U.S. Food and Drug Administration (FDA) Draft Action Levels for Lead in Juice (2022)

On April 27, 2022, the U.S. Food and Drug Administration (FDA) issued a draft guidance proposing “action levels” for lead in juice: 10 parts per billion (ppb) for ready-to-drink apple juice and 20 ppb for all other ready-to-drink juices and juice blends. The step was part of the U.S. Food and Drug Administration’s Closer to Zero plan for lowering children’s exposure to lead, arsenic, cadmium and mercury from food. The metal itself is described on the site’s Lead page, and the wider picture on its Heavy Metals in Food page.

This page reports what the U.S. Food and Drug Administration’s own documents say: what was proposed and when, why apple juice was given a lower number, what an action level is and is not, how the U.S. Food and Drug Administration arrived at the numbers, the effect the agency estimated, what the draft does not do, its status as of October 18, 2026, and how it fits the U.S. Food and Drug Administration’s other lead actions. No juice, brand or manufacturer is named here.

Table of Contents

  1. What the U.S. Food and Drug Administration Did in April 2022
  2. The Two Draft Levels: 10 ppb and 20 ppb
  3. Why Apple Juice Has the Lower Level
  4. What an Action Level Is
  5. How the U.S. Food and Drug Administration Arrived at the Numbers
  6. The Effect the U.S. Food and Drug Administration Estimated
  7. The Closer to Zero Plan Behind It
  8. What the Draft Does Not Do
  9. Dates and Legal Status as of October 18, 2026
  10. How It Fits Earlier and Later U.S. Food and Drug Administration Lead Actions
  11. Primary Documents
  12. Key Research Papers
  13. Connections
  14. Featured Videos

1. What the U.S. Food and Drug Administration Did in April 2022

In a constituent update dated April 27, 2022, the U.S. Food and Drug Administration announced that it had “issued draft guidance to industry providing action levels for lead in single-strength (ready to drink) apple juice and in other single-strength juices and juice blends.” The document is titled “Action Levels for Lead in Juice: Draft Guidance for Industry.”

Two days later, on April 29, 2022, the U.S. Food and Drug Administration published a notice of availability for the draft in the Federal Register, the U.S. government’s daily journal of agency rules and notices (87 FR 25491–25493, FR Doc. 2022-09255). A notice of availability does not itself set any requirement; it tells the public that a document exists and how to comment on it.

Comments went to Docket No. FDA-2019-D-5609. A docket is the public file in which an agency collects the documents and public comments for one action. The Federal Register notice asked for comments by June 28, 2022, “to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance.”

A guidance document describes the U.S. Food and Drug Administration’s current thinking on a subject. A draft guidance is a version put out for public comment before the agency decides whether, and in what form, to finalize it.

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2. The Two Draft Levels: 10 ppb and 20 ppb

The Federal Register abstract states that the draft guidance, “when finalized, would establish action levels of 10 parts per billion (ppb) for lead in single-strength (ready-to-drink) apple juice and 20 ppb for lead in all other single-strength juice types, including juice blends that contain apple juice.”

“Single-strength” means juice in the form in which it is drunk, as opposed to a concentrate that is diluted before drinking. The U.S. Food and Drug Administration’s documents use “single-strength” and “ready to drink” for the same thing.

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3. Why Apple Juice Has the Lower Level

The U.S. Food and Drug Administration’s constituent update explains that the apple juice level is lower “because, as the most commonly consumed juice by young children, apple juice may contribute a greater share of their potential lead exposure than other juices.”

On why lead was a priority at all, the same update states: “The U.S. Food and Drug Administration has prioritized reducing lead exposure because it is associated with serious health effects, including effects on the developing brain, such as impaired intellectual development.” The fruit itself is covered on the site’s Apples page.

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4. What an Action Level Is

The U.S. Food and Drug Administration’s Closer to Zero program page describes action levels as “one regulatory tool the U.S. Food and Drug Administration uses to help lower levels of chemical contaminants in foods when a certain level of a contaminant is unavoidable.” It defines them as “a level of contamination at which a food may be regarded as adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act.” “Adulterated” is the legal term for food that breaks the federal food-safety law, for example by containing a harmful substance.

