FDA Warns Magic Power Coffee Marketer

BROOKLYN, N.Y.FDA issued a warning letter to INZ Distributors Inc., the online marketer of Magic Power Coffee, on Aug. 23, stating the product is an unapproved and misbranded drug. The agency noted laboratory analysis found Magic Power Coffee contains hydroxythiohomosildenafil, a chemical similar to the active ingredient in Viagra, a drug for treating erectile dysfunction (ED). FDA issued a consumer warning on the adulterated product in mid-June, urging consumers to cease using the product, as the drug compound can interact with other prescription medications and cause dangerously low blood pressure.

In its warning letter to INZ, FDA noted the directions for use and marketing of the product for enhancing sexual function position Magic Power Coffee as a drug; the presence of the drug compound also make the product a drug, although it is a new drug that has not been recognized as safe for intended use. Because the hydroxythiohomosildenafil is not declared on the product label, the product is therefore misbranded.

In addition, the agency observed Magic Power Coffee is described as a dietary supplement," but represented as a conventional food in its imagery and by using a Nutrition Facts" panel versus a Supplement Facts" panel. FDA noted while the product may be positioned as a food," it could not be lawfully marketed as such because the drug compound found in Magic Power Coffee is not GRAS nor subject of a prior sanction allowing its use in food products.