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

The U.S. Food and Drug Administration (FDA) issued its final guidance document, “Inorganic Arsenic in Rice Cereals for Infants: Action Level Guidance for Industry,” which finalizes the approach proposed in FDA’s April 2016 draft guidance for addressing arsenic levels in infant rice cereal.  FDA’s non-binding Guidance, which applies to all types of infant rice cereals (e.g., white rice, brown rice, organically grown, and conventionally grown), encourages manufacturers to reduce infants’ dietary exposure to inorganic arsenic by setting an action level that FDA believes to be achievable by industry through the use of current good manufacturing practices (particularly, selective sourcing of rice and rice-derived ingredients with lower levels of inorganic arsenic and testing).

As noted in the Guidance, “arsenic is an element that occurs in the environment from both natural and manmade sources, including erosion of arsenic-containing rocks, volcanic eruptions, contamination from mining and smelting ores, and previous or current use of arsenic-containing pesticides.” “Arsenic is found in both inorganic and organic forms (together referred to as total arsenic), and inorganic arsenic is generally considered more toxic than organic arsenic.” “Consumption of inorganic arsenic has been associated with cancer, skin lesions, cardiovascular disease and diabetes in humans,” as well as “adverse pregnancy outcomes and neurodevelopmental toxicity as adverse health effects.”  FDA’s surveys and analyses revealed relatively higher levels of inorganic arsenic in rice and rice products, including infant rice cereal; further, FDA indicates that “[r]ice and rice products are a greater potential source of dietary inorganic arsenic exposure for infants and children than for adults, because the dietary patterns of infants and children are often less varied than those of adults, and because infants and children consume more food relative to their body weight than do adults.”

The action level for inorganic arsenic in infant rice cereals that FDA considers achievable with the use of current good manufacturing practices, based on data, sampling, and test results, is 100 micrograms per kilogram (µg/kg), or 100 parts per billion (ppb).  Pursuant to the Guidance, FDA intends to analyze samples of infant rice cereals for total arsenic, and to speciate samples containing more than 100 µg/kg or 100 ppb total arsenic to determine inorganic arsenic levels.  The Guidance further indicates that FDA intends to consider the action level, on a case-by-case basis, as an “important source of information” for determining whether infant rice cereal is “adulterated”—and enforcement action is warranted—pursuant to Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(1)) and 21 C.F.R. § 109.4.

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 220


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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...