Food

Questions and Answers on Lead in Foods

1. What is lead?

Lead is a toxic substance present in our environment in small amounts. In the United States people may be exposed to lead when it is present in dust or dirt, drinking water, or food.

2. Why is lead in food products?

Lead in soil can be deposited on or absorbed by plants, including plants grown for food. Lead that gets in or on the plant cannot always be completely removed by washing or other steps in the processing of the food. As a result many foods contain very small amounts of the element -- in the range of parts per billion (ppb).

3. Why is the FDA concerned about lead in food?

Exposure to lead is measured by testing for the level of lead in a person’s blood. There is no known identified safe blood lead level, and chronic exposure to lead can seriously harm a child’s health, increasing the risk for damage to the brain and nervous system, slowed growth and development, learning and behavior problems, and hearing and speech problems.

4. Does the FDA test foods for the presence of lead?  

The FDA has monitored levels of lead in foods for decades through the Total Diet Study (TDS), the Agency's ongoing market basket survey in which about 280 core foods (TDS foods) in the U.S. food supply are collected, prepared as for consumption, and analyzed to determine levels of various contaminants and nutrients in those foods. The FDA also tests for lead in foods under the Toxic Elements in Food and Foodware and Radionuclides in its Food Compliance Program. The TDS includes a wide range of foods, representative of the diet of the U.S. consumer. Although lead is still present in many foods, of the 8,801 foods collected and analyzed between 2005 and 2013, 88% had levels that were too low to be detected.

5. What levels for lead in foods, if any, has the FDA set and why?

To date, the FDA has set specific lead levels for a variety of foods. We set a guidance level for candy likely to be consumed frequently by small children (100 ppb). We established an Import Alert for certain dried fruits found to contain lead above 100 ppb. We also set an allowable level for lead in bottled water (5 ppb) at the time the Environmental Protection Agency (EPA) established public drinking water lead requirements. And in 2001, at the time that the FDA was developing its juice safety requirements, known as the Juice HACCP Regulation, the agency established a guidance level for lead in fruit juices of 50 ppb. More generally, the FDA has—and uses—the authority to take action on a case-by-case basis where a particular food is found through routine or targeted testing to be adulterated with lead.

The FDA’s Center for Food Safety and Applied Nutrition recently has established a Toxic Elements Working Group whose mission in part is to develop a strategy for prioritizing and modernizing the Center’s activities with respect to food/toxic element combinations using a risk-based approach.

6. Why doesn’t the FDA establish zero tolerance for lead in food?

Lead is in food because it is in the environment and lead cannot simply be removed from food. Absent our ability to prevent lead from entering the food supply, the FDA’s goal is to protect human health by ensuring that consumer exposure to lead is limited to the greatest extent feasible. For example, for bottled water we set an allowable level of 5 parts per billion having determined that this was achievable and the lowest level of lead that could be reliably measured in water.

7. Why doesn’t the FDA use the same level (5 parts per billion) it set for bottled water for all foods? 

We focus on limiting exposure to lead to the greatest extent feasible for different types of foods, and we do so by determining what is achievable when the food is processed under good manufacturing practices. For bottled water that level is 5 ppb, but that is not the case for many other foods.

8. What is the FDA doing now?

The FDA is continuing to work to further limit the amount of lead in foods to the greatest extent feasible, especially in foods frequently consumed by children. Our efforts are informed by current research on the health risks of lead exposure and technological and manufacturing changes in food production. Among these efforts, the FDA’s Toxic Elements Working Group is reevaluating its methods for determining when it should take action with respect to measured levels of lead in particular foods, including those consumed by infants and toddlers.

9. Has the FDA determined a maximum daily level for lead exposure from foods? 

In 1993, the FDA established a maximum daily intake level (6 µg/day), known as the Provisional Tolerable Total Dietary Intake level (PTTDI) based on the Centers for Disease Control and Prevention (CDC)’s Level of Concern of 10 micrograms of lead per deciliter of blood (µg/dL). The PTTDI helps the FDA in assessing the risk of lead in food in various aspects of its regulatory mission such as in supporting enforcement actions, rulemaking and guidance development.

At the time the FDA set the 6 µg/day level, the agency stated that its Provisional Level “may be reduced if additional research shows that even lower levels of lead cause adverse health effects.” In the last decade, new scientific information has become available with respect to neurotoxic effects of low levels of exposure to lead. This prompted the EPA to lower its air quality standard, the CDC to replace its Level of Concern with a reduced reference value level, and the Joint WHO and FAO Committee on Food Additives (JECFA) to withdraw its Provisional Tolerable Level for lead. In the meantime, the FDA has been reviewing its provisional level.

10. What is the FDA doing internationally regarding lead in foods?

In addition to our role in monitoring the safety of foods on the U.S. market and taking regulatory action when warranted, the FDA participates with an international body, Codex Alimentarius Commission (Codex), to review the scientific data concerning lead and other contaminant levels in foods. These international discussions can lead to recommendations for standards individual countries may adopt. In 2011, JECFA withdrew the provisional tolerable intake for lead and further stated that it was not possible to establish a level that would be health protective. This led the Codex Committee for Contaminants in Foods (CCCF) to re-examine maximum levels for lead for various foods, starting with foods most often consumed by infants and young children, with a view to reducing maximum levels where appropriate. For example, in 2015, Codex revised the level for fruit juices downward to 30 ppb from 50 ppb. This reduction was recommended by a working group established to review lead levels and led by the U.S. delegate to Codex. The FDA may take Codex standards into consideration in conducting our own analysis of the appropriate methods to limit exposure to lead in foods in the U.S.

Page Last Updated: 05/09/2017
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