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Wellmune approved as novel food in the EU

Our team is preparing to travel to Vitafoods Europe in Geneva, Switzerland, next week. The timing couldn’t be better given the breaking news that Wellmune WGP is approved as a novel food in the EU, opening the door for broadscale incorporation of Wellmune in food and beverage products.

One year ago, the European Food Safety Authority issued a positive scientific opinion on Wellmune as a novel food.

We have two European distributors. Immetec is our primary distributor with the exception of Italy where our distributor is DKSH. According to Jan Oddvar Johansen, Immitec chairman, “Wellmune WGP is finally ‘ready to go’ in the European Union. The food and beverage industry has an unprecedented chance to capitalize on the commercial potential of introducing Wellmune to a market of savvy, increasingly health conscious consumers.”

He added, “The fact that Wellmune WGP will finally be available in Europe should transform the way in which governments, business and consumers approach preventative health. Make no mistake, this breakthrough could dwarf the impact that Omega 3 had several years ago.”

If you’re attending Vitafoods, be sure to visit Immitec at stand 1239 for more information. Several Wellmune experts from Biothera will be attending as well and we’re eagerly awaiting the NBT 2012 awards ceremony, as Wellmune is a named a finalist in the R&D category!

Making sense of nutritional supplement labels

Published on 29 February 2012 by in Blog

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Making sense of nutritional supplement labels

You’ve probably seen product information statements on supplements sold online or in stores. Sometimes the terms used in those descriptions, or on the labels, can be unclear or downright confusing! Here’s a glossary of commonly used terms and their significance.

Research Terms

Bioavailability – The rate at which our body absorbs a nutrient. If the bioavailability is too low, the nutrient might be expelled from our bodies before we can get its benefit.

Clinically proven – The product/ingredient has tested in a clinical study to see how it works in people, and the results support the health claim(s). To evaluate a “clinically proven” claim, look for multiple double-blind, placebo-controlled studies using that specific brand, that were conducted by university-level experts in that research field. Be sure that the product includes the same efficacious serving sizes used in the clinical studies.

Human clinical research – Research done using people as subjects. Participants are generally within a subject group that researchers believe are likely to benefit from the ingredient or product being tested.

In-vitro research – Research conducted on organs, tissues or cells outside of the living body.

In-vivo research – Research conducted on organs, tissues or cells within the living body.

Pre-clinical research – A stage of research that begins before clinical trials (testing in humans) can begin, and during which important data is collected.

Regulatory Terms

Efficacy – A measure of how effective an ingredient or supplement is at delivering its benefit.

Food grade – Meets standards set by the U.S. Department of Agriculture for human consumption.

GRAS-approved – “Generally recognized as safe” means the U.S. Food and Drug Administration agrees with the opinion from an independent panel of experts, which has reviewed science and safety data and determined that an ingredient or product is safe. The FDA issues “no objection” letters when it reviews a voluntarily submitted self-affirmed GRAS dossier and has no objections to the finding of the GRAS panel of experts.

Kosher – Foods or food products that have been processed in accordance with Jewish Dietary laws. In addition to religious and ethnic considerations, a Kosher certification may also be perceived to indicate higher quality.

GMO – Genetically modified organisms. Some nutritional supplements are GMO-free or will specify they are non-GMO. This means that no alteration was made to DNA of the food product used in an ingredient or supplement. Some groups are concerned that there is too little known about the long-term health impact of eating genetically modified foods.

Immune boosters – Also known as immunostimulators, these are substances such as herbs, vitamins and minerals that can stimulate the immune system to grow and multiply the number of infection-fighting cells in the body.

Naturally derived – A product that contains ingredients derived from nature with minimal processing.

Naturally occurring – An ingredient that is delivered in its natural form.

Other Important Terms

Nutraceutical – A combination of the words “nutrition” and “pharmaceutical,” it refers to any substance that is a food or part of a food and provides medical or health benefits.

Non-allergenic – Will not cause an allergic reaction.

Pharmaceutical grade – A term commonly used to indicate that the ingredients used in a supplement meet the highest standards for purity and concentration. The product must be at least 99 percent pure, without additives or unnecessary substances.

Monograph – Official standards that specify the kinds and amounts of ingredients that a drug or substance may contain, the directions for its use, the conditions in which it may be used, and any reasons to withhold its use. Monographs are published by the United States Pharmacopeia (see below).

United States Pharmacopeia (USP) – The USP is a nonprofit, scientific organization that sets standards for the identity, strength, quality and purity of medicines, food ingredients and dietary supplements manufactured, distributed and consumed worldwide. More than 130 countries rely on USP standards.

 

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EAGAN, MN — May 11, 2011 — The European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies has issued a positive scientific opinion on Wellmune WGP® as a novel food, Biothera, the manufacturer of Wellmune WGP, announced today.

Wellmune WGP would be the only yeast-derived beta glucan to receive the novel food designation and be permitted for use in foods, beverages and supplements in Europe.

Wellmune WGP is a natural ingredient that is clinically proven to safely prime the immune system to keep the body healthy.  Numerous peer-reviewed studies demonstrate that Wellmune WGP mobilizes billions of innate immune cells that are part of the body’s natural defenses without over stimulating the immune system.

“We are pleased with the finding of EFSA’s review of our clinical and safety data supporting Wellmune WGP,” said Richard Mueller, chief executive officer of Biothera.  “We have ongoing discussions with a number of companies about product concepts in anticipation of this opinion from EFSA.”

The novel food designation from EFSA will further expand worldwide regulatory approval of Wellmune WGP.  Food, beverage and supplement products containing Wellmune WGP are sold in more than 30 countries today.  Recently the China Ministry of Health also approved Wellmune WGP by giving the ingredient Novel Foods status.

Biothera’s European distribution partner is Immicare AB, based in Sweden.  Biothera also works with DKSH for distribution of its ingredients in Italy.  Contact information for Immicare AB and all Biothera distributors is available at http://www.wellmune.com/for-manufacturers/distribution/.

About Wellmune WGP
Wellmune WGP is a natural ingredient derived from the cell wall of a proprietary strain of baker’s yeast (Saccharomyces cerevisiae).  Wellmune WGP is patented, Kosher, Halal, non-allergenic and GMO-free.  The ingredient is recipient of an IFT Innovation Award and a Frost & Sullivan Excellence in Research Award. Wellmune WGP is a product of Biothera, a U.S. biotechnology company dedicated to improving immune health.  More information is available at www.wellmune.com or follow us on Facebook and Twitter.

Contact:
David Walsh
VP Communications
Biothera, the Immune Health Company
651-256-4606 (direct)
dwalsh@biothera.com