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FDA Statement

FOR IMMEDIATE RELEASE
Statement
April 13, 2006

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Benzene in Soft Drinks

FDA is committed to ensuring the safety of food and beverages consumed by Americans and providing timely and factual information when safety questions are raised. We are issuing this statement today to better describe the steps FDA is taking in response to reports that benzene has been found in some soft drinks.

Benzene, a carcinogen, is found in the environment from natural and man-made sources. In November 2005, FDA received reports that benzene had been detected at low levels in some soft drinks containing benzoate salts (an antimicrobial agent) and ascorbic acid (Vitamin C), particularly under certain conditions of storage, shelf life and handling.

FDA's Center for Food Safety and Applied Nutrition (CFSAN) initiated a survey of benzene levels in soft drinks following receipt of the November 2005 reports. This survey indicates that the vast majority of beverages sampled (including those containing both benzoate salts and ascorbic acid) contain either no detectable benzene levels or are well below the 5 parts per billion (ppb) U.S. water standard. The results of this survey, which will be released in the near future, indicate that the levels of benzene in these beverages do not pose a safety concern.

FDA's Total Diet Study (TDS) results from 1995 to 2001, as recently reported by the press, indicated benzene levels in soft drinks that were well above and inconsistent with CFSAN's more recent survey results. The TDS results were also well above and inconsistent with levels reported in previous and current peer-reviewed literature and with hundreds of recent domestic and international government and beverage industry results. We are working to determine the source of the differences. As with any data that appear to be inconsistent, FDA believes it is important to closely examine the reasons for such differences.

The TDS is an ongoing FDA program that determines levels of various contaminants and nutrients in a wide variety of foods. The analytical procedures used in the TDS are designed to detect multiple pesticide residues, industrial chemicals, and toxic and nutrient elements in many foods, not just benzene in beverages. Ongoing investigations into the analytical method used by the TDS suggest that elevated benzene levels can be formed by the procedures used to analyze beverage samples. This raises major concerns about the reliability of the TDS data for benzene in beverages and could explain why these data indicate higher levels of benzene than the levels reported in the more recent surveys by CFSAN and others, as noted above. We are continuing our investigation of the TDS data for benzene, and will make the results available when the investigation is complete.

FDA is also continuing to follow up with companies to ensure that processing conditions are established that will ensure that benzene formation is avoided or minimized.

FDA believes that the results of CFSAN's recent survey indicate that the levels of benzene found in soft drinks do not pose a safety concern.

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FDA Letter to Environmental Working Group (March 21, 2006)

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