Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
 
 
 
Action Levels for Lead in Food Intended 
for Babies and Young Children: Draft 
Guidance for Industry 
 
Draft Guidance
  
This guidance is being distributed for comment purposes only. 
 
 
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to 
ensure that FDA considers your comment on this draft guidance before we begin work on the 
final version of the guidance, submit either electronic or written comments on the draft 
guidance within 60 days of publication in the Federal Register of the notice announcing the 
availability of the draft guidance.  Submit electronic comments to 
http://www.regulations.gov.  Submit written comments to the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852.  All comments should be identified with the docket number FDA-2022-D-0278 listed 
in the notice of availability that publishes in the Federal Register.  
 
For questions regarding this draft document contact the Center for Food Safety and Applied 
Nutrition (CFSAN) at 240-402-1700. 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
 
January 2023 
   
     
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Table of Contents  
 
I. INTRODUCTION ...................................................................................................3   
II. BACKGROUND ....................................................................................................4   
III. LEAD LEVELS FOUND IN FOOD INTENDED FOR BABIES AND YOUNG 
CHILDREN ...............................................................................................................6   
A. Products and Data Included in the Evaluation of Lead in Food Intended for 
Babies and Young Children ................................................................................6   
B. Toxic Elements Program and FDA Survey Data ...........................................6   
C. Total Diet Study Data .....................................................................................7   
D. Summary of FDA Data ...................................................................................8   
IV. FDAS ACTION LEVELS FOR LEAD IN FOOD INTENDED FOR BABIES AND 
YOUNG CHILDREN ..................................................................................................8   
A. Exposure Assessment ......................................................................................9   
B. Achievability Assessment ..............................................................................1  0 
V. CONCLUSION ....................................................................................................1  1 
VI. REFERENCES ..................................................................................................1  2 
VII. TABLES .........................................................................................................1  4 
 
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Action Levels for Lead in Food Intended 
for Babies and Young Children:  Draft 
Guidance for Industry1 
  
 
This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
Administration's (FDA or we) on this topic.  It does not establish any rights for any person and is 
not binding on FDA or the public.  You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.  To discuss an alternative approach, 
contact the FDA staff responsible for this guidance at the phone number listed on the title page. 
 
I. Introduction 
 
FDA is committed to reducing lead in food.  FDAs 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 FDAs action levels 
for lead in processed food intended for babies and young children:2 
 
  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. 
 
 
1 This guidance has been prepared by the Office of Food Safety, Division of Plant Products and Beverages in the 
Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.  
2 Processed food intended for babies and young children refers to food packaged in jars, pouches, tubs, and boxes 
represented or purported to be specifically for babies and young children less 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).  It does not include raw 
agricultural commodities or homemade foods (e.g., fruit purees prepared at home).  This guidance does not apply to 
infant formula, or any beverages, including toddler drinks.  Lead in juices are addressed in a separate draft guidance, 
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-
action-levels-lead-juice.  
 
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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, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe FDAs 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.   
 
II. Background 
 
Lead is toxic to humans and can affect people of any age or health status.  Lead is especially 
harmful to vulnerable populations, including infants, young children, people who are pregnant 
and their fetuses, and others with chronic health conditions.  Even low lead exposure can harm 
childrens health and development, specifically the brain and nervous system.  Neurological 
effects of lead exposure during early childhood include learning disabilities, behavior 
difficulties, and lowered IQ.  Lead exposures also may be associated with immunological, 
cardiovascular, renal, and reproductive and/or developmental effects (Ref. 1).  Because lead can 
accumulate in the body, even low-level chronic exposure can be hazardous over time (Ref. 2).   
 
