Botanical Regulation: Comparison of the United States and Canada

Abstract

Botanicals are defined as ingredients or finished products “of or relating to plants” or “a substance obtained from a plant.” Botanicals have been used by humans since the beginning of civilization. Archaeological excavation documents the medicinal use of plants by humans dating back as far as 60,000 years [1]. Today about 80% of the world still uses plants and plant-based products to treat medical conditions [2]. Botanicals can be regulated as foods, food and dietary ingredients, drugs, devices, cosmetics, flavorings, color additives, fragrances and more. When used in healthcare, botanicals have defied regulatory harmonization. Even within the North American continent the regulatory approach to botanicals diوٴers by country. Нis article will discuss the Canadian and US perspectives on botanical regulation: how they are similar, and where they diverge.