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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 University of Missouri School of Law Scholarship Repository Faculty Publications Faculty Scholarship 2-2019 The Surprising Reach of FDA Regulation of Cannabis, Even after Descheduling Erika Lietzan Sean M. O'Connor Follow this and additional works at: https://scholarship.law.missouri.edu/facpubs Part of the Food and Drug Law Commons 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 containinga cannabinoidderived from cannabis-cannabidiol(CBD) for two rare seizure disorders. This would all seem to bode well for proponents offull federal legalization of medical cannabis. But some traditionalproviders 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. Traditionalproviders may believe that descheduling cannabis would free them to promote and distribute their products free of federal intervention, both locally and nationally. Otherproducers appearto assume that descheduling would facilitate a robust market in cannabis-based edibles and dietary supplements. In fact, neitherof these things is true. If cannabiswere descheduled, the FDA's complex and comprehensive regulatmy framework governingfoods, * 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 ofMassachusetts, Boston. The Author thanks Nephi Stella, Karen Boxx, Mowgli Holmes, Hilary Bricken, Daniel Shortt, andJason Liu. ** Associate Professor of Law, University of Missouri School of La;r, J.D., Duke Law School; M.A., History, University of CaliforniaLos Angeles; B.A., History, University of North Carolinaat Chapel Hill. The Author thanks AlissaJijon 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 approvalprocess, the cost of which will be prohibitivefor most current traditionalproviders. Likely also unexpected to some, there is no pathway forwardfor conventionalfoods containingcannabis constituents, with the (probably exclusive) exception of certain hemp seed ingredients, if thosefoods 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-includingthose 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 surprisingreach 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 (11) 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 20191 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. 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,' 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 CannabisIndustry Poisedfor 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.' Tetrahydrocannabinols (THC) and cannabimimetic agents (compounds that mimic the effects of cannabinoids) are also listed in Schedule I. 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." 0 These licenses are rare and hard to come by. The Department of Justice (DOJ), and more specifically, the Drug Enforcement Agency (DEA) generally enforce the CSA.1 2 Their actions with regard to illicit trade in drugs are usually perceived to be straightforward criminal prosecutions: "Miami Vice"- or "Cops"-style drug busts." There is a misperception that such enforcement is not available in states with recreational or medical marijuana laws, at least with regard to state law-compliant cannabis enterprises." The reality and risks associated with marijuana and its cannabinoids, ACP believes that it is time to review the evidence to determine whether reclassification is appropriate."). 8. § 812(b) (1) (A)-(C); see also infra Part II. 9. See§ 812(c); § 812(d) (2) (A). 10. §§ 821-823; Synthetic Drugs, Real Danger: Hearing Before the Subcomm. on Crime, Terrorism, Homeland Sec. & Investigations of the H. Comm. on the Judiciary, 114th Cong. 4 (2016) (statement of David Earl Nichols, Ph.D., Adjunct Professor of Chemical Biology and Medicinal Chemistry at the University of North Carolina at Chapel Hill, NC) ("Obtaining a Schedule I license is not a trivial matter .... [T]he investigator must have a strong personal belief that something useful will be discovered by their research that is of sufficient importance to justify the regulatory demands of a Schedule I license. To wit, a researcher must submit an application to the DEA that includes the investigator's scientific credentials, the description of the laboratory, a precise description of the work to be carried out, listing the specific substance to be used, and a calculation of how much
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