Legal and Regulatory Perspectives on Dietary Supplements and Foods

Abstract

SUMMARY Dietary supplements, including vitamins, minerals, tissue extracts, amino acids, protein products, and herbal preparations to enhance health or prevent disease are used by nearly fifty percent of the U.S. population. They are a 12+ billion dollar market. The purpose of this review is to provide background information on the prevalence and uses of dietary supplements, the legislation pertaining to dietary supplements, including the Dietary Supplement Health and Education Act of 1994 and the Food and Drug Modernization Act of 1997, and to summarize their impact on the quality, safety, and marketing of dietary supplements. Four case examples, white willow bark, sassafras, ephedrine, and St. John's Wort are presented. Finally, the problems associated with the current regulatory standards and the potential changes that could improve the quality, standardization, and safety are discussed.