‘Drank’ spanked by FDA over melatonin content

02-Mar-2010 - Last updated on 02-Mar-2010 at 18:35 GMT

The Food and Drug Administration has told a Texas start-up its melatonin-containing beverage breaches the Federal Food, Drug, and Cosmetic Act because the nutrient associated with promoting sleep is not approved as a food additive.

“We are not aware of any basis to conclude that melatonin is GRAS [generally recognized as safe] for use in conventional foods,” the FDA wrote in its letter to Innovative Beverage Group chief executive officer, Peter Bianchi.

The company has 15 days to either provide evidence backing the product’s safety or remove it from the market in its current form.

In its letter, FDA highlighted numerous studies and a monograph which referenced certain safety concerns in regard to melatonin.

“Various credible sources and reports in the scientific literature… describe information on melatonin that would raise safety concerns about its use as a food ingredient,” FDA wrote.

These concerns – usually in medical use of melanonin – included the potential to increase spontaneous malignant tumor incidence in female mice; loss of photoreceptor cells in aging retinas if significant exposure to sunlight is factored in; drops in blood pressure; increases in atherosclerotic plaque buildup; hyperglycemia in patients with type-1 diabetes; gynecomastia in men; decreased sperm count and motility.

The monograph said children and pregnant women should avoid melatonin.

“You should take prompt action to correct this violation and prevent its future recurrence,” FDA said. “Failure to do so may result in enforcement action without further notice.”

FDA added: “The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products. We want you to be aware that FDA did not conduct an all inclusive review of the labeling or ingredients for your product ‘Drank’ or other products you manufacture or distribute. It is the responsibility of a manufacturer to ensure that foods the firm markets are safe and otherwise in compliance with all applicable legal and regulatory requirements.”

In Europe, the European Food Safety Authority last week issued an opinion that affirmed melatonin’s ability to reduce the effects of jetlag but did not support its proposed sleep benefits.

That opinion can be found here.