FDA sends letters to alcoholic energy drink manufacturers stating that their products are unsafe
(WASHINGTON, D.C.) Attorney General Tom Miller joined the U.S. Food and Drug Administration (FDA) in announcing the issuance of warning letters today to four manufacturers of alcoholic energy drinks (AEDs). The warning letters 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.
“What a terrible product. It’s a product that provides caffeine and alcohol in a way that masks its effects, so the unsuspecting person drinks far more than they should. What an awful product,” Miller said.
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 1.5 to two cups of coffee in just one can.
“On the state level we’ve felt for some time that caffeinated alcoholic drinks are inherently unsafe,” Miller said. “And I say what a bold move, what an effective move today by the FDA. We appreciate it.”
Last year, Miller joined other state attorneys general and the San Francisco city attorney in asking the FDA to determine that the use of caffeine in alcoholic beverages is not ‘Generally Recognized as Safe,’ or ‘GRAS,’ under FDA law. In support of that request, the Attorneys General submitted a report by experts in medicine, forensic toxicology, and public health documenting the dangers presented by these beverages, whose caffeine and other stimulant ingredients mask -- but do not offset -- alcohol intoxication.
Last November, FDA informed manufacturers of AEDs that FDA 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, FDA would take appropriate action to ensure that the products are removed from the marketplace. Over the past year, medical and public health research has continued to confirm the dangers presented, particularly among young people with whom these beverages are most popular.
Today’s action represents a significant and necessary step forward in removing these dangerous products from Iowa store shelves and the nation’s store shelves once and for all,” said Miller. “AEDs attract young people who wrongly believe that the caffeine will offset the intoxicating effects of the alcohol. This is a bold act in the public interest, and in the interest of young people of Iowa and this country, which I view as extremely important.”
Miller and other members of the National Association of Attorneys General (NAAG) Youth Access to Alcohol Committee have taken previous actions regarding AEDs. In 2008, 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 caffeinated alcoholic beverages altogether. However, smaller AED manufacturers introduced products packaged in larger containers (up to 23.5 ounces) and containing a higher percentage of alcohol (up to 12% alcohol by volume.
FDA’s warning letters 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.