Editor: Caleb Acquah (PhD)

GFI | GLOBAL REGULATORY WATCH

The FDA has proposed its first cadmium action levels for baby food and, alongside them, long-awaited guidance on controlling chemical hazards. Most products already meet the numbers. The harder question is how manufacturers keep every lot below them when cadmium arrives with the raw material and no processing step can take it out.

Key Takeaways

• FDA proposed cadmium action levels for baby food on October 22, 2026. Levels range from 10 to 45 ppb depending on the food category, and comments on the levels close December 22, 2026.
• The levels are draft and non-binding. Once final, they would mark concentrations at which FDA may regard a food as adulterated, considered alongside other factors in enforcement decisions.
• Most products already comply. FDA’s own data show 84% to 100% of samples at or below the proposed levels, so the levels work mainly as a ceiling on outlier lots.
• Cadmium is a sourcing problem, not a processing problem. It enters crops through soil and water, and washing, cooking or thermal treatment do little to remove it.
• FDA also released Chapter 12 of its preventive controls guidance, covering chemical hazards, including supply-chain controls for ingredients. Comments on that chapter close January 21, 2027.
• The U.S., EU and Canada again reflect regulatory convergence without regulatory harmonization: category-specific U.S. benchmarks, a single binding EU limit and surveillance-led oversight in Canada.

What FDA Proposed

The announcement falls under Closer to Zero, FDA’s programme to reduce childhood dietary exposure to arsenic, lead, cadmium and mercury. The new draft guidance proposes the following cadmium action levels for processed foods intended for children younger than two [1][2]:

• Fruits, vegetables and mixtures, including grain- and meat-based mixtures but excluding single-ingredient carrots: 10 ppb
• Single-ingredient carrots: 25 ppb
• Dry infant cereals: 45 ppb
• Yogurts, puddings and custards: 20 ppb
• Single-ingredient meats: 25 ppb

The levels apply to packaged foods marketed for babies and young children, sold in jars, pouches, tubs or boxes, including ready-to-eat purees and dry infant cereals. They do not apply to infant formula, toddler drinks and other beverages, raw agricultural commodities, homemade foods, or snack foods such as puffs and freeze-dried snacks. FDA says it is still collecting data on grain-based snacks [6].

Action levels are not legally binding. Consistent with 21 CFR 109.6(d), they reflect concentrations at which FDA may regard a food as adulterated under the Federal Food, Drug, and Cosmetic Act [2]. FDA describes the levels as achievable with appropriate controls and says in the draft that it expects industry to keep reducing cadmium over time [1].

A Ceiling, Not a Reset

FDA anchored the levels to a toxicological reference value of 0.21 to 0.36 µg per kg of body weight per day, based on kidney and bone effects. It analysed 1,430 samples collected between fiscal years 2009 and 2024 and modelled exposure at the 90th percentile of consumption [6]. Dry infant cereals had the highest mean concentration at 15.0 ppb, followed by single-ingredient carrots at 12.7 ppb; fruits averaged about 1.0 ppb.

The agency estimates that 93% of fruit, vegetable and mixture samples, 84% of single-ingredient carrot samples, 98% of dry infant cereals and all yogurt and meat samples already sit at or below the proposed levels. Projected reductions in 90th-percentile exposure are about 28% for fruits, vegetables and mixtures, 32% for carrots, 5% for infant cereals and none for yogurts or meats [6].

More telling, FDA’s modelling shows 90th-percentile exposure from each category on its own was already below the lower bound of the reference value before any action level was applied [6]. These levels are designed to remove high-cadmium outliers and lock in current performance, not to force a step change. The separate, looser carrot threshold and the small expected gain for infant cereal, the highest-cadmium category, reflect FDA trading exposure reduction against continued access to iron-rich cereals and nutrient-dense vegetables.

That makes compliance look easy on average. It is harder at the lot level. A carrot puree averaging 13 ppb can still produce lots above 25 ppb if raw-material cadmium varies by field, season or region. The action level bites on variability, and variability lives upstream.

Why Cadmium Starts in the Field

Most hazards processors know how to manage can be reduced inside the plant. Pathogens are killed by validated thermal steps; foreign material is caught by screens, magnets and X-ray. Cadmium does not behave this way.

Cadmium enters crops from soil, water and air [7]. Uptake depends heavily on soil chemistry: acidic soils, low organic matter and a history of cadmium-bearing phosphate fertiliser all increase the amount plants absorb. Root vegetables, leafy greens and cereal grains accumulate it efficiently, which is why carrots and infant cereals dominate FDA’s data. Once inside plant tissue, washing does little and peeling or milling removes only part of it. There is no kill step.

The practical levers are agricultural and commercial: origin and field selection based on soil data, liming and low-cadmium fertiliser inputs, varietal choice, and ingredient specifications with explicit cadmium limits backed by certificates of analysis and verification testing. Blending to dilute high-cadmium lots is a tempting shortcut, but FDA’s approach emphasises reducing cadmium at source.

