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FDA draft guidance would set cadmium action levels for processed baby foods

2 min read

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FDA has opened comments on draft cadmium action levels for certain processed foods intended for children under two. The recommendations range from 10 parts per billion for most fruit, vegetable and mixed foods to 45 parts per billion for dry infant cereals. They are not final or binding. Comments are due December 22 for consideration before FDA starts the final guidance.

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FDA is proposing cadmium action levels for certain processed foods intended for babies and children under two. Its October 23 notice opens public comment on draft industry guidance; it does not put final limits into effect.

Which foods and levels

The notice lists five proposed levels, measured in parts per billion, or ppb:

  • 10 ppb: fruits, vegetables other than single-ingredient carrots, and mixtures, including grain- and meat-based mixtures.
  • 25 ppb: single-ingredient carrots.
  • 45 ppb: dry infant cereals.
  • 20 ppb: yogurts, puddings and custards.
  • 25 ppb: single-ingredient meats.

The age and food categories matter. These are recommendations for the specified processed foods intended for children under two, rather than a single threshold for every food a child might eat.

FDA says the draft aims to establish achievable action levels that help further reduce cadmium in the food supply. It asks for comments on the levels generally and on data or other information that could support different levels for the categories.

What an action level would mean

FDA says that, if finalized, the action levels would indicate cadmium concentrations at which it may regard food as adulterated under the Federal Food, Drug, and Cosmetic Act. The agency would consider the levels alongside other factors when deciding whether to bring an enforcement action in a particular case.

The notice also says finalized guidance would express FDA's current thinking, create no rights and bind neither FDA nor the public. An alternative approach may be used if it meets applicable statutes and regulations. The draft figures therefore are not a final rule or a determination about the safety of an individual product.

How to comment

Submit comments by December 22, 2026, to ensure FDA considers them before it begins work on final guidance. The notice says comments on guidance can also be submitted at any time.

Use docket FDA-2025-D-4023 at Regulations.gov, or follow the notice's paper-submission instructions. Electronic comments and attachments will be posted publicly. FDA directs people submitting confidential information to use its specified paper process, including a separate redacted copy.

The notice gives no date for issuing final guidance.

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