11/13/2009-Winston-Salem, NC-- Today, the FDA issued a request to the manufacturers of alcoholic energy drinks (AEDs) to produce in 30 days safety data related to adding caffeine and other stimulants to their products. The request resulted in part because of a campaign by Wake Forest University Baptist Medical Center emergency physician Mary Claire O'Brien, M.D., and a colleague who wrote a letter urging such action to the chairs of the Youth Access to Alcohol Committee of the National Association of Attorneys General.
Based on her research of alcoholic energy drinks and a thorough understanding of relevant government regulations, O'Brien fully supports today's move by the FDA. She is available today for interviews, by phone, in person, or by live satellite video uplink.
Alcoholic energy drinks, or caffeinated alcoholic beverages, are a class of alcoholic beverages to which are added caffeine and other stimulants, such as guarana, that are metabolized as caffeine. AEDs are a fast-growing segment of the alcoholic beverage marketplace, with surging sales and market growth, particularly among youth.
There has been a growing movement over the last year by several state attorneys general who have called upon the manufacturers of AEDs to take them off the market.
Research by O'Brien, associate professor of emergency medicine and public health sciences at Wake Forest University Baptist Medical Center, helped to bring the issue to light and has been cited in these states.
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 sexual assault and injury.
The FDA has not approved caffeine for any use at any level in alcoholic beverages, said O'Brien. A food additive is presumed "unsafe" unless its particular use has been approved by federal regulation or is generally recognized as safe, or "GRAS," under the conditions of its intended use.
Under the GRAS guidelines, the burden is on the manufacturer to prove that:
- an additive is safe for its intended use based on published scientific literature
- there is a consensus of scientific opinion regarding the safety of the use of the substance.
"Therefore, the FDA is now issuing a mandate to the manufacturers of these products to produce safety data. The burden of proof is on them, as it should be." O'Brien said. "We cannot say what action the FDA will take if the manufacturers are unable to produce safety data, but we believe the responsible thing to do would be to remove these products from the marketplace."
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