Olestra |
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| ChemCases.com Directory ChemCases.com Home Concept Map 1 Concept Map 2 Back to Olestra 9. FDA Approval Ahead to Olestra 13. Olestra Public Approval and Controversy Chemical Concepts Fats play a significant and unique role in bodily function.
We will see how researchers used these simple chemical concepts to invent and develop olestra and we will use these principles ourselves to evaluate and decide on nutritional issues
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Olestra 10. Testing for
Digestion and Toxicity Two of the most tested aspects of olestra are its potential for toxicity and its potential to cause any harmful effects to the digestive tract with the digestion and elimination process. Since olestra passes through the tract undigested it does have potential for some physiological and functional effects. Procter and Gamble felt it was important to look at several aspects of this issue and consequently designed and conducted studies in the following areas: A. Toxicity studies
B. Digestion studies
After numerous clinical trials by Procter & Gamble with a variety of animal tests and methods, the FDA concluded that olestra was not absorbed and non toxic. There was some evidence of gastrointestinal complaints in some people and this has led to the warning labels that are currently on olestra containing products. The details of these studies are available in the FDAs final rule report that is published in the Federal Register Volume 61 No. 20 pp 3118-3173. While the details of these many studies are quite voluminous, some of the chemical principals behind the studies are worth noting. In nearly all of the absorption studies that showed no olestra was absorbed into the body, some portion of the olestra molecule was radiolabeled with carbon-14 so it could be traced throughout the subject. In some cases the fatty acids were labeled and different parts of the animals were tested to see if some of this radiolabeled carbon was detected in organs where the metabolic products of olestra might typically be found such as the liver or in body fat deposits. The sucrose that makes up olestra was also radiolabeled and the urine was sampled for detection of olestra. In cases where the detection limits were thought to be too low, samples of higher radioactivity were selected to increase the detectability. The use of radioactive isotopes is a very important and common method for following a carbon atoms path through all of the digestive and chemical processes in our body. Regarding the issue of any potential toxicity of olestra, it seems that the FDA, Procter & Gamble, and various consumer interest groups are satisfied that Olestra is completely non toxic. Potential GI distress is of major concern to possible customers and this is an issue that is still generating controversy. While Procter & Gamble is presenting and conducting further studies that show any GI incidents are not beyond the statistical norm, a consumer watch-dog group, CSPI, is claiming that considerable problems exist with olestra. These web sites express completely conflicting viewpoints. These issues will be among the several that you must weigh as you consider the overall value of olestra. At this point, return to the Olestra Concept Map to examine some of the other issues regarding olestra. |
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