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BOX ES-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).

Signal Detection

Given the large number of dietary supplement ingredients and that dietary supplements are assumed to be safe in general, it is unlikely that FDA will have the resources or need to evaluate each ingredient uniformly. Thus it is assumed that some “signal” will indicate that an ingredient’s safety may need to be reviewed. When a signal is detected and the credibility of the signal and its relationship to a serious adverse effect in humans is evaluated, it is up to FDA to decide to take the next step.

Given the significant number of dietary supplement ingredients, FDA’s attention should focus on signals that indicate that a serious5health problem may result due to ingestion of a dietary supplement ingredient.

5  

Serious—any experience resulting in any of the following outcomes: death, a life-threatening adverse experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes previously listed (in accordance with 21 C.F.R. § 600.80 [2002] and 21 C.F.R. § 314.80 [2002]).



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