Issue: May 2016
Perspective from Benard P. Dreyer, MD
April 01, 2016
2 min read

FDA issues draft guidance for inorganic arsenic in infant rice cereal

Issue: May 2016
Perspective from Benard P. Dreyer, MD
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The FDA has announced a proposal to reduce inorganic arsenic in infant rice cereal, a leading source of arsenic exposure in infants, according to a press release.

The agency has recommended a new voluntary limit or “action level” of 100 parts per billion for the amount of inorganic arsenic in infant rice cereal, paralleling levels set by the European Commission for rice intended for the production of food for infants and young children.

The FDA has determined that the majority of infant rice cereal presently on the market already adheres to the proposed action level.

Susan Mayne

“Our actions are driven by our duty to protect the public health and our careful analysis of the data and the emerging science,” Susan Mayne, PhD, director of the FDA’s Center for Food Safety and Applied Nutrition, said in the release. “The proposed limit is a prudent and achievable step to reduce exposure to arsenic among infants.”

The proposed limit is based on extensive FDA testing of rice and nonrice products, as well as a 2016 risk assessment of studies demonstrating links between inorganic arsenic exposure and adverse pregnancy outcomes and neurological effects in early life.

According to FDA findings, inorganic arsenic exposure in infants and pregnant women can result in a child’s decreased performance on developmental tests that assess learning, based on epidemiological evidence including dietary exposures.

The FDA has released data surveying the levels of inorganic arsenic in 76 samples of rice cereals for infants. Data indicated that 47% of infant rice cereals sampled from retail stores in 2014 met the agency’s proposed action level of 100 parts per billion inorganic arsenic, and 78% were at or below 110 parts per billion inorganic arsenic.

The FDA also tested more than 400 samples of other foods usually eaten by infants and toddlers; all the nonrice foods were found to be well below the level of 100 parts per billion inorganic arsenic.

While the FDA is not recommending that the general population of consumers change their current rice consumption patterns based on the presence of arsenic, the agency is providing specific information for pregnant women and infants to help reduce exposure. The FDA has acknowledged that infant rice cereal is a common “starter” food for infants, and consumption of iron-fortified cereals for infants and toddlers is actively encouraged by the AAP.

With regard to inorganic arsenic in rice, the FDA recommends that parents and caregivers:

  • feed infants iron-fortified cereals to ensure they are receiving enough of this important nutrient;
  • feed infants rice cereal fortified with iron, which is a good source of nutrients but should not be the only source or necessarily the first source. Other fortified infant cereals include oat, barley and multigrain; and
  • provide toddlers with a well-balanced diet, which includes a variety of grains.