The NDI notification process is not for the faint-hearted, with a large percentage of firms going through it emerging at the other end with a thumbs-down from the FDA, noted Embria’s regulatory counsel Kevin Boot.
"The clean acknowledgement letter Embria received from the FDA signifies the successful completion of the NDI process, which is something many suppliers and manufacturers are still struggling to attain.”
No concern about immune fatigue
He added: “EpiCor received a clean acknowledgement letter that means all populations can take EpiCor year round. The safety of EpiCor confirmed there’s no concern about immune fatigue, which can be a concern for other immune ingredients."
As EpiCor was technically ‘grandfathered in’ as a dietary ingredient safe for use in supplements under the 1994 Dietary Supplements Health and Education Act, it was not formally required to go through the NDI process, noted Embria’s president Paul Faganel.
"This positions Embria as a more trusted source for our partners, and provides additional assurance to our existing and future clientele that we have exercised our due diligence.”
A range of immune-related benefits
A dried product derived from a proprietary multi-stage fermentation process that produces beneficial metabolites containing vitamins, minerals, amino acids and antioxidants, EpiCor is claimed to help activate Natural Killer (NK) cells, which play a key role in the innate immune system, the body’s first line of defense against invading pathogens.
Research suggests that EpiCor also works when the adaptive immune system kicks in by activating B cells, which support antibody production, claims Embria.
Finally, EpiCor also contains antioxidants that mop up harmful free radicals.
Clinical studies on EpiCor link it 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).
The ingredient, which received self-affirmed GRAS (generally recognized as safe) status in May 2006, is distributed in the US by B&D Nutritional Ingredients, and used in a variety of supplements from Agro Labs’ Superfruit Immune Booster to Natrol’s Immune Boost, Now Foods’ EpiCor Plus Immunity product and Garden of Life’s Immune Balance DAILY supplement.