FDA WARNING_LETTER - Shoreside Enterprises Inc. - January 09, 2014

The FDA conducted an inspection of Shoreside Enterprises, Inc. in Tampa, FL, from January 6-9, 2014, focusing on their product "Triple MiracleZen Platinum Male Sexual Performance Enhancement." Laboratory analysis confirmed the product contains undeclared sildenafil, tadalafil, and dapoxetine, which are active pharmaceutical ingredients in FDA-approved prescription drugs or investigational new drugs. Consequently, "Triple MiracleZen Platinum" is excluded from the definition of a dietary supplement and is deemed an unapproved new drug under sections 201(p) and 505(a) of the FD&C Act, as it is not generally recognized as safe and effective and lacks an FDA-approved application. Furthermore, it is classified as a prescription drug under section 503(b)(1)(A) due to potential harmful effects requiring professional supervision. The product is also misbranded under sections 502(f)(1) for lacking adequate directions for use, 502(a) because its labeling is false and misleading by failing to declare the active ingredients, and 502(f)(2) for lacking adequate warnings, posing serious health risks. The introduction of this misbranded drug into interstate commerce violates section 301(a). The FDA acknowledged the voluntary destruction of other products and a nationwide recall of "Triple MiracleZen Platinum" initiated on January 16, 2014, but requested follow-up. The firm must respond within fifteen working days with corrective actions, documentation, and a timetable to prevent recurrence, or face potential legal action including seizure, injunction, and prosecution.