FDA Warns Bebida Beverage Company Over Use of Melatonin in KOMA Unwind

Screen Shot 2015-04-10 at 4.56.11 PMThe U.S. Food and Drug Administration (FDA) has issued a warning letter to North Carolina-based Bebida Beverage Company over the use of melatonin in Koma Unwind, its self-described “liquid relaxation drink.”

In a complaint dated March 4, the FDA stated that KOMA Unwind “is adulterated under Section 402 of the Federal Food, Drug, and Cosmetic Act, because it bears or contains an unsafe food additive.” Melatonin, a neurohormone used primarily as a sleep aid, gives KOMA Unwind its “unwinding” properties. Melatonin is only allowed to be packaged and sold in supplement form, and is not approved for use in food and beverages by the FDA.

While Koma Unwind is listed as a dietary supplement on its label, the FDA’s contention is that because the product is represented as a conventional food in several other capacities, including its description as a “lightly carbonated beverage” on its website and having a Nutrition Facts panel on its label, it is held to the standards of a beverage and therefore is not in compliance with its regulations.

“FDA is not aware of data to establish the safety of melatonin for use as an ingredient in conventional food,” the report reads. “On the contrary, reports in the scientific literature have raised safety concerns about the use of melatonin. Among these are concerns about effects on blood glucose homeostasis and effects on the reproductive/developmental, cardiovascular, ocular and neurological systems.”

The FDA took similar action against Revolt Distribution in 2012 for its use of melatonin in its Slowtivate relaxation drink. The company has since discontinued production of the product.

Bebida Beverage Company has been given 15 business days to respond to the FDA’s letter and address its plans to correct the aforementioned violations.