FDA WARNING_LETTER - Earthborn Products, Inc. - September 25, 2012

On May 2, 2013, the FDA issued a Warning Letter to Earthborn Products, Inc., following an inspection of their dietary supplement manufacturing facility in San Diego, CA, on September 15 and 25, 2012. The letter identified significant violations regarding their "Colloidal Silver 100 ppm TDS" and "Siberian Chaga Extract" products.

The FDA determined that the products are unapproved new drugs under section 201(g)(1) and 201(p) of the Act, due to therapeutic claims on labels, brochures, and the company website (e.g., "Universal Antibiotic," effective against "650 different infectious conditions," "anti-tumor benefits," "effective against influenza virus and various cancer cells," "activity against HIV"). These claims establish the products' intent for disease treatment, prevention, or mitigation, requiring FDA approval under section 505(a). Furthermore, the products are misbranded under section 502(f)(1) because they lack adequate directions for layperson use for conditions not amenable to self-diagnosis.

Even if not classified as drugs, the products are adulterated under section 402(g)(1) for failing to meet Current Good Manufacturing Practice (CGMP) requirements (21 CFR Part 111). Specific CGMP violations include: 1. Failure to establish finished product