Lead is widely present in the environment due to both its natural occurrence and to human 
activities that have introduced it into the environment.  Because lead may be present in 
environments where food crops used to make food intended for babies and young children are 
grown, various foods may contain small amounts of lead.  Potential sources of lead in food 
include contaminated soil where crops are grown, contaminated water, atmospheric deposition 
from industrial activities, and old lead-containing equipment used to process food.  As a result of 
the first three sources, agricultural crops (e.g., root vegetables) can take up lead from 
contaminated soil and contaminated soil may be deposited on plant surfaces (e.g., leafy 
vegetables and cereal grains).  Studies suggest that manufacturers may be able to reduce lead 
levels in food by using practices such as thoroughly peeling root vegetables and thoroughly 
washing fruits and vegetables, particularly leafy vegetables (Refs. 3, 4, 5, 6).  It is possible in 
some cases for manufacturers who have found elevated lead levels in sources of food intended 
for babies and young children to choose sources of food or food ingredients with lower lead 
levels or no detectable lead.  Manufacturers could also consider increased testing of ingredients 
or finished products that are historically known to contain elevated lead levels; this is particularly 
important for ingredients or finished products intended for babies and young children.  
Additionally, manufacturers could consider examining their facilities, processes, and equipment 
to ensure that they are not contributing to lead in their products (Refs. 7, 8).    
 
In 1999, the Joint World Health Organization (WHO)/Food and Agriculture Organization (FAO) 
Expert Committee on Food Additives (JECFA) released a toxicological assessment for lead, 
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which maintained the provisional tolerable weekly intake (PTWI) for lead of 25 micrograms per 
kilogram body weight (g/kg bw) but noted that foods with high levels of lead remain in 
commerce (Ref. 9).   
 
In 2011, JECFA reassessed the safety of lead and withdrew the PTWI for lead.  JECFA further 
concluded that it was not possible to establish a new PTWI [for lead] that would be considered 
to be health protective (Ref. 7).  JECFA concluded that in populations with prolonged dietary 
exposures to higher levels of lead, measures should be taken to identify major contributing 
sources and, if appropriate, to identify methods for reducing dietary exposure that are 
commensurate with the level of risk reduction (Ref. 9).   
 
No safe level of lead exposure has been identified for protecting childrens health.  To help 
assess risk from lead, in 2018, FDA developed interim reference levels (IRLs) for dietary lead to 
replace FDA provisional tolerable total daily intakes (PTTDIs), which had been developed in the 
early 1990s.  FDA updated the IRLs in 2022 (Ref. 2), using the Centers for Disease Control and 
Preventions (CDC) updated blood level reference value (BLRV) of 3.5 g/deciliter (dL) blood 
lead level and dietary conversion factors calculated by the Environmental Protection Agency to 
derive IRLs of 2.2 g/day for children and 8.8 g/day for women of child-bearing age 
(WOCBA), respectively.  The IRL for WOCBA is protective against possible fetal lead exposure 
in women who are not yet aware that they are pregnant (Ref. 2).  
 
The IRL is tied to a biological marker of exposure (blood lead levels) and represents the dietary 
lead needed to achieve a blood lead level 10 times lower than that associated with the CDCs 
BLRV.  The CDC BLRV is a screening tool used to identify children who have higher levels of 
lead exposure and represents the level at which public health interventions should be initiated.  
The IRL represents the maximum daily dietary intake of lead from food that corresponds to the 
CDCs BLRV of 3.5 ug/dl, with an additional 10x safety factor applied.  Even though no safe 
level of lead exposure has yet been identified for children's health, the IRL serves as a useful 
benchmark in evaluating the potential for adverse effects of dietary lead.  In particular, FDA is 
focused on the potential for neurodevelopmental effects from lead exposure, as review of the 
scientific literature indicates that such adverse effects of lead consistently occur at a blood lead 
level associated with FDAs IRL for children. 
 
In 2021, FDA initiated the Closer to Zero action plan that identifies actions we will take to 
reduce exposure to toxic elements, including lead, from foods eaten by babies and young 
children to as low as possible (Ref. 10).  The plan outlines an iterative approach for achieving 
continual improvements over time, reducing childrens exposure to lead and other toxic elements 
from food through activities such as setting action levels.  We will identify IRLs for certain toxic 
elements as appropriate and may use the IRLs to help inform the development of action levels.  
The plan commits to consulting with stakeholders, including on the achievability of reducing 
toxic element levels in foods intended for babies and young children, and notes the importance of 
minimizing the potential for unintended consequences on the availability of nutritious foods for 
children.  FDA intends to update the IRL and this guidance if, for example, CDC updates its 
BLRV or if other scientific information becomes available which could help us refine our IRL.  
Updates to the IRL will result in an evaluation of the lead action levels to determine whether the 
levels continue to be appropriate.         
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As the next step toward developing action levels under the Closer to Zero action plan, this 
guidance evaluates processed foods intended for babies and young children.  In developing the 
action levels for these foods, we want to ensure that dietary exposure from the identified foods 
does not cause consumers to exceed the IRL.  To do this, we consider intake of the food and the 
maximum level of lead that could be in the food without causing the IRL to be exceeded.  We 
consider intake at the 90th percentile consumption level for the food/food category.  By doing 
this, we account for consumers with high intake in our analysis of what the maximum lead level 
could be in the food without causing the consumer to be exposed to lead levels exceeding the 
IRL.  Our proposed action levels also reflect the considerations discussed below. 
 
