Attorneys General File for Reconsideration of Heavy Metals Petition

The attorneys general of 21 states have filed a petition for reconsideration for a citizen petition denied May 2, 2022, that urged the U.S. Food and Drug Administration (FDA) “to adopt a series of interim guidance measures intended to complement the long-term approach of the Closer to Zero Plan,” which aims to reduce the amount of contaminants in baby foods. The attorneys general sought interim guidance to (i) set action levels for inorganic arsenic, lead, cadmium and mercury; (ii) set an action level for inorganic arsenic in infant rice cereal that is lower than the existing action level of 100 parts per billion; and (iii) issue guidance to industry that testing for heavy metals is a “preventive control” manufacturers should perform. The reconsideration petition takes issue with multiple points in the denial, including the argument that FDA did not consider relevant information as to its own authority. The attorneys general again urge FDA to issue interim proposed action levels for three of the heavy metals at issue—inorganic arsenic, cadmium and mercury, removing lead from its request—and, in addition, they reiterate the second and third points of the original petition.