Is Four Loko dangerous? The FDA doesn’t say

Since Americans have been mixing rum with caffeinated cola beverages for over a century, and in recent years, voraciously downing Red Bull vodkas, you’d think the Food and Drug Administration (FDA), in breathlessly moving to ban Four Loko and other alcoholic energy drinks this week, would have distinguished the two.

But according to the FDA, they aren’t different at all.

The only evidence the FDA relied on to show the danger of Four Loko, Joose and other booze-laced energy drinks were studies that examined consumption of “alcohol mixed with energy drink” generally. One study explicitly limited its focus to Red Bull vodkas.

“The most widely cited study in the war on [alcoholic energy drinks]… does not mention pre-mixed [drinks] in any way, making it impossible to distinguish between pre-mixed drinks and the consumption of cocktails – such as vodka and Red Bull or ‘Jaeger Bombs,’ which contain Jagermeister and Red Bull,” says a May 27 study by Baylen Linnekin for the Competitive Enterprise Institute.

In other words, the FDA relied on research on Red Bull vodkas to ban Four Loko while leaving Red Bull vodkas untouched.

In telling Four Loko’s manufacturer it was toast, the FDA offered this rationale: “In one study, a mixture of an energy drink and alcohol reduced subjects’ subjective perception of intoxication but did not improve diminished motor coordination or slower visual reaction times using objective measures.”

That would be the study that explicitly examined only Red Bull vodka consumption.

One reason Four Loko and Joose were singled out is that the FDA doesn’t have legal authority to regulate how food products are mixed.

“We can’t regulate what you do in the privacy of your home or at the bar,” said FDA spokesman Michael Herndon, with a tinge of wistfulness in his voice, “but we do advise against it.”

In moving to ban Four Loko, the agency is relying on a rarely used provision in a 1958 law governing food additives.

Under the law, the onus is on manufacturers to prove their additives are “generally recognized as safe.”

Since the FDA hadn’t explicitly approved of adding caffeine to malt liquor, the companies had thirty days to prove their products were safe. They supplied the FDA with evidence about caffeine’s safety, but it wasn’t enough.

“Addressing the safety of caffeine alone are not sufficient to establish the safety, and the general recognition of the safety, of beverages that combine caffeine with alcohol,” said the FDA.

Notably, the FDA isn’t saying drinking a Four Loko is unsafe from a health standpoint. It’s not an issue of the drinks being poisonous or causing cancer. The agency isn’t even saying the drinks cause dangerous behavior. The FDA is saying there are studies which suggest drinking alcohol combined with caffeine might encourage “potentially hazardous behaviors” and you, Phusion Projects, couldn’t prove that’s not the case.

“The agency is unaware of any data that address the complex, potentially hazardous behaviors that have been identified in the scientific literature as associated with these beverages or that otherwise alleviate our concerns about the effects of consuming these pre-mixed caffeine and alcohol beverages,” the FDA said in its warning letter.