The Food and Drug Administration (“FDA”) announced last week the publication of a final rule banning bisphenol-A (“BPA”) from use in infant formula packaging – a decision made based on proof of industry abandonment rather than safety concerns. In July 2012, then-U.S. Representative Edward J. Markey filed a food additive petition seeking to amend the food additive regulations in 21 C.F.R. § 175.300 to no longer provide for the use of BPA-based epoxy resins as coatings in packaging for infant formula because these uses have been abandoned. Under 21 C.F.R. § 171, et. seq., the petitioner may propose that FDA amend a food additive regulation if the petitioner can demonstrate that there are ”old uses abandoned” for the relevant food additive.
BPA-based epoxy resins are formed by the reaction of 4,4'-isopropylidenediphenol (i.e., BPA), and epichlorohydrin. Under current FDA policy, BPA-based epoxy resins may be safely used as the food-contact surfaces of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, in accordance with the prescribed conditions of § 175.30. As followers of the agency’s position on BPA know, FDA currently considers BPA safe for many food contact uses and issued its most recent justification for this position in March 2013, available here.
As of July 2012, however, FDA banned BPA from use in infant and toddler products such as baby bottles and sippy cups. Like the agency’s decision last week, FDA’s decision regarding baby bottles and sippy cups was made in response to a petition filed by the American Chemistry Council, which was also based on industry abandonment.
The final rule became effective on July 12, 2013.