The Council for Responsible Nutrition (CRN) submitted a citizen petition to the Food and Drug Administration (FDA) requesting that FDA:
- FDA exercise its statutory authority to establish a regulation under which hemp-derived cannabidiol (CBD) may be legally marketed as a dietary ingredient;
- Clarify when a hemp-derived substance is subject to the preclusion provisions of 21 USC 321(ff)(3)(B); and
- Enforce existing dietary supplement regulations with respect to CBD-containing products being marketed as dietary supplements.
This blog post provides background on the legal provisions FDA views as preventing the lawful marketing of CBD as a dietary supplement and food – known as the “exclusionary clauses” of the Federal Food, Drug, and Cosmetic Act (FFDCA) as well as a summary of CRN’s citizen petition and how the requested actions would alter the regulatory scheme for CBD products.