There are numerous preparations that are marketed in the U.S. as dietary supplements.
Whether an IND is needed for a clinical investigation evaluating a dietary supplement is determined by the intent of the clinical investigation. If the clinical investigation is intended only to evaluate the dietary supplement’s effect on the structure or function of the body, an IND is not required. However, if the clinical investigation is intended to evaluate the dietary supplement’s ability to diagnose, cure, mitigate, treat, or prevent a disease, an IND is required under part 312.
For further information see
- FDA Guidance IND Determination
- Dietary Supplement FAQs
- Educational Presentation Dietary Supplements and INDs
- Dietary Supplement Decision Tree Coming soon
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