FDA Taking Baby Steps on BPA

January 21st, 2010. By Hunter West

Last week the US Food and Drug Administration did an about-face on its stance with regard to bisphenol-A (BPA), saying Friday that it has had “some concern about the potential effects of BPA on the brain, behavior and prostate gland of fetuses, infants and children,” and would join other federal health agencies in studying the chemical in both animals and humans. 

This, in contrast to its report of 2008, when the agency deemed the chemical safe. 

Not that the FDA is saying that BPA is unsafe. Far from it. “If we thought it was unsafe, we would be taking strong regulatory action,” said Dr. Joshua Sharfstein, the principal deputy commissioner of the drug agency, at a news briefing late last week. 

However, it is a hint—baby steps here—that the FDA is taking a harder line on issues than it appeared to take previous to the Obama Administration. Needless to say safety advocates are buoyed by the change of position, short of being overjoyed given their entrenched view that the FDA has not gone far enough. 

The chemical industry from whence the BPA originates, is also not happy with the news. 

Hardly surprising, as both camps line up and defend their respective positions—the chemical industry saying that the FDA’s concerns are unfounded, while the safety advocates say the FDA hasn’t gone far enough. Then there’s the FDA, trying to come up in the middle and be fair to everybody. 

But at least they’re looking. Rather than remain cocooned in a kind of Pleasantville (the movie, with apologies to any real ‘Pleasantvilles’ out there), outfitted with blinders and assuming that everybody, everywhere will be doing their respective jobs adequately and there is no real need for oversight, the FDA is seeking a second opinion. 

That second opinion is where this new position came from, together with a more aggressive Administration that has tipped the scales of accountability more towards the consumer and away from Big Business. 

The sequence of events that unfolded as a prerequisite to this latest change in thinking by the FDA began with the release of a draft report in 2008, concluding that in the FDA’s view BPA was safe (caveat: the FDA’s definition of safe falls to the mantra that the benefit must outweigh the risk. Risk, it seems, is a given.) 

However, not too long after the FDA released its report, along comes the National Toxicology Program (NTP), which issued its own report under the auspices of the National Institute of Health (NIH). The NTP, in its view, noted that there was “some concern” with regard to BPA in products that come into contact with food, liquids and other products ingested by humans, due to potential effects on the brain, behaviors and prostate in fetuses, infants and children. 

With such a diverging report in front of them, the powers that be at the ‘new-and-improved’ FDA asked an independent panel of scientific advisers to review its own draft. 

The review, to say the least, was scathing. The panel accused the federal drug agency of ignoring important evidence and giving consumers a false sense of security about the chemical. 

The refreshing aspect of all of this, is the departure from what the FDA has so often done in the past: ignore hard evidence and expert opinion from learned individuals in the scientific community in an effort to maintain the status quo to the benefit of, according to the perception, business and commerce. 

In the past, the FDA has dismissed the advice of its own scientists. 

This time, however the FDA respected the second opinion enough to reconsider its position on BPA. It promised to reconsider and it fulfilled that commitment. On Friday, the agency announced its revised, albeit cautious position. 

“We are for the first time saying we believe there is some concern about the substance’s safety, and we’ve closed the gap between NIH. and FDA.,” Dr. Sharfstein of the FDA. said in an interview with the New York Times, published on January 15^th. 

What’s next? The spending of $30 million by the government on BPA research in humans and animals. That study will take place within the next two years, in an effort to provide greater clarity on the cautious position the FDA has just taken—and perhaps, move the agency to a more conclusive stance. 

There are also changes in the works governing how BPA is regulated. At the moment BPA is classed as a food additive, which means it takes forever to make any changes to its regulatory framework. There is hope the status of BPA can be changed to that of ‘food contact substance’—a move that would provide the FDA more clout and allow the agency to act more quickly if it was ever deemed necessary. 

There are also changes in the works that may result in a more refined snapshot of just how BPA affects humans in a more realistic way. More traditional methods of testing involved large doses of BPA that would provide clear evidence for the emergence of tumors or organ damage. Smaller doses, that are more representative of human exposure, would paint a more accurate picture. The downside is that results from such test exposures would be harder to interpret and take more time and study, to foster conclusions. 

And even with the FDA’s updated stance on BPA, there are dissenters on both sides. 

Diana Zuckerman, president of the National Research Center for Women and Families, said the FDA had not gone far enough, because its recommendations put the responsibility on families, rather than the companies making products containing BPA. In addition, Ms. Zuckerman said, the focus on safety should not be limited to children, because studies have linked the chemicals to heart and liver disease and other problems in adults. 

The American Chemical Council, which represents companies that make and use BPA, issued a statement saying BPA was safe, praising the health agencies as confirming that there was no proof of harm to people by it, but also saying, “We are disappointed that some of the recommendations are likely to worry consumers and are not well founded.” 

It is the FDA’s role to acknowledge both sides of the argument—short of outright accommodation—then form its own conclusion based on sound, independent research. The nation’s health and well being is at stake, and it is the regulator’s job to uphold that safety in a factual and impartial manner, rather than cave to special interests on both sides of the equation. 

Friday’s change of position, however small, is a move in the right direction. 

Baby steps. But a giant leap nonetheless.      

Tags: BPA, FDA

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