Dietary supplements, used widely by Americans, are regulated by the Dietary Supplement Health and Education Act of 1994 (1), an amendment to the Federal Food, Drug and Cosmetic Act. The Dietary Supplement Health and Education Act provides that

any product marketed as a dietary supplement cannot contain an article that is approved as a new drug unless the product was marketed before the drug’s approval. Any component of the product may be considered to be an article. Evidently, the law is intended to maintain the incentive for pharmaceutical companies to bring new drugs to market, a process that involves extensive and expensive preclinical and clinical evaluations. In this issue of the Journal, Heber et al (2) report on a clinical trial of Cholestin (Pharmanex, Simi Valley, CA), a product relat-ed to red yeast rice. Red yeast rice has been used in China as a food colorant and flavor enhancer for centuries. Another related Chinese product, Xuezhikang, has been shown to lower plasma cholesterol concentrations. In the current double-blind clinical trial, 83 men and women with above average LDL-cholesterol concentrations were randomly assigned to receive Cholesti