10 years after FDA issued its draft guidance on arsenic in apple juice, the agency has announced the same level as final guidance.
Background:Arsenic (As) is a natural trace element commonly found in soils, but soil levels are also often enhanced because of human activities such as the past use of arsenic-containing pesticides. Arsenic is present in the environment in various inorganic and organic chemical forms with widly differing toxicity. Inorganic arsenic is considered the most toxic form, with a broad variety of neurologic, cardiovascular, dermatologic, and carcinogenic effects, including peripheral neuropathy, diabetes, ischemic heart disease, melanosis, keratosis, and impairment of liver function. Arsenic in soil is taken up by some crops, including apples.
In December 16, 2011 FDA had
published their results on arsenic in apple juice based on 160 samples analyzed between 2005 and 2011. The results showed levels from not detected up to 45 ppb.
In 2012 Consumer Reports
published their results on a study of arsenic in apple and grape juice with some alarming findings:
- Roughly 10 % of just samples had total arsenic levels that exceeded federal drinking-water standards. Most of that arsenic was inorganic arsenic,
- 25 % of samples had arsenic levels higher than the FDA's bottled-water limit of 5 ppb.
These findings have prompted Consumers Union, the advocacy division of Consumer Reports, to urge the FDA to set arsenic and lead standards for apple and grape juice to a level that at least meet the 5 ppb lead limit for bottled water. They recommend an even lower arsenic limit for juice: 3 ppb.
In 2013 FDA proposed a threshold of 10 ppb for inorganic arsenic, the carcinogenic form of the element, in apple juice. This is the same level set by EPA for arsenic in drinking water. Since then, the FDA says, it has incorporated new data on inorganic arsenic levels in apple juice, arsenic’s health effects, and manufacturers’ ability to reduce levels below 10 ppb.
The new final guidance:The new guidance sets the level at 10 parts per billion (ppb), the same as the agency’s draft guidance issued in 2013. The agency published the action level, which is not enforceable, in a final guidance document for industry on June 2.
Consumer Reports has questioned the public health impact of the final guidance. Brian Ronholm, director of food policy for Consumer Reports, said: “Today’s announcement by FDA will have minimal impact on public health because the action level should be lower than 10 ppb based on current science. Plus, they waited until a vast majority of the industry was already meeting this level, so this announcement is virtually irrelevant.”
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last time modified: November 26, 2023
