FDA WARNING_LETTER - Nova Products, Inc. - March 21, 2014

The FDA issued a Warning Letter to Nova Products, Inc. on September 26, 2014, following inspections from January 13 to February 7, 2014, and March 21, 2014. The letter identifies several products, including "Xzone 1200," "Mojo Risen," "Black Ant," "African Black Ant," "Xzen 1200," "Xzen Gold," "Xzone Gold," and "Xzen Platinum," as unapproved new drugs and misbranded drugs.

Laboratory analysis confirmed these products contain undeclared active pharmaceutical ingredients: sildenafil (in all listed products) and tadalafil (in "Xzone 1200," "Xzen 1200," "Xzen Gold," "Xzone Gold," and "Xzen Platinum"). Sildenafil and tadalafil are active ingredients in FDA-approved prescription drugs (Viagra and Cialis, respectively) for erectile dysfunction. Since these ingredients were not marketed as dietary supplements or food prior to their drug approval, the products are excluded from the dietary supplement definition and are considered unapproved new drugs under FDCA sections 505(a) and 301(d).

Furthermore, the products are misbranded under FDCA sections 502 and 301(a) because they are prescription drugs lacking adequate directions for use (502