Embria Health

Safety and Efficacy

A whole food is natural and minimally processed. EpiCor is made using the same safe and natural yeast (Saccharomyces cerevisiae) used in making bread. The whole yeast cells go through a specialized fermentation process where S. cerevisiae cells produce beneficial metabolites. This high-metabolite, nutritious broth is then gently dried down to a powder. Nothing is extracted, synthesized or purified.

Yes, multiple published safety and human clinical studies confirm that EpiCor is safe for adults and children. Also, an independent panel of food safety experts concluded EpiCor meets FDA requirements to be considered GRAS (Generally Recognized as Safe). Finally, Embria provided to the US Food and Drug Administration comprehensive safety data on EpiCor as part of its New Dietary Ingredient Notification.

Embria successfully submitted a New Dietary Ingredient (NDI) notification to the FDA for EpiCor. Manufacturers can have the peace of mind knowing that choosing EpiCor means being in full compliance with the Federal Food, Drug, and Cosmetic (FD&C) Act pertaining to new ingredients introduced into the marketplace after October 14, 1994.

A daily consumption of up to 3.0 grams (3,000 mg) of EpiCor is acceptable for adults and up to 500 mg of EpiCor for children over the age of four years old. Although higher levels may also be safe, these are the levels presented in Embria’s NDI for EpiCor.

All of the published human clinical trials were done on healthy adults consuming a daily dose of 500 mg of EpiCor. Embria used the accepted practice of attributing efficacy to children based on body weight in our NDI with the FDA and established that the efficacious dose of EpiCor for children is a daily dose of 125 mg of EpiCor for every 40 lbs. of body weight.

EpiCor is considered Generally Recognized as Safe (GRAS) according to an independent panel of experts who evaluated a comprehensive body of peer-reviewed literature and related information regarding the safety, identity, method of manufacture, composition and specifications for EpiCor. Based on this review, the experts concluded that EpiCor is GRAS for use as a nutritional supplement, a flavoring agent and an antioxidant in all food at levels as high as 3.0 grams daily.

This GRAS determination complies with the Federal Food, Drug and Cosmetic Act (FD&A) as well as the other laws and regulations administered by the U.S. Food and Drug Administration (FDA), which include it’s policies for all GRAS determinations and notifications. The GRAS panel was comprised of independent experts with extensive knowledge in the areas of food safety and toxicology. Their backgrounds included former leadership roles within the FDA, U.S. Environmental Protection Agency (EPA), and other governmental and academic institutions that focus on health and safety.

EpiCor is the dried fermentate resulting from the anaerobic fermentation of Saccharomyces cerevisiae, which has a history of safe use that goes back for thousands of years. The technology for EpiCor brand dried fermentate has been studied and used for over 70 years. All nutrients used to manufacture EpiCor are “food grade” and of the highest quality.

To further substantiate EpiCor’s safety, Embria commissioned a scientific paper on the safety of EpiCor, which was published in the peer-reviewed International Journal of Toxicology. An online abstract of the article can be found at:http://ijt.sagepub.com/content/31/1/34.

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