Please visit Investigation of Elevated Lead Levels: Cinnamon Applesauce Pouches for up-to-date information on the current recall and investigation of multiple brands of applesauce products.
The FDA's work to reduce the use of lead in cans combined with the phaseout of lead in gasoline resulted in a dramatic decline in lead exposure from foods by the mid-1980s.
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:
- To Help Protect Children from Environmental Contaminants, Healthy Food Choices for Your Baby Aged 6-12 Months
- What You Can Do to Limit Exposure to Arsenic and Lead from Juices
- The Key to a Well-Balanced Diet is Eating a Variety of Healthy Foods
Resources from Other Federal Government Agencies:
- United States Environmental Protection Agency - Lead
- United States Environmental Protection Agency-Heavy Metals in Cultural Products
- United States Centers for Disease Control and Prevention (CDC) - Childhood Lead Poisoning Prevention Program
- Agency for Toxic Substances and Disease Registry
- National Institutes of Health, National Institute of Environmental Health Sciences
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:
- the Total Diet Study;
- the FDA’s Toxic Elements in Food and Foodware, and Radionuclides in Food compliance program; and
- Other surveys, which may be conducted annually or in response to reports of elevated contaminant levels in certain products or to focus on a specific food or food group.
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).
- Analytical Results for Arsenic, Lead, Cadmium, and Mercury in Foods Intended for Babies and Young Children- TEP (FY2008-FY2021) in PDF, in XLSX
Sampled under the FDA’s Toxic Elements in Food and Foodware, and Radionuclides in Food – Import and Domestic Compliance Program, Updated March 2023
- Analytical Results for Lead in Food Intended for Babies and Young Children (FY2020-2021) in PDF, in XLSX
Sampled as part of an FDA survey of toxic elements in foods intended for babies and young children, Posted January 2023
- Dataset for Lead and Cadmium in Infant and Toddler Foods in XLSX - (FY2013-FY2014)
- Analytical Results for Lead in Juice -TEP FY2005-FY2018 - PDF, in XLSX
Sampled under the FDA’s Toxic Elements in Food and Foodware, and Radionuclides in Food – Import and Domestic Compliance Program, Posted April 2022
Scientific Articles and Reports
- A survey of toxic elements in ready to eat baby foods in the US market 2021 (2022)
- Updated interim reference levels for dietary lead to support FDA's Closer to Zero action plan (2022)
- FDA Total Diet Study (TDS) FY2018-FY2020 Elements Report and Data (2022)
- Targeting Coordinated Federal Efforts to Address Persistent Hazardous Exposures to Lead (2022)
- Perspective on Cadmium and Lead in Cocoa and Chocolate (2020)
- U.S. Food and Drug Administration's interim reference levels for dietary lead exposure in children and women of childbearing age (2020)
- Lead exposures in older children (males and females 7-17 years), women of childbearing age (females 16-49 years) and adults (males and females 18+ years): FDA total diet study 2014-16 (2019)
- Children’s exposures to lead and cadmium: FDA total diet study 2014-16 (2019)
- Cadmium and lead in cocoa powder and chocolate products in the US Market (2018)
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.
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.
- 21 CFR Part 129 - Processing and Bottling of Bottled Drinking Water
- 21 CFR Part 165.110 - Bottled Water
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.
- 21 CFR Part 109.16—Unavoidable Contaminants in Food for Human Consumption and Food Packaging Material—Ornamental and decorative ceramicware
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.
- Import Alert 99-42 for heavy metal (including lead) contamination of foods
- Import Alert 99-45 unsafe food additive
- Import Alert 52-08 lead and cadmium in ceramicware
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
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.