Action Levels for Lead in Processed Food Intended for Babies and Young Children; Guidance for Industry; Availability
Published Date: 1/7/2025
Notice
Summary
The FDA just released new guidance to limit lead in processed foods made for babies and kids under 2 years old. This helps keep little ones safer by reducing lead exposure in their food. Food makers should follow these action levels starting now to protect kids’ health without big costs or delays.
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Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Lead limits for baby foods
If you feed babies or young children under 2 years old, FDA set action levels for lead in processed foods: 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; and 20 ppb for single-ingredient root vegetables and for dry infant cereals. FDA announced this final guidance on January 7, 2025 and says it will use these levels to help reduce lead in the food supply.
Enforcement thresholds for food makers
If you manufacture processed foods intended for children under 2, FDA's final guidance establishes action levels for lead (10 ppb for many foods and 20 ppb for root vegetables and dry infant cereals) that the agency may regard as indicating the food is adulterated under section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act. FDA says it intends to consider these action levels, among other factors, when deciding whether to bring enforcement action; the guidance was announced January 7, 2025.
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