FDA WARNING_LETTER - Glucorell, Inc. / Anafit, Inc. - August 07, 2012

The FDA issued a Warning Letter to Glucorell, Inc. and Anafit, Inc., both located in Orlando, Florida, following inspections from July 24 to August 7, 2012. The firms, which hold and distribute dietary supplements manufactured, packaged, and labeled by contract manufacturers, were found in serious violation of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering their products adulterated.

Additionally, FDA's April 2013 review of the firms' websites (www.insulow.com and www.theafstore.com) revealed that Insulow and Tyler Liver Detoxification Factors products are promoted with therapeutic claims, classifying them as unapproved new drugs under the Federal Food, Drug, and Cosmetic Act. These products are not generally recognized as safe and effective for their claimed uses and lack FDA-approved applications. Insulow is also deemed misbranded due to inadequate directions for layperson use for a condition not amenable to self-diagnosis.

CGMP violations include: 1. Failure to establish and follow written procedures for quality control operations, including material review, disposition decisions, and approval for release of packaged dietary supplements (21 CFR 111.103, 111.140(b)(1), 111.127(h)). The firms lacked documentation of contract manufacturers' compliance and