FDA Finalizes Action Level of 10 ppb for Inorganic Arsenic in Apple Juice
The U.S. Food and Drug Administration (FDA) has released a final guidance for industry, titled, Action Level for Inorganic Arsenic in Apple Juice, which identifies an action level of 10 parts per billion (ppb) for inorganic arsenic in apple juice.
The final guidance is consistent with the action level laid out in a draft guidance in 2013.
The results of FDA testing initiatives reflect a reduction 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 However, since the release of the draft guidance, FDA identified some apple juice samples with inorganic arsenic levels above 10 ppb. Therefore, FDA is finalizing an action level of 10 ppb, which the agency says is an achievable level with the use of good manufacturing practices.
FDA expects that the 10 ppb action level, though non-binding, will help encourage manufacturers to reduce levels of inorganic arsenic in apple juice. The agency will continue its current practice of monitoring arsenic in apple juice samples and, if testing identifies inorganic arsenic in apple juice above 10 ppb, FDA may take enforcement actions, taking into consideration other factors.
As lower arsenic levels are more protective of public health, FDA expects to revisit the action level as part of the “Closer to Zero” action plan.
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