Natural Product Information

If the clinical study uses a natural product as an intervention, the product must adhere to the NCCAM Policy on Natural Product Integrity. In addition, NCCAM requires investigators to contact the U.S. Food and Drug Administration (FDA) for determination as to whether an Investigational New Drug (IND) application will be needed for the study. The FDA makes the determination as to whether a clinical study using a natural product must be conducted under an IND. NCCAM requires written documentation from the FDA for any waivers or exemptions for INDs.