A Canadian group approached Vedic in 2004 to conduct a study in India that would be acceptable to US regulators. This was the first study for us that had to meet US standards because so far we had been serving only the Indian market. We took up the challenge to design a study to meet FTC and FDA standards for dietary supplement clinical research. This study was to determine the joint protection potential of a natural mineral supplement, Sierrasil with and without cat’s claw extract. Possibly for the first time, the gold standard of human research – Good Clinical Practice (ICH/FDA GCP) was applied to a food supplement study. Our client received an NPN based on this publication and went on to use these label claims in Canada as well as in the US.
