FDA In Brief: FDA Takes Action to Limit Inorganic Arsenic Levels in Infant Rice Cereal

Español

August 5, 2020

Media Inquiries:   Nathan Arnold,   301-796-6248

The following quote is attributed to Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition:

“The FDA is finalizing guidance today that will help protect public health by reducing infants’ exposure to inorganic arsenic, which has been associated with neurodevelopmental effects.

“It is important to note that the agency’s data show that most products on the market are already below this level and that parents and caregivers should know that a well-balanced diet also includes a variety of grains like oats and barley.

“Our action is yet another step as part of a broader effort, led by the FDA’s Toxic Elements Working Group, to identify, target and prioritize agency efforts to reduce exposure to toxic elements from food, especially in people most vulnerable to the health effects of toxic elements in food, including infants and children.”

Additional Information

• Today, the U.S. Food and Drug Administration issued guidance finalizing the 2016 draft guidance for inorganic arsenic in infant rice cereals and identifying the agency’s intended sampling and enforcement approach.
• The guidance identifies an action level of 100 micrograms per kilogram (µg/kg) or 100 parts per billion (ppb) which protects public health by reducing infants’ dietary exposure to inorganic arsenic and is achievable by industry.
• FDA testing of infant rice cereals over the last decade suggests that manufacturers are already making significant progress in reaching this action level through good manufacturing practices, such as selective sourcing and testing of rice and rice-derived ingredients (e.g., rice flour) to ensure lower levels of inorganic arsenic.
• Results from sampling in 2018 show that 76% of samples were at or below the 100 ppb level, compared to 47% of samples tested in 2014 and 36% of samples tested between 2011-2013.

Related Information

• FDA's Toxic Elements Working Group
• FDA’s 2016 Proposal to Limit Arsenic in Rice
• FDA: Arsenic in Food and Dietary Supplements
• FDA: Arsenic in Rice Risk Assessment
• What FDA Is Doing to Protect Consumers from Toxic Metals in Food
• FDA: What You Can Do to Limit Exposure to Arsenic
• Testing for Inorganic Arsenic in Rice Cereal for Infants: XLSX (31KB) | PDF (561KB)

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.