Manufacturers Assured Ingredient is Safe for Use in
Functional Foods and Supplements
CEDAR RAPIDS, Iowa, May 30, 2006 - Embria Health Sciences announced today that its new high-metabolite immunogen ingredient, EpiCor (tm), has successfully achieved self-determined Generally Regarded as Safe (GRAS) status. The process involved an intense review of EpiCor's safety and toxicology data by an expert panel comprised of members with extensive Food and Drug Administration (FDA), Environmental Protection Agency (EPA) and National Institute of Health (NIH) experience.
"EpiCor's proven safety as exemplified by its supporting research and GRAS status will provide peace of mind to manufacturers," said Paul Faganel, Embria Health Sciences president and CEO, "We look forward to the positive impact we believe EpiCor will bring to the health of people worldwide."
Faganel said EpiCor is an all-natural, high-metabolite immunogen that nourishes the body's immune system to strengthen resistance and maintain wellness. It is manufactured through a proprietary, multi-stage fermentation and drying process called MetaGen4 (tm), and is safe for everyday use. EpiCor is new to the human nutrition market, although it is backed by more than 60 years of experience in animal nutrition products.
As part of the self-determination process, the expert panel was provided extensive ingredient information including the background of the ingredient, usage history, summary of anticipated daily intake and literature search. Upon completion of the material review, the panel then conducted a safety assessment. The panelists include:
---Theodore M. Farber, Ph.D., DABT (Chair) – Consulting Toxicologist. Previously with the Environmental Protection Agency (EPA) as Chief of Toxicology Branch, and with the Food and Drug Administration (FDA) as Director of Division of Drug and Environmental Toxicology.
---Norbert Page, Ph.D., DABT – Adjunct Professor of Toxicology at University of Maryland. Formerly held positions with the FDA, EPA and National Institute of Health (NIH) and was past president of the Society of Toxicology.
---Joseph Borzelleca, Ph.D., DABT – Professor Emeritus, Pharmacology and Toxicology at Medical College of Virginia and Virginia Commonwealth University and current editor for international journal, Food and Chemical Toxicology. Previously was president of the Society of Toxicology.
EpiCor's potential for impacting the human nutrition market was discovered by accident. In early 2000, executives and employees of Embria's parent company, a leading manufacturer of animal nutrition products, realized they had filed significantly fewer health insurance claims and had unusually low sick leave rates than employees of similarly sized companies. After the company's insurance provider confirmed the employees' observations, studies were conducted to determine if the employees' unusually good health was related to their handling of the company's fermented yeast products. The results showed that those who worked directly with the company's yeast products had increased natural killer (NK) cell activity, higher antioxidant activity, a better ratio of immune helper cells to suppressor cells and lower levels of undesirable immune complexes.
The executives realized they had an ingredient with the potential to benefit millions of people around the world and soon founded Embria Health Sciences to explore the human potential of the yeast products. After extensive research, EpiCor was developed specifically for the human nutritional supplement industry.
Embria Health Sciences, www.embriahealth.com, combines science and nature to bring high-quality, research-based natural ingredients to the global human nutrition market. Headquartered in Cedar Rapids, Iowa, Embria's key products are manufactured using a proprietary technology, which produces vital metabolites that deliver nutritional benefits and support increased bioavailability. Embria Health Sciences holds "Nutrition Business Journal's" 2005 product merit awards for its selenium ingredient, eXselen (tm).
# # #