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Posted June 7, 2013

Maker of Colloidal Silver and Mushroom Extract Supplements Warned For Manufacturing Violations and Drug Claims

On May 2, 2013, the FDA issued a warning letter to Earthborn Products, Inc., following a facility inspection which the dietary supplements Colloidal Silver 100 ppm TDS and Siberian Chaga Extract to be adulterated because they were were prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practices regulations for dietary supplements.

These violations include failure to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient and failure to include master manufacturing records written instructions for specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of a dietary supplement.

Statements made about Colloidal Silver 100 ppm TDS and Siberian Chaga Extract on labels and in brochures were found to be drug claims.

Colloidal Silver 100 ppm TDS was promoted for conditions like colds and flu, sinus infections, athlete's foot with statements such as "Anything that requires the application of a disinfectant, antiseptic ...or antibiotic, first try colloidal silver," and "The strongest and safest broad-spectrum antibiotic ever known."

(See ConsumerLab's answer to the question, Is ingesting colloidal silver helpful for any condition and is it safe to use? for more information.)

Siberian Chaga Extract is a mushroom extract promoted for flu, HIV and cancer, with statements such as "Chaga shows activity against HIV," and "a possible treatment for a wide variety of diseases and health problems, including... the flu... HIV and certain types of cancer."

Colloidal Silver 100 ppm TDS and Siberian Chaga Extract were also found to be misbranded because the labels failed to provide adequate directions for use.