The agency told New York-based INZ Distributors Inc it had 15 days to alter the marketing and formulation of Magic Power Coffee or remove the product from the market.
The FDA said the product was not classified as a food because it was not consumed primarily for its “taste, aroma, or nutritive value”, and if it was, it would be adulterated by the presence of hydroxythiohomosildenafil, therefore breaching section 402(a)(2)(c) of the Food, Drug and Cosmetic Act.
The fact that neither was it an approved drug meant it also breached sections 505(a) and 301(d).
Aside from the FDA taking umbrage at the product for containing hydroxythiohomosildenafil and making unauthorized treatment of disease claims, the warning letter illustrates current FDA thinking about the borderline between foods, drugs and food supplements.
The agency said the product’s marketing placed it as a drug even if its appearance was that of a food – or in this case coffee.
Magic Power Coffee labeling included the statement that, "for best results use approximately 30-45 minutes prior to engaging in sexual intercourse."
“The intended use of a product may be determined by, among other things, its labeling, advertising, and the circumstances surrounding its distribution,” FDA New York district director, Ronald M Pace wrote in the warning letter dated August 23.
It went on: “‘Magic Power Coffee’ is represented as a conventional food … For example, the product is labeled as coffee, and the label includes images of a cup of coffee and coffee beans, and a "Nutrition Facts" panel.”
But…“Due to the presence of the synthetic active pharmaceutical ingredient, hydroxythiohomosildenafil, and the above-mentioned label claims, Magic Power Coffee is not consumed primarily for its taste, aroma, or nutritive value. It is therefore a drug within the meaning of the Act. See Nutrilab v. Schweiker, 713 F.2d 335 (7th Cir. 1983).”