On April 24, 2013, the FDA issued a warning letter to Glucorell, Inc., following a facility inspection which found the company’s products, including Insulow and Tyler Liver Detoxification Factors, to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to establish and follow written procedures for the responsibilities of the quality control operations, failure to establish written procedures for the review and investigation of product complaints, and failure to establish and follow written procedures for handling returned dietary supplements.

A review of Glucorell’s websites also found statements made about Insulow and Tyler Liver Detoxification Factors to be drug claims.

Insulow contains lipoic acid and biotin. It was promoted for the treatment of diabetes, with statements such as “Insulow, recommended in Diabetes Solutions by Dr. R. Bernstein, is pure R+ Lipoic acid complexed with essential Biotin.”

(See ConsumerLab.com’s Reviews of Alpha Lipoic Acid Supplements and B Vitamin Supplements and Energy Drinks (Including Biotin)Supplements for tests of related products.)

Tyler Liver Detoxification Factors was promoted with statements such as “Detoxification Factors supplies the nutritional precursors & co-factors essential for both Phase I & Phase II liver detoxification pathways.”

(See ConsumerLab.com’s Review of Milk Thistle Supplements for tests of related products.)

To read the FDA’s warning letter, use the link below.