Washington State Attorney General Rob McKenna congratulated the US Food and Drug Administration (FDA) today for acting on the request of attorneys general from around the country to restrict some of the most dangerous alcoholic products targeted toward young adults.
In a news conference today featuring representatives from a number of federal agencies as well as Iowa Attorney General Tom Miller, the FDA announced it found that alcoholic energy drinks – high-proof alcohol packed with caffeine and other stimulants – are not recognized as safe. The agency issued warning letters to four manufacturers of alcoholic energy drinks (AEDs), stating, “As it is used in your products, caffeine is an unsafe food additive.”
The manufacturers include:
• New Century Brewing Co. – manufacturer of the product, “Moonshot”
• United Brands Company, Inc. – manufacturer of the products, “Joose” and “Max”
• Charge Beverages Corporation – manufacturer of the products, “Core High Gravity HG Green,” “Core High Gravity HG Orange,” and “Lemon Lime Core Spiked”
• Phusion Projects Inc. – manufacturer of the product, “Four Loko.”
The FDA’s warning letters give the manufacturers 15 days to respond in writing and inform FDA of the specific steps that each will take to remedy the violation and prevent its recurrence.
“We’re grateful to the FDA for recognizing that, as witnessed in Washington state and across the country, alcoholic beverages pre-mixed with caffeine and other stimulants create a dangerous combination,” McKenna said. “ State attorneys general have long believed that these potentially lethal products were created for those too young to understand the dangers—and that caffeine as an additive to alcohol was never authorized under laws to protect public health.”
Under the Federal Food, Drug, and Cosmetic Act, a food additive is unsafe and unlawful unless its use has been approved by the FDA or if there is evidence, generally known and accepted by qualified experts, that it’s safe.
Last year, McKenna joined other state attorneys general in a letter 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 of these beverages, whose caffeine and other stimulant ingredients mask – but do not offset – intoxication.
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 contain the alcohol equivalent of five or six beers and the caffeine equivalent of as many as two cups of coffee in just one can.
“In our letter to FDA, we expressed concern there is no common understanding or consensus among qualified scientific experts supporting the safety of adding caffeine to alcoholic beverages,” McKenna said. “On the contrary, we found there was a strong, emerging consensus of scientific opinion, confirmed by studies published in the past year, that the combination of caffeine and alcohol in AEDs is not safe and poses a serious public health risk.”
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 the manufacturers 30 days to submit substantiating data. The FDA warned that if it determined that the use of caffeine in 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.
“We’re pleased the FDA conducted detailed research and took the necessary steps to restrict these dangerous beverages from the marketplace,” McKenna said. “AEDs trade on the popularity of non-alcoholic energy drinks to attract young people who wrongly believe that the caffeine will offset the intoxicating effects of the alcohol.
“Fueled by aggressive youth-targeted marketing campaigns on social network sites and college campuses, these companies promote excessive drinking and enhanced abilities,” McKenna said. “Unfortunately, with increased consumption of these beverages among teens and college students, reports of alcohol poisoning, serious injuries, sexual assaults and hospitalizations have become all too common. The FDA was right to issue warning letters rejecting the manufacturers’ unfounded claims that these products are safe.”
McKenna and other members of the National Association of Attorneys General (NAAG) Youth Access to Alcohol Committee have taken previous actions regarding AEDs.
• In 2007, 30 attorneys general, including McKenna, urged the federal Alcohol and Tobacco Tax and Trade Bureau to stop alcohol manufacturers from making misleading health-related statements when advertising alcoholic beverages combined with caffeine or other stimulants.
• In 2008, McKenna and 24 state AGs pressed MillerCoors Brewing to drop Sparks Red, an energy drink with boosted alcohol content. The same year, several AGs launched investigations of MillerCoors and Anheuser-Busch, two major producers of AEDs.
McKenna is working with the state Liquor Control Board (LCB) , local and college officials to ensure the prompt removal of these dangerous products from the marketplace and to help educate young people and the community as a whole about the dangers of self-mixed as well as pre-mixed alcoholic energy drinks. On Nov. 10, the state LCB issued an emergency rule banning the sale of AEDs in Washington effective Nov. 18.
