FDA issues Warning Letter to makers of "Viagra Coffee"

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Latest step in FDA's decade-long crackdown on so-called "dietary supplements" designed and marketed to treat erectile dysfunction and enhance sexual performance

This article was originally published in the Westlaw Journal Products Liability Report.

Recently, INZ Distributors, Inc./Magic Power Coffee, Inc (Magic Power) came under FDA scrutiny for the marketing of its Magic Power Coffee product, a product available only through online sales. The company claims its product is a "100% natural" dietary supplement that can enhance sexual performance. Despite being labeled as an all-natural dietary supplement, a laboratory investigation conducted by the FDA revealed that at least one batch of the coffee product also contained hydroxythiohomosildenafil, a similar compound of the drug sildenafil, the active ingredient in Pfizer's Viagra.

This undisclosed inclusion of a pharmaceutical component prompted the FDA to warn consumers on June 19, 2010 to avoid the product and to report any adverse health effects to the FDA. Despite a mass voluntary recall of all production dates up to May 8, 2010, the FDA then issued a Warning Letter to Magic Power on August 23, 2010, notifying the company that the current marketing and distribution of the Magic Power Coffee product was in violation of multiple provisions of the Federal Food, Drug and Cosmetic Act (the Act).

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