FDA WARNING_LETTER - Innovative Beverage Groups Holdings, Inc

The FDA issued a Warning Letter to Innovative Beverage Group, Inc. regarding their product "Drank," which contains melatonin. The FDA determined that "Drank" is adulterated under section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act because melatonin is an unapproved food additive.

The letter clarifies that any substance intentionally added to a conventional food must be used in accordance with a food additive regulation, be subject to a prior sanction, or be Generally Recognized As Safe (GRAS). The FDA states there is no food additive regulation for melatonin, no prior sanction, and no basis to conclude it is GRAS for use in conventional foods. The letter details the criteria for GRAS status, including common use prior to January 1, 1958, or scientific procedures requiring the same quantity and quality of evidence as a food additive approval.

The FDA cites scientific literature and a Natural Standard monograph highlighting safety concerns about melatonin, including increased spontaneous malignant tumor incidence in mice, toxicity to retinal photoreceptor cells in rats, potential drops in blood pressure, increased atherosclerotic plaque buildup, hyperglycemia in diabetics, reduced glucose tolerance, gynecomastia, decreased sperm count/motility, and unestablished safety in children, pregnant women, or those attempting pregnancy.

Given these safety concerns, the FDA concludes that melatonin in "Drank" does not meet GRAS criteria and is an unapproved food additive, rendering the product adulterated. Innovative Beverage