III. Lead Levels Found in Food Intended for Babies and Young 
Children  
 
A. Products and Data Included in the Evaluation of Lead in Food Intended 
for Babies and Young Children  
 
FDA routinely monitors lead in food consumed by babies and young children through our Toxic 
Elements in Food and Foodware and Radionuclides in Food  Import and Domestic Compliance 
Program (the Toxic Elements Program or TEP),3 special FDA surveys, and the Total Diet Study 
(TDS).4  The TEP is a targeted monitoring program that monitors levels of certain toxic 
elements, including lead, in foods and foodware.  Foods selected for analysis include those that 
are suspected of having elevated levels of toxic elements based on historical data or other 
information available to us.  For lead analysis under the TEP, we place particular emphasis on 
foods consumed by babies and young children, who are especially sensitive to leads adverse 
health effects because of their smaller body sizes and rapid development.  We augment TEP 
collections by periodically conducting surveys to collect and analyze toxic elements in foods of 
interest, in this case, foods for babies and young children.  The TDS is an ongoing market basket 
study representative of the U.S. diet that includes analysis of toxic elements such as lead. 
   
As part of our evaluation, we examined the TEP data collected between fiscal years (FY) 2008 
through 2021, FDA survey data collected in FY 2013-14 and FY 2021 (Tables 1 and 2), and 
TDS data collected between FY 2014-20 (Table 3) to determine current lead levels in foods 
intended for babies and young children.  We then evaluated the ability of industry to achieve 
lower lead levels, using TEP data and FDA survey data.  We also reviewed the TDS data as a 
complementary analysis.   
 
B. Toxic Elements Program and FDA Survey Data 
 
The 863 TEP (Ref. 11) and survey samples (Refs. 12, 13) include U.S. domestic and imported 
products, and consist of processed foods made specifically for babies and young children.  To 
analyze these data for purposes of this guidance, we have separated these processed foods into 
 
3 https://www.fda.gov/Food/FoodborneIllnessContaminants/ChemicalContaminants/ucm2006907.htm.  
4 http://www.fda.gov/Food/FoodScienceResearch/TotalDietStudy/default.htm. 
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the following food categories for babies and young children: dry infant cereals (e.g., rice, wheat, 
and multi-grain cereals); fruits (single-ingredient or combination); vegetables (single ingredient 
or combination); mixtures (any combination of fruits, vegetables, grain, and meat); yogurts, 
custards/puddings, and single-ingredient meats (Table 1).   
 
Table 2 shows the mean, standard deviation, and 90th and 95th percentiles of the data for each of 
the food categories for babies and young children.  Lead concentrations varied among food 
categories for babies and young children.  Fruits and mixtures had low lead levels, with means of 
1.0 ppb and 3.0 ppb and 90th-95th percentiles of 2.4-3.7 ppb and 6.8-11.1 ppb, respectively.  
Yogurts, custards/puddings, and single-ingredient meats similarly had low lead levels, with a 
mean of 0.9 ppb and 90th-95th percentiles of 1.7-2.3 ppb.  Vegetables had a mean lead level of 5.6 
ppb and 90th-95th percentiles of 16.0-20.5 ppb.  When single-ingredient root vegetables were 
placed in a separate category, the vegetables category had a lower mean and lower 90th-95th 
percentiles of 2.3 ppb and 6.6-10.2 ppb, respectively.  Root vegetables had a mean of 8.5 ppb 
and 90th-95th percentiles of 20.2-25.7 ppb (Table 2, italics). 
 
Dry infant cereals had higher lead concentrations than fruits, vegetables, mixtures, yogurts, 
custards/puddings, and single-ingredient meats, with a mean of 8.3 and 90th-95th percentiles of 
20.1-23.0 ppb.    
 
