FDA Issues Guidance on Lead Action Levels for Processed Baby Food

FDA considers the following action levels to be achievable by the food industry when control measures are taken to minimize the presence of lead.

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The U.S. Food and Drug Administration (FDA) has issued guidance on action levels for lead in processed foods intended for babies and young children.

The agency’s Closer to Zero initiative is a science-based, iterative approach to decreasing toxic elements, including lead, in foods over time. FDA considers the following action levels to be achievable by the food 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 agency’s Closer to Zero initiative outlines other actions it will take to further reduce lead (as well as other toxic elements) in food.

The FDA has also issued a document that presents background and rationale for its action levels for lead in processed food intended for babies and young children. 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 younger 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).

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
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). The agency says it intends to consider these action levels, in addition to other factors, such as its 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.