Heavy Metals in Food: What FDA's Cadmium Draft and Chapter 12 Mean for Canadian Exporters

On 23 October 2026, the United States Food and Drug Administration took two steps that should put chemical hazards at the top of every food safety agenda. It proposed new action levels for cadmium in processed food for babies and young children, and it released a draft chapter of its preventive controls guidance that tells manufacturers exactly how inspectors expect chemical hazards to be analyzed and controlled. For Canadian companies that sell food into the United States, or that hold a Safe Food for Canadians licence at home, these are not distant American headlines. They change what a defensible food safety plan has to show.

This article explains what FDA proposed, how it connects to the broader Closer to Zero initiative, and the concrete work a Canadian exporter or licence holder should start now. The comment window on the cadmium draft closes 22 December 2026, and FDA is hosting a public webinar on 16 November 2026, so the time to review your preventive controls is this quarter, not after the guidance is final.

Executive Summary

FDA has proposed, for the first time, action levels for cadmium in processed food intended for babies and young children under two years of age. It issued the draft on the same day as a new draft chapter on controlling chemical hazards, Chapter 12 of the preventive controls for human food guidance. Together they signal that heavy metals and other chemical contaminants are now a front-line expectation, not a footnote. Key points:

• The proposed cadmium action levels range from 10 parts per billion for fruits, vegetables and mixtures to 45 parts per billion for dry infant cereals. They are draft and not binding, but they set the level at which FDA may consider a food adulterated.
• Draft Chapter 12 tells facilities to treat toxic elements such as arsenic, cadmium and lead as supply-chain hazards for baby food, and to use supplier controls and finished-product testing as verification.
• Canadian exporters are reached through their US importer's Foreign Supplier Verification Program, and at home through the chemical-hazard analysis their Safe Food for Canadians preventive control plan already requires.
• Comments on the cadmium draft are due 22 December 2026, and FDA will hold a Closer to Zero webinar on 16 November 2026.

What Changed on 23 October 2026

In short: FDA proposed cadmium action levels for baby food and published draft guidance on how to control chemical hazards under its preventive controls rule. Why it matters: these documents tell food manufacturers and the inspectors who audit them what good chemical-hazard control looks like, and they extend a trend that began with lead and arsenic. What to do: read both documents, map them to your own products, and decide whether your current controls would survive scrutiny.

The first document is a draft guidance titled Action Levels for Cadmium in Processed Food Intended for Babies and Young Children, announced in the Federal Register on 23 October 2026 under docket FDA-2025-D-4023. It proposes the cadmium concentrations at which FDA may regard these foods as adulterated under section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act. The second is draft Chapter 12, Control of Chemical Hazards, part of FDA's larger draft guidance on hazard analysis and risk-based preventive controls for human food.

Both sit inside FDA's Closer to Zero initiative, a multi-year effort to reduce children's dietary exposure to arsenic, lead, cadmium and mercury. FDA finalized lead action levels for baby food in January 2025 and has long had an action level for inorganic arsenic in infant rice cereal. Cadmium is the next element in that sequence.

Proposed cadmium action levels (draft, processed food for children under two)

A part per billion is one microgram per kilogram. These are draft figures. They could change before the guidance is final, and FDA stresses that action levels are not binding limits. They are the point at which the agency may act, and alternative approaches are allowed if they meet the law.

Why Chemical Hazards Are Suddenly the Focus

What it is: draft Chapter 12 is FDA's plain explanation of how to find and control chemical hazards in a food safety plan. Why it matters: it names the hazards inspectors will expect you to have considered, and it sets the evidence standard for saying a hazard does not need a preventive control. What to do: use it as a template to pressure-test your own hazard analysis.

Chapter 12 covers far more than heavy metals. It addresses toxic elements such as arsenic, cadmium and lead, plus mycotoxins, pesticide and veterinary drug residues, environmental contaminants such as dioxins and PFAS, process-related contaminants such as acrylamide and 3-MCPD esters, and economically motivated adulteration such as lead-based colours added to spices. Food allergens are handled in a separate chapter. For each hazard that is reasonably foreseeable, a facility has to decide whether it can be managed through good manufacturing practices and prerequisite programs or whether it needs a preventive control.