C. Total Diet Study Data  
 
From FY 2014 to FY 2020, we collected and analyzed 686 samples of processed foods intended 
for babies and young children under the TDS program.5  Most TDS samples are not samples of 
individual foods; they are composites (averages) of three retail samples, all from different 
cities.  Because the compositing provides an average result, and our achievability analysis is 
based on percentiles of lead concentrations in individual samples, we did not use the TDS data in 
the achievability analysis.  The types of baby foods analyzed included dry infant cereals, fruits 
(single ingredient or combination), vegetables (single ingredient or combination), mixtures (any 
combination of fruits, vegetables, grains, and meat), and yogurts, custard/pudding, and single-
ingredient meats.6  All food categories had mean lead concentrations well below 10 ppb, with the 
exception of root vegetables, which had a mean concentration of 11.6 ppb.  As with the TEP and 
FDA survey data, lower mean lead levels were observed for fruits, mixtures, yogurts, 
custards/puddings, and single-ingredient meats.  However, dry infant cereal samples in the TDS 
had lower mean lead levels than samples from the TEP and FDA survey data. 
   
 
5 TDS results can be found online at: https://www.fda.gov/food/total-diet-study/analytical-results-total-diet-study. 
6 Infant formula and bottled water labeled for infants are also collected through the TDS program, but were not 
included in this analysis because they are composite samples (see section III.C). TDS infant formula data indicate 
that the majority of samples collected contain no lead (<limit of detection, which is 4.0 ppb).  Grain-based snacks 
(e.g., arrowroot cookies, puffs, rusks, teething biscuits) also were analyzed; however, they are not addressed in this 
guidance.  FDA is seeking additional information on this category of foods to inform whether an action level would 
be appropriate. 
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D. Summary of FDA Data   
 
FDAs review of data indicates that different types of food intended for babies and young 
children exhibit different lead concentrations (Tables 2 and 3).  In addition, for the TEP and 
survey data, 85 percent of samples had lead levels lower than 10 ppb, while for the TDS data 97 
percent of samples had lead levels lower than 10 ppb.  The mean lead levels for the categories of 
food intended for babies and young children were below 10 ppb (Tables 2 and 3) except for root 
vegetables (Table 3). 
 
IV. FDAs Action Levels for Lead in Food Intended for Babies and 
Young Children  
 
When evaluating possible action levels under 21 CFR 109.6 for lead in foods intended for babies 
and young children less than two years old, we took into account several considerations, 
including: 
 
  the action level should minimize the likelihood that a consumer will be exposed to lead 
levels exceeding the IRL; 
  as appropriate, there should be a limited number of unique action levels for simplicity; 
  the action levels should result in a reduction in exposure to lead; and 
  for those baby foods where lead levels are already relatively low, the action levels should 
be established where achievability is in the 90th-95th percentile range.7 
 
Based on these considerations, the applicable criteria in 21 CFR 109.6, and analysis of the data, 
we identified the following action levels for lead in processed food intended for babies and 
young children:  
 
  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. 
 
For fruits, vegetables (excluding single-ingredient root vegetables), mixtures, yogurts, 
custards/puddings, and single-ingredient meats, all of which have low lead levels, action levels 
can be established at 10 ppb.  
 
Based on data used in this analysis, single-ingredient root vegetable products have higher lead 
levels than other vegetables (Table 2, italics).  Root vegetables can absorb lead more readily 
 
7 This approach is consistent with the approach followed for setting international standards and the approach FDA 
has taken with respect to action levels for lead in other foods, as appropriate.  The Codex Committee on 
Contaminants in Foods has used an achievability estimate of about 95% to recommend reductions in maximum 
levels (MLs) for lead in juices when more than 95% of the samples traded internationally had lead concentrations at 
or below proposed new MLs.  FDA has used a similar approach in developing action levels for lead in juice, see 
https://www.fda.gov/food/chemical-metals-natural-toxins-pesticides-guidance-documents-regulations/draft-
supporting-document-establishing-fdas-action-levels-lead-juice.  
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from the soil than other crops (Ref. 14).  Moreover, at an action level of 10 ppb (the action level 
provided in this guidance for other vegetable products), root vegetable achievability was only 
71%.  For root vegetables, we expect that an action level of 20 ppb will help minimize the 
likelihood of significant exposure to lead, while also considering achievability.  At the action 
level of 20 ppb, root vegetables have an achievability rate of 88%.  Root vegetables are a source 
of several nutrients important in growth and development for babies and young children, and a 
lower action level could reduce the availability of single-ingredient root vegetable foods on the 
market intended for infants and young children.  Therefore, we consider it appropriate to place 
single-ingredient root vegetables in their own category.   
 
