FDA Risk Assessment on BPA

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Statement on FDA BPA Assessment

IFC Supports FDA in its Risk Assessment of Bisphenol A

The International Formula Council* (IFC) agrees with the U.S. Food and Drug Administration’s (FDA) conclusion that the present margin of safety for bisphenol A (BPA) in food contact applications, including infant formulas, is adequate and does not need to be lowered.  The FDA’s risk assessment (US FDA, 2008) was based, in part, on several appropriately conducted multigenerational rodent studies showing no BPA-associated risks at intake levels representative of current human exposures. 

The FDA’s risk assessment focused on the endpoints of carcinogenesis as well as reproductive and developmental toxicity related to BPA in food contact applications.  FDA will publish a separate safety assessment on BPA exposure from other FDA-regulated products at a later date.  FDA’s recent assessment incorporated information from several comprehensive safety assessments conducted by other agencies around the world, including the U.S. National Toxicology Program (NTP-CERHR, 2007; NTP, 2008; NTP-CERHR, 2008), Health Canada (2008), the European Food Safety Authority (EFSA, 2006; EFSA, 2008), the European Union (EU, 2008), the Norwegian Scientific Committee for Food Safety (NSCFS/VKM, 2008), and the Japanese National Institute of Advanced Industrial Science and Technology (JNIAIST, 2007).  All of these agencies, as well as FDA, agreed there is no safety risk to consumers associated with BPA at present levels of intake.  However, Health Canada has proposed to ban polycarbonate baby bottles as a precautionary measure, but also stated that the nutritional benefits of canned infant formula far outweigh the potential risks of exposure to BPA. 

As an industry, members of the IFC take all safety issues very seriously.  Our research and development programs are targeted to produce the highest quality of infant formula products available.  When new information becomes available on substances like BPA, we support bringing the information forward through the accepted process of scientific peer review and evaluation.  This helps ensure that it is evaluated with consideration to existing science and that policies are driven by sound science.

Parents and health professionals can be assured infant formula is safe and nutritious.