ALCOHOL LAW ADVISOR
ALCOHOL LAW ADVISOR
Regulatory and Distribution Law Updates for the Alcohol Industry
ALCOHOL LAW ADVISOR
Regulatory and Distribution Law Updates for the Alcohol Industry

FDA “Action Level” for Arsenic in Apple Juice

By on July 23, 2013

On Friday, July 12, the U.S. Food and Drug Administration (FDA) proposed a new “action level” for arsenic in apple juice.  The FDA’s Federal Register notice and other supporting documents that accompanied the announcement are linked below.

An action level generally establishes the threshold at which FDA will consider a food or food ingredient “adulterated” within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act).  For apple juice, FDA proposes a 10 parts per billion (PPB) level.  This level is considerably lower than the 23 PPB “level of concern” previously established by FDA.

The FD&C Act’s ingredient safety standards apply to all “food” – a term defined broadly in the Act to encompass all alcohol beverages.  Thus, the 10 PPB standard will be applied to apple juice used to manufacture hard cider.  As such, cider producers should review the implications of the proposed standard on their own operations and give thought to implementing procedures to comply with the 10 PPB standard in the future.

Click here to read the FDA’s notice in the Federal Register.

Click here to read the draft Guidance for Industry Arsenic in Apple Juice: Action Level.

Click here to read the draft Supporting Document for Action Level for Arsenic in Apple Juice.

Marc SoriniMarc Sorini
Marc E. Sorini concentrates on issues facing the alcohol beverage industry, with a particular focus on the supplier tier and non-beverage alcohol users. He heads the Firm's Alcohol Regulatory & Distribution Group and is recognized as one of the leading lawyers in his field. Read Marc Sorini's full bio.

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