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Federal Drug Administration Initiates Investigation of AEDs

On November 13, 2009, the Federal Food and Drug Administration notified 27 AED manufacturers that it was initiating an investigation of the safety and legality of their products.

In its letter to the manufacturers, the FDA noted that it had not previously approved adding caffeine to alcohol products. Under its regulations this practice is therefore permitted only if it is determined to be Generally Recognized As Safe (GRAS). The agency requested that the manufacturers provide supporting data and information to meet the GRAS standards within 30 days. The letter concluded that if the manufacturers failed to meet the GRAS standards, the FDA “will take appropriate action to ensure that [the AED in question] will be removed from the marketplace.”

The FDA stated that its action was prompted in part by a letter it received from 18 State Attorneys General and one city attorney expressing concerns about AEDs. The Attorneys General included a letter from five eminent scientists and health professionals reviewing the available research literature on the health and safety risks associated with combining caffeine and alcohol.

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