by Heidi Green
November 12, 2008

Here’s some good news: Pressure is building for the Food and Drug Administration (FDA) to finally take some action about Bisphenol A (BPA).

Still, as reported by baby gooroo in May, the bad news is that any action might be a long time coming.

A review of the problem
BPA is a chemical found in baby bottles, sippy cups, the lining of infant formula cans, many plastic water bottles, and lots of other products. As reported by the Center for the Evaluation of Risks to Human Reproduction (of the National Institutes of Health), BPA could be posing some risk to the brain development of babies and children. The National Toxicology Program concluded that there is “some concern” for the effects of BPA in fetuses, infants and children on neural and behavioral factors as well as factors related to the prostate gland, mammary gland, and early puberty for females.

In the past, the FDA has pooh-poohed such suggestions. Its long-standing statement that BPA is safe has remained unchanged.

What’s new
In recent weeks, this statement has been dealt a powerful one-two punch. The first blow came in a large-scale research study reported in JAMA, a respected medical journal. A research team led by Dr. Iain Lang examined data from an extensive national U.S. survey (National Health and Nutrition Examination Survey). They looked at BPA concentration in urine and health conditions. They concluded that higher urinary BPA concentrations were associated with cardiovascular diagnoses, diabetes, and liver enzyme abnormalities. While the study could not prove cause-and-effect (it included no control group), the conclusions are startling—and completely consistent with earlier BPA studies conducted in rodents, which did show cause-and-effect. (Don’t miss Dr. Lang’s explanation of his study, available through the Guardian.)

A month later, a review of the FDA’s earlier assessment of BPA has been harshly criticized by a subcommittee of experts from the agency’s own advisory Science Board. The panel is, the FDA recognizes, composed of “distinguished scientists” and their report—expressed in 17 highly critical pages—cannot be dismissed easily.

Here are some of their concerns:

• The FDA assessment should consider cumulative exposure and risk to infants.

• The FDA assessment lacked “an adequate number of infant formula samples” and inaccurately assessed what samples it did include.

• The FDA excluded too many studies from its assessment and relied too heavily on a pair of studies sponsored by the plastics industry.

• The FDA assessment should be redone to include more studies, including those that have been published since its initial assessment.

• The level of acceptable exposure (5 mg/kg bw/day) in the FDA assessment is too high.

• The FDA’s conclusion that BPA can be “adequate[ly]” accepted to be safe is, in fact, inadequate.

Although the committee said it could not determine whether BPA was harmful or whether it should be banned from food and beverage containers, these are as close to fighting words as scientists are likely to get.

FDA’s disappointing response
So, imagine you’re the FDA. A group of scientists chosen by your own advisory board for their expertise in BPA slaps your approach to the topic and chastises you for inaccurately concluding there is no cause for concern about safety. What do you do? Do you admit that you erred on the side of industry? Do you issue a statement of caution about BPA while you commission scientific study about the safety of this questionable and potentially dangerous substance?

The FDA’s actual response is sure to disappoint. Admitting no problem with its draft assessment, the FDA maintains that BPA exposure poses no “immediate health risk to the general population, including infants and babies.” They recognize that parents may “as a precaution” wish to “use alternatives for their bottle-fed babies,” but the implication of this statement is that such choices are extreme. In addition, although BPA is ubiquitous, the responses fail to address any other means of exposure. (And they provide a link “to the report” that is a bit more wild-goose-chase than it is transparent-information-sharing.)

Why there’s still hope
Because the FDA’s advisory Science Board voted to accept the report, it now moves along to FDA Commissioner Andrew von Eschenbach. The agency has vowed to respond within 30 days, although by law it has until February 2009, when the Science Board is scheduled to re-convene. Von Eschenbach has several options. He can call for the FDA to draft a new report that includes the most recent findings, reject the panel’s report and accept the FDA’s original conclusion about BPA’s safety, ban the chemical from baby products (as has been done in Canada), or state that no conclusion can be drawn until new studies are completed. Even some newspaper editors are calling on von Eschenbach to take a firm stance on this issue.

What parents can do
As discussed before on baby gooroo, parents can try to minimize their children’s exposure to this chemical. BPA-free bottles and sippy cups are currently available, and parents who don’t want to choose glass can look for polypropylene or polyethylene bottles marked “BPA free.”

Also, stay informed. Listen when you hear BPA mentioned on the news. Write letters to the editor (or blog posts) about this important topic. Write to the FDA to show your support for the subcommittee’s report.

Finally, shop deliberately. Wal-mart and Toys ‘R Us have vowed to phase out BPA-containing products, but this switch may not be complete yet. Urge manufacturers and retailers to step up to the challenge that the government has not, and eliminate BPA to protect our children’s health.