FDA Seeks Comments on 'Arsenic in Apple Juice' Study

FDA is seeking public comments on a draft guidance for industry entitled 'Arsenic in Apple Juice: Action Level' and two supporting documents entitled 'Supporting Document for Action Level for Arsenic in Apple Juice' and 'A Quantitative Assessment of Inorganic Arsenic in Apple Juice' - The draft guidance "... identifies for the industry an action level for inorganic arsenic in apple juice [10 micrograms/kilogram (μg/kg) or 10 parts per billion (ppb)] that FDA considers protective of human health and achievable with the use of good manufacturing practices. It also describes FDA’s intended sampling and enforcement approach ..." - The draft supporting document "... reviews data on arsenic levels, health effects, and achievability, and explains FDA’s rationale for identifying an action level for inorganic arsenic in apple juice of 10 μg/kg. The risk assessment document provides estimates of arsenic exposure and risk to humans at different hypothetical limits for inorganic arsenic in apple juice ..."

The title of the July 15, 2013 Federal Register Notice is "Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for Action Level for Arsenic in Apple Juice; A Quantitative Assessment of Inorganic Arsenic in Apple Juice; Availability"