Dietary supplement or drug? The case of Cholestinc

Abstract

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 related 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 Cholestin (4 capsules containing 2.4 g product) or rice powder placebo capsules for 12 wk. On average, LDL-cholesterol concentrations were reduced by 22% in those assigned to Cholestin and by 1% in those assigned to placebo after 12 wk of supplementation. Cholestin contains, by weight, 0.4% 3-hydroxy-3-methylglutaryl coenzyme A (HMGCoA) reductase inhibitors of the statin class, and the authors conclude that “the reduced costs of the red yeast rice dietary supplement compared with prescription drugs could provide a new and novel approach for the maintenance of healthier cholesterol concentrations,” as applied to the prevention of coronary artery disease. Cholestin is currently sold in this country as a dietary supplement for healthy adults. The package insert instructs the user not to take more than 2 capsules twice daily (2.4 g) and warns of the possibility of toxicity of HMGCoA inhibitors of the statin class, including “diseases of the liver and skeletal muscle.” The package insert states that Cholestin is intended to maintain “desirable cholesterol levels” and not to “diagnose, treat, cure or prevent any disease” (to conform with the Dietary Supplement Health and Education Act). The package insert notes that “too much cholesterol in your blood results in excess build-up on the walls of arteries” that “restricts or may even block the flow of blood” and “that’s why blood cholesterol plays an important part in deciding your risk of getting coronary heart disease.” The package insert also states: “The proprietary all-natural ingredient in Cholestin has been clinically proven in studies involving thousands of people at various dosages to promote healthy cholesterol concentrations by its ability to lower total cholesterol, lower LDL ‘bad’ cholesterol and triglyceride levels, and to increase HDL ‘good’ cholesterol levels.”