FDA Sets New Arsenic Level For Apple Juice

July 15, 2013

The U.S. Food and Drug Administration is drafting guidance for the level of arsenic deemed safe in apple juice. The FDA guidance says:

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 FDA considers achievable with the use of good manufacturing practices is 10 micrograms/kilogram (µg/kg) or 10 ppb.  FDA considers the action level for inorganic arsenic in apple juice to be protective of public health.  The action level can reduce human exposure to inorganic arsenic that may be found in apple juice.  

FDA intends to take the following sampling and enforcement approach to arsenic in apple juice. FDA intends to initially analyze apple juice samples for total arsenic. FDA intends to speciate samples containing more than 10 µg/kg or 10 ppb total arsenic to determine inorganic arsenic levels. Consistent with 21 CFR 109.6, FDA intends to consider the action level of 10 µg/kg or 10 ppb inorganic arsenic, in addition to other factors, when considering whether to bring enforcement action in a particular case.

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