FDA WARNING_LETTER - INZ Distributors Inc. / Magic Power Coffee Inc.

On September 29, 2010, the FDA issued a Warning Letter to INZ Distributors, Inc. regarding their product "Magic Power Coffee." The FDA's laboratory analysis found that "Magic Power Coffee" contains hydroxythiohomosildenafil, an analogue of sildenafil (the active ingredient in Viagra), which is an FDA-approved drug for erectile dysfunction (ED).

The FDA determined that "Magic Power Coffee" is an unapproved new drug and a misbranded drug. It is considered a drug under sections 201(g)(1)(B)&(C) of the Act because it is intended to affect the structure or function of the body and for use as an ED treatment, as evidenced by the presence of hydroxythiohomosildenafil and claims like "Serving Passion One Cup at a Time" and directions for use prior to sexual intercourse. As a new drug, it violates sections 505(a) and 301(d) of the Act because no FDA-approved application is in effect for it.

Furthermore, "Magic Power Coffee" is a prescription drug under section 503(b)(1)(A) due to its potential for harmful effects, requiring professional supervision. It is misbranded under section 502(f)(1) because it lacks adequate directions for lay use, which is impossible for prescription drugs without an approved application. It is also misbranded under section 502(a