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Posted February 13, 2013

Herbal Supplement Maker Warned For Manufacturing Violations, Misbranding

On February 6, 2013, the FDA issued a warning letter to Genesis Herb Company LLC, following a facility inspection which found the company's Seizure, Relax, Formula ARTH, Disintegrate, Gout, Plantain, and Colloidal Silver dietary supplements to be adulterated because they were prepared, packed, or held under conditions which do not meet Current Good Manufacturing Practices regulations.

Violations of these regulations include failure to establish and follow written procedures for quality control operations, failure to prepare and follow a written master manufacturing record for each unique dietary supplement formulation, and failure to perform identity testing for incoming dietary ingredients.

Seizure, Formula ARTH, Disintegrate and Gout were found to be misbranded because the labels fail to identify the products as dietary supplements, as required by federal regulations.

Seizure, Relax, Formula ARTH, Disintegrate, Gout, Plantain, and Colloidal Silver were also found to be misbranded because the labels fail to bear a Supplement Facts panel.

Descriptions and ingredient lists for these supplements were not made available.

See ConsumerLab.com's answer to the question, Is ingesting colloidal silver helpful for any condition and is it safe to use? see Reviews of Valerian Supplements and Joint Health Supplements for tests of related products.