Wake Forest Baptist Researcher Hopes for FDA Action

November 12, 2010

Alcoholic energy drinks have been making national headlines and four states to date have banned their sale following reports of blackouts and unsafe behaviors, especially among college students. These actions are encouraging to Wake Forest University Baptist Medical Center emergency physician Mary Claire O’Brien, M.D., who conducted groundbreaking research into the dangers of the manufactured drinks.

The addition of caffeine to alcohol has never been approved by the Food and Drug Administration (FDA). Last year the FDA issued a mandate to the manufacturers of alcoholic energy drinks (AEDs) to produce safety data related to adding caffeine and other stimulants to their products. O’Brien applauds the FDA investigation but is frustrated by its lengthy delay in recalling these products.

“Manufactured alcoholic energy drinks are dangerous, and because they are cheap, they attract young drinkers,” said O’Brien, associate professor of emergency medicine and public health sciences at Wake Forest Baptist. “Caffeine has the ability to mask the affects of alcohol; it impairs the ability of the drinker to tell that they are drunk. The caffeine permits the drinker to be stimulated and stay awake in order to drink more, well beyond the amount they would otherwise be able to tolerate if they were only drinking alcohol. But an awake drunk is still drunk.”

Alcoholic energy drinks, or caffeinated alcoholic beverages, are a class of alcoholic beverages that have added caffeine and other stimulants, such as guarana, which metabolize as caffeine. AEDs are a fast-growing segment of the alcoholic beverage marketplace, with surging sales and market growth, particularly among youth. Just this week, several students at St. Joseph’s University in Philadelphia were hospitalized after consuming Four Loko, a caffeinated malt beverage containing 12% alcohol and the same amount of caffeine as a cup and a half of coffee. The same product made headlines last month after nine Central Washington University students who consumed it at a party were hospitalized after either blacking out or becoming seriously sickened. Similar problems with caffeinated alcohol have been reported recently in dozens of college newspapers.

Over the last couple of years, there has been a growing national movement among state attorneys general, law enforcement agencies, college and university officials, and public health groups, who have called upon the manufacturers of AEDs to take them off the market. A food additive is presumed “unsafe” unless its particular use has been approved by federal regulation or is generally recognized as safe under the conditions of its intended use, said O’Brien.

“In combination with alcohol, caffeine is not generally recognized as safe, and it has never been approved for use in manufactured drinks other than in colas,” she said. Therefore, she adds, the burden of proof is on the manufacturer to prove that it is safe for its intended use based on published scientific literature.

O’Brien’s research found that college students who reported consuming alcohol mixed with energy drinks also had significantly higher prevalence of alcohol-related consequences such as riding with a drunken driver, sexual assault, and serious injury. Last year she was part of a group of experts who reviewed the existing scientific literature on caffeinated alcohol, determining that “there is no scientific consensus that these products are safe,” she said.

The safety issue of AEDs is also being raised overseas. On Nov. 9, O’Brien participated in a news briefing via teleconference for Scottish Parliament. Scotland’s Shadow Health Secretary Jackie Baillie has called for support of a bill amendment that would impose limits there on the amount of caffeine that may be added to alcohol.

“There is no law and no precedent that permits the addition of caffeine to alcohol, period,” O’Brien said. “There is no science out there to support that it is safe to add caffeine to manufactured alcoholic products.”

Media Relations

Bonnie Davis: bdavis@wakehealth.edu, 336-713-1597