FDA WARNING_LETTER - Bebida Beverage Company

On March 4, 2015, the FDA issued a Warning Letter to Bebida Beverage Company (BeBevCo) for its "Koma Unwind Liquid Relaxation" product. The FDA determined the product is adulterated under Section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the Act) because it contains melatonin, an unapproved food additive. Melatonin is a neurohormone and is not approved for use in conventional foods, nor is it generally recognized as safe (GRAS). The FDA cited safety concerns regarding melatonin's effects on blood glucose, reproductive, cardiovascular, ocular, and neurological systems.

Additionally, the product is misbranded under Section 403 of the Act. Despite being represented as a conventional food (e.g., "lightly carbonated beverage," sold in a 12 oz. can with a Nutrition Facts label), the product label falsely identifies it as a "Dietary Supplement." Other misbranding violations include the failure to bear a statement of identity on the Principal Display Panel (Section 403(i)(1)) and improper nutrition information format (Section 403(q)). Specific nutrition labeling errors include incorrect serving size declaration (entire can must be one serving), inclusion of unpermitted components (Milk Thistle, Valerian Root, Rose Hips Extract) within the Nutrition Facts panel, and failure to include the "Not a significant source of