The Surprising Reach of FDA Regulation of Cannabis, Even after Descheduling

Abstract

As more states legalize cannabis, the push to “deschedule” it from the Controlled Substances Act is gaining momentum. At the same time, the FDA recently approved the first conventional drug containing a cannabinoid derived from cannabis—cannabidiol (“CBD”) for two rare seizure disorders. This would all seem to bode well for proponents of full federal legalization of medical cannabis. But some traditional providers are wary of drug companies pulling medical cannabis into the regular small molecule drug development system. The FDA’s focus on precise analytical characterization and on individual active and inactive ingredients may be fundamentally inconsistent with the “entourage effects” theory of medical cannabis. Traditional providers may believe that descheduling cannabis would free them to promote and distribute their products free of federal intervention, both locally and nationally. Other producers appear to assume that descheduling would facilitate a robust market in cannabis-based edibles and dietary supplements. In fact, neither of these things is true. If cannabis were descheduled, the FDA’s complex and comprehensive regulatory framework governing foods, drugs, and dietary supplements would preclude much of this anticipated commerce. For example, any medical claims about cannabis would require the seller to complete the rigorous new drug approval process, the cost of which will be prohibitive for most current traditional providers. Likely also unexpected to some, there is no pathway forward for conventional foods containing cannabis constituents, if those foods cross state lines. And it will certainly come as a shock to many that federal law already prohibits the sale of dietary supplements containing CBD—including those already on the market. In this article, we describe in detail this surprising reach of the FDA and then outline three modest—but legal—pathways forward for cannabis-based products in a world where cannabis has been descheduled.

Keywords: cannabis, marijuana, medical marijuana, FDA, food and drug law, health law, regulatory law, administrative law