Cannabis-Derived Botanical Drugs: A Viable Regulatory Pathway for Marketing Medical Edibles?

Daniel L. Flint and Deborah M. Shelton


There is a belief among some firms in the cannabis industry that cannabis-infused edibles (“edibles”) could be legally marketed under federal law if cannabis were de-scheduled from the Controlled Substances Act (CSA). Yet, despite this belief, many of these products would remain illegal under current federal law because they would be marketed in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). Some firms in the cannabis industry have further assumed that FDA lacks the authority to regulate edibles under the FDCA when such products are sold and distributed within the confines of a single state. While technically true—FDA’s jurisdiction does generally require a nexus to interstate commerce—this understanding is too simplistic and may leave cannabis firms with a false sense of security over the legal status of their products. This article confirms that the present options for legally marketing edibles in compliance with the FDCA are currently limited and thus proceeds to evaluate an alternative approach: the development of FDA-approved, cannabis-derived botanical drugs. While finding that cannabis-derived botanical drugs are viable from a regulatory perspective, this article concludes that the prospect of competition from recreational cannabis products is likely to discourage many cannabis firms from pursuing this approach. In the end, this article predicts that the respective competitive landscapes for CBD- and THC-containing products may evolve somewhat differently and that ultimately Congress may decide to intervene in this space to preserve the integrity of a nationwide market for FDA-regulated products.