FDA WARNING_LETTER - 221 Enterprises, LLC. - April 30, 2014

The FDA issued a Warning Letter to 221 Enterprises, LLC, regarding "S.W.A.G" (Sex With A Grudge), marketed as a dietary supplement. An April 2014 website review and laboratory analysis revealed "S.W.A.G" contains undeclared sildenafil, an active ingredient in the FDA-approved erectile dysfunction drug Viagra.

This renders "S.W.A.G" an unapproved new drug under sections 505(a) and 301(d) of the FDCA, as sildenafil was approved as a drug before being marketed as a dietary supplement. The product is also a drug under section 201(g)(1) due to its intended effects on the human body, as evidenced by claims like "improve blood flow to the penis" and "increase testosterone levels." It is further classified as a new drug under section 201(p) because it is not generally recognized as safe and effective.

Additionally, "S.W.A.G" is a misbranded drug under sections 502, 503, and 301(a) of the FDCA. Containing a PDE-5 inhibitor, it is a prescription drug requiring professional supervision, thus lacking adequate directions for lay use (502(f)(1)). The failure to disclose sildenafil makes its labeling false or misleading (502(