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The FDA sent letters to four companies that market the beverages. The letters say the companies have 15 days to take action or the FDA could seek a court order barring them from selling the products.
The drinks, popular among college students, make it difficult for drinkers to tell how intoxicated they are. This can put them at increased risk for alcohol poisoning or risky behavior, such as driving drunk.
The FDA said it performed lab tests on the drinks and concluded they were not safe for consumption.
"FDA does not find support for the claim that the addition of caffeine to these alcoholic beverages is 'generally recognized as safe,' which is the legal standard," said Joshua M. Sharfstein, the agency's principal deputy commissioner.
"To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern," he said.
One can of Four Loko, the most popular of the drinks, can pack the same punch as four cans of beer and a cup of coffee.
"I call them killer cocktails," said Utah Attorney General Mark Shurtleff, according to The Washington Post. "Young people have been dying after drinking this stuff. It's about time we're finally doing something."
On the eve of the FDA's announcement, the maker of Four Loko, Phusion Projects said Tuesday night it would reformulate its energy drinks to remove caffeine, guarana and taurine.
"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 Chicago-based company said in a statement.
The drinks have been linked to several deaths and hospitalizations of young people around the country in recent months. Critics and health experts say the caffeine masks the effects of the alcohol, which can lead to over-consumption.
"For somebody who's older, this could lead to a heart attack or stroke," Vincent Pedre, a doctor in New York City, told NBC New York.
Sen. Charles Schumer, D-N.Y., who has been pushing for the ban, said FDA action would be a "warning" to beverage companies.
"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," Schumer said in advance of the FDA announcement.
Four Loko has become a target of critics. With its colorful cans and flavors like blue raspberry and fruit punch, the drink comes in a 23.5-ounce can with 6 percent or 12 percent alcohol and costs around $2.50. It's got as much caffeine as a tall Starbucks coffee and the amount of alcohol found in four beers.
"My heart starts messing up, starts skipping," one Four Loko drinker told NBC New York. "I feel like I'm on a drug, I'm not myself."
The FDA described the move by Phusion Projects as a "positive step." Still, the FDA said that the company had failed to address the drinks that are currently in circulation.
If Phusion and the other companies don't address the matter within 15 days, the FDA could take drastic steps, including seizing drinks.
Washington, Michigan, Utah and Oklahoma have banned the caffeine-alcohol drinks, while Connecticut and New York have struck agreements to keep the products out. Other states were considering bans.
Despite the removal of caffeine, Four Loko's maker insisted the blend is safe.
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"We have repeatedly contended -- and still believe, as do many people throughout the country -- that the combination of alcohol and caffeine is safe. If it were unsafe, popular drinks like rum and colas or Irish coffees that have been consumed safely and responsibly for years would face the same scrutiny that our products have recently faced," the company said.With word of a ban circulating, fans have been looking to stock up. "Quick! Get your Four Loko while you can!!!!" a poster said this morning on a Facebook page called Four Loko. Another page, R.I.P. Four Lokos, went up on Nov. 1. Its mission: "Don't ban Four Loko's!!!!!!!!!"
