Attorney General Gansler Applauds FDA's Letters to Alcoholic Energy Drink Manufacturers Stating That Their Products Are Unsafe
MD ( Nov. 17, 2010) - Attorney General Douglas F. Gansler today applauded the U.S. Food and Drug Administration’s (FDA) issuance of warning letters to four manufacturers of alcoholic energy drinks (AEDs), that state that the caffeine in their alcoholic beverages, including popular brands Four Loko and Joose, are “unsafe food additives,” making these products adulterated under federal law.
“I am pleased that the FDA has taken the first step in what will ultimately lead to these dangerous products being removed from store shelves once and for all,” said Attorney General Gansler. “Today’s action by the FDA confirms what we have been telling the alcohol industry since the beginning of 2007 – these beverages are dangerous. AEDs attract young people who wrongly believe that the caffeine will offset the intoxicating effects of the alcohol. In fact, the caffeine in these products only mask, not offset, alcohol intoxication. I applaud the FDA’s issuance of warning letters rejecting the manufacturers’ unfounded claims that these products are safe.”
AEDs are alcoholic beverages to which caffeine and other stimulants, such as guarana, have been added at the point of manufacture. Packaged in 23.5 ounce cans resembling energy drinks with fruit flavors like Fruit Punch, Lemonade and Watermelon, some AEDs like Four Loko contain the alcohol equivalent of five or six beers and the caffeine equivalent of four to five colas or one to two cups of coffee in just one can.
Last year, Attorney General Gansler asked the FDA to determine that the use of caffeine in alcoholic beverages is not “Generally Recognized as Safe,” or “GRAS,” under FDA law (http://www.oag.state.md.us/Press/2009/111309.htm). Last November, the FDA informed manufacturers of AEDs that it was not aware of any basis for concluding that the use of caffeine in alcoholic beverages is GRAS and gave them 30 days to submit substantiating data, warning that if it determined that the use of caffeine in their alcoholic beverages is not GRAS, the FDA would take appropriate action to ensure that the products are removed from the marketplace. FDA’s warning letters issued today require that the manufacturers take prompt action to correct their violations of federal law, and that failure to do so may result in enforcement action.
Attorney General Gansler has been a leader in efforts to remove AEDs from the market since 2007 (http://www.oag.state.md.us/Press/2007/051107.htm). In 2008, Attorney General Gansler wrote to the Tobacco Tax and Trade Bureau (TTB), urging it to take immediate action to
investigate allegations that certain AEDs contained unsafe levels of caffeine (http://www.oag.state.md.us/Press/2008/022108.htm). In 2008, the Attorneys General initiated investigations of the two leading manufacturers of AEDs at that time: MillerCoors Brewing and Anheuser-Busch. The investigations concluded with the companies agreeing to cease production of their AEDs altogether (http://www.oag.state.md.us/Press/2008/062608.htm , http://www.oag.state.md.us/Press/2008/121808.htm). However, smaller AED manufacturers introduced products like Joose and Four Loko packaged in larger containers (up to 23.5 ounces) and containing a higher percentage of alcohol (up to 12% alcohol by volume).
Unfortunately, with increased consumption of these beverages among teens and college students, reports of alcohol poisoning, serious injury including sexual assault, and hospitalizations have become all too common. “Over the past few months hardly a day has gone by that we have not heard or seen a news report about teens or young adults seriously injuring themselves or others after consuming AEDs,” said Attorney General Gansler. “Sadly, here in Maryland, a young woman lost her life just last week after reportedly consuming one of these beverages. As the FDA’s letters make clear, there is simply no way to consume these beverages safely.”
Attorney General Gansler is working with State and local officials to determine the further steps necessary to ensure the prompt removal of these dangerous products from the marketplace.