The chapter is explicit that for foods intended for babies and young children, applicable toxic elements in ingredients should generally be treated as supply-chain hazards. That means the control sits upstream, with the supplier, and the manufacturer verifies it. In FDA's worked example, a baby-food maker tests finished product each quarter for arsenic, cadmium and lead, and uses those results to decide whether to reanalyze its food safety plan. Testing here is a verification activity, not the control itself.

That distinction matters. You cannot test your way to safe food. A quarterly composite that comes back below an action level does not prove every lot was compliant, because contaminants are rarely distributed evenly across a crop or a production run. The real control is choosing low-contaminant sources, writing specifications into purchase agreements, qualifying suppliers, and auditing them. Testing confirms the system is working.

Do These Rules Reach Canadian Companies?

Yes, through two doors. If you export food to the United States, your American importer must run a Foreign Supplier Verification Program that confirms you control the hazards in your product, including toxic elements where they are reasonably foreseeable. If you sell inside Canada under a Safe Food for Canadians licence, your preventive control plan already has to analyze chemical hazards. The FDA documents simply raise the bar for what that analysis should look like.

The export door is the one most Canadian manufacturers underestimate. Under the US rule, the importer is accountable, but the importer gets its evidence from you. If a shipment of your product is found above a cadmium action level, FDA can treat it as adulterated, refuse it at the border and place your product on an import alert, which means detention without physical examination for future shipments. Our guide to FSVP for Canadian food exporters explains what your US importer will ask you to provide.

At home, Canada does not simply mirror the FDA numbers. Health Canada maintains a List of Contaminants and Other Adulterating Substances in Foods, incorporated by reference under Division 15 of the Food and Drug Regulations, and sets maximum levels for specific contaminant and food combinations. Where no maximum level exists, the Food and Drugs Act still prohibits selling food that contains a poisonous or harmful substance, and Health Canada can assess the risk case by case. The Canadian Food Inspection Agency enforces these rules. So a Canadian product can be compliant in Canada and still be refused in the United States if it exceeds an FDA action level, and the reverse is also possible. You have to know both frameworks.

Closer to Zero: where each element stands

How to Build Chemical Hazards into Your Preventive Control Plan

What to do: treat chemical hazards with the same rigour you already apply to Listeria or allergens. A preventive control plan that names only biological and physical hazards, or that waves away heavy metals in a single line, is the gap inspectors look for. The steps below work for both an FSVP file and a Safe Food for Canadians preventive control plan.

1. Identify reasonably foreseeable chemical hazards for each product and each ingredient. For plant-based ingredients grown in soil, toxic elements are usually foreseeable. Document the hazards you considered and the reasoning for any you ruled out.
2. Decide where the control sits. For toxic elements, the control is almost always at the supplier, so set it up as a supply-chain-applied control with written approval and verification.
3. Write numeric specifications into purchase agreements. Tell suppliers the maximum level you will accept for cadmium, lead and arsenic in each ingredient, and require a certificate of analysis for incoming lots.
4. Qualify and verify suppliers. Use audits, record review and periodic sampling and testing. Keep the supporting records in the food safety plan so they are available for official review.
5. Use finished-product testing as verification, not as the control. Set a testing frequency, define what an out-of-specification result triggers, and link it to reanalysis of the plan.
6. Validate your laboratory method. Make sure the method's limit of detection is well below the action level you are checking against, and that the lab is accredited for the matrix.
7. Reanalyze when something changes. A new supplier, a new growing region, a drought year or a new FDA action level are all triggers to revisit the hazard analysis.

Chemical Hazard Compliance Checklist

• Every product and ingredient has a documented chemical-hazard analysis, including toxic elements where foreseeable.
• Supplier approval and verification procedures exist for ingredients that carry a chemical hazard.
• Purchase specifications state numeric maximums for cadmium, lead and arsenic where relevant.
• Certificates of analysis are collected, reviewed and retained for incoming high-risk ingredients.
• A finished-product testing plan defines frequency, methods and out-of-specification actions.
• The laboratory method's detection limit is below the applicable action or maximum level, and the lab is accredited.
• Reanalysis triggers are written down and followed when suppliers, sources or regulations change.
• For US exports, your importer has an FSVP file that reflects your chemical-hazard controls.

