FDA WARNING_LETTER - Charge Beverages Corporation

The FDA issued a Warning Letter to Charge Beverages Corporation regarding their products "Core High Gravity HG Green," "Core High Gravity HG Orange," and "Lemon Lime Core Spiked." The FDA determined that caffeine, when directly added to alcoholic beverages and packaged in combined form, is an unsafe food additive. This renders the products 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)].

The FDA states there is no food additive regulation authorizing caffeine's use in alcoholic beverages, nor is there evidence of prior sanction or Generally Recognized As Safe (GRAS) status under these conditions. The company failed to respond to a November 12, 2009, FDA request for evidence supporting GRAS or prior sanction status.

The FDA cited safety concerns, including scientific literature suggesting that combining caffeine and alcohol may reduce the subjective perception of intoxication without improving impaired motor coordination or reaction times, potentially leading to higher alcohol consumption and hazardous behaviors, especially among young adults. The FDA noted that the products' marketing and packaging appear to target young adults, who are particularly vulnerable.

The company's Alcohol and Tobacco Tax and Trade Bureau (TTB) COLA approval does not constitute FDA food additive approval or GRAS status. Charge Beverages Corporation must take prompt action to correct this violation and prevent recurrence. Failure to comply may