On January 6, 2025, the U.S. Food and Drug Administration (FDA) issued the final Guidance for Industry: Action Levels for Lead in Processed Food Intended for Babies and Young Children.
The guidance establishes the following action levels for packaged processed foods intended for babies and young children less than two years of age:
- 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
- 20 ppb for dry infant cereals
“Processed food in this guidance refers to packaged food (e.g., in jars, pouches, tubs, or boxes) represented or purported to be for babies and young children less than two years old. It may include ready to-eat foods (e.g.,
purees) as well as semi-prepared foods (i.e., dry infant cereals).”
Background
In January 2023, the FDA published the draft guidance document as part of the Closer to Zero initiative “to reduce dietary exposure to contaminants to as low as possible, while still maintaining access to nutritious foods”. The action levels did not change between the draft and final version of the guidance document.
Link:
https://www.fda.gov/food/hfp-constituent-updates/fda-issues-final-guidance-industry-action-levelslead-processed-food-intended-babies-and-young
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