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WARNING SHOT: The FDA has sent lengthy warning letters to four makers of caffeinated alcoholic beverages--including Four Loko, Joose, Max, Core and Moonshot--saying that these products are being marketed in violation of the Federal Food, Drug, and Cosmetic Act (FFDCA).
Image: IMAGE COURTESY OF THE FDA
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Caffeinated alcoholic beverages such as Four Loko and Joose are being removed from store shelves amidst concerns over their powerful stimulant-sedative combination. Now the federal government is weighing in on these party drinks, saying they are unsafe and should not be marketed to young people. The U.S. Food and Drug Administration (FDA) on Wednesday sent lengthy warning letters to four makers of such caffeinated alcoholic beverages—Charge Beverages Corp., New Century Brewing Co., Phusion Projects and United Brands Co.—informing these companies that their products are being marketed in violation of the Federal Food, Drug, and Cosmetic Act.
After a yearlong investigation of alcoholic drinks with caffeine added, the agency has determined these beverages are a "public health concern" and has warned the four companies that the caffeine added to their malt alcoholic beverages, including Four Loko, Joose and Core, is an "unsafe food additive." These companies now have 15 days to explain to the FDA how they will address this problem.
Phusion Projects, which makes Four Loko, has attempted to preempt the government's crackdown, announcing Tuesday that it will remove caffeine, guarana and taurine from its products, even though the company contends that the combination of alcohol and caffeine is safe. In a statement on the company's site, company co-founders Chris Hunter, Jeff Wright and Jaisen Freeman note that all of Phusion's product formulas and packaging were reviewed and approved by the U.S. Department of Treasury's Tobacco Tax and Trade Bureau before being offered to consumers.
In a press release issued prior to the FDA's announcement, United Brands CEO and president Michael Michail stated that his company would adhere to federal and state health and safety guidelines. Charge Beverages and New Century had not issued statements related to the FDA's announcement as of Wednesday afternoon.
At a press conference announcing the FDA's findings, Joshua Sharfstein, FDA principal deputy commissioner, said he wouldn't characterize the agency's action as "an outright ban. Our conclusion is that the drinks are adulterated and do not meet safety standards."
The warning letters read like legal documents and explain the FDA's position that alcoholic drinks with added caffeine are in violation of its regulations. If the manufacturers do not respond in the allotted two weeks, the government could seize their products or file an injunction to prevent them from continuing to make these beverages.
The FDA says it examined the published peer-reviewed literature on the co-consumption of caffeine and alcohol, consulted with experts in the fields of toxicology, neuropharmacology, emergency medicine and epidemiology as well as reviewed information provided by product manufacturers. FDA says it also performed its own independent laboratory analysis of these products and listened to experts who have raised concerns that caffeine can mask some of the sensory cues individuals might normally rely on to determine their level of intoxication.
A typical alcoholic energy drink is 24 ounces (0.7 liters) and has a 12 percent alcohol content—compared with a 12-ounce (0.35-liter) can of beer, which normally has 4 to 5 percent—plus the caffeine equivalent of five cups of coffee. "The consumption of these drinks may lead to serious problems," Thomas Gould, an associate professor of psychology at Temple University in Philadelphia, recently told Scientific American. "If co-administration of alcohol and caffeine allow people to drink for longer periods of time because of reduced sedation, they may consume more alcohol; this could lead to serious health risks, such as near-lethal blood alcohol levels as seen in the Central [Washington] University case." Last month nine C.W.U. students were hospitalized after drinking caffeinated malt liquor.
Charge Beverages, New Century Brewing, Phusion Projects and United Brands were singled out based on three criteria: the companies advertise the direct addition of caffeine to their products, they sell their products in single serving containers and they are easy to obtain and test.
Caffeinated alcoholic beverage makers who did not make the FDA's list are not off the hook, Sharfstein warned, adding, "We expect these letters to be read across the industry."
The FDA's actions come after several states, including Michigan, New York and North Carolina, have called for caffeinated alcoholic beverages to be removed from store shelves.
When asked whether the FDA was concerned that there would be run on these products by thirsty young drinkers, Sharfstein said, "We don't think it's a good idea for people to rush out and buy these products."
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7 Comments
Add CommentI guess they never consulted a bartender or have heard of a "rum & coke." Thanks for protecting me from myself, big brother.
Reply | Report Abuse | Link to thisI've not seen on my pub crawls in the UK any brands of this sort. The drink the the clubs is not rum and coke but vodka and 'Red Bull' a heavily caffeinated concoction in 200ml cans.There are supermarket own-brand versions. There is another sort of coke (illegal) of course in the clubs with the same effect. Presumably the US is ripe for a marketing campaign for 'Red Bull' product now the FDA 'advertised' its purpose.
Reply | Report Abuse | Link to thisA Rum and Coke (1oz rum + 4oz coke) has about 11mg of caffeine. One of these drinks has about 550mg of caffeine. So you would have to drink 50 rum and cokes to get the same amount of caffeine as a single "energy drink." And people are drinking a lot more then just one of these drinks a night when partying.
Reply | Report Abuse | Link to this@Nekura, I agree with your point but Four Loko has 260mg not 550. (http://bit.ly/d5N3Fb) Alcohol or not... that's just too much caffeine, not to mention guarana which is a natural stimulant that your body processes similar to caffeine! I've had 2 cans of redbull (154mg total) in one night and got serious heart burn from it so 2 or 3 cans of these drinks would probably kill me!
Reply | Report Abuse | Link to thisLegislating these drinks is a tough issue though because it opens up the discussion to other alcohol+caffeine products like Espresso Vodka (Three Olives and Van Gogh) which I DO purchase and would hate to lose.
p.s. I have tried one of these energy malt beverages and I just figured they were going to be a short lived thing because, on taste alone, they're terrible. IMO.
I went by the articles statement of "equivalent of five cups of coffee" with 110mg/cup, but it's still 24 rum and cokes, more then enough to get plastered, in one drink.
Reply | Report Abuse | Link to thisMost coffee flavoured liquors have 4-10mg per serving, incidental from the coffee, not 250-500+mg added explicitly because it's a stimulant. There is a big difference.
The last time I saw a Red Bull can, it had warnings not to mix it with alcohol, but that was back when it first came out.
It seems pretty obvious that this is just publicity-driven pseudo-science on the part of the FDA.
Reply | Report Abuse | Link to thisTheir very statements are nothing but suppositions and extrapolations.
It gets real tiresome to see how many "authoritative agencies" are really run by third rate intellects who work mightily to "seem like they know what they are talking bout" but are far less capable that the propaganda they would have us swallow whole.
The disease of knee-jerk response to worried-simpletons with a "cause" has grown to epidemic proportions.
The simpletons with a "cause" are trying to give meaning to their vapid, sheltered, pet-like existeence.
The knee-jerk responders are generally avoiding doing any of the work they were hired to do.. since they generally are the sort who shirk work.. and, too often, are simply incompetent to perform the duties for which they were hired... thus they love it when some pointless media event gives them an opportunity to pretend they are busy and useful.
Instead.. they are showing us they area waste of time and money.