Legal and Regulatory Issues Governing Cannabis and Cannabis-derived Products in the United States
- 1GW Pharmaceuticals, United Kingdom
This chapter provides an in-depth discussion of the legal and regulatory frameworks surrounding cannabis in the US, including federal law—as dictated by the Controlled Substances Act (CSA) and governed by various federal agencies like the FDA and DEA—as well as state law—as regulated by each state’s laws and regulations authorizing medical and/or adult use cannabis. First, the chapter discusses the definition and classification of cannabis under the Controlled Substances Act (CSA), including scheduling under the CSA as well as the process for and potentiality of removing cannabis from Schedule I. Then, it describes the activities relating to industrial hemp that are permitted under the 2014 Farm Bill. Next, the chapter addresses state-level cannabis laws. The chapter also analyzes the question of whether state cannabis laws are invalidated and superseded by federal law. Moreover, this section examines the factors underlying the extent of the Department of Justice’s enforcement actions relating to state-authorized cannabis activities. The chapter then turns to CBD (cannabidiol) in particular, discussing CBD’s legal status under the CSA; the FDA’s role in regulating and approving CBD products for medical purposes; and the steps required to take an investigational CBD product through that approval process. The chapter concludes by contending that, while cannabis has had a long and twisting history, and although cannabis-derived products face daunting obstacles to achieving FDA approval as well as rescheduling under both federal and state law, the recent success of one product (Epidiolex®) should inspire other manufacturers to develop [additional cannabis-derived products through the FDA process.
Keywords: Cannabidiol, Cannabis, Schedule I, Rescheduling, Controlled Substances, PREEMPT, Farm bill, HEMP, adult use, medical cannabis, FDA approval
Received: 07 Nov 2018;
Accepted: 09 May 2019.
Edited by:Mahmoud A. ElSohly, School of Pharmacy, University of Mississippi, United States
Reviewed by:Charles Pollack, Thomas Jefferson University, United States
Hanan Abramovici, Health Canada, Canada
Copyright: © 2019 Mead. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Ms. Alice Mead, GW Pharmaceuticals, Cambridge, United Kingdom, email@example.com