Posted April 11, 2013

Glutathione Supplement Maker Warned For Manufacturing Violations and Drug Claims

On April 5, 2013, the FDA issued a warning letter to The Glutathione Corporation following a facility inspection which found the company's supplements, including Ultrathione 500 Glutathione, Ultrathione 1000 Sports Pack, Ultrathione Performance, Ultrathione Extreme Performance, Ultrathione Health Pack, Ophthalmic Nutrients 1500, Ultimate Travel Smart & Strong, Guardian, and Ultrathione Extreme Performance Plus, to be adulterated because they were prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practices (CGMPs) requirements for dietary supplements.

These violations include failure to establish specifications for each component used in the manufacture of a dietary supplement, failure to prepare a written master manufacturing record for each unique dietary supplement formulation, and failure to establish and follow written procedures for the responsibilities of the quality control operations.

In addition, statements made on the company's website about Ultrathione 500 Glutathione, Ultrathione 1000 Sports Pack, Ultrathione Performance, Ultrathione Extreme Performance, Ultrathione Health Pack, Ophthalmic Nutrients 1500, Ultimate Travel Smart & Strong, Guardian, and Ultrathione Extreme Performance were determined to be drug claims.

These products were promoted for a variety of uses with statements such as "people who use APC's Glutathione products…have a significant reduction in Seasonal Respiratory Infections," and "GSH corrects pathologic processes that are found…in…diseases such as Pulmonary Emphysema, Cystic Fibrosis, Pulmonary Hypertension, and Diabetic Vascular Complications."

These products were also found to be misbranded due to improper labeling. The nutrition information, for example, was not enclosed within a Supplement Facts Panel box, as required by federal regulations.

See ConsumerLab.com's answer to the question, Do glutathione supplements work to prevent aging or for other conditions?, and see Reviews of Alpha Lipoic Acid Supplements and Vitamin C Supplements (both of which are thought to play a role in glutathione levels) for tests of related products.

For more information about this warning, use the link below.