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Draft Guidance for Industry: Action Levels for Lead in Food Intended for Babies and Young Children January 2023


Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-0278

Docket Number:
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition

FDA is committed to reducing lead in food. FDA’s Closer to Zero action plan is a science-based, iterative approach to decreasing toxic elements, including lead, in foods over time, including by setting action levels. The purpose of this guidance is to provide information to industry on the action levels for lead in food intended for babies and young children. 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, our Closer to Zero action plan outlines other actions we will take to further reduce lead (as well as other toxic elements) in food and our expectation is that industry will strive for continual reductions over time.

Additionally, this document will present the background and rationale for FDA’s action levels for lead in processed food intended for babies and young children:

  • 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 root vegetables (single ingredient); 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). We intend to consider these action levels, in addition to other factors, such as our confidence in a measured analytical value, when considering whether to bring enforcement action in a particular case.

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

Download the Draft Guidance

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