Attorney General Janet T. Mills Applaud's FDA's Letters to Alcoholic Energy Drink Manufacturers Stating that Their Products are Unsafe

November 17, 2010

Contact: Kate Simmons 207) 626-8577

Maine Attorney General Janet T. Mills Applauds FDA?s Letters to Alcoholic Energy Drink Manufacturers Stating That Their Products Are Unsafe

Augusta - Attorney General Janet T. Mills applauded the U.S. Food and Drug Administration?s (FDA) issuance of warning letters today to four manufacturers of alcoholic energy drinks (AEDs) stating that the caffeine in their alcoholic beverages, including the popular brands ?Four Loko? and ?Joose,? are ?unsafe food additives,? making these products adulterated under federal law.

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 5 or 6 beers and the caffeine equivalent of 4 to 5 colas or 1.5 to 2 cups of coffee in just one can.

Last year, Attorney General Mills 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, the FDA informed manufacturers of AEDs that the Administration 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. 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.

?Following the FDA?s year-long review, today?s action represents a significant step forward in removing these dangerous products from the market once and for all,? said Attorney General Mills. ?By trading on the popularity of non-alcoholic energy drinks, AEDs attract young people who wrongly believe that the caffeine will offset the intoxicating effects of the alcohol. These beliefs are fueled by aggressive youth-targeted marketing campaigns on social network sites and activities that promote excessive drinking. I applaud the FDA?s issuance of warning letters rejecting the manufacturers? unfounded claims that these products are safe.?

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 college students somewhere in this country seriously injuring themselves or others after consuming AEDs, most often Four Loko,? said Attorney General Mills. ?As FDA?s letters make clear, there is no way to consume these beverages safely.?

Attorney General Mills 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).

The 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.

Mills noted that these drinks are classified as ?distilled spirits? in Maine and cannot be sold as a malt beverage or beer. Therefore, can only be sold in stores that are allowed to sell liquor. For this reason, these products are not as prevalent in Maine as in other states.