FDA Regulatory Documents and Resources

IND Application Submission

An Investigational New Drug (IND) application must be submitted to the FDA if the FDA determines that one is required. The FDA website has more information about the IND application process.

The FDA website also has instructions for submitting an IND application, which includes the required forms.

The design of the study, rather than the product itself, determines if an IND application is needed. The FDA has published guidance to help investigators better understand which types of human research studies require IND applications. The guidance has a specific section on foods and dietary supplements.

IND Exemption Requests

In some cases, clinical investigations may be exempt from IND application requirements. The FDA has developed specific guidance for exemptions from IND requirements.

Botanical Drug Development

The FDA has developed specific guidance for the development of botanical drugs. This guidance includes information about the IND application process.

In 2020, the FDA published an article in the Journal of Natural Products describing its scientific and regulatory approach to botanical drug development. The article summarizes the number of IND applications submitted and the types of IND studies, as well as the FDA’s approach to working with IND sponsors.

Small Business Innovation Research (SBIR) Applicants

The FDA has explicit requirements for the information that must be included on the label of a dietary supplement and for the statements that can be made on a label regarding the content of a product. Details can be found in the FDA’s Dietary Supplement Labeling Guide.

Dietary supplements can make claims that describe an effect on the structure or function of the body, but they cannot make “disease claims,” which require FDA approval. The FDA provides a guide for compliance with structure/function claims.

NIH awardees can request regulatory consultations with the SEED Innovator Support Team by sending an email to SBIR@od.nih.gov including their name, PO name, award number, and questions.

Small Business and Industry Pre-IND Meeting Requests

The FDA provides guidance to commercial or research sponsors of INDs to help plan natural product drug development programs. This guidance can help prevent clinical hold issues and assist with preparation of a complete IND application. See the FDA website for Small Business and Industry Assistance: Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting.