FDA WARNING_LETTER - RT Naturals, LLC - January 19, 2010

On July 15, 2010, the FDA issued a Warning Letter to RT Naturals, LLC, following an inspection from December 17, 2009, to January 19, 2010, and a review of their website, www.roaringtiger.com. The letter addresses violations concerning the marketing of "Roaring Tiger Male Performance Enhancer" patch, "Roaring Tiger Male Performance Enhancer Pre-Performance Wipes," "Roaring Tiger HD Black Label," "Roaring Tiger Virility +," and "Roaring Tiger Max."

The "Roaring Tiger Male Performance Enhancer" patch and "Roaring Tiger Male Performance Enhancer Pre-Performance Wipes" are deemed unapproved new drugs under sections 201(g)(1)(C) and 201(p) of the Act, and their sale violates sections 301(d) and 505(a). These topical products are not dietary supplements as they are not "intended for ingestion." The wipes also contain aminophylline, an FDA-approved drug, making them excluded from the dietary supplement definition per section 201(ff)(3)(B). Furthermore, the wipes are misbranded prescription drugs under sections 503(b)(1)(A) and 502(f)(1) due to lack of adequate directions for use, violating section 301(a