Glycomix, a carbohydrate consultancy owned by Chris Lawson was approached by a North American health food company which had purchased the rights, from a Canadian academic to an anti-obesity product. The product consisted of a mixture of food approved polysaccharides that when added to drinks, smoothies etc. produced a high viscosity at very low concentration (higher than that expected by a sum of the parts) resulting in a feeling of satiety when consumed. Claims were then made regarding reduced calorie intake, lowering of blood sugar and cholesterol. The product sold in substantial amounts through CostCo and Walmart.

Both Health Canada and FDA questioned these claims and in particular the reasons for the huge increase in viscosity resulting from apparently simply mixing the components. The suggestion was made that in the manufacturing process (dissolving the components in water followed by granulation) it was possible that new covalent bonds had been formed. As the company had no analytical data to provide to the regulators, they were told that unless they could produce the information sales would be prohibited.

Using a combination of in-house facilities and external laboratories, Glycomix undertook a comprehensive analytical programme which demonstrated that no new covalent bonds had been formed (methylation analysis). It was further demonstrated by the use of SECMALS (size exclusion chromatography/Maldi mass spectroscopy) and the analytical ultracentrifuge that non-covalent bonding was responsible for the unusual viscosity behaviour of the product. The work was published in peer-reviewed papers and Glycomix presented the results to both Health Canada and FDA who accepted the findings.

Categories: Regulatory

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