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NewsNovember, 2009 U.S. Department of Heath & Human Services; Food and Drug Administration Agency notified nearly 30 Manufacturers of caffeinated alcoholic beverages that it intends to look into 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).
The FDA requested that, within 30 days, the companies produce evidence of their rationale, with supporting data and information, for concluding that the use of caffeine in their product is GRAS or prior sanctioned. FDA's letter informed each company that if FDA determines that the use of caffeine in the firm's alcoholic beverages is not GRAS or prior sanctioned, FDA will take appropriate action to ensure that the products are removed from the marketplace. |
FDA has not approved the use of caffeine in alcoholic beverages and thus such beverages can be lawfully marketed only if their use is subject to a prior sanction or is GRAS. For a substance to be GRAS, there must be evidence of its safety at the levels used and a basis to conclude that this evidence is generally known and accepted by qualified experts.