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  1. Environmental Contaminants in Food

Lead in Food and Foodwares

What's New

January 6, 2025 

The FDA issued the final “Action Levels for Lead in Processed Food Intended for Babies and Young Children: Guidance for Industry.” The guidance provides information to industry on the action levels for lead in processed food intended for babies and young children and supports our Closer to Zero initiative to reduce dietary exposure to contaminants, including lead, in foods to as low as possible over time, while maintaining access to nutritious foods. 

December 12, 2024

The FDA issued a letter to retailers and distributors of cookware products to inform them that certain imported cookware products made from aluminum, brass, and aluminum alloys known as Hindalium/Hindolium or Indalium/Indolium, demonstrate the potential to leach lead into food. The letter informs retailers and distributors of cookware that such products should not be distributed in the U.S. market. The FDA was made aware of this issue through collaboration with the Public Health Department of Seattle and King County (PHSKC) on their testing of imported cookware and associated high blood lead levels in resettled refugee populations. For a list of the cookware products that may leach lead, view the Public Health Department of Seattle and King County Table of Cookware That Contains Lead.

The FDA continues to monitor ground cinnamon for lead through its work with states to test cinnamon sold directly to consumers at retail and with a series of post-incident activities following the October 2023 recall of WanaBana apple cinnamon fruit puree products due to elevated lead levels linked to cinnamon in those products and the concern for lead toxicity in children. Please visit FDA’s Post-Incident Response Activities: Elevated Lead and Chromium Levels in Cinnamon Applesauce Pouches for information on public health alerts related to certain ground cinnamon products and additional agency activities concerning lead in cinnamon. 

Lead may be present in food from the environment where foods are grown, raised, or processed. Levels of lead in the environment can vary depending on natural geographical makeup and proximity to current or past use or manufacturing of products made with lead. For example, lead has entered the environment from the past widespread use of lead in paint, gasoline, and plumbing materials, as well as many other products. While many commercial and industrial uses of lead have been phased out, there are still some products used or made in the U.S. that contain lead, and it is still used in products made in other countries.

Because there is no known safe level of exposure to lead, the FDA monitors and regulates levels of lead in foods. While it is not possible to completely prevent lead from entering the food supply, for foods that contain lead, it may be possible to reduce the levels through changes to agricultural or manufacturing practices. By law, food manufacturers have a responsibility to significantly minimize or prevent chemical hazards when needed.

To determine if the level of lead in a food is a potential health concern, the FDA considers the toxicity of lead and potential exposure based on the level of lead measured in the food and estimated consumption. We also may consider the risks specific to vulnerable subpopulations (e.g., very young children). If the agency finds that the level of lead causes the food to be unsafe, we will take regulatory action. This may include working with the manufacturer to resolve the issue, and as necessary, taking steps to prevent the product from entering, or remaining in, the U.S. market.

Among the FDA’s top priorities is maintaining access to foods that are sources of nutrients while limiting consumer exposure to contaminants. Having adequate nutrition is vital to growth and development for babies and children and helps promote health and prevent disease throughout our lifespan. The FDA collaborates with state and federal partners, industry, and other stakeholders to identify and facilitate the implementation of sustainable and effective strategies for growing, sourcing, processing, and manufacturing foods that contain lower levels of environmental contaminants, such as lead, while maintaining their nutritional quality and accessibility.

For more information about the FDA’s specific activities to reduce exposure to arsenic, lead, mercury, and cadmium from foods consumed by babies and young children, please visit the Closer to Zero page.

Lead in the environment can be taken up by plants and ingested by animals and enter the food supply. Lead is more common in certain foods and in foods grown in geographical areas with higher levels of environmental lead contamination. In addition, lead used in pottery may leach into foods.

Testing results that detect lead do not necessarily mean the food should be avoided. Because many of the most nutritious foods can also contain contaminants, consumers should eat a variety of nutrient-dense foods across and within the main food groups of vegetables, fruits, grains, dairy, and protein. This is good for nutrition and can also limit exposure to a contaminant from a specific food. In addition, research studies have found that good nutrition can also help protect from the effects of exposure to contaminants.

The FDA’s goal is to limit consumer exposure to lead, with a focus on protecting the very young, through developing regulations, action levels, and providing educational information.

Resources from the FDA:

Resources from Other Federal Government Agencies:

Lead is toxic to humans and can affect people of any age or health status. The potential for adverse health effects from consuming food contaminated with lead vary depending on the level of lead in the food; age of the consumer; length, amount, and frequency of exposure to lead in the food; and other exposures to different sources of lead and to beneficial nutrients.

The most serious effects of lead exposure can occur during times of active brain development. High levels of exposure to lead in utero, infancy, and early childhood can lead to neurological effects such as learning disabilities, behavior difficulties, and lowered IQ. The very young are particularly vulnerable to the potential harmful effects from lead exposure because of their smaller body sizes and rapid metabolism and growth. For adults, chronic lead exposure is associated with kidney dysfunction, hypertension, and neurocognitive effects.

More information about health effects can be found by visiting the Centers for Disease Control and Prevention (CDC).

The FDA tests food for environmental contaminants, such as lead, to monitor the safety of the U.S. food supply, enforce FDA regulations, inform agency guidance to industry, and provide the public with accurate, science-based information. Testing may be targeted to a specific category of food, such as foods commonly eaten by children under 2 years of age, or to a specific food or food group. Testing may also be conducted in response to reports of elevated contaminant levels in certain foods. Testing may occur at FDA laboratories, laboratories we contract with, or at state laboratories as part of our cooperative agreement with states.

