Following the news of at least one death linked to consumption of a caffeinated alcoholic beverage and the ban of the products by four states, the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued simultaneous warnings on Nov. 17 to four makers of the popular college-campus beverages.  The FDA’s warning focused on the formulation of the products, while the FTC questioned how these drinks are being marketed to consumers, specifically “young, inexperienced drinkers.”

The FDA told companies—which sell Four Loko, Joose, Core Spiked, Moonshot and other caffeine-spiked alcoholic drinks—that caffeine added to malt beverages is an unsafe food additive. “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.”

The companies have 15 days to respond to the FDA, explaining how they will remove the products from market or why they are safe. The agency warned the companies that further action, including seizure of their products, is possible under federal law.

In its warning, the FTC said the caffeinated alcohol drinks present “unusual risks to health and safety” and that the marketing of such products may constitute an unfair or deceptive practice that violates the FTC act. “Consumers might mistakenly assume that these beverages are safe because they are widely sold,” said David Vladeck, Director of the FTC’s Bureau of Consumer Protection.  “In fact, there is good reason to believe that these caffeinated alcohol drinks pose significant risks to consumer health and safety.  Consumers – particularly young, inexperienced drinkers – may not realize how much alcohol they have consumed because caffeine can mask the sense of intoxication.”