FDA: Guidance for Industry: Action Levels for Lead in Processed Food Intended for Babies and Young Children
FDA is committed to reducing lead in food. FDA’s Closer to Zero initiative is a science-based, iterative approach to decreasing toxic elements, including lead, in foods over time, including by setting action levels. The purpose of the guidance is to provide information to industry on the action levels for lead in processed food intended for babies and young children (i.e., those less than two years old).
FDA considers the action levels described in this guidance to be achievable by industry when control measures are taken to minimize the presence of lead. Although action levels are levels at which FDA may regard a food as adulterated, the Closer to Zero initiative outlines other actions that will be taken to further reduce lead (as well as other toxic elements) in food and the expectation is that industry will strive for continual reductions over time.
The action levels for processed foods intended for babies and young children 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.
Consistent with 21 CFR 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 (FD&C Act).