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 others 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.

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 as 5 micrograms per deciliter (µg/dL). At this level it is recommended parents, doctors, public health officials, and communities take steps to 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, such as the FDA's 2008 Survey on Lead in Women's and Children's Vitamins.

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 takes 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 at which the CDC recommends clinical monitoring of lead exposure in children. The FDA calculated the current IRL 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. The FDA will continue to research and evaluate the health effects and dietary exposure to lead and will update the IRL as appropriate.

Recent 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 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.

Recent 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 and analyzes them for specific elements based on a set collection schedule for both seafood and non-seafood. If laboratory results are found to exceed the normal concentrations in these foods, 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.

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.

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 recommended guidelines to industry on specific foods and drinks more likely to be consumed by small children, including limiting lead in candy to a maximum level of 0.1 ppm and in juice to 50 ppb.

For more on the FDA’s guidance to industry on maximum levels for lead in candy and juice, please see:

• 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.

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 preventing certain imported products from entering the U.S. 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

To help increase the likelihood that ceramic tableware imported from China meets it U.S. safety standards, the FDA has a memorandum of understanding with the Certification and Accreditation Administration of the People's Republic of China. 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.

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

Guidance for Industry by Date Issued

From the FDA

• Lead in Lead-Glazed Traditional Pottery
• Bottled Water Everywhere: Keeping It Safe
• Combination Metals Testing
• FDA Regulates the Safety of Bottled Water Beverages Including Flavored Water and Nutrient-Added Water Beverages

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