The Surprising Reach of FDA Regulation of Cannabis, Even after Descheduling
69 Pages Posted: 20 Sep 2018
Date Written: August 15, 2018
The push for “descheduling” cannabis from the Controlled Substances Act (“CSA”) often presumes that current herb-based medical cannabis providers would simply have greater freedom to do what they currently do. At the same time, some of these traditional providers are wary of pharmaceutical companies pulling medical cannabis into the regular small molecule drug development system that might ignore the holistic “entourage effect” of the full range of substances available from smoking or ingesting whole flower cannabis. These providers may see descheduling as helping them compete with the pharmaceutical industry by allowing unfettered promotion and sale of whole flower-based products. The reality is far more complicated. The Food and Drug Administration (“FDA”) is already ramping up both its enforcement and regulatory review processes for medical cannabis. And descheduling does not eliminate FDA authority over cannabis products. Considering the current state of medical cannabis research as well as the differing goals and philosophies of the traditional medical cannabis community and the conventional drug development community, we predict three pathways forward for medical cannabis after descheduling. The first is purely intrastate whole flower product providers regulated primarily by state law and not the FDA. The second is conventional drug development governed by the FDA. And the third is national brand dietary supplements, also regulated by the FDA. The relative distribution among these pathways will turn on factors such as perceived or clinically measured efficacy, price, time-to-market, side effects, and preferences for “holistic,” “natural,” and even “organic” remedies.
Keywords: cannabis, marijuana, medical marijuana, FDA, food and drug law, health law, regulatory law, administrative law
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