Committee on the Framework for Evaluating the Safety of's Proposed Framework for Evaluating the Safety of Dietary PDF

By Committee on the Framework for Evaluating the Safety of Dietary Supplements, National Research Council

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Amino acids, for example, might be considered unapproved food additives, and some botanicals might be more appropriately considered as drugs (FDA, 1993). S. RDAs (FDA, 1993). Industry and consumers reacted quickly and strongly to these potential regulatory restrictions. Extensive public debate ensued over the importance of dietary supplements in health, consumers' freedom to access information about supplements, and the controversy over FDA's regulatory approach. As a result, Congress passed legislation limiting FDA regulation of dietary supplements.

Please use the print version of this publication as the authoritative version for attribution. INTRODUCTION AND BACKGROUND 22 TABLE 1–1 Current Status of Foods, Drugs, and Dietary Supplements under Food and Drug Administration (FDA) Regulation Status Dietary Supplements Foodsa Food Additives New Drugsb Premarket approval required Noc Nod Yes Yes Risk-benefit analysis conducted by FDA prior to marketing No No No Yes Postmarket reporting or surveillance by industry required No No Rarely Yes FDA FDA Manufacturer Manufacturer Burden of proof for demonstrating safety or lack thereof a Foods (including conventional foods and dietary supplements), unlike drugs, are considered to be safe (reasonable certainty of no harm), and thus risk-benefit analysis is not applicable.

Schilcher, Commission E, March 19, 2002). The published monographs do not include references and are relatively short. Each monograph provided one of three approval ratings for the substance reviewed: (1) positive (approved—substance is considered reasonably safe when used according to the dosage, contraindications, and other warnings specified in the monograph), (2) negative (unapproved—safety concerns outweigh the potential benefits of a substance), or (3) negative-null (unapproved —no risk was found, but also no substantiation of efficacy).

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Proposed Framework for Evaluating the Safety of Dietary Supplements -- For Comment by Committee on the Framework for Evaluating the Safety of Dietary Supplements, National Research Council


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