Embria announces new GRAS level for EpiCor

Embria Health Sciences has announced GRAS designation for its EpiCor ingredient that gives new reassurance of its safety at intake levels 6 times higher than the previous GRAS designation.

EpiCor is a yeast fermentate an a natural high-metabolite immunogen reported to have the antioxidant (ORAC) potency three times that of any known fruit. It is said to cause a four-fold increase in the activity of the 'natural killer' cells that guard the immune system.

In 2006, EpiCor was the subject of a GRAS determination that allowed it to be used at a proposed maximum daily level of 500mg. But while studies have established that the ingredient is efficacious at a dose of 500g, consumers sometimes consume more than one serving of a product.

Now, following a safety and toxicology review by an independent panel of scientists, the ingredient is GRAS at a level of 3g per serving for all food and beverages. This means that even if someone were to consumer more, the safety data shows it is still safe up to this level.

Paul Flaganel, president of Embria Health Sciences, said: “EpiCor’s GRAS determinations give functional food and beverage makers the opportunity to meet consumer demand for safe and effective immune balancing products that can be conveniently incorporated into their daily diet.”

The panel included scientists with regulatory, pharmacology and toxicological experience, including some with affiliations to the Food and Drug Administration, Environmental Protection Agency, and the National Institutes of Health.

EpiCor can be used in a broad range of food and beverage products, including bars, breads, juices, snacks, hard candy, soups, spreads and tofu.

Human clinical studies have indicated that it can decrease the incidence of seasonal allergy symptoms. Last year, a study published in the journal Urologic Nursing reported that supplementation with EpiCor, can boost the immune system and reduce the occurrence of cold and flu symptoms by 21 per cent.