Well, that was fast. After a year-long investigation of pre-made, highly-caffeinated alcoholic beverages, the US FDA today warned four companies to go decaf.
The U.S. Food and Drug Administration today warned four companies that the caffeine added to their malt alcoholic beverages is an “unsafe food additive” and said that further action, including seizure of their products, is possible under federal law.
The companies receiving Warning Letters and their products are:
• Charge Beverages Corp.: Core High Gravity HG, Core High Gravity HG Orange, and Lemon Lime Core Spiked
• New Century Brewing Co., LLC: Moonshot
• Phusion Projects, LLC (doing business as Drink Four Brewing Co.): Four Loko
• United Brands Company Inc.: Joose and Max
FDA’s action follows a scientific review by the Agency. FDA 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, and reviewed information provided by product manufacturers. FDA also performed its own independent laboratory analysis of these products.
“FDA does not find support for the claim that the addition of caffeine to these alcoholic beverages is ‘generally recognized as safe,’ which is the legal standard,” said Dr. Joshua M. Sharfstein, Principal Deputy Commissioner. “To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern.”
Experts have raised concerns that caffeine can mask some of the sensory cues individuals might normally rely on to determine their level of intoxication. The FDA said peer-reviewed studies suggest that the consumption of beverages containing added caffeine and alcohol is associated with risky behaviors that may lead to hazardous and life-threatening situations.
That last paragraph was what I focused upon in my post over the weekend that was stimulated by a frontpage Raleigh News & Observer article by higher ed reporter, Eric Ferreri (@campus_notes). Large amounts of caffeine taken with a 23.5 ounce beverage containing 12% (v/v) ethanol deceives the drinker into thinking they are less drunk than their motor skills or blood alcohol concentration would reveal. I’m not one for a nanny state but this is in a nutshell is the threat to public health with highly-caffeinated alcoholic beverages.
A couple of my dear Twitter followers were having sport with me today about these products and some asked why FDA is acting on these products but not the practice of mixing vodka and Red Bull or whiskey with coffee. The major reason is that these are prepared food products (I’d also add that Four Loko has four times the caffeine as a typical Red Bull).
From the FDA’s Q&A today:
Under what authority is FDA issuing these Warning Letters?
FDA is issuing the four Warning Letters under its authority to implement the Federal Food, Drug, and Cosmetic Act (the FFDCA). Under the FFDCA, a substance added to food (such as caffeine added to an alcoholic beverage) is deemed an “unsafe food additive” and is unlawful unless its particular use has been approved by FDA, is the subject of a prior sanction, or is generally recognized as safe (GRAS). A food that contains an unsafe food additive is deemed adulterated under Section 402(a)(2) of the FFDCA [21 U.S.C. 342(a)(2)]; adulterated foods are subject to agency enforcement actions, including seizure.
The FDA has only listed caffeine as GRAS as an ingredient for use in cola-type beverages in concentrations of no greater than 200 parts per million. There is no food additive regulation that permits the addition of caffeine, at any level, to an alcoholic beverage. Based on the information FDA has reviewed, the agency does not consider the use of caffeine in the products listed above to be GRAS.
What puzzles me is that most of the public and media concern has been with regard to the caffeine with little discussion of the alcohol content. As I noted over the weekend, one can of Four Loko is approximately the same volume and alcohol content as an entire bottle of wine (or 4+ decent beers.). In fact, the folks at BuzzFeed got it wrong yesterday when they offered their own recipe for homebrewed Four Loko: Five watermelon Jolly Rancher candies, a caffeine pill, a can of Sprite, a can of Monster Energy Drink, and a 40 oz bottle of St. Ides malt liquor. St. Ides is 8.3% ABV and when diluted out with the soda and energy drink, you’ve got about 68 oz of 4.9% ABV swill.
BuzzFeed friends and readers: You’d still have to drink 58 oz of this loathsome assault on humanity to equal the amount of alcohol in a single 23.5 oz can of Four Loko. This fact alone should make apparent to even defenders of Red Bull and vodka that this stuff is, uh, roughly four crazy drinks.
Four. Crazy. Drinks.
I finally get it.
So now, assuming the companies respond to their FDA warning letters, we’ll simply have products in the cooler that are insipid, fruit-flavored beverages with 12% alcohol.