FDA WARNING_LETTER - New Century Brewing Co

The FDA issued a Warning Letter to New Century Brewing Company, LLC regarding their product "Moonshot," an alcoholic beverage containing directly added caffeine. The FDA determined that caffeine, as used in "Moonshot," is an unsafe food additive, rendering the product 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 letter details the criteria for GRAS status, emphasizing that it requires consensus among qualified experts based on publicly available data, which is lacking for caffeine in alcoholic beverages.

The FDA cited scientific literature raising safety concerns, including behavioral effects in young adults, reduced subjective perception of intoxication without improved motor coordination, and potential for increased alcohol consumption. The agency also expressed concern that the product's marketing targets young adults, who are particularly vulnerable to these adverse effects.

New Century Brewing Company's assertion that Alcohol and Tobacco Tax and Trade Bureau (TTB) approval (COLA) makes the product lawful was rejected, as COLA does not equate to FDA food additive approval or GRAS status.

The FDA requires prompt action to correct the violation and prevent recurrence. Failure to comply may result in enforcement