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Posted July 19, 2012

FDA Warns Company Selling Mineral Supplements as Treatments

On June 28, 2012, the FDA issued a warning letter to Prismic Light International for multiple Good Manufacturing Practices (GMP) violations, promoting dietary supplements as drugs, and misbranding products. Manufacturing violations included not maintaining written procedures, failing to calibrate equipment and failing to perform identity testing on ingredients. Prismic Light's Cell Renew and Cell Silver were declared unapproved new drugs by the FDA because of therapeutic claims made by the company. In addition, these supplements, and another supplement, Cell Renew Essential Silica, were found to be misbranded because certain nutrition and serving size information was missing from the products' labels. 

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