Lead is poisonous 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 people with chronic health conditions. High levels of lead exposure can seriously harm children's health and development, specifically the brain and nervous system. Neurological effects from high levels of lead exposure during early childhood include learning disabilities, behavior difficulties, and lowered IQ. Because lead can accumulate in the body, even low-level chronic exposure can be hazardous over time. 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. There is no identified safe blood lead level. However, the Centers for Disease Control and Prevention (CDC) recommends that doctors begin monitoring children who have a blood lead level measured at or above 3.5 micrograms per deciliter (µg/dL). At this reference level, it is recommended that parents, doctors, public health officials, and communities take steps to identify and reduce the child's future exposure to lead.

The FDA's Center for Food Safety and Applied Nutrition (CFSAN) monitors lead levels to inform FDA guidance and enforce FDA rules. Testing may be targeted to a specific food group, such as food commonly eaten by infants and toddlers, or to a specific food or food additive. Testing may also be conducted in response to reports of elevated lead levels in certain foods, including dietary supplements.

Interim Reference Level

The FDA assesses whether the amount of lead in a food product is high enough to raise a person’s blood lead level to a point of concern. To do this, the agency calculated a maximum daily intake for lead from food, called the Interim Reference Level (IRL). In determining the IRL, the FDA took into account the amount of a particular food a person would need to consume daily, as well as other factors, that would result in blood lead levels of 5 ug/dL, the level prior to October 2021 at which the CDC recommended clinical monitoring of lead exposure in children. Since the CDC’s announcement that they reduced the blood level for lead to 3.5 ug/dL at which clinical monitoring should begin, the FDA has been continuing to research and evaluate the health effects associated with dietary exposure to lead to update the IRL.

The FDA’s current IRL is calculated at 3 µg per day for children and 12.5 µg per day for adults. These levels allow for differences across human populations and are set 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 adult level is particularly important for women of childbearing age, to protect against possible fetal exposure in women who are unaware that they are pregnant, and against infant exposure during nursing.

Relevant Scientific Articles:

• U.S. Food and Drug Administration's interim reference levels for dietary lead exposure in children and women of childbearing age (2020)
• A review of the evidence to support interim reference level for dietary lead exposure in adults (2020)

Total Diet Study

A long-standing way that the FDA has monitored lead and other toxic elements in foods is through the Total Diet Study (TDS). Several times a year, FDA staff buy, prepare, and analyze about 265 kinds of foods and beverages that represent the foods U.S. consumers eat. These data are assessed to estimate on average how much the entire U.S. population, some subpopulations, and each person consumes each year. Since the TDS began in 1961 to measure radioactive contamination, it has been extended to include pesticide residues, industrial and other toxic chemicals, and nutrient elements in food. The FDA uses the TDS results to help guide areas of focus for our food-safety and nutrition programs.

Relevant Scientific Articles:

• 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)

Toxic Elements in Food and Foodware Compliance Program

The FDA also monitors foods that can be a significant dietary source of certain toxic elements under the Toxic Elements in Food and Foodware, and Radionuclides in Food Compliance Program. For lead, the FDA places particular emphasis on foods that may be significant sources of lead in the diets of children.

To implement the program, FDA staff collect samples of selected foods, foodwares, and food contact surfaces, such as ceramicware, and analyze them for specific elements based on a set collection schedule. If laboratory results are found to exceed the normal concentrations in these foods or food contact applications, they are brought to the attention of CFSAN. CFSAN evaluates these situations on a case-by-case basis and may recommend additional action, as appropriate.

Lead in Juice Sampling Results

The FDA has conducted routine surveillance for lead in juice for many years and found that juice generally has low levels of lead. If the FDA determines that lead levels in juice samples are elevated, we may take action on a case-by-case basis. 

• 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

International Scientific Activities

FDA experts participate in an 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 lead and other 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.

Lead, if present in food, occurs as 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). It is the legal responsibility of companies that produce and grow foods and manufacture products that are sold in the U.S. and intended for food use to comply with FDA regulations and with the Federal Food, Drug and Cosmetic Act, to ensure they are safe. 

Bottled Water

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

Juice and Candy

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 support 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

Tableware

To limit the amount of lead that may leach into foods from tableware, the FDA sets allowable levels used in 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.

Import Alerts and Enforcement

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

To view recent Import Alerts for lead, please see:

• Import Alert 20-03 for dried fruits
• Import Alert 20-05 for juice and juice concentrate
• Import Alert 23-18 for spices and spice products
• Import Alert 54-17 for dietary supplements
• Import Alert 99-12 for lead solder in cans
• Import Alert 99-42 for heavy metal (including lead) contamination of foods

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.

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

From the FDA

• What You Can Do to Limit Exposure to Arsenic and Lead from Juices
• Lead in Lead-Glazed Traditional Pottery
• Bottled Water Everywhere: Keeping It Safe
• FDA Regulates the Safety of Bottled Water Beverages Including Flavored Water and Nutrient-Added Water Beverages
• Lead in Cosmetics

From Other Federal Government Agencies

• United States Environmental Protection Agency
• United States Centers for Disease Control and Prevention (CDC)
• United States Consumer Product Safety Commission
• National Institutes of Health, National Institute of Environmental Health Sciences