The FDA issued a letter Friday to 30 beverage manufacturers, giving them 30 days to provide evidence that the combination of caffeine and alcohol is safe.
"Today the FDA has listed caffeine only as an ingredient for use in soft drinks," said Deputy Commissioner Dr. Joshua Sharfstein. "The agency has not approved caffeine for use in alcoholic beverages."
FDA officials stressed they have not reached a conclusion about the safety of beverages like Joose and Charge. Instead they are questioning the companies' legal rationale for marketing the products.
"There are some unusual safety questions raised by the addition of caffeine to these alcoholic beverages," said FDA special adviser Mike Taylor. "So the burden is on the companies to provide evidence that supports the conclusion this use is safe."
The FDA decided to take action at the urging of state attorneys general from New York, California, Maryland and 14 other states, who contend the drinks appeal to underage drinkers and encourage reckless behavior. Young adults already are the primary demographic for marketing of highly caffeinated drinks like Red Bull.
In their letter to the FDA, the attorneys general say caffeine can mask the effects of alcohol, leading to "increased risk-taking and other serious alcohol related problems such as traffic accidents, violence, sexual assault and suicide."
Larger brewers like Anheuser-Busch already have removed caffeine from their alcoholic energy drinks. Remaining manufacturers include smaller firms like Los Angeles-based Joose Beverage and Portland, Ore.-based Charge Beverages.
Calls placed to those companies Friday were not immediately returned. Other companies receiving the FDA letter include: Mix Master Beverage Co. of Stateline, Nev., Blank Beverages Co. of San Diego, Calif., and Phusion Projects LLC of Chicago.
The market for caffeinated alcoholic drinks is about 1 percent of the total beer industry, making its annual sales about $1 billion, said Eric Shepard, executive editor of trade publication Beer Marketer's Insights.
The companies could challenge the FDA request by noting that their products already were approved by the Alcohol and Tobacco Tax and Trade Bureau, Shepard said.
However, a spokesman for the Treasury Department bureau said its regulators fully support the FDA action.