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FDA chastised for using flawed methods in baby bottle risk assessment

Got BPA?

By Jaime L. Hartman Oct 29 2008, 01:01 PM

The Food and Drug Administration (FDA) suffered some verbal abuse today from a highly critical report which complained that the agency ignored scientific evidence and used flawed methods when it determined that bisphenol A (BPA), a chemical widely used to harden the plastic in baby bottles and the popular Nalgene bottles, is not harmful. 

The panel of scientists from government and academia who composed the report wrote that the FDA did not take into consideration studies that have likened BPA to prostate cancer, diabetes, and other health problems in animals. The report went on to criticize the FDA for not using enough infant formula samples to execute a proper analysis, and for not adequately accounting for variations among those samples.

The FDA’s evaluation of BPA “creates a false sense of security” and “overlooks a wide range of potentially serious findings,” the report stated.

The panel also found that the chemical could pose a risk to children at levels at least 10 times lower than the amount the agency says is safe. Disturbingly, many of the studies that the panel of experts said the FDA ignored were reviewed by the National Toxicology Program, which reported in September that it had “some concern” that BPA can affect brain and behavioral development in infants and small children.

But this is not the first time the FDA has taken a hit from the scientific community. The regulatory body frequently hears allegations from critics of the FDA that the agency relies too heavily on industry-funded studies.

Fortunately, the expert science panel that drafted the report isn't simply a group of overprotective parents, they are part of the FDA's outside science board - experts who advise the FDA on complex issues. The full science board, scheduled to meet and hear the panel's presentations Friday, can endorse the subcommittee's report or write its own. 

In response to the report, the FDA issued a statement reiterating that the present consensus among international regulatory agencies is that current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies.

"The committee gave us valuable guidance on how we can improve our assessment using the current data. But they did not say in any way that I can find that there is an immediate health risk," Norris Alderson, FDA associate commissioner for science told Reuters.

But the Canadians aren't buying it, and have already banned the use of BPA in baby bottles based upon their own reviews out of an abundance of caution.

With or without a government ban, consumers are already driving the marketplace.  Retailers have already begun selling BPA-free baby bottles in response to consumer concerns and the trade group that represents BPA manufacturers said its members would promptly phase out the use of BPA in baby bottles and infant formula packaging if the FDA asked it to do so.

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Read More: Food And Drug Administration (FDA), Public Health, Others

 
 
 
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