FDA Acknowledges EpiCor® NDI Notification

ANKENY, IowaEmbria Health Sciences successfully submitted a New Dietary Ingredient (NDI) notification for EpiCor® and received an acknowledgment letter from FDA. According to the notification, EpiCor is safe for all populations to take year round.

"Combined with the large body of clinical studies demonstrating EpiCors ability to support year-round immune health, this milestone will give Embrias partners added confidence to take a quality product to market," said Kevin Boot, regulatory counsel for Embria Health Sciences.

 EpiCor was covered under the FDAs "grandfather clause" because it was on the market prior to the passing of the Dietary Supplement Health and Education Act of 1994 (DSHEA), completing the NDI Notification process was not a requirement. However, Embria said it was confident that completing the NDI process would be an added benefit to their customers and manufacturing partners.

Embrias flagship ingredient, EpiCor®, is an all-natural product 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 EpiCors 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.