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FDA Issues Draft Guidance for Level of Inorganic Arsenic in Apple Juice

August 23, 2013

The U.S. Food and Drug Administration (FDA) issued draft guidance for manufacturers on the action level for inorganic arsenic in apple juice in what it considers protective of human health and achievable with the use of good manufacturing practices.

Arsenic is an element that occurs in the environment from both natural and anthropogenic sources, including erosion of arsenic-containing rocks, volcanic eruptions, contamination from mining and smelting ores, and previous or current use of arsenic-containing pesticides. Arsenic is found in both inorganic and organic forms, together referred to as total arsenic. Inorganic arsenic is generally considered more toxic than organic arsenic, as consumption of inorganic arsenic has been associated with cancer, skin lesions, developmental effects, cardiovascular disease, neurotoxicity, and diabetes in humans.

Apple juice is one source of exposure to arsenic from food. Apple juice is a greater potential source of dietary inorganic arsenic exposure for children than for adults, because children's dietary patterns are often less varied than those of adults, and they consume more apple juice relative to their body weight than do adults.

Because of the potential for human health risks associated with exposure to inorganic arsenic, human exposure to inorganic arsenic should not exceed levels achievable with the use of good manufacturing practices. The action level for inorganic arsenic in single-strength (ready to drink) apple juice that the FDA considers achievable with the use of good manufacturing practices is 10 micrograms/kilogram (µg/kg) or 10 ppb.

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