Contamination of Botanical Dietary Supplements byDigitalis lanata

Abstract

For many years, the Food and Drug Administration (FDA) regulated botanical dietary-supplement ingredients, in most circumstances, under the provisions for food additives of the Federal Food, Drug, and Cosmetic Act to ensure that they were safe and wholesome. Currently, dietary supplements (such as botanical products, vitamins and minerals, amino acids, and tissue extracts) are regulated under the Dietary Supplement Health and Education Act of 1994, which includes several provisions that apply only to dietary supplements and dietary ingredients of dietary supplements. Included in these provisions was the removal of the ingredients of dietary supplements from regulation as food additives and the requirement that the FDA bear the burden of proof that a marketed dietary supplement presents a serious or unreasonable risk under the conditions of use on the label or as commonly consumed. This requirement is in contrast to what is required for drugs, which must be shown to be safe and effective for a particular indication before they are approved for marketing.