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FDA Requires Proof of Safety for Alcoholic Energy Drinks

FDA Requires Proof of Safety for Alcoholic Energy Drinks

Chicago Tribune

WASHINGTON – Alcoholic energy drinks, marketed under provocative names such as Evil Eye, Max Fury and Slingshot Party Gel, have quickly gained a foothold among younger drinkers.

Now the producers of those beverages have a new, perhaps unwanted audience. The U.S. Food and Drug Administration on Friday said it will ask them for proof that their products, which blend caffeine and alcohol, are safe.

The FDA never has approved the addition of caffeine to an alcoholic beverage, and a task force of state attorneys general have urged the agency to scrutinize the combination. They argue that the caffeine can mask the intoxicating effects of alcohol, possibly leading to an increase in drunken driving, sexual assault and other destructive behavior.

In the absence of FDA approval, the burden of proving that a new combination of food or drink is safe falls on the manufacturer, said Joshua Sharfstein, the agency’s principal deputy commissioner.

“We’re asking for their side of the story,” Sharfstein said. “Why they consider adding caffeine (to alcoholic drinks) to be safe or legal. … They should have the evidence already and we’re just asking for that.”

Sharfstein said “the FDA has not reached a conclusion” about the drinks’ safety, “but we’ve heard some serious concerns.”

If the FDA determines that use of caffeine in the drinks is unsafe, it could force them off the market.

In a Sept. 25 letter to the FDA, the attorneys general task force said that “there is a strong emerging consensus of scientific opinion that the combination of caffeine and alcohol … poses a serious public health risk.”

“The ultimate goal is a nationwide ban on alcohol energy drinks marketed to young drinkers,” said Connecticut Attorney General Richard Blumenthal, a co-chair of the task force.

The task force also includes the attorneys general of California, Illinois, New York and 14 other state, territorial and city chief law enforcement officials.

Drink makers have 30 days to respond to the FDA request.

“It’s way past the time these products should have been pulled,” said Michele Simon, research and policy director at the Marin Institute, an alcohol watchdog group. “I can’t imagine what these companies could come up with to satisfy the FDA’s request.”