Black International Enterprise, LLC dba Puba Store – FDA Warning Letter, Aug 19, 2013

On July 10, 2014, the FDA issued a Warning Letter to Black International Enterprises LLC dba Puba Store following an inspection from August 14-19, 2013. The FDA found that products marketed as dietary supplements—"Mojo Risen," "Xzen Platinum," "Xzen Gold," "Xzen 1200," "Xzen XPress," and "Xzone Premium"—were unapproved new drugs and misbranded.

Laboratory analyses confirmed these products contained undeclared active pharmaceutical ingredients (APIs): "Xzone Premium" had tadalafil, sildenafil, and dapoxetine; "Mojo Risen" had noracetildenafil; and "Xzen Xpress," "Xzen Gold," "Xzen 1200," and "Xzen Platinum" contained sildenafil and/or tadalafil. These APIs are active ingredients in FDA-approved prescription drugs for erectile dysfunction (Viagra, Cialis) or are sildenafil analogues, and dapoxetine is an SSRI.

The products are considered unapproved new drugs because they contain drug ingredients not marketed as dietary supplements prior to their drug approval dates, and their labeling makes drug claims (e.g., "rock hard erections," "prevent premature ejaculation"). They are misbranded because they are prescription drugs lacking adequate directions for layperson use and their labeling is false/misleading by failing to declare the potent APIs,