Four Loko and Other Alcoholic Energy Drink Makers "Making Progress," Says FDA

Nov. 25, 2010— -- Just a week after issuing warning letters to four manufacturers of alcoholic energy drinks, the U.S. Food and Drug Administration announced the drink makers have made "significant progress" in complying with the agency's regulations.

Phusion Projects, the Chicago-based manufacturer of Four Loko, announced before receiving the FDA warning letter that it would remove caffeine-containing ingredients from their beverages. The company also said it will no longer ship its alcoholic energy drinks and would remove them from store shelves by December 13.

United Brands said it has stopped shipping its drink, Joose, and will also have products off store shelves by December 13. In addition, the company will no longer market Max, another beverage mentioned in the FDA's letter.

Charge Beverages and New Century Brewing told the FDA it will no longer manufacture any caffeinated alcoholic beverages, and Charge Beverages said it hasn't shipped any since early November.

The FDA issued warning letters to the companies after determining that caffeine is an "unsafe food additive." The letters also threatened further action if the companies did not comply.

While not an outright ban, the FDA said it's the first step in that direction.

"[It's] part of the process that FDA uses that leads to these products being removed from the market," said Dr. Joshua Sharfstein, the agency's principal deputy commissioner.

The Federal Trade Commission said in a statement that it also sent letters to the same four companies warning that marketing of the beverages may constitute an "unfair or deceptive practice that violates the FTC Act."

U.S. Senator Charles E. Schumer (D-N.Y.) issued a press statement before the letters were formally issued praising the FDA's action.

"Let these rulings serve as a warning to anyone who tried to peddle dangerous and toxic brews to our children. Do it and we will shut you down," said Schumer (D-NY).

The FDA warning letters come about a year after the FDA first decided to review the safety of caffeinated alcoholic beverages last November. The agency sent letters to about 30 manufacturers of these drinks alerting them of the review.

At the time the letters were sent, one of the issues the FDA said it planned to look into was whether it's legal to add caffeine to alcoholic beverages. Current regulations place significant restrictions on the addition of caffeine to beverages.

"The only way that caffeine is permitted to be added to beverages is to cola-type beverages in amounts not to exceed 200 parts per million, which is about twice the amount actually present in a can of Coca-Cola," said Dr. Mary Claire O'Brien, associate professor of emergency medicine at Wake Forest University Medical Center in Winston-Salem, NC.

"Though a lot of people are familiar with drinking a caffeinated beverage or an alcoholic beverage, few of them are familiar with drinking the combination," said Dr. Matthew Davis, associate professor of pediatrics and communicable diseases and an associate professor of public policy at the Ford School of Public Policy at the University of Michigan in Ann Arbor. "That combination is up to five beers at once in a single serving of a caffeinated alcoholic beverage and about the equivalent of one cup of coffee in terms of caffeine."