The FDA today issued warning letters to four companies that make caffeinated alcoholic beverages. This came nearly a year after the agency asked 30 manufacturers to provide their rationale, and supporting data and information, for concluding that their use of caffeine in an alcoholic beverage is GRAS (generally recognized as safe) or prior sanctioned.
“FDA does not find support for the claim that the addition of caffeine to these alcoholic beverages is ‘generally recognized as safe,’ which is the legal standard,” said Dr. Joshua M. Sharfstein, Principal Deputy Commissioner. “To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern.”
According to the FDA, its action follows a scientific review by the Agency. FDA examined the published peer-reviewed literature on the co-consumption of caffeine and alcohol, consulted with experts in the fields of toxicology, neuropharmacology, emergency medicine, and epidemiology, and reviewed information provided by product manufacturers. FDA also performed its own independent laboratory analysis of these products.
Although the warning letters were sent to only four companies who did not respond to the agency's letter last year that asked for the safety data, it appears that the agency is on the path to ban all caffeinated alcoholic beverages.
