FDA Issues Warning to Four Loko, 3 Other Drink Makers

Nov. 17, 2010— -- The U.S. Food and Drug Administration issued warning letters to four companies Wednesday for adding caffeine to their malt alcoholic beverages, according to an agency press release. The letters identified caffeine as an "unsafe food additive" and said that further action -- including seizure of the caffeine-containing products -- is possible under federal law.

While not an outright ban, the FDA says 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 companies have 15 days to respond to the letters to inform the FDA what they are doing to bring their products into compliance with federal law. If the FDA still finds the companies in violation, the agency can seek injunctions to either remove products from store shelves or prevent the company from manufacturing the products.

The four companies cited in an FDA statement as receiving warning letters are:

Meanwhile, 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."

On Tuesday, a press statement from the office of U.S. Senator Charles E. Schumer presaged the action by the government agencies.

"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).

Also on Tuesday, the makers of the drink Four Loko, Chicago-based Phusion Projects, said they would remove caffeine-containing ingredients "after trying unsuccessfully to navigate a difficult and politically-charged regulatory environment at both the state and federal levels," in a statement posted on their website.

United Brands, the makers of Joose, said they will work closely with the FDA to meet federal regulations and said it will keep the drink's "high quality and natural flavors."

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."