U.S. FDA Issues Draft Guidance for Lead in Foods for Babies and Young Children

Feb. 2 2023

The U.S. Food and Drug Administration (FDA) issued a document entitled “Draft Guidance for Industry: Action Levels for Lead in Food Intended for Babies and Young Children.” The draft guidance provides action levels for lead in foods intended for babies and young children. Comments on the document may be submitted by March 27, 2023.

Limits
In accordance with 21 CFR 109.6, the draft guidance would establish the following action levels for lead in processed foods for babies and young children less than two years old:

• 10 ppb for fruits, vegetables (excluding single-ingredient root vegetables), mixtures, yogurts, custards/puddings, and single-ingredient meats;
• 20 ppb for root vegetables (single ingredient); and
• 20 ppb for dry infant cereals.

Foods above these action levels would be considered adulterated under the FDA. Along with other factors, these levels would be used to determine if enforcement action would be taken in a particular case.

Enforcement
FDA guidance documents generally do not establish legally enforceable responsibilities and should be considered as recommendations unless specific regulatory requirements are cited.

The FDA is requesting either online or written comments on this guidance document. They are particularly interested in whether there is data and information to support lower levels for these foods.

FDA Proposed Rule in Federal Register:
https://www.govinfo.gov/content/pkg/FR-2023-01-25/pdf/2023-01384.pdf

FDA Draft Guidance for the Industry:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-action-levels-lead-food-intended-babies-and-young-children

How Does this Impact You? Contact Us to Discuss
Bureau Veritas can help verify that your products will meet your customer’s expectations as well as all applicable regulations. We can help you reduce cost and time-to-market, minimize the risk of recalls and returns, increase sales and customer satisfaction, and eliminate previously unidentified threats to your company’s reputation. Our services help to protect both your bottom line and your peace of mind.

If you have any questions on these final rules, please contact your customer service representative or email: info@us.bureauveritas.com.
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