BPA is used to make polycarbonate plastic and epoxy resins that protect canned foods and beverages (see www.packworld.com/view-25931).
The FDA’s Science Board was tasked with reviewing the agency’s initial decision. States an Oct. 31 report on the Wall Street Journal’s online Health Web site, “The panel said in its report it disagrees with the FDA’s decision to dismiss many other studies on BPA. The subcommittee finds that the draft assessment conclusions are not supported by the available data and science,” the report said. It added that the studies dismissed by the FDA “raise additional and unsettling concerns.”
FDA’s commissioner Andrew von Eschenbach addressed the situation in his online column, “The FDA this Week: Andy’s Take” (see www.fda.gov/oc/vonEschenbach/andys_take/default.html). In it, he said, “This report presenting a contrary point of view is exactly what FDA needed to hear. Rather than a rebuke of our position, the report was a strong affirmation of our process—a process to identify information that will better inform our regulatory decision-making.
“Science is always evolving” but these new scientific data must be assembled into information and converted to knowledge upon which our regulatory decisions are based. We cannot short-circuit or avoid this process of rigorous analysis, critical assessment, and stringent validation. Only then will we have the strong scientific foundation upon which to make an enduring regulatory decision to approve a product, change a drug label, or issue a call for change in or removal of a product.”
