PrintFDA Warns Makers of Caffeinated Alcoholic Drinks
December 3, 2010
The U.S. Food and Drug Administration (FDA) has sent warning letters to four companies that make drinks containing caffeine and alcohol, declaring that caffeine is an "unsafe food additive" in alcoholic drinks. The letters warn that further action, including seizure of their products and prosecution against the manufacturers, may occur.
The drink makers create products like Four Loko (made by Phusion Projects), Moonshot (New Century Brewing Co.), Joose (United Brands Co.) and Core High Gravity HG (Charge Beverages Corp.). News reports have linked these caffeine-alcohol drinks—some of which contain 12% alcohol—with a number of accidents, assaults and hospitalizations nationwide.
"[The] 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 FDA official Joshua M. Sharfstein in a news release. "To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern."
One manufacturer, Phusion Projects, has announced that it will remove caffeine and other stimulants from Four Loko, despite insisting that its products are safe. "We are taking this step after trying—unsuccessfully—to navigate a difficult and politically-charged regulatory environment at both the state and federal levels," a company news release states. "We have repeatedly contended—and still believe, as do many people throughout the country—that the combination of alcohol and caffeine is safe."
Medical experts, however, have expressed concern that caffeine mixed with alcohol is a uniquely dangerous combination. The website for the Centers for Disease Control and Prevention (CDC) states: "When alcoholic beverages are mixed with energy drinks, a popular practice among youth, the caffeine in these drinks can mask the depressant effects of alcohol...Drinkers who consume alcohol mixed with energy drinks are three times more likely to binge drink...than drinkers who do not report mixing alcohol with energy drinks."
In October 2010, nine students at Central Washington University in Ellensburg, Washington, were hospitalized after consuming Four Loko, according to news reports: their blood alcohol levels were as high as 0.35%. The drink, sometimes referred to as "Blackout in a Can," is now banned in Washington state, as well as in New York, Michigan, Oklahoma and other states.
Sources: FDA news release; CDC: Caffeinated Alcoholic Beverages Fact Sheet; and Phusion Projects news release