In evaluating data about the likelihood that a consumer will be exposed to lead levels exceeding 
the IRL, we also weighed certain product-specific considerations.  For example, dry infant cereal 
is often the first food introduced to an infant population and may be the only solid food 
consumed for an extended period of time during a critical period of development.  With these 
considerations in mind, we set an action level for dry infant cereal that is sufficiently health 
protective.  At the action level of 20 ppb, dry infant cereals have an achievability rate of 90%. 
 
We discuss the exposure assessment and achievability assessments used to support these action 
levels in more detail below. 
 
A. Exposure Assessment  
 
To examine the effect of the proposed action levels for food intended for babies and young 
children on lead exposure, we compared the estimated concentration of lead in these foods and 
dietary exposure to lead from these foods with and without the action levels.  As shown in Table 
4, the mean concentrations of lead and the 90th percentile (representing an upper bound) dietary 
exposures for babies and young children (0-23 months) in the absence of the action levels are as 
follows:  
  fruits, vegetables (excluding single-ingredient root vegetables), mixtures, yogurts, 
custards/puddings, and single-ingredient meats (2.3 ppb, 0.81 g/day);  
  root vegetables (8.5 ppb, 0.89 g/day); and  
  dry infant cereals (8.3 ppb, 0.32 g/day).  
This upper bound percentile (90th percentile) was chosen as a health protective measure to 
account for babies and young children (0-23 months) who consume larger amounts of food and 
would therefore have higher exposures.  As shown in Table 4, for Scenario A, the 90th percentile 
dietary exposures for babies and young children are below the IRL for lead of 2.2 g/day for 
children.  For scenario B, removing all samples with lead concentrations greater than the action 
level from the datasets results in a decrease in the estimated mean lead concentrations and the 
estimated dietary exposures from these foods.  The estimated mean lead concentrations and 90th 
percentile dietary exposures are as follows:  
  fruits, vegetables (excluding single-ingredient root vegetables), mixtures, yogurts, 
custards/puddings, and single-ingredient meats (1.7 ppb, 0.60 g/day); 
  root vegetables (6.2 ppb, 0.65 g/day); and 
  dry infant cereals (6.3 ppb, 0.25 g/day). 
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The action levels for lead are estimated to result in the following reductions in lead exposure 
from consumption of these foods at the 90th percentile consumption level for babies and young 
children:  
  fruits, vegetables (excluding single-ingredient root vegetables), mixtures, yogurts, 
custards/puddings, and single-ingredient meats (26%); 
  root vegetables (27%); and 
  dry infant cereals (24%). 
 
B. Achievability Assessment  
 
To assess achievability, or manufacturers ability to achieve the action levels for lead, we 
determined the percentage of samples in each food category that fell at or below the proposed 
action levels.  The achievability for each food category at the proposed action levels is in the 
90 - 95% range identified in Section IV, with the exception of root vegetables, as shown 
below:   
 
  96% for fruits, vegetables (excluding single-ingredient root vegetables), mixtures, yogurts, 
custards/puddings, and single-ingredient meats, at 10 ppb;  
  88% for root vegetables, at 20 ppb; and 
  90% for dry infant cereals, at 20 ppb (Table 4).   
 
In summary, for the combined category of fruits, vegetables (excluding single-ingredient root 
vegetables), mixtures, yogurts, custards/puddings, and single-ingredient meats, an action level of 
10 ppb reduces dietary exposure to lead for babies and young children by 26% at the 90th 
percentile consumption level and has an achievability of 96%.   
 
An action level of 20 ppb for single-ingredient root vegetables reduces dietary exposure to lead 
for babies and young children by 27% at the 90th percentile consumption level and has an 
achievability of 88%.   
 