The constituent update explains why lead cannot simply be set to zero: “Because lead in the environment can be absorbed by plants and animals and because it, like other elements, does not disappear over time, it is not possible to remove lead entirely from the food supply.” It adds that action levels “are established based on the unavoidability of the poisonous or deleterious substances and do not represent permissible levels of contamination where it is avoidable.”

The program page makes the same point in different words: “Action levels do not establish a permissible level of contamination.” It also states that the agency “does not need an action level for a contaminant to take enforcement action on a food product that violates safety laws,” and that, by law, food manufacturers and processors have a responsibility to put preventive controls in place as needed to significantly minimize or prevent exposure to chemical hazards, including lead, arsenic, cadmium and mercury.

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5. How the U.S. Food and Drug Administration Arrived at the Numbers

The constituent update says the draft levels “are guided by the U.S. Food and Drug Administration’s IRL for lead, a measure of the contribution of lead in food to blood lead levels.” An interim reference level (IRL), in the U.S. Food and Drug Administration’s words, is “a measure of exposure from food that the U.S. Food and Drug Administration may use to determine if the amount of exposure to an individual element across foods could result in a specific health effect.” Under the Closer to Zero plan, the U.S. Food and Drug Administration had committed to identifying IRLs and using them among the key factors in setting action levels.

Besides the IRL, the U.S. Food and Drug Administration said it considered:

The Closer to Zero page gives the history of the lead IRL: it was identified in February 2020, and in 2022 the U.S. Food and Drug Administration completed an update of the IRL for lead “to align with U.S. Centers for Disease Control and Prevention’s 2021 updated blood lead reference value (U.S. Centers for Disease Control and Prevention’s BLRV of 3.5 µg/dL).” The page dates that update to August 2022, after the juice draft was issued. The U.S. Centers for Disease Control and Prevention (CDC) is the Centers for Disease Control and Prevention; the blood lead reference value is discussed on the site’s Lead page.

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6. The Effect the U.S. Food and Drug Administration Estimated

The U.S. Food and Drug Administration gave two estimates in its constituent update:

The update also states that “Most juices have low levels of lead that are below the draft action levels,” so “it is reductions in the level of lead in juices with levels higher than the draft action levels that will have the largest impact in reducing lead exposure from juices.” It notes that, historically, action levels “have promoted the implementation of measures to further reduce the level of a toxic element in specific foods.”

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7. The Closer to Zero Plan Behind It

The constituent update presents the juice levels as support for the agency’s “broader effort to reduce exposure to arsenic, lead, cadmium, and mercury from foods” under the Closer to Zero action plan. The U.S. Food and Drug Administration’s program page lists the plan’s announcement on April 8, 2021.

According to that page, the U.S. Food and Drug Administration prioritized foods commonly eaten by babies and young children “because their smaller body sizes and metabolism make them more vulnerable to the harmful effects of these contaminants.” The page describes four stages that repeat over time:

  1. Evaluate the science, including setting interim reference levels;
  2. Propose action levels in draft guidance open for public comment;
  3. Consult with stakeholders on whether the levels are feasible and achievable;
  4. Finalize the action levels, then assess industry’s progress and consider whether to adjust them.

The page explains that, based on the data then available, the U.S. Food and Drug Administration would start with lead “while we evaluate data for arsenic, cadmium, and mercury.” It also states that it is “crucial to ensure that measures taken to limit arsenic, lead, cadmium, and mercury in foods do not have unintended consequences—like eliminating from the marketplace foods that have significant nutritional benefits or reducing the presence of one element while increasing another.” Its events list records a U.S. Food and Drug Administration stakeholder webinar on the juice draft held on June 14, 2022.

