FDA Action Levels for Lead in Baby Food (2025)

Table of Contents

1. What the FDA Did
2. The Three Action Levels and the Foods They Cover
3. What an “Action Level” Means
4. Foods the Guidance Leaves Out
5. The Health Background the Guidance Gives
6. The Testing Data Behind the Levels
7. Expected Effect: Exposure Reduction and Achievability
8. What Changed From the 2023 Draft
9. What the Guidance Does Not Do
10. Dates and Legal Status as of October 11, 2026
11. How It Fits the FDA’s Earlier Lead Actions
12. Primary Documents
13. Key Research Papers
14. Connections

1. What the FDA Did

The FDA issued a final guidance for industry titled “Action Levels for Lead in Processed Food Intended for Babies and Young Children.” It was announced in a Federal Register notice of availability, FR Doc. 2024-31534, published at 90 FR 1135–1136 under Docket No. FDA-2022-D-0278. (The Federal Register is the U.S. government’s daily journal of agency rules and notices; a docket is the public file that collects a document and the comments on it.) The notice was signed on December 27, 2024 by the FDA’s Deputy Commissioner for Policy, Legislation, and International Affairs, and the guidance document itself is dated January 2025 and was issued by the FDA’s Human Foods Program.

The notice’s summary states that the guidance “establishes action levels for lead in certain processed foods intended for babies and young children less than 2 years old” and “is intended to set achievable action levels that will help further reduce lead in the food supply.” It also states that the guidance finalizes the draft dated January 2023.

A guidance document is the FDA’s written statement of its “current thinking” on a topic. In the words of the notice, it “does not establish any rights for any person and is not binding on FDA or the public,” and a company may use an alternative approach if it satisfies the applicable statutes and regulations.

Back to Table of Contents

2. The Three Action Levels and the Foods They Cover

The guidance applies to “processed food,” which it defines as packaged food — for example in jars, pouches, tubs or boxes — represented or purported to be for babies and young children less than two years old. It may include ready-to-eat foods such as purees and semi-prepared foods such as dry infant cereals. The levels are (one part per billion equals one microgram of lead per kilogram of food):

• 10 ppb for fruits; vegetables (except single-ingredient root vegetables); mixtures, including grain- and meat-based mixtures; yogurts; custards and puddings; and single-ingredient meats.
• 20 ppb for single-ingredient root vegetables.
• 20 ppb for dry infant cereals.

The guidance defines its terms closely. “Single-ingredient root vegetables” means a food made of either carrots or sweet potatoes, with or without water or preservatives: a puree of sweet potatoes, water and ascorbic acid counts, while a puree of carrots, white potatoes and water, or of sweet potatoes and apples, is a “mixture” and falls under the 10 ppb level. “Dry infant cereals” covers dried cereals without additions and dried cereals containing dried fruits or vegetables such as apple, banana or carrot.

The guidance explains the two higher levels. Root vegetables, it says, “can absorb lead more readily from the soil than other crops,” and at 10 ppb only 79 percent of the single-ingredient root vegetable samples tested would have met the level; it adds that root vegetables are a source of several nutrients important for growth and development, and that a lower level could reduce the availability of these foods on the market. For dry infant cereal, it notes that cereal is “often the first food introduced” to infants and may be the only solid food eaten for an extended period during a critical period of development, and it says the 20 ppb level was set to reduce exposure while also considering achievability.

Back to Table of Contents

3. What an “Action Level” Means

The levels are issued under a specific FDA regulation, 21 CFR 109.6. Under section 109.6(d), an action level marks the level of a contaminant at which the FDA may regard a food as adulterated — legally unfit for sale — within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act. The notice states that the FDA intends to consider the action levels, “in addition to other factors,” when deciding whether to bring enforcement action in a particular case; the guidance names one such factor as “our confidence in a measured analytical value.”

An action level is therefore not a tolerance or a ban. The guidance calls the levels “not binding” and says they are “intended to encourage manufacturers to maintain lead levels in processed food intended for babies and young children below the action levels.” Its conclusion states that the FDA “considers on a case-by-case basis whether a food that contains a contaminant is adulterated,” and that, in the agency’s experience, “action levels have been effective tools for encouraging manufacturers to lower the levels of contaminants in their products.”

