EstroG-100 OKd for Sale in Canada

ORANGE COUNTY, Calif.Health Canada and the Natural Health Products Directorate (NHPD) approved of the use of EstroG-100 in Canada by issuing Product License Number 80026169 to Sunbio CORP. This designation allows product manufacturers to include EstroG-100 in supplements sold in Canada.

EstroG-100 is a blend of phytochemicals that contain phytoestrogen developed by screening 71 herbal extracts via non-reproductive tract target tissue response for their effects on menopausal symptoms.

FDA provided Sunbio with a letter of no objection in October 2010, in response to Sunbio's EstroG-100 filing for an NDI (new dietary ingredient) status. The recent validation of EstroG-100 by Health Canada means the ingredient can be sold in both the American and Canadian markets.

Clinical evidence on EstroG-100 includes a phase I and a phase II human clinical, a four-week toxicology, a 13-week toxicology, three genetic toxicology studies, a binding affinity test using the model created by NIH, a MCF-7 in vitro analysis showing no cancer affinity, and a liver protective study as validated by WHO.

Also, EstroG-100's USA-based Phase II, randomized, placebo controlled, human clinical study was recently peer-reviewed. These results will be published in the Journal of Phytotherapy Research in the coming months, according to the company.