The U.S. Food and Drug Administration (FDA) has finalized new guidance setting action levels for lead in processed foods intended for babies and young children under two years of age. These action levels represent the thresholds at which the FDA may consider a food product to be adulterated under the Federal Food, Drug, and Cosmetic Act (FFDC), which could lead to enforcement actions.
The guidance applies to packaged, processed foods marketed for babies and toddlers, including products such as purees, ready-to-eat foods, dry infant cereals, and grain- and meat-based mixtures, typically found in jars, pouches, tubs, or boxes. However, the action levels specified do not extend to infant formula, beverages, or snacks like puffs and teething biscuits. The FDA is also collecting data on grain-based snacks to assess whether additional action levels may be necessary for these products in the future.
Under the new guidelines, the FDA has set the following action levels for processed foods:
- 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain- and meat-based), yogurts, custards, puddings, and single-ingredient meats.
- 20 ppb for single-ingredient root vegetables.
- 20 ppb for dry infant cereals.
These action levels will guide the FDA in determining whether enforcement actions should be pursued for foods containing lead above these thresholds. While the agency strongly encourages the food industry to adhere to these levels, it is important to note that the guidance is non-binding and does not create legally enforceable requirements.
This initiative is part of the FDA’s ongoing Closer to Zero effort, which aims to reduce the exposure of babies and young children to lead and other toxic heavy metals in food products. Additionally, action levels for lead in juices were addressed in a separate draft guidance published in April 2022.
The new guidelines are expected to help further reduce the risks associated with lead exposure for young children, who are particularly vulnerable to the harmful effects of heavy metals.
