The U.S. Food and Drug Administration (FDA) has issued a warning letter to Dewmar international BMC Inc., alleging that the company misbrands its lean slow motion…potion beverage as a dietary supplement, when the product is in fact represented as a conventional food in marketing materials. This is reportedly the first warning letter of its kind since FDA issued its final guidance on liquid dietary supplements in January 2014.
“Your use of the term ‘dietary supplement’ below the nutrition Facts panel on your product labels does not make your products dietary supplements, because your lean slow motion…potion products are represented for use as conventional foods,” wrote FDA District Director Patricia Schafer. Citing Dewmar’s description of its products as beverages on the cans’ information panels and referencing the company’s Website, which refers to the products as the “#1 relaxation beverage” and “the most potent relaxation drink,” FDa noted that Dewmar’s products (i) “have the appearance and packaging of carbonated soft drinks”; (ii) include a nutrition Facts label; (iii) are sold in single-serving pop-top aluminum cans and appear to be carbonated soft drinks; and (iv) contain “typical ingredients for carbonated soft drinks,” such as citric acid, carbonated water and sugar.
The agency has also called into question Dewmar’s use of melatonin, a neurohormone predominantly used as a sleep aid to treat sleep-related disorders. according to the agency, because lean slow motion…potion is effectively marketed as a beverage, and melatonin is an unapproved food additive under section 409 of the Federal Food, Drug, and Cosmetic act, the product is considered an adulterated food and should be removed from the market.