CHICAGO, IL (February, 2005) – PharmaNutrients, a leading research and development company and supplier of proprietary, science-based nutritional ingredients, announced its formal filing of structure-function claims with FDA for numerous body composition benefits associated with CLA One.
PharmaNutrients notified the Food and Drug Administration (FDA), Office of Nutritional Products Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition of the following claims:
-CLA One reduces body fat
-CLA One maintains lean body mass
-CLA One increases lean body mass
These structure claims are direct statements that are easy for consumers to understand. Most importantly, these claims are supported by studies published in peer-reviewed journals. Dr. Susie Rockway, Director of Research and Development at PharmaNutrients, stated: “Having been involved with the initial CLA research with the dairy industry in the late ‘80’s, it is gratifying for me to see the tremendous growth in scientific interest and understanding of CLA’s role in physiological parameters. CLA research has moved from its initial discovery as a potent anti-carcinogen, to now we are seeing results that CLA reduces body fat stores while preserving and increasing muscle mass.”
With this submission, CLA One now holds a stronger position in the body composition category. As the only US-produced CLA, PharmaNutrients’ CLA One also includes WARF-cla patent licenses, comprehensive scientific data and FDA-filed structure-function claims.
Mark Nottoli, President and founder of PharmaNutrients explained: “This filing strengthens and reinforces our position as a leader in CLA innovation and research. This is the first in a series of structure-function claims we expect to file in the coming year. Our customers now have powerful, validated claims they need to be successful in the marketplace. We are also excited about our upcoming launch of an entirely new cla technology, CLA One DG (diglyceride) in the next few weeks.”
Dr. Rockway further stated: “The characteristic of CLA to “save” muscle tissue while burning fat calories provides a healthy, complementary approach to dieting and exercise. Increasing muscle mass, a highly metabolic tissue, increases tone and promotes a better ability to utilize calories.”
About PharmaNutrients, Inc.:
Dedicated to creating products to enhance wellness, PharmaNutrients (www.pharmanutrients.com) supports research investigating fatty acids and soluble fibers. The company's activities encompass multiple technology platforms focused on creating solutions to obesity-related health issues including weight management, inflammation, diabetes and cardiovascular health. PharmaNutrients’ conjugated linoleic acid and chitosan-based products are used in a wide range of dietary supplements.
PharmaNutrients is recognized for creating the first nutritional dietary supplement targeted at “Body Composition” by introducing Tonalin CLA and creating the “Fat Binding” market with Absorbitol brand chitosan complex. Since its de-merger with Natural ASA of Norway in 1999, PharmaNutrients has developed new applications for CLA beyond the established weight management market. The firm’s efforts focus on promising research demonstrating CLA may help maintain a healthy heart and veins, healthy cholesterol and triglyceride levels, and act as an anti-oxidant and exhibit anti-atherogenic properties.
Mark A. Nottoli, President