Navigating FDA Regulatory Requirements for Clinical Trials on Natural Products
August 10, 2021
If you’re planning to submit a grant application for a clinical trial involving a natural product, check out our new Natural Products Clinical Trials Resource. It can help you understand the U.S. Food and Drug Administration (FDA) regulatory requirements for research on natural products, including the need for an Investigational New Drug (IND) application for some clinical trials. And we hope it will help you smoothly navigate the requirements that apply to your proposed study.
The new resource includes:
- A flow chart for the process for determining whether the FDA may require an IND application for your proposed research, with tips for interacting with the FDA regarding the IND process.
- Information about helpful FDA regulatory documents and resources, including instructions for submitting an IND application, guidance on obtaining exemptions from IND requirements, and resources on botanical drug development.
- Definitions of terms important in the regulation of dietary supplements and other natural products, such as Generally Recognized as Safe (GRAS) and new dietary ingredient (NDI).
- Answers to frequently asked questions about when INDs may be needed for NCCIH funded research.
- Examples of natural products clinical trials funded by the National Center for Complementary and Integrative Health (NCCIH).
How We Developed This Resource
NCCIH created this new resource in response to an August 2020 roundtable in which we brought together academic researchers, representatives from industry, and representatives from the Federal Government to discuss the regulation of natural products clinical research. At the roundtable, we talked about the differences in the perspectives that researchers and regulators bring to natural products clinical trials, and the challenges investigators face in understanding and complying with the complex regulations that apply to studies in this field. Colleagues from the FDA shared information on the distinctions among different categories of FDA-regulated products, such as drugs, dietary supplements, and cosmetics, and explained recent FDA innovations to streamline communications with investigators. Researchers from academia and industry described their personal experiences preparing for clinical trials that either did or did not require an IND.
After receiving input from the roundtable participants, we built the new online resource, obtained feedback on its content from our colleagues at the FDA, and conducted informal user testing with volunteers from the research community. We would like to thank everyone who helped to ensure that the new resource is accurate, informative, and easy to understand.
Please Send Us Your Feedback
We consider the new Natural Products Clinical Trials Resource to be a living toolbox and we will continue to refine and update to meet the needs of the research community. We hope it will be helpful for grant applicants, particularly small businesses and applicants who are submitting their first proposal for a natural products clinical trial. However, to make sure that investigators get the most use from it, we need to hear from you.
Please take a little time to look over the website and see whether it provides helpful guidance to inform your submission of an NIH application for a clinical trial. Are the documents and resources useful? Is anything unclear? Are there additional topics you would like us to cover? We would appreciate your feedback. You can leave a comment on this blog post or send an email to Dr. Craig Hopp at firstname.lastname@example.org or to Dr. Wendy Weber at email@example.com. We look forward to hearing from you.
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