C ONTAMINATION OF B OTANICAL D IETARY S UPPLEMENTS BY D IGITALIS LANATA

OR many years, the Food and Drug Adminis- tration (FDA) regulated botanical dietary-sup- plement ingredients, in most circumstances, under the provisions for food additives of the Fed- eral 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 pro- visions that apply only to dietary supplements and dietary ingredients of dietary supplements. Included in these provisions was the removal of the ingredi- ents 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 con- sumed. This requirement is in contrast to what is re- quired for drugs, which must be shown to be safe and effective for a particular indication before they are approved for marketing. The case of a previously healthy patient who pre- sented with a toxic serum digoxin level after the in- gestion of botanical dietary supplements was re- ported to the FDA in 1997. We sought to determine the source of the patient's exposure to cardiac gly- cosides and to investigate the extent and duration of distribution of the suspect raw material and the products containing it. We also investigated a sec- F