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FDA Issues Warning Letters to Four Manufacturers of Caffeinated Alcoholic Beverages

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Center for Food Safety and Applied Nutrition - Food and Drug Administration

November 17, 2010

These Beverages Present a Public Health Concern

On November 17, 2010, FDA warned four companies that the caffeine added to their alcoholic malt beverages is an "unsafe food additive" and that the products named in the Warning Letters are being marketed in violation of the Federal Food, Drug, and Cosmetic Act. Further action, including seizure of their products, is possible under federal law.
 
The companies receiving Warning Letters and their products are:
  • Charge Beverages Corporation, which makes “Core High Gravity HG Green”, “Core High Gravity HG Orange”, and “Lemon Lime Core Spiked;”
  • New Century Brewing Company, LLC, which makes “Moonshot;”
  • Phusion Projects, LLC (doing business as Drink Four Brewing Company), which makes “Four Loko;” and
  • United Brands, which makes “Joose” and “Max.” 

FDA’s action follows a scientific review by the Agency. FDA examined the published peer-reviewed literature on the co-consumption of caffeine and alcohol, consulted with experts in the fields of toxicology, neuropharmacology, emergency medicine, and epidemiology, and reviewed information provided by product manufacturers. FDA also performed its own independent laboratory analysis of these products.

Other alcoholic beverages containing added caffeine may be subject to FDA action in the future if the available scientific data and information indicate that the use of caffeine in those products is not generally recognized as safe (GRAS).

Additional information about caffeinated alcoholic beverages can be found at http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm190366.htm.