Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
 
 
Action Levels for Lead in Juice:  
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Draft Guidance
  
This guidance is being distributed for comment purposes only.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ensure that FDA considers your comment on this draft guidance before we begin work on the 
final version of the guidance, submit either electronic or written comments on the draft 
guidance within 60 days of publication in the Federal Register of the notice announcing the 
availability of the draft guidance.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-2019-D-5609 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 
 
 
April 2022 
    Contains Nonbinding Recommendations 
Draft-Not for Implementation 
Table of Contents 
 
 
I. Introduction .......................................................................................... 3
 
II. Background ......................................................................................... 3
 
III. Action levels ....................................................................................... 5
 
IV. References .......................................................................................... 6
 
 
 
 
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Action Levels for Lead in Juice:  Draft 
1
Guidance for Industry
 
  
 
 
This draft guidance, when finalized, will represent the current thinking of the Food and Drug 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 to the extent feasible. FDAs Closer to Zero action 
plan is a science-based, iterative approach to decreasing toxic elements (such as lead) in foods 
over time, including by setting action levels. This guidance provides information to industry on 
the action levels for lead in juice.  The action levels for lead in juice in this document would, if 
finalized, replace the current level of 50 parts per billion (ppb) described in the Guidance for 
Industry: Juice Hazard Analysis Critical Control Point Hazards and Controls Guidance (Juice 
HACCP Guidance), First Edition (Ref. 1).  FDA considers the action levels described in this 
guidance to be achievable by industry (or you) when measures are taken to minimize the 
presence of lead.   
 
The contents of this document do not have the force and effect of law and are not meant to bind 
the public in any way, unless specifically incorporated into a contract. This document is intended 
only to provide clarity to the public regarding existing requirements under the law.  FDA 
guidance documents, including this guidance, should be viewed only as recommendations, unless 
specific regulatory or statutory requirements are cited.  The use of the word should in FDA 
guidance means that something is suggested or recommended, but not required. 
 
II. Background 
 
Juice2 can become contaminated with lead through sources such as produce used to make juice 
(Ref. 1) and old lead-containing equipment, such as old lead-soldered machinery (Ref. 2).  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, pregnant women and their fetuses, 
and others with chronic health conditions.  Even low lead exposure can harm childrens health 
 
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 As stated in 21 CFR 120.1(a), juice means the aqueous liquid expressed or extracted from one or more fruits or 
vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or 
puree.  
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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. 3).  Because lead can accumulate in the body, 
even low-level chronic exposure can be hazardous over time (Ref. 4).  FDA has taken actions to 
address lead in juice, a food commonly consumed by young children. 
 
In 1993, we established an emergency action level of 80 ppb and above for lead in juice packed 
in lead soldered cans as a measure to limit the presence of lead in juice while we undertook 
rulemaking to revoke the prior sanctions for lead soldered cans and ultimately prohibit their use 
for packing food (58 FR 17233).3   
 
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 
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.  In 2001, the Codex Alimentarius Commission (Codex), an international food 
standards organization, established a maximum level (ML) of 50 ppb for lead in ready-to-drink 
fruit juices, including fruit nectars, that are in international trade.  FDA concurred with the 
Codex ML and adopted 50 ppb as the recommended level not to be exceeded for lead in juice in 
the Guidance for Industry: Juice Hazard Analysis Critical Control Point Hazards and Controls 
Guidance (Juice HACCP Guidance), First Edition (FDA, 2004).   
 
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. 5).  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. 5).   
 
In 2012, Codex initiated work to reevaluate the previously established MLs for lead in multiple 
commodities in the Codex General Standard for Contaminants and Toxins in Food and Feed 
(GSCTFF) (Codex Stan 193-1995) (Ref. 6), prioritizing review of MLs for foods (such as juice) 
that are highly consumed by children.   
 
This work, led by the U.S., as a member of Codex, resulted in the reduction of the lead ML for 
fruit juices in general from 50 ppb to 30 ppb and for grape juice from 50 ppb to 40 ppb.  The ML 
for fruit juices made from berries and other small fruits was retained at 50 ppb.  This analysis 
was based on the achievability of lower MLs following review of international data on lead in 
fruit juices.  
 
Because no safe level of lead exposure has been identified for childrens health, in 2018, FDA 
developed interim reference levels (IRLs) for dietary lead to replace FDA provisional tolerable 
total daily intakes (PTTDIs) (Ref. 4) which had been developed in the early 1990s.  FDA used 
 
3 In the Federal Register of June 27, 1995 (60 FR 33106), we issued a final rule to prohibit the use of lead solders in 
the construction of food cans.  The rule is codified at 21 CFR 189.240. 
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the Centers for Disease Control and Prevention (CDC) reference value of 5 g/deciliter (dL) 
blood lead4 level, the level at which public health interventions should be initiated for children, 
and dietary conversion factors calculated by the Environmental Protection Agency to derive 
IRLs of 3 g/day for children and 12.5 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. 4). 
 
