FDA Extends Comment Period For Proposed Action Level For Arsenic in Apple Juice

WASHINGTONThe U.S. Food and Drug Administration (FDA) has extended the comment period to Nov. 12, 2013 for its proposed an action level" of 10 parts per billion (ppb) for inorganic arsenic in apple juice, which is the same level set by the U.S. Environmental Protection Agency (EPA) for arsenic in drinking water.

The draft guidance identifies for the industry an action level for inorganic arsenic in apple juice that the FDA considers protective of human health and achievable with the use of good manufacturing practices. It also describes the FDAs intended sampling and enforcement approach. The agency pointed out that while it issued the action plan, its testing and analysis confirm overall safety of apple juice.

Arsenic Concerns

FDAs proposal of action levels for inorganic arsenic in apple juice comes after a few years of controversy stirred up by media regarding dangerous" levels of the chemical. In September 2011, Dr. Mehmet Oz, host of The Dr. Oz Show," told viewers that tests hed commissioned found 10 of three dozen apple-juice samples with total arsenic levels exceeding 10 parts per billion (ppb).

FDA promptly issued a press release reassuring consumers about the safety of apple juice, and claiming most arsenic in juices and other foods is of the organic type that is essentially harmless." While the maximum level of arsenic allowed in bottled water is 10 micrograms in one liter of bottled water or 10 parts per billion (ppb), there is no federal arsenic threshold established for fruit juices, however, FDA is collecting all relevant information to evaluate and determine if setting guidance or other level for inorganic arsenic in apple juice is appropriate.

Just two months later in November 2011, a Consumer Reports investigation caused widespread consumer angst when it showed it tested 88 samples of apple and grape juice from five well-known brands, including Motts, Minute Maid and Welchs, and found that 10% of the samples surpassed government drinking-water standards of 10 parts per billion (ppb), and 25% of the samples had lead levels higher than the bottled-water limit of 5 ppb. Most of the arsenic detected in the tests was inorganic, a known carcinogen, rather than the organic form, which is considered nontoxic.