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Response to Letter from Washington Department of Agriculture Concerning the FDA's Questions and Answers Document Entitled "Reported Findings of Low Levels of Lead in Some Food Products Commonly Consumed by Children."

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Food and Drug Administration
College Park, MD 20740

February 1, 2013

Dan Newhouse
State of Washington
Department of Agriculture
P.O. Box 42560
Olympia, Washington 98504

Dear Mr. Newhouse:

This is in response to your letter of January 30, 2013, in which you asked several questions concerning the Food and Drug Administration’s (FDA) Questions and Answers (Q&A) document entitled "Reported Findings of Low Levels of Lead in Some Food Products Commonly Consumed by Children," which is posted on our website at; http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVegetablesJuices/ucm233520.htm:

This document was originally posted on November 10, 2010, and a revised version was posted on November 29, 2011. Your questions arise from changes that appeared in the revised document. You noted that the statement in the original document "None of the juices or other foods tested by FDA in the July 2010 survey contained levels of lead the FDA would consider to pose an unacceptable risk to health," is not in the revised document which instead states that "the lead levels typically found in these foods are below FDA's current tolerable intake levels for lead." You asked whether FDA has changed its position that the low levels of lead in the products covered by the Q&A do not pose unacceptable health risks, or has it merely used different language in the two versions to express the same position.

Stating that the levels are below the tolerable intake level, is another way of saying the products do not pose an unacceptable risk to health. Although we chose to state our conclusion using an objective benchmark (the tolerable intake level), the meaning remains the same.

Secondly, you asked that if FDA considers the subject products of the Q and A to be suitable for consumption, why the Q&A suggests that FDA may be planning to lower the acceptable level for lead in juice products.

In our "Juice HACCP Hazards and Controls Guidance First Edition," which is posted on our website at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Juice/ucm072557.htm, we recommended that if juice firms determine that lead is a hazard that is reasonably likely to occur in their juice, they should establish controls to ensure that lead levels do not exceed 50 parts per billion.

FDA has long sought to reduce lead levels in food to the extent practicable. Should the data for lead in juice indicate that juice products currently available are typically considerably below our current guidance level, we might consider it prudent to lower our guidance level so that the level is more consistent with the levels of lead that are currently achievable in the production of juice.

Finally, you asked whether FDA believes that the lead levels in the products that are the subject of the Q&A warrant a consumer advisory about the presence of lead in them. We have monitored fruit juices (baby foods and canned fruit and vegetable products) for elevated levels of lead for many years as part of our annual Total Diet Study and our Toxic Elements in Food and Food Ware Program. We generally issue consumer advisories related to heavy metals only when the potential intake levels are high enough to pose a risk to sensitive populations. In this case, we have established that the lead levels in fruit juices (and the other products addressed in the Q&A) do not pose an unacceptable risk to health. A lead advisory for these foods is unnecessary and could inaccurately communicate to consumers that these foods pose a health risk.



Michael M. Landa
Center for Food Safety
and Applied Nutrition

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