Last November, the FDA warned almost 30 beverage companies that produce alcoholic energy drinks that the agency would be investigating their safety and legality. Now a year later, the FDA has sent out new letters to four of these companies notifying them that adding caffeine to alcohol was unsafe and unapproved. In addition, the Treasury Department announced that these products cannot be legally shipped due to their mislabeling.
“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,” the FDA’s principal deputy commissioner, Joshua M. Sharfstein, said in a statement yesterday.
Phusion Projects, maker of the controversial mixed alcohol-energy drink Four Loko, is voluntarily ceasing sales of the beverage in New York and will remove caffeine, taurine and guarana from the list of ingredients used. Four Loko contains 12 percent alcohol by volume, and drinking one can is equivalent to consuming five beers and a cup of coffee. The company’s managing partners, however, still maintain that an alcohol and caffeine combination is safe. “If it were unsafe, popular drinks like rum and colas or Irish coffees...would face the same scrutiny that our products recently faced,” they said in a statement yesterday.
“Is there medical or scientific data that this combination is more harmful than drinking the caffeine and alcohol separately? Why is the government involved in the discussion absent scientific evidence that this combination is particularly toxic?” questions ACSH's Dr. Gilbert Ross. “Even though I agree with Phusion Project’s reasoning, I think it will be extremely difficult to successfully contest this dictum by the FDA, and I believe the agency is reacting due to media and political pressure.”