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8. What the Draft Does Not Do

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9. Dates and Legal Status as of October 18, 2026

Status: still a draft. The U.S. Food and Drug Administration’s Closer to Zero page (content current as of January 6, 2025) lists “Lead in Juices” at the “Consult” stage, with “April 2022: Issued draft guidance,” “June 2022: Stakeholder webinar” and a target of 2025 for the final step. A check of the Federal Register through October 18, 2026 found no notice of a final version, a withdrawal or any other later document in Docket FDA-2019-D-5609; the April 2022 notice is the only one. A finalization announced only outside the Federal Register cannot be ruled out from these records.

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10. How It Fits Earlier and Later U.S. Food and Drug Administration Lead Actions

Before: the juice draft built on the interim reference level for lead the U.S. Food and Drug Administration identified in February 2020, and on the Closer to Zero plan of April 2021, which said the agency would start by proposing action levels for lead. The Closer to Zero page also lists 2022 U.S. Food and Drug Administration releases of analytical results for lead in juice and for arsenic in apple juice.

After: the U.S. Food and Drug Administration’s Closer to Zero page records that draft action levels for lead in foods intended for babies and young children followed in January 2023, with a stakeholder webinar in March 2023 and final guidance in January 2025. That guidance is reported on the site’s U.S. Food and Drug Administration Action Levels for Lead in Baby Food (2025) page, which notes that juices are handled in this separate juice guidance rather than in the baby-food levels.

Other lead stories in the U.S. Food and Drug Administration section include the U.S. Food and Drug Administration Investigation of Lead in Cinnamon Applesauce Pouches (2023) and the U.S. Food and Drug Administration Lead Alerts on Ground Cinnamon (2024). Among the U.S. Food and Drug Administration’s other 2022 contaminant actions is the lower fluoride limit for fluoridated bottled water.

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11. Primary Documents

  1. U.S. Food and Drug Administration. U.S. Food and Drug Administration Issues Draft Guidance to Industry on Action Levels for Lead in Juice. Constituent Update, April 27, 2022 — fda.gov constituent update
  2. Food and Drug Administration, U.S. Department of Health and Human Services (HHS) (2022). Action Levels for Lead in Juice; Draft Guidance for Industry; Availability. Notice of availability. Federal Register 87 FR 25491, April 29, 2022. Docket No. FDA-2019-D-5609 — FR Doc. 2022-09255
  3. U.S. Food and Drug Administration. Closer to Zero: Reducing Childhood Exposure to Contaminants from Foods. Program page, content current as of January 6, 2025 — fda.gov Closer to Zero page
  4. Public docket FDA-2019-D-5609 — regulations.gov FDA-2019-D-5609

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Key Research Papers

  1. 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
  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. 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
  4. Spungen JH (2019). Children’s exposures to lead and cadmium: FDA total diet study 2014-16. Food Additives & Contaminants: Part A 36(6):893-903 — PubMed PMID: 30985263
  5. Hoffman-Pennesi D, Winfield S, Gavelek A, Santillana Farakos SM, Spungen J (2024). Infants’ and young children’s dietary exposures to lead and cadmium: FDA total diet study 2018-2020. Food Additives & Contaminants: Part A 41(11):1454-1479 — PubMed PMID: 39236048
  6. Mehri F, Heshmati A, Ghane ET, Mahmudiono T, Fakhri Y (2024). Concentration of Heavy Metals in Traditional and Industrial Fruit Juices from Iran: Probabilistic Risk Assessment Study. Biological Trace Element Research 202(11):5296-5305 — PubMed PMID: 38191759

The first paper is a pooled analysis of children’s blood lead and intellectual function across several international cohorts. The second and third are U.S. Food and Drug Administration scientists’ papers on the interim reference levels for dietary lead that guide the agency’s action levels. The fourth and fifth report children’s dietary lead exposure measured in the U.S. Food and Drug Administration Total Diet Study. The last is a survey of heavy metals in fruit juices sold outside the United States.

PubMed Topic Searches

  1. PubMed: lead in fruit juice
  2. PubMed: dietary lead exposure in children
  3. PubMed: interim reference level for dietary lead

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Connections

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