Epicor achieves self-determined GRAS status
clearing self-determined GRAS status for its new immunogen
ingredient for use in functional foods.
The Iowa-based ingredients maker announced that its high-metabolite immunogen ingredient, manufactured through a fermentation process, has successfully achieved self-determined Generally Regarded as Safe (GRAS) status with the aid of an expert panel. The status has not been officially reviewed by the FDA though.
"We are seriously considering having the FDA review the self-determined GRAS decision at some point in the future," Embria Health Sciences president, Paul Faganel told NutraIngredients-USA.com.
In theory, GRAS status should help the company by bringing more credibility to its product.
Diamond V Mills, Embria Health Sciences' parent company initially stumbled on the idea for Epicor, an immunogen that claims to nourish the body's immune system.
"We knew it could help animals and humans, but we didn't know how," Stuart Reeves, R&D and technical services recently told NutraIngredients-USA.com.
For more than 60 years Diamond V has been making a propriety yeast culture to increase milk production in cattle. But when farmers reported their animals were not getting sick, the company suspected the culture could have other uses.
Further, in 2004 insurance adjusters noticed Diamond V employees had far lower rates of sickness than other workplaces. The company thought the culture could be actually boosting the immune systems of the workers who handled it.
Under the Federal Food, Drug, and Cosmetic Act any substance intentionally added to food is subject to pre-market approval by the Food & Drug Administration (FDA), unless it is already recognized among qualified experts as being safe. Ingredients for dietary supplements are not subject to this review.
