Biogenix USA, LLC – FDA Warning Letter, Aug 1, 2013

On July 12 – August 1, 2013, the FDA inspected a dietary supplement repacking and distribution facility in Alpharetta, GA. The inspection revealed that "HAM," "CE6," and "SARMZ" products are unapproved new drugs and misbranded drugs. Laboratory analysis confirmed "HAM" contains undeclared tadalafil and vardenafil, while "CE6" and "SARMZ" contain ostarine. Tadalafil and vardenafil are active ingredients in FDA-approved ED drugs (Cialis, Levitra) and were not marketed as dietary supplements prior to drug approval. Ostarine is under substantial clinical investigation as a new drug and was not marketed as a dietary supplement before its investigation.

These products are considered drugs because they are intended to affect body structure/function or treat disease, and are "new drugs" as they are not generally recognized as safe and effective. They are also prescription drugs due to potential harmful effects requiring practitioner supervision. Marketing these products without FDA-approved applications violates sections 505(a) and 301(d) of the FDCA.

Furthermore, these products are misbranded under section 502 of the FDCA because they lack adequate directions for use, and "HAM" is misbranded for failing to declare active ingredients, making its labeling false or misleading and lacking adequate warnings.

For other dietary supplement products, the facility failed to comply with