FDA Issues Final Guidance To Industry for Inorganic Arsenic in Apple Juice.
To support their goal of minimizing the amount of contaminants in food meant for babies and children, the FDA released their final guidance for the industry in June 2023, entitled “Action Level for Inorganic Arsenic in Apple Juice.”
Background Knowledge: Inorganic vs. Organic Arsenic
Organic arsenic is gets its namesake due to its arsenic atom being attached to a carbon atom, such as ribose or a sugar molecule. The molecular compound is more complex in nature, but it is generally harmless.
Inorganic arsenic compounds do not contain carbon and are genetically simple molecules. Because of this, exposure to inorganic arsenic is associated with cancer, diabetes, adverse birth outcomes, and various negative human health effects. According to McGill University, inorganic arsenic compounds, such as arsenic trioxide, have been historically used as a lethal poison called “inheritance powder.”
According to the FDA, arsenic may be present in food because of its existence in the environment where foods are grown or processed. Arsenic is present in air, soil, and water in the event of human activity, such as the use of arsenic-containing pesticides or pollution from fracking, mining, ore smelting, and coal-fired power plants.
THE NON-BINDING ACTION LEVEL
The final guidance is intended to support the FDA’s goal of reducing exposure to environmental contaminants from foods commonly consumed by babies and young children as part of their “Closer to Zero” action plan.
“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,” the FDA said in a constituent update ahead of the guidance release. “However, since the release of the draft guidance, we have identified some apple juice samples with inorganic arsenic levels above 10 ppb.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.”
With this final guidance, the FDA expects the final guidance will help “encourage manufacturers to reduce levels of inorganic arsenic in apple juice.” It is not possible to remove arsenic from the environment or from the food supply. In this case, an action level is the FDA’s response when faced with unavoidable levels of contamination. Moving forward, the FDA will use this guidance to determine if additional enforcement over industry manufacturers will be necessary.