Embria Health Sciences, Ankeny, IA, has successfully completed FDA’s New Dietary Ingredient (NDI) notification process for EpiCor. Since EpiCor was covered under the FDA’s Grandfather clause, completing the NDI Notification process was not a requirement. However, Embria felt that completing the NDI process would be an added benefit to its customers and manufacturing partners.

"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," said Kevin Boot, regulatory counsel for Embria. “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."