FDA Approves Inorganic Arsenic Limits in Baby Rice Cereal
In August, the US FDA finalized their previously-issued guidance on inorganic arsenic in rice cereals for infants. After evaluation of the health risks associated with infant exposure to inorganic arsenic, as well as the testing results of commercially-available products, the FDA has concluded that good manufacturing practices can reliably produce rice cereals with no more than 100 µg/kg (ppb) inorganic arsenic. Consequently, 100 µg/kg inorganic arsenic has been set as the action level for these products.
What does this mean for companies manufacturing or selling rice-based infant cereals? Products should undergo reflexive testing, wherein they are initially evaluated for total arsenic content. Any products containing greater than 100 ppb total arsenic should then be further analyzed for inorganic arsenic. Companies should also consider testing incoming sources of rice and other raw ingredients for inorganic arsenic content to help ensure that the finished products made from them will fall within the FDA guideline. Any finished products containing greater than 100 ppb inorganic arsenic may be considered adulterated under section 402(a)(1) of the FD&C Act and potentially subject to enforcement action by the FDA.
Brooks Applied Labs (BAL) has been supporting the safety of the food supply by offering testing services for metal contaminants (e.g., arsenic, cadmium, lead, and mercury) and inorganic arsenic for over a decade. In fact, partly because of our expertise, BAL was the only commercial laboratory involved in the recent certification of a new reference material for infant food testing, BARI-1.
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