[co-author: Stephanie Kozol]*
In recent years, the safety of baby food has become a top priority for state attorneys general (AG) and federal agencies. In April 2021, the U.S. Food and Drug Administration (FDA) announced its “Closer to Zero” plan to “reduce dietary exposure to contaminants to as low as possible, while maintaining access to nutritious foods.” However, multiple coalitions of state AGs have been vocal in advocating for more stringent and urgent measures. Over the last four years, these coalitions have urged the FDA to take decisive action to ensure the safety of baby food products, particularly as it relates to the presence of toxic metals. In January 2025, the FDA issued final guidance setting action levels for lead in processed foods intended for babies and young children under the age of two.
The Push for Stricter Guidelines
In February 2021, New York AG Letitia James expressed deep concerns about allegedly high levels of toxic metals, including arsenic, lead, cadmium, and mercury in baby foods being sold by some of the nation’s largest manufacturers. In her letter to the acting FDA commissioner, she claimed that, without additional oversight, baby food manufacturers “have been able to set their own internal standards for levels of toxic metals.” She called on the FDA to set standards for all baby foods and require manufacturers to test their finished products for toxic metals.
A few months later, in October 2021, James led a coalition of 23 AGs in a petition to the FDA requesting the agency to “issue interim proposed action levels for four toxic heavy metals in all relevant categories of infant and toddler food.” The petition argued that many of the timelines the FDA proposed in their “Closer to Zero” plan were too far off, and the magnitude of the safety risk these heavy metals pose necessitated interim action levels. Specifically, this petition called on the FDA to (i) propose science-based limits for inorganic arsenic, lead, cadmium, and mercury; (ii) lower the existing FDA action level for inorganic arsenic in infant rice cereal; and (iii) instruct baby food manufacturers to test finished products for toxic heavy metals.
We saw continued state AG advocacy after the FDA denied the 2021 petition in June 2022 when a coalition of 22 AGs issued a letter to the FDA commissioner, FDA deputy commissioner, and U.S. Department of Agriculture (USDA) secretary. This letter urged these agencies to take immediate and robust action to address “children’s exposure to neurotoxic heavy metals” by accelerating the timelines of the “Closer to Zero” plans.
In February 2024, a coalition of 20 AGs once again called on the FDA to take urgent action, alleging that “some manufacturers and distributors of baby foods in the U.S. currently lack a clear understanding of the proper way to apply preventive controls.” This request referenced a widespread recall of certain cinnamon applesauce pouches, which had lead levels more than 200 times the action levels the FDA had proposed in their draft guidance. This letter reinforced the AGs’ arguments for immediate action on toxic heavy metals in baby food.
The FDA’s New Guidance on Lead Action Levels
On January 6, the FDA took an initial step in addressing some of the concerns raised in these AG efforts by releasing their final guidance, establishing action levels for lead in processed food intended for babies and young children.
Under 21 CFR 109.6(d), the FDA may establish action levels, which set the level of a substance at which the FDA may treat the food as “adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).” These are not legally enforceable guidelines, but rather reflect the FDA’s recommendations for those in the industry.
The FDA considered the practical implications of these action levels, such as the need for a limited number of action levels to ensure simplicity, the goal of reducing exposure to lead, and data demonstrating the varied levels of lead concentrations in different types of processed foods intended for babies and young children. As such, the FDA set the following action levels:
- 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures, yogurts, custards/puddings, and single-ingredient meats;
- 20 ppb for single-ingredient root vegetables; and
- 20 ppb for dry infant cereals.
The action levels are separated into these categories due to differences in food properties, the levels of lead found in these products, and achievability. For example, root vegetables can absorb lead more readily from the soil than other crops while fruits, other vegetables, mixtures, yogurts, custards/puddings, and single ingredients of meats tend to have lower levels of lead compared to single-ingredient root vegetables and dry infant cereals.
These guidelines do not apply to raw agricultural commodities, homemade foods, snack foods (including grain-based or freeze-dried snacks), infant formula, or any beverage (including toddler drinks).
The FDA reiterates that these are nonbinding recommendations, intended to encourage manufacturers to maintain levels of lead in these processed foods below the action levels to reduce risks associated with dietary lead exposures for young children and babies.
Conclusion
The FDA’s “Closer to Zero” initiative lays out a timeline for evaluating the data and establishing action levels for arsenic, cadmium, and mercury in foods intended for babies and young children as well as action levels for lead in juices. Currently, the FDA is targeting finalized action levels for lead in juices in 2025, with the goal of the other contaminants’ action levels to follow the completion of reviewing data and the issuance of draft guidance.
The FDA’s issuance of final guidance on action levels for lead in processed foods intended for babies and young children marks a significant step forward in addressing the concerns raised by state AGs. While these guidelines are not legally enforceable, they represent a regulatory effort to reduce the risks associated with dietary lead exposure in young children.
*Senior Government Relations Manager
