The Food and Drug Administration (FDA) recently issued a warning letter to the New York-based manufacturer of “Magic Power Coffee,” a product that purportedly contains the active ingredient used in erectile dysfunction medications. According to the letter, INZ Distributors, Inc., has marketed the coffee as a conventional food despite the presence of hydroxythiohomosildenafil, an analogue of sildenafil that is a phosphodiesterase type 5 inhibitor “well known to have an effect on the structure or function of the body.” The company has also included instructions to use its product “approximately 30-45 minutes prior to engaging in sexual intercourse.”
On the basis of the synthetic active pharmaceutical ingredient and these labeling claims, FDA has concluded that “Magic Power Coffee” is not primarily consumed “for its taste, aroma or nutritive value.” The agency has thus deemed the product an unapproved new drug and a misbranded drug in violation of the Food, Drug, and Cosmetic Act. “Furthermore,” the letter states, “if ‘Magic Power Coffee’ were a food, which it is not, it would be adulterated under section (402)(a)(2)(C) of the Act (21 U.S.C. § 342(a)(2)(C)).”
FDA has given INZ Distributors, Inc., 15 working days from receipt of the warning letter to correct these violations or risk enforcement action without further notice.