Bisphenol A: Science Panel Rips Apart FDA Report

An external subcommittee of scientists just administered a dose of bitter medicine to the FDA. The subcommittee reviewed a deeply flawed FDA report on the chemical Bisphenol A (BPA) and concluded that the Agency bungled the science, failing to protect people from this chemical.

Bisphenol A is a big concern for consumers because of its widespread occurrence in food and drink. FDA has approved its use in the lining of food cans, including cans of infant formula. It is also used to make polycarbonate plastic, including in some water bottles.  At everyday levels of exposure, this chemical has been linked to a wide range of potentially serious health effects including reproductive abnormalities, behavioral changes, cancer, diabetes, obesity and heart disease.

The FDA put out a deeply flawed assessment of Bisphenol A, which we now have learned drew heavily on an industry document provided to the Agency by the American Chemistry Council, a lobbying arm of the chemical industry. The assessment ignored scores of independent scientific studies, ignored important information about exposures to consumers, and failed to adequately account for uncertainty in the science.

These subcommittee scientists didn't let FDA get away with it.

Here are some key excerpts of their report: 

• Bisphenol A is present in food contact applications resulting in dietary exposure of BPA to infants, children and adults...the FDA assessment would be strengthened by considering cumulative exposures and differential risk in neonates.
• The draft FDA exposure assessment has important limitations including that it lacks an adequate number of infant formula samples and relies on mean values rather than accounting for the variability in samples.
• The draft FDA report does not articulate reasonable and appropriate scientific support for the criteria applied to select data for use in the assessment...
• ... the assessment lacks an adequate characterization of uncertainties in its estimates of both exposure and effects.
• The weight-of-the-evidence...provides scientific support for use of a point of departure substantially below (i.e., at least one or more orders of magnitude lower than) the 5 mg/kg bw/day level selected in the draft FDA assessment.
• Coupling together the available qualitative and quantitative information... provides a sufficient scientific basis to conclude that the Margins of Safety defined by FDA as "adequate" are, in fact, inadequate.

I applaud these scientists for blowing the whistle on shoddy FDA science, and standing up for public health.

They've called on FDA to do a better job and so have we. Earlier this week, NRDC called on the FDA to ban this toxic chemical from our food packaging.

The ball is in FDA's court and this Friday, we'll learn how they plan to respond.

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