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.
In almost every instance, the FDA relied on only the absence of evidence Four Loko and the other drinks are safe – the guilty until proven innocent approach afforded by the law.
This despite the fact that the FDA had been “investigating” the safety of the products for a year after a group of state attorneys general urged action.
Democratic senators pushed for the results of the investigation to be made public in August. But according to Herndon, there was never any internal report or summary of the findings. Instead, the FDA sent warning letters to four companies, starting the banning process.
The only evidence at all in the warning letters the drinks are actually dangerous are three bullet points about the publicly available academic literature – the studies on Red Bull vodka consumption.
Interestingly, the FDA could theoretically use this same legal authority to put the screws to any food product that adds caffeine, such as Perky Jerky beef jerky or caffeinated mints.
The only product the FDA has explicitly permitted to add caffeine is cola-type beverages.
Industry fears, and food safety advocates hope, that the whole slew of non-alcoholic energy drinks are on the chopping block next.
Leading the charge at the FDA is a former staffer for California Democrat Rep. Henry Waxman, Dr. Joshua Sharfstein, the principal deputy commissioner.
Insiders describe Sharfstein as a particularly aggressive regulator and the driving force behind a series of unusually broad uses of the FDA’s authority in the first two years of President Obama’s reign over the executive branch.
In April 2009, the FDA cited drug companies for failing to include a comprehensive description of risks their drugs pose in 70-character Google ads. Previously the government had allowed the companies to keep the information on the page to which the ads linked to.
In May 2009, the FDA issued a stern warning to General Mills, telling the cereal manufacturer that claims on boxes of Cherrios about its health benefits are “serious violations” of federal law.
In October 2009, the FDA finalized a plan to require special, taste-destroying processing to oysters to stop a virus that targets 30 oyster-eaters per year. After encountering stiff resistance, the agency backed off.