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FDA Cans Alcoholic Beverages that Contain Caffeine

MedpageToday

The FDA has acted to effectively ban the sale of beverages that combine caffeine and alcohol, including Four Loko and Joose, by declaring that caffeine is an unsafe food additive for alcoholic beverages.

The agency issued warning letters Wednesday to four makers of caffeinated alcoholic beverages, saying that addition of caffeine to their malt beverages is not "generally recognized as safe (GRAS)," the industry standard.

"Several studies have shown that stimulants mask the intoxicating effects of alcohol," Joshua Sharfstein, MD, deputy FDA commissioner, told reporters. This can lead to overconsumption of the beverages and, subsequently, alcohol poisoning, he said.

Most of the drinks contain 12% alcohol by volume and are sold in 24- to 32-oz cans. So, one can contains as much alcohol as four or five regular-sized beers.

"Young, inexperienced drinkers may not realize just how impaired they are and drink to the point of alcohol poisoning," David Vladeck, director of the bureau of consumer protection at the Federal Trade Commission, said on the call.

The four manufacturers include Four Loko maker Phusion Projects, Joose maker United Brands Company, Charge Beverages Corp., and New Century Brewing Co.

Earlier today, Chicago-based Phusion Products, issued a statement saying it intended "to reformulate its products to remove caffeine, guarana, and taurine nationwide."

"Going forward, Phusion will produce only non-caffeinated versions of Four Loko," the company said.

Robert McKenna, attorney general of the state of Washington -- one of four states that has already taken action against the beverages -- said on the call that the company's move is a "cynical ploy."

"It's like an employee who is about to get fired saying, I quit!" McKenna said. Several state attorneys launched their own investigations into the products in 2007 and subsequently brought the issue to the FDA's attention, he added.

The Federal Trade Commission will also notify manufacturers that they're potentially marketing the products illegally, the FDA said, and that further action including seizure of the products, is possible under federal law.

The FDA action follows a scientific review begun in November 2009 into the safety of the drinks. At that time, the agency sent letters to 30 manufacturers -- far more than the four that received warning letters today.

Sharfstein said the agency's review is ongoing, and may lead to action against other products.

There's been a spate of recent action on caffeinated alcoholic beverages. A handful of states -- including Oklahoma, Utah, Michigan, and Washington -- have banned Four Loko in the wake of a rash of hospitalizations, heart attacks, and death associated with its consumption.

Just this week, the New York liquor authority and the state's largest beer distributors agreed to stop selling the drinks, according to a release from Sen. Charles Schumer (D-N.Y.), who announced the FDA's pending decision on Tuesday.

And on Monday, Connecticut Attorney General and the state's senator-elect Richard Blumenthal sent a letter to FDA Commissioner Margaret Hamburg, MD, calling for the ban of the energy drinks.

Two deaths may be associated with use of the drinks. An 18-year-old Long Island resident, Nicole Lynn Celestino, allegedly died in August of cardiac arrest after drinking four cans of Four Loko on top of a diet pill she had taken earlier in the day.

And the family of 20-year-old Jason Keiran of Florida is suing the drink maker over claims that it caused him to behave so erratically that he shot himself.

The FDA's warning letters request that the companies inform the agency in writing within 15 days of the specific steps that will be taken to remedy the violation and prevent its recurrence.

If a company does not believe its products are in violation, it may present its reasoning and any supporting information as well.