FDA WARNING_LETTER - Dr Benedict S Liao Md - June 04, 2013

The FDA issued a Warning Letter to Dr. Benedict Schue-Schie Liao of Garfield Medical Group, LLC / Oeyama-Moto Medical Group / Oeyama-Moto Cancer Research Foundation following inspections in October 2012 and May-June 2013, and a review of their website and product handout. The letter addresses the firm's "Allesgen" product, which is promoted as a drug under Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) due to claims of diagnosing, curing, mitigating, treating, or preventing diseases like cancer. The FDA determined "Allesgen" is an unapproved "new drug" under Section 201(p) of the Act, as it is not generally recognized as safe and effective. Consequently, its sale without an approved application violates Sections 301(d) and 505(a) of the Act. The firm's Investigational New Drug (IND) applications never went into effect, and FDA never authorized clinical trials, meaning the exemption under Section 505(i) and 21 CFR Part 312.40(a)(1) does not apply. Furthermore, "Allesgen" is misbranded under Section 502(a) of the Act because its labeling contains false and misleading representations, such as suggesting FDA review and permission for patient treatment. The introduction of this misbranded drug into interstate commerce also violates Section 301(a) of the Act. The firm is required to respond within fifteen working days, outlining specific corrective actions and prevention plans, or face potential legal action including seizure and injunction.