The guidance also records that the FDA consulted the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS), which regulates meat products, about including single-ingredient meats and meat-containing mixtures. It states that FSIS supports the action levels and intends to consider them, with other factors, when deciding on its own actions.

Back to Table of Contents

4. Foods the Guidance Leaves Out

A footnote in the guidance lists what “processed food intended for babies and young children” does not include:

• raw agricultural commodities;
• homemade foods, such as fruit purees prepared at home;
• snack foods, including grain-based or freeze-dried snacks such as arrowroot cookies, puffs, rusks and teething biscuits — the FDA says it is continuing to collect data on grain-based snacks to decide whether an action level for them would be appropriate;
• infant formula;
• any beverages, including toddler drinks.

The same footnote says action levels for lead in juices are addressed in a separate draft guidance. On infant formula, the guidance notes that formula collected through the FDA’s Total Diet Study was not part of this analysis, and that most formula samples in that study contained no measurable lead (below the 4.0 ppb limit of detection).

Back to Table of Contents

5. The Health Background the Guidance Gives

The guidance states that lead “is toxic to humans and can affect people of any age or health status,” and that it is especially harmful to infants, young children, pregnant women and their developing fetuses, and others with chronic health conditions. It says even low exposure can harm children’s brain and nervous system development, with neurological effects in early childhood that include learning disabilities, behavioral difficulties and lowered IQ, and that lead exposure may also be associated with immunological, cardiovascular, kidney, and reproductive or developmental effects. Because lead can build up in the body, it adds, even low-level chronic exposure can be hazardous over time.

How lead gets into food. The guidance lists contaminated soil, contaminated water, deposits from industrial air pollution, and old lead-containing processing equipment. Root vegetables can take up lead from soil, water and air, and soil can settle on the surfaces of leafy vegetables and cereal grains. It cites studies suggesting that thorough peeling of root vegetables and thorough washing of fruits and vegetables can lower lead levels during manufacturing.

“No safe level.” The guidance recounts that in 2011 the Joint FAO/WHO Expert Committee on Food Additives (JECFA) withdrew its earlier provisional tolerable weekly intake for lead, concluding that “it was not possible to establish a new PTWI [for lead] that would be considered to be health protective.” It states that “no safe level of lead exposure has been identified for protecting children’s health.”

The FDA’s benchmark: the interim reference level. In 2018 the FDA set interim reference levels (IRLs) for dietary lead of 3 micrograms per day for children and 12.5 micrograms per day for women of childbearing age, replacing higher limits from the early 1990s. In 2022 it lowered them to 2.2 micrograms per day for children and 8.8 micrograms per day for women of childbearing age. The IRL is derived from the Centers for Disease Control and Prevention’s blood lead reference value of 3.5 micrograms per deciliter, with an extra ten-fold safety factor. The guidance notes that the CDC value is a screening tool based on the 97.5th percentile of blood lead in U.S. children aged 1–5, “not what is considered safe,” and that the IRL serves as a benchmark rather than a safe threshold. The FDA’s goal in setting the action levels, it says, was that exposure from these foods would not push children above the IRL, measured at the 90th percentile of consumption so that children who eat more of a food are accounted for. Blood lead testing is described on the site’s Heavy Metals Panel page.

Back to Table of Contents

6. The Testing Data Behind the Levels

The FDA drew on three of its own monitoring sources: the Toxic Elements Program (a targeted program that tests foods suspected of higher toxic-element levels, with particular emphasis on foods eaten by babies and young children), special FDA surveys, and the Total Diet Study (an ongoing “market basket” study of the U.S. diet). It used Toxic Elements Program data from fiscal years 2009 through 2024, survey data from fiscal years 2013–14, 2021 and 2023, and Total Diet Study data from fiscal years 2014–2020. Lead was measured by inductively coupled plasma mass spectrometry (ICP-MS), with samples analyzed as sold.

