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GRAS Status

Author: Dr. Edward Group 05/26/2009
 

ChromeMate®’s GRAS Status

Nutraceuticals patented form of biologically active, niacin-bound chromium, has successfully been affirmed GRAS (Generally Recognized as Safe) for use in functional beverages by the Burdock Group, the nations leading toxicology specialists in evaluating the safety of food and beverage ingredients. The process involved an intensive review of all safety and toxicology data by a panel of scientific experts.

Generically known as chromium nicotinate or chromium polynicotinate, ChromeMate® is a unique, patented form of oxygen-coordinated, niacin-bound chromium that plays a vital role in proper insulin function, maintenance of healthy blood sugar and normal cholesterol levels, energy production, and promotion of healthy body weight. Protected by three U.S. Patents, four international patents and other worldwide patents pending, ChromeMate® is the only form of niacin-bound chromium with proven biological activity.

Studies have shown that ChromeMate® is 18-times more bioactive than other forms of niacin-bound chromium and, in animal studies used to evaluate bio-availability in humans, is absorbed and retained 600 percent greater than chromium chloride and 300 percent greater than chromium picolinate*. Additional clinical (human) and sub-clinical (animal) studies have shown that ChromeMate® promotes normal cholesterol levels, reduces body weight, increases lean body mass and promotes proper insulin function in the body. One study showed that ChromeMate® plus exercise in obese women resulted in significant weight loss, while chromium picolinate did not. Another study in obese human subjects showed that ChromeMate® reduced body fat, while sparing lean muscle mass. All these human clinical studies demonstrated no adverse effects of ChromeMate®.

A wide range of studies, which provide the foundation for GRAS affirmation, have also been conducted to validate the safety of ChromeMate®. A 90-day sub-chronic toxicity study that evaluated body weight, feed and water intake, hepatic lipid peroxidation and DNA fragmentation, hematology and clinical chemistry, selected organ weights as such and as a percentage of body weight and brain weight, and 32 organ histopathology, showed no adverse effects after administering three doses of ChromeMate®: (i) a human equivalency dose (HED), (ii) 10x HED and (iii) 25x HED of the supplement. Acute oral toxicity testing revealed no oral toxicity at levels up to 5,000 mg/kg of body weight and the median lethal dose (LD 50) was greater than 5,000 mg/kg. No dermal toxicity was observed. No significant skin and eye irritation potential of ChromeMate® was observed. Amesbacterial reverse mutation assay and mouse lymphoma tests demonstrated that ChromeMate® is non-mutagenic and does not have genotoxic potential. Far in excess of the recommended daily dosage of 200-400 micrograms, these tests indicate that it is highly unlikely a single, dose would cause harm.

Two elements were key in the decision to certify ChromeMate® for GRAS status,stated Dr. George Burdock, president of the Burdock Group. First was the historical foundation; trivalent chromium is essential for carbohydrate and lipid metabolism in animals and humans, and has a history of safe use. Further support came from extensive toxicology studies on salts of trivalent chromium, including ChromeMate®, that provided safety confirmation according to modern scientific standards. This information, along with other data reviewed, provided the substantiation needed to confidently make the GRAS determination.

The scientific panels decision to confer GRAS status on ChromeMate® is an important one for the industry and for consumers,stated InterHealth president & CEO William SkipSeroy. Consumers continue to embrace functional foods and beverages as major components of a healthy lifestyle. Given the plethora of ineffective and sometimes dangerous products on the market today, the proven safety and efficacy of ChromeMate®, as exemplified by its clinical research and GRAS status, is especially important for consumers who seek safe and efficacious assistance in their quest for optimal health.

The panel of experts who made the GRAS determination included Joseph Borzelleca, Ph.D. (Professor Emeritus, Medical College of Virginia), who has more than 40 years experience in determining the safety of food and beverage ingredients; Robert Cousins, Ph.D. (Boston Family Professor of Human Nutrition and Biochemistry, University of Florida); and George Burdock, Ph.D. (president, Burdock Group). Dr. Burdock is also president of the Food Safety Specialty Section of the Society of Toxicology, the largest toxicological society in the world.

A product of InterHealth Nutraceuticals Inc., ChromeMate® is a value-added dietary ingredient available to manufacturers for inclusion in a full array of dietary supplements and nutraceutical food and beverage products. InterHealth researches, develops, manufactures, markets and distributes specialty nutritional ingredients, which are sold to manufacturers worldwide.

*Results of six tissues tested one hour after administration. Absorption and retention decreased in all groups at each successive time point measured, but continued to be greatest in animals fed ChromeMate®.

Posted In: Chromemate

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