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

Constituent Update

June 1, 2023

Today, 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 However, since the release of the draft guidance, we have identified some apple juice samples with inorganic arsenic levels above 10 ppb. Therefore, we are finalizing an action level of 10 ppb because we consider 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 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, we expect to revisit this action level as part of the FDA’s “Closer to Zero” action plan.

Additional Information

Arsenic may be present in food because it is in the environment where foods are grown, raised, or processed. Arsenic in the soil, air, and water may occur naturally or may be present due to human activity, such as the past use of arsenic containing pesticides or pollution from mining, fracking, and coal-fired power plants. Exposure to inorganic arsenic is associated with adverse human health effects, including cancer, diabetes, adverse birth outcomes, and cardiovascular and neurodevelopmental effects. It is not possible to entirely remove arsenic from the environment or from the food supply. Therefore, the FDA sets action levels when a level of a contaminant is unavoidable, to inform industry on the level of contamination above which the FDA may regard certain foods as adulterated. Action levels do not establish a permissible level of contamination where it is avoidable.

Constituent Update

Subscribe to Constituent Updates