The U.S. Food and Drug Administration is expected to rule this week that caffeine is an unsafe food additive to alcoholic beverages, Sen. Chuck Schumer (D-NY) announced Tuesday.

The agency’s ruling will effectively prohibit the sale of controversial alcoholic energy drinks in the United States.  Schumer also announced that the Federal Trade Commission (FTC) plans to notify manufacturers that they are engaged in the potential illegal marketing of unsafe alcoholic drinks.

Late Tuesday, Phusion Projects, one of the drink makers most under scrutiny, announced  it will remove caffeine, guarana and tuaurine from its products nationwide.  According to a statement, it will produce only a non-caffeinated version of its Four Loko brand going forward.

“We are taking this step after trying – unsuccessfully – to navigate a difficult and politically-charged regulatory environment at both the state and federal levels,” the statement said.

Four Loko has been at the center of the storm brewing around alcoholic energy drinks.  In the past several weeks, the popular fruit-flavored malt liquor, widely known as “black-out in a can,” has been linked to hospitalizations and even deaths.

Oklahoma, Michigan, Utah, and Washington have all imposed bans on beverages that combine stimulants with alcohol.  Last week, the New York State Liquor Authority and that state’s largest beer distributors agreed to stop selling the drinks.

A number of colleges and universities, including the University of Washington, Ramapo College, Worcester State University, the University of Rhode Island and the Wentworth Institute of Technology have also taken action to limit access to the drinks.

“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.  He said the federal ruling “should be the nail in the coffin of these dangerous and toxic drinks.  Parents should be able to rest a little easier knowing that soon their children won’t have access to this deadly brew.”

Michele Simon, research and policy director of the Marin Institute and author of “Appetite for Profit: How the Food Industry Undermines Our Health and How to Fight Back,” applauded the pending FDA crackdown.

“We are thrilled that at long last FDA is taking action, and we welcome FTC action, which is also long overdue,” she said. “But even with these two agencies taking these important steps, we still need states to continue to use their regulatory and statutory authority to get the products off the market because we do not know how far the federal government will go to get the job done.

Simon noted that the Marin Institute has maintained since 2007 that these products contain illegal additives and that they are being deceptively marketed to youths.

Schumer’s statement cited a recent study which found that young and underage drinkers who combine alcohol with caffeine are more likely to suffer injury, be the victim of sexual assault, drive while intoxicated, and require medical attention than drinkers who consume caffeine-free beverages.

“In 2008, Anheuser-Busch InBev NV and MillerCoors LLC reformulated caffeinated alcoholic beverages under pressure from several states and regulatory bodies, but smaller companies like the manufacturers of Four Loko and Joose managed to remain unnoticed,” Schumer said.

Even as it announced it would reformulate Four Loko, its signature drink, Phusion Projects insisted that its pre-mixed beverages are no different than rum and coke or other traditional drinks that fuse alcohol and caffeine.

“We have repeatedly contended – and still believe, as do many people throughout the country – that the combination of alcohol and caffeine is safe,” read its statement. “[I]f our products were unsafe, we would not have expected the federal agency responsible for approving alcoholic beverage formulas – the Tobacco Tax and Trade Bureau (TTB) – to have approved them.   Yet, all of our product formulas and packaging were reviewed and approved by the TTB before being offered to consumers.”

FDA has not issued a statement regarding its decision on the matter.  Spokesman Sebastian Cianci told Food Safety News Tuesday that the agency is still completing its review.  But
the agency is expected to make a formal announcement on alcoholic energy drinks as early as today.