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FDA Investigates Safety of Caffeinated Alcoholic Beverages

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By: Sean Moloughney

Editor, Nutraceuticals World

FDA is considering whether caffeine can lawfully be added to alcoholic beverages. The agency recently notified nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to investigate the safety and legality of their products. Under the Federal Food, Drug and Cosmetic Act, a substance added intentionally to food (such as caffeine in alcoholic beverages) is deemed “unsafe” and is unlawful unless its particular use has been approved by FDA regulation, the substance is subject to a prior sanction or the substance is Generally Recognized As Safe (GRAS). FDA has not approved the use of caffeine in alcoholic beverages, and so these beverages can be lawfully marketed only if their use is subject to a prior sanction or GRAS. To date, FDA has only approved caffeine as an additive for use in soft drinks in concentrations of no greater than 200 parts per million.

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