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Drugs or Dietary Supplements: FDA's Enforcement of DSHEA

Marlys J. Mason

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Abstract

The Dietary Supplement Health and Education Act broadened the definition of a dietary supplement and loosened the restrictions for health claims on supplement labeling. The Act has left an unclear boundary between supplements and drugs. In this article, the author examines the legal debate surrounding the definition and regulation of drugs and supplements. The author also discusses recent Food and Drug Administration enforcement activities and court challenges.

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What this paper is about

The Dietary Supplement Health and Education Act broadened the definition of a dietary supplement and loosened the restrictions for health claims on supplement labeling. The Act has left an unclear boundary between supplements and drugs. In this article, the author examines the legal debate surrounding the definition and regulation of drugs and supplements. The author also discusses recent Food and Drug Administration enforcement activities and court challenges.

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OpenAlex reports 20 citations for this work. Citation counts describe recorded attention and do not establish research quality.

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Available abstract

The Dietary Supplement Health and Education Act broadened the definition of a dietary supplement and loosened the restrictions for health claims on supplement labeling. The Act has left an unclear boundary between supplements and drugs. In this article, the author examines the legal debate surrounding the definition and regulation of drugs and supplements. The author also discusses recent Food and Drug Administration enforcement activities and court challenges.

Key concepts: Food and drug administration, Dietary supplement, Enforcement, Education Act, Business, Medicine, Herbal supplement, Alternative medicine

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