On November 18, 2010, the Food and Drug Administration (FDA) issued Warning Letters to Phusion Projects, LLC (Phusion), United Brands Company, Inc. (United), Charge Beverages Corporation (Charge), and New Century Brewing Company, LLC (New Century Brewing), alerting the companies that their pre-packaged caffeinated alcoholic products are adulterated beverages in violation of § 402(a)(2)(C) of the Federal Food Drug and Cosmetic Act (the Act).

In recent months, these beverages have come under intense scrutiny from the media and legislators at the local, state and federal levels of government because of the cheap and allegedly dangerous high that detractors say they provide to college students and young adults. Sold in attractive, single-serve cans and available in a variety of fruity flavors, these products mix caffeine and up to 12% alcohol by volume, or the alcoholic equivalent of four to five cans of beer, per serving package. Although not new to the market (MillerCoors and Anheuser-Busch previously pulled similar products in 2008 after pressure from state governments), efforts to ban these products increased again this fall after Phusion Projects' popular Four Loko product was implicated in a number of recent accidents and the deaths of at least five individuals, four of whom were under the legal drinking age of 21.

As concerns about the dangerous effects of combining caffeine with alcohol grew, the affected manufacturers attempted to quell the negative publicity that their products were receiving by claiming that they were no different than typical drinks served at bars, such as Red Bull and vodkas or rum and colas. Phusion also pointed out that flavored alcoholic beverages already exist on the market in the form of bubblegum, raspberry and blueberry vodkas, all of which contain several times the alcohol by volume of a can of Four Loko. Likewise, United maintained that its “Joose” product contains only half the caffeine quantity of a Red Bull or Monster energy drink, and less caffeine per ounce than found in a can of carbonated cola. Additionally, both Phusion and United cited aggressive "responsible drinking policies" aimed at promoting safe and legal consumption of their products to retailers and consumers alike.

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