The FDA monitors and regulates levels of arsenic in certain foods because it can cause serious and life-threatening health problems. The FDA also monitors arsenic levels in dietary supplements and cosmetics.
Arsenic is a naturally occurring element in the environment that can enter the food supply through soil, water or air. Arsenic levels in the environment are generally low but can vary depending on the natural geological makeup of local areas. For example, volcanic eruptions can bring arsenic from the earth’s interior to the surface. Contamination from mining, fracking, coal-fired power plants, arsenic-treated lumber, and arsenic-containing pesticides also contribute to increased levels of arsenic in certain locations.
As a naturally occurring element, it is not possible to remove arsenic entirely from the environment or food supply. The FDA, therefore, seeks to limit consumer exposure to arsenic to the greatest extent feasible. As part of this effort, in 2017 the FDA created the Toxic Elements Working Group, in part, to reevaluate when the FDA should take action on measured levels of arsenic in particular foods.
- the type of arsenic (organic or inorganic);
- the level of exposure; and
- the age of the person exposed to the arsenic.
Organic vs Inorganic Arsenic
Organic arsenic compounds contain arsenic with carbon; and are not related to organic farming practices. Inorganic arsenic compounds contain arsenic with a non-carbon element such as oxygen. This distinction is important because current research indicates that the level of toxicity and the associated health effects are more severe from exposure to inorganic arsenic as compared with organic arsenic.
Health effects from organic arsenic are however an emerging area of science. For example, some scientific studies have shown that two forms of organic arsenic found in certain foods, dimethylarsinic acid (DMA) and monomethylarsonic acid (MMA), may be a health concern. The FDA is monitoring emerging research on possible health risks from these forms of organic arsenic and will continue to monitor both inorganic and organic forms of arsenic in foods, as needed.
Levels of Exposure
Adverse health effects from arsenic exposure generally require levels of arsenic not typically found in food. According to the World Health Organization and the Centers for Disease Control and Prevention, the most common source of high levels of inorganic arsenic is contaminated drinking water. In the U.S., to reduce health risks associated with arsenic exposure from drinking water, the U.S. Environmental Protection Agency has set the maximum contaminant level (MCL) of arsenic in public drinking water at 10 parts per billion (ppb), and the FDA adopted this level for bottled water as well. Because private well water is not routinely tested by government agencies, people who get their water from private wells are advised to test for arsenic (and other contaminants) and contact their state drinking water well program if a problem is suspected.
Long-term exposure to inorganic arsenic has been associated with skin disorders and increased risks for skin, bladder, and lung cancers. Short-term exposure to very high amounts of inorganic arsenic can result in nausea, vomiting, bruising, and numbness or burning sensations in the hands and feet.
Inorganic arsenic exposure in utero and in the very young is associated with impaired intellectual development, such as decreased performance on certain developmental tests that measure learning. For this reason, the FDA prioritizes monitoring and regulating products that are more likely to be consumed by very young children.
- they are commonly consumed by infants and young children;
- infants and children’s dietary patterns are often less varied than those of adults, and
- infants and children consume more food relative to their body weight than do adults.
The FDA tests for toxic elements through:
- the Total Diet Study;
- the FDA’s Toxic Elements in Food and Foodware, and Radionuclides in Food compliance program; and
- sampling assignments.
Sampling assignments may be conducted in response to reports of elevated arsenic levels in certain foods or to focus on a specific food, food additive, or specific food group (such as foods commonly eaten by infants and toddlers).
The FDA tests for “total arsenic” levels in foods. If needed, the FDA can further test samples to determine the levels of organic and inorganic arsenic species. See the Health Effects from Arsenic Exposure section above for explanation on the distinction between arsenic types.
Arsenic Rice and Rice Products Sampling Results
The FDA places a high priority on monitoring levels of arsenic in rice and rice products because as rice plants grow, they absorb arsenic more readily than other food crops. Rice is also a highly consumed food worldwide. Therefore, because of the plant itself and its popularity, it is a leading food source of inorganic arsenic.
- Analytical Results from Inorganic Arsenic in Rice Cereals for Infants, Non-rice Infant Cereal and Other Foods Commonly Eaten by Infants and Toddlers (XLSX, 79KB), Posted April 2016
- Analytical Results from Inorganic Arsenic in Rice and Rice Products Sampling (PDF: 767KB), Posted September 2013
Arsenic in Apple Juice Sampling Results
The FDA has conducted routine surveillance for arsenic in apple juice for many years. Apple juice generally has low levels of inorganic arsenic. Total arsenic levels in apple juice samples have routinely been below 10 ppb, the same allowable level in drinking water.
