December 3, 2021

Volume XI, Number 337

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New FDA Plan to Reduce Toxic Elements in Baby Food

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.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 102
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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