Lead in Food, Foodwares, and Dietary Supplements | FDA

Posted: December 13, 2021 at 2:04 am

FDA Monitoring and Testing of Lead in Food, including Dietary Supplements and Foodwares

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 persons 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 g per day for children and 12.5 g 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 CDCs 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.

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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.

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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.

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Lead in Food, Foodwares, and Dietary Supplements | FDA

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