FDA WARNING_LETTER - United Brands Company Inc

The FDA issued a Warning Letter to United Brands Company, Inc. concerning its "Joose" and "Max" alcoholic beverage products, which contain directly added caffeine. The FDA determined that caffeine, as used in these products, is an unsafe food additive, rendering 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 agency clarified that caffeine in this context is a food additive under section 201(s) of the Act, and its use is not authorized by any food additive regulation, nor is it generally recognized as safe (GRAS) or subject to a prior sanction, as per 21 CFR Part 170. The FDA cited significant safety concerns, including behavioral effects, altered perception of intoxication, potential for increased alcohol consumption, and the targeting of young adults. The company's previous response and a COLA from TTB did not alleviate these concerns. United Brands Company, Inc. must take prompt action to correct this violation and prevent recurrence, providing a written response within fifteen days detailing specific corrective steps and supporting documentation. Failure to comply may lead to enforcement actions such as product seizure, injunctions, and prosecutions, as the company is responsible for ensuring product safety and compliance.