The encyclopedia · Legal & Compliance · Product decision · 2010
Four Loko mixed caffeine with 14% alcohol — the FDA gave them 15 days to fix it
Nine college students were hospitalized with blood alcohol up to 0.35%. The FDA called the caffeine an unsafe additive and Four Loko had to reformulate in 2010.
Phusion Projects · FDA · 2010-11
What happened
Four Loko, launched in 2005 by three Ohio State graduates, was a 23.5-ounce can of malt liquor at up to 14% ABV — roughly equivalent to five beers — combined with caffeine, taurine, and guarana. The caffeine masked the feeling of intoxication, letting drinkers consume far more alcohol than they realized. The product was popular on college campuses and priced at $2–3 per can.
In October 2010, nine students at Central Washington University, ages 17 to 19, were hospitalized after drinking Four Loko at a house party. Blood alcohol levels ranged from 0.12% to 0.35% — the latter potentially lethal. At Ramapo College in New Jersey, 23 people were hospitalized. States began banning the product: Washington, New York, and Oregon all moved within weeks.
On 17 November 2010, the FDA issued warning letters to four manufacturers of caffeinated alcoholic beverages, declaring added caffeine an 'unsafe food additive' and a 'public health concern.' Companies had 15 days to respond. Phusion Projects announced the removal of caffeine, guarana, and taurine the day before the letters were sent. Reformulated Four Loko returned to shelves in late December 2010 — same can, same alcohol, no stimulants. Before the change, original cans were resold at nearly five times retail price online.
Why it happened
- Combining caffeine with high-ABV alcohol created a product that masked intoxication — drinkers could not tell how impaired they were.
- The $2–3 price point and college-campus marketing put the product directly in front of the most vulnerable demographic.
- Phusion Projects waited until hospitalizations and state bans forced the issue, rather than reformulating proactively when the safety concerns first emerged in 2009.
- The FDA's 'unsafe food additive' determination left no room for negotiation — the company had 15 days to comply or face product seizure.
The lesson
If your product's selling point is that the customer cannot tell how impaired they are, the regulator will notice. The caffeine-alcohol mix was a feature — and that is why the FDA ended it.
Aftermath
Four Loko continues to sell as a high-ABV malt beverage without caffeine. The brand has become a cultural reference point for reckless college drinking. Phusion Projects survived and continues to operate. The case led to permanent FDA scrutiny of caffeinated alcoholic beverages.
Sources
- FDA warning letter to Phusion Projects, Inc., 17 November 2010 — caffeine in "Four Loko" is an unsafe food additive; product adulterated under 402(a)(2)(C); reply required within fifteen (15) days
- FDA — Caffeinated Alcoholic Beverages, 17 November 2010 (four manufacturers warned; seizure possible under federal law)
- Four Loko — Wikipedia (launched 2005; 14% ABV with caffeine/taurine/guarana; 9 CWU students hospitalized Oct 2010, BAC up to 0.35%; 23 hospitalized at Ramapo College; FDA warning letters 17 Nov 2010; reformulated Dec 2010; original cans resold at 5× price)
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