WASHINGTON—Dewmar International BMC Inc. is misrepresenting its beverage products as dietary supplements and selling a substance that is not proven to be safe, according to a March 27, 2014 warning letter from FDA.
The warning letter demonstrates that FDA considers a company's marketing materials, statements on its label and ingredients in deciding whether a product is a dietary supplement or a conventional food.
FDA wrote the warning letter just a few months after issuing its guidance distinguishing liquid dietary supplements from conventional beverages.
"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," Patricia Schafer, FDA's District Director of the New Orleans District, wrote.
In support of its position, FDA cited Dewmar's description of its products as beverages on the cans' information panels and referenced the company's website, which refers to its products as the "#1 relaxation beverage" and "the most potent relaxation drink."
FDA further pointed out Dewmar's products "have the appearance and packaging of carbonated soft drinks," include "a Nutrition Facts label" and contain "typical ingredients for carbonated soft drinks" such as citric acid, carbonated water and sugar. Additionally, the agency referenced a message on the website from Dewmar President Marco Moran, who referred to the company's products as "relaxation beverages" and "beverage brand."
FDA is not solely concerned with Dewmar's representation of its products as dietary supplements. Melatonin, a neurohormone that is predominantly used as a sleep aid, is an unapproved food additive and adulterated because it is not the subject of a prior sanction or generally recognized as safe (GRAS), according to the agency.
"FDA is not aware of data to establish the safety of melatonin for use as an ingredient in conventional foods. On the contrary, reports in the scientific literature have raised safety concerns about the use of melatonin," Schafer stated, citing melatonin's effects on blood glucose homeostasis, reproductive/developmental systems, cardiovascular, ocular and neurological systems.
FDA does allow melatonin in dietary supplements, which carry labeling restrictions for use and population. However, since Dewmar's Lean Slow Motion…Potion products are represented as conventional food, FDA does not consider it a supplement, despite the "supplement" wording on the label.
FDA raised similar concerns about melatonin in Lazy Cakes, a product represented as food, but labeled as a dietary supplement, in a 2011 letter to HBB LLC d.b.a. Baked World.
A spokesperson for Dewmar International BMC did not immediately respond today to a request for comment on the warning letter.
Food and dietary supplement lawyer Justin Prochnow, a shareholder with Greenberg Traurig LLP, said in an email that the letter "reinforces the notion that you must be consistent in your marketing and advertising of your products as supplements or beverages."
"This will likely not be the last letter industry sees over this issue," Prochnow added.