FDA Warns Drink Makers Mixing Caffeine, Alcohol
NOVEMBER 17, 2010, 2:48 P.M. ET
By DAVID KESMODEL
online.wsj.com
The U.S. Food and Drug Administration warned four makers of caffeine-infused malt beverages Wednesday that the products don't meet safety requirements, and it threatened to seize the drinks.
The agency sent warning letters to companies including United Brands Co., the maker of Joose, and Phusion Projects LLC, the maker of Four Loko, which earlier this week said it removed the caffeine in anticipation of federal action.
The FDA told the companies that they are marketing their products in violation of federal law and have 15 days to say how they will address the problem.
"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 Joshua M. Sharfstein, principal deputy commissioner, in prepared remarks. "To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern."
The move follows a series of highly publicized incidents in recent weeks in which underage drinkers and others turned up hospitalized after consuming Four Loko, a popular fruit-flavored drink. States including Michigan, Oklahoma and Washington responded by prohibiting the sale of premixed beverages blending caffeine and alcohol.
The FDA said its action follows a scientific review of peer-reviewed research into the combination of alcohol and caffeine, along with its own independent laboratory study.
Consumer-advocacy groups, physicians and others have raised concerns for several years that caffeine and other stimulants in the beverages may mask feelings of drunkenness, prompting drinkers to act recklessly, such as driving while intoxicated.
The other companies that received warning letters are Charge Beverages Corp. and New Century Brewing Co.
On Tuesday, Phusion Projects, the maker of Four Loko, announced that it is reformulating its beverages nationwide, removing caffeine and other stimulants. "We are taking this step after trying – unsuccessfully – to navigate a difficult and politically charged regulatory environment," the Chicago company said.
Malt beverages containing caffeine have been on the market for more than four years. Their labels and formulas were approved by the federal Alcohol and Tobacco Tax and Trade Bureau. Manufacturers of the products argue that they are little different than mixed drinks that people have consumed for years, such as rum-and-coke or Irish coffee, which is laced with whiskey. A number of vodka, whiskey and other alcohol products also contain caffeine.
In 2008, brewing giants Anheuser-Busch InBev NV and MillerCoors LLC agreed under pressure from state attorneys general to remove caffeine from drinks, including MillerCoors's Sparks. Soon thereafter, Four Loko and United Brands's Joose snared market share in the category, offering versions with flavors such as blue raspberry and watermelon with up to 12% alcohol.
Last year, the attorneys general and health-advocacy experts urged the FDA to take a hard look at the safety of the drinks. In November 2009 the agency asked manufacturers to submit evidence that the products were safe and began scientific studies.
Write to David Kesmodel at david.kesmodel@wsj.com
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