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BOX 1-1
Legal Definition of a Dietary Supplement as Defined by the Dietary Supplement Health and Education Act of 1994

The term dietary supplement:

  1. means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

    1. a vitamin;

    2. a mineral;

    3. an herb or other botanical;

    4. an amino acid;

    5. a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or

    6. a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E).

Dietary supplements are further defined as products that are labeled as dietary supplements and are not represented for use as a conventional food or as a sole item of a meal or the diet. Supplements can be marketed for ingestion in a variety of dosage forms including capsule, powder, softgel, gelcap, tablet, liquid, or, indeed, any other form so long as they are not represented as conventional foods or as sole items of a meal or of the diet (FDCA, as amended, § 402).

and enzymes, as well as concentrates, metabolites, constituents, or extracts of these.1 Within each of these categories, products may be pure single entities of known or unknown chemical constituents, mixtures in which all or some components are known, or mixtures of unknown chemical components.

Within its definition of dietary supplements (Box 1-1), DSHEA included ingredients that have not traditionally been recognized as nutrients or as having nutritional functions, such as botanicals and hormones (Nesheim, 1999). It clarified that these substances could be considered supplement ingredients, not drug ingredients, when labeled appropriately. As with conventional foods, dietary supplements are to be presumed safe—that is, it is assumed that they do not present a significant2 or unreasonable risk of injury or illness when consumed as recommended.

1  

While these are not dietary supplement categories specified by DSHEA, they illustrate the diversity of products currently marketed as dietary supplements.

2  

The origin of the use of the standard “significant or unreasonable risk” relative to dietary supplements is the DSHEA legislation; thus “significant” is used qualitatively and does not imply a statistical determination.



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