Common Mistakes

• Treating heavy metals as not reasonably foreseeable without any supporting data. If the ingredient is grown in soil, you need evidence, not an assumption.
• Relying on a single annual composite test as proof of control. Contaminants are not evenly distributed, so one sample does not clear a year of production.
• Confusing an action level with a legal limit. An action level is where FDA may act. A product below it can still be challenged, and a product above it can be deemed adulterated.
• Assuming Canadian compliance guarantees US market access. The two frameworks use different numbers and different foods.
• Leaving the specification out of the purchase agreement. If the number is not in the contract, the supplier has no duty to meet it.

Frequently Asked Questions

What are FDA's proposed cadmium action levels for baby food?

FDA's October 2026 draft proposes 10 parts per billion for fruits, vegetables and mixtures, 25 ppb for single-ingredient carrots and single-ingredient meats, 20 ppb for yogurts, puddings and custards, and 45 ppb for dry infant cereals, in processed food for children under two years. These are draft figures and could change before the guidance is final.

Are action levels legally binding?

No. Action levels are not binding limits. They are the concentrations at which FDA may regard a food as adulterated and may consider taking enforcement action, alongside other factors. Alternative approaches are allowed if they comply with the law.

Do the FDA rules apply to Canadian exporters?

Indirectly but firmly. Your US importer must verify under its Foreign Supplier Verification Program that you control reasonably foreseeable hazards, including toxic elements. Product above an action level can be deemed adulterated and refused entry, and repeat problems can lead to an import alert.

Does Canada have its own limits for cadmium and lead in food?

Health Canada sets maximum levels for some contaminant and food combinations through its List of Contaminants and Other Adulterating Substances in Foods, incorporated by reference under Division 15 of the Food and Drug Regulations. Where no maximum level exists, the Food and Drugs Act still prohibits selling food with a poisonous or harmful substance. The Canadian Food Inspection Agency enforces these rules.

What is draft Chapter 12 of the preventive controls guidance?

It is FDA's draft guidance on controlling chemical hazards in a food safety plan. It covers toxic elements, mycotoxins, pesticide and drug residues, environmental and process contaminants, and economically motivated adulteration, and it explains how to analyze each hazard and decide on controls under the preventive controls rule.

When is the comment deadline and how can we take part?

Comments on the cadmium draft are due 22 December 2026 under docket FDA-2025-D-4023, and FDA is hosting a Closer to Zero webinar on 16 November 2026. Submitting a comment, even a short technical one, is a practical way to shape the final numbers and to show your quality program is engaged.

How MFLRC Can Help

MF License and Regulatory Consultants helps Canadian food manufacturers and exporters turn a regulatory change like this into a defensible food safety plan. We build and review preventive control plans under the Safe Food for Canadians Regulations, develop the chemical-hazard analysis and supplier verification that FDA now expects, and prepare FSVP files your US importer can rely on. With CFIA inspecting thousands of food facilities and FDA tightening heavy-metal expectations, a gap assessment now is far cheaper than a border refusal or a recall. We also support supplier qualification, specification development and mock inspections, the same discipline we bring to low-moisture and other complex food hazards.

Exporting food to the United States, or holding a Safe Food for Canadians licence? Book a chemical-hazard review of your preventive control plan with MFLRC before FDA's new guidance becomes the inspector's yardstick.

Conclusion

Cadmium is only the latest element in a steady march toward tighter chemical-hazard expectations. The companies that fare best will not wait for the guidance to be final. They will read the draft, map it to their products, strengthen their supplier controls, and treat heavy metals with the same seriousness they already give to physical and biological hazards. A food safety plan that can show how it controls toxic elements, and verify that control with sound testing, is the plan that passes an audit and keeps product moving across the border.

Sources and References

• FDA, Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance (Federal Register, 23 October 2026, docket FDA-2025-D-4023)
• FDA, Closer to Zero: Reducing Childhood Exposure to Contaminants from Foods
• FDA, Final Guidance: Action Levels for Lead in Processed Food Intended for Babies and Young Children (January 2025)
• FDA, Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (including draft Chapter 12, Control of Chemical Hazards)
• FDA, Webinar on Closer to Zero Updates Including Cadmium Action Levels, 16 November 2026
• Health Canada, Maximum Levels for Chemical Contaminants in Foods