New toxicology data on the yeast fermentate was recently published in the International Journal of Toxicology, showing no safety concerns for the ingredient in a range of tests, including a year-long chronic oral toxicity study in rats.
In an email to NutraIngredients-USA, Larry Robinson, PhD, VP of scientific affairs at Embria Health Sciences, LLC said that the peer-reviewed safety article will help “simplify and speed up the company’s international registrations because foreign governments place great emphasis on the quality of safety data that's been published in recognized journals”.
"This publication in such a top-tier journal was easy to accomplish since the data was so strong and had already been used in our successful NDI notification and subsequent FDA acknowledgement.
“We'll also use this EpiCor now stands alone among immune health ingredients in the strength of our portfolio of scientific studies and published articles showing impeccable safety and efficacy,” added Dr Robinson.
EpiCor and Embria were born out of suspicions that the culture could have other uses following farmers' reports that their animals were not getting sick.
Moreover, in 2004 insurance adjusters noticed that Diamond V, Embria's parent company, employees had far lower sick rates than other workplaces. The company thought the culture could be boosting the immune systems of workers who handled it.
The ingredient is a fermentate preparation of Saccharomyces cerevisiae.
For the peer-review article, researchers from AIBMR Life Sciences, NIS Labs and the Central Veterinary Institute (Hungary) performed a series of toxicology studies, including tests for mutagenicity, genotoxicity or mitogenicity.
Results showed “no evidence of genotoxicity or mitogenicity […] in any of the in vitro or in vivo studies”.
In addition, 90 and one year studies with rats revealed no “toxic clinical symptoms or histopathological lesions […] in the acute, subchronic, or chronic oral toxicity studies”.
The no observable adverse effect level (NOAEL) for EpiCor was 1500 mg per kg of body weight per day, based on results of a 90-day study in rats, while the one year study indicated an NOAEL of 800 mg per kg of body weight per day.
Immune balance, not modulation
The ingredient has been linked to a range of immune-related benefits, including a reduction in cold- and flu-like symptoms in non-vaccinated individuals (Journal of Alternative and Complementary Medicine, Vol. 16, pp. 213-218), a reduction in the incidence and duration of cold and flu symptoms in subjects who had been vaccinated (Urologic Nursing, Vol. 28, pp. 50-55), and an improvement in allergy symptoms like runny nose (Advances in Therapy, Vol. 26, pp. 795-804).
Source: International Journal of Toxicology
Published online ahead of print, doi: 10.1177/1091581811425195
“Safety Evaluation of a Proprietary Food-Grade, Dried Fermentate Preparation of Saccharomyces cerevisiae”
Authors: A.G. Schauss, R. Glavits, J. Endres, G.S. Jensen, A. Clewell