The FDA has issued warnings to the following manufacturers of caffeinated alcoholic beverages, stating that these products present a public health concern:

• 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

According to the FDA, the caffeine contained in these malt alcoholic beverages is an “unsafe food additive” and said that further action, including seizure of these products, is possible under federal law. This action comes as a result of a scientific review conducted by the FDA. Peer-reviewed studies indicate that consuming these beverages, which contain added caffeine and alcohol, is associated with risky behaviors that in turn may lead to hazardous and life-threatening situations, the FDA stated.

The warning letters say that the beverage products are in violation of the Federal Food, Drug, and Cosmetic Act (FFDCA). In addition, the warning letters request each manufacturer provide the FDA of the specific steps it will be taking to correct the violation and prevent its recurrence – this must be presented in writing within 15 days. If a manufacturer does not believe its beverage products are in violation of the FFDCA, it may present its reasoning and other supporting documentation.

Previous to this warning letter being issued, Phusion Projects, LLC, announced it will be reformulating its products to remove caffeine, guarana, and taurine, and will produce only non-caffeinated versions of Four Loko.