Four Loko was effectively banned in its original form in November 2010 when the FDA declared that caffeine added to alcoholic malt beverages is an “unsafe food additive.” The original 23.5-ounce can packed 12% alcohol alongside 156 milligrams of caffeine, guarana, and taurine, a combination that masked how drunk people actually were and led to a wave of hospitalizations among young drinkers.
What Made the Original Formula Dangerous
The “four” in Four Loko referred to its four key ingredients: alcohol, caffeine, guarana (a caffeine-rich plant), and taurine (an amino acid some believed could boost performance). A single can contained roughly the equivalent of four or five standard drinks’ worth of alcohol, but the caffeine kept drinkers feeling alert even as their blood alcohol climbed to dangerous levels.
This creates what researchers have called “wide-awake drunk.” Caffeine blocks the brain receptors responsible for making you feel sleepy and uncoordinated when you drink. Normally, those effects act as a built-in warning system: you get drowsy, you slow down, you stop drinking. Caffeine shuts that signal off. At the same time, caffeine amplifies the pleasurable, rewarding effects of alcohol by boosting dopamine activity in the brain. The result is that people drink more, feel less impaired than they actually are, and chase stronger effects of both substances simultaneously.
The Incident That Sparked the Crackdown
In October 2010, nine students aged 17 to 19 from Central Washington University were hospitalized after a house party in Roslyn, Washington. Their blood alcohol levels ranged from .123 to .35, with the highest level approaching a potentially fatal concentration. Investigators from the Washington State Attorney General’s office linked the hospitalizations directly to alcoholic energy drinks, ruling out earlier suspicions of date-rape drugs.
That incident became national news and set off a rapid chain of state-level actions. Washington’s Liquor Control Board voted to ban alcoholic energy drinks statewide, effective November 18, 2010. New York’s governor announced that Phusion Projects, Four Loko’s maker, was pulling the product from the state, and the New York State Liquor Authority formally banned sales as of November 19. Michigan and Oklahoma both voted to ban alcoholic energy drinks over health and safety concerns. Pennsylvania’s liquor control board sent letters urging distributors to stop selling the drink, stopping just short of a formal ban. Utah, which runs its own alcohol distribution system, had never allowed the products to be sold in the first place.
The FDA’s Federal Action
On November 17, 2010, the FDA sent warning letters to four companies producing caffeinated alcoholic malt beverages, including Phusion Projects. The letters stated that the added caffeine was an “unsafe food additive” under federal law and warned that further action, including seizure of their products, was possible. This classification was the result of a year-long FDA evaluation of these products.
The Alcohol and Tobacco Tax and Trade Bureau, which regulates alcohol labeling, followed up by notifying the same companies that if the FDA deemed their products adulterated, they would also be considered mislabeled under federal alcohol law, making it illegal to sell or ship them across state lines. Between the FDA’s safety ruling and the TTB’s labeling authority, the two agencies effectively made it impossible to legally distribute the original formula.
How the Product Was Reformulated
Facing federal enforcement and a growing list of state bans, Phusion Projects announced in late November 2010 that it would remove caffeine, guarana, and taurine from Four Loko’s formula. The reformulated version kept the high alcohol content but dropped all three stimulants, eliminating the combination that regulators and health officials had identified as the core danger.
Four Loko didn’t disappear from shelves entirely. It returned as a non-caffeinated malt beverage, still sold in large cans with high alcohol content. But the version that earned its reputation, the one that combined a potent dose of alcohol with enough stimulants to keep drinkers from realizing how intoxicated they were, was gone.
The FTC Settlement Over Labeling
The regulatory scrutiny didn’t end with the reformulation. In 2013, the Federal Trade Commission took action against Phusion Projects for deceptive advertising. The resulting settlement required the company to include an “Alcohol Facts” panel on any product containing more than 1.2 ounces of pure alcohol (the equivalent of about two standard drinks). This was designed to make it harder for consumers to underestimate how much alcohol they were actually consuming from a single can. A modified order in 2014 revised the disclosure format to align with federal labeling guidance.
The caffeine-in-alcohol rule still stands today. The FDA has not reversed its classification of caffeine as an unsafe additive in pre-packaged malt beverages. While you can obviously order a vodka Red Bull at a bar, manufacturers cannot sell pre-mixed caffeinated alcoholic drinks on store shelves. The distinction comes down to who adds the caffeine: a bartender mixing two legal products at your request is different, in regulatory terms, from a manufacturer selling a pre-made combination that the FDA has deemed unsafe.