- Results of Arsenic Analysis in Single-Strength Apple Juice, 2011 (ORA Sampling Assignment 2011102701), Posted December 2011
- Arsenic in Apple Juice Analytical Results, 2005-2011 Toxic Elements Food and Foodware Program, Updated December 2011
- Arsenic in Pear Juice Analytical Results, 2005-2011, Updated February 14, 2012
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 arsenic and other contaminant levels in foods. These international discussions can lead to recommendations for standards individual countries may adopt and codes of practice to prevent or reduce the presence of contaminants in food.
The FDA, through its regulatory authority under the Federal Food, Drug, and Cosmetic Act, limits levels of arsenic (as well as other contaminants) in bottled water by establishing allowable levels in the quality standard for bottled water. For arsenic, this level is set to the same amount allowed by the U.S. Environmental Protection Agency for public drinking water, 10 ppb.
Infant Rice Cereal
The FDA issued draft guidance to industry to not exceed inorganic arsenic levels of 100 ppb in infant rice cereal. As part of its analysis to support this action level, the FDA conducted a risk assessment and determined that establishing an action level of 100 ppb could reduce the mean concentration of inorganic arsenic in brown-rice infant cereals from 119.0 ppb to 79.0 ppb and in white-rice infant cereals from 103.9 to 83.5 ppb.
For more on the FDA’s current draft guidance to industry on action levels for inorganic arsenic in infant rice cereal and related documents, please see:
- FDA Statement on Testing and Analysis of Arsenic in Rice and Rice Products
- News Release: FDA Proposes Limit for Inorganic Arsenic in Infant Rice Cereal
- Draft Guidance for Industry: Inorganic Arsenic in Rice Cereals for Infants: Action Level
- Supporting Document for Draft Guidance for Industry on Inorganic Arsenic in Rice Cereals for Infants: Action Level
- Arsenic in Rice and Rice Products Risk Assessment Report, March 2016
- External Peer Review Report: Arsenic in Rice and Rice Products Risk Assessment: Draft Report, Addendum, and Model, December 2015
- FDA’s Response to External Peer Review1 on FDA’s “Arsenic in Rice and Rice Products Risk Assessment: Draft Report” (July 2015), “Addendum to FDA’s Arsenic in Rice and Rice Products Risk Assessment,” and “Arsenic in Rice and Rice Products Risk Assessment Cancer Model" Note: you may request access to the risk model related to this risk assessment by sending a note to FDAFoodSafetyRiskModel@fda.hhs.gov.
The FDA issued draft guidance to industry to not exceed inorganic arsenic levels of 10 ppb in apple juice. This is the same level set by the U.S. Environmental Protection Agency (EPA) for arsenic in drinking water.
For more information on the FDA’s current draft guidance to industry on action levels for inorganic arsenic in apple juice and related documents, please see:
- News Release: FDA proposes “action level” for arsenic in apple juice
- Draft Guidance for Industry: Arsenic in Apple Juice: Action Level
- Supporting Document for Action Level for Arsenic in Apple Juice
- Quantitative Assessment of Inorganic Arsenic in Apple Juice
- Peer Review Report: Risk Assessment of Arsenic in Apple Juice
Import Alerts and Enforcement
The FDA has issued Import Alerts for arsenic in certain foods that may pose an increased risk for arsenic exposure. The FDA issues Import Alerts to provide information to FDA field staff so that they can keep dangerous products from other countries out of the U.S.
To view recent Import Alerts for arsenic, please see:
- Import Alert 20-05 on fruit juices and fruit juice concentrates,
- Import Alert 29-02 on bottled water and flavored water beverages, and
- Import Alert 54-17 on Ayurvedic dietary supplements.
FDA has the authority to take enforcement action when foods, including dietary supplements, are found through routine or targeted testing to have levels of arsenic that are unsafe. For example, the FDA has also overseen the recall of products, such as fruit juices and bottled mineral water, when levels of arsenic were at a level of concern.
Code of Federal Regulations
Guidance for Industry by Date Issued
From the FDA
- What You Can Do to Limit Exposure to Arsenic
- Use Caution With Ayurvedic Products
- Bottled Water Everywhere: Keeping It Safe
- FDA Regulates the Safety of Bottled Water Beverages Including Flavored Water and Nutrient-Added Water Beverages
- Combination Metals Testing
- Total Diet Study
From Other Federal Government Agencies
- United States Environmental Protection Agency
- United States Environmental Protection Agency Drink Water Contaminants – Standards and Regulations
- United States Environmental Protection Agency: Private Drinking Well Water Programs in Your State
- United States Centers for Disease Control and Prevention (CDC)
- Agency for Toxic Substances and Disease Registry
- National Institutes of Health, National Institute of Environmental Health Sciences
Tips for Limiting Exposure to Arsenic
- Check your well water
- Eat a varied and nutritious diet
- Learn about juice recommendations for children
- Get strategies for rice and infant rice cereal
Learn more on What You Can Do to Limit Exposure to Arsenic