FDA WARNING_LETTER - Prolatis - August 05, 2010

On December 2, 2010, the FDA issued a Warning Letter to Prolatis (aka Hyper Interactive Media, LLC and Crush, LLC) regarding their product "ProLatis'." The letter states that "ProLatis'" is an unapproved new drug and is misbranded.

On August 5, 2010, FDA investigators obtained two samples of "ProLatis'" which, despite being labeled as a dietary supplement, were found to contain sulfoaildenafil, an analogue of sildenafil (the active ingredient in Viagra). The product's labeling, with claims like "All-Natural Male Performance Pill" and "Take 1-2 capsules 2 hours before sexual activity," indicates it is intended to affect the body's structure or function, classifying it as a drug under section 201(g)(1)(C) of the Act. Since sulfoaildenafil is a synthetic active pharmaceutical ingredient, not a nutrient or dietary ingredient, claims about sexual function improvement do not conform to section 403(r)(6) of the Act.

"ProLatis'" is considered a new drug under section 201(p) because it is not generally recognized as safe and effective. Its distribution without an FDA-approved application violates sections 301(d) and 505(a) of the Act. Furthermore, it is a prescription drug under section 503