The U.S. Food and Drug Administration (“FDA”) has now issued draft Action Levels for Cadmium in Processed Food Intended for Babies and Young Children. After years of study and discussion, the FDA’s long-awaited draft action levels for cadmium are an important step forward in the Agency’s Closer to Zero initiative, which will inform industry and provide predictability to baby food manufacturers and marketers. Under Closer to Zero, launched in 2021 in response to broad concerns regarding heavy metals in foods for infants and children under the age of two, the FDA committed to an iterative approach of establishing, and then progressively lowering, action levels for heavy metals in foods eaten by babies and young children. This is the first announcement of a new action level for a heavy metal in connection with Closer to Zero in the nearly two years since the FDA finalized its action levels for lead in baby food, despite earlier commitments to issue proposed action levels sooner.
Although the guidance is only a draft, it signals that the FDA has determined that cadmium content above these levels poses a reasonably avoidable health hazard. Plaintiffs in consumer litigation may also cite the FDA’s draft action levels to support claims that a baby food product’s cadmium content violates consumer protection laws. Finally, some states have enacted laws that require the disclosure of heavy metals test results and make the distribution of baby food exceeding an FDA action level unlawful in such states. This means that manufacturers and marketers also need to ensure their products comply with the draft action levels, if finalized, to remain in compliance with varying state laws.
What Is an Action Level?
When a contaminant cannot be entirely removed from the food supply, the FDA may set an action level for that “poisonous or deleterious substance” under 21 CFR 109.6(d), at which the FDA may consider a food adulterated. It is not a safety threshold or a safe harbor. Instead, the FDA views action levels as an important source of information that it weighs, along with other factors, when determining whether a food is adulterated and whether to take enforcement action. Since the FDA finalized its action levels for lead in baby food, the FDA and states have used the action levels as a means to urge voluntary recalls of baby foods exceeding such action levels.
What Infant Foods Are Covered?
The action levels apply to processed (i.e., packaged) food represented or purported to be for babies and young children under two years old. The action levels do not apply to infant formulas, any beverages (including toddler drinks), raw agricultural commodities, homemade foods, or snack foods, including grain-based or freeze-dried snacks. However, the FDA is still collecting data on grain-based snacks, and we urge manufacturers and marketers of snacks specifically marketed for very young children to exercise caution.
What Are the Proposed Action Levels?
| Infant Processed Food Type | Proposed Action Level |
|---|---|
Fruits Vegetables (excluding single-ingredient carrots) Mixtures (including grain- and meat-based mixtures) | 10 parts per billion (ppb) |
Yogurts Puddings Custards | 20 ppb |
Single-ingredient carrots Single-ingredient meats | 25 ppb |
Dry infant cereals | 45 ppb |
Next Steps
- Consider submitting comments, whether on your own or as a member of an industry association, within the 60-day window electronically at regulations.gov under Docket No. FDA-2025-D-4023 or in writing to FDA’s Dockets Management Staff.
- Identify which of your products are covered by this guidance.
- Identify raw material specifications and any internal heavy metals limits that may not be consistent with the draft action levels.
- Review existing test data and begin taking practical steps to reduce cadmium levels where necessary. The FDA provided examples of steps that growers and manufacturers may be able to take to reduce cadmium levels:
- Add soil amendments to reduce the availability of cadmium for uptake by crops;
- Thoroughly peel root vegetables and wash fruits and vegetables, particularly leafy vegetables;
- Choose sources of food or food ingredients with lower cadmium levels or no detectable cadmium;
- Consider increased testing of ingredients or finished products that are historically known to contain elevated cadmium levels; and
- Consider examining facilities, processes, and equipment to ensure manufacturers are not contributing to cadmium in their products (Note: Along with this guidance, the FDA issued a Draft Preventive Controls for Chemical Hazards, which we will address in a separate alert).
Prepared by Suzie Trigg and Carleigh Lenz Mathis as of October 22, 2026. See FDA, Action Levels for Cadmium in Processed Food Intended for Babies and Young Children: Draft Guidance for Industry (October 2026).
