• On April 8, 2021, the U.S. Food and Drug Administration (FDA) unveiled Closer to Zero, a new action plan for reducing exposure to toxic elements from foods eaten by babies and young children to as low as possible. The plan (announced here) describes FDA’s approach as an iterative process involving four stages: (1) Evaluate the science, (2) Propose action levels, (3) Consult with stakeholders, and (4) Finalize action levels for lead, arsenic, cadmium, and mercury. A graphic display of the stages shows that FDA’s ongoing research, monitoring, and compliance efforts will continue separately at the center of a cycle of continual improvement.
  • FDA’s Closer to Zero action plan is scheduled to unfold in three phases as follows:
    • Phase 1, which is scheduled for completion by April 2022, will focus on lead and arsenic. FDA will propose action levels for lead in categories of baby foods (e.g., cereals, infant formula, pureed fruits and vegetables) and other foods commonly eaten by babies and young children, and FDA will consult with stakeholders and federal partners on issues such as feasibility and share best practices for reducing or preventing lead contamination. With respect to arsenic, FDA will work on the first phase, evaluating the science.
    • In Phase 2, scheduled for April 2022 – April 2024, FDA plans to finalize the action level for lead, propose action levels for arsenic, and begin the evaluation stage for cadmium and mercury.
    • In Phase 3, which is set to begin April 2024 and continue indefinitely, FDA plans to propose action levels for cadmium and mercury, finalize action levels for arsenic, and loop back to the evaluation stage for lead, to assess the feasibility of attaining even lower levels.
  • Closer to Zero follows FDA’s March 5, 2021 announcement of new activities – including a commitment “in the near term” to review current action levels and develop additional action levels for contaminants in key foods – that respond to a February 4, 2021 Congressional report on the finding of heavy metals in baby foods in the U.S.
  • Keller and Heckman will continue to monitor and report on FDA’s regulatory activities, as well as congressional investigation and litigation involving heavy metals in baby food.