Received for publication March 7, 2005.
Revised April 12, 2005.
Accepted for publication April 13, 2005.

Can Claims, Misleading Information and Manufacturing Issues Regarding Dietary Supplements be Improved in the United States of America?

Abstract

The safety and effectiveness of OTC drugs are assessed through the FDA's OTC Drug Review. Prescription drugs are approved through the rigorous new drug application process (NDA). In contrast, dietary supplements are regulated as foods and the FDA must determine that a dietary supplement ingredient poses a "significant or unreasonable risk of illness or injury" instead of requiring the manufacturer to provide safety data. According to the FDA there are more than 29,000 different dietary supplements available to consumers today. This momentum has its roots in consumer interest in health and self-care and suggests that Americans are searching for alternatives to conventional foods for physical and mental well-being. A Committee on the Framework for Evaluating the Safety of Dietary Supplements was formed under the auspices of the Food and Nutrition Board that produced a report entitled "Dietary Supplements: A Framework for Evaluating Safety". Categories of specific information identified for use are: (1) human data, (2) animal studies, (3) in vitro experiments, and, (4) information on related substances. Several factors were identified to guide the FDA in applying the framework. Two of these are: (1) "the appropriate scientific standard to be used to overturn this basic assumption of safety is to demonstrate significant or unreasonable risk, not prove that an ingredient is unsafe", and, (2) "approaches taken by diverse organizations and governmental bodies, both within and outside the United States, which evaluate the safety and at times efficacy of dietary supplement ingredients, vary in their relevance to the protection of the American public from risks associated with consumption of dietary supplement ingredients".

Key words: DSHEA, FDA, dietary supplements, natural products, regulation, regulatory affairs

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