An action level of 20 ppb for dry infant cereals reduces dietary exposure to lead for babies and 
young children by 24% at the 90th percentile consumption level and has an achievability of 90%.   
 
Based on our review of lead levels in foods intended for babies and young children that we 
collected from FY 2008 to FY 2021, in consideration of the IRL for lead of 2.2 g/day for 
children (as shown in Table 4), and in accordance with 21 CFR 109.6, we are establishing the 
following action levels for lead: 
 
  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. 
 
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Though not binding, these action levels are intended to encourage manufacturers to maintain lead 
levels in food intended for babies and young children below the action levels, thus reducing risks 
associated with dietary lead exposures.  The establishment of these action levels for lead in food 
intended for babies and young children in this guidance is consistent with FDAs longstanding 
policy of reducing consumers lead exposure.  The action is focused on certain foods intended 
for babies and young children, who are more sensitive than adults to the neurodevelopmental 
effects of lead exposure.   
 
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 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. 
 
We have consulted with the United States Department of Agriculture Food Safety Inspection 
Service (FSIS) on the inclusion of single-ingredient meats and mixtures that include meats as an 
ingredient in this guidance.  FSIS supports the action levels developed by FDA and intends to 
consider these action levels, in addition to other factors, when considering appropriate FSIS 
actions in a particular case.   
 
FDA recommends that the industry producing the foods in this guidance continue to work to 
lower the lead concentrations in these products to the greatest extent possible under current good 
manufacturing practices.  As part of our Closer to Zero action plan, we intend to further engage 
with stakeholders on proposed action levels for other toxic elements in foods intended for babies 
and young children, including the achievability of such levels, and the feasibility of further 
reducing the presence of lead in food.  We plan to monitor the levels of lead in food and 
childrens exposure to lead from food to assess whether to adjust the action levels for the food 
intended for babies and children described in this guidance, or whether to add additional foods or 
food categories for babies and young children to this guidance as new information becomes 
available. 
 
V. Conclusion  
 
The action levels are part of our efforts under the Closer to Zero action plan to reduce exposure 
to toxic elements from foods eaten by babies and young children to the lowest possible levels.  In 
our experience, action levels have been effective tools for encouraging manufacturers to lower 
the levels of contaminants in their products.  We established these action levels in consideration 
of our IRLs for dietary lead, and the action levels are achievable by industry when control 
measures are taken to minimize the presence of lead.   
 
