FDA Issues Warning Letter: Caffeinated Alcoholic Beverages

[Missouriwatcher]

NOV. 17, 2010 The U.S. Food and Drug Administration today warned four companies that the caffeine added to their malt alcoholic beverages is an ?unsafe food additive? and said that further action, including seizure of their products, is possible under federal law.

The companies receiving Warning Letters and their products are:
? Charge Beverages Corp.: Core High Gravity HG, Core High Gravity HG Orange, and Lemon Lime Core Spiked
? New Century Brewing Co., LLC: Moonshot
? Phusion Projects, LLC (doing business as Drink Four Brewing Co.): Four Loko
? United Brands Company Inc.: 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.

?FDA does not find support for the claim that the addition of caffeine to these alcoholic beverages is ?generally recognized as safe,? which is the legal standard,? said Dr. Joshua M. Sharfstein, Principal Deputy Commissioner. ?To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern.?

Experts have raised concerns that caffeine can mask some of the sensory cues individuals might normally rely on to determine their level of intoxication. The FDA said peer-reviewed studies suggest that the consumption of beverages containing added caffeine and alcohol is associated with risky behaviors that may lead to hazardous and life-threatening situations...

FDA?s action today follows a November 2009 request to manufacturers to provide information on the safety of adding caffeine to their products.

FDA is aware that on November 16, Phusion Projects, LLC, the maker of Four Loko, announced its intention to remove caffeine and other stimulants from its drinks. FDA views this announcement as a positive step. FDA has not yet heard officially from the company about this announcement, including how quickly it will remove present product from circulation and how quickly it will reformulate its product. FDA intends to work with Phusion Projects, LLC and the other manufacturers to assure their products meet safety standards...
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm234109.htm
http://www.fda.gov/Food/FoodIngredientsPackaging/ucm190366.htm

 

[Missouriwatcher]

Re: FDA Issues Warning Letter: Caffeinated Alcoholic Beverages

Update on Caffeinated Alcoholic Beverages
Since issuing the Warning Letters, the FDA has had discussions with all four companies. As a result of those discussions, significant progress has been made.

Phusion Projects has advised the FDA that it has ceased producing caffeinated alcoholic beverages, is no longer shipping such products, and expects to have all of its caffeinated alcoholic beverages off retail store shelves by December 13. Phusion Projects is the maker of Four Loko.

United Brands has informed FDA that it has ceased shipping its caffeinated alcoholic beverage Joose and, similarly, expects to have its product off retail store shelves by December 13. United Brands also informed FDA that it no longer markets Max, another caffeinated alcoholic beverage listed in the Warning Letter.

Charge Beverages has notified FDA that it ceased producing its caffeinated alcoholic beverages, Core High Gravity HG, Core High Gravity HG Orange, and Lemon Lime Core Spiked, in September and has not shipped any caffeinated alcoholic beverages since early November.

New Century Brewing has advised the FDA that it has ceased manufacturing its caffeinated alcoholic beverage, Moonshot.
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm234900.htm