Chapter 12 Moves Chemical Hazards Into the Food Safety Plan

The cadmium numbers will draw the headlines. Chapter 12 may have the broader effect. Under FDA’s preventive controls rule, every covered facility must identify known or reasonably foreseeable hazards, including chemical ones, and control those that require it. FDA had listed its chemical-hazards chapter as “coming soon” since the guidance first appeared in 2016 [3].

The new chapter is intended to help manufacturers evaluate chemical hazards and choose appropriate CGMPs or preventive controls, explicitly including supply-chain controls for ingredients, to significantly minimise or prevent them. It includes worked examples across a range of chemical-hazard scenarios, and FDA links it directly to Closer to Zero, saying it may help companies reduce heavy metals and meet action levels once finalised [4][7].

When a hazard is controlled by a supplier rather than the receiving facility, the preventive controls rule generally requires a supply-chain program: approved suppliers, documented verification such as testing or audits, and records. Read together, the two documents point toward heavy-metal control that is documented in the food safety plan and verified through suppliers, not demonstrated after the fact by finished-product testing alone. That framework reaches well beyond baby food, to any manufacturer whose hazard analysis identifies heavy metals, mycotoxins or pesticide residues in incoming ingredients.

Regulatory Convergence Without Regulatory Harmonization

The EU has applied a binding maximum level of 0.040 mg/kg (40 ppb) for cadmium in processed cereal-based foods and baby foods for infants and young children since 2014, now carried in Regulation (EU) 2023/915 [9]. FDA’s proposal is tighter for purees, at 10 ppb for fruits, vegetables and mixtures, and slightly looser for dry infant cereal, at 45 ppb. Direct comparisons need care, because the basis on which each limit applies differs.

Canada takes a different route again. Health Canada and the CFIA monitor cadmium in baby foods through annual surveys, and Canada has binding maximum levels for inorganic arsenic in rice-based infant foods and for lead in infant formula [10]. GFI could not identify a cadmium-specific maximum level for Canadian baby food. Meanwhile, California’s AB 899 already requires baby-food manufacturers to test for arsenic, cadmium, lead and mercury and publish the results, making outlier lots visible to consumers regardless of federal enforcement.

The direction is shared; the mechanisms are not. A company supplying the U.S., Canada and the EU now faces category-specific U.S. benchmarks, a single EU limit and surveillance-led Canadian oversight. The simplest response is to specify ingredients to the most stringent applicable level for each category and market, rather than run separate supply streams.

What This Means for Food Companies

Baby-food manufacturers should benchmark at least two years of ingredient and finished-product cadmium data against each proposed level, looking at the upper tail rather than the mean, and identify which SKUs and raw materials drive exceedances. Analytical methods, typically ICP-MS, need quantification limits comfortably below 10 ppb to verify the fruit and vegetable level. Ingredient suppliers should expect explicit cadmium specifications, more frequent certificates of analysis and requests for evidence of upstream controls such as soil testing and fertiliser records. All FSMA-covered manufacturers should review their hazard analyses against Chapter 12, particularly where control of a chemical hazard rests with a supplier.

One practical caution on deadlines: the two documents sit in separate dockets with separate closing dates, but at least one FDA communication pairs the cadmium guidance with the later date [2][4][8]. Companies preparing comments should confirm the deadline for their specific docket on Regulations.gov before filing.

The cadmium action levels are measured rather than dramatic. Most products already comply, and FDA has calibrated the numbers to protect access to nutritious foods. Their real significance lies in what they ask of the supply chain, and Chapter 12 gives that expectation a home inside the FSMA food safety plan. For baby-food manufacturers, the line that matters most may no longer run through the factory. It runs through the field.

Related on GFI: U.S. GRAS Reform Could Reshape How Food Ingredients Reach the American Market and Allulose Has a Zero-Sugar Problem: One Ingredient, Five Regulatory Systems, Different Answers.

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Sources

1. U.S. Food and Drug Administration. Action Levels for Cadmium in Processed Food Intended for Babies and Young Children: Draft Guidance for Industry. October 2026. FDA
2. U.S. Food and Drug Administration. Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability. 91 FR 66796. October 23, 2026. Docket FDA-2025-D-4023. Federal Register
3. U.S. Food and Drug Administration. Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food. Chapter 12 added October 2026. Docket FDA-2016-D-2343. FDA
4. U.S. Food and Drug Administration. Dear Tribal Leader Letter on Closer to Zero Updates. October 22, 2026. FDA
5. U.S. Food and Drug Administration. Closer to Zero: Reducing Childhood Exposure to Heavy Metals from Foods. Program page. FDA
6. Contemporary Pediatrics. FDA Proposes Cadmium Action Levels for Baby Food Under Closer to Zero. October 22, 2026. Article
7. Food Safety Magazine. FDA Proposes Cadmium Action Levels for Baby Foods, Issues Preventive Controls Guidance for Chemical Hazards. October 22, 2026. Article
8. Western Growers Association. FDA Advances Efforts to Reduce Cadmium in Children’s Food. October 2026. Article
9. European Commission. Commission Regulation (EU) 2023/915 on Maximum Levels for Certain Contaminants in Food. April 25, 2023.
10. Health Canada. Proposal to Add a Maximum Level for Inorganic Arsenic in Rice-based Foods Intended Specifically for Infants and Young Children. Health Canada