FDA WARNING_LETTER - Phusion Projects Inc.

The FDA issued a Warning Letter to Phusion Projects, LLC (dba Drink Four Brewing Company) regarding their product "Four Loko," an alcoholic beverage containing directly added caffeine. The FDA determined that caffeine, as used in "Four Loko," is an unsafe food additive, rendering the product adulterated under section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 342(a)(2)(C)].

The FDA states that there is no food additive regulation authorizing caffeine's use as a direct addition to alcoholic beverages, nor is there evidence of prior sanction or Generally Recognized As Safe (GRAS) status under these conditions. The company submitted a GRAS Notice (GRN No. 000347) on June 25, 2010, in response to a November 12, 2009, FDA request for evidence of GRAS or prior sanction status. However, the FDA reviewed the notice and found it insufficient, citing concerns from scientific literature about the safety of caffeinated alcoholic beverages.

Specific safety concerns include behavioral effects in young adults, reduced subjective perception of intoxication without improved motor coordination, and potential for higher alcohol consumption. The FDA noted that the GRAS Notice primarily relied on caffeine-alone studies, which are insufficient for combined products, and that the peer-reviewed literature collectively raises safety concerns despite purported study limitations