Regulatory Watch

FDA Issues Final Guidance to Industry on Action Level for Inorganic Arsenic in Apple Juice

The final guidance identifies for industry the action level of 10 parts per billion (ppb) for inorganic arsenic in apple juice.

The FDA announced the availability of a final guidance for industry entitled "Action Level for Inorganic Arsenic in Apple Juice." The final guidance identifies for industry the action level of 10 parts per billion (ppb) for inorganic arsenic in apple juice, issued in draft by the agency in 2013. The guidance supports the FDA’s goal to reduce exposure to environmental contaminants from foods commonly consumed by babies and young children.

The FDA’s 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 However, since the release of the draft guidance, The FDA has identified some apple juice samples with inorganic arsenic levels above 10 ppb. Therefore, it is finalizing an action level of 10 ppb because the FDA considers this level achievable with the use of good manufacturing practices.

The FDA expects that the 10 ppb action level, though non-binding, will help to encourage manufacturers to reduce levels of inorganic arsenic in apple juice. The agency says 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. As lower arsenic levels are more protective of public health, the organization expects to revisit this action level as part of its “Closer to Zero” action plan.