Definition and Regulation of Dietary Supplements

The Dietary Supplement Health and Education Act (DSHEA) of 1994 issued by the US Food and Drug Administration (FDA) defines the term "dietary supplement" as a product that collectively meets the following requirements [5]:

  • A product (other than tobacco) intended to supplement the diet or contain one or more of the following: vitamin, mineral, herb or other plant-derived substance (e.g., ginseng, garlic), amino acid, concentrate, metabolite, constituent, or extract.
  • A product intended for ingestion in pill, capsule, tablet, or liquid form
  • A product not represented for use as a conventional food or as the sole item of a meal or diet

The FDA requires that all dietary supplements be labeled as such. However, unlike drugs, dietary supplements do not need approval before they are marketed. The manufacturers and distributors of supplements are responsible for ensuring their safety and making sure that label claims are accurate and truthful. For more information concerning the regulation of dietary supplements marketed within the United States, the reader is referred to the FDA's Center for Food Safety and Applied Nutrition help-line (1-888723-3366) or their website (http://www.cfsan.fda.gov/list.html).

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