Advisory Panel Issues Draft Peer Review Criticizing FDA’s Bisphenol A Exposure Assessment
A subcommittee of FDA’s Science Board has released its peer review of the agency’s draft assessment of bisphenol A (or BPA) for use in food
contact applications. The FDA’s draft assessment concluded, on the basis of industry-funded studies, that “an adequate margin of safety exists for BPA at current levels of exposure from food contact uses.” Further information about the draft assessment appears in issue 272 of this Update.
According to the peer review, scheduled to be reviewed by FDA’s Science Board on October 31, 2008, the FDA properly focused on dietary exposures to children, “because they are likely to have both greater exposures and susceptibility than adults as a function of food consumption patterns, metabolism, vulnerability of developing systems and other factors.” The peer review then criticizes the agency’s assessment for its lack of “an adequate number of infant formula samples” and reliance “on mean values rather than accounting for the variability in samples.” The panel scientists also concluded, (i) “The draft FDA report does not articulate reasonable and appropriate scientific support for the criteria applied to select data for use in the assessment”; (ii) the agency should include other studies in its assessment, including several “published after the draft assessment was finished”; (iii) “the assessment lacks an adequate characterization of uncertainties in its estimates of both exposure and effects”; and (IV) “the Margins of Safety defined by FDA as ‘adequate’ are, in fact, inadequate.”
The FDA responded by agreeing that “additional research would be valuable,” but continued to assert that consumers should not be concerned, stating, “Consumers should know that, based on all available evidence, the present consensus among regulatory agencies in the United States, Canada, Europe, and Japan is that current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies.” Still, the agency notes, “Parents who, as a precaution, wish to use alternatives for their bottle-fed babies can use glass and other substitutes for polycarbonate plastic bottles; avoid heating formula in polycarbonate plastic bottles; and consult their pediatrician about switching to powdered infant formula.”
Bisphenol A is widely used in plastic bottles and lines metal cans, including those used for infant formula. Recent studies have purportedly linked the chemical to diabetes, heart disease, memory loss, learning impairments, depression, prostate and breast cancer, reproductive disorders, and developmental problems. The Judicial Panel on Multidistrict Litigation is currently considering whether to transfer the 24 pending federal cases involving bisphenol A to a single court for pre-trial proceedings. See FDA Statement, October 28, 2008; Product Liability Law 360, October 29, 2008.
