FDA Seeks to “Strengthen its Oversight of BPA”

By Ricardo Carvajal –

While calling for further research on bisphenol A ("BPA"), a chemical used in the manufacture of some plastics, FDA has acknowledged that it has "some concern about the safety of BPA:" 

At this interim stage, FDA shares the perspective of the National Toxicology Program that recent studies provide reason for some concern about the potential effects of BPA on the brain, behavior, and prostate gland of fetuses, infants and children.  FDA also recognizes substantial uncertainties with respect to the overall interpretation of these studies and their potential implications for human health effects of BPA exposure.  These uncertainties relate to issues such as the routes of exposure employed, the lack of consistency among some of the measured endpoints or results between studies, the relevance of some animal models to human health, differences in the metabolism (and detoxification) of and responses to BPA both at different ages and in different species, and limited or absent dose response information for some studies.

FDA is pursuing additional studies to address the uncertainties in the findings, seeking public input and input from other expert agencies, and supporting a shift to a more robust regulatory framework for oversight of BPA to be able to respond quickly, if necessary, to protect the public.

In addition, FDA is supporting reasonable steps to reduce human exposure to BPA, including actions by industry and recommendations to consumers on food preparation.  At this time, FDA is not recommending that families change the use of infant formula or foods, as the benefit of a stable source of good nutrition outweighs the potential risk of BPA exposure.

The agency is directing consumers to a list of "reasonable steps families and parents can take to minimize exposure to BPA" issued by the Department of Health and Human Services ("HHS").  According to HHS, domestic manufacturers have largely abandoned the use of BPA in the manufacture of bottles and cups for infants.  With respect to liquid infant formula sold in cans, HHS made clear that "[i]nfant formula in this packaging can offer important health advantages for some infants, and the proven benefit of good nutrition outweighs the potential risk of BPA exposure."  With respect to powdered infant formula mix, HHS noted that it "typically has no detectable level of BPA."

FDA's statement that it is "supporting a shift to a more robust regulatory framework for oversight of BPA" is of special interest to manufacturers.  The current food contact uses of BPA were approved through the issuance of food additive regulations before the advent of the notification process currently used for food contact substances.  Food additive regulations are not specific to manufacturers; thus, any manufacturer can use BPA consistent with an approving regulation without notifying the agency.  Further, amending or revoking a food additive regulation requires FDA to engage in rulemaking.  In contrast, food contact notifications are specific to manufacturers, and FDA can deem a food contact notification to no longer be "effective" upon written notice to the notifier and publication of a Federal Register notice – a mechanism that is much less burdensome than rulemaking.