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Abstract

Increasing use of dietary supplements in the United States has commanded attention to regulatory issues regarding these products. Prior to the Dietary Supplement Health and Education Act of 1994 (DSHEA), regulation of dietary supplements was a gray area—they were classified somewhere between food and drugs. Regulations governing the acceptable claims for dietary supplements were finalized in January 2000, yet many issues remain controversial concerning the questionable safety and efficacy of these products. Premarketing approval based upon clinical trials is not required for dietary supplements, making it difficult to determine safety, efficacy, and potential drug interactions. Little is known about the use of dietary supplements in pregnancy or in pediatric populations. Many supplements do not have standards for quality, strength, and purity. These concerns, as well as others, must be addressed in order to provide patients with safe and effective dietary supplements that could be instrumental in preventing disease and promoting health.

Keywords

Dietary supplement DSHEA Structure/function Drug interactions Pregnancy

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Issues in the Regulation of Dietary Supplements

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