Embria Health Sciences, manufacturer of the immune-balancing ingredient EpiCor®, has successfully completed the Food and Drug Administration’s NDI (New Dietary Ingredient) Notification process. Kevin Boot, regulatory counsel for Embria Health Sciences, believes this accomplishment will have far-reaching benefits for the ingredient supplier and its customers.
"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," Boot said. "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."
Paul Faganel, president of Embria Health Sciences, believes this will make
EpiCor more desirable in the eyes of manufacturers. "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."
"Combined with the large body of clinical studies demonstrating EpiCor’s ability
to support year-round immune health, this milestone will give Embria’s partners
added confidence to take a quality product to market," added Boot.
Since EpiCor was covered under the FDA’s Grandfather clause, completing the
NDI Notification process was not a requirement for the Iowa-based ingredient
supplier. However, Embria was confident that completing the NDI process would
be an added benefit to their customers and manufacturing partners.
About Embria Health Sciences and EpiCor®
Embria Health Sciences combines science and nature to bring high-quality,
research-based natural ingredients to the global human nutrition market.
Embria’s flagship ingredient, EpiCor®, is an all-natural product that helps the
body balance the immune system and is manufactured using a proprietary
technology. EpiCor contains protein, fiber, vitamins, minerals, amino acids,
antioxidants and other metabolites that deliver nutritional benefits and support
immune health. Clinical studies have found EpiCor’s immune-balancing
properties provide year-round support by helping the body boost or suppress
immune response as needed. EpiCor was the first immune health ingredient to
receive the SupplySide West Scientific Excellence Award, in recognition of the
compelling clinical studies published in peer-reviewed publications such as the
Journal of Alternative and Complementary Medicine, Advances in Therapy and