With FDA’s newly released draft guidance on Action Levels for Cadmium in Processed Food Intended for Babies and Young Children, the agency is getting closer to completion of the published action levels on the heavy metals designated as its primary focus in its Closer to Zero initiative.
Current status of these Closer to Zero guidances:
- Lead: Final guidance was published on lead in 2025 (with draft guidance for juices issued in 2022 with final guidance targeted for 2027).
- Inorganic arsenic: Draft guidance is targeted for 2027.
- Mercury: FDA’s research has shown mercury to not be a concern, so the agency is not prioritizing it at this time.
- Cadmium: Draft guidance proposed October 2026.
With all of these focused on processed food represented or meant to be for babies and children under two years of age, the newest guidance for cadmium sets action levels at amounts FDA considers to be achievable by industry “when control measures are taken to minimize the presence of cadmium.” The action levels are:
- 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient carrots), and mixtures (including grain- and meat-based mixtures);
- 25 ppb for single-ingredient carrots;
- 45 ppb for dry infant cereals;
- 20 ppb for yogurts, puddings, and custards;
- 25 ppb for single-ingredient meats.
Cadmium was included as a hazardous heavy metal in the Closer to Zero initiative because it is widely present in the environment, so it can easily penetrate food; and, with a long half-life (10 to 33 years) in humans, even low-level chronic dietary exposure can cause adverse effects. Because of this, even though guidance documents do not establish legally enforceable responsibilities, a food with a level above those specified would be regarded by FDA as adulterated.
Thus, the guidance levels were based on the Toxicological Reference Value (TRV) for cadmium, which is a range rather than a fixed value and represents cadmium exposure levels that are associated with the most sensitive adverse health effects from cadmium exposure. FDA considers the intake of the food and the maximum level of cadmium that could be in the food without exceeding the lower TRV level; intake is focused on the 90th percentile consumption level to account for children with higher intakes.
The guidance also cites further rationale for the levels, including the toxic elements program and FDA survey data, total diet study data, and exposure and manufacture achievability assessments. FDA also states that it will be monitoring the levels of cadmium in food and children’s exposure to determine if the action levels should be adjusted and if additional foods or food categories should be added.
With lead being the first of the Closer to Zero heavy metals for which FDA has issued final guidance (January 2025), it’s a good time to take another look at that guidance to determine where you are in compliance. The guidance focuses on processed food, whether ready-to-eat or semi-prepared, with action levels set at:
- 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain- and meat-based mixtures), yogurts, custards/puddings, and single-ingredient meats.
- 20 ppb for single-ingredient root vegetables.
- 20 ppb for dry infant cereals.
FDA’s Closer to Zero focus on heavy metals is due to both the hazards they can pose as well as the fact that it’s not possible to entirely remove them from the environment or the food supply. Thus, the action levels set in the guidances can, at least, help to lower their levels in foods when some level of contaminant is unavoidable.
It also is important to remember that, while guidances are not binding, and action levels can help reduce heavy metals in foods, FDA can and does take enforcement action if a food product is deemed to be adulterated or otherwise violate food safety regulations. To this point TAG has seen FDA take action on lead levels in infant foods that are only marginally above the guidance levels. We should expect the same with cadmium, especially in the context of foods for babies and small children. So our recommendation is to know what the levels of both lead and cadmium are in any foods that are targeted toward infants and babies and control such risks in your finished products.
In summary, the FDA’s recently released draft guidance on Action Levels for Cadmium in Processed Food Intended for Babies and Young Children. Cadmium was included as a hazardous heavy metal in the Closer to Zero initiative because it is widely present in the environment, so it can easily penetrate food, and, with a long half-life (10 to 33 years) in humans, even low-level chronic dietary exposure can cause adverse effects. With the release of draft guidance for Cadmium, FDA is getting closer to completing the published action levels on the heavy metals designated as its primary focus in its Closer to Zero initiative. Now is a good time to take another look at that guidance to determine where you are in compliance.