We intend to consider the proposed action levels as an important source of information for 
determining whether a food for babies and young children is adulterated within the meaning of 
section 402(a)(1) of the FD&C Act.  FDA considers on a case-by-case basis whether a food that 
contains a contaminant is adulterated.  When considering whether to bring an enforcement action in a 
particular case, we will consider whether the lead causes a particular food to be adulterated under 
section 402(a)(1) of the FD&C Act. 
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VI. References
The following references marked with an asterisk (*) are on display at the Dockets Management 
Staff, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  You 
may see them in person at this location between 9 a.m. and 4 p.m., Monday through Friday; they 
are also available electronically at https://www.regulations.gov.  References without asterisks are 
not on public display at https://www.regulations.gov because they have copyright restriction.  
Some may be available at the website address, if listed.  References without asterisks are 
available for viewing only at the Dockets Management Staff.  FDA has verified the website 
addresses, as of the date this document publishes in the Federal Register, but websites are 
subject to change over time. 
1. HHS, National Toxicology Program, 2012.  NTP Monograph on Health Effects of Low-
Level Lead.  Available at:
https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_5
08.pdf.*
2. Flannery, B.M., K. B. Middleton., 2022.  Updated Interim Reference Levels for Dietary Lead 
to Support FDAs Closer to Zero Action Plan.  Reg. Toxicol. Pharmacol., 133.
3. Kolasinac, S.M., Lekic, S. S., Golijan, J. et al. 2018.  Bioaccumulation Process and Health 
Risk Assessment of Toxic Elements in Tomato Fruit Grown under Zn Nutrition Treatment. 
Environmental Monitoring and Assessment, 190; 508.
4. Office of Solid Waste and Emergency Response, U.S. Environmental Protection Agency, 
2014.  Technical Review Workgroup Recommendations Regarding Gardening and Reducing 
Exposure to Lead-Contaminated Soils.  Available at:
https://semspub.epa.gov/work/HQ/174577.pdf *
5. Huang, F., Zhou H., Gu, J., et al. 2020.  Differences in Absorption of Cadmium and Lead 
Among Fourteen Sweet Potato Cultivars and Health Risk Assessment.  Ecotoxicology and 
Environmental Safety, 203; 111012.
6. Entwistle, J. A., Amaibi, P. M., Dean, J. R., et al., 2019.  An Apple a Day? Assessing 
Gardeners' Lead Exposure in Urban Agriculture Sites to Improve the Derivation of Soil 
Assessment Criteria.  Environmental International, 122; 130-141.
7. Codex Alimentarius, 2021.  Revision of the Code of Practice for the Prevention and 
Reduction of Lead Contamination in Foods.  Available at
https://www.fao.org/3/cc0579en/cc0579en.pdf.
8. FDA, 2018.  Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft 
Guidance for Industry.  Available at https://www.fda.gov/media/100002/download.*
9. WHO/FAO Joint Expert Committee on Food Additives, 2011.  Evaluation of Certain 
Contaminants in Food, 73rd Report of the World Health Organization/Food and Agriculture 
Organization of the United Nations Joint Expert Committee on Food Additives.  WHO 
Technical Report Series 960.  Available at:
https://apps.who.int/iris/bitstream/handle/10665/44515/WHO_TRS_960_eng.pdf?sequence= 
1.*
10.FDA, 2021.  Closer to Zero: Action Plan for Baby Foods.  Available at
https://www.fda.gov/food/metals-and-your-food/closer-zero-action-plan-baby-foods.*
 12  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
11.FDA, 2023. Analytical Results for Lead in Food Intended for Babies and Young Children 
Sampled under the FDAs Toxic Elements in Food and Foodware and Radionuclides in Food
Import and Domestic Compliance Program, FY 2008 to FY 2021. Available at
https://www.fda.gov/media/164564/download.*
12.FDA Survey FY 2013-14.  Available at: https://www.fda.gov/food/metals-and-your-
food/combination-metals-testing.*
13.FDA Survey FY 2021. Analytical Results for Lead in Food Intended for Babies and Young 
Children, FY2021.  Available at https://www.fda.gov/media/164565/download.*
14.Pourrut, B., M. Shahid, C. Dumat, P. Winterton, E. Pinelli, 2011.  Lead uptake, toxicity, and 
detoxification in plants.  Reviews of Environmental Contamination and Toxicology, 
213:113-136.*
 13  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
VII. Tables  
 
Table 1.  Summary of Data used in Analysis of Lead in Food for Babies and Young 
Children  
 
Table 2.  Analysis of Lead Data from the Toxic Element Program and FDA Surveys by 
Food Category  
 
Table 3.   Analysis of Lead Data from the Total Diet Study (FY2014-2020) by Food 
Category for Babies and Young Children 
 
Table 4:   Summary Data for Food Categories for Babies and Young Children:  
Action Levels, Achievability, and Mean Lead Concentations/90th Percentle Lead 
Exposures from Food Consumption for Babies and Young Children (0-23 
months) With and Without Action Levels 
 
 
   
 14  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
Table 1. Summary of Data Used in Analysis of Lead in Foods for Babies and Young 
Children  
 
Number of  Food Categories for Babies and 
Data Set  Fiscal Year 
Samples  Young Children 
Toxic Element  dry infant cereals, fruits,  mixtures, 
2008-20218  356 
Program (TEP)  vegetables 
FDA Survey 1  2013-149  147  dry infant cereals,  mixtures 
fruits, mixtures, vegetables, 
FDA Survey 2  202110  360  yogurts, custards/puddings, single-
ingredient meats 
 
 
Table 2. Analysis of Lead Data from the Toxic Element Program and FDA Surveys by 
Food Category 
 
Food Category for  Number  Mean  
90th Percentile   95th Percentile  
Babies and Young  of  std. dev 
(ppb)  (ppb) 
Children  Samples  (ppb)  
Fruits (single 
ingredient or  110  1.0  1.2  2.4  3.7 
combination) 
Mixtures  266  3.0  5.0  6.8  11.1 
Yogurts, 
custards/puddings, 
33  0.9  0.7  1.7  2.3 
single-ingredient 
meats  
Vegetables (single 
ingredient or  98  5.6  7.3  16.0  20.5 
combination) 
Vegetables (single 
ingredient or 
combination 
47  2.3  3.6  6.6  10.2 
excluding single-
ingredient root 
vegetable products) 
Root vegetables  51  8.5  8.4  20.2  25.7 
Dry infant cereals  356  8.3  8.8  20.1  23.0 
 
