After the February 2021 Congressional report triggered public outrage, the FDA faced pressure to act. In August 2021, the agency launched ‘Closer to Zero’ — an action plan specifically designed to reduce childhood exposure to arsenic, lead, cadmium, and mercury in infant and toddler foods. The FDA committed to establishing ‘action levels’ for these metals — concentrations above which it would take enforcement action against food manufacturers. In January 2023, the agency published proposed action levels for lead in processed baby foods (in the range of 10–20 ppb, depending on product category).

As of early 2026, those proposed action levels have not been finalized. They remain in the comment and rulemaking process — not binding law. Baby food manufacturers are not legally required to meet any specific heavy metal standard in their products, even as of today. Consumer advocates and public health researchers have characterized the FDA’s pace as inadequate given the severity of the documented risk. The FDA’s own Total Diet Study — which independently tests commercially available foods for contaminants — confirmed the findings of the Congressional report: significant heavy metal contamination in rice-based baby foods, vegetable purees, and other infant products.

The FDA’s regulatory failures are relevant to the lawsuit in two ways. First, the absence of binding standards means that manufacturers cannot point to FDA compliance as a legal defense — the ‘we followed the rules’ argument fails when no binding rules existed. Second, the FDA’s own Total Diet Study data, available to plaintiffs through FOIA, provides additional third-party confirmation of the contamination that supplements the defendants’ own internal testing records.