FDA WARNING_LETTER - Complete H2O Minerals Corporation - June 05, 2014

An FDA inspection of a dietary supplement manufacturing facility in West Columbia, SC, from June 3-5, 2014, revealed serious violations. Several products were deemed unapproved new drugs and misbranded drugs due to disease treatment/prevention claims on their labels (e.g., "vital for repair of blood vessels," "antiparasitic," "reduce the risk of diabetes," "antibacterial, antiviral, and antifungal," "effective in conjunction with cancer treatments," "anti-inflammatory effects," "vital for wound healing," "alleviating elevated blood sugar levels," "lower blood pressure," "fight cavities," "attenuate nitric oxide production," "vasoconstriction," "prevention of osteoporosis," "preventing heart disease"). These products are not generally recognized as safe and effective, lacking FDA approval, and are misbranded as they lack adequate directions for layperson use.

Additionally, the facility's dietary supplements were adulterated due to non-compliance with current good manufacturing practice (cGMP) regulations (21 CFR Part 111). Violations included: failure to establish finished product specifications (21 CFR 111.70(e)), lack of written master manufacturing records (21 CFR 111.205(a)), failure to prepare batch production records (21 CFR 111.255(a)), absence of written quality control procedures (21 CFR 111.10