Innovative Beverage Group Inc.’s drink called “Drank” contains the unapproved food additive melatonin, the U.S. Food & Drug Administration (FDA) disclosed Tuesday.

Melatonin is a hormone that controls sleep and wake cycles.  It is sold as a food supplement.

FDA released a January 13 “Warning Letter” to the Houston-based Innovative Beverage Group, stating that the use of Melatonin in “Drank” means the beverage is adulterated or impure under the Federal Food, Drug, and Cosmetic Act.

“Any substance intentionally added to a conventional food, such as the beverage product “Drank,” must be used in accordance with a food additive regulation, unless the substance is the subject of a prior sanction or is generally recognized as safe (GRAS) among qualified experts for use in foods,” explained FDA’s Dallas Director Reynaldo R. Rodriguez.

“There is no food additive regulation in effect that provides for the safe use of melatonin, and we are not aware of any information to indicate that melatonin is the subject of a prior sanction.  Likewise we are not aware of any basis to conclude that melatonin is GRAS for use in conventional foods.”

Rodriguez’s letter to Peter Bianchi, chief executive officer of Innovative Beverage, was made public Tuesday by FDA.

FDA said melatonin is a neurohormone, primarily used for treatment of sleep disorders.   FDA cited studies that raise safety concerns about the use of melatonin as a food ingredient.  For example:

•    A 2001 study found that melatonin increased spontaneous malignant tumors, causing the authors to advise against it use as an anti-aging drug.

•    A recent study finding that melatonin is toxic to retinal photoreceptor cells.

•    The Natural Standard monograph finds melatonin should not be used by children or pregnant women, and reduces the sperm count in men.

“In light of these safety concerns, the use of melatonin in the beverage product “Drank” does not satisfy the criteria of GRAS status outlined above,” Rodriguez added.

FDA asked for prompt action from the Texas beverage maker to correct the violation.

Two other beverage companies received “Warning Letters.”  An Oct. 5 letter to Jamaica, NY-based Mystical One LLC and an Oct. 28 letter to Brooklyn, NY-based Juices International Inc. were also made public Tuesday.

Mystical One, which produces fresh carrot juice, does not have written Hazard Analysis and Critical Control Point (HACCP) and Sanitation Standard Operating Procedure (SSOP) plans.  Among FDA’s concerns are the practices that could lead to cross contamination, inadequate hand washing facilities, protection of food, packaging materials and food contact services, and keeping pests out.

FDA had similar findings for Juices International, which makes vegetable and fruit juices.  The company does not have a written HACCP plan for its various carrot juices to control food safety hazard of pathogens, especially to prevent botulism.

Those products have been implicated in “several instances of botulism poisoning from refrigerated carrot juice,” FDA noted.

Juices International also needs an SSOP plan.  Among its problems are flies and ants in production areas, poor hand washing facilities, cross-contamination issues, and food residue remaining in juicing machinery after cleaning.

FDA gives “Warning Letter” recipients 15 working days to respond to the agency with details on how they plan to comply with agency demands.   The companies have already had a chance to respond to an FDA 483, post inspection report.