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The Surprising Reach of FDA Regulation of Cannabis Even After Descheduling

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The Surprising Reach of FDA Regulation of Cannabis Even After Descheduling American University Law Review Volume 68 Issue 3 Article 3 2019 The Surprising Reach of FDA Regulation of Cannabis Even After Descheduling Sean M. O'Connor University of Washington - Seattle Campus, [email protected] Erika Lietzan University of Missouri School of Law, [email protected] Follow this and additional works at: https://digitalcommons.wcl.american.edu/aulr Part of the Food and Drug Law Commons Recommended Citation O'Connor, Sean M. and Lietzan, Erika (2019) "The Surprising Reach of FDA Regulation of Cannabis Even After Descheduling," American University Law Review: Vol. 68 : Iss. 3 , Article 3. Available at: https://digitalcommons.wcl.american.edu/aulr/vol68/iss3/3 This Article is brought to you for free and open access by the Washington College of Law Journals & Law Reviews at Digital Commons @ American University Washington College of Law. It has been accepted for inclusion in American University Law Review by an authorized editor of Digital Commons @ American University Washington College of Law. For more information, please contact [email protected]. The Surprising Reach of FDA Regulation of Cannabis Even After Descheduling This article is available in American University Law Review: https://digitalcommons.wcl.american.edu/aulr/vol68/ iss3/3 THE SURPRISING REACH OF FDA REGULATION OF CANNABIS, EVEN AFTER DESCHEDULING SEAN M. O’CONNOR* ERIKA LIETZAN** As more states legalize cannabis, the push to “deschedule” it from the Controlled Substances Act is gaining momentum. At the same time, the Food and Drug Administration (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, * Boeing International Professor and Founding Director of the Cannabis Law & Policy Project, University of Washington School of Law; J.D., Stanford Law School; M.A., Philosophy, Arizona State University; B.A., History, University of Massachusetts, Boston. The Author thanks Nephi Stella, Karen Boxx, Mowgli Holmes, Hilary Bricken, Daniel Shortt, and Jason Liu. ** Associate Professor of Law, University of Missouri School of Law; J.D., Duke Law School; M.A., History, University of California Los Angeles; B.A., History, University of North Carolina at Chapel Hill. The Author thanks Alissa Jijon and Patricia Zettler for comments and James Kopfensteiner (University of Missouri Class of 2018) for research assistance. 823 824 AMERICAN UNIVERSITY LAW REVIEW [Vol. 68:823 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, with the (probably exclusive) exception of certain hemp seed ingredients, 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 as well as those made from “hemp,” which has recently been descheduled under the 2018 Farm Bill. This Article describes in detail the surprising reach of the FDA and then outlines three modest, but legal, pathways forward for cannabis-based products in a world where cannabis has been descheduled. TABLE OF CONTENTS Introduction ................................................................................ 825 I. History and Overview of the Medical Cannabis Industry .... 836 II. Cannabis and “Marihuana” Under the Controlled Substances Act ............................................... 851 III. FDA Regulation Relevant to Medical Cannabis ................ 858 A. Medical Cannabis as “Drug” ...................................... 861 1. Regulation of medical cannabis under the FDA’s new drug authorities ................................. 861 2. Pathway to market under the new drug authorities ............................................................. 868 a. Chemistry, manufacturing, and controls ...... 871 b. Preclinical and clinical data .......................... 873 c. Route of administration ................................ 878 3. Approval and risk management .......................... 881 4. Consequences of using the new drug pathway .... 884 B. Medical Cannabis as (or in) Food ............................. 886 1. The drug exclusion rule: the 301(ll) problem . 887 2. Regulation as a food additive: the 402(a) problem ................................................................ 889 3. No claims could be made .................................... 891 4. Risk of the FDA invoking new drug authorities.. 894 C. Medical Cannabis in Dietary Supplements ............... 896 D. The Possibility of Non-Regulation, with Caveats ..... 902 E. Summary .................................................................... 906 IV. Three Pathways for Federal Legal Medical Cannabis Following Descheduling .................................. 907 2019]THE SURPRISING REACH OF FDA REGULATION OF CANNABIS 825 A. Medical Cannabis Providers Engaged in Purely Intrastate Operations ................................................ 907 B. Development of Pharmaceutical Products Containing Cannabis Constituents and Synthetic Cannabinoids ............................................................. 909 1. Synthetic cannabinoids ........................................ 909 2. Naturally derived CBD ......................................... 914 3. Current conventional drug research and development ......................................................... 920 C. Dietary Supplements ................................................. 923 Conclusion .................................................................................. 924 INTRODUCTION As a number of states have legalized cannabis—at least for state law purposes—a quasi-licit above-ground industry has emerged.1 This industry is enormous, with estimates into the billions of dollars of annual revenues.2 Along with this economic opportunity, one of the selling points of legalization for voters is that an illicit and often dangerous underground industry will be transformed into a safe and well-regulated one.3 Yet, “marihuana”—defined to include much of what is derived from the plant Cannabis sativa L.4—is still illegal under the federal Controlled Substances Act (CSA).5 “Marihuana” is expressly listed in Schedule I of the CSA,6 which means there were government findings, credible or not,7 that: (1) it “has a high potential for abuse”; (2) it “has 1. State Medical Marijuana Laws, NAT’L CONF. ST. LEGISLATURES (Oct. 17, 2018), http://www.ncsl.org/research/health/state-medical-marijuana-laws. 2. See, e.g., Thomas Pellechia, Legal Cannabis Industry Poised for Big Growth, in North America and Around the World, FORBES (Mar. 1, 2018), https://www.forbes.com/ sites/thomaspellechia/2018/03/01/double-digit-billions-puts-north-america-in-the-w orldwide-cannabis-market-lead (estimating North American industry revenues in 2017 at $9.2 billion). 3. See, e.g., 2013 Wash. Legis. Serv. Ch. 3 § 1 (West) (“The people intend to stop treating adult marijuana use as a crime and try a new approach that: . (3) Takes marijuana out of the hands of illegal drug organizations and brings it under a tightly regulated, state-licensed system similar to that for controlling hard alcohol.”). 4. 21 U.S.C. § 802(16) (2012). For further details on the origin and exact scope of this definition, see infra Part II. 5. 21 U.S.C. §§ 801–904. 6. See § 812(c), Schedule I(c)(10). 7. Am. Coll. Physicians, Supporting Research into the Therapeutic Role of Marijuana: An Addendum by the Health and Public Policy Committee 17 (2008) (“Considering the evidence available today about the potential therapeutic benefits 826 AMERICAN UNIVERSITY LAW REVIEW [Vol. 68:823 no currently accepted medical use in treatment in the United States”; and (3) “[t]here is a lack of accepted safety” for use of the drug or other substance under medical supervision.8 Tetrahydrocannabinols (THC) and cannabimimetic agents (compounds that mimic the effects of cannabinoids) are also listed in Schedule I.9 Manufacturing, distributing, dispensing, or possessing with the intent to do any of the foregoing is allowed under the CSA only for individuals who have been issued a so-called “Schedule I license.”10 These licenses are rare and hard to come by.11 The Department of Justice (DOJ), and more specifically, the Drug Enforcement Agency (DEA) generally enforce the CSA.12 Their actions with regard to illicit trade in drugs
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