What are Dietary supplements?
Congress defined the term “dietary supplements” in the Dietary Supplements Health and Education Act (DSHEA) of 1994. Dietary supplements products taken by mouth that contains a “dietary ingredient” intended to supplement the diet. The “dietary ingredients” in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of “foods,” not drugs, and requires that every supplement be labeled a dietary supplements.
What is “New dietary ingredient” in dietary supplements?
The Dietary Supplements Health and Education Act (DSHEA) of 1994 defined both of the terms “dietary ingredient” and “new dietary ingredient” as components of dietary supplements. In order for an ingredient of a dietary supplements to be a “dietary ingredient,” it must be one or any combination of the following substances:
- an herb or other botanical,
- a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or
- a concentrate, metabolite, constituent or extract.