FDA WARNING_LETTER - www.sharco.tv

The FDA's Center for Biologics Evaluation and Research reviewed the websites http://www.shacro.tv and http://biologicalmiracle.com, determining that the product "SHACRO" is promoted for conditions that classify it as an unapproved drug under section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 USC 321(g)) and a biological product under section 351(i) of the Public Health Service Act (42 USC 262). The websites make numerous therapeutic claims, including treating serious infectious diseases like Cancer, HIV, Herpes, Avian Flu, Swine Flu, pneumonia, and Parkinson's disease, and feature testimonials asserting cures for various ailments. The FDA states that to introduce a biologic into interstate commerce, a valid biologics license is required, or an investigational new drug application (IND) for clinical use. SHACRO lacks both an approved BLA and an IND. Consequently, the shipments of this unapproved product violate the Act and PHS Act (21 U.S.C. 331). The firm is required to take prompt action to correct these violations and notify the FDA in writing within 15 working days of the steps taken or planned, with failure to comply potentially leading to regulatory actions such as seizure or injunction.