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 advice to consumers.

Consumers are advised that:

• Eating a variety of age-appropriate nutrient-dense foods across and within the main food groups of vegetables, fruits, grains, dairy, and protein foods, including foods intended for infants and young children, is good for nutrition and for food safety.
• Ensure your child has good nutrition—this not only supports their health and development but can also help to protect them from the effects of contaminants.
• Caregivers do not need to throw out processed or packaged baby foods or stop feeding certain foods to babies and children. Eliminating entire food groups from a children’s diet may result in nutrient deficiencies and potential poor health outcomes.
• Lead that gets into or on plants cannot be completely removed by washing or other food processing steps.
• Making homemade baby foods is not likely to reduce the levels of lead in food since the lead in plants and animals from the environment generally occurs during the growing process. It also could result in higher levels of lead in the homemade version, since baby food manufacturers have a greater ability, compared with consumers, to implement strategies, such as testing ingredients used in final products or sourcing fresh fruit and vegetables from areas with lower levels of lead.

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 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 long-term adverse health effects from consuming lead vary depending on the level in the food or water, length of time of exposure, age of the consumer, and other exposures happening at the same time—either to lead from other sources, or other contaminants or to beneficial nutrients.
• Fetuses, infants, and children are particularly vulnerable to the potential harmful effects from lead exposure because of their smaller body sizes, metabolism, and rapid growth.
• Exposure to high levels of lead during times of active brain development can lead to neurological effects such as learning disabilities, behavior difficulties, and lowered IQ.

For adults, chronic lead exposure is associated with kidney dysfunction, hypertension, and neurocognitive effects.

Lead exposure is measured by testing for the level of lead in a person's blood. The Centers for Disease Control and Prevention (CDC) uses a blood lead reference level of 3.5 micrograms per deciliter (µg/dL) to identify children with blood levels that are higher than most children’s levels.

The FDA tests food for arsenic, lead, cadmium, and mercury to monitor the safety of the U.S. food supply, enforce FDA regulations, and inform agency guidance to industry and advice to consumers. 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.

Interim Reference Level

The FDA has calculated a maximum daily intake for lead from food, termed the interim reference level (IRL), to help us assess if the level of lead found in food may be a health concern. The IRL is based on the blood reference level of 3.5 micrograms of lead per deciliter of whole blood (ug/dL) identified by the Centers for Disease Control and Prevention (CDC). The blood reference level is the level at which the CDC recommends clinical monitoring of lead exposure in children. The IRL includes 10x safety factor which means that it is nearly ten times less than the actual 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 level 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.

Scientific Articles and Reports

Articles and reports authored by FDA researchers.

• 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)
• Perspective on Cadmium and Lead in Cocoa and Chocolate (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)

Lead in Food Intended for Babies and Young Children Sampling Results

The FDA has conducted routine surveillance and targeted surveys for arsenic, lead, cadmium, and mercury in foods, including those commonly consumed by babies and children under 2 years of age. Data on lead in the tables below helped to inform the FDA’s action levels for lead in foods intended for babies and young children and were posted when the FDA issued draft guidance to industry. Data on arsenic, cadmium, and mercury will help inform the development of action levels.

• 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

Lead in Juice Sampling Results

The FDA has conducted routine surveillance for lead in juice. The data in the table below helped to inform FDA’s development of action levels for lead in juices.

• 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

FDA regulations require industry to meet certain safety guidelines. It is the legal responsibility of companies that produce and grow foods and manufacture products sold in the U.S. and intended for food use to comply with FDA regulations and with the Federal Food, Drug and Cosmetic Act. The FDA issues guidance to industry to help them meet their legal responsibility.

Lead, if present in food, is a contaminant. The FDA regulations and guidance seek to limit the amount of lead that can occur unintentionally in food, foodware, cookware, and packaging. There are no FDA authorized uses of lead as a color additive or food additive (including as a food contact substance).

For some contaminants, the FDA has issued guidance to industry on action levels when a certain level of a contaminant is unavoidable. Guidance on action levels inform industry on the levels of contamination at or above which the FDA may regard certain foods as adulterated (i.e., that it violates the law). Action levels do not establish a permissible level of contamination. If the agency finds that the level of a contaminant causes the food to be unsafe, we take action, which may include working with the manufacturer to resolve the issue and taking steps to prevent the product from entering, or remaining in, the U.S. market.

Bottled Water Regulation

The FDA, through its regulatory authority under the Federal Food, Drug, and Cosmetic Act, 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 at 5 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.

Tableware Regulation and Action Levels

To limit the amount of lead that may leach into foods from tableware, the FDA issued a policy with maximum leaching levels for glazed ceramic pottery (for use in serving, storing and preparing foods) and silver flatware and tableware and 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.

The FDA also issued 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 Ceramicware in response to mislabeled traditional pottery imported from Mexico. In addition, FDA’s Food Code, which represents the agency’s best advice for a uniform system of provisions that address the safety and protection of food offered at retail and in food service, includes limits for lead in tableware, serviceware, and food contact surfaces.

Food Intended for Babies and Young Children Action Levels

The FDA has issued draft guidance to industry on recommended maximum levels of lead in food intended for babies and young children.

• Draft Guidance for Industry:  Action Levels for Lead in Food Intended for Babies and Young Children

Juice and Candy Action Levels

The FDA has issued guidance to industry on recommended maximum levels of lead in candy and juice, as they are more likely to be consumed by small children. For guidance and supporting documents, please see:

• Draft Guidance for Industry: Action Levels for Lead in Juice
• Draft Supporting Document for Establishing FDA’s Action Levels for Lead in Juice
• Guidance for Industry: Lead in Candy Likely to Be Consumed Frequently by Small Children
• Guidance for Industry: Juice HACCP Hazards and Controls Guidance First Edition

Import Alerts and Enforcement

The FDA has also taken actions to identify foods or food contact articles that may pose an increased risk for lead exposure. The FDA has issued several import alerts that provide information about certain imported products that may be detained without physical examination based on their history of high lead levels.

To view recent Import Alerts for lead, please see:

• Import Alert 99-42 for heavy metal (including lead) contamination of foods
• Import Alert 99-12 for lead solder in cans

The FDA has the authority to take enforcement action on a case-by-case basis where foods, including dietary supplements and spices, are found through routine or targeted testing to have levels of lead that may pose health concerns.

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.

Code of Federal Regulations

• 21 CFR Part 129 - Processing and Bottling of Bottled Drinking Water
• 21 CFR Part 165.110 - Bottled Water
• 21 CFR Part 189.240 - Lead solder

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).

Guidance for Industry by Date Issued