The Confidence Game: Creating and Establishing Reliable Methods for Determining the Quality of Pretty Much Everything. Paula N. Brown, Natural Health & Food Products Research Group, British Columbia Institute of Technology, Burnaby, BC, Canada
Testing methods are at the heart of much of the global economy. Outcries over the presence of adulterated products include incidences of economic adulteration with inferior or incorrect ingredients, presence of noxious substances such as toxic elements, myco- and phyto-toxins, pesticides, and undeclared pharmaceutical ingredients. Super- or sub-potent therapeutic products ranging from conventional drug products to dietary supplements and natural health products undermine industry as well as the public health. The most problematic such incidents can result in death; caused for instance by adulteration of protein-based ingredients with melamine and cyanuric acid or the presence of aflatoxigenic fungal hotspots in rail cars full of grain intended for pet food. Though public reaction is quick to focus on the inadequacy of supply chain monitoring systems, a deeper issue is the adequacy of test methods used for the evaluation of product and ingredient quality. Some analytical challenges are more easily addressed than others and include identity/quantity tests for single moieties in simple products and determination of complex mixtures of compounds of various chemical classes in complex matrices. Reliable analytical solutions for qualitative analysis of complex materials, e.g. identification of botanical raw materials and finished products, have been more elusive. The creation and utility of analytical methods depends on numerous factors. For quantitative analysis, the compounds to be measured must be established so that a basis for specification setting can created and specification appropriate tests can be crafted. In the natural products field, basic research on bioactive substance(s) will lead to quality specifications that describe minimum and maxim levels of salubrious and hazardous constituents. The level of specificity and sensitivity required of a botanical identity test must be established (identification to the level of species or genus; presence of less than a certain percent of non-target biomass). Irrespective of the complexity of the analytical challenge or the innovation involved in the application of new technological solutions, methods must be experimentally demonstrated to be scientifically valid, fit for purpose, rugged, precise, and accurate. This award address will present an overview of experiences, ranging from method development on new analytical platforms to the development and administration of laboratory performance programs and experimental approaches to the demonstration of fitness for purpose of software packages for qualitative determination of authenticity and provenance of complex natural products.
2022 Harvey W. Wiley Award is the Association’s highest honor for lifetime scientific achievement.
