The health effects from arsenic exposure depend on:

• 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.

Age

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.

The FDA tests arsenic levels in foods as part of a comprehensive approach to monitoring toxic elements and nutrients. The agency prioritizes monitoring inorganic arsenic levels in foods more likely to be eaten by infants and toddlers. These foods are a greater potential source of dietary inorganic arsenic exposure for infants and young children than for adults, because:

• 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 in 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: Testing for Inorganic Arsenic in Rice Cereal for Infants - PDF, in XLSX
  Posted March 2020

• Analytical Results from Inorganic Arsenic in Rice Cereals for Infants, Non-rice Infant Cereal and Other Foods Commonly Eaten by Infants and Toddlers - PDF, in XLSX
  Posted April 2016

• Analytical Results from Inorganic Arsenic in Rice and Rice Products Sampling - PDF
  Posted September 2013 

Arsenic in Apple Juice Sampling Results

The FDA has conducted routine surveillance for arsenic in apple juice for many years and found that apple juice generally has low levels of inorganic arsenic. Total arsenic levels in apple juice samples have been routinely below 10 ppb, the FDA’s action level for inorganic arsenic in apple juice.  If samples have more than 10 ppb total arsenic, the FDA further analyzes the samples to determine the amount of inorganic arsenic.

• Analytical Results of Arsenic in Single-Strength Apple Juice - 2011 (ORA Sampling Assignment 2011102701)
  Posted December 2011

• Analytical Results for Arsenic in Apple Juice - 2005-2011
  Updated December 2011

• Analytical Results Arsenic in Pear Juice - 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, such as the Code of Practice for the Prevention and Reduction of Arsenic Contamination in Rice, to prevent or reduce the presence of contaminants in food.

Bottled Water

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 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 guidance to industry on action levels for inorganic arsenic in infant rice cereal and related documents, please see:

• Guidance for Industry: Inorganic Arsenic in Rice Cereals for Infants August 2020
• Supporting Document for Action Level for Inorganic Arsenic in Rice Cereals for Infants August 2020
• Constituent Update: FDA Issues Final Guidance for Industry on Action Level for Inorganic Arsenic in Infant Rice Cereals August 2020
• Arsenic in Rice and Rice Products Risk Assessment March 2016

Apple Juice

Apple juice is the most popular juice for young children and is a source of exposure to inorganic arsenic. In 2013, the FDA provided a draft action level of 10 parts per billion (ppb) to motivate industry to implement strategies to lower levels of inorganic arsenic in single-strength (ready to drink) apple juices. 

• News Release: FDA proposes “action level” for arsenic in apple juice July 2013
• Draft Guidance for Industry: Action Level for Arsenic in Apple Juice July 2013 
• Supporting Document for Action Level for Arsenic in Apple Juice July 2013
• Quantitative Assessment of Inorganic Arsenic in Apple Juice July 2013
• Peer Review Report on the Risk Assessment of Arsenic in Apple Juice December 2012

Import Alerts and Enforcement

The FDA has issued Import Alerts for 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 
• Import Alert 99-42 on heavy metals in foods

The 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

21 CFR Part 165.110 - Bottled Water

Guidance for Industry by Date Issued

From the FDA

• What You Can Do to Limit Exposure to Arsenic
• What You Can Do to Limit Exposure to Arsenic and Lead from Juices
• 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