The FDA tests for environmental contaminants, including lead, through:

In addition, the FDA has been conducting research to optimize testing methods to measure increasingly smaller amounts of these environmental contaminants. Currently, FDA’s Elemental Analysis Manual Method 4.7 is used by the FDA to analyze for lead, cadmium, as well as other elements in all foods to concentrations as low as 3 parts per billion (ppb).

Testing Results

Scientific Articles and Reports

Interim Reference Level

An interim reference level (IRL) is a benchmark the FDA may use to determine if the amount of exposure to the contaminant in food is a potential health concern. IRLs also may be used to inform action levels, which are the level of contaminant in a food above which the FDA may consider a food harmful to health and in violation of the FDA’s safety laws.

Although no safe level for lead exposure has been identified, the FDA has calculated an IRL for lead based on the Centers for Disease Control and Prevention’s (CDC) blood reference level of 3.5 micrograms of lead per deciliter of whole blood (µg /dL). The blood reference level is the level at which the CDC recommends clinical monitoring of lead exposure in children.

The IRL for lead includes a 10x safety factor. This means that it is nearly ten times lower than the amount of lead intake from food that would be required to reach the CDC’s blood reference level. The calculated IRLs are 2.2 micrograms (µg) per day for children and 8.8 µg per day for females of childbearing age. The IRL for females of childbearing age is to protect against possible fetal exposure in women who are unaware that they are pregnant and to protect against infant exposure during nursing.

International Scientific Activities

FDA experts participate in the international standard-setting body, Codex Alimentarius Commission (Codex). The purpose of Codex is to protect the health of consumers and promote fair trade practices by adopting scientifically based standards, guidelines, and codes of practice across all areas of food safety and quality. Its work includes reviewing the scientific data concerning contaminant levels in foods. These international discussions can lead to recommendations for standards individual countries may adopt.

Recommendations from Codex about reducing lead in foods can be found in the Code of Practice for the Prevention and Reduction of Lead Contamination in Foods.

Federal Regulations

There are no FDA regulations that authorize lead for use as a color additive or food additive (including as a component of foodware, cookware, or food contact surfaces). The FDA seeks to limit the amount of lead in foods when it is not otherwise possible to prevent lead entirely.

It is the legal responsibility of companies that grow or produce foods, or manufacture products intended for use with foods sold in the U.S., to comply with the Federal Food, Drug, and Cosmetic Act and FDA’s regulations.

If the FDA determines that the level of lead causes the food to be unsafe, the agency will take regulatory action. This may include working with the manufacturer to resolve the issue, and as necessary, taking steps to prevent the product from entering, or remaining, in the U.S. market.

Bottled Water: The FDA limits the level of lead (as well as other contaminants) in bottled water by establishing allowable levels in the quality standard for bottled water. For lead, this level is set to 5 parts per billion (ppb). This level is below the 15 ppb allowed by the U.S. Environmental Protection Agency for lead in public drinking water, as the tap water standard takes into account lead that can leach from pipes.

Lead Solder: Lead solders are alloys of metals that include lead and are used in the construction of metal food cans. The FDA banned the use of lead in can solder for any food sold in the U.S.

Labeling Ornamental Ceramicware: The FDA established labeling requirements for ornamental and decorative ceramicware containing lead. These ceramicwares must contain a specific label identifying the danger of using it with food.

Import Alerts

The FDA issues import alerts to prevent potentially violative products from being distributed in the United States. The agency has issued import alerts for certain foods and products from certain manufacturers that may pose a food safety hazard due to the presence of elevated levels of lead.

Guidance for Industry

The FDA issues guidance for industry to describe the agency’s current thinking on a regulatory issue. For example, guidance on action levels communicates to industry the levels of contaminants in foods at which the FDA may take enforcement action. Unlike regulations, guidance is not legally binding for the FDA or industry.

Guidance for Industry and Support Documents by Date Issued

TitleIssued Date
Guidance for Industry: Action Levels for Lead in Processed Food Intended for Babies and Young ChildrenJanuary 2025

Draft Guidance for Industry: Action Levels for Lead in Juice

April 2022
Letter Concerning the Withdrawal of "Guidance for Industry and FDA: 1991 Letter to Bureau of Alcohol, Tobacco and Firearms Regarding Lead in Wine"January 2017
Guidance for Industry: The Safety of Imported Traditional Pottery Intended for Use with Food and the Use of the Term "Lead Free" in the Labeling of Pottery; and Proper Identification of Ornamental and Decorative CeramicwareNovember 2010
Guidance for Industry: Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement PolicyNovember 2006
Supporting Document for Recommended Maximum Level for Lead in Candy Likely To Be Consumed Frequently by Small ChildrenNovember 2006
Guidance for Industry: Juice HACCP Hazards and Controls Guidance First EditionMarch 2004
Guidance for Industry: Action Levels for Poisonous or Deleterious Substances in Human Food and Animal FeedAugust 2000
Guidance for Industry: Letter to Manufacturers, Importers, and Distributors of Imported Candy and Candy WrappersJune 1995
Chemical Contaminants, Metals, Natural Toxins & Pesticides Guidance Documents & Regulations 

The FDA Food Code

The Food Code is a model for adoption by state, local, tribal, territorial regulatory agencies for regulating the retail and food service segment of the industry (restaurants and grocery stores and institutions such as nursing homes). It represents the agency’s best advice for a uniform system of provisions that address the safety and protection of food, and includes limits for lead in tableware, serviceware, and food contact surfaces.

Compliance Policy Guides

The FDA issues compliance policy guides for FDA staff to assist in their evaluation of evaluating industry compliance with FDA safety requirements. These guides are intended for FDA use but are made publicly available.

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