Science based authentication, validation & safety of botanical ingredients

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Abstract: As per the provisions of DSHEA, the FDA has primary responsibility for ensuring that appropriate regulatory actions are taken against marketed products that present significant health risks or bear false or misleading label claims. The development and dissemination of research-based, scientifically valid information requires cooperation between academia, government, and industry. As a part of the FDA program to establish ‘Centers of Excellence (COE)’ in support of research relevant to their mission, in 2001 the office of dietary supplements at CFSAN, established an agreement with the National Center for Natural Products Research at the University of Mississippi. This agreement represents a cooperative effort to address critical research needs in the botany, chemistry, and biology aspects of dietary supplement ingredients, especially those of priority safety concern to CFSAN. Through two decades of the long-standing, successful inter-institutional cooperative research agreement, researchers at the COE addressed the ongoing quality and safety issues with botanical ingredients in dietary supplements and cosmetics. Specifically, several botanically-verified materials and chemical markers were established and utilized to address the quality and authenticity of more than 10,000 finished products. More than 200 independent analytical methods were designed, and the development of such tools was instrumental in addressing quality control issues with dietary supplement products. These findings allowed regulators to develop a critical scientific base to recall several thousands tainted botanical supplement products containing synthetic artifacts or others exogenous components. In addition to the state-of-the-art instrumentation available at the COE, in-house medicinal plant garden and collaborative research agreements with national and international botanical research partners allowed the COE to amass several thousand botanicals for both research and training purposes. As result of these cohesive scientific efforts, on average, the COE contributed more than 50 publications and generated about 1000 citations per year for the last 10 years, addressing various quality and safety issues with botanical ingredients integral to various dietary supplements and other products. The current proposal is a request for continued support to address critical quality and safety aspects of botanical ingredients’ in various finished products. This request aligns with CFSAN’s mission to assure public health. The COE will continue to augment the development of a prioritized list of botanicals of concern, implement reference materials, and develop suitable analytical methods for establishing the invaluable scientific base for requlatory compliance. The proposed diverse activities and resulting tools could provide an important arsenal to regulators to develop, implement and modify regulatory guidance to assure the quality and safety of botanical ingredients in dietary supplements, cosmetics, and other formulations.