 
8 Available at https://www.fda.gov/media/164564/download.   
9 These FDA survey data are available at: https://www.fda.gov/food/metals-and-your-food/combination-metals-
testing.  
10 Available at https://www.fda.gov/media/164565/download.   
 15  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Table 3. Analysis of Lead Data from the Total Diet Study (FY2014-2020)11 by Food 
Category for Babies and Young Children  
 
Food Category for Babies and  Number of 
Mean  std. dev (ppb) 
Young Children  Samples 
Fruits (single type or combination)  231  0.17  0.91 
Mixtures  210  2.5  3.9 
Yogurts, custards/puddings, single-
83  0.49  3.4 
ingredient meats  
Vegetables (single type or 
139  4.9  7.0 
combination) 
Vegetables (single type or 
combination excluding single- 89  1.1  2.3 
ingredient root vegetables products)  
Root vegetables  50  11.6  7.6 
Dry infant cereals  23  2.6  2.9 
 
   
 
11 In 2018, the TDS sampling protocol was changed. See 
http://www.fda.gov/Food/FoodScienceResearch/TotalDietStudy/default.htm.  In 2019, 241 samples of baby food 
were collected as part of a special TDS sampling assignment. 
 16  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
Table 4. Summary Data for Food Categories for Babies and Young Children: Action 
Levels, Achievability, and Mean Lead Concentrations/90th Percentile Lead Exposures from 
Food Consumption for Babies and Young Children (0-23 months) With and Without 
Action Levels  
 
Scenario B: 
90th  Scenario 
Scenario A: No  Scenario B:  With Action 
Percentile  A: No  Reduction 
Action Level  With Action  Level 
2-day  Action  in 
Food Category for  Achiev Estimated Pb  Level  Estimated Pb 
Action  Average  Level  Exposure 
Babies and Young  - Exposure from  Estimated  Exposure 
Level  Intake,  Estimated  at the 90th 
Children  ability  Baby Food at  Mean Pb  from  
Eaters  Mean Pb  Percentile
the 90th  Concentration  Baby Food at 
Only, 0-23  Concen- 15 
Percentile13  14  the 90th 
mo12  tration 
Percentile13 
  ppb  %  g/day  ppb  g/day  ppb  g/day  % 
Fruits, vegetables 
(excluding single-
ingredient root 
vegetable products),  10   96  353  2.3  0.81  1.7  0.60  26 
mixtures, yogurts, 
custards/ puddings, 
single- ingredient meat 
Root Vegetables  20  88  105  8.5  0.89  6.2  0.65  27 
Dry infant cereals  20  90  39  8.3  0.32  6.3  0.25  24 
 
 
 
12 Concentration in sample (ug/kg) * 1 kg/1000 g conversion factor*upper-level consumption (g/day) = estimated 
total exposure (g/day). 
13 Exposure estimates were calculated based on lead concentration data from the TEP and FDA survey data, and on 
baby food consumption data from What We Eat in America (WWEIA), the food consumption portion of the 
National Health and Nutrition Examination Survey (NHANES), 2003-2018.  Estimates are for eaters only, 0-23 
months.  The 90th percentile lead exposures (representing an upper bound) from baby foods for NHANES/WWEIA 
respondents were calculated as products of the 90th percentile of the 2-day average consumption of each food 
category for babies and young children and the mean lead concentration in that food category.  The term eaters 
only for the purposes of this data set means individuals from the survey that consumed this product to calculate 
intake.  The 90th percentile dietary exposures for babies and young children are below the IRL for lead of 2.2 
g/day for children. 
14 Mean lead concentrations in Scenario B were calculated after removal of the TEP and FDA survey data for 
samples with concentrations above the action level. 
15 Calculated as ((lead exposure under Scenario A- lead exposure under Scenario B)/ lead exposure under Scenario 
A)*100.  Calculations are based on unrounded data.