DEWMAR INTERNATIONAL BMC, INC – FDA Warning Letter

The FDA issued a Warning Letter to Dewmar International BMC, Inc. for its "Lean Slow Motion?Potion" beverage products (Easta Pink, Purp, and Yella varieties). The FDA determined these products are adulterated under Section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) because they contain melatonin, an unapproved food additive. Melatonin is a neurohormone and is not authorized for use in conventional foods as a food additive, nor is it generally recognized as safe (GRAS) for such use.

The products are also misbranded under Section 403 of the Act. Despite being represented as conventional foods (e.g., described as beverages, packaged like soft drinks, and containing typical soft drink ingredients), the labels incorrectly state "DIETARY SUPPLEMENT." Additionally, the products fail to bear a proper statement of identity and their nutrition information is not in the appropriate format as specified in 21 CFR 101.9. Specific misbranding issues include the declaration of "Acai Berry Extract" within the nutrition label, incorrect or missing declarations for saturated fat, trans fat, and cholesterol, and the omission of the "Not a significant source of ___" statement when using the simplified Nutrition Facts labeling format.

Dewmar International BMC, Inc. is required to take prompt action to correct these violations and respond in writing within 15 working days, detailing corrective steps, prevention plans