Cultivating Evidence-Based Pathways for Cannabis Product Development: Implications for Consumer Protection^†

Disparities between federal and state cannabis regulation, coupled with protracted federal enforcement, have facilitated the proliferation of a multi–billion dollar cannabis industry that generally evades compliance with federal consumer protection laws. The Federal Food, Drug and Cosmetic Act (FDCA) established regulatory pathways for the lawful development of products such as food, drugs, and dietary supplements. The FDCA uses a science-based approach to protect consumers from harmful products, but early inconsistencies between state and federal cannabis regulation prevented and/or discouraged the cannabis industry from complying with FDCA requirements. Cannabis products are promoted as safe and attributed with providing effective therapeutic treatment for numerous medical conditions, yet the claims often lack the rigorous evidence-based support typically expected by regulators and the medical community. The Food and Drug Administration (FDA) has announced its expectation that cannabidiol (CBD) products comply with the FDCA and follow a science-based approach to product development. The FDA is addressing violations involving unsubstantiated CBD health claims and is working to clarify the future regulatory pathway for CBD products. Meanwhile, the state-approved cannabis market continues to operate, selling numerous products that have circumvented the FDCA consumer protections. This article examines the need for strengthening consumer protections in the cannabis market. We use evidence-based medicine as a model to address the importance of science-based product development and to contextualize a science-based comparison of regulatory pathways for cannabis drugs, food, and dietary supplements.

Duke Scholars

Author Rikin Patel