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 (Ref. 7).  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.  FDA 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, and notes the importance of minimizing the potential for unintended 
consequences on the availability of nutritious foods for children.  
 
In response to the 2011 JECFA conclusion, the Codex adoption of lower MLs for fruit juices 
based on achievability, as well as FDAs development of IRLs and the Closer to Zero plan, FDA 
reevaluated the 50 ppb lead level recommended in the current Juice HACCP Guidance (Ref. 1).  
Given that no safe level of lead exposure from food has been identified by JECFA (Ref. 5), 
FDAs reevaluation has focused on review of U.S. data to determine if lower levels of lead in 
juice were achievable and if lower levels would reduce lead exposures in vulnerable populations.   
 
III. Action levels  
 
Based on our review of lead levels in juice samples that were collected by FDA after the 50 ppb 
level for juice was established in 2004, in consideration of the IRL for lead of 3 g/day for 
children, and in accordance with 21 CFR 109.6, we are establishing an action level for lead of 10 
ppb for apple juice on a single-strength (ready-to-drink) basis and an action level for lead of 20 
ppb for other single-strength juice types, including juice blends that contain apple juice (Ref. 8).  
The lower action level for apple juice is based on the fact that apple juice is the most commonly 
consumed juice type by young children in the U.S.  For apple juice, an action level of 10 ppb is 
estimated to reduce dietary exposure to lead for children by 46% at the 90th percentile 
consumption level (see Ref. 8).  For other fruit and vegetable juice types, an action level of 20 
ppb is estimated to reduce dietary exposure to lead for children by 19% at the 90th percentile 
consumption level.  Though not binding, these action levels are intended to encourage 
manufacturers to maintain lead levels in juices below the action levels, thus reducing risks 
associated with dietary lead exposures.  The establishment of these action levels for lead in juice 
is consistent with FDAs longstanding policy of reducing consumers lead exposure.  Therefore, 
it is important that HACCP controls are considered to minimize the presence of this contaminant.  
The action is focused on juice, a product consumed frequently by infants and children, who are 
more sensitive than adults to the neurodevelopmental effects of lead exposure.  The action levels 
 
4 The reference value of 5 g/deciliter (dL) blood lead was updated in 2021 by the CDC.  Additional information is 
available at: https://www.cdc.gov/media/releases/2021/p1028-blood-lead.html.  
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differ from international levels established by Codex, as the action levels reflect data from 
samples in the U.S. (from both import and domestic products in the marketplace), while Codex 
levels are based on international data.   
 
Consistent with 21 CFR 109.4, these action levels define the levels of lead contamination that 
may cause the juice products described in this guidance to be regarded as adulterated.  We intend 
to consider these action levels, in addition to other factors, when considering whether to bring 
enforcement action in a particular case.  When this draft guidance is finalized, we intend to 
update the Juice HACCP Guidance (Ref. 1) to reflect the new action levels. 
 
FDA recommends that the juice industry continue to work to lower the lead concentrations in 
juices to the extent possible under current good manufacturing practices.  As part of our Closer 
to Zero plan, we intend to further engage with stakeholders on proposed action levels, including 
the achievability of such levels, and the feasibility of further reducing the presence of lead in 
food.  After action levels are finalized, 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 lead in 
juice. 
 
IV. 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.  FDA, 2004.  Guidance for Industry: Juice Hazard Analysis Critical Control Point Hazards 
and Controls Guidance, First Edition; Final Guidance.  Available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-
industry-juice-hazard-analysis-critical-control-point-hazards-and-controls-guidance-first.* 
2.  Codex Alimentarius, 2021.  Revision of the Code of Practice for the Prevention and 
Reduction of Lead Contamination in Foods in Report of the 14th Session of the Codex 
Committee on Contaminants in Foods (REP21/CF). Available at: https://www.fao.org/fao-
who-codexalimentarius/meetings/detail/en/?meeting=CCCF&session=14.   
3.  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. 
4.  Flannery, B.M., L.C. Dolan, D. Hoffman-Pennesi, A. Gavelek, O.E. Jones, R. Kanwal, B. 
Wopert, K. Gensheimer, S. Dennis, S. Fitzpatrick, 2020. U.S. Food and Drug 
Administrations interim reference levels for dietary lead exposure in children and women of 
childbearing age. Reg. Toxicol. Pharmacol. 110:1-20. 
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5.  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.  
6.  Codex Alimentarius, 2021.  General Standard for Contaminants and Toxins in Food and 
Feed, CXS 193-1995.  https://www.fao.org/fao-who-codexalimentarius/sh-
proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex
%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf.   
7.  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.*  
8.  FDA, 2022b.  Draft Supporting Document for Establishing FDAs Action Levels for Lead in 
Juice. Available at 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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