Monday 22 May 2017

When is a “Ban” Really a “Ban”? FDA Announces New Rule Revoking BPA’s Approved Use in Infant Formula Packaging

The US Food and Drug Administration announced a new rule barring the use of  bisphenol A (BPA) in infant formula packaging. The announcement comes a year after Rep. Edward Markey (D-Mass.) petitioned the Agency for change following a slew of studies on the safety of BPA. Rep. Markey’s petition, however, didn’t seek a ban based on safety. Instead it relied on a technicality under the Food Drug and Cosmetic Act § 171.130 to prohibit food additives by revoking a food additive’s approval when it has been completely abandoned. BPA although not added to food, is applied to a food contact surface, and must still be approved a food additive to legally be used.  Abandonment may be based on the abandonment of certain authorized food additive uses for a substance (e.g., if a substance is no longer used in certain product categories), or on the abandonment of all authorized food additive uses of a substance (e.g., if a substance is no longer being manufactured). Re. Markey’s petition public information and information collected from a survey of all of the U.S. registered manufacturers of infant formula to support the finding BPA was completely abandoned in formula packaging.

Three objections were raised to the proposed rule revoking BPA’s approved food additive status. The FDA in its final rule only received 21 comments on the petition, of those three raised objections the use of BPA was abandoned. This prompted the Agency to request more information on the basis for abandonment. Those raising the objections conceded their objections were based on a right to use BPA in the future.

The ban is temporary. The FDA makes clear the use of BPA is “made without prejudice” and any manufacturer may seek approval establishing safe conditions of use for BPA-based epoxy coatings in infant formula packaging, via the food contact notification process.

This statement from the Agency makes it important to understand this isn’t a ban, but a technical revocation of a food additive that is abandoned. Not unlike removing an outdated law from the law books. There is still an opportunity to use BPA in infant formula packaging following the procedures used for any food additive.

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