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. 

Cell Renew contains oxygen and hydrogen, plus minerals like copper and zinc, and was promoted as having antibacterial, antiviral and antifungal properties for the treatment of infection. Cell Silver contains similar ingredients, in addition to silver, and was promoted for the treatment of viral and bacterial infections and for the repair of lung damage resulting from emphysema.

Cell Renew Essential Silica contains a blend of minerals, amino acids and enzymes as well as silica. It was promoted for healthy skin, immune health, and healthy aging.

See ConsumerLab.com's Reviews of Zinc Supplements and Multivitamin and Mineral Supplements for tests of products with similar ingredients. Also see the answer to the question, Is ingesting colloidal silver helpful for any condition and is it safe to use? for more information.

For more details regarding the FDA's warning letter, use the link below.