Embria Health

Product Manufacturer Questions

  • How can EpiCor be identified on a product label?
  • Can EpiCor be identified in other ways on a product label?
  • What are the Structure/Function claims for EpiCor?
  • What is the safe, maximum dose of EpiCor for adults and children?
  • What is the efficacious dose of EpiCor for adults and for children?
  • Is EpiCor heat stable?
  • What is EpiCor’s shelf life?
  • Can EpiCor be combined with other ingredients in formulations?
  • Is EpiCor a beta glucan?
  • Is EpiCor yeast?
  • Is EpiCor soluble?
  • Does the recommended dosage need to be taken in one dose?
  • What product delivery forms are possible with EpiCor?
  • Does EpiCor have a flavor?
  • What makes EpiCor a “whole food”?
  • Is EpiCor safe?
  • Does EpiCor have an NDI on file with the FDA?
  • What is the safe, maximum dose of EpiCor for adults and children?
  • What is the efficacious dose of EpiCor for adults and for children?
  • Is EpiCor Generally Recognized as Safe?
  • Has the safety of EpiCor been demonstrated?

Embria successfully submitted a New Dietary Ingredient (NDI) notification to the FDA for EpiCor. Manufacturers can have the peace of mind knowing that choosing EpiCor means being in full compliance with the Federal Food, Drug, and Cosmetic (FD&C) Act pertaining to new ingredients introduced into the marketplace after October 14, 1994.

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.

A daily consumption of up to 3.0 grams (3,000 mg) of EpiCor is acceptable for adults and up to 500 mg of EpiCor for children over the age of four years old. Although higher levels may also be safe, these are the levels presented in Embria’s NDI for EpiCor.

All of the published human clinical trials were done on healthy adults consuming a daily dose of 500 mg of EpiCor. Embria used the accepted practice of attributing efficacy to children based on body weight in our NDI with the FDA and established that the efficacious dose of EpiCor for children is a daily dose of 125 mg of EpiCor for every 40 lbs. of body weight.

EpiCor is considered Generally Recognized as Safe (GRAS) according to an independent panel of experts who evaluated a comprehensive body of peer-reviewed literature and related information regarding the safety, identity, method of manufacture, composition and specifications for EpiCor. Based on this review, the experts concluded that EpiCor is GRAS for use as a nutritional supplement, a flavoring agent and an antioxidant in all food at levels as high as 3.0 grams daily.

This GRAS determination complies with the Federal Food, Drug and Cosmetic Act (FD&A) as well as the other laws and regulations administered by the U.S. Food and Drug Administration (FDA), which include it’s policies for all GRAS determinations and notifications. The GRAS panel was comprised of independent experts with extensive knowledge in the areas of food safety and toxicology. Their backgrounds included former leadership roles within the FDA, U.S. Environmental Protection Agency (EPA), and other governmental and academic institutions that focus on health and safety.

EpiCor is heat and pressure stable under conditions normally found in food processing.

Embria has conducted real-time stability studies showing that EpiCor is stable for three years when stored as recommended in a dry environment in its original closed container. EpiCor is packaged in 25 kilogram poly-lined fiber drums.

EpiCor is the dried fermentate resulting from the anaerobic fermentation of Saccharomyces cerevisiae, which has a history of safe use that goes back for thousands of years. The technology for EpiCor brand dried fermentate has been studied and used for over 70 years. All nutrients used to manufacture EpiCor are “food grade” and of the highest quality.

To further substantiate EpiCor’s safety, Embria commissioned a scientific paper on the safety of EpiCor, which was published in the peer-reviewed International Journal of Toxicology. An online abstract of the article can be found at:http://ijt.sagepub.com/content/31/1/34.

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.

EpiCor is perfectly suited for further formulation to achieve maximum clinical results due to the documented modes of action identified in peer-reviewed journals. All the published clinical research on EpiCor has been done on the basis of a daily dose of 500 mg. Embria encourages manufacturers to refer to the Embria document, "Biochemical Markers Observed in EpiCor Studies” to determine how best to complement the benefits of EpiCor with other ingredients.

EpiCor is not a beta glucan. EpiCor is a natural whole food classified as “dried fermentate” resulting from a microbial fermentation. It contains many additional components that both strengthen and direct the proper immune response depending on the body’s needs.

EpiCor is not yeast. EpiCor is “dried fermentate” made using many ingredients including Saccharomyces cerevisiae (simple baker’s yeast); however these constituents and compounds are a minor part of the overall make-up of EpiCor.

EpiCor has been successfully formulated into ready-to-drink beverages and dry mixes. EpiCor is highly soluble and dispersible in water however, it is not 100% soluble.

The recommended daily adult dosage, 500 mg, does not need to be taken in one dose. It can be split into several dosages during the day.

EpiCor has been successfully formulating into two-piece, hard-shell capsules, time-release tablets, soft gels, chewable tablets, dry powders, concentrated drink mixes (i.e., “stick packs”), gummies, chews and lozenges.

EpiCor has a naturally pleasant savory. In addition, it can be successfully masked and formulated into chewable tables, drink mixes, gummies, soft chews and lozenges.

EpiCor is produced according to current Good Manufacturing Practices (cGMP) for food, as promulgated by the U.S. Food and Drug Administration (FDA) in Title 21 of the Code of Federal Regulations, Part 110. In addition, Embria applies FDA's principles for Hazard Analysis and Critical Control Point (HACCP) to prevent contamination from foreign matter. Embria’s cGMP standing is certified by NSF for the sale, distribution or use of EpiCor.

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