Clinical Pharmacist and Master’s student in Clinical Pharmacy with research interests in pharmacovigilance, behavioral interventions in mental health, and AI applications in clinical decision support. Experience includes digital health research with Bloomsbury Health (London) and pharmacovigilance practice in patient support programs. Published work covers drug awareness among healthcare providers, postpartum depression management, and patient safety reporting. 
Clinical Pharmacist and Master’s student in Clinical Pharmacy with research interests in pharmacovigilance, behavioral interventions in mental health, and AI applications in clinical decision support. Experience includes digital health research with Bloomsbury Health (London) and pharmacovigilance practice in patient support programs. Published work covers drug awareness among healthcare providers, postpartum depression management, and patient safety reporting. What was reviewed?
This review summarizes the Federal Register notice announcing the final guidance titled “Action Levels for Lead in Processed Food Intended for Babies and Young Children.” It explains the FDA action levels for lead in baby food, clarifies the foods in scope, and outlines how FDA intends to use these levels when considering enforcement decisions under section 402(a)(1) of the FD&C Act. The guidance is final, reflects FDA’s current thinking under 21 CFR 10.115, and finalizes the January 2023 draft after public comment. FDA also added information on its testing method and clarified the intended age group as less than 2 years old. These elements collectively define the operational parameters for the FDA action levels for lead in baby food.
Who was reviewed?
The guidance addresses U.S. food manufacturers and related industry stakeholders producing processed foods intended for babies and young children under 2 years of age, including fruits, vegetables, meat- and grain-based mixtures, single-ingredient meats, yogurts, custards/puddings, single-ingredient root vegetables, and dry infant cereals. It is nonbinding but signals FDA’s approach to determining when such foods may be regarded as adulterated, and it points industry to where the most current version can be accessed and how comments may be submitted to the docket. This audience framing is central to implementing the FDA action levels for lead in baby food.
Most important findings
| Critical point | Details |
|---|---|
| Final action levels established | FDA sets 10 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. |
| Enforcement context | Under 21 CFR 109.6(d), FDA may regard food exceeding these levels as adulterated within FD&C Act §402(a)(1) and consider enforcement actions case by case, alongside other factors. |
| Scope clarified vs. draft | Final guidance clarifies the foods covered and the intended consumers’ age (<2 years), responding to comments on the january 25, 2023 draft and april 6, comment-period reopening. < td> |
| Methodology transparency | FDA added information about the method it uses to test for lead in food and incorporated additional Toxic Elements Program and special survey data to inform exposure and achievability assessments. |
| Legal nature of guidance | Issued under FDA’s Good Guidance Practices (21 CFR 10.115), the document represents current thinking; it does not create rights and permits alternative approaches meeting applicable requirements. |
| Access and docketing | The notice provides electronic access points for the guidance and explains that comments can be submitted to Docket No. FDA-2022-D-0278 at Regulations.gov at any time. |
| Publication details | Notice published January 7, 2025; Federal Register citation 90 FR 1135; dated December 27, 2024, with a subsequent correction notice listed for April 21, 2025. |
Key implications
For regulatory impacts, the final FDA action levels for lead in baby food convert prior draft expectations into clear ppb thresholds that FDA may use in adulteration assessments. For certification requirements, HTMC schemes should align with 10 ppb and 20 ppb category limits and document laboratory methods consistent with FDA’s approach. For industry applications, manufacturers should map product portfolios to the specified categories and institute targeted ingredient controls, especially for single-ingredient root vegetables and dry cereals. For research gaps, more public detail on method performance and variability could support uniform compliance. Practical recommendations include verifying supply-chain sources, implementing routine lot-based testing, and maintaining records demonstrating achievability and corrective actions.
Citation
Food and Drug Administration. Action Levels for Lead in Processed Food Intended for Babies and Young Children; Guidance for Industry; Availability. Federal Register. 2025 Jan 7;90(4):1135-1136. Document No. 2024-31534
Lead is a neurotoxic heavy metal with no safe exposure level. It contaminates food, consumer goods and drinking water, causing cognitive deficits, birth defects and cardiovascular disease. HMTC’s rigorous lead testing applies ALARA principles to protect infants and consumers and to prepare brands for tightening regulations.
