A year after it began reviewing whether energy drinks that combine alcohol and caffeine are safe or legal, the Food and Drug Administration is expected to take a stand on the drinks as soon as Wednesday, according to law enforcement officials in several states.
The agency declined to say what it would do, but several food safety lawyers who once worked for it said a likely option was to use warning letters to inform manufacturers that the drinks were adulterated and, therefore, not safe.
With new reports of young people falling ill or dying after drinking the potent blends of alcohol and caffeine, state and federal regulators have been pressured to address the matter. Several states have moved to ban the drinks on their own, and this weekend New York’s largest beer distributors agreed to stop delivering caffeinated alcoholic beverages to retailers by Dec. 10. Some state officials, meanwhile, have criticized the F.D.A. for not completing its review sooner.
“To be very blunt, there’s just no excuse for the delay in applying standards that clearly should bar this kind of witch’s brew,” said Senator-elect Richard Blumenthal, Democrat of Connecticut, who as the state’s attorney general has led a campaign against the drinks.
At issue for the F.D.A. is whether adding caffeine to alcoholic beverages is “generally regarded as safe,” an agency designation that requires accepted scientific evidence.
Asked about the status of the F.D.A.’s review, Beth Martino, a spokeswoman for the agency, said only that it was continuing. “We’re taking a careful and thorough look at the science and the safety of these products,” Ms. Martino said.
The state law enforcement officials, who spoke on the condition of anonymity because they were not authorized to discuss the F.D.A.’s investigation publicly, said they did not know what conclusions had been reached.
Four Loko, the top-selling caffeinated alcoholic drink, has been blamed for several deaths over the last several months, a period during which the brand’s availability spread to all but three states. In August, an 18-year-old in Palm Coast, Fla., died after drinking Four Loko in combination with diet pills. The following month, a 20-year-old in Tallahassee, Fla., started playing with a gun and fatally shot himself after drinking several cans of Four Loko over a number of hours.
The drink, sold in fruit flavors like blue raspberry and lemon-lime, has an alcohol content of 12 percent and includes as much caffeine as a cup of coffee. It is sold in 23.5-ounce cans.
Although there is little research on the effects of mixing caffeine and alcohol, several studies have suggested that people get more intoxicated and engage in riskier behavior when they drink the combination beverages than when they drink alcohol alone. Caffeine masks the effects of alcohol, doctors say, tricking users into believing they can keep drinking well past the point of drunkenness.
Phusion Projects, which makes Four Loko, has said that drinking premixed alcohol and caffeine is no different from drinking a few glasses of wine with dinner and having coffee afterward. But Dr. Mary Claire O’Brien, a professor of emergency medicine at Wake Forest University, warned the F.D.A. last year that the combination was dangerous. Dr. O’Brien said that ingesting both substances at the same time had a much more potent effect than either one by itself.
“There’s a particular interaction that goes on in the brain when they are consumed simultaneously,” she said. “The addition of the caffeine impairs the ability of the drinker to tell when they’re drunk. What is the level at which it becomes dangerous? We don’t know that, and until we can figure it out, the answer is that no level is safe.”
Several food safety experts said the length of the F.D.A. review indicated the complexity of the problem.
“It suggests this is turning out to be a difficult issue for them to get a handle on,” said Ricardo Carvajal, a lawyer at Hyman, Phelps & McNamara in Washington and a former associate chief counsel at the F.D.A.
A warning letter to the manufacturers would serve as “a shot across the bow,” Mr. Carvajal said. Such letters would probably give the companies a deadline to reformulate the drinks voluntarily or take them off the market.
“Then it would be up to the manufacturers to decide if they are going to fold or fight back,” said Mr. Carvajal, who left the F.D.A. in 2007.
He said the F.D.A. had been more aggressive about issuing warning letters since Margaret Hamburg became commissioner in 2009.
It is less likely, Mr. Carvajal and others said, that the F.D.A. will seize the beverages and ask a court to order manufacturers to stop selling them.
Marc Scheineson, a lawyer with Alston & Bird in Washington and a former associate commissioner of the F.D.A., said seizure was a “last resort.”
“The F.D.A. doesn’t like to use it because you have to go to court and convince the Department of Justice to agree to take the case,” Mr. Scheineson said.
Neither possibility would be good news for Phusion Projects, a small Chicago company whose success is due almost entirely to Four Loko, one of only three beverages it makes.
After its founding in 2005 by three recent college graduates, the company rapidly expanded distribution and sales with a grass-roots marketing campaign directed toward college students. It hired college students to work as interns, provided them with cases of its drinks and urged them to pass out samples at bars near their campuses.
“We were essentially hired to throw parties and introduce the product to our friends,” said Rachael Minucciani, who was an intern at Phusion Projects in 2006, when she was a senior at Ball State in Muncie, Ind. “They said, ‘Take the product, take the merchandise and run with it.’ ”
Four years later, the company has 90 employees, and had annual sales of $144 million in the year that ended on Oct. 31, according to the SymphonyIRI Group, a market research firm based in Chicago. Those totals do not include sales at liquor stores or retailers that require memberships like Sam’s Club. Young people appear to be drinking Four Loko at an astounding rate, based on testaments posted daily on Facebook pages that pay tribute to the beverage.
The popularity of such drinks has caught college officials, doctors, lawmakers and federal regulators off guard. Long accustomed to fighting alcohol abuse among young people, officials are now scrambling to confront the new and less understood threat of combining high amounts of alcohol with caffeine.
In one case in September, a 19-year-old arrived at Temple University Hospital in Philadelphia complaining of crushing chest pains and shortness of breath. Doctors determined he was having a heart attack, but the usual examinations did not reveal the cause.
The young man reported that he had spent the night drinking Four Loko. Dr. Robert McNamara, chairman of the emergency medicine department at Temple’s medical school, concluded that the drink had probably led to the heart attack.
“We’ve seen this with cocaine and speed and other stimulants, but not with an alcoholic drink,” Dr. McNamara said. “Our advice when he left the hospital was, ‘Don’t ever drink Four Loko again.’ ”
A few weeks ago, Jennifer Machado, a junior at the University of California, Santa Cruz, attended a party where the theme was “Edward Four Loko Hands.” Some guests held cans of Four Loko in each hand. “It does a number on my body,” said Ms. Machado, who did not participate because of her bad experiences with Four Loko.
Donald Misch, director of the Wardenburg Health Center at the University of Colorado at Boulder, said he worried about calling too much attention to Four Loko. “There’s a fear that the more we talk about it then the more people would be inclined to give it a try,” Mr. Misch said.
But Daniel Ferguson, whose 18-year-old niece, Nicole Celestino, went into cardiac arrest and died in August after combining Four Loko and diet pills, said the more publicity the drink received, the better.
“No one in our family who was over the age of 20 had ever even heard of Four Loko,” Mr. Ferguson said.
In recent days, amid reports of young people stockpiling the drink in anticipation of its being banned, a new Facebook tribute page, called R.I.P. Four Loko, has been created. As of Monday night, the page had 8,500 friends.
One person posted a picture of about 20 stacked Four Loko cans and the words “Stock up.”
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