
"The FDA is out-of-step with scientific and medical research," she says. "This illustrates the need for a major overhaul of how the government protects us against dangerous chemicals."
And Janssen notes that the NRDC is not alone in worrying about BPA.
"Numerous scientific bodies of scientists and physicians, including the Endocrine Society, the President's Cancer Panel appointed by President George W. Bush, the American Academy of Pediatrics, the American Congress of Obstetricians and Gynecologists and the American Medical Association have all publicly declared that BPA is a potential health threat," Janssen recently blogged.
SOURCES: News release, FDA. FDA statement via email with Douglas Karas, FDA public information officer. NRDC statement. NRDC petition. FDA letter to NRDC, March 30, 2012. News release, Consumers Union.
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