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).
Testing Results
- 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.
