Beltway Beat

FDA’s Guidance for Industry: Action Levels for Lead in Processed Food Intended for Babies and Young Children

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January 7, 2025


• Categories: Beltway Beat, Food Manufacturing

The Food and Drug Administration (FDA) announced on its website the availability of a final guidance for industry entitled “Action Levels for Lead in Processed Food Intended for Babies and Young Children.” The guidance establishes action levels for lead in certain processed foods intended for babies and young children less than 2 years old. The guidance is intended to set achievable action levels that will help further reduce lead in the food supply.

In accordance with § 109.6 (21 CFR 109.6), this guidance establishes the following action levels for lead in processed food intended for babies and young children less than 2 years old:

• 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; and 20 ppb for dry infant cereals

Consistent with § 109.6(d), these action levels reflect levels of lead at which FDA may regard the food as adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1)). FDA said it intends to consider these action levels, in addition to other factors, when considering whether to bring enforcement action in a particular case.