The 1,452 Toxic Elements Program and survey samples covered both U.S. and imported products. The guidance reports these average (mean) lead levels:

• fruits: 1.2 ppb;
• mixtures: 2.7 ppb;
• yogurts, custards/puddings and single-ingredient meats: 1.1 ppb;
• vegetables other than single-ingredient root vegetables: 2.1 ppb;
• single-ingredient root vegetables: 8.2 ppb, with 90th to 95th percentiles of 20.9–23.9 ppb;
• dry infant cereals: 7.8 ppb, with 90th to 95th percentiles of 20.0–23.0 ppb.

Across these samples, 90 percent of all processed baby-food samples had lead below 10 ppb. The Total Diet Study’s 689 samples, which are mostly composites of three retail samples from different cities, showed 94 percent below 10 ppb; there, every category’s mean was well below 10 ppb except root vegetables, at 11.6 ppb. Because composites give an “average” result, the FDA used the Total Diet Study only as a complementary check and not in its achievability calculation.

Back to Table of Contents

7. Expected Effect: Exposure Reduction and Achievability

The guidance states the considerations it used: that the levels minimize the chance of a child exceeding the IRL, that there be few distinct levels for simplicity, that the levels actually reduce exposure, and that for foods already low in lead the levels sit where about 90–95 percent of products can meet them. It describes this as consistent with the approach used for international standards, noting that the Codex Committee on Contaminants in Foods has used an achievability estimate of about 95 percent when recommending lower maximum levels for lead in juices.

Achievability — the share of tested samples at or below each level:

• 97 percent for the 10 ppb group (fruits, most vegetables, mixtures, yogurts, custards/puddings, single-ingredient meats);
• 88 percent for single-ingredient root vegetables at 20 ppb;
• 91 percent for dry infant cereals at 20 ppb.

Estimated reduction in lead exposure at the 90th percentile of consumption for children aged 0–23 months, calculated by removing every sample above the action level from the data set:

• 19 percent for the 10 ppb group (from 0.78 to 0.61 micrograms per day);
• 29 percent for single-ingredient root vegetables (from 0.87 to 0.62 micrograms per day);
• 24 percent for dry infant cereals (from 0.30 to 0.23 micrograms per day).

The guidance reports that even without the action levels, the 90th-percentile exposure from each of these food categories was already below the children’s IRL of 2.2 micrograms per day. These percentages are the FDA’s modeled estimates for these food categories, as stated in the guidance; they are not measurements of children’s blood lead.

Back to Table of Contents

8. What Changed From the 2023 Draft

The draft, titled “Action Levels for Lead in Food Intended for Babies and Young Children,” was announced on January 25, 2023 (88 FR 4797) with comments due March 27, 2023; on April 6, 2023 (88 FR 20525) the FDA reopened the comment period until May 8, 2023. The draft proposed the same three numbers: 10 ppb, 20 ppb for single-ingredient root vegetables, and 20 ppb for dry infant cereals.

The draft asked whether data could support lower levels, and noted that 90.6 percent of samples in the 10 ppb group would meet a level of 5 ppb. It also asked for comment on grain-based snacks, reporting a mean of 11.1 ppb across 122 Toxic Elements Program and survey samples and 17.6 ppb across 44 Total Diet Study samples. The final guidance kept 10 ppb and left grain-based snacks out while the FDA collects more data.

According to the 2025 notice, the FDA “received several comments” and changed the guidance to clarify which foods it addresses, including the age range of the foods’ intended consumers; added information about the method the FDA uses to test for lead; made editorial changes; and collected and analyzed additional samples from the Toxic Elements Program and special surveys. The guidance states that the sample count grew by 594 between the draft and the final version. The title also gained the word “Processed.”

On April 21, 2025 the FDA published a correction (FR Doc. 2025-06786, 90 FR 16692). It changes only one citation in the January notice’s background, so that the draft is cited as 88 FR 4797; the action levels were not affected.

