Embria Health

Labeling

The common and usual name for EpiCor is “dried fermentate (made using Saccharomyces cerevisiae).” This is the identity Embria used in its NDI notification to the FDA and in current documentations.

Embria acknowledges that the unique nature of EpiCor means that there may be additional ways to identify EpiCor. Therefore, manufacturers have some flexibility in how they decide to label EpiCor in the Supplement Facts or Nutrition Facts panel as well as in the Ingredients section. Please contact Embria’s Regulatory Affairs department for more information.

Since the finished goods manufacturer is responsible for ensuring the accuracy and truthfulness of Structure Function claims, the quality of the science of the ingredients in its formulas is extremely important. Six studies conducted on healthy adult populations and published in peer-reviewed journals support a wide range of possible structure/function (S/F) claims for EpiCor. Manufacturers will further find peace of mind knowing that the in vivo published studies on EpiCor with humans and animals and as well as in vitro studies were conducted using rigorous research protocols. Please contact Embria’s Sales department for S/F claims direction.

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