The U.S. Food and Drug Administration has proposed action levels for cadmium in several categories of processed foods intended for babies and children under two years old.
The draft guidance, published October 23, 2026, is part of FDA’s broader effort to reduce young children’s exposure to toxic elements in food. Although the proposed levels are not currently binding, they may eventually influence FDA enforcement decisions, product specifications, supplier controls and testing programs.
Comments on the proposal are due December 22, 2026.
Proposed Cadmium Action Levels
FDA proposed the following action levels:
- 10 parts per billion: Fruits, vegetables other than single-ingredient carrots, and mixtures, including grain-based and meat-based mixtures
- 25 parts per billion: Single-ingredient carrots
- 45 parts per billion: Dry infant cereals
- 20 parts per billion: Yogurts, puddings and custards
- 25 parts per billion: Single-ingredient meats
The action levels apply to processed foods represented or labeled for babies and children under two years old.
FDA said the proposed limits are intended to be achievable by industry while continuing to reduce cadmium in the food supply.
What an Action Level Means
The draft guidance does not establish a binding legal limit. Once finalized, however, the action levels would reflect cadmium concentrations at which FDA may regard a food as adulterated under the Federal Food, Drug, and Cosmetic Act.
FDA would consider the action level along with other factors when deciding whether to pursue enforcement in a particular case.
That distinction is important. A product exceeding a final action level would not automatically be subject to enforcement, but the result could increase the risk of detention, refusal, recall or other regulatory action.
Why Cadmium Requires Upstream Controls
Cadmium is an environmental contaminant that can enter food through soil, water and agricultural inputs. Its presence does not necessarily indicate deliberate adulteration or poor sanitation.
Because the contamination may begin at the agricultural or ingredient level, finished-product testing alone may not provide an adequate compliance strategy. Companies may need to examine:
- Growing regions and agricultural conditions
- Ingredient and raw-material specifications
- Supplier testing programs
- Laboratory methods and detection limits
- Certificates of analysis
- Lot-level traceability
- Corrective-action procedures
- Alternative suppliers or ingredient sources
Companies should also determine whether their laboratories can reliably test at the low concentrations identified in the draft guidance.
Implications for Food Importers and FSVP Programs
Importers subject to the Foreign Supplier Verification Programs rule should evaluate whether cadmium is a known or reasonably foreseeable hazard for the foods they import.
Depending on the food, supplier and existing controls, the proposed guidance may affect:
- Hazard analyses
- Foreign-supplier approval procedures
- Testing frequency
- Review of supplier records
- Corrective-action protocols
- Product specifications and purchase agreements
Importers should avoid assuming that a general certificate of analysis addresses the proposed limits. Testing records should identify the substance tested, methodology, reporting threshold, sampled lot and laboratory responsible for the analysis.
Private-label companies should also confirm which party is responsible for supplier verification, testing and regulatory responses under their manufacturing agreements.
What Companies Should Do Now
Companies importing or selling foods intended for children under two should:
- Determine which products fall within the categories addressed by the draft guidance.
- Compare current product specifications with FDA’s proposed action levels.
- Review historical cadmium-testing results by product, ingredient and supplier.
- Confirm that laboratory methods can measure the proposed concentrations accurately.
- Reevaluate supplier-verification activities and FSVP hazard analyses.
- Review contracts to determine responsibility for testing, nonconforming products and recalls.
- Consider submitting supporting data or comments to FDA by December 22.
Companies that believe the proposed levels are not technologically achievable, do not reflect available scientific data or may cause unintended supply-chain consequences should consider participating in the public-comment process.
For additional information, review FDA’s Federal Register notice and proposed action levels.
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References
- Federal Register: Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability (91 FR 66796, October 23, 2026)
- FDA: Action Levels for Cadmium in Processed Food Intended for Babies and Young Children, Draft Guidance for Industry
- FDA: Draft Guidance Text (PDF)
- Regulations.gov: Docket No. FDA-2025-D-4023 (submit comments)
- FDA: Hazard Analysis and Risk-Based Preventive Controls for Human Food, Draft Guidance for Industry
