What action has been taken at the Federal level to address the health and safety concerns associated with AEDs?
On November 13, 2009, the Food and Drug Administration (FDA) issued a notification to nearly 30 manufacturers of AEDs. This letter indicated the manufacturers would have 30 days to produce evidence that adding caffeine to alcohol in their product is Generally Recognized as Safe (GRAS) or has been subject to a prior sanction. At this time, the FDA has only approved caffeine as an additive to cola-type beverages with a concentration of no more than 200 parts per million. There are no food additive regulations that allow the addition of caffeine to alcoholic beverages.
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