Makers of alcoholic energy drinks get FDA warning

The U.S. Food and Drug Administration issued warning letters Wednesday to four manufacturers of alcoholic energy drinks, saying the caffeine is an "unsafe food additive."

The combination of caffeine and alcohol in the drinks creates a public health concern and can lead to "a state of wide-awake drunk," said FDA Commissioner Margaret Hamburg.

Consumption of the drinks has been associated with alcohol poisoning and cases of risky or aggressive behaviour that has resulted in car accidents and assaults, she said.

The government could eventually seize the products if the companies continue to make and market them. The companies have 15 days to respond to the letters and either explain how they will take their products off the market or defend their drinks as safe.

Several college students have been hospitalized in recent months after consuming the drinks. The FDA said experts have raised concerns that the caffeine in the drinks can mask a person's feeling of intoxication, leading to risky behavior. Many of those who consume the drinks are underage drinkers.

In response to such incidents, four states have banned the beverages, and others are considering similar action.

Phusion Projects to remove caffeine

With the FDA decision imminent, Phusion Projects, which manufactures the popular Four Loko, announced late Tuesday that it would reformulate its drinks and remove the caffeine.

The company's statement said it was altering the drinks after unsuccessfully trying to deal with "a difficult and politically charged regulatory environment at both the state and federal levels."

"We have repeatedly contended — and still believe, as do many people throughout the country — that the combination of alcohol and caffeine is safe," said Chris Hunter, Jeff Wright and Jaisen Freeman, who identify themselves as Phusion's three co-founders and current managing partners.

The FDA said it views the Phusion Projects announcement as a positive step, but officials said they have not yet heard directly from the company about its timeline for taking the drinks off the market.

The FDA also issued warning letters to Charge Beverages Corp., New Century Brewing Co. and United Brands Company Inc.

Last year, the FDA notified more than two dozen manufacturers of caffeinated alcoholic beverages that it never had specifically approved the addition of caffeine to alcoholic drinks and that it was studying whether it was unsafe and should be outlawed.

The agency noted the mix's growing popularity among college students and its potential health and safety issues.

Wednesday's letters focused on seven drinks made by four manufacturers, but Deputy Commissioner Josh Sharfstein said he expects the agency's message to resonate beyond those brands.

"We expect these warning letters to be read across the industry," he said.