FAQs for Manufacturers.
If you have questions, we have answers. From manufacturing to marketing and efficacy, we have the information manufacturers need to make informed decisions with Wellmune®.
What is Wellmune?
Wellmune is a natural food, beverage and supplement ingredient clinically proven to help strengthen the immune system making it easier for people of all ages to be well and stay well. A proprietary baker’s yeast beta 1,3/1,6 glucan, Wellmune is patented, Kosher, Halal, non-allergenic, gluten-free, organic compliant and available in Non-GMO Project Verified.
What products contain Wellmune?
Wellmune is currently in hundreds of foods, beverage and supplement products in more than 60 countries worldwide. Wellmune can be used in a variety of applications, including:
|Yogurt||Juices & Smoothies||Capsules & Tablets|
|Sports & Nutrition Bars||Enhanced Waters||Gummies & Chewables|
|Meal Replacements||Children’s Beverages||Powdered Mixes|
|Snacks & Granola Bars||Sports & Energy Drinks||Shots|
|Milk & Other Dairy||Soft Gels|
How is Wellmune labeled in the ingredient statement?
Regulatory requirements vary by market or country in how Wellmune, the natural immune health ingredient is labeled in an ingredient statement. The U.S. FDA recognized name for this ingredient listing is “baker’s yeast beta glucan.”
What marketing claims can be made with Wellmune?
Over a dozen clinical studies demonstrate Wellmune has been shown to help:
- Improve general immune health.
- Maintain overall physical health.
- Protect against the harmful effects of stress.
- Promote healthy energy levels and mental clarity.
Regulatory requirements vary by market or country around claims that can be stated about Wellmune. We encourage our customers to consult with their legal counsel before finalizing their label claims but actively work with our partners in this area.
What is the market for immune-enhancing products?
Great opportunities exist to use nutrition for immunity benefits. As a top-desired consumer benefit—second to only general health and wellness—demand is high for foods and beverages that provide immune support. Additionally, immune health supplements are projected to grow 39% through 2020.
As functional food, beverage, and supplement markets evolve, immune health ingredients that are safe, natural and clinically-proven will lead to stronger innovation and resonate with consumers.
What is the difference between Wellmune and other immune health ingredients?
- Solid and consistent clinical results support the overall effectiveness of Wellmune across a broad range of consumers (athletes, children, older adults, and individuals with stressful lifestyles), and covers safety, mechanism of action, and human clinical studies.
- The vast majority of Wellmune clinical studies have been published in peer-reviewed science or medical journals.
- The research supporting Wellmune, which demonstrates biomarker outcomes and physical health outcomes, was conducted with on our own ingredient/biological strain. This is important because the efficacy of functional ingredients is affected by its chemical structure, which varies by biological strain.
- Wellmune is a leading global brand recognized by consumers for its clinically-proven immune health benefits and can meet the growing demand for immune health products.
What is the effective serving size for Wellmune?
An efficacious daily serving varies based on age and weight. Wellmune’s clinical research supports a recommended serving of 250 mg per day for adults and 35mg–100 mg for children depending on age.
Product formulation & manufacturing.
In what type of formulation application is Wellmune available?
It is available in two powder forms:
- Dispersible for food and select beverage applications.
- Water soluble for certain beverage applications with clarity or other manufacturing requirements. In water at 1mg per milliliter, soluble Wellmune is odorless, clear and has a mild if any, taste.
Where is Wellmune manufactured?
Wellmune is produced in at multiple GMP-qualified facilities in the Americas.
Is Wellmune stable?
Yes. As a dry ingredient, Wellmune has a five-year shelf life from the date of manufacture. Wellmune has not encountered food-processing conditions that diminish its efficacy.
Are there any food or beverage formulation restrictions?
Wellmune is compatible from a flavor and stability standpoint and with most processing conditions encountered in food or beverage manufacturing. Products should align with the goals of health and wellness, and formulated to which Wellmune benefits can be achieved with daily use.
What quality standards are in place?
Kerry is dedicated to excellence in food safety and quality and is a partner you can trust. Our ultimate aim is to help you make products your consumers enjoy and in which they have complete confidence. All Kerry manufacturing facilities are certified against one or more Global Food Safety Initiative (GFSI) programs.
How does Wellmune help strengthen the immune system?
Wellmune is taken up into the body through specialized immune tissue in the intestines. There, immune cells engulf Wellmune and degrade it into smaller fragments that bind to neutrophils, the most abundant immune cells in the body. Primed by Wellmune, neutrophils more quickly recognize and kill foreign challenges such as bacteria or viruses.
What clinical studies demonstrate the effectiveness of Wellmune?
Over a dozen peer-reviewed, published studies consistently demonstrate Wellmune has significant immune benefits across several market segments including sports nutrition, healthy aging, and families and children. Using industry accepted clinical methods and designs (randomized, double-blind placebo-controlled study design), the scientific understanding of Wellmune’s mechanism of action in the body is well documented in published, peer-reviewed research. Clinical studies have consistently demonstrated:
- The ability of Wellmune to support healthy human immune responses to stress in a variety of populations.
- That Wellmune reduces the incidence of upper respiratory tract infection symptoms and improves an overall sense of well-being in people of all ages experiencing physical or lifestyle stress.
Is Wellmune safe and effective for those with diseases or health conditions?
Wellmune has been well-studied for safety and immune health benefits. Research also demonstrates that Wellmune does not over-stimulate the immune system. Wellmune enhances natural immune function and is safe for daily consumption.
What is the method used to measure the active component in Wellmune?
Wellmune Glucan Enzymatic Method (GEM®) is a solution to shortcomings of traditional glucan assays. The inability to distinguish or differentiate between polysaccharides often results in an overestimation of the actual beta glucan content. GEM relies upon selective enzymes that are specific for beta glucan and break it down to glucose while leaving other polysaccharides intact. The GEM analytical methods were adopted by the United States Pharmacopeia for the development of the first official monograph for beta glucan from baker’s yeast. The monograph was published in the Food Chemicals Codex and the USP Dietary Supplements Compendium, internationally recognized compendiums of standards for the purity and identity of food and supplement ingredients.
What scientific publications provide information about Wellmune’s technology?
Research on Wellmune has been published in leading peer-reviewed science and medical journals, including Nature, Nutrition, Journal of Nutrition & Food Sciences, British Journal of Nutrition, Journal of the American College of Nutrition, Journal of Sports Science and Medicine, and Journal of Applied Research. A complete listing of journals can be found on our Research page.