FDA Issues Final Guidance for Industry on Action Levels for Lead in Processed Food for Babies and Young Children
On Jan. 6, 2025, the U.S. Food and Drug Administration (FDA) issued guidance for industry on the action levels for lead in processed food intended for babies and young children. The action levels reflect the levels of lead at which the FDA may regard the food as adulterated under the Federal Food, Drug, and Cosmetic Act. The guidance titled “Action Levels for Lead in Processed Food Intended for Babies and Young Children: Guidance for Industry” supports our Closer to Zero initiative to reduce dietary exposure to contaminants, including lead, in foods to as low as possible over time, while maintaining access to nutritious foods.
The action levels for processed foods described in the guidance are as follows: 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.
Although not binding, the FDA would consider action levels, in addition to other information, when considering whether to bring enforcement action in a particular case. It is not possible to remove lead entirely from the environment or the food supply. Setting action levels like those in the guidance can help lower levels of contaminants in foods when a certain level of a contaminant is unavoidable.
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Source: U.S. Food and Drug Administration
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