New Bisphenol A study has limited capability to assess human health effects

Sep 16 2008

The American Chemistry Council is aware of a new study on bisphenol A published today in the Journal of the American Medical Association that reports a statistical association between urinary bisphenol A concentrations and medical disorders in adults. As with any study, it is critically important to understand how the design of a study can limit interpretation of the study findings.

The new study is a statistical analysis that attempts to correlate urinary concentrations of bisphenol A, which reflect very recent exposure, with the incidence of cardiovascular disease and diabetes. However, the onset and development of these diseases occurred over time periods well before the bisphenol A exposure measurements were made. Because of this and other inherent limitations, the study is not capable of establishing a cause and effect relationship between bisphenol A and these health effects.

The study is primarily useful for generating hypotheses that can be tested with more appropriate experiments or analyses. As noted by the authors of the study, independent replication and follow-up studies are needed to confirm their findings and to provide evidence on whether the associations are causal. Until such work has been completed, it is premature to draw any conclusions on human health effects.

"Overall, due to inherent limitations in study design, this new study cannot support a conclusion that bisphenol A causes any disease," stated Steven G. Hentges, Ph.D. of the American Chemistry Council's Polycarbonate/BPA Global Group. "The weight of scientific evidence continues to support the conclusion of governments worldwide that bisphenol A is not a significant health concern at the trace levels present in some consumer products."

The extensive science supporting the safety of bisphenol A has been evaluated by government bodies around the world, most recently by the US Food and Drug Administration (FDA). The draft FDA assessment, which reaffirmed the safety of food-contact products containing bisphenol A, will be peer-reviewed by a subcommittee of the FDA Science Board on September 16 and is expected to be finalized later this year.