AOR is now GMP Certified and holds an establishment licence with Health Canada.
Excellence in Quality Control
In the regulatory vacuum of the North American dietary supplement industry, quality control has always been a concern. Along with opening up the market to greater freedom of choice, the Dietary Supplements Health and Education Act (DSHEA) also had the unfortunate effect of hampering the regulation of the manufacture of dietary supplements. To date, the US Food and Drug Administration (FDA) has yet to implement Good Manufacturing Practice (GMP) regulations in the United States – and even when they do, DSHEA strongly limits the standards to which American dietary supplement companies can be held. It is clear that the final rule will impose GMPs which can statutorily only be modestly more rigorous than those used for foods, including all aspects of production. This means that, from purity of raw materials, to “acceptable” levels of contaminants, to precision in manufacturing specifications, FDA is forbidden to hold American dietary supplement manufacturers to higher standards than are used for instant noodles or processed meat products. Moreover, FDA will only inspect a premise if there is a complaint: the GMPs are to be self-policed, with no proactive inspections or formal licensing procedure to be imposed on companies.
From the beginning, AOR implemented a process of self-imposed quality control, creating internal standard operating procedures (SOPs) that were modeled on the pharmaceutical industry’s for purity and rigor. Formal, regulatory requirements for the manufacture of dietary supplements have now been brought into the Canadian industry by the new Natural Health Products Directorate (NHPD), using GMPs which are again modeled standards established for use in pharmaceutical labs. AOR has received its site license from Health Canada, and operates its facilities under standards created to meet or exceed the statutory requirements laid out under the new regulations.
All AOR products and raw materials are subject to a regular and ongoing process of third-party analysis by independent analytical laboratories to ensure purity and potency. The most appropriate available assay technique is always used for analysis of active ingredients and detection of contaminants, in consultation with internal Quality Control staff and external technicians and experts. For most anylates, high-performance liquid chromatography (HPLC) is the preferred technology.
Documentation
Health-conscious individuals, radical life-extensionists, and health practitioners who incorporate orthomolecules and botanicals into their practice often work in new territory, outside of the bounds acknowledged by the medical establishment. To make judgements on which supplements will best support their health, individuals and their health care providers need clear, science-based literature to document a supplement’s benefits. Unfortunately, is far too common in the supplement industry to see wild claims made with no documentation, and product literature which is vague to the point of being void of meaning or which is written with assumptions about the reader’s intelligence which are frankly insulting.
AOR has always distinguished itself by providing high-quality literature to support its advanced formulations. Indeed, AOR recognizes that they have a special duty to provide research summaries that are both scientifically accurate and readily understood by practitioners and educated laypeople alike, because of the nature of our line. AOR’s supplements are so effective in large part because of the rigor of the science that backs them and the innovative use of novel ingredients – or forms of ingredients, or even applications of ingredients – with which few but specialist researchers are typically familiar. Compared to products based on repackaging established cash cows, AOR formulations require a higher degree of education to be used effectively.
To meet this need, AOR has consistently created literature which carefully backs up its claims, refusing to dumb down the science while taking care not to speak over the head of an intelligent lay audience with an interest in science and a willingness to engage with new ideas and to develop familiarity with new research developments.
Yesterday, Today, and Tomorrow
AOR is dedicated to continuing to advance the cause of healthy life extension through a continuous process of renewal, struggling against the forces that institutionalize stagnation in the supplement industry. Through novel, exclusive contract arrangements, AOR has repeatedly released natural biotechnologies only previously available to research laboratories, overthrowing the forces of inertia that keep revolutionary advances imprisoned in the ivory towers of research. AOR has put advanced new orthomolecules and botanicals into the hands of the natural health care provider, the health-conscious, the seeker of alternatives, and the radical life-extensionist.
A little more than a decade ago, AOR was created to bring something new to the Canadian supplement world: not just new supplements, but a new spirit. In a marketplace dominated by half-baked notions, slipshod product quality, and shoddy research, strive to remain true to a commitment to Innovative Research and Scientific Integrity – and to you. With our recent expansions into the United States and the UK, AOR is now forging new relationships with health-conscious consumers, retailers, and health care practitioners, who alone can ultimately choose to bring the fruits of AOR’s labors into your store, into your practice … and into your life.
This information is copyright the editor of Advances magazine and may not be reproduced in whole or in part in any medium without the express permission of Advanced Othomolecular Research. Used with permission.
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