On October 22, 2026, FDA issued a draft guidance proposing action levels for cadmium in certain processed foods intended for babies and young children less than two years old. In announcing the proposal, FDA explained that “low-level exposure to cadmium is common and generally not harmful, but that higher levels of exposure can pose risks to human health.” FDA also acknowledged that cadmium is widely present in nature and therefore can occur at low levels in food, and recognized that it may not be possible to completely eliminate heavy metals from food. At the same time, FDA noted that manufacturers can take measures to reduce cadmium levels and stated that action levels have been shown to be an effective tool.
The draft guidance proposes the following action levels:
- 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; and
- 25 ppb for single-ingredient meats.
The proposed action levels apply to processed foods packaged in jars, pouches, tubs, boxes, or similar containers that are represented or purported to be for babies and young children under two years old. Covered foods may include ready-to-eat foods, such as purees, and semi-prepared foods, such as dry infant cereals. The proposed action levels do not apply to raw agricultural commodities, infant formula, beverages (including toddler drinks), or snack foods (including grain-based and freeze-dried snacks). FDA states that it is continuing to collect data on grain-based snacks to determine whether an action level may be appropriate.
Although the proposed action levels are not legally enforceable, when finalized, FDA may consider foods containing cadmium above these levels to be adulterated under section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act. In determining whether to take enforcement action, FDA may consider the action levels along with other factors, such as its confidence in the measured analytical value.
FDA launched its Closer to Zero initiative in 2021 to address dietary exposure to arsenic, lead, cadmium, and mercury in foods for babies and young children, while maintaining access to nutritious foods. FDA’s efforts to date include action levels for inorganic arsenic in infant rice cereal and lead in processed foods intended for babies and young children, as well as proposed action levels for lead in juice. The cadmium proposal is the latest step in these efforts, with FDA also planning to issue draft guidance in 2026 addressing inorganic arsenic in foods intended for babies and young children.
FDA’s proposal comes amid continued federal and state attention to heavy metals in foods for infants and young children. In April 2026, Rep. Krishnamoorthi (D-IL) and others reintroduced the Baby Food Safety Act, which would require FDA to establish limits for lead, cadmium, mercury, and arsenic in infant and toddler foods and to establish testing and related requirements for manufacturers. States have also taken action in recent years. For example, California, Maryland, Virginia, and Illinois have enacted laws requiring baby food manufacturers to test products for certain heavy metals and publicly disclose certain testing results.
At the same time that FDA announced the cadmium proposal, the Agency also issued draft guidance addressing the control of chemical hazards under the Preventive Controls for Human Food regulation. According to FDA, the guidance is intended to help manufacturers evaluate potential chemical hazards and identify appropriate CGMPs or preventive controls to reduce those hazards in food, including to help meet action levels established under Closer to Zero. The draft guidance on the control of chemical hazards includes separate examples illustrating how manufacturers can establish and implement supply-chain programs related to the “control of toxic elements during production of shelf-stable baby foods” and the “production of dry infant rice cereal.”
Comments on the proposed cadmium action levels are due December 22, 2026.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.
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