The Food and Drug Administration (FDA) has issued warning letters to four manufacturers of alcoholic energy drinks (AEDs), calling the caffeine added to these malt beverages an “unsafe food additive” and threatening further action against Charge Beverages Corp.; New Century Brewing Co., LLC; Phusion Projects, LLC; and United Brands Company Inc. FDA apparently released its decision after conducting a scientific review that encompassed peer-reviewed literature, expert consultations, information provided by manufactures, and its own independent laboratory analysis. The agency’s findings evidently raised concerns “that caffeine can mask some of the sensory cues individuals might normally rely on to determine their level of intoxication,” leading to “hazardous and life-threatening situations.”

As FDA Principal Deputy Commissioner Joshua Sharfstein summarized in a November 17, 2010, press release, “FDA does not find support for the claim that the addition of caffeine to these alcoholic beverages is ‘generally recognized as safe [GRAS],’ which is the legal standard. To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern.”

In its letter to Phusion Projects, the agency specifically claims that a caffeinated malt beverage known as Four Loko “is adulterated under section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(2)(C)].” Rejecting the company’s GRAS submission for this product, FDA notes that no regulations or prior sanctions currently authorize “the use of caffeine as a direct addition to alcoholic beverages.” It also cites “publicly available literature” suggesting, among other things, that “caffeine alters the perception of alcohol intoxication” and may result “in higher amounts of alcohol consumed per drinking occasion, a situation that is particularly dangerous for naive drinkers.”

“It is FDA’s view that the caffeine content of your beverage could result in central nervous system effects if a consumer drank one or more containers of your product,” concludes the letter to Phusion Projects. “You should take prompt action to correct this violation and prevent its recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions and prosecutions against manufacturers and distributors of those products.”

Meanwhile, the Federal Trade Commission (FTC) has also issued letters to the same AED companies, warning “that marketing of such beverages may constitute an unfair or deceptive practice that violates the FTC Act.” The commission has thus instructed the letter recipients “to notify the agency within 15 days of the actions they have taken” to rectify the situation. “Even in the absence of express safety claims, the very act of offering goods for sale creates an implied representation that the goods are reasonably fit for their intended uses and free of gross safety hazards,” states one letter. “In addition, the non-disclosure of rare but serious safety risks may constitute an unfair practice.” See The Associated Press, November 17, 2010.

Both agencies announced the rulings following pressure from state attorneys general as well as local and federal lawmakers, all of whom have cited reports linking AEDs to college student hospitalizations. Their concerns had already led several liquor control authorities, including those in Michigan, New York, Pennsylvania, and Washington, to ban the products from store shelves. Additional details about these developments appear in Issues 370, 371 and 372 of this Update.

Highlighting one case in which a young adult allegedly went into cardiac arrest after combining AEDs and a diet pill, U.S. Senator Charles Schumer (D-N.Y.) has since described FDA’s action as “the nail in the coffin of these dangerous and toxic drinks.” Other media sources have also reported a lawsuit claiming that a Florida State University sophomore accidently shot himself while intoxicated on Four Loko. The Center for Science in the Public Interest (CSPI), however, has expressed some doubt that the required product reformulations will address such incidents. “Four Loko and Joose might no longer have caffeine, but they still contain three to four beers’ worth of alcohol in 23-ounce, single-serving cans,” opines CSPI Executive Director Michael Jacobson in a November 17 statement. “That these drinks are made with kid-friendly flavors like watermelon, blue raspberry, and lemonade says all one needs to know about their target audience.” See DeLauro Press Release, Law360 and The New York Times, November 15, 2010; Advertising Age and Schumer Press Release, November 16, 2010; Huffington Post and NBC New York, November 17, 2010.

In response to these allegations, Phusion Projects has committed to removing caffeine, guarana and taurine from its products. But at least two of the other AED manufacturers have voiced some disappointment over the FDA’s review process. “It’s not clear how they came to their decision,” New Century CEO Rhonda Kallman was quoted as saying. “Moonshoot beer is an all-craftbrewed beer, 4 percent or 5 percent alcohol with 69 milligrams of caffeine, much less than a cup of coffee. It’s a little caffeine dumped in a craft beer, and somehow they’ve lumped it in with these neon-colored, 12 percent alcohol, fruit juice things in a single-serve can–that’s not what I do.” See Phusion Projects Press Release and United Brands Company, Inc. Press Release, November 16, 2010; Law360, November 17, 2010.