The FDA has notified the makers of alcohol energy drinks, such as Joose and Liquid Charge, that they have 30 days to establish that adding caffeine to the alcohol is safe and legal. The request comes in response to health concerns expressed by the Attorney Generals of 18 different states and one city attorney about the safety of caffeinated alcoholic beverages.
A letter was sent to about 30 different companies last Friday by the FDA, warning that the regulatory agency is looking into the safety and legality of energy drinks with alcohol. The FDA indicates that under the Federal Food, Drug, and Cosmetic Act, adding caffeine to alcoholic beverages is deemed unsafe since it has not been approved.
Products targeted by the FDA include Smirnoff Raw Tea Malt Beverage by Diageo North America, Inc., Joose by United Brands Company, Inc., 24/7 by Mix Master Beverage Co., Liquid Charge by Charge Beverages Corp. and others. (See FDA List of Manufacturers of Caffeinated Alcoholic Beverages).
The manufacturers can avoid regulatory action against their products if they are able to prove that the alcohol energy drinks are lawfully marketed under a prior decision, or if they can show that the substance that was added is Generally Recognized As Safe (GRAS). To be considered GRAS, there must be evidence of the substances safety at the levels it is being used. There must also be a basis to conclude that the evidence is generally known and accepted by qualified experts.
The FDA says it is unaware of any basis that the companies who create caffeinated alcoholic beverages could have used to conclude that their products were legal, and the agency would like to see the rationale for their decisions to market the products.
The addition of caffeine is only currently approved and deemed safe in non-alcoholic soft drinks, at concentrations of 200 parts per million or less. The drinks targeted by the FDA warning are alcoholic beverages, and some of the drinks exceed that amount.
Alcohol energy drinks are heavily used by underage drinkers and college students, often involving binge drinking and other reckless behavior. A 2007 study by researchers from Wake Forest University found that mixing alcohol, a depressant, and caffeine, a stimulant, can cause the drinker to be unaware of how intoxicated they actually are. The study found that college students who mixed caffeine and alcohol were more likely to be hurt, injured, ride with an intoxicated driver, or take advantage of someone else sexually.
In October 2008, a group of one hundred scientists and physicians, led by a neuroscientist at Johns Hopkins School of Medicine, sent a petition to the FDA urging the agency to increase regulation of all energy drinks, including non-alcohol energy drinks, such as Red Bull, Rock Star, Monster and Full Throttle. The experts indicated that the wide disparity in caffeine and alcohol content in various brands of energy drinks is not properly noted on the products, increasing the risk of caffeine intoxication and alcohol-related injuries.
In recent years, some major beverage manufacturers decided to remove caffeinated alcoholic drinks from the market under an agreement with FDA. Both Anheuser-Busch and MillerCoors removed caffeine from Tilt, Sparks, and Bud Extra, and agreed not to market any other caffeinated alcoholic beverages.
A product liability lawsuit was filed against MillerCoors over Sparks last September by the Center for Science in the Public Interest, a consumer advocacy group. The Center charged that Sparks contained unauthorized additives and posed a safety and health risk to consumers. The lawsuit also alleged that Sparks was actively marketed to minors and other young people. Anheuser-Busch faced similar lawsuits from advocacy groups and state attorney generals before they pulled Tilt and Bud Extra.