Urethane in Alcoholic Beverages under Investigation

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The Food and Drug Administration is carefully evaluating studies to determine if there could be a long-term health risk to consumers from urethane in alcoholic beverages.

Urethane is a chemical substance that forms naturally during the fermentation process. It causes cancer in animals, but it is not known if it poses any significant health risk to humans. Based on data currently available, FDA does not believe that urethane levels in alcoholic beverages currently on the market are an immediate short-term health risk.

Until all scientific research is completed and evaluated, and regulations established, FDA is working with industry to reduce any potential risk to humans from urethane and is participating in tests to find out if the small amounts of urethane present in alcoholic beverages might be harmful.

Industry has voluntarily agreed to develop and use manufacturing techniques to reduce urethane's levels as much as possible. The Distilled Spirits Council of the United States (DISCUS), the American Association of Vintners, and the Wine Institute have told FDA they are studying how urethane forms during fermentation and are changing manufacturing processes to control its formation in alcoholic beverages.

FDA and the Bureau of Alcohol, Tobacco and Firearms (ATF) have done limited surveys of the urethane content in alcoholic beverages, and FDA has evaluated existing urethane toxicity dam. In addition, at FDA's request, the National Toxicology Program, a federally funded research group, has done an initial study in animals to help FDA determine if urethane in alcohol poses a significant risk to humans.

Follow-up studies are not complete, …