The agency has warned four companies that the caffeine added to their malt alcoholic drinks is an “unsafe food additive” and threatened product seizures if appropriate action is not taken. The companies concerned are Charge Beverages Corp, New Century Brewing Co., Phusion Projects and United Brands Company.
Warning letters are being sent out following a scientific review conducted by the FDA on the co-consumption of caffeine and alcohol.
The review, which itself comes after the FDA asked manufacturers last November to provide evidence on the safety of their products, raised serious concerns about caffeinated alcoholic drinks. In particular, it questioned how they affect the ability of drinkers to judge their level of intoxication.
The FDA said peer-reviewed studies suggest that caffeinated alcoholic drinks can lead people to take risks that may be hazardous or life threatening.
It has therefore concluded that the use of caffeine in the products made by the four companies mentioned is not ‘generally recognised as safe’ (GRAS).
“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.”
This does not add up to an outright ban on caffeinated alcoholic drinks but it does set a precedent for other manufacturers looking to combine alcohol and caffeine.
The FDA said: “Other alcoholic beverages containing added caffeine may be subject to agency action in the future if the available scientific data and information indicate that the use of caffeine in those products is not GRAS.”
In the meantime, for the four companies that have received warning letters, they have 15 days to respond. If the FDA believes that a violation of the Federal Food, Drug, and Cosmetic Act (FFDCA) has continued it may then take enforcement action which could include product seizures or an injunction to halt production.
Phusion Projects, the maker of Four Loko, has already announced that it will be removing caffeine from its alcoholic drinks. But in a statement released earlier this week, Phusion said it is taking the voluntary despite its belief that its products are safe.
Co-founder and managing partner Jaisen Freeman said: “We still believe that combining caffeine and alcohol is safe - if that weren't the case, Irish coffees and rum and colas would be under scrutiny as well. But we want our company to be known for cooperation and collaboration, not controversy.”