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  1. CFSAN Constituent Updates

FDA Issues Final Guidance for Industry on Action Level for Inorganic Arsenic in Infant Rice Cereals

Constituent Update

August 5, 2020

Today the U.S. Food and Drug Administration issued guidance finalizing the 2016 draft guidance for inorganic arsenic in infant rice cereals and identifying the agency’s intended sampling and enforcement approach.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. The FDA is taking this action because exposure to inorganic arsenic is associated with neurodevelopmental effects.

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. Both white rice and brown rice cereals showed improvement in meeting the 100 ppb level, but the improvement was greatest for white rice cereals, which tend to have lower levels of inorganic arsenic overall.

Infant rice cereals fortified with iron are a good source of nutrients for infants and are often used as the first or only infant cereal given. However, other iron-fortified infant cereals including oat, barley, and multigrain can be a first or early infant cereal. Pregnant women are also advised to eat a variety of grains as part of a well-balanced diet.

The FDA’s announcement today is part of a broader effort, led by the Toxic Elements Working Group, to identify, target, and prioritize FDA efforts to reduce exposure to toxic elements from food. The agency will continue to monitor research developments on adverse health effects to determine if new data support changes to our action level. We intend to consider the action level of 100 µg/kg or 100 ppb inorganic arsenic as an important source of information regarding whether infant rice cereal is adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act.

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