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There are numerous preparations that are marketed in the U.S. as dietary supplements. The definition of dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) of 1994 includes:
- A dietary supplement is a product taken by mouth that is intended to supplement the diet and that contains a dietary ingredient.
- 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.
Under DSHEA, a dietary supplement is not considered a drug and is not subject to the premarket approval requirements for drugs if the intended use for which it is marketed is only to affect the structure or any function of the body (i.e., not intended to be used for a therapeutic purpose).
If a dietary supplement, which is available without a prescription, is used in a research study, is an IND needed?
For example, a clinical investigation designed to study the relationship between a dietary supplement's effect on normal structure or function in humans (e.g., calcium and bone mass) or to characterize the mechanism by which a dietary supplement acts to maintain such structure or function (e.g., fiber and bowel regularity) would not need to be conducted under an IND. However, a clinical investigation designed to evaluate a dietary supplement's ability to prevent osteoporosis or to treat diarrhea or constipation would need to be conducted under an IND under part 312.
See FDA Guidance IND Determination for further information.