Regulatory considerations for researchers of natural products in the United States

This chapter serves as an aid for scientists involved in university and governmental research programs on how to integrate their observations and discussions with other professionals for satisfying regulatory requirements as a supplement to their research projects. The regulatory considerations in transitioning from a basic research project into a marketable product are described, including (1) the registration process, (2) data requirements, and (3) providing rationale and support from acceptable literature sources in place of generating new studies. Information on institutional infrastructure related to product development is also provided.