Back to Table of Contents

9. What the Guidance Does Not Do

• It is not a binding limit. The notice says the guidance “is not binding on FDA or the public,” and the levels are not tolerances or bans; whether a particular food is adulterated is decided case by case.
• It does not cover infant formula, juices, toddler drinks or other beverages, nor snacks such as puffs and teething biscuits, nor homemade or raw foods (section 4).
• It does not set levels for other toxic elements. The guidance addresses lead only; it says the FDA intends to engage with stakeholders on proposed action levels for other toxic elements in foods for babies and young children.
• It is not consumer advice. The FDA’s guidance page and the guidance itself state that the action levels “are not intended to direct consumers in making food choices.” In the same passage, the FDA’s guidance tells parents and caregivers that it recommends feeding children a varied and nutrient-dense diet across and within the main food groups of vegetables, fruits, grains, dairy and protein foods.
• It does not say lead below the levels is safe. The guidance repeats that no safe level of lead exposure has been identified for children, and states the FDA’s expectation that industry “will strive for continual reductions over time.”

Back to Table of Contents

10. Dates and Legal Status as of October 11, 2026

• December 27, 2024: notice of availability signed.
• January 2025: final guidance issued by the Human Foods Program; the FDA guidance page shows its content as current as of January 6, 2025.
• January 7, 2025: notice of availability published in the Federal Register (90 FR 1135).
• April 21, 2025: citation correction published (90 FR 16692).

Status: a final guidance, in place. It has no comment deadline: under 21 CFR 10.115(g)(5) anyone may comment on any FDA guidance at any time, through Docket No. FDA-2022-D-0278. As of October 11, 2026, no later Federal Register document changes the action levels. The guidance itself says the FDA intends to update the IRL and the guidance if, for example, the CDC updates its blood lead reference value, and will monitor lead in food to decide whether to adjust the levels or add foods.

Back to Table of Contents

11. How It Fits the FDA’s Earlier Lead Actions

Early 1990s to 2022: the intake benchmarks. According to the guidance, the FDA’s provisional tolerable total daily intakes for lead from the early 1990s were replaced in 2018 by the lower interim reference levels, which were lowered again in 2022 (section 5). Each step lowered the yardstick against which dietary lead is judged.

2021: Closer to Zero. The guidance states that in 2021 the FDA started Closer to Zero to identify actions that would reduce exposure to toxic elements, including lead, from foods eaten by babies and young children “to as low as possible while maintaining access to nutritious foods.” The plan describes an iterative approach, with action levels as one tool, consultation with stakeholders on what is achievable, and attention to unintended effects on the availability of nutritious foods. An October 2021 Federal Register notice (86 FR 56711) announced a public meeting under the plan on the impacts of toxic element exposure and nutrition at different developmental stages.

2023: the draft. The January 2023 draft set out the levels that the 2025 guidance finalized unchanged (section 8). The guidance also refers to a separate draft guidance on lead in juices, which uses a similar achievability approach.

2025: the final levels. The guidance describes the January 2025 action levels as consistent with the FDA’s “longstanding policy of reducing consumers’ lead exposure,” and as one step in an iterative process: the FDA says it will keep monitoring lead in food and children’s exposure, may adjust these levels or add food categories, and intends to engage stakeholders on action levels for other toxic elements. State testing programs are separate from this federal guidance; one state’s results are summarized on the site’s Florida Food-Toxin Testing Results news page.

Back to Table of Contents

12. Primary Documents

1. Food and Drug Administration, HHS (2025). Action Levels for Lead in Processed Food Intended for Babies and Young Children; Guidance for Industry; Availability. Federal Register 90:1135–1136, 7 January 2025. Docket No. FDA-2022-D-0278 — FR Doc. 2024-31534
2. U.S. Food and Drug Administration, Human Foods Program (2025). Action Levels for Lead in Processed Food Intended for Babies and Young Children: Guidance for Industry. January 2025. Docket No. FDA-2022-D-0278 — guidance document (PDF, fda.gov)
3. U.S. Food and Drug Administration. Guidance landing page, “Guidance for Industry: Action Levels for Lead in Processed Food Intended for Babies and Young Children,” content current as of 01/06/2025 — fda.gov › regulatory-information › FDA guidance documents › guidance-industry-action-levels-lead-processed-food-intended-babies-and-young-children (given as plain text)
4. Food and Drug Administration, HHS (2025). Action Levels for Lead in Processed Food Intended for Babies and Young Children; Guidance for Industry; Availability; Correction. Federal Register 90:16692, 21 April 2025 — FR Doc. 2025-06786
5. Food and Drug Administration, HHS (2023). Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability. Federal Register 88:4797, 25 January 2023. Docket No. FDA-2022-D-0278 — FR Doc. 2023-01384
6. Food and Drug Administration, HHS (2023). Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Reopening of the Comment Period. Federal Register 88:20525, 6 April 2023 — FR Doc. 2023-07187
7. Food and Drug Administration, HHS (2021). Closer to Zero Action Plan: Impacts of Toxic Element Exposure and Nutrition at Different Crucial Developmental Stages; Public Meeting; Request for Comments. Federal Register 86:56711, 12 October 2021 — FR Doc. 2021-22109
8. Public docket FDA-2022-D-0278 — regulations.gov FDA-2022-D-0278

Back to Table of Contents

Key Research Papers

1. Flannery BM, Middleton KB (2022). Updated interim reference levels for dietary lead to support FDA’s Closer to Zero action plan. Regulatory Toxicology and Pharmacology 133:105202 — PubMed PMID: 35690180
2. Flannery BM, Dolan LC, Hoffman-Pennesi D, Gavelek A, Jones OE, Kanwal R, Wolpert B, Gensheimer K, Dennis S, Fitzpatrick S (2020). U.S. Food and Drug Administration’s interim reference levels for dietary lead exposure in children and women of childbearing age. Regulatory Toxicology and Pharmacology 110:104516 — PubMed PMID: 31707132
3. Pourrut B, Shahid M, Dumat C, Winterton P, Pinelli E (2011). Lead uptake, toxicity, and detoxification in plants. Reviews of Environmental Contamination and Toxicology 213:113-136 — PubMed PMID: 21541849
4. Huang F, Zhou H, Gu J, Liu C, Yang W, Liao B, Zhou H (2020). Differences in absorption of cadmium and lead among fourteen sweet potato cultivars and health risk assessment. Ecotoxicology and Environmental Safety 203:111012 — PubMed PMID: 32684522
5. Canfield RL, Henderson CR Jr, Cory-Slechta DA, Cox C, Jusko TA, Lanphear BP (2003). Intellectual impairment in children with blood lead concentrations below 10 microg per deciliter. New England Journal of Medicine 348(16):1517-1526 — PubMed PMID: 12700371
6. Lanphear BP, Hornung R, Khoury J, Yolton K, Baghurst P, Bellinger DC, Canfield RL, Dietrich KN, Bornschein R, Greene T, Rothenberg SJ, Needleman HL, Schnaas L, Wasserman G, Graziano J, Roberts R (2005). Low-level environmental lead exposure and children’s intellectual function: an international pooled analysis. Environmental Health Perspectives 113(7):894-899 — PubMed PMID: 16002379

The first four papers appear in the reference list of the FDA guidance (references 2, 10, 16 and 5). The last two are studies of children’s blood lead below 10 micrograms per deciliter and intellectual function; an erratum to the 2005 pooled analysis was published in 2019 (Environmental Health Perspectives 127(9):99001).

PubMed Topic Searches

1. PubMed: lead in baby food and infant cereal
2. PubMed: dietary lead exposure in children
3. PubMed: low-level lead exposure and children’s IQ
4. PubMed: lead uptake by root vegetables from soil

Back to Table of Contents

Connections

• FDA Actions of 2025
• FDA and Regulation
• Infant Botulism Formula Outbreak (2025)
• Cesium-137 in Shrimp and Spice Imports (2025)
• Food Chemical Oversight: GRAS and Post-Market Review (2025)
• Lead Poisoning: Sources, Health Effects, and Prevention
• Heavy Metals in Food
• Arsenic
• Cadmium
• Toxic Minerals
• Heavy Metals Panel
• Florida Food-Toxin Testing Results

Back to Table of Contents