FDA WARNING_LETTER - Kanec USA, Inc. - April 19, 2010

On October 8, 2010, the FDA issued a Warning Letter to Kanec USA, Inc. following an inspection from March 31 to April 19, 2010. The inspection revealed significant violations concerning "STUD Capsule For Men" and "XOX For Men," labeled as dietary supplements.

Laboratory analysis confirmed "STUD Capsule For Men" contained sildenafil and "XOX For Men" contained sildenafil and tadalafil. These are active pharmaceutical ingredients in prescription drugs Viagra and Cialis, respectively, approved for erectile dysfunction. Since sildenafil and tadalafil were not marketed as dietary supplements or food prior to their drug approval dates (March 27, 1998, and November 21, 2003, respectively), these products are deemed unapproved new drugs under sections 201(g)(1) and 201(p) of the Act. Their sale without FDA-approved applications violates sections 301(d) and 505(a).

Furthermore, these products are considered prescription drugs under section 503(b)(1)(A) due to potential harmful effects requiring professional supervision. They are misbranded under section 502(f)(1) because their labeling lacks adequate directions for lay use, as sildenafil and tadalafil require professional supervision. The products are also misbranded under section 502(a)