FDA Statement: Arsenic in Apple Juice

Below are the statements that we have received from the FDA since September, including an email sent to the show on November 29, 2011.

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Below is an email from the FDA to The Dr. Oz Show:

Sent: Tuesday, November 29, 2011 10:25 PM

Subject: RE: interview request

Thank you for the invitation to participate in tomorrow's taping based on Consumer Reports' article on arsenic in the food supply, particularly apple juice. While we are not able to participate, we want to make sure you have the most current information about FDA's activities surrounding this issue.

First, I would like to point you to updated information available on our website: http://www.fda.gov/Food/FoodSafety/FoodContaminantsAdulteration/Metals/ucm280209.htm. FDA has posted additional analytical results for arsenic in apple juice and the letter the agency sent to Food and Water Watch regarding arsenic in apple juice.

Second, I would like to provide the following points to clarify and update FDA's comments during the background briefing held last month:

  • FDA is continuing to review and collect data on arsenic in apple juice. As stated in our letter recently to Food and Water Watch, we are seriously considering setting a guidance or other level for arsenic in apple juice. In order to set such a level, we are doing an assessment that will take cancer outcomes into account.
  •  A small number of samples of arsenic in apple juice did find inorganic arsenic to be the predominant type. We want to know which is the predominant type and that is why we are in the process of testing and speciating 90 samples so that we will have sufficient data for our assessment. It is important to speciate arsenic in foods, including apple juice. Even in foods where inorganic arsenic seems to predominate, there are still instances where organic arsenic predominates. We recognize the need to collect more data on arsenic species and we are doing this aggressively at this time.
  •  Although it is correct that total arsenic testing is easier and more cost effective, if we are to take regulatory action based on inorganic levels of arsenic, we would need to speciate. The importance of this is explained in the comment above.
  •  We are continuing to take a look at what is the appropriate level to use based on a number of factors including the data, the assessment and the feasibility of particular levels.
  •  We are striving to do this assessment quickly and hope to be able to do so. We have been studying this issue for years and do have a lot of data on total arsenic in apple juice.
  • We have been reviewing data for arsenic levels in other juices and foods as well. We recognize that the industry has changed and that more food is coming from overseas.
  •  A guidance level would provide for public input.
  •  Industry takes note of our levels of concern and other levels.
  •  Industry is responsible for the safety of the foods they produce. FDA also has responsibility as a regulatory agency. Further, we have to work with foreign governments when it comes to food safety.

Lastly, here are our responses to your follow-up questions:

  • Why didn't the FDA consider cancer risks in its 2008 assessment?
The 2008 assessment was designed for short term (less than a lifetime) exposure to arsenic, and we, therefore, looked at risks associated with short term exposure such as cardiovascular effects. Cancer risk is more appropriate for assessments designed for long term exposure to arsenic from lifetime consumption of apple juice, and that is what we are in the process of doing now.
  •  What data does the FDA now have that shows cancer risk should be included in the risk assessment?
When setting guidance or other level for a chemical contaminant in a food, FDA designs assessments that consider potential cancer risks due to long term exposure to that chemical contaminant from lifetime consumption of that food. 

We are considering setting guidance or other level for inorganic arsenic in apple juice and the assessment will consider potential cancer risks due to long term exposure to inorganic arsenic from lifetime consumption of apple juice. 
  •  Does considering cancer outcomes now mean that the Level of Concern will likely be lower than 23 ppb?
The agency is currently collecting the necessary data for an updated risk assessment. We won’t know what an appropriate level might be until data collection and analysis is completed.
  •  What caused the suspicion that the predominant species of arsenic in apple juice is inorganic?
It is not a suspicion. We have reviewed the limited data consisting of a 2009 University of Arizona study on 5 samples of apple juice and FDA’s results for 4 apple juice samples and in those cases found the arsenic in those instances to be mostly inorganic arsenic. As stated in our letter to Food and Water Watch, we are undertaking additional research that will provide the more comprehensive information necessary to help us determine the ratio of inorganic and organic forms of arsenic in apple juice.
  •  What caused the suspicion that there is harmful organic arsenic in apple juice?
Again, this is not a suspicion. In our questions and answers posted on our website, we explain that some scientific studies have shown that two forms of organic arsenic found in apple juice could also be harmful, and for that reason, the FDA counts these two forms of organic arsenic in with the overall content for inorganic arsenic.
  •  We want to make sure we understand FDA's current thinking on the cancer risk of arsenic and the Level of Concern. Does the following represent FDA's current position?
As stated in the letter to Food and Water Watch, FDA is considering setting a guidance or other level for arsenic in apple juice. We are still collecting the necessary data to conduct the assessment needed for setting such a level. We have not made a decision nor come to a conclusion regarding an updated level. Once data collection and analysis is complete, FDA will determine what action is needed.
  •  When do you expect the Guidance Level will be put out to the public?
We are moving forward swiftly with the necessary research. At this time, we do not have a date.

Best,

FDA Office of Public Affairs