Are INDs required for studies evaluating the uses of botanical dietary supplement as dietary supplements?
No. When a lawfully marketed botanical dietary supplement is studied for its dietary supplement use (i.e., structure and/or function claims), an IND is not required. Structure and function claims are statements that describe the effect a dietary supplement may have on the structure or function of the human body. Refer to FDA/CFSAN: Structure/Function Claims, Small Entity Compliance Guide for further information.
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