FDA Sets 10 ppb Action Level for Inorganic Arsenic in Apple Juice

The FDA has issued a final guidance “Action Level for Inorganic Arsenic in Apple Juice,” which identifies for industry the action level of 10 parts per billion (ppb) for inorganic arsenic in apple juice. The guidance supports the FDA’s goal to reduce exposure to environmental contaminants from foods commonly consumed by babies and young children.

The FDA noted that its testing results reflect a trend in reductions in the amount of inorganic arsenic in apple juice on the market, with an increasing percentage of samples testing below 3 ppb and 5 ppb. However, since the release of the draft guidance in 2013, the agency has identified some apple juice samples with inorganic arsenic levels above 10 ppb—the level the agency considers achievable with the use of good manufacturing practices.

Though non-binding, the FDA expects that the 10 ppb action level will help to encourage manufacturers to reduce levels of inorganic arsenic in apple juice. The agency said that it will continue its current practice of monitoring arsenic in apple juice samples and if testing identifies inorganic arsenic in apple juice above 10 ppb, the FDA will consider this action level, in addition to other factors, to determine whether to take enforcement action.

 

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