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.