The agency set the threshold at 10 parts per billion (ppb) of inorganic arsenic, which matches the standard for total arsenic -- both inorganic and organic -- set for drinking water by the Environmental Protection Agency (EPA). There has been no arsenic standard for fruit juices to date.
"The FDA is establishing this threshold to provide guidance to industry," according to a press release. "The agency takes the action level into account when considering an enforcement action, if it finds a food product exceeds the threshold."
But the FDA's action is not the same as the EPA's setting an arsenic standard, Aaron Barchowsky, PhD, of the University of Pittsburgh, explained in an interview with MedPage Today.
"This is actually an advisory and a level of concern such that the FDA would not go after a source of apple juice that is below that level of concern," which makes a difference in terms of regulation, he said.
He also said that the FDA's level is more conservative than the EPA's because the drinking water standard was based on the assumption that people drink 2 to 3 liters a day. It is assumed that people aren't drinking that much apple juice, "and probably if you did, you'd have much worse health problems than anything arsenic could do to you," Barchowsky said.
In announcing the action, the FDA maintained that apple juice remains largely safe, as it has in the past.
"We have been studying this issue comprehensively, and based on the agency's data and analytical work, the FDA is confident in the overall safety of apple juice for children and adults," FDA Commissioner Margaret Hamburg, MD, said in a statement.
Although the agency has been monitoring arsenic levels in apple juice for the past 2 decades, the issue came to the forefront in September 2011, when Mehmet Oz, MD, a thoracic surgeon at Columbia University and host of The Dr. Oz Show, aired a segment on levels of arsenic found in popular brands of apple juice.
Oz reported that at least one sample from four of five brands had total levels of arsenic that exceeded the 10-ppb threshold established for drinking water.
The FDA and others criticized the report because the analysis did not distinguish between the organic form of arsenic, which is considered nontoxic, and the inorganic form, which has been tied to a range of health problems, including skin lesions, developmental defects, cardiovascular disease, neurotoxicity, diabetes, and cancer. The agency had tried to convince Oz not to air the segment.
An analysis released by Consumer Reports in November 2011 provided some support for Oz. It showed that about 10% of the apple juice samples tested had total arsenic levels above 10 ppb and that most of the arsenic was, in fact, inorganic, counter to what the FDA had claimed.
After the Consumer Reports results were released, the FDA said that it was determining whether a guidance level should be set for arsenic in apple juice.
The agency said it based the new 10-ppb standard on two analyses. In the first, the agency tested 94 samples of apple juice, showing that 95% contained less than 10 ppb of total arsenic and all of them contained less than that level of inorganic arsenic.
The other analysis was an FDA-authored, peer-reviewed assessment of the long-term risk of cancer stemming from exposure to inorganic arsenic in apple juice.
"The resulting risk estimates indicate that there are per capita urinary tract and lung cancer risks of approximately 1 in 100,000," the authors wrote. That was based on a modeled disease rate of 8.0 cases (95% CI 0.0-21.3) per million people consuming an average amount of apple juice. The risk would be higher for people consuming more juice.
"At the 10 parts per billion [level] in apple juice, the public should be really reassured that there's a huge margin of safety there," Barchowsky said.
Please continue reading By Todd Neale, Senior Staff Writer, MedPage Today