FDA Proposes Cadmium Action Levels for Baby Foods, Issues Preventive Controls Guidance for Chemical Hazards
The U.S. Food and Drug Administration (FDA) has announced new draft action levels for cadmium in processed foods intended for babies and young children, alongside new draft guidance to help food manufacturers identify and control chemical hazards, including heavy metals.
The actions are part of FDA's Closer to Zero initiative, which aims to continually reduce dietary exposure to toxic elements, including arsenic, cadmium, lead, and mercury, among babies and young children.
Proposed Cadmium Action Levels for Baby Foods
FDA issued a new draft guidance for industry proposing the following action levels for cadmium in processed foods intended for children younger than two years of age:
- 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient carrots), and mixtures, including grain- and meat-based mixtures
- 25 ppb for single-ingredient carrots
- 45 ppb for dry infant cereals
- 20 ppb for yogurts, puddings, and custards
- 25 ppb for single-ingredient meats.
The proposed action levels apply to packaged foods marketed for babies and young children, including ready-to-eat (RTE) purees and semi-prepared products such as dry infant cereals. They do not apply to infant formula, beverages, raw agricultural commodities, homemade foods, or snack foods.
Cadmium occurs naturally in the environment and can also be introduced through pollution, allowing it to enter foods through contaminated soil, water, and air. Chronic dietary exposure to cadmium can cause adverse effects on the kidneys and bones, and babies and young children may be particularly susceptible to heavy metals because of their smaller body sizes and developing physiological systems.
To develop the proposed action levels, FDA evaluated cadmium occurrence data from its monitoring programs and surveys, alongside dietary exposure and the achievability of reduced cadmium concentrations in different food categories. The agency said it considered the proposed levels achievable when manufacturers implement appropriate measures to minimize cadmium contamination.
Although FDA action levels are not legally binding, they represent concentrations at which the agency may consider a food adulterated under the Federal Food, Drug, and Cosmetic Act. FDA may consider these levels, alongside other factors, when determining whether enforcement action is warranted.
Building on Previous Closer to Zero Actions
The proposed cadmium action levels build on FDA's previous efforts to reduce toxic elements in foods consumed by babies and young children. In January 2025, FDA finalized action levels for lead in processed baby foods. The final guidance established lead action levels of 10 ppb for most covered fruits, vegetables, mixtures, and certain other foods, and 20 ppb for single-ingredient root vegetables and dry infant cereals.
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Additionally, in 2023, FDA finalized an action level of 10 ppb for inorganic arsenic in apple juice.
FDA Issues Draft Guidance on Preventive Controls for Chemical Hazards
Alongside the proposed cadmium action levels, FDA issued Chapter 12 of its draft guidance, Hazard Analysis and Risk-Based Preventive Controls for Human Food.
The new chapter addresses the identification, evaluation, and control of chemical hazards under FDA's Preventive Controls for Human Food regulation, established by the Food Safety Modernization Act (FSMA).
The guidance is intended to help manufacturers identify potential chemical hazards and implement appropriate Current Good Manufacturing Practices (cGMPs) and risk-based preventive controls, including supply-chain controls for ingredients, to significantly minimize or prevent those hazards.
FDA included practical examples addressing different chemical hazards in human foods. According to the agency, the guidance, when finalized, may help manufacturers reduce heavy metal concentrations in their products and better meet action levels established under Closer to Zero.
FDA also updated its Closer to Zero webpage to reflect ongoing activities and announced a webinar scheduled for November 16, 2026, to discuss the new guidance and related food chemical safety initiatives.
