Background on bisphenol A and Dr. Philbert's work with the FDA
Background on bisphenol A (BPA)
Bisphenol A is a chemical that was approved by the FDA in the early 1960s for use in certain food contact materials. In recent years, concerns have been raised about BPA's safety.
Examination of those concerns by the scientific community has led to the U.S. Food and Drug Administration acknowledging in January 2010 that there is “some concern” that BPA could cause some adverse health effects in children.
How the FDA reached this conclusion
The U.S. Food and Drug Administration convened a committee to review BPA safety and that committee concluded, in the spring of 2008, that food and beverage containers made with BPA were safe. However, the agency said it would continue to review new studies and data on BPA, noting that the “FDA’s work in assessing the safety of these products is never truly final.”
The FDA also convened a panel called the FDA Science Board Subcommittee on BPA. This panel of outside scientists was to evaluate the FDA’s spring 2008 assessment on the safety of bisphenol A.
That panel was chaired by Professor Martin Philbert of the U-M School of Public Health. Dr. Philbert is a professor of toxicology, senior associate dean for research in the School of Public Health and interim director of the U-M Risk Science Center. The center has a mission to assess, quantify and communicate health risks to the public.
The subcommittee report, released Oct. 31, 2008, raised important questions about the FDA’s initial draft safety assessment and concluded that the margins of safety defined by the FDA as adequate were, in fact, inadequate. Further study to address the potential low-dose effects of BPA was recommended.
The report of the FDA Science Board Subcommittee on BPA, chaired by Dr. Philbert, was accepted without change by the FDA Science Board in December 2008. The work of that panel has concluded.
FDA review continues
While BPA continues to be under review, the FDA changed its position on BPA in January 2010 to one that is consistent with the final report of Dr. Philbert’s subcommittee. An update on the FDA Web site notes that:
“… on the basis of results from recent studies using novel approaches to test for subtle effects, both the National Toxicology Program at the National Institutes of Health and FDA have some concern about the potential effects of BPA on the brain, behavior, and prostate gland in fetuses, infants, and young children.”
Scientific studies continue to assess the health risks of BPA.
Gift to U-M prompts review
While Dr. Phibert was leading the FDA Science Board Subcommittee on BPA in 2008, questions were raised about a possible conflict of interest between his FDA service and his role as interim director of the Risk Science Center after the center received a $5 million gift from U-M alumni Charles and Rita Gelman. Charles Gelman formerly owned the Ann Arbor-based Gelman Sciences and has publicly disputed the risks of BPA.
After review by the FDA, the federal agency determined that Dr. Philbert had no conflict of interest.
In addition to that determination by the FDA, the U-M said Professor Philbert had complied with all U-M conflict of interest policies.
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Links to additional information on bisphenol A:
FDA ignored evidence when calling BPA safe (10-29-08)