FDA Warns Dewmar International Over Melatonin in Lean

Is it a beverage in a dietary supplement’s clothing, or is it vice-versa?

The FDA has sent a warning letter to yet another relaxation drink company, Lean Slow Motion… Potion, over confusing label claims that indicate the brand is a dietary supplement despite its being marketed largely as a beverage.FDA

According to the letter, dated March 27 to Dewmar International – the maker of Lean, which has been on the market for several years – the brand calls itself a dietary supplement but uses a “Nutrition Facts Panel,” which is required for food or beverage products.

Additionally, the brand’s use of melatonin – an amino acid known for its sleep-inducing properties – is called into question by the FDA in the letter. According to the agency, because Lean is effectively marketed as a beverage, and melatonin is not approved for use as a safe food additive (the designation usually represented by the acronym GRAS, or Generally Recognized as Safe), the product is considered an adulterated food and needs to be removed from the market.

“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… products are represented for use as conventional foods,” Patricia K. Schafer, the FDA’s New Orleans district director wrote to the company.

Reached by BevNET, Dewmar International CEO Marco Moran said his company was preparing a formal response.

“We’ve taken the necessary steps to be able to effectively and immediately respond to the FDA,” Moran said. “We are extremely confident that we will have the matter resolved without any irreparable damage to the brand or to the company, as we are working in full cooperation under the guides, rules and regulations set forth by the FDA to handle the matter accordingly.”

Lawyer Justin Prochnow, who handles FDA cases regularly, noted that the agency’s pursuit of Lean is in keeping with its recently announced intention to enforce consistent labeling of food and supplement marketing. It’s also reflective of an ongoing agency concern about the use of melatonin as a food additive rather than a supplement, something it has expressed in letters in the past to companies like Drank and Slowtivate and the brownie company Lazy Cakes.

“It’s not GRAS for beverage,” Prochnow said. “That’s what they have a problem with.”