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Natural Products Clinical Trials Resource

Understanding U.S. Food and Drug Administration Requirements for Natural Products Clinical Trials Research

Natural Product FDA Clinical Trial Diagram
Flow Chart: Do I need to submit an IND?

The National Center for Complementary and Integrative Health (NCCIH) Natural Products Clinical Research Resource has been created to provide an overview of the information needed for a grant application both at the time of funding and before starting an NCCIH-funded clinical trial that will use a natural product. NCCIH supports clinical research that uses natural products, including botanicals, dietary supplements, vitamins, minerals, and probiotics.

The U.S. Food and Drug Administration (FDA) establishes and enforces the regulatory requirements for clinical research on natural products when they may be used as drugs. Because NCCIH is a Federal agency, any research supported with NCCIH funding must adhere to relevant FDA regulations.

Only the FDA has the authority to interpret and enforce its regulatory requirements and to make decisions about whether proposed clinical research needs an Investigational New Drug (IND) application. When the FDA determines whether a clinical trial requires an IND application, it considers several factors, including the intended use of the study data, the objectives of the trial, the characteristics of the natural product, what is known about the safety of the product, the participants in the study, and consistency with other IND decisions. For each proposed clinical trial, NCCIH requires written documentation from the FDA if the FDA requires an IND application or if it grants a waiver or exemption.

Who is this resource for?

This resource is for investigators planning to submit a grant application to NCCIH that includes a natural product and meets the National Institutes of Health (NIH) definition of a clinical trial. NCCIH offers this information and these resources to help research investigators understand the requirements and regulations for clinical trials that involve natural products.

Is it difficult to submit an IND application?

Although it can be daunting to contact the FDA about the necessity of an IND application, the need to submit an IND application should not dissuade investigators from pursuing research. NCCIH has funded dozens of trials that have been conducted with INDs. Investigators often serve as the study sponsor for the academic submission of clinical trial IND applications. After going through the IND application process, most of these investigators report that they were intimidated at first, but the process was not as bad as they thought it would be, and that the FDA had good questions that focused on protecting participant safety. Many academic investigators complete the IND applications themselves and do not